Registered office and advisors
Targovax ASA Lilleakerveien 2 C TARGOVAX ASA 0283 Oslo Norway (A public limited company incorporated under the laws of Norway)
Listing of the Company’s Shares on Oslo Axess
Offering and listing of up to 2,666,667 Offer Shares with Subscription Rights for Eligible Shareholders at a Subscription Price of NOK 7.50 per Offer Share
This prospectus (the "Prospectus") has been prepared in connection with the listing (the "Listing") of the shares (the "Shares") in
Targovax ASA (the "Company"), a public limited company incorporated under the laws of Norway (together with its consolidated subsidiaries,
"Targovax" or the "Group") on Oslo Axess ("Oslo Axess"), a stock exchange operated by Oslo Børs ASA, and the subsequent offering (the
"Subsequent Offering") of up to 2,666,667 new shares in the Company with a nominal value of NOK 0.10 each (the "Offer Shares") at a subscription price of NOK 7.50 per Offer Share (the "Subscription Price") as resolved by the extraordinary general meeting of the Company held Joint Global Coordinators and Joint Bookrunners on 6 July 2016. ABG Sundal Collier Norge ASA Arctic Securities AS DNB Markets Munkedamsveien 45E Vika Atrium Haakon VIIs gate 5 Dronning Eufemias gate 30 The shareholders of the Company as of 21 June 2016 (and being registered as such in the Norwegian Central Securities Depository (the "VPS") on 23 June 2016 pursuant to the two days’ settlement procedure in VPS (the "Record Date")), other than shareholders who were part of the pre- N-0250 Oslo N-0116 Oslo N-0021 Oslo sounding for or were allocated shares in the private placement of 14,685,000 new shares, each with a nominal value of NOK 0.10, (the "Private Norway Norway Norway Placement Shares") completed by the Company on 7 July 2016 (the "Private Placement") and shareholders in jurisdictions other than Norway where an offer to participate in the Subsequent Offering is not allowed or would require approval or registration of a prospectus or similar measures, (the "Eligible Shareholders") will be granted non-transferable subscription rights (the "Subscription Rights") that, subject to applicable law, will give preferential right to subscribe for, and be allocated, Offer Shares at the Subscription Price. Legal Adviser to the Company Legal Adviser to the Joint Global Coordinators and Joint Each Eligible Shareholder will be granted 0.42939 Subscription Rights for each existing Share registered as held by such Eligible Shareholders as Advokatfirmaet Thommessen AS Bookrunners of the Record Date, rounded down to the nearest whole Subscription Right. Each whole Subscription Right will give the right to subscribe for, and Haakon VII’s gate 10 Advokatfirmaet Wiersholm AS be allocated, one Offer Share, subject to applicable securities laws. Over-subscription and subscription without Subscription Rights will be N-0161 Oslo Dokkveien 1 permitted. Norway N-0250 Oslo Norway The subscription period in the Subsequent Offering will commence at 09:00 hours Central European Time ("CET") on 11 July 2016 and expire at 16:30 hours CET, on 8 August 2016 (the "Subscription Period").
Subscription Rights that are not used to subscribe for Offer Shares before the expiry of the Subscription Period will have no value and will lapse without compensation to the holder.
The Shares, including the Private Placement Shares, are, and the Offer Shares will be, registered in the Norwegian Central Securities Depository (the "VPS") in book-entry form. All Shares will rank in parity with one another and carry one vote per Share. Except where the context requires otherwise, references in this Prospectus to "Shares" will be deemed to include the existing Shares, including the Private Placement Shares, and the Offer Shares. Investing in the Shares involves a high degree of risk. Prospective investors should read the entire document and, in particular, consider Section 2 "Risk Factors" beginning on page 12 when considering an investment in the Company.
The Shares have not been, and will not be, registered under the U.S. Securities Act or with any securities regulatory authority of any state or other jurisdiction in the United States, and are being offered and sold: (i) in the United States only to QIBs as defined in Rule 144A or in other transactions exempt from registration requirements under the U.S. Securities Act; and (ii) outside the United States in compliance with Regulation S. The distribution of this Prospectus and the offer and sale of the Offer Shares in certain jurisdictions may be restricted by law. Persons in possession of this Prospectus are required to inform themselves about and to observe any such restrictions. See Section 17 "Selling and Transfer Restrictions".
The due date for the payment of the Offer Shares is expected to be on or about 12 August 2016. Delivery of the Offer Shares is expected to take place on or about 17 August 2016 through the facilities of the VPS.
Prior to the Listing, the Shares have not been publicly traded. The Company applied for the Shares (including the Private Placement Shares, but excluding the Offer Shares) to be admitted for trading and listing on Oslo Axess on 30 June 2016, and the board of directors of Oslo Stock Exchange approved the listing application of the Company on 5 July 2016, subject to certain conditions being met. All such conditions have been met as of the date of this Prospectus. Trading in the Shares (including the Private Placement Shares, but excluding the Offer Shares) on Oslo Axess is expected to commence on or about 8 July 2016, under the ticker code "TRVX".
Joint Global Coordinators and Joint Bookrunners ABG Sundal Collier Arctic Securities DNB Markets
The date of this Prospectus is 7 July 2016
www.kursiv.no Targovax ASA – Prospectus
IMPORTANT INFORMATION
This Prospectus has been prepared in connection with the Listing of the Shares on Oslo Axess (including the Private Placement Shares, but excluding the Offer Shares), and the Subsequent Offering and listing of the Offer Shares in the Company.
This Prospectus has been prepared to comply with the Norwegian Securities Trading Act of 29 June 2007 no. 75 (the "Norwegian Securities Trading Act") and related secondary legislation, including the Commission Regulation (EC) no. 809/2004 implementing Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 regarding information contained in prospectuses, as amended, and as implemented in Norway (the "EU Prospectus Directive"). This Prospectus has been prepared solely in the English language. The Financial Supervisory Authority of Norway (Nw.: Finanstilsynet) (the "Norwegian FSA") has reviewed and, on 7 July 2016, approved this Prospectus in accordance with Sections 7-7 and 7-8 of the Norwegian Securities Trading Act. The Norwegian FSA has not controlled or approved the accuracy or completeness of the information included in this Prospectus. The approval by the Norwegian FSA only relates to the information included in accordance with pre-defined disclosure requirements. The Norwegian FSA has not made any form of control or approval relating to corporate matters described in or referred to in this Prospectus.
For definitions of certain other terms used throughout this Prospectus, see Section 19 "Definitions and Glossary".
The Company has engaged ABG Sundal Collier Norge ASA ("ABG Sundal Collier"), Arctic Securities AS ("Arctic Securities") and DNB Markets, a part of DNB Bank ASA ("DNB Markets") as Joint Global Coordinators and Joint Bookrunners (the "Joint Bookrunners").
The information contained herein is current as at the date hereof and subject to change, completion and amendment without notice. In accordance with Section 7-15 of the Norwegian Securities Trading Act, significant new factors, material mistakes or inaccuracies relating to the information included in this Prospectus, which are capable of affecting the assessment by investors of the Offer Shares between the time of approval of this Prospectus by the Norwegian FSA and the Listing of the Offer Shares on Oslo Axess, will be included in a supplement to this Prospectus. Neither the publication nor distribution of this Prospectus, nor the sale of any Offer Share, shall under any circumstances imply that there has been no change in the Group’s affairs or that the information herein is correct as at any date subsequent to the date of this Prospectus.
No person is authorized to give information or to make any representation concerning the Group or in connection with the Listing, the Subsequent Offering or the sale of the Offer Shares other than as contained in this Prospectus. If any such information is given or made, it must not be relied upon as having been authorized by the Company or the Joint Bookrunners or by any of the affiliates, representatives, advisors or selling agents of any of the foregoing.
The distribution of this Prospectus and the offer and sale of the Offer Shares in certain jurisdictions may be restricted by law. This Prospectus does not constitute an offer of, or an invitation to purchase, any of the Offer Shares in any jurisdiction in which such offer or sale would be unlawful. Neither this Prospectus nor any advertisement or any other offering material may be distributed or published in any jurisdiction except under circumstances that will result in compliance with applicable laws and regulations. Persons in possession of this Prospectus are required to inform themselves about and to observe any such restrictions. In addition, the Shares are subject to restrictions on transferability and resale and may not be transferred or resold except as permitted under applicable securities laws and regulations. Investors should be aware that they may be required to bear the financial risks of this investment for an indefinite period of time. Any failure to comply with these restrictions may constitute a violation of applicable securities laws. See Section 17 "Selling and Transfer Restrictions".
This Prospectus and the terms and conditions of the Subsequent Offering as set out herein and any sale and purchase of Offer Shares hereunder shall be governed by and construed in accordance with Norwegian law. The courts of Norway, with Oslo as legal venue, shall have exclusive jurisdiction to settle any dispute which may arise out of or in connection with the Listing, Subsequent Offering or this Prospectus.
In making an investment decision, prospective investors must rely on their own examination, and analysis of, and enquiry into the Group and the terms of the Subsequent Offering, including the merits and risks involved. None of the Company or the Joint Bookrunners, or any of their respective representatives or advisers, is making any representation to any offeree or purchaser of the Shares regarding the legality of an investment in the Shares by such offeree or purchaser under the laws applicable to such offeree or purchaser. Each investor should consult with his or her own advisors as to the legal, tax, business, financial and related aspects of a purchase of the Shares.
All Sections of the Prospectus should be read in context with the information included in Section 4 "General Information".
NOTICE TO NEW HAMPSHIRE RESIDENTS
NEITHER THE FACT THAT A REGISTRATION STATEMENT OR AN APPLICATION FOR A LICENCE HAS BEEN FILED UNDER CHAPTER 421-B OF THE NEW HAMPSHIRE REVISED STATUTES WITH THE STATE OF NEW HAMPSHIRE NOR THE FACT THAT A SECURITY IS EFFECTIVELY REGISTERED OR A PERSON IS LICENCED IN THE STATE OF NEW HAMPSHIRE CONSTITUTES A FINDING BY THE SECRETARY OF STATE OF NEW HAMPSHIRE THAT ANY DOCUMENT FILED UNDER RSA 421-B IS TRUE, COMPLETE AND NOT MISLEADING. NEITHER ANY SUCH FACT NOR THE FACT THAT AN EXEMPTION OR EXCEPTION IS AVAILABLE FOR A SECURITY OR A TRANSACTION MEANS THAT THE SECRETARY OF STATE HAS PASSED IN ANY WAY UPON THE MERITS OR QUALIFICATIONS OF, OR RECOMMENDED OR GIVEN APPROVAL TO, ANY PERSON, SECURITY OR TRANSACTION. IT IS UNLAWFUL TO MAKE, OR CAUSE TO BE MADE, TO ANY PROSPECTIVE PURCHASER, CUSTOMER OR CLIENT ANY REPRESENTATION INCONSISTENT WITH THE PROVISIONS OF THIS PARAGRAPH.
NOTICE TO INVESTORS IN THE UNITED STATES Because of the following restrictions, prospective investors are advised to consult legal counsel prior to making any offer, resale, pledge or other transfer of the Shares. The Offer Shares have not been and will not be registered under the U.S. Securities Act or with any securities regulatory authority of any state or other jurisdiction in the United States and may not be offered, resold, pledged or otherwise transferred within the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and in compliance with any applicable state securities laws. All offers and sales in the United States will be made only to QIBs as defined in Rule 144A or in other transactions exempt from registration requirements under the U.S. Securities Act. All offers and sales outside the United States will be made in reliance on Regulation S. Prospective purchasers are hereby notified that sellers of Offer Shares may be relying on an exemption from the provisions of Section 5 of the U.S. Securities Act. See Section 17.2.1 "United States".
Targovax ASA – Prospectus
Any Shares offered or sold in the United States will be subject to certain transfer restrictions as set forth under Section 17.3 "Transfer restrictions".
The securities offered hereby have not been recommended by any United States federal or state securities commission or regulatory authority. Further, the foregoing authorities have not passed upon the merits of the Subsequent Offering or confirmed the accuracy or determined the adequacy of this Prospectus. Any representation to the contrary is a criminal offense under the laws of the United States.
In the United States, this Prospectus is being furnished on a confidential basis solely for the purposes of enabling a prospective investor to consider purchasing the particular securities described herein. The information contained in this Prospectus has been provided by the Company and other sources identified herein. Distribution of this Prospectus to any person other than the offeree specified by the Joint Bookrunners or their representatives, and those persons, if any, retained to advise such offeree with respect thereto, is unauthorized and any disclosure of its contents, without prior written consent of the Company, is prohibited. This Prospectus is personal to each offeree and does not constitute an offer to any other person or to the public generally to purchase Offer Shares or subscribe for or otherwise acquire any Shares.
NOTICE TO INVESTORS IN THE UNITED KINGDOM This Prospectus is only being distributed to and is only directed at (i) persons who are outside the United Kingdom (the "UK") or (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (iii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "Relevant Persons"). The Offer Shares are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such Shares will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.
NOTICE TO INVESTORS IN THE EEA In any member state of the European Economic Area (the "EEA") that has implemented the EU Prospectus Directive, other than Norway (each, a "Relevant Member State"), this communication is only addressed to and is only directed at qualified investors in participating member states of the European Union (each a "Member State") within the meaning of the EU Prospectus Directive. The Prospectus has been prepared on the basis that all offers of Offer Shares outside Norway will be made pursuant to an exemption under the EU Prospectus Directive from the requirement to produce a prospectus for offer of shares. Accordingly, any person making or intending to make any offer within the EEA of Offer Shares which is the subject of the Subsequent Offering contemplated in this Prospectus within any EEA member state (other than Norway) should only do so in circumstances in which no obligation arises for the Company or any of the Joint Bookrunners to publish a prospectus or a supplement to a prospectus under the EU Prospectus Directive for such offer. Neither the Company nor the Joint Bookrunners have authorized, nor do they authorize, the making of any offer of Shares through any financial intermediary, other than offers which constitute the final placement of Offer Shares contemplated in this Prospectus.
Each person in a Relevant Member State other than, in the case of paragraph (a), persons receiving offers contemplated in this Prospectus in Norway, who receives any communication in respect of, or who acquires any Offer Shares under, the offers contemplated in this Prospectus will be deemed to have represented, warranted and agreed to and with the Joint Bookrunners and the Company that: a) it is a qualified investor as defined in the EU Prospectus Directive; and b) in the case of any Offer Shares acquired by it as a financial intermediary, as that term is used in Article 3(2) of the Prospectus Directive, (i) such Offer Shares acquired by it in the Subsequent Offering have not been acquired on behalf of, nor have they been acquired with a view to their offer or resale to, persons in any Relevant Member State other than qualified investors, as that term is defined in the EU Prospectus Directive, or in circumstances in which the prior consent of the Joint Bookrunners has been given to the offer or resale; or (ii) where such Offer Shares have been acquired by it on behalf of persons in any Relevant Member State other than qualified investors, the offer of those Offer Shares to it is not treated under the EU Prospectus Directive as having been made to such persons.
For the purposes of this provision, the expression an "offer to the public" in relation to any of the Offer Shares in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase any of the Offer Shares, as the same may be varied in that Relevant Member State by any measure implementing the EU Prospectus Directive in that Relevant Member State, and the expression "EU Prospectus Directive" means Directive 2003/71/EC (and amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member State), and includes any relevant implementing measure in each Relevant Member State and the expression "2010 PD Amending Directive" means Directive 2010/73/EU.
See Section 17 "Selling and Transfer Restrictions" for certain other notices to investors.
ENFORCEMENT OF CIVIL LIABILITIES The Company is a public limited company incorporated under the laws of Norway. As a result, the rights of holders of the Company’s Shares will be governed by Norwegian law and the Company’s articles of association (the "Articles of Association"). The rights of shareholders under Norwegian law may differ from the rights of shareholders of companies incorporated in other jurisdictions. The members of the Company’s board of directors (the "Board Members" and the "Board of Directors", respectively) and the members of the Group’s management (the "Management") are not residents of the United States, and a substantial portion of the Company’s assets are located outside the United States. As a result, it may be difficult for investors in the United States to effect service of process on the Company or its Board Members and members of Management in the United States or to enforce in the United States judgments obtained in U.S. courts against the Company or those persons, including judgments based on the civil liability provisions of the securities laws of the United States or any state or territory within the United States. Uncertainty exists as to whether courts in Norway will enforce judgments obtained in other jurisdictions, including the United States, against the Company or its Board Members or members of Management under the securities laws of those jurisdictions or entertain actions in Norway against the Company or its Board Members or members of Management under the securities laws of other jurisdictions. In addition, awards of punitive damages in actions brought in the United States or elsewhere may not be enforceable in Norway. The United States and Norway do not currently have a treaty providing for reciprocal recognition and enforcement of judgments (other than arbitral awards) in civil and commercial matters.
Targovax ASA – Prospectus
AVAILABLE INFORMATION
The Company has agreed that, for so long as any of the Offer Shares are "restricted securities" within the meaning of Rule 144(a)(3) under the U.S. Securities Act, it will during any period in which it is neither subject to Sections 13 or 15(d) of the U.S. Securities Exchange Act of 1934, as amended (the "U.S. Exchange Act"), nor exempt from reporting pursuant to Rule 12g3-2(b) under the U.S. Exchange Act, provide to any holder or beneficial owners of Shares, or to any prospective purchaser designated by any such registered holder, upon the request of such holder, beneficial owner or prospective owner, the information required to be delivered pursuant to Rule 144A(d)(4) of the U.S. Securities Act.
Targovax ASA – Prospectus
TABLE OF CONTENTS
1 SUMMARY ...... 2 2 RISK FACTORS ...... 12 2.1 Risks related to the Group and the industry in which the Group operates ...... 12 2.2 Risks related to laws, regulations and litigation ...... 20 2.3 Risks related to financing and market risk ...... 21 2.4 Risks related to the Subsequent Offering, the Listing and the Shares ...... 22 3 RESPONSIBILITY FOR THE PROSPECTUS ...... 26 4 GENERAL INFORMATION ...... 27 4.1 Other important investor information ...... 27 4.2 Presentation of financial and other information ...... 27 4.3 Cautionary note regarding forward-looking statements ...... 28 5 REASONS FOR THE SUBSEQUENT OFFERING AND THE LISTING ...... 30 6 DIVIDENDS AND DIVIDEND POLICY ...... 31 6.1 Dividend policy ...... 31 6.2 Legal constraints on the distribution of dividends ...... 31 6.3 Manner of dividend payment ...... 31 7 INDUSTRY AND MARKET OVERVIEW ...... 32 7.1 The pharmaceutical industry ...... 32 7.2 The cancer market ...... 33 7.3 Immunotherapy and the immunotherapy market ...... 34 7.4 Drug development ...... 38 8 BUSINESS OF THE GROUP ...... 41 8.1 Overview ...... 41 8.2 Competitive strengths ...... 42 8.3 Strategy ...... 43 8.4 History and important events ...... 44 8.5 Overview of the Group’s science ...... 45 8.6 ONCOS-102’s and TG01’s differentiating features ...... 46 8.7 Competition ...... 54 8.8 Research and development, patents and licenses ...... 55 8.9 Material contracts ...... 62 8.10 Dependency on contracts, patents and licenses etc...... 62 8.11 Legal proceedings ...... 62 8.12 Information technology...... 63 8.13 Office leases ...... 63 9 CAPITALISATION AND INDEBTEDNESS ...... 64 9.1 Capitalization ...... 64 9.2 Net financial indebtedness...... 64 9.3 Working capital statement...... 65 9.4 Contingent and indirect indebtedness ...... 65 10 SELECTED FINANCIAL AND OTHER INFORMATION ...... 66 10.1 Introduction and basis for preparation ...... 66 10.2 Summary of accounting policies and principles ...... 66 10.3 Statement of profit or loss ...... 66 10.4 Statement of other comprehensive income ...... 66 10.5 Statement of financial position ...... 67 10.6 Statement of cash flow ...... 67 10.7 Statement of changes in equity ...... 68 10.8 Auditor ...... 69 10.9 Financial review ...... 70 10.10 Borrowings, contractual cash obligations and other commitments ...... 72 10.11 Investments ...... 72 Targovax ASA – Prospectus
10.12 Related party transactions ...... 72 10.13 No off-balance sheet arrangements ...... 72 10.14 Trend information ...... 72 10.15 Significant changes ...... 72 10.16 Recent developments ...... 73 11 UNAUDITED PRO FORMA FINANCIAL INFORMATION ...... 74 11.1 Introduction ...... 74 11.2 General information and purpose of the unaudited condensed pro forma financial information ...... 74 11.3 Basis of preparation ...... 74 11.4 Unaudited condensed pro forma financial information for the year ended 31 December 2015 ...... 75 12 BOARD OF DIRECTORS, MANAGEMENT, EMPLOYEES AND CORPORATE GOVERNANCE ...... 79 12.1 Introduction ...... 79 12.2 The Board of Directors ...... 79 12.3 Management ...... 82 12.4 Remuneration and benefits ...... 84 12.5 Share option programs ...... 85 12.6 Restricted stock unit program ...... 86 12.7 Benefits upon termination ...... 87 12.8 Pensions and retirement benefits ...... 87 12.9 Loans and guarantees ...... 87 12.10 Employees ...... 87 12.11 Nomination committee ...... 88 12.12 Remuneration committee ...... 88 12.13 Audit committee ...... 88 12.14 Corporate governance committee ...... 88 12.15 External scientific and clinical advisors ...... 88 12.16 Corporate governance ...... 89 12.17 Conflicts of interests etc...... 89 13 CORPORATE INFORMATION AND DESCRIPTION OF SHARE CAPITAL ...... 91 13.1 Company corporate information ...... 91 13.2 Legal structure ...... 91 13.3 Share capital and share capital history ...... 91 13.4 Admission to trading ...... 92 13.5 Ownership structure ...... 92 13.6 Authorization to increase the share capital and to issue Shares ...... 93 13.7 Other financial instruments ...... 93 13.8 Shareholder rights ...... 93 13.9 The Articles of Association and certain aspects of Norwegian law ...... 93 14 SECURITIES TRADING IN NORWAY ...... 97 14.1 Introduction ...... 97 14.2 Trading and settlement ...... 97 14.3 Information, control and surveillance ...... 97 14.4 The VPS and transfer of Shares ...... 98 14.5 Shareholder register – Norwegian law ...... 98 14.6 Foreign investment in shares listed in Norway ...... 98 14.7 Disclosure obligations ...... 98 14.8 Insider trading ...... 99 14.9 Mandatory offer requirement ...... 99 14.10 Compulsory acquisition ...... 99 14.11 Foreign exchange controls ...... 100 15 TAXATION ...... 101 15.1 Norwegian taxation ...... 101 16 THE COMPLETED PRIVATE PLACEMENT AND THE SUBSEQUENT OFFERING ...... 104 16.1 The Private Placement ...... 104 Targovax ASA – Prospectus
16.2 The Subsequent Offering ...... 105 16.3 Dilution ...... 111 16.4 Expenses of the Private Placement, the Subsequent Offering and the Listing ...... 112 16.5 Lock-up ...... 112 16.6 Disclosure regarding subscription of shares by the members of the Management and the Board of Directors outside the Subsequent Offering ...... 113 16.7 Interest of natural and legal persons involved in the Subsequent Offering ...... 113 16.8 Participation of major existing shareholders and members of the Management, supervisory and administrative bodies in the Subsequent Offering ...... 113 16.9 Publication of information in respect of the Subsequent Offering ...... 114 16.10 Governing law and jurisdiction ...... 114 17 SELLING AND TRANSFER RESTRICTIONS ...... 115 17.1 General ...... 115 17.2 Selling restrictions ...... 116 17.3 Transfer restrictions ...... 118 18 ADDITIONAL INFORMATION ...... 121 18.1 Auditor and advisors ...... 121 18.2 Documents on display ...... 121 19 DEFINITIONS AND GLOSSARY ...... 122
APPENDICES
APPENDIX A ARTICLES OF ASSOCIATION ...... A1
APPENDIX B FINANCIAL STATEMENTS FOR TARGOVAX ASA FOR THE YEAR ENDED 31 DECEMBER 2015, WITH COMPARABLE FIGURES FOR THE YEAR ENDED 31 DECEMBER 2014 ...... B1
APPENDIX C INTERIM FINANCIAL STATEMENTS FOR TARGOVAX ASA FOR THE THREE MONTH PERIOD ENDED 31 MARCH 2016 ...... C1
APPENDIX D INDEPENDENT PRACTITIONER’S ASSURANCE REPORT ON THE COMPILATION OF UNAUDITED PRO FORMA FINANCIAL INFORMATION ...... D1
APPENDIX E SUBSCRIPTION FORM...... E1 1 SUMMARY Summaries are made up of disclosure requirements known as "Elements". These Elements are numbered in Sections A – E (A.1 – E.7) below. This summary contains all the Elements required to be included in a summary for this type of securities and the issuer. Because some Elements are not required to be addressed, there may be gaps in the numbering sequence of the Elements. Even though an Element may be required to be inserted in the summary because of the type of securities and issuer, it is possible that no relevant information can be given regarding the Element. In this case a short description of the Element is included in the summary with the mention of "not applicable".
Section A – Introduction and Warnings
A.1 Warning This summary should be read as introduction to the Prospectus; any decision to invest in the securities should be based on consideration of the Prospectus as a whole by the investor; where a claim relating to the information contained in the Prospectus is brought before a court, the plaintiff investor might, under the national legislation of the Member States, have to bear the costs of translating the Prospectus before the legal proceedings are initiated; and civil liability attaches only to those persons who have tabled the summary including any translation thereof, but only if the summary is misleading, inaccurate or inconsistent when read together with the other parts of the Prospectus or it does not provide, when read together with the other parts of the Prospectus, key information in order to aid investors when considering whether to invest in such securities.
A.2 Warning Not applicable. No consent is granted by the Company for the use of the Prospectus for subsequent resale or final placement of the Shares.
Section B - Issuer
B.1 Legal and commercial name Targovax ASA.
B.2 Domicile and legal form, The Company is a public limited company organized and existing under the legislation and country of laws of Norway pursuant to the Norwegian Public Limited Companies Act. incorporation The Company was incorporated in Norway on 8 October 2010, and the Company’s registration number in the Norwegian Register of Business Enterprises is 996 162 095.
B.3 Current operations, Targovax is a clinical stage immuno-oncology company developing principal activities and targeted immunotherapy treatments for cancer patients. Targovax has a markets broad and diversified immune therapy portfolio and aim to become a leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology. The Company’s vision is to "arm patient’s immune system to fight cancer" by extending and transforming the lives of cancer patients with first-in- class specific therapeutic cancer vaccines. The Group’s pipeline includes a number of product candidates aimed at different cancer types like pancreas, melanoma, mesothelioma, colorectal cancer and ovarian cancer. Each vaccine is designed to harness the patient’s own immune system to fight the cancer while also delivering a favorable safety and tolerability profile. Targovax head office is in Oslo and it has an R&D subsidiary in Finland. On 2 July 2015, the Norwegian part of Targovax acquired all the shares in Oncos, then a clinical-stage biotechnology company based in Helsinki, which also is focusing on the design and development of targeted cancer immunotherapy (the "Combination"). Following the Combination, Oncos is a wholly-owned subsidiary of the Company and has been renamed Targovax Oy. Targovax is targeting two complementary approaches to cancer
2 immunotherapy: (i) a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of patients with pancreatic cancers, 50% of colorectal cancer and 20-30% of all cancers; and (ii) a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors, potentially reinstating the immune system's capacity to recognize and attack cancer cells. Prior to the Combination, Targovax was solely focusing on immunotherapy for patients with RAS-mutated cancer. RAS mutations are key drivers of cancer progression which are found in 20 - 30% of all cancers . There are few treatment options available for patients with RAS mutations, and the options available have limited efficacy, which highlights the significant medical need for these patients. The Group’s technology is specific and works by educating the patient’s own immune system to recognize and kill cancer cells. Studies to date have shown that the Group’s lead vaccine for RAS-mutated cancer, TG01, induces immune responses in cancer patients, which may translate clinically to a survival benefit, and has an acceptable safety and tolerability profile with few side effects. In an ongoing clinical trial it has also been demonstrated that TG01 can effectively induce immune response when used in combination with gemcitabine chemotherapy. Interim 1-year survival data has also shown encouraging results, albeit in a small number of patients. Up to six months of combination therapy was generally well tolerated with few side effects. TG01-related anaphylactic reactions were seen at two occasions in connection with TG01 booster treatments post combination therapy. Therefore, Targovax has added a third cohort to the study with a reduced number of TG01-doses. The preliminary results from this cohort with a reduced number of TG01 administrations show that immune response is induced at the similar level as with the earlier vaccination schedule which had a higher number of administrations. The Group's other lead compound, ONCOS-102, has successfully completed Phase I clinical studies where it has shown systemic tumor specific immune activation and indications of potential clinical anti-tumor efficacy in patients with different solid tumors. ONCOS-102 will enter further clinical studies in the near future for the treatment of solid tumors such as melanoma, malignant pleural mesothelioma and ovarian cancer. The Group is currently conducting one Phase I/II clinical trial with TG01 in resected pancreatic cancer and is initiating several clinical trials in multiple cancer types with high medical need during 2016 with TG02 and ONCOS- 102. Targovax has Orphan Drug Designation with the FDA and EMA for TG01 in pancreatic cancer and ONCOS-102 in malignant plural mesothelioma, ovarian cancer and soft tissue sarcoma. Soft tissue sarcoma is an indication currently not being pursued by Targovax. While the research and development strategy is designed in-house, the Group collaborates with academic institutions to execute its development strategy. Similarly, the Group uses external contract manufacturing organizations ("CMOs") to produce its compounds. The Group has employed experienced personnel that are capable of directing work that is performed by the CMOs. This approach to product development allows the Group to easily change research directions and efforts when needed and to quickly bring in new technologies and expertise when necessary. The Group remains committed to the discovery, development and delivery to patients of its innovative therapeutic cancer treatments. The Group’s technology can be combined with other treatment
3
approaches, including surgery, radiation, chemotherapy or other immune therapies.
B.4a Significant recent trends The Company has not experienced any changes or trends that are significant to the Company between 31 March 2016 and the date of this Prospectus, nor is the Company aware of such changes or trends that may or are expected to be significant to the Company for the current financial year.
B.5 Description of the Group The Company is the parent company in the Group. The Group’s operations are carried out by the Company and its wholly-owned subsidiaries Targovax Oy and Targovax AG. Targovax Oy is incorporated in Finland and Targovax AG is incorporated in Switzerland.
B.6 Interests in the Company As of 28 June 2016, the Company had 211 shareholders. The Company’s and voting rights 20 largest shareholders as of the same date are shown in the table below.
Shareholders Number of Shares1 Percent
Handelsbanken Stockholm Clients AC2 ...... 8,488,918 31.55% Radiumhospitalets Forskningsstift...... 3,410,589 12.68% Datum Invest AS ...... 2,462,000 9.15% Arctic Funds PLC ...... 907,000 3.37% Timmuno AS ...... 724,650 2.69% Prieta AS...... 720,000 2.68% Portia AS ...... 599,561 2.23% Danske Bank A/S ...... 587,971 2.19% Nordnet Bank AB ...... 569,022 2.11% Verdipapirfondet KLP Aksjenorge ...... 460,000 1.71% Eltek Holding AS ...... 442,000 1.64% Statoil Pensjon ...... 433,716 1.61% Storebrand Vekst ...... 426,000 1.58% Pactum AS ...... 400,000 1.49% Birk Venture AS ...... 378,980 1.41% OP-Europe Equity Fund ...... 357,869 1.33% Tobech Invest AS ...... 286,449 1.06% Viola AS ...... 280,000 1.04% Kommunal Landspensjonskasse ...... 270,000 1.00% Verdipapirfondet DNB Grønt Norden ...... 250,919 0.93% Others ...... 4,449,723 16.54% Total ...... 26,905,367 100% 1 Excluding the Private Placement Shares which were issued on 7 July 2016 2 Nominee account of Healthcap V LP / OFP V Advisor AB
There are no differences in voting rights between the shareholders. Shareholdings owning 5% or more of the Shares will, following the Listing, have an interest in the Company’s share capital, which is notified pursuant to the Norwegian Securities Trading Act. The Company is not aware of any arrangements the operation of which may at a subsequent date result in a change of control of the Company. As of the date of this Prospectus, no shareholder, other than HealthCap V L.P. (approximately 31%), The Norwegian Radium Hospital Research Foundation (approximately 13%) and Datum Invest AS (approximately 9%) holds more than 5% or more of the issued Shares.
B.7 Selected historical key The following selected financial information has been extracted from the financial information Company’s unaudited condensed interim financial statements as of and for the three month period ended 31 March 2016, with comparable figures as of and for the three month period ended 31 March 2016 (the Interim Financial Statements) and the Company’s audited financial statements as of and for the year ended 31 December 2015, with comparable figures as of and for the year ended 31 December 2014 (the Financial Statements). The Financial Statements have been prepared in accordance with IFRS, while the Interim Financial Statements have been prepared in accordance with IAS 34. The selected financial information included herein should be read in 4
connection with, and is qualified in its entirety by reference to the Financial Information included in Appendix B and Appendix C of this Prospectus.
Three months ended Year ended In TNOK 31 March 31 December
2015 2014
(unaudited) (unaudited) 2015 2014 Selected statement of profit or loss and other comprehensive income information Total revenue ...... - - 146 72 Total operating expenses ...... -30,976 -6,720 -89,762 -17,642 Operating profit/loss (-) ...... -30,976 -6,720 -89,616 -17,570 Net financial items ...... -555 -31 -269 -77 Total comprehensive loss for the period ...... -31,531 -6,751 -89,885 -17,646 Loss for the period ...... -31,457 -6,751 -91,816 -17,646 Exchange differences arising from the translation of foreign operations ...... -6,735 0 - -
As of As of
31 March 31 December 2015
(unaudited) 2015 2014 Selected statement of financial position information Total non-current assets ...... 351,969 359,070 150 Total current assets ...... 156,226 185,455 67,213 Total assets ...... 508,196 545,114 67,362 Total equity ...... 389,226 422,873 60,673 Total non-current liabilities ...... 95,426 96,821 - Total current liabilities ...... 23,544 25,420 6,689 Total equity and liabilities ...... 508,196 545,114 67,362
Three months ended Year ended 31 December 31 March 2015
(unaudited) 2015 2014 Selected statement of cash flow information Cash flows from operating activities ...... -32,958 -80,890 -13,835 Cash flows from investing activities ...... -19 -1,155 -160 Cash flows from financing activities ...... -213 191,204 68,178 Total cash flow ...... -33,190 111,468 54,182 Cash and cash equivalents at end of period...... 140,885 173,898 62,552
B.8 Selected key pro forma The following table sets out certain selected key unaudited pro forma financial information financial information for the Group for the year ended 31 December 2015. On 2 July 2015, the Company acquired all the shares in Oncos. The transaction was structured as a share for share exchange whereby the Company issued 9,429,404 new shares to the shareholders of Oncos as consideration for the shares in Oncos (the Combination). On 9 July 2015, the Company completed a private placement with gross proceeds of NOK 200 million (the 2015 Private Placement). The Combination and the 2015 Private Placement were mutually conditional upon each other. The unaudited Pro Forma Financial Information set out below has been prepared by the Company to show how the Combination and the
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2015 Private Placement might have affected the Company’s income statement information for the year ended 31 December 2015 as if the Company had acquired Oncos and completed the 2015 Private Placement on 1 January 2015.
Consolidated Pro forma Unadjusted information IFRS adjustment Pro forma information of of Oncos adjustments for the financial
the Company (unaudited, of Oncos Transactions information
(audited, IFRS) FGAAP) (unaudited) (unaudited) (unaudited) Year ended 31 December 2015 TNOK TNOK TNOK TNOK TNOK
Total revenue ...... 146.0 146.0 Total operating expenses ...... -89,762.0 -8,575,1 203.0 -98,134.1 Operation profit/loss (-) ...... -89,616.0 -8,575.1 203.0 -97,988.1 Net financial items ...... -269.5 -2,376.4 -4,119.3 5,293.8 -1,471.4 Loss before income tax ...... -89,885.5 -10,951.5 -3,916.3 5,293.8 -99,459.4 Loss for the period ...... -91,815.5 -10,951.5 -3,916.3 5,293.8 -101,389.4
B.9 Profit forecast or estimate Not applicable. No profit forecast or estimate are made.
B.10 Audit report qualifications Not applicable. There are no qualifications in the audit reports.
B.11 Insufficient working capital Not applicable. The Company is of the opinion that the working capital available to the Company is sufficient for the Company’s present requirements, for the period covering at least 12 months from the date of this Prospectus.
Section C - Securities
C.1 Type and class of securities The Company has one class of Shares in issue and all Shares in that class admitted to trading and provide equal rights in the Company. Each of the Shares carries one vote. identification number The Shares have been created under the Norwegian Public Limited Companies Act and are registered in book-entry form with the VPS under ISIN NO0010689326.
C.2 Currency of issue The Shares are issued in NOK.
C.3 Number of shares in issue As of the date of this Prospectus, the Company’s share capital is NOK and nominal value 4,159,036.70 divided into NOK 41,590,367 Shares, with each Share having a nominal value of NOK 0.10.
C.4 Rights attaching to the The Company has one class of Shares in issue, and in accordance with the securities Norwegian Public Limited Companies Act, all Shares in that class provide equal rights in the Company. Each of the Shares carries one vote.
C.5 Restrictions on transfer The Articles of Association do not provide for any restrictions on the transfer of Shares, or a right of first refusal for the Company. Share transfers are not subject to approval by the Board of Directors.
C.6 Admission to trading The Company has applied for admission to trading of its Shares (on Oslo Axess and the board of directors of Oslo Stock Exchange approved the listing application of the Company on 5 July 2016, subject to certain condition being met. All such conditions are fulfilled as of the date of this Prospectus. The Company currently expects commencement of trading in the Shares (excluding the Offer Shares) on Oslo Axess, on 8 July 2016. The Company has not applied for admission to trading of the Shares on any other stock exchange or regulated market.
C.7 Dividend policy The Company has not paid any dividends for the years ended 31 December 2015 and 2014 or previous years. The Group is focusing on the development of pharmaceutical products and does not anticipate paying any cash dividend until sustainable profitability is achieved.
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Section D - Risks
D.1 Key risks specific to the Key risks related to the Company and the industry in which the Company Company or its industry operates The Group has incurred significant operating losses since inception and the Group expects to incur substantial and increasing losses in the foreseeable future Clinical development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. The Group has limited clinical data and its clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates, which would prevent or delay regulatory approval and commercialization The Group’s business is highly dependent on the success of its lead product candidates, TG01 and ONCOS-102, which together with the Group’s other product candidates will require significant additional clinical testing before the Group can seek regulatory approval and potentially commercialize products Any significant delay or failure in the conduct of present or future clinical studies may adversely impact the Group’s ability to obtain regulatory approval for and commercialize its current and future product candidates The carrying amount of the Company's patented technology constitutes a significant portion of the total assets in the Company's consolidated financial statements and any impairment loss recognized will have a material adverse effect on the Group's financial position The Group’s product candidates may cause undesirable side effects that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, if approved, and result in other significant negative consequences The Group has obtained orphan drug designations for TG01 in pancreatic cancer and ONCOS-102 in malignant plural mesothelioma and ovarian cancer, but the Group may be unable to maintain the benefits associated with orphan drug designation The success of the Group is dependent on its ability to obtain acceptable prices and reimbursements on its product candidates The Group relies, and will continue to rely, upon third-parties for clinical trials, product development and manufacturing The Group is subject to a number of manufacturing and supply chain risks, any of which could substantially increase its costs and limit and/or delay the supply of its product candidates The Group may not be able to enter into partnership agreements The Group faces an inherent business risk of liability claims in the event that the use or misuse of the compounds results in personal injury or death The success, competitive position and future revenues will depend in part on the Group’s ability to protect its intellectual property and know-how Patent applications filed by others could limit the Group’s freedom to operate The Group may not be able to maintain sufficient insurance to cover all risks related to its operations The Group faces significant competition from other biotechnology and pharmaceutical companies The Group may lose market exclusivity and face competition from low-cost generic products
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The Group may not be able to successfully implement its clinical, regulatory and commercial strategy The Group is highly dependent on its key personnel, and if the Group is not successful in attracting and retaining highly qualified personnel, the Group will not be able to successfully implement its business plan The Group’s business involves use of hazardous materials, chemicals and biological compounds and is thus exposed to environmental risks Key risks related to laws, regulations and litigation The Group may be subject to litigation and disputes that could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects The Group is exposed to risks related to regulatory processes and changes in regulatory environment Even if the Group obtains regulatory approval for a product candidate, the Group’s products will remain subject to regulatory scrutiny Key risks related to the financing and market risk The Group will require additional financing to achieve its goals, and a failure to obtain this necessary capital when needed could force the Group to delay, limit, reduce or terminate its product development or commercialization efforts Present or future debt levels could limit the Group’s flexibility to obtain additional financing and pursue other business opportunities Interest rate fluctuations could in the future materially and adversely affect the Group’s business, financial condition, results of operations, cash flows, time to market and prospects Fluctuations in exchange rates could affect the Group’s cash flow and financial condition
D.3 Key risks specific to the Key risks related to the Subsequent Offering, the Listing and the Shares securities Eligible Shareholders who do not participate in the Subsequent Offering may experience dilution in their shareholding. If the Subsequent Offering is withdrawn, the Subscription Rights will no longer be of value. The Company will incur increased costs as a result of the Listing and being a publicly traded company The market value of the Shares may fluctuate significantly, which could cause investors to lose a significant part of their investment There is no prior regulated market for the Shares, and an active trading market may not develop The Company’s ability to pay dividends is dependent on the availability of distributable reserves and the Company may be unwilling to pay any dividends in the future regardless of availability of distributable reserves Future sales, or the possibility for future sales of substantial numbers of Shares may affect the Shares’ market price Future issuances of Shares or other securities may dilute the holdings of shareholders and could materially affect the price of the Shares Pre-emptive rights to secure and pay for Shares in any additional issuance may be unavailable to U.S. or other shareholders Investors may be unable to exercise their voting rights for Shares registered in a nominee account Investors may be unable to recover losses in civil proceedings in jurisdictions other than Norway
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Norwegian law may limit shareholders’ ability to bring an action against the Company The transfer of Shares is subject to restrictions under the securities laws of the United States and other jurisdictions Exchange rate fluctuations could adversely affect the value of the Shares and any dividends paid on the Shares for an investor whose principal currency is not NOK
Section E - Offer
E.1 Net proceeds and estimated The transaction costs for the Company related to the Private Placement, expenses the Listing and the Subsequent Offering is estimated to be approximately NOK 10 million (including VAT) based on the assumption that the maximum number of Offer Shares are applied for and allocated in the Subsequent Offering. Based on the same assumption, the net proceeds of the Private Placement and Subsequent Offering will be approximately NOK 120 million.
E.2a Reasons for the Offering The Company has applied for the Listing of all of its Shares on Oslo Axess. and use of proceeds The Company believes that the completed Private Placement, the Listing and the Subsequent Offering will: diversify and increase the shareholder base; further improve its ability to attract and retain key management and employees; strengthen the working capital of the Company; provide a regulated market for the Shares and give the Company improved access to the capital markets for potential future funding; and strengthen the Group’s profile with investors and business partners. The expected net proceeds from the Private Placement, the Subsequent Offering and the existing cash is expected to finance the Group to the end of 2017, which is beyond six clinical data read-outs. The Company currently anticipates that it will use the net proceeds from the Private Placement and the Subsequent Offering as follows: Finance a clinical trial of ONCOS-102 in mesothelioma (in combination with standard of care chemotherapy) to first data read-outs in 2017; Finance a clinical trial ONCOS-102 in melanoma (in sequence with a check point inhibitor) to first data read-outs in 2017; Finance a clinical trial of TG02 in colorectal cancer) to first data read-outs in 2017; Finance Targovax’s share of clinical 2016-2017 trial costs related to planned collaboration trials with Ludwig Cancer Research / Cancer Research Institute (potentially in several indications and potentially including ovarian) as well as with Sotio (in prostate); Finance the follow-up of the fully recruited trial of TG01 in resected pancreatic cancer; and Finance CMC and manufacturing activities to related to these trials. It is expected that 60-65 % of R&D costs in 2016-17 will be devoted to the Oncos platform. At the date of the Prospectus, the Company cannot predict all of the specific uses for the net proceeds, or the amounts that will be actually spent on the uses described above. The exact amounts and the timing of the actual use of the net proceeds will depend on numerous factors,
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amongst others progress, costs and results of the Group’s preclinical and clinical development program as other developments in the field of cancer treatment, and regulatory results and developments.
E.3 Terms and conditions of the The Subsequent Offering consists of an offer by the Company to issue up Offering to 2,666,667 Offer Shares at a subscription price of NOK 7.50 per Offer Share, being equal to the subscription price in the Private Placement. Subject to all Offer Shares being issued, the Subsequent Offering will result in approximately NOK 20 million in gross proceeds to the Company. Eligible Shareholders, being shareholders of the Company as of 21 June 2016 (as registered in the VPS on 23 June 2016 pursuant to the two days’ settlement procedure in VPS (the Record Date), other than shareholders who were part of the pre-sounding for or were allocated shares in the Private Placement completed by the Company on 7 July 2016 and shareholders in jurisdictions other than Norway where an offer to participate in the Subsequent Offering is not allowed or would require approval or registration of a prospectus or similar measures, will be granted non-transferable Subscription Rights that, subject to applicable law, will give preferential right to subscribe for, and be allocated, Offer Shares at the Subscription Price. Oversubscription and subscription without subscription rights is permitted. The Eligible Shareholders will be granted 0.42939 Subscription Rights for each existing Share registered as held by such Eligible Shareholders as of the Record Date, rounded down to nearest whole Subscription Right. Each whole Subscription Right provides a preferential right to subscribe for, and be allocated, one Offer Share at the Subscription Price, subject to applicable securities law. The Subscription Rights will be distributed free of charge. The Subscription Rights are non-transferable and will accordingly not be listed on any regulated market place. The Subscription Period will commence on 11 July 2016 and end on 8 August 2016 at 16:30 hours (CET). The Subscription Rights must be used to subscribe for Offer Shares before the end of the Subscription Period (i.e., 8 August 2016 at 16:30 hours (CET)). Subscription Rights which are not exercised before 8 August 2016 at 16:30 hours (CET) will have no value and will lapse without compensation to the holder. The payment of the Offer Shares allocated to a subscriber falls due on or about 12 August 2016. The delivery of the Offer Shares allocated to such subscriber in the Subsequent Offering is expected to take place on or about 17 August 2016.
E.4 Material and conflicting The Joint Bookrunners or their affiliates have provided from time to time, interests and may provide in the future, investment and commercial banking services to the Company and its affiliates in the ordinary course of business, for which they may have received and may continue to receive customary fees and commissions and may come to have interests that may not be aligned or could potentially conflict with the interests of the Company and investors in the Company. The Joint Bookrunners do not intend to disclose the extent of any such investments or transactions otherwise than in accordance with any legal or regulatory obligation to do so.
The Joint Bookrunners will receive a management fee in connection with the Private Placement and the Subsequent Offering and, as such, have an interest in the Private Placement and the Subsequent Offering.
E.5 Selling shareholders and There are no selling shareholders in the Offering. lock-up agreements The Company, the members of the Board of Directors and the Management and three major shareholders in the Company (HealthCap V L.P., The Norwegian Radium Hospital Research Foundation and Prieta AS) have entered into customary lock up undertakings with the Joint 10
Bookrunners in connection with the completion of the Private Placement. The lock up undertakings will be effective for a period of 12 months following completion of the Private Placement for the Company and the members of the Board of Directors and the Management, and for a period of six months for the major shareholders.
E.6 Dilution resulting from the The percentage of immediate dilution resulting from the Private Placement Offering for the Company’s shareholders who did not participate in the Private Placement is approximately 35%. The percentage of immediate dilution resulting from the Subsequent Offering, based on an issuance of 2,666,667 Offer Shares under the Subsequent Offering, for the existing shareholders who do not participate in the Subsequent Offering is approximately 6%.
E.7 Estimated expenses Not applicable. No expenses or taxes will be charged by the Company or charged to investor the Joint Bookrunners to the applicants in the Subsequent Offering.
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2 RISK FACTORS An investment in the Shares involves inherent risk. Before making an investment decision with respect to the Shares, investors should carefully consider the risk factors and all information contained in this Prospectus, including the Financial Information and related notes. The risks and uncertainties described in this Section 2 are the principal known risks and uncertainties faced by the Group as of the date hereof that the Company believes are the material risks relevant to an investment in the Shares. An investment in the Shares is suitable only for investors who understand the risks associated with this type of investment and who can afford to lose all or part of their investment. The absence of negative past experience associated with a given risk factor does not mean that the risks and uncertainties described herein should not be considered prior to making an investment decision in respect of the Shares. If any of the following risks were to materialize, individually or together with other circumstances, they could have a material and adverse effect on the Group and/or its business, financial condition, results of operations, cash flows, time to market and/or prospects, which could cause a decline in the value and trading price of the Shares, resulting in the loss of all or part of an investment in the same.
The order in which the risks are presented does not reflect the likelihood of their occurrence or the magnitude of their potential impact on the Group’s business, financial condition, results of operations, cash flows, time to market and/or prospects. The risks mentioned herein could materialize individually or cumulatively. The information in this Section 2 is as of the date of this Prospectus.
2.1 Risks related to the Group and the industry in which the Group operates The Group has incurred significant operating losses since inception and the Group expects to incur substantial and increasing losses in the foreseeable future
The Group is a clinical-stage biopharmaceutical group of companies with a limited operating history. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable.
The Group has financed its operations primarily through the sale of equity securities, convertible debt and grants and loans from the Finnish Funding Agency for Technology and Innovation ("Tekes"). Since its inception, most of the Group’s resources have been dedicated to the preclinical and clinical development of its product candidates. The size of the Group’s future losses will depend, in part, on the Group’s future expenses and its ability to generate revenue, if any. The Group has no products approved for commercial sale and has not generated any revenue from product sales to date, and it continue to incur significant research and development and other expenses related to its ongoing operations. As a result, the Group is not profitable and has incurred losses in each period since inception. Based on the unaudited condensed Pro Forma Financial Information (as defined below), the Group had a loss of NOK 79,6 million for the financial year 2015. The Group expects to continue to incur significant losses for the foreseeable future, and it expects these losses to increase as it continues its research and development of, and seek regulatory approvals for, its product candidates.
To become and remain profitable, the Group must succeed in developing and, eventually, commercializing products that generate revenues. This will require the Group to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of the Group’s products, discovering additional product candidates, obtaining regulatory approval for these product candidates and marketing and selling any products for which the Group may obtain regulatory approval. The Group may never succeed in these activities and, even if it does, may never generate revenue that is significant enough to achieve profitability. Should any of these risks materialize, it could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
Clinical development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. The Group has limited clinical data and its clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates, which would prevent or delay regulatory approval and commercialization
Before obtaining regulatory approvals for the commercial sale of the Group’s product candidates, the Group must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that its product candidates are both safe and effective for use in each target indication. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Drug development involves moving drug candidates through research and extensive testing of activity and side effects in preclinical models before authorization is given for further testing in humans in the clinical stage. The clinical stage is divided into three consecutive Phases (I, II and III) with the aim to reveal the safety and efficacy of a drug candidate before an application for marketing authorization can be 12
filed with the relevant health authorities. The Group’s lead product candidates, TG01 and ONCOS-102, are currently in Phase II and Phase I of the clinical stage, respectively. Failure can occur at any time during the development. Each individual development step is associated with the risk of failure. As a result, an early stage drug candidate carries a considerable higher risk of failure than a later stage candidate. Moreover, the commencement and completion of clinical trials may be delayed by several factors, including but not limited to unforeseen safety issues, issues related to determination of dose, lack of effectiveness during clinical trials, slower than expected patient enrolment in clinical studies, unforeseen requirements from the regulatory agencies relating to clinical studies, inability or unwillingness of medical investigators to follow the proposed clinical protocols and termination of license agreements necessary to complete trials. On average, five out of 5,000 drugs make it through the preclinical phase, and historically only one out of these five is approved by the U.S. Food and Drug Administration (the "FDA") for marketing1. Moreover, only 2 of 10 marketed drugs return revenues that match or exceed R&D costs2. It takes on average 12 years to develop a drug2.
The Group has limited clinical data and the results of preclinical studies and early clinical trials of the Group’s product candidates may not be predictive of the results of later-stage clinical trials. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. The Group cannot be certain that it will not face similar setbacks. Most product candidates that commence clinical trials are never approved as commercial products. For a variety of reasons, most attempts by other companies to develop peptide based cancer vaccines in the past have not been successful and have not received marketing approval. Should the Group’s clinical studies fail to demonstrate adequately the safety and efficacy of one or more of its product candidates it could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group’s business is highly dependent on the success of its lead product candidates, TG01 and ONCOS- 102, which together with the Group’s other product candidates will require significant additional clinical testing before the Group can seek regulatory approval and potentially commercialize products
The Group does not have any products that have gained regulatory approval. Its business and future success depend on its ability to obtain regulatory approval of, and then successfully commercialize, its lead product candidate, TG01 and ONCOS-102. These two, as well as the Group’s other product candidates, are in the early stages of development. The Group’s ability to develop, obtain regulatory approval for, and successfully commercialize TG01 and ONCOS-102 effectively will depend on several factors, including but not limited to the following:
• successful completion of the clinical trials;
• receipt of marketing approvals;
• establishing commercial manufacturing and supply arrangements;
• establishing a commercial infrastructure;
• acceptance of the product by patients, the medical community and third-party payers;
• establishing fair market share while competing with other therapies;
• successfully executing the Group’s pricing and reimbursement strategy;
• a continued acceptable safety and adverse event profile of the product following regulatory approval; and
• qualifying for, identifying, registering, maintaining, enforcing and defending intellectual property rights and claims covering the product.
All of the Group’s product candidates, including TG01 and ONCOS-102, will require additional clinical and nonclinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient
1 http://www.medicinenet.com/script/main/art.asp?articlekey=9877 (accessed 10 July 2015) 2 Vernon JA, Golec JH, DiMasi JA. Drug development costs when financial risk is measured using the fama-french three-factor model. Health Econ. 2010;19(8):1002-1005
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commercial manufacturing capacity and significant marketing efforts before the Group can generate any revenue from product sales. The Group is not permitted to market or promote any of its product candidates before it receive regulatory approval from the from the FDA to market in the U.S., from the European Medicines Agency (the "EMA") to market in Europe, as well as from equivalent regulatory authorities in other foreign jurisdictions. The Group may never receive such regulatory approval for any of its products candidates. If the Group is unable to develop or receive marketing approval for TG01 and/or ONCOS-102 in a timely manner or at all, the Group could experience significant delays or an inability to commercialize TG01 and/or ONCOS-102, which could materially and adversely affect the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
Any significant delay or failure in the conduct of present or future clinical studies may adversely impact the Group’s ability to obtain regulatory approval for and commercialize its current and future product candidates
The Group depends on collaboration with partners, medical institutions and laboratories to conduct clinical testing in compliance requirements from appropriate regulatory authority in the country of use. The Group’s ability to complete clinical studies in a timely fashion, or at all, depend on several factors, including but not limited to the following:
• delays in the planning of future clinical studies;
• delays in the CMC (chemistry, manufacturing, control) and QA work related to drug substance and drug product in present or future clinical studies;
• delays in, or inability of, attracting and retaining highly qualified managerial, scientific and medical personnel to assist in the clinical studies;
• delays in obtaining, or failures to obtain, regulatory approval to commence clinical studies because of safety concerns of regulators relating to the Group’s product candidate or failure to follow regulatory guidelines regarding general safety issues;
• actions by regulators to place a proposed study on clinical hold or to temporarily or permanently stop a trial for a variety of reasons, principally for safety concerns;
• delays in recruiting patients to participate in a clinical study, and the rate of patients enrolment, which is itself a function of many factors, including size of the patients population, the proximity of patients to the clinical trial sites, the eligibility criteria for the study and the nature of the protocol;
• the inability to fully control experimental conditions;
• compliance of patients and investigators with the protocol and applicable regulations; failure of clinical studies and clinical investigators to be in compliance with relevant clinical protocol, or similar requirements in other countries;
• failure of third party clinical managers to satisfy their contractual duties, comply with regulations or meet expected deadlines;
• delays or failures in reaching agreement on acceptable terms with prospective study sites;
• the Group’s partners in clinical studies, the performance of which the Group cannot control;
• changes in the standard of care from initiation to completion of a clinical study; and
• determination by regulators that the clinical design is not adequate.
Any significant delay or failure in the conduct of clinical studies may adversely impact the Group’s ability to obtain regulatory approval for and commercialize its current and future product candidates, which again could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
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The carrying amount of the Company's patented technology constitutes a significant portion of the total assets in the Company's consolidated financial statements and any impairment loss recognized will have a material adverse effect on the Group's financial position
The carrying amount of the patented technology (ONCOS-102) reflects the value of the consideration shares issued by the Company in its acquisition of Oncos Therapeutics Oy in 2015. That acquisition was completed on a significantly higher pricing than the current subscription price of NOK 7.50 per share in the Subsequent Offering. The carrying amount of the patented technology constitutes a significant portion of the total assets in the Company's consolidated financial statements. A number of factors, including the prevailing market conditions, the competitive situation of the Group or any failures in the expected development of the product may result in an impairment loss for the patented technology. Any impairment loss recognized will have a material adverse effect on the Group's financial position.
The Group’s product candidates may cause undesirable side effects that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, if approved, and result in other significant negative consequences
Undesirable side effects caused by the Group’s product candidates could cause the Group or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, EMA or comparable foreign regulatory authorities. Results of the Group’s clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.
If unacceptable side effects arise in the development of the Group’s product candidates, the Group could suspend or terminate its clinical trials or the FDA, EMA or comparable foreign regulatory authorities could order the Group to cease clinical trials or deny approval of the Group’s product candidates for any or all targeted indications. Treatment- related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. In addition, side effects may not be appropriately recognized or managed by the treating medical staff.
Additionally, if one or more of the Group’s product candidates receives marketing approval, and the Group or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:
• regulatory authorities may withdraw approvals of such product;
• regulatory authorities may require additional warnings on the label;
• the Group may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
• health care professionals or patients may not accept the product and prefer competing alternatives;
• the Group could be sued and held liable for harm caused to patients;
• the regulators may require additional data from studies; and
• the Group’s reputation may suffer.
Any of these events could prevent the Group from achieving or maintaining market acceptance of the particular product candidate, if approved, and could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group has obtained orphan drug designations for TG01 in pancreatic cancer and ONCOS-102 in malignant plural mesothelioma and ovarian cancer, but the Group may be unable to maintain the benefits associated with orphan drug designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biopharmaceutical intended to treat a rare disease or condition, which is defined as one occurring in a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug or biologic will be recovered from sales in the United States. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. In addition, if a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product 15
is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including a full Biologics License Application, to market the same biologic for the same indication for 7 years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient product quantity. In Europe, the EMA offer similar support and advantages to products which have an orphan drug designation. It is granted to rare diseases defined as occurring 5<10,000 and provide marketing exclusivity for 10 years.
Even though the Group has received orphan drug designation for TG01 in pancreatic cancer and ONCOS-102 in malignant plural mesothelioma and ovarian cancer, the Group may not be the first to obtain marketing approval of either product candidate for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products.
The success of the Group is dependent on its ability to obtain acceptable prices and reimbursements on its product candidates
In most markets, drug prices and reimbursement levels are regulated or influenced by authorities, other healthcare providers, insurance companies or health maintenance organizations. Furthermore, the overall healthcare costs to society have increased considerably over the last decades and governments all over the world are striving to control them. There can be no guarantee that the Group’s final products, if any, will obtain the selling prices or reimbursement levels foreseen by the Group. If actual prices and reimbursement levels granted to the Group’s products prove lower than anticipated, it might have a negative impact on such products’ profitability and/or marketability, which again could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group relies, and will continue to rely, upon third-parties for clinical trials, product development and manufacturing
The Group cannot be certain that it will be able to enter into or maintain satisfactory agreements with third-party suppliers, like contract research organizations for the conduct of clinical studies or manufacturers. The Group’s need to amend or change providers for the conduct of clinical studies might impact the timelines of the conduct of such studies. The Group’s failure to enter into agreements with such suppliers or manufacturers on reasonable terms, or at all, could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group may also not be able to rapidly alter production volumes to respond to changes in future commercial sale or demand of a product candidate. Poor manufacturing performance of third party manufacturers, a disruption in the supply or the Group’s failure to accurately predict the demand for any future commercial sale of a product could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group is subject to a number of manufacturing and supply chain risks, any of which could substantially increase its costs and limit and/or delay the supply of its product candidates
The process of manufacturing the Group’s product candidates is complex, highly regulated and subject to several risks, including but not limited to:
The manufacturing of drug products is subject to product loss due to contamination, equipment failure, improper installation or operation of equipment or vendor or operator fault. Minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If contaminations are discovered in the Group’s product candidates or in the manufacturing facilities in which the products are made, these manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
The manufacturing facilities in which the Group’s product candidates are made could be materially and adversely affected by equipment failures, labor shortages, natural disasters, power failures and several other factors.
In order to supply investigational medicinal products to clinical trials, the Group and the Group’s contract manufactures needs to comply with relevant EU and US good manufacturing practice ("GMP") guidelines. The Group and the contract manufactures will be subject to inspections by relevant authorities in order to confirm compliance with relevant GMP guidelines and other applicable regulatory requirements. Any failure to follow GMP or other regulatory requirements or delay, interruption or other issues that arise in the
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manufacture of the Group’s investigational medicinal products as a result of a failure in the facilities or operations to comply with regulatory requirements or pass any inspecting could significantly impair the Group’s ability to develop and commercialize its candidates, including leading to delays in availability, imposition of sanctions, warning letters, failure to grant market approvals, delays, suspension or withdrawal of approvals, license revocation, recalls of products, operation restrictions and criminal prosecutions and damage of reputation and its business.
GM-CSF is a necessary component of TG01 and TG02 immunotherapy. Any failure in producing or supplying any TG01, TG02 and GM-CSF products to appropriate quality standards set from time to time by regulatory authorities could significantly impair the Group’s ability to develop and commercialize its candidates.
Any adverse developments affecting manufacturing operations for the Group’s product candidates and/or damage that occurs during shipping may result in delays, inventory shortages, lot failures, withdrawals or recalls or other interruptions in the supply of the Group’s drug substance and drug product. The Group may also have to write off inventory, incur other charges and expenses for supply of drug product that fails to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing alternatives. Inability to meet the demand for any of its product candidates, if approved, could damage the Group’s reputation and the reputation of its products among physicians, healthcare payers, patients or the medical community, which could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group may not be able to enter into partnership agreements
The Group’s business strategy is to retain marketing rights and actively participate in the commercialization of its lead product candidates, while exploring potential partnering opportunities in selected geographies, partly through collaborative agreements with pharmaceutical or biotechnology companies. The Company cannot give any assurance that such agreements will be obtained on acceptable terms, nor that the Company will be able to enter into any such agreements at all. Furthermore, should such agreements be executed, there can be no assurance that the cooperation will work in practice and that agreements are adhered to or not terminated by the other party.
The Group faces an inherent business risk of liability claims in the event that the use or misuse of the compounds results in personal injury or death
The Group faces an inherent risk of product liability as a result of the clinical testing of its product candidates and will face an even greater risk if it commercializes any products. For example, the Group may be sued if its product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. If the Group cannot successfully defend itself against product liability claims, it may incur substantial liabilities or be required to limit commercialization of its product candidates. Even successful defense would require significant financial and management resources.
The Group has not experienced any clinical trial liability claims to date, but it may experience such claims in the future. The Group currently maintains clinical trial liability insurance for each trial. The insurance policy may not be sufficient to cover claims that may be made against the Group. Clinical trial liability insurance may not be available in the future on acceptable terms, or at all. Any claims against the Group, regardless of their merit, could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The success, competitive position and future revenues will depend in part on the Group’s ability to protect its intellectual property and know-how
The Group’s commercial success will depend in part on its ability to obtain and maintain intellectual property protection with respect to its proprietary technology and products. This will require the Company to obtain and maintain patent protection for its products, methods, processes and other technologies, to preserve trade secrets, to prevent third parties from infringing on proprietary rights and to operate without infringing the proprietary rights of third parties. To date, the Group holds certain exclusive patent rights and has filed several patent applications, see Section 8.8.6 "Patent and patent applications", however, the Group cannot predict the degree and range of protection any patents will afford against competitors and competing technologies, including whether third parties will find ways to invalidate or otherwise circumvent the patents, if and when additional patents will be issued, whether or not others will obtain patents claiming aspects similar to those covered by the Group’s patents and patents applications, whether the Group will need to initiate litigation or administrative proceedings, or whether such litigation or proceedings are initiated by third parties against the Group which may be costly or whether third parties will claim that the Group’s technology
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infringes upon their rights. The Group does not know whether any of the pending patent applications will result in the issuance of patents that effectively protect its technology or products. Should the Group not be able to protect its intellectual property and know-how, it could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
Patent applications filed by others could limit the Group’s freedom to operate
Competitors may claim that one or more of the Group’s product candidates infringe upon their patents or other intellectual property. Resolving a patent or other intellectual property infringement claim can be costly and time consuming and may require the Group to enter into royalty or license agreements. If this should be necessary, the Group cannot guarantee that it would be possible to obtain royalty or license agreements on commercially advantageous terms. A successful claim of patent or other intellectual property infringement could subject the Group to significant damages or an injunction preventing the manufacture, sale or use of the Group’s affected products or otherwise limit the freedom to operate. Any of these events could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group may not be able to maintain sufficient insurance to cover all risks related to its operations
The Group’s business is subject to a number of risks and hazards, including, but not limited to industrial accidents, labor disputes and changes in the regulatory environment. Such occurrences could result in damage to properties, personal injury, monetary losses and possible legal liability. Although the Group seeks to maintain insurance or contractual coverage to protect against certain risks in such amounts as it considers reasonable, its insurance may not cover all the potential risks associated with the Group’s operations, which could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group faces significant competition from other biotechnology and pharmaceutical companies
The biopharmaceutical industry is characterized by intense competition and rapid innovation. The Group’s competitors may be able to develop other compounds or drugs that are able to achieve similar or better results. Many major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions continue to invest time and resources in developing novel approaches to immuno-oncology. Promising results have spurred significant competition from major pharmaceutical and biotechnology companies alike. The Group’s competitors include, among others, NewLink Genetics Corp., GlobeImmune, Inc., Aduro Biotech, Inc., Bavarian Nordic, Inc. and Vaximm AG (cancer vaccines) and Amgen, Inc., Advantagene, Inc., Transgene SA, PsiOxus Therapeutics, Ltd., Cold Genesys, Inc., ORCA Therapeutics B.V., Oncolytics Biotech, Inc., SillaJen, Inc., Viralytics, Ltd. and DNAtrix, Inc (oncolytic viruses). Many of the Group’s competitors have substantially greater financial, technical and other resources than the Group does, such as larger research and development staff and experienced marketing and manufacturing organizations and well-established sales forces. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in the Group’s competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. The Group’s competitors may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or less costly than the Group’s product candidates or may develop proprietary technologies or secure patent protection that the Group may need for the development of its technologies and products.
Even if the Group obtain regulatory approval of its product candidates, the availability and price of its competitors’ products could limit the demand and the price the Group is able to charge for its product candidates. The Group may not be able to implement its business plan if the acceptance of its product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment to the Group’s product candidates, or if physicians switch to other new drug or biologic products or choose to reserve the Group’s product candidates for use in limited circumstances. For additional information regarding the Group’s competition, see Section 8.7 "Competition".
The Group may lose market exclusivity and face competition from low-cost generic products
The Group’s product candidates and/or related technology are or are expected to be protected by patent rights that are expected to provide the Group with exclusive marketing rights in various countries. However, patent rights are of varying strengths and durations. Loss of market exclusivity and the introduction of a generic version of the same or a similar medicine typically results in a significant and sharp reduction in net sales for the relevant product, given that generic manufacturers typically offer their versions of the same medicine at lower prices. The Group’s results may be affected by changes in public sentiment.
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The pharmaceutical industry is under the close scrutiny of the public, governments and the media. In addition, there is significant pressure on the industry from certain nations to make the products available to their population at drastically lower costs. Any increase in such negative public sentiment or increase in public scrutiny or pressure from such nations could lead, among other things, to changes in legislation, to changes in the demand for the products, additional pricing pressures with respect to the products, or increased efforts to undercut intellectual property protections. Such changes could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group may not be able to successfully implement its clinical, regulatory and commercial strategy
The Group’s strategy as described in Section 8.3 "Strategy" is to (i) complete TG01 and rapidly advance ONCOS-102 into Phase II clinical trials as well as to rapidly advance TG02 into a Phase I clinical trial, (ii) evaluate the combination of ONCOS-102 and check point inhibitors (CPIs) in non-responding check point inhibitor (CPI) patients, (iii) evaluate the combination of TG02 and CPIs in select sub-groups of cancer patients, (iv) optimize the Group’s manufacturing capabilities to ensure later stage clinical trials and commercial supply, (v) expand its intellectual property profile, (vi) selectively pursue partnerships and collaborations, (vii) progress further targeted therapeutic cancer vaccines candidates to the product development stage and (viii) explore the combination of the Group’s peptide therapeutic cancer vaccines for RAS mutations together with its viral therapeutic cancer vaccines. Achieving the Group’s objectives involves inherent costs and uncertainties and there is no assurance that the Group will achieve its objectives or other anticipated benefits. Further, there is no assurance that the Group will be able to undertake its activities within their expected time frame, that the costs of any of the Group’s objectives will be at expected levels or that the benefits of its objectives will be achieved within the expected timeframe or at all.
The Group’s projections of both the number of people who have the cancers it is targeting, as well as the subset of people with these cancers who have received one or more prior treatments, and who have the potential to benefit from treatment with the Group’s product candidates, are based on the Group’s beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these cancers. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for the Group’s product candidates may be limited or may not be amenable to treatment with the Group’s product candidates. Even if the Group obtains significant market share for its product candidates, because the potential target populations are small, the Group may never achieve profitability without obtaining regulatory approval for additional indications, including to be used as first or second line therapy.
The Group’s ability to successfully implement its strategy could also be affected by factors beyond its control, such as the economic development in the markets in which it operates and the availability of acquisition and development opportunities in each market. Any failures, material delays or unexpected costs related to implementation of the Group’s strategy could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group is highly dependent on its key personnel, and if the Group is not successful in attracting and retaining highly qualified personnel, the Group will not be able to successfully implement its business plan
The Group’s ability to compete in the highly competitive biotechnology and pharmaceutical industries and its ability to comply with complex EU and US guidelines related to its development work depend upon its ability to attract and retain highly qualified managerial, scientific and medical personnel. The loss of a key employee might impede the achievement of the scientific development and commercial objectives. Competition for key personnel with the experience that is required is intense and is expected to continue to increase. There is no assurance that the Group will be able to retain key personnel, nor can assurances be given that the Group will be able to recruit new key personnel in the future. Any failure to attract or retain such personnel could result in the Group not being able to successfully implement its business plan and could impact the compliance of the Group’s quality system and thereby the compliance of the Group’s development work, which again could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
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The Group’s business involves use of hazardous materials, chemicals and biological compounds and is thus exposed to environmental risks
The Group believes that its safety procedures for handling and disposing of such materials comply with applicable regulations, however, there will always be a risk of accidental contamination or injury. If liable for an accident, the Group could incur significant costs, damages or penalties that could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.2 Risks related to laws, regulations and litigation The Group may be subject to litigation and disputes that could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects
The Group may in the future be involved from time to time in litigation and disputes. The operating hazards inherent in the Group’s business may expose the Group to, amongst other things, litigation, including personal injury litigation, intellectual property litigation, contractual litigation, environmental litigation, tax or securities litigation, as well as other litigation that arises in the ordinary course of business.
The Group is currently not involved in any litigation. However, it may in the future be involved in litigation matters from time to time. The Group cannot predict with certainty the outcome or effect of any claim or other litigation matter. The ultimate outcome of any litigation matter and the potential costs associated with prosecuting or defending such lawsuits, including the diversion of the Management’s attention to these matters, could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group is exposed to risks related to regulatory processes and changes in regulatory environment
Cancer therapies are sometimes characterized as first line, second line or third line, and the FDA and EMA often approves new therapies initially only for third line use. When cancer is detected early enough, first-line therapy, usually chemotherapy, hormone therapy, surgery, radiotherapy or a combination of these, is sometimes adequate to cure the cancer or prolong life without a cure. Second- and third-line therapies are administered to patients when prior therapy is not effective. The Group expects to initially seek approval of its product candidates as a therapy for patients who have received one or more prior treatments. Subsequently, for those products that prove to be sufficiently beneficial, if any, the Group would expect to seek approval potentially as a first-line therapy, but there is no guarantee that the Group’s product candidates, even if approved, would be approved for first-line therapy, and, prior to any such approvals, the Group may have to conduct additional clinical trials.
Further, the Group’s operations could be affected by changes in intellectual property legal protections and remedies, trade regulations and procedures and actions affecting approval, production, pricing, reimbursement and marketing of products, as well as by unstable governments and legal systems and inter-governmental disputes. Any of these changes could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
Even if the Group obtains regulatory approval for a product candidate, the Group’s products will remain subject to regulatory scrutiny
Any product candidate for whom the Group obtains marketing approval, along with the manufacturing processes, qualification testing, post-approval clinical data, labeling and promotional activities for such product, will be subject to continual and additional requirements of the different national and regional regulatory authorities. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. The different regulatory authorities closely regulates the post-approval marketing and promotion of pharmaceutical and biological products to ensure such products are marketed only for the approved indications and in accordance with the provisions of the approved labeling.
In addition, late discovery of previously unknown problems with the Group’s products, manufacturing processes, or failure to comply with regulatory requirements, may lead to various adverse results, including, but not limited to, restrictions on such products, manufacturers or manufacturing processes, requirements to conduct post-marketing clinical trials, withdrawal of the products from the market, refusal to approve pending applications or supplements to approve applications that the Group submits and refusals to permit the import or export of the Group’s products.
The regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of the Group’s product candidates. If the Group is slow or unable to adapt
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to changes in existing requirements or the adoption of new requirements or policies, or if the Group is not able to maintain regulatory compliance, it may lose any marketing approval that it may have obtained, which could have a material adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.3 Risks related to financing and market risk The Group will require additional financing to achieve its goals, and a failure to obtain this necessary capital when needed could force the Group to delay, limit, reduce or terminate its product development or commercialization efforts
The Group’s operations have consumed substantial amounts of cash since inception. The Group expects to continue to spend substantial amounts to continue the clinical development of its product candidates. The exact amounts needed are unknown. If the Group is able to gain regulatory approval for any of its product candidates, it will require significant additional amounts of cash in order to launch and commercialize any such product candidates. In addition, other unanticipated costs may arise. Because the design and outcome of the Group’s planned and anticipated clinical trials is highly uncertain, the Group cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of its product candidates. The net proceeds from the Private Placement and the Subsequent Offering are not expected to be sufficient to enable the Group to complete such development and commercialization.
The Group’s future capital requirements depend on many factors, including but not limited to:
• the scope, progress, results and costs of researching and developing the Group’s product candidates, and conducting preclinical studies and clinical trials;
• the size of the organization needed to take product candidates through clinical trials and potentially commercialization;
• the timing of, and the costs involved in, obtaining regulatory approvals for the Group’s product candidates if clinical trials are successful;
• the cost of commercialization activities for the Group’s product candidates, if any of its product candidates is approved for sale, including marketing, sales and distribution costs;
• the cost of manufacturing the Group’s product candidates for clinical trials in preparation for regulatory approval and in preparation for commercialization;
• the Group’s ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;
• the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;
• the timing, receipt and amount of sales of, or royalties on, the Group’s future products, if any; and
• the emergence of competing cancer therapies and other adverse market developments.
Adequate sources of funding may not be available when needed or may not be available on favorable terms. The Group’s ability to obtain such additional capital or financing will depend in part upon prevailing market conditions as well as conditions of its business and its operating results, and those factors may affect its efforts to arrange additional financing on satisfactory terms. If the Group raises additional funds by issuing additional shares or other equity or equity-linked securities, it will result in a dilution of the holdings of existing shareholders. If the Group raises additional capital through debt financing, the Group may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the Group is unable to obtain adequate financing when needed, it may have to delay, reduce the scope of or suspend one or more of its clinical trials or research and development programs or its commercialization efforts, which could have a material adverse effect on the Group’s business, financial condition and results of operations.
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Present or future debt levels could limit the Group’s flexibility to obtain additional financing and pursue other business opportunities
The Group may incur additional indebtedness in the future. The current or future level of debt could have important consequences to the Group, including that:
• the Group’s ability to obtain additional financing for working capital, capital expenditures, acquisitions or other purposes may be impaired or such financing may be unavailable on favorable terms;
• the Group’s costs of borrowing could increase as it becomes more leveraged;
• the Group may need to use a substantial portion of its cash from operations to make principal and interest payments on its debt, reducing the funds that would otherwise be available for operations, future business opportunities and dividends to its shareholders;
• the Group’s debt level could make it more vulnerable than its competitors with less debt to competitive pressures, a downturn in its business or the economy generally; and
• the Group’s debt level may limit its flexibility in responding to changing business and economic conditions.
The Group’s ability to service its current or future debt will depend upon, among other things, its future financial and operating performance, which will be affected by prevailing economic conditions as well as financial, business, regulatory and other factors, some of which are beyond its control. If the Group’s operating income is not sufficient to service its current or future indebtedness, the Group will be forced to take action such as reducing or delaying its business activities, acquisitions, investments or capital expenditures, selling assets, restructuring or refinancing its debt or seeking additional equity capital. The Group may not be able to affect any of these remedies on satisfactory terms, or at all, which could have a material adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
Interest rate fluctuations could in the future materially and adversely affect the Group’s business, financial condition, results of operations, cash flows, time to market and prospects
Currently, the Group has no long-term debt other than its debt to Tekes. The debt to Tekes carry an annual interest equal to the European Central Bank’s steering rate less 3 percentage points, but in no event less than 1%. The current interest is 1% per annum. The Group may in the future be exposed to interest rate risk primarily in relation to any future interest bearing debt issued at floating interest rates and to variations in interest rates of bank deposits. Consequently, movements in interest rates could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
Fluctuations in exchange rates could affect the Group’s cash flow and financial condition
The Group has currency exposure to both transaction risk and translation risk related to its operating expenses. Transaction risk arises when future commercial transactions or recognized assets or liabilities are denominated in a currency that is not the entity’s functional currency. The Group undertakes various transactions in foreign currencies and is consequently exposed to fluctuations in exchange rates. The exposure arises largely from research expenses. The Company is mainly exposed to fluctuations in EUR, GBP, USD and CHF.
Translation risk arises due to the conversion of amounts denominated in foreign currencies to NOK, the Group’s reporting and functional currency. One of the Group’s subsidiaries has EUR as its reporting and functional currency, while another has CHF. Consequently, any change in exchange rates between its operating subsidiary’s functional currency and NOK affect its consolidated statement of profit or loss and other comprehensive income and statement of financial position when the result of that operating subsidiary is translated into NOK for reporting purposes.
2.4 Risks related to the Subsequent Offering, the Listing and the Shares Eligible Shareholders who do not participate in the Subsequent Offering may experience significant dilution in their shareholding.
Eligible Shareholders who do not participate in the Subsequent Offering may experience dilution in their shareholding.
Subscription Rights that are not exercised by the end of the Subscription Period will automatically expire without compensation to the holder. To the extent that an Eligible Shareholder does not exercise its Subscription Rights prior to the expiry of the Subscription Period, whether by choice or due to a failure to comply with procedures set forth in
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Section 16.2.7 "Subscription Procedures", or to the extent that an Eligible Shareholder is not permitted to subscribe for Offer Shares as further described in Section 17 "Selling and transfer restrictions", such Eligible Shareholders' proportionate ownership and voting interests in the Company after the completion of the Subsequent Offering will be diluted.
The Company will incur increased costs as a result of the Listing and being a publicly traded company
As a publicly traded company with its Shares listed on Oslo Axess, the Company will be required to comply with Oslo Axess’ reporting and disclosure requirements and with corporate governance requirements. As a consequence, the Company will incur additional legal, accounting and other expenses to comply with these and other applicable rules and regulations. The Company anticipates that its incremental general and administrative expenses as a publicly traded company will include, among other things, costs associated with annual and quarterly reports to shareholders, shareholders’ meetings, investor relations, incremental director and officer liability insurance costs and officer and director compensation. In addition, the Board of Directors and Management may be required to devote significant time and effort to ensure compliance with such rules and regulations, which may entail that less time and effort can be devoted to other aspects of the business. Any such increased costs, individually or in the aggregate, could have an adverse effect on the Group’s business, financial condition, results of operations and cash flows.
The market value of the Shares may fluctuate significantly, which could cause investors to lose a significant part of their investment
An investment in the Shares may decrease in market value as well as increase. The market value of the Shares could fluctuate significantly in response to a number of factors beyond the Company’s control, including quarterly variations in operating results, adverse business developments, changes in financial estimates and investment recommendations or ratings by securities analysts, announcements by the Company or its competitors of new product and service offerings, significant contracts, acquisitions or strategic relationships, publicity about the Company, its products and services or its competitors, lawsuits against the Group, unforeseen liabilities, changes in management, changes to the regulatory environment in which it operates or general market conditions.
There is no prior regulated market for the Shares, and an active trading market may not develop
Although the Company has been registered on the Norwegian OTC ("NOTC"), prior to the Listing, the Shares have not been traded on a regulated public market place, and there can be no assurances that an active trading market for the Shares will develop or be sustained or that the Shares could be resold at or above the Offer Price. The market value of the Shares could be substantially affected by the extent to which a secondary market develops for the Shares following completion of the Listing.
The Company’s ability to pay dividends is dependent on the availability of distributable reserves and the Company may be unwilling to pay any dividends in the future regardless of availability of distributable reserves
Norwegian law provides that any declaration of dividends must be adopted by the shareholders at the Company’s general meeting of shareholders (the "General Meeting") or by the Board of Directors pursuant to a power of attorney granted by the General Meeting. Dividends may only be declared to the extent that the Company has distributable funds and the Board of Directors finds such a declaration to be prudent in consideration of the size, nature, scope and risks associated with the Company’s operations and the need to strengthen its liquidity and financial position. As the Company’s ability to pay dividends is dependent on the availability of distributable reserves, it is, among other things, dependent upon receipt of dividends and other distributions of value from its subsidiaries and companies in which the Company may invest.
When the decision to declare dividend is made by the General Meeting, the General Meeting may as a general rule not declare higher dividends than the Board of Directors has proposed or approved. If, for any reason, the General Meeting does not declare dividends in accordance with the proposal by the Board of Directors, a shareholder will, as a general rule, have no claim in respect of such non-payment, and the Company will, as a general rule, have no obligation to pay any dividend in respect of the relevant period.
The Group is focusing on the development of pharmaceutical products and does not anticipate paying any cash dividend until sustainable profitability is achieved. In addition, the Company may choose not, or may be unable, to pay dividends in future years. The amount of dividends paid by the Company, if any, for a given financial period, will depend on, among other things, the Company’s future operating results, cash flows, financial position, capital requirements, the sufficiency of its distributable reserves, the ability of the Company’s subsidiaries to pay dividends to the Company, credit terms, general economic conditions, legal restrictions (as set out in Section 6.2 "Legal constraints on the distribution of dividends") and other factors that the Company may deem to be significant from time to time. 23
Future sales, or the possibility for future sales of substantial numbers of Shares may affect the Shares’ market price
The market price of the Shares could decline as a result of sales of a large number of Shares in the market after the Offering or the perception that these sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult for the Company to sell equity securities in the future at a time and at a price that it deems appropriate.
The Company cannot predict what effect, if any, future sales of the Shares, or the availability of Shares for future sales, will have on their market price. Sales of substantial amounts of the Shares in the public market following the Offering, or the perception that such sales could occur, may adversely affect the market price of the Shares, making it more difficult for holders to sell their Shares or the Company to sell equity securities in the future at a time and price that they deem appropriate.
Future issuances of Shares or other securities may dilute the holdings of shareholders and could materially affect the price of the Shares
The Company may in the future decide to offer additional Shares or other securities in order to finance new capital- intensive projects, in connection with unanticipated liabilities or expenses or for any other purposes and to honor options granted under the Group’s share option programs. There is no assurance that the Company will not decide to conduct further offerings of securities in the future. Depending on the structure of any future offering, certain existing shareholders may not have the ability to purchase additional equity securities. If the Company raises additional funds by issuing additional equity securities, the holdings and voting interests of existing shareholders could be diluted.
Pre-emptive rights to secure and pay for Shares in any additional issuance may be unavailable to U.S. or other shareholders
Under Norwegian law, unless otherwise resolved at a General Meeting, existing shareholders have pre-emptive rights to participate on the basis of their existing ownership of Shares in the issuance of any new shares for cash consideration. Shareholders in the United States, however, may be unable to exercise any such rights to subscribe for new shares unless a registration statement under the U.S. Securities Act is in effect in respect of such rights and shares or pursuant to an exemption from, or in transactions not subject to, the registration requirements of the U.S. Securities Act and other applicable securities laws. Shareholders in other jurisdictions outside Norway may be similarly affected if the rights and the new shares being offered have not been registered with, or approved by, the relevant authorities in such jurisdiction. The Company has not filed a registration statement under the U.S. Securities Act in connection with the Offering or sought approvals under the laws of any other jurisdiction outside Norway in respect of any pre-emptive rights or the Shares, does not intend to do so, is under no obligation to do so, and doing so in the future may be impractical and costly. To the extent that the Company’s shareholders are not able to exercise their rights to subscribe for new shares, their proportional interests in the Company will be reduced.
Investors may be unable to exercise their voting rights for Shares registered in a nominee account
Beneficial owners of the Shares that are registered in a nominee account (such as through brokers, dealers or other third parties) may not be able to vote for such Shares unless their ownership is re-registered in their names with the VPS prior to any General Meeting. There is no assurance that beneficial owners of the Shares will receive the notice of any General Meeting in time to instruct their nominees to either effect a re-registration of their Shares or otherwise vote for their Shares in the manner desired by such beneficial owners.
Investors may be unable to recover losses in civil proceedings in jurisdictions other than Norway
The Company is a public limited company organized under the laws of Norway. All of the Board Members and the members of the Management reside in Norway, except from Per Samuelsson (Board Member), who resides in Sweden, Johan Christenson (Board Member), who resides in Sweden, Robert Burns (Board Member), who resides in the UK, Eva-Lotta Coulter (Board Member), who resides in the UK and Diane Mellett (Board Member), who resides in France. As a result, it may not be possible for investors to effect service of process in other jurisdictions upon such persons or the Company, to enforce against such persons or the Company judgments obtained in non-Norwegian courts, or to enforce judgments on such persons or the Company in other jurisdictions.
Norwegian law may limit shareholders’ ability to bring an action against the Company
The rights of holders of the Shares are governed by Norwegian law and by the Articles of Association. These rights may differ from the rights of shareholders in other jurisdictions. In particular, Norwegian law limits the circumstances under which shareholders of Norwegian companies may bring derivative actions. For instance, under Norwegian law, any action brought by the Company in respect of wrongful acts committed against the Company will be prioritized over 24
actions brought by shareholders claiming compensation in respect of such acts. In addition, it may be difficult to prevail in a claim against the Company under, or to enforce liabilities predicated upon, securities laws in other jurisdictions.
The transfer of Shares is subject to restrictions under the securities laws of the United States and other jurisdictions
The Shares have not been registered under the U.S. Securities Act or any U.S. state securities laws or any other jurisdiction outside of Norway and are not expected to be registered in the future. As such, the Shares may not be offered or sold except pursuant to an exemption from, or in transactions not subject to, the registration requirements of the U.S. Securities Act and other applicable securities laws. See Section 17 "Selling and Transfer Restrictions". In addition, there is no assurances that shareholders residing or domiciled in the United States will be able to participate in future capital increases or rights offerings.
Exchange rate fluctuations could adversely affect the value of the Shares and any dividends paid on the Shares for an investor whose principal currency is not NOK
The Shares will be priced and traded in NOK on Oslo Axess, and any future payments of dividends on the Shares will be denominated in NOK. Investors registered in the VPS who have not supplied the VPS with details of their bank account, will not receive payment of dividends unless they register their bank account details with Nordea Bank Norge ASA ("Nordea"), being the Company’s VPS registrar. The exchange rate(s) that is applied when denominating any future payments of dividends to the relevant investor's currency will Nordea's exchange rate on the payment date. Exchange rate movements of NOK will therefore affect the value of these dividends and distributions for investors whose principal currency is not NOK. Further, the market value of the Shares as expressed in foreign currencies will fluctuate in part as a result of foreign exchange fluctuations. This could affect the value of the Shares and of any dividends paid on the Shares for an investor whose principal currency is not NOK.
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3 RESPONSIBILITY FOR THE PROSPECTUS This Prospectus has been prepared in connection with the Subsequent Offering described herein and the Listing of the Shares on Oslo Axess.
The Board of Directors of Targovax ASA accepts responsibility for the information contained in this Prospectus. The members of the Board of Directors confirm that, having taken all reasonable care to ensure that such is the case, the information contained in the Prospectus is, to the best of their knowledge, in accordance with the facts and contains no omission likely to affect its import.
7 July 2016
The Board of Directors of Targovax ASA
Jonas Einarsson Bente-Lill Bjerkelund Romøren Lars Lund-Roland Chairperson Board member Board member
Per Samuelsson Robert Burns Johan Christenson Board member Board member Board member
Eva-Lotta Coulter Diane Mellett Board member Board member
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4 GENERAL INFORMATION 4.1 Other important investor information The Company has furnished the information in this Prospectus. No representation or warranty, express or implied is made by the Joint Bookrunners as to the accuracy, completeness or verification of the information set forth herein, and nothing contained in this Prospectus is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future. The Joint Bookrunners assume no responsibility for the accuracy or completeness or the verification of this Prospectus and accordingly disclaims, to the fullest extent permitted by applicable law, any and all liability whether arising in tort, contract or otherwise which it might otherwise be found to have in respect of this Prospectus or any such statement.
Neither the Company nor the Joint Bookrunners, or any of their respective affiliates, representatives, advisers or selling agents, is making any representation to any offeree or purchaser of Shares regarding the legality of an investment in the Shares. Each investor should consult with his or her own advisors as to the legal, tax, business, financial and related aspects of a purchase of the Shares.
Investing in the Shares involves a high degree of risk. See Section 2 "Risk Factors" beginning on page 12.
4.2 Presentation of financial and other information 4.2.1 Financial information The Company’s audited financial statements as of and for the year ended 31 December 2015, with comparable figures as of and for the year ended 31 December 2014, have been prepared in accordance with International Financial Reporting Standards as adopted by the European Union ("IFRS") (the "Financial Statements"). The Financial Statements are included in Appendix B. The Company’s unaudited condensed interim financial statements as of and for the three month period ended 31 March 2016, with comparable figures as of and for the three month period ended 31 March 2015, have been prepared in accordance with International Accounting Standard 34 "Interim Financial Reporting" as adopted by the EU ("IAS 34") (the "Interim Financial Statements"). The Financial Statements and the Interim Financial Statements are together referred to as the "Financial Information".
On 2 July 2015, the Company acquired all the shares in Oncos Therapeutics Oy ("Oncos"). The transaction was structured as a share for share exchange whereby the Company issued 9,429,404 new shares to the shareholders of Oncos as consideration for the shares in Oncos (the "Combination"). On 9 July 2015, the Company completed a private placement with gross proceeds of NOK 200 million (the "2015 Private Placement"). The Combination and the 2015 Private Placement were mutually conditional upon each other. As a result of the Combination, the Company has, in addition to the Financial Information, included unaudited condensed pro forma financial information (the "Pro Forma Financial Information") in this Prospectus to show how the Combination could have affected the Company’s statement of profit or loss and other comprehensive income for the year ended 31 December 2015 as if the Combination occurred on 1 January 2015. Oncos’ audited financial statements as of and for the year ended 31 December 2014 (the "Oncos Oy Financial Statements") have been prepared in accordance with Finnish Generally Accepted Accounting Principles ("FGAAP") and are presented in EUR. The Oncos Oy Financial Statements were on 16 September 2015 restated for all periods presented with a cumulative adjustment as at the beginning of the earliest period presented recognized in retained earnings of the shareholders’ equity. The adjustments were as follows: (i) capitalized R&D costs were recognized as personnel expenses and other operating expenses and the related amortization recognized was eliminated accordingly and (ii) the previously unrecognized interest charge on convertible loans was recorded as financial expenses using the effective rate of interest method. Oncos’ unaudited trial balances as of and for the nine month period ended 30 September 2015 have been prepared based on the principles of FGAAP (the "Oncos Oy Trial Balances"). Oncos Therapeutics AG ("Oncos AG"), the wholly owned subsidiary of Oncos, has prepared unaudited trial balances as of and for year ended 31 December 2014 and as of and for the nine month period ended 30 September 2015 (the "Oncos AG Trial Balances"). The Oncos AG Trial Balances have been prepared based on the principles of Swiss Generally Accepted Accounting Principles ("SGAAP"). From 2 July 2015, Oncos and Oncos AS have been consolidated into the Interim Financial Statements. The Pro Forma Financial Information does not purport to represent what the Company’s actual statement of profit or loss and other comprehensive income would have been had the events which were the subject of the adjustments occurred on the relevant dates. The Pro Forma Financial Information does not include all of the information required for financial statements under IFRS and should be read in conjunction with the Financial Information. See Section 11 "Unaudited Pro Forma Financial Information" for further information about the basis of preparation of the Pro Forma Financial Information.
4.2.2 Industry and market data This Prospectus contains statistics, data, statements and other information relating to markets, market sizes, market shares, market positions and other industry data pertaining to the Group’s future business and the industries and 27
markets in which it may operate in the future. Unless otherwise indicated, such information reflects the Company’s estimates based on analysis of multiple sources, including data compiled by professional organizations, consultants and analysts and information otherwise obtained from other third party sources, such as annual financial statements and other presentations published by listed companies operating within the same industry as the Company may do in the future. Unless otherwise indicated in the Prospectus, the basis for any statements regarding the Company’s competitive position in the future is based on the Company’s own assessment and knowledge of the potential market in which it may operate.
The Company confirms that where information has been sourced from a third party, such information has been accurately reproduced and that as far as the Company is aware and is able to ascertain from information published by that third party, no facts have been omitted that would render the reproduced information inaccurate or misleading. Where information sourced from third parties has been presented, the source of such information has been identified. The Company does not intend, and does not assume any obligations to update industry or market data set forth in this Prospectus.
Industry publications or reports generally state that the information they contain has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. The Company has not independently verified and cannot give any assurances as to the accuracy of market data contained in this Prospectus that was extracted from these industry publications or reports and reproduced herein. Market data and statistics are inherently predictive and subject to uncertainty and not necessarily reflective of actual market conditions. Such statistics are based on market research, which itself is based on sampling and subjective judgments by both the researchers and the respondents, including judgments about what types of products and transactions should be included in the relevant market.
As a result, prospective investors should be aware that statistics, data, statements and other information relating to markets, market sizes, market shares, market positions and other industry data in this Prospectus (and projections, assumptions and estimates based on such information) may not be reliable indicators of the Company’s future performance and the future performance of the industry in which it operates. Such indicators are necessarily subject to a high degree of uncertainty and risk due to the limitations described above and to a variety of other factors, including those described in Section 2 "Risk Factors" and elsewhere in this Prospectus.
4.2.3 Other information In this Prospectus, all references to "NOK" are to the lawful currency of Norway, all references to "EUR" are to the lawful common currency of the EU member states who have adopted the Euro as their sole national currency, all references to "USD" or "U.S. Dollar" are to the lawful currency of the United States and all references to "CHF" are to the lawful currency of Switzerland. No representation is made that the NOK, EUR, USD or CHF amounts referred to herein could have been or could be converted into NOK, EUR, USD or CHF, as the case may be, at any particular rate, or at all. The Financial Information is published in NOK.
4.2.4 Rounding Certain figures included in this Prospectus have been subject to rounding adjustments (by rounding to the nearest whole number or decimal or fraction, as the case may be). Accordingly, figures shown for the same category presented in different tables may vary slightly. As a result of rounding adjustments, the figures presented may not add up to the total amount presented.
4.3 Cautionary note regarding forward-looking statements This Prospectus includes forward-looking statements that reflect the Company’s current views with respect to future events and financial and operational performance. These forward-looking statements may be identified by the use of forward-looking terminology, such as the terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "will", "would" or, in each case, their negative, or other variations or comparable terminology. These forward-looking statements as a general matter are all statements other than statements as to historic facts or present facts and circumstances. They appear in the following Sections in this Prospectus, Section 7 "Industry and Market Overview", Section 8 "Business of the Group" and Section 10 "Selected Financial and Other Information", and include statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, financial strength and position of the Group, operating results, liquidity, prospects, growth, the implementation of strategic initiatives, as well as other statements relating to the Group’s future business development and financial performance, and the industry in which the Group operates.
Prospective investors in the Shares are cautioned that forward-looking statements are not guarantees of future performance and that the Group’s actual financial position, operating results and liquidity, and the development of the 28
industry and potential market in which the Group may operate in the future, may differ materially from those made in, or suggested by, the forward-looking statements contained in this Prospectus. The Company cannot guarantee that the intentions, beliefs or current expectations upon which its forward-looking statements are based will occur.
By their nature, forward-looking statements involve, and are subject to, known and unknown risks, uncertainties and assumptions as they relate to events and depend on circumstances that may or may not occur in the future. Because of these known and unknown risks, uncertainties and assumptions, the outcome may differ materially from those set out in the forward-looking statements. Important factors that could cause those differences include, but are not limited to:
implementation of its strategy and its ability to further grow;
the development and regulatory approval of the Company’s products;
the Company’s ongoing clinical trials and expected trial results;
technology changes, new products and services introduced into the Company’s potential market;
ability to develop additional products and enhance existing products;
the competitive nature of the business the Company may operate in and the competitive pressure and changes to the competitive environment in general;
earnings, cash flow and other expected financial results and conditions;
fluctuations of exchange and interest rates;
changes in general economic and industry conditions, including competition and pricing environments;
political and governmental and social changes;
changes in the legal and regulatory environment;
environmental liabilities;
access to funding; and
legal proceedings.
The risks that are currently known to the Company and which could affect the Group’s future results and could cause results to differ materially from those expressed in the forward-looking statements are discussed in Section 2 "Risk Factors".
The information contained in this Prospectus, including the information set out under Section 2 "Risk Factors", identifies additional factors that could affect the Company’s financial position, operating results, liquidity and performance. Prospective investors in the Shares are urged to read all Sections of this Prospectus and, in particular, Section 2 "Risk Factors" for a more complete discussion of the factors that could affect the Group’s future performance and the industry in which the Group operates when considering an investment in the Company.
These forward-looking statements speak only as at the date on which they are made. The Company undertakes no obligation to publicly update or publicly revise any forward-looking statement, whether as a result of new information, future events or otherwise. All subsequent written and oral forward-looking statements attributable to the Company or to persons acting on the Company’s behalf are expressly qualified in their entirety by the cautionary statements referred to above and contained elsewhere in this Prospectus.
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5 REASONS FOR THE SUBSEQUENT OFFERING AND THE LISTING The Company applied for the Listing of all of its Shares (including the Private Placement Shares but excluding the Offer Shares) on Oslo Axess on 30 June 2016, and the board of directors of the Oslo Stock Exchange approved such listing application on 5 July 2016, subject to certain conditions being met. All such conditions have been met as of the date of this Prospectus.
The purpose of the Subsequent Offering is to enable the Eligible Shareholders to subscribe for Shares in the Company at the same price as in the Private Placement, thus limiting dilution of their shareholding. Eligible Shareholders are shareholders of the Company as of 21 June 2016 (as registered in the VPS on the Record Date), other than shareholders who were part of the pre-sounding for or were allocated shares in the Private Placement completed by the Company on 6 July 2016 and shareholders in jurisdictions other than Norway where an offer to participate in the Subsequent Offering is not allowed or would require approval or registration of a prospectus or similar measures.
The Company believes that the completed Private Placement, the Listing and the Subsequent Offering will:
diversify and increase the shareholder base;
further improve its ability to attract and retain key management and employees;
strengthen the working capital of the Company;
provide a regulated market for the Shares and give the Company improved access to the capital markets for potential future funding; and
strengthen the Group’s profile with investors and business partners.
The expected net proceeds from the Private Placement, the Subsequent Offering and the existing cash is expected to finance the Group to the end of 2017, which is beyond six clinical data read-outs. The Company currently anticipates that it will use the net proceeds from the Private Placement and the Subsequent Offering as follows:
Finance a clinical trial of ONCOS-102 in mesothelioma (in combination with standard of care chemotherapy) to first data read-outs in 2017;
Finance a clinical trial ONCOS-102 in melanoma (in sequence with a check point inhibitor) to first data read- outs in 2017;
Finance a clinical trial of TG02 in colorectal cancer) to first data read-outs in 2017;
Finance Targovax’s share of clinical 2016-2017 trial costs related to planned collaboration trials with Ludwig Cancer Research / Cancer Research Institute (potentially in several indications and potentially including ovarian) as well as with Sotio (in prostate);
Finance the follow-up of the fully recruited trial of TG01 in resected pancreatic cancer; and
Finance CMC and manufacturing activities to related to these trials.
It is expected that 60-65% of the R&D costs in 2016-17 will be devoted to the Oncos platform.
At the date of the Prospectus, the Company cannot predict all of the specific uses for the net proceeds, or the amounts that will be actually spent on the uses described above. The exact amounts and the timing of the actual use of the net proceeds will depend on numerous factors, amongst others progress, costs and results of the Group’s preclinical and clinical development program as other developments in the field of cancer treatment, and regulatory results and developments.
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6 DIVIDENDS AND DIVIDEND POLICY 6.1 Dividend policy The Company has not paid any dividends for the years ended 31 December 2015 and 2014 or previous years. The Group is focusing on the development of pharmaceutical products and does not anticipate paying any cash dividend until sustainable profitability is achieved.
6.2 Legal constraints on the distribution of dividends Dividends may be paid in cash, or in some instances, in kind. The Norwegian Public Limited Companies Act of 13 June 1997 no. 45 (the "Norwegian Public Limited Companies Act") provides the following constraints on the distribution of dividends applicable to the Company:
Section 8-1 of the Norwegian Public Limited Companies Act provides that the Company may distribute dividends to the extent that the Company’s net assets, following the distribution covers (i) the share capital, (ii) the reserve for valuation variances and (iii) the reserve for unrealized gains. The amount of any receivable held by the Company which is secured by a pledge over Shares in the Company, as well as the aggregate amount of credit and security which, pursuant to Section 8–7 to 8-10 of the Norwegian Public Limited Companies Act fall within the limits of distributable equity, shall be deducted from the distributable amount.
The calculation of the distributable equity shall be made on the basis of the balance sheet included in the approved annual accounts for the last financial year, provided, however, that the registered share capital as of the date of the resolution to distribute dividends shall be applied. Following the approval of the annual accounts for the last financial year, the General Meeting may also authorize the Board of Directors to declare dividends on the basis of the Company’s audited annual accounts. Dividends may also be resolved by the General Meeting based on an interim balance sheet which has been prepared and audited in accordance with the provisions applying to the annual accounts and with a balance sheet date not further into the past than six months before the date of the General Meeting’s resolution.
Dividends can only be distributed to the extent that the Company’s equity and liquidity following the distribution is considered sound by the Board of Directors, acting prudently.
In deciding whether to propose a dividend and in determining the dividend amount, the Board of Directors will take into account legal restrictions, as set out in the Norwegian Public Limited Companies Act, the Company’s capital requirements, including capital expenditure requirements, its financial condition, general business conditions and any restrictions that its contractual arrangements in place at the time of the dividend may place on its ability to pay dividends and the maintaining of appropriate financial flexibility. Except in certain specific and limited circumstances set out in the Norwegian Public Limited Companies Act, the amount of dividends paid may not exceed the amount recommended by the Board of Directors.
The Norwegian Public Limited Companies Act does not provide for any time limit after which entitlement to dividends lapses. Subject to various exceptions, Norwegian law provides a limitation period of three years from the date on which an obligation is due. There are no dividend restrictions or specific procedures for non-Norwegian resident shareholders to claim dividends. For a description of withholding tax on dividends applicable to non-Norwegian residents, see Section 15 "Taxation".
6.3 Manner of dividend payment Any future payments of dividends on the Shares will be denominated in the currency of the bank account of the relevant shareholder, and will be paid to the shareholders through the VPS. Shareholders registered in the VPS who have not supplied the VPS with details of their bank account, will not receive payment of dividends unless they register their bank account details with the VPS registrar (Nordea). The exchange rate(s) that is applied when denominating any future payments of dividends to the relevant shareholder's currency will be Nordea's exchange rate on the payment date. Dividends will be credited automatically to the VPS registered shareholders' accounts, or in lieu of such registered account, at the time when the shareholder has provided Nordea with their bank account details, without the need for shareholders to present documentation proving their ownership of the Shares. Shareholders' right to payment of dividend will lapse three years following the resolved payment date for those shareholders who have not registered their bank account details with Nordea within such date. Following the expiry of such date, the remaining, not distributed dividend will be returned from Nordea to the Company.
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7 INDUSTRY AND MARKET OVERVIEW 7.1 The pharmaceutical industry 7.1.1 International trends The global market for prescription drug sales has demonstrated a compound annual growth rate ("CAGR") of some 4% between 2005 and 2014, and is expected to grow by a robust 4.8% per year (CAGR) to reach USD 987bn by 2020 (EvaluatePharma, 2015).
Figure 1 Prescription drug sales (EvaluatePharma, 2015
USA was the largest market for prescription drug sales in 2014, amounting to USD 224.9bn or 30% of total worldwide prescription drug sales, followed by Europe by USD 130.4bn or 17.5%. Sales in emerging markets have been among the main drivers of growth in total revenues. According to IMS Health, sales growth CAGR in Asia, Africa and Latin America was around twice the global growth CAGR between 2009 and 2014. 4
The pharmaceutical market is currently exposed to opposing forces that will determine the industry’s future. Tailwinds are the demographic shift towards a larger elderly population as well as a longer life expectancy. The graph below summarizes the development in the population (i) older than 60 years, (ii) older than 65 years and (iii) older than 85 years, measured as a percentage of the total population. According to the U.S. Department of Health and Human Services; Administration for Community Living ("AoA") the percentage of the population older than 60 years is projected to be 26% in 2050, compared to 18% in 2010. As the world population grows, the number of patients with chronic diseases rises, and new and/or other diseases are becoming more abundant. Also, the middle class is grows fast in certain parts of the world, and the social focus on healthcare is increasing. These factors are assumed to increase the demand for healthcare in the future. .
Figure 2 Development in population aid (source: AoA)
Even if several key factors are indicating potential for high growth in the industry, there are also headwinds currently impacting the market. Among the most important ones are governmental interference with current market conditions. Governments and health authorities are increasingly discussing pricing power of pharmaceutical companies and fear of
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stricter pricing controls and regulations are looming. The holistic picture is however more complex, as a balance must be found between controlling healthcare costs on one hand while incentivizing pharmaceutical companies to develop new and innovative treatments for diseases with high unmet medical needs on the other.
Drug regulatory authorities are looking to maintain high standards for the drugs that receive market authorization, while accelerating approval and attempting to limit time to market for new and efficacious treatments. History provides a number of examples of drugs that have passed governmental criteria, but later were taken off the market due to severe side-effects. Well known examples are Bextra and Vioxx which were withdrawn from the marketplace after fatalities attributed to the products were reported.
7.2 The cancer market 7.2.1 General The market for cancer therapeutics has experienced lower growth than anticipated in recent years. World-wide spending on cancer drugs reached USD 91 billion in 2013, with a CAGR of 5.4% spanning from 2008 to 2013. The same market grew with a CAGR of 14.2% from 2003 to 2008, which indicates a severe slowdown that can partly be explained by fewer major breakthroughs. 3 However, with many new drug candidates in the pipeline, there was increased activity in the equity capital market during 2014 and 2015, with numerous companies applying for listing in the US and Europe.
7.2.2 Cancer epidemiology The World Health Organization’s ("WHO") Globocan report estimates that cancer accounted for 8.2 million deaths in 2012, which makes it the world’s most deadly group of diseases. In 2012, 32.6 million individuals lived with a 5-year cancer diagnosis, while 14.1 million new cases of cancer were reported. 4 The overview below summarizes the estimated cancer incidence and mortality worldwide for men and women, respectively. Today, cancer accounts for about one in every seven deaths worldwide. By 2030 the American Cancer Society expects the number of new incidents of cancer to be 21.7 million per year, and the number of deaths by cancer to increase to 13.0 million.5
Figures 3 Cancer incidents and mortality (Source: WHO Globocan 2012)
3 Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report, IMS Institute for Healthcare Informatics, 2014 4 WHO Globocan 2012 5 Cancer Facts & Figures 2014, American Cancer Society, 2014
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7.2.3 Traditional cancer treatments The cancer therapy (oncology) market is highly diversified, and the optimal cancer treatment should be individualized, depending on the type, stage and differentiation of the cancer, as well as the patient’s overall physical condition and age. A patient’s treatment plan may consist of one or many different treatment modalities, depending on the situation. For some cancer patients treatment is of a curative intent, while for others, the intent is to relieve suffering and to increase quality of life (palliative care). Traditionally, surgery, chemotherapy, radiation therapy and hormone therapy are among the most common treatments. However, new and innovative approaches like targeted therapies and immunotherapy are increasingly being utilized for the treatment of cancer.
Surgery Surgery is used both to diagnose and to treat cancer. During surgery it is possible to remove entire or parts of cancer tissue to test it to clarify the stage of cancer, and evaluate what measures can be taken in order to treat the patient. Surgery can in some cases cure the patient from cancer, given that the cancer has not spread to vital parts of the body prior to surgery being performed or that the cancer can be resected in its entirety.6
Chemotherapy Chemotherapy is a systematic cancer treatment that involves the use of cytotoxic drugs, and is often used as an adjuvant treatment given in addition to surgery or radiation therapy in order to kill any remaining cancer cells or control the tumor. This type of treatment may consist of one drug or a combination of drugs, administered either intravenously or orally. Patients may experience severe side-effects from some types of chemotherapy that significantly affect their quality of life and/or prevent the therapy to continue. The main reason why patients suffer from side-effects is that chemotherapy drugs indiscriminately target both normal, healthy cells as well as cancer cells.7 Fortunately, targeted therapies that more specifically target oncogenic molecules and hence have milder side effects are more commonly used these days, while chemotherapy may be used to control the cancer by slowing down its growth in cases where it is not possible to eliminate the cancer or reduce the risk of recurrence.8
Radiation therapy Radiation therapy is a cancer treatment that involves the use of different types of high-energy external beam radiation to irradiate and destroy cancer cells. Radiation therapy can be used as part of a treatment plan with other treatments such as surgery or chemotherapy or as monotherapy. It is a treatment that aims to target only the tumor tissue.9 However, side effects often occur because the radiation can also damage surrounding healthy cells and tissue. Major improvements in technology have led to more precise radiation treatment resulting in fewer side effects.10
Hormone therapy Hormone therapy is a form of systemic therapy that works to add, block or remove hormones to stop or slow down the growth of cancer cells affected by fluctuating hormone levels. Some types of cancers, i.e. breast cancer and prostate cancer, are hormone sensitive or hormone dependent, and will therefore be susceptible to hormone therapy11.
7.3 Immunotherapy and the immunotherapy market Over the last few decades the understanding of the immune system’s role in cancer has increased, and with it, the focus on immunotherapy. In contrast to the traditional cancer treatments, immunotherapy utilizes the body’s own immune system to fight cancer.
The immune system is a natural defense system that recognizes danger signals such as foreign bodies, bacteria and cancer cells. Almost all human cells showcase on their surface a sample of the proteins of which they are made (in the form of protein fragments called peptides), that can be recognized by cells of the adaptive immune cells, so called T- cells. Normal cells display a range of normal peptides on their surface complexes that will pass through the control checkpoint and do not trigger a reaction by T-cells. Cancer cells however, carry mutations in certain genes and thus produce mutated proteins on their surface that are recognized by T-cells. This triggers the T-cell to attack and kill the
6 http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/surgery/surgery-treatment-toc (accessed 13 January 2015) 7 http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Chemotherapy/Chemotherapy.aspx (accessed 10 July 2015) 8 http://www.cancer.net/navigating-cancer-care/how-cancer-treated/chemotherapy/what-chemotherapy 9 http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Radiotherapy/Radiotherapy.aspx (accessed 10 July 2015) 10 http://www.cancer.net/navigating-cancer-care/how-cancer-treated/radiation-therapy (accessed 10 July 2015) 11 http://www.cancercenter.com/treatments/hormone-therapy/ (accessed 21 August 2015)
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cancer cell. However, sometimes mutations do not change the shape of the peptides drastically enough or the cells learn how to evade the immune system. Cancers with RAS mutations are one such example. T-cells do not easily recognize these slightly abnormal RAS peptides and therefore the T-cells do not readily recognize and kill the cancer cells. See section 8.5.2 for more on the immune system.
Cancer immunotherapies have the goal to elicite an immune response eliminating or slowing the growth of tumor cells12. Cancer immunotherapy involves stimulating the immune system to work harder or smarter to attack the tumor cells, and has become an important additional treatment option within cancer treatment. The immune system can be utilized in several ways, but the most common is to increase or "boost" the immune system and to stimulate it to recognize the cancer cells as foreign bodies that are to be removed. Immunotherapies are being developed in multiple forms, including checkpoint inhibitors, therapeutic vaccines, bispecific antibody-based approaches, small molecules and cell based therapies13.
Even though immunotherapy has been studied in relation to oncology for decades, only in the past decade has cancer immunotherapy shown unprecedented responses in patients with advanced-stage cancers. In 2010, the first ever personalized therapeutic vaccine was approved, followed by the first approval of checkpoint inhibitor in 2011. These landmark events marked a major turning point in immunotherapy, starting a new era of oncology drug development. Interest in immunotherapy was rekindled and in 2013 science magazine wrote about cancer immunotherapy as breakthrough of the year. Newer immunotherapies are able to activate specific immune cells leading to improved targeting of cancer cells, efficiency and safety.
Immunotherapy is now an important additional treatment modality in the fight against many types of cancer14 and represents one of the fastest growing and most promising biotech segments today. The percentage of immuno- oncology addressable cancers is expected to increase to at least 60% by 2023 due to combination strategies.
Figure 4 Global immuno-oncology market (Source: Citi Research, 2013)
According to a report by Citi Research, the immunotherapy market will experience considerable growth over the next years, increasing from USD 1.1 billion in 2012 to an estimated USD 35 billion in 2023, corresponding to 29% annual growth. According to a report by Decision Resources Group 15, major-market share of cancer immunotherapies by geographical regions are expected to develop as shown in the figures below. Decision Resources Group believe the market will reach USB 13.3 billion in 2023. This is a lower number than Citi Research’s estimate, but altogether, significant growth is expected.
12 Decision Resource Special Report – Cancer Immunotherapies May 2015 13 Citi Research 2013 14 http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/immunotherapy/immunotherapy-what-is-immunotherapy (10 July 2015) 15 Decision Resource Special Report – Cancer Immunotherapies May 2015, projections based on seven major pharmaceutical markets; United States, France, Germany, Italy, Spain, United Kingdom, and Japan.
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Figure 5 Development in major-market shares of cancer immunotherapies (Source: Decision Resources Special Report, 2015)
Also supporting the growing immunotherapy market is an increased number of immuno-oncology deals during the last decade. In 2004 there were 7 immuno-oncology deals compared to 82 deals in 2015. The figures below provide historical information on the development in number of deals as well as total deal value within the immuno-oncology sector.
Number of immuno-oncology deals 2004 – 2015 Total deal value (USDm) 2004 – 2015
18000 16582 90 82 16000 80 14000 70 12000 60 10000 50 44 8000 40 34 29 5531 6000 30 4001 17 3288 2958 20 14 4000 7 9 8 99 5 2000 634 10 66 470 6 255 565 303 0 0 200420052006200720082009201020112012201320142015 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Figure 6 Historical development of deals within the immunotherapy sector (Source: GlobalData, 2015)
7.3.1 Immunotherapy – monotherapy The approval of ipilimumab (Yervoy), the first approved checkpoint inhibitor, created a revolution in immunotherapy and cancer treatment in general. As illustrated below, immuno-oncology therapies have the potential to shift the curve of long term survival of patients. Immunotherapy has the potential to increase long term survival, even more so if immunotherapeutic agents are used in combination.
Figures 7 Long term survival of cancer patients (Source: Citi Research 2013)
Checkpoint inhibitors The scientific turning point for immunotherapies came with the understanding that T cell immune responses are controlled through on and off switches, so called immune checkpoints, which let the immune system attack foreign cells while preventing damage to healthy tissue. Immune checkpoint molecules are receptors on T cells that need to be 36
activated (or de-activated) to start an immune response. Some cancer cells can bind to these receptors on activated T cells and turn them off. Immune checkpoint inhibitors are drugs that can prevent cancer cells from turning off the T cells by binding either to the receptors on the T-cells or on the tumor cells. This allows the T cells to stay activated, attack tumor cells and infiltrate the tumor to stop it from growing.
There are several checkpoint molecules on T cells and hence a number of different checkpoint inhibitors (CPIs) in clinical use (e.g. Yervoy, an antibody to CTLA-4, and the more recently introduced Keytruda (pembrolizumab) and Opdivo (nivolumab) which are antibodies to PD-1.) and several other in development, for example PD-L1 inhibitors.
However, not all patients do respond to CPI’s and some cancer types are more likely to respond to checkpoint inhibitors than others. Several reports, including the Immunotherapies Report by Decision Resources highlight the future role of checkpoint inhibitors in combination with current cancer treatment regimens or other immunotherapies rather than as monotherapy. Therapeutic vaccines and oncolytic viruses Therapeutic cancer vaccines are intended to treat existing cancer by strengthening the body’s natural defenses against cancer16. Therapeutic vaccines are meant to train the body’s immune system to recognize and destroy cancer cells. These vaccines are designed to be specific, meaning that they should target the tumor cells without affecting healthy cells. One such target is a family of proteins called RAS. RAS proteins are ubiquitously expressed in all cell lineages and play an important role in regulating cell growth and division. Mutation of RAS can cause sustained cell division and thus drive cancer development. According to a publication by Fernandez-Medarde et al (2011) RAS-mutation are early cancer markers present in up to 30% of all cancer types17.
Currently only one therapeutic cancer vaccine (Sipuleucel-T/Provenge; Dendreon) is approved for clinical use in the USA. There are many therapeutic cancer vaccines in development.
Within immunotherapy there are several different variations and approaches. Oncolytic viruses (OVs) are naturally or genetically modified viruses that selectively infect and kill cancer cells and spread within the tumor, while leaving normal tissue virtually unaffected. The virus can be injected directly into the tumor and subsequently kills the cancer cells through a process were the cell membrane is broken down (often referred to as "lysis"). When the cell membrane is broken down, unique tumor antigens are released and the immune system learns to recognize the unique cancer cells of each patient. As a result, the patient’s immune cells (i.e. T cells) will start to find and kill other, similar cancer cells. In late October 2015 the oncolytic virus Imlygic (talimogene laherparepvec or T-vec) was the first ever oncolytic virus therapy approved by the FDA and the EMA followed closely by approving Imlygic for the use in the EU. The market approval of Imlygic is very important for Targovax’s Oncos platform of oncolytic andenoviruses. As Imlygic is the first oncolytic, genetically modified virus to be approved, this establishes regulatory and reimbursement pathways for oncolytic viruses, as well as demonstrates that an oncolytic virus can be a treatment modality accepted by the medical community. The approval of Amgen’s Imlygic has spurred great interest of other Big Pharma companies in oncolytic viruses as a product category.
16 Lollini PL, Cavallo F, Nanni P, Forni G. Vaccines for tumour prevention. Nature Reviews Cancer 2006; 6(3):204–216. 17 «Ras in cancer and developmental diseases», Fernández-Medarde A. And Santos E. (2011); http://www.ncbi.nlm.nih.gov/pubmed/21779504
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Figures 9 RAS mutations in cancer types (Source: Cancer Res, PS 2012, Nov 15, 2012)
To treat RAS positive cancers it is thought one can use peptide-based cancer vaccine drug candidates that target RAS- mutations. These peptides are injected into the skin of the patient and subsequently the immune system learns to recognize the RAS-mutations and activates immune cells (i.e. T cells) to kill the cancer cells with RAS-mutated proteins.
7.4 Drug development 7.4.1 Overview The development of a pharmaceutical product is a risk-filled, time-consuming and expensive process, which, providing the drug is approved for marketing, has the potential for high returns on investment. On average, five out of 5,000 drugs make it through the preclinical phase, and historically only one out of these five is approved by the FDA for marketing. Moreover, only 2 of 10 marketed drugs return revenues that match or exceed R&D costs.18 It takes on average 12 years to develop a drug.19
7.4.2 Phases The process of developing a drug product candidate is divided into several phases, each used to describe the different aspects of the drug product candidate. The different phases are: the discovery phase, the preclinical development phase and the clinical phase. If a drug confirms to be effective throughout these phases and is approved by the regulatory authorities, it can be marketed and sold to the public.
The discovery phase is often a time-consuming and complicated process. It involves a lot of research time and effort as companies may often screen multiple therapeutic targets and several thousand potential drug candidates at this stage. Most of the potential drug candidates created in this phase do not make it into preclinical testing, but are discarded based on poor results. The drug candidates that do show promising results are tested more in depth in the next phase of the drug development. The first patent applications are normally also filed at this stage.20
In the preclinical development phase, drug candidates that have shown promising results in the discovery phase are tested further in living organisms. The focus during the preclinical phase is on documenting a drug candidate’s safety, efficacy and toxicity in various cell lines (in-vitro) or animal models (in-vivo). Studying a drug’s toxicity (side-effects) is a requirement and prerequisite that is imposed by the authorities in order to maximize patient safety during clinical trials. The preclinical phase also involves extensive testing of the dosing regimen and how the drug product candidate should be administered. If a drug satisfies the necessary requirements it can be tested in humans in what is referred to as the clinical phase.21
18 Vernon JA, Golec JH, DiMasi JA. Drug development costs when financial risk is measured using the fama-french three-factor model. Health Econ. 2010;19(8):1002-1005 19 http://www.medicinenet.com/script/main/art.asp?articlekey=9877 (accessed 10 July 2015) 20 http://www.fda.gov/ForPatients/Approvals/default.htm (accessed 10 July 2015) 21 http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405658.htm (accessed 10 July 2015)
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The clinical phase involves extensive testing of the drugs effect on humans, and is divided into three sub-phases.
Phase I Phase I focuses on safety and pharmacology of a compound. During this stage, different doses of a compound are administered to a small group of healthy volunteers who are closely supervised. Phase I oncology studies are in the vast majority of cases conducted in actual cancer patients, and not healthy volunteers, and test the safety of the new drug/regimen. These studies usually start with low doses, which are gradually increased, while evaluating how the side-effects change. Data on how the drug is absorbed, distributed and metabolized are also collected. It is common to include approximately 20 to 100 individuals (normal subjects or patients) in this sub-phase of clinical development.22 A Phase I/II study is one study having both Phase I objectives and early Phase II objectives.
Phase II Phase II studies focus on more in-depth testing on how effective a drug product candidate is for a specific type of disease. Studies are based on a limited number of patients, but are large enough to provide sufficient statistical power to assess efficacy. Phase II oncology studies are conducted in patients who suffer from the condition the new drug is intended to treat and aim to test the efficacy of the new drug/regimen and to confirm the product safety profile. A wider population of as many as a couple of hundred volunteer patients participate in this part of the clinical development process.23
Phase III If a drug product candidate successfully completes Phase II it can be evaluated in the Phase III setting which is usually one or several studies aimed at generating the data needed for licensing the medicine with regulatory agencies such as FDA/EMA. In this Phase the drug is often compared to a treatment approved for the same disease that is already on the market (standard of care). The focus is on confirming previous efficacy and safety findings in a larger population. These studies can last from one to eight years and involve anything from several hundred to several thousand patients. If a drug is successful in all three clinical phases, a new drug application (an "NDA") is submitted to the FDA or the equivalent governmental agency in other parts of the world. The NDA contains all information obtained during the testing phase. The regulatory agency then completes an independent review and makes its recommendations. The standard time of review is 12 months. However, sometimes NDAs which address areas of significant medical need may be granted faster approval processes. After the product is approved, it can be marketed.24
7.4.3 Development of cancer drugs The development of a cancer drug can often be shorter and less complicated than the development of drugs for other indications, because of the great medical need for new therapies, the life threatening nature of the disease, as well as the low number of cancer patients that can be treated.
• Phase I can involve testing on cancer patients, which will give an early indication of the drugs’ efficacy.
• It is possible to apply for fast-track review if a drug shows superior efficacy, or spares serious side effects compared to treatments that are currently available. A drug has a high probability of being awarded fast track if it shows exceptional results at an early stage and the market currently lacks valuable treatment alternatives.
• Health authorities in the U.S., the EU and in Japan can also grant certain drugs orphan designation, if the drug treats a disease that only affects a small number of people. This is a way of stimulating research and development of drugs for less common diseases. An orphan drug designation can result in a series of advantages, including premium pricing, lower registration fees and extended market exclusivity for up to ten years.25
In some cases promising results from Phase II can be sufficient to receive a marketing approval for a specific drug product candidate. This is often referred to as accelerated approval ("AA").26 The FDA has developed the AA program
22 http://www.cancer.net/navigating-cancer-care/how-cancer-treated/clinical-trials/phases-clinical-trials (accessed 10 July 2015) 23 http://www.cancer.net/navigating-cancer-care/how-cancer-treated/clinical-trials/phases-clinical-trials (accessed 10 July 2015) 24 http://www.cancer.net/navigating-cancer-care/how-cancer-treated/clinical-trials/phases-clinical-trials (accessed 10 July 2015) 25 http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm (accessed 9 July 2015) 26 http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313768.htm (accessed 9 July 2015)
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to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. The criteria for being granted AA are the following27:
• The drug must be intended to treat a serious condition. A serious condition is defined by the FDA as a disease or condition associated with morbidity that has substantial impact on day-to-day functioning.
• The drug provides a meaningful therapeutic benefit over existing treatments.
• The drug demonstrates an effect on an endpoint that is reasonably likely to predict clinical benefit. A clinical endpoint is a characteristic or variable that directly measures a therapeutic effect of a drug, for example how a patient feels, functions or survives. A clinical benefit is a positive therapeutic effect that is clinically meaningful in the context of a given disease. There are two types of endpoints that can be used as a basis for AA which are (i) a surrogate endpoint that is considered reasonably likely to predict clinical benefit, and (ii) a clinical endpoint that can be measured earlier than irreversible morbidity or mortality ("IMM") that is reasonably likely to predict an effect on IMM or other clinical benefit. Determining whether an endpoint is reasonably likely to predict clinical benefit is a matter of judgment that will depend on the biological plausibility of the relationship between the disease, the endpoint and the desired effect and the empirical evidence to support that relationship.
• The drug must be produced by using fully developed processes and controls to Good Manufacturing Practice (GMP) standards. While AA represents a shortcut to the market by reducing the need for clinical testing, it does not reduce in any way the requirements to the quality of the drug and its manufacturing
Drugs granted AA must meet the same statutory standards for safety and effectiveness as those granted traditional approval. Under AA, the FDA can rely on a particular kind of evidence, such as a drug’s effect on a surrogate endpoint, as a basis for approval. Companies that receive an AA for a drug product candidate are normally required to conduct the rest of the clinical development program post-approval.
7.4.4 The orphan drug market An orphan drug is a therapeutic agent specifically developed for a rare ("orphan") disease. The orphan drug market, when compared with the overall drug pharmaceutical market, is exempted from several governmental regulations, which increases profitability and makes research and development less onerous. The market has shown promising signs of growth over the last couple of years, and in 2013 orphan drug sales increased by 6.8% versus previous year, to reach USD 90 billion. In comparison, overall prescription drug sales (excluding generics) grew by only 0.1% in the same period, and amounted to a total of USD 650 billion. The worldwide orphan drug market is estimated to grow to USD 176 billion by 2020. This area of development grows at a CAGR of 10.5%, almost double that of the overall prescription drug pharmaceutical market.28
27 http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313768.htm (accessed 9 July 2015) 28 Orphan Drug Report 2014, EvaluatePharma, 2014 (accessed 9 July 2015)
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8 BUSINESS OF THE GROUP 8.1 Overview Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aim to become a leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology.
The Company’s vision is to "arm patient’s immune system to fight cancer" by extending and transforming the lives of cancer patients with first-in-class specific therapeutic cancer vaccines. The Group’s pipeline includes a number of product candidates aimed at different cancer types like pancreas, melanoma, mesothelioma, colorectal cancer and ovarian cancer.
Each vaccine is designed to harness the patient’s own immune system to fight the cancer while also delivering a favorable safety and tolerability profile.
Targovax head office is in Oslo and it has an R&D subsidiary in Finland. On 2 July 2015, the Norwegian part of Targovax acquired all the shares in Oncos, then a clinical-stage biotechnology company based in Helsinki, which also is focusing on the design and development of targeted cancer immunotherapy (the "Combination"). Following the Combination, Oncos is a wholly-owned subsidiary of the Company and has been renamed Targovax Oy.
Targovax is targeting two complementary approaches to cancer immunotherapy:
(i) a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of patients with pancreatic cancers29, 50% of colorectal cancer30 and 20-30% of all cancers31; and
(ii) a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune- stimulating transgenes targeting solid tumors, potentially reinstating the immune system's capacity to recognize and attack cancer cells.
Prior to the Combination, Targovax was solely focusing on immunotherapy for patients with RAS-mutated cancer. RAS mutations are key drivers of cancer progression which are found in 20 - 30% of all cancers32. There are few treatment options available for patients with RAS mutations, and the options available have limited efficacy, which highlights the significant medical need for these patients.
The Group’s technology is specific and works by educating the patient’s own immune system to recognize and kill cancer cells.
Studies to date have shown that the Group’s lead vaccine for RAS-mutated cancer, TG01, induces immune responses in cancer patients, which may translate clinically to a survival benefit, and has an acceptable safety and tolerability profile with few side effects. In an ongoing clinical trial it has also been demonstrated that TG01 can effectively induce immune response when used in combination with gemcitabine chemotherapy. Interim 1-year survival data has also shown encouraging results, albeit in a small number of patients. Up to six months of combination therapy was generally well tolerated with few side effects. TG01-related anaphylactic reactions were seen at two occasions in connection with TG01 booster treatments post combination therapy. Therefore, the Group has added a third cohort to the study with a reduced number of TG01-doses. The preliminary results from this cohort with a reduced number of TG01 administrations show that immune response is induced at the similar level as with the earlier vaccination schedule which had a higher number of administrations.
The Group's other lead compound, ONCOS-102, has successfully completed Phase I clinical studies where it has shown systemic tumor specific immune activation and indications of potential clinical anti-tumor efficacy in patients with different solid tumors. ONCOS-102 will enter further clinical studies in the near future for the treatment of solid tumors such as melanoma, malignant pleural mesothelioma and ovarian cancer.
29 Miglio, U. et al; KRAS mutational analysis in ductal adenocarcinoma of the pancreas and its clinical significance; Pathol Res Pract. 2014; 210(5):307-11. 30 Van Cutsem, E. et al; Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Treatment and RAS Mutations in Colorectal Cancer; J Clin Oncol. 2015; 33(7):692-700 31 Fernandez-Medarde, A. and Santos, E.; RAS in Cancer and Developmental Diseases; Genes & Cancer. 2011; 2(3):344–358 32 Fernandez-Medarde, A. and Santos, E.; RAS in Cancer and Developmental Diseases; Genes & Cancer. 2011; 2(3):344–358
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The Group is currently conducting one Phase I/II clinical trial with TG01 in resected pancreatic cancer and is initiating several clinical trials in multiple cancer types with high medical need during 2016 with TG02 and ONCOS-102.
Targovax has Orphan Drug Designation with the FDA and EMA for TG01 in pancreatic cancer and ONCOS-102 in malignant plural mesothelioma, ovarian cancer and soft tissue sarcoma. Soft tissue sarcoma is an indication currently not being pursued by Targovax.
While the research and development strategy is designed in-house, the Group collaborates with academic institutions to execute its development strategy. Similarly, the Group uses external contract manufacturing organizations ("CMOs") to produce its compounds. The Group has employed experienced personnel that are capable of directing work that is performed by the CMOs. This approach to product development allows the Group to easily change research directions and efforts when needed and to quickly bring in new technologies and expertise when necessary. The Group remains committed to the discovery, development and delivery to patients of its innovative therapeutic cancer treatments.
Biotech companies at Targovax’s stage of development normally do not have a developed strategy for commercialization. Targovax has an opportunistic attitude to out-licensing and partnering, and at the same time eventually preparing a stand-alone alternative to commercialization. Geographically, Targovax and/or its future partners, will target large countries with mature reimbursement systems. This is the norm in the biotech and pharma industry and does not imply that Targovax will not aim to sell its products in smaller and less mature markets, but USA and top-5 Europe will be prioritized before rest of Europe, Japan, Canada and Australia. After these, other markets will follow.
The Group’s technology can be combined with other treatment approaches, including surgery, radiation, chemotherapy or other immune therapies.
8.2 Competitive strengths Targovax believes that it has a number of competitive strengths that will enable it to successfully commercialize its therapeutic cancer vaccines in the market place. These strengths include that:
• Targovax has unique technologies with promising data: The Group’s clinical experience to date confirms that both TG01 and ONCOS-102 can be used safely and observed immune responses are consistent with the assumed mechanism of action of the Group’s technology platforms. The Group has a solid immuno-oncology pipeline with both technology platforms suitable for combination therapies with both chemotherapy and other immunotherapies, for example check point inhibitors (CPIs). Furthermore, the Company has a strong pipeline with programs in several indications which provide the Group with a broad and diversified pipeline of products.
• Targovax has multiple shots on goal: Targovax has a strong focus on novel immunotherapies with two technologies and three clinical stage product candidates in developement. Between these three candidates, Targovax has one ongoing trial and plans five new combination trials covering a total of six indications. Six efficacy readouts are expected in 2017 and six in 2018.
• Targovax has Orphan Drug Designation in four indications: The Group has Orphan Drug Designation for TG01 in pancreatic cancer and ONCOS-102 in malignant plural mesothelioma, ovarian cancer and soft tissue sarcoma (there is currently no clinical development plan related to soft tissue sarcoma). An Orphan Drug Designation can result in a number of advantages for the Group, including premium pricing, lower registration fees and extended market exclusivity for seven (US) and ten (Europe) years.
• Targovax is positioned as a leading immuno-oncology specialist: The immuno-oncology market is poised for strong growth and is expected, by some analysts, to reach USD 35 billion by 2023 33 . The combination of the Group’s peptide therapeutic cancer vaccines for RAS mutations together with its viral therapeutic cancer vaccines has created an attractive development platform for immunotherapies.
• Targovax has an experienced management team and board: The Group has a strong executive management team and board with relevant biotech pharmaceutical drug development and commercial and international experience. The highly experienced and competent organization enables the Group with accelerated development and efficient execution.
33 Citi Research: “Immunotherapy - The Beginning of the End for Cancer”, A Baum, 22 May 2013
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• Targovax has ongoing clinical collaborations: The Group has ongoing clinical collaborations with Ludwig Cancer Research and Cancer Research Institute of the U.S., as well as Sotio a.s. of the Czech Republic, both in order to generate combination data between ONCOS-102 and other innovative cancer immunotherapies.
• Targovax is backed by leading life science focused investors: The Company has a strong shareholder base, including specialist investor HealthCap. The Group is further backed by highly recognized Norwegian early stage investors and reputable institutions.
• Targovax has a strong intellectual property position: The Group has a strong intellectual property position with patent applications either filed, pending or granted that expire from year 202934.
Targovax uses well established state of the art production technologies: The Group uses well established state of the art production technologies securing low cost of goods. The Group works with contract manufacturers where the production process is currently being tailored and optimized to ensure high quality products for all stages of clinical trials as well as commercial product.
Targovax has stable and easy to handle products compared to cell based products: Targovax has stable products that are easy to handle securing uncomplicated logistics compared to cell based products.
8.3 Strategy Targovax, an innovation driven immuno-oncology specialist, is committed to develop, manufacture and deliver to patients innovative targeted first-in-class therapeutic cancer vaccines to extend and transform the lives of cancer patients with solid tumors. The Group is aiming to become a leading immuno-oncology development company with a broad and diversified portfolio of therapeutic cancer vaccine candidates in multiple cancer forms. The Group’s targeted therapeutic cancer vaccines are ideally positioned to be combined with Standard-of-Care chemotherapies as well as other types of immunotherapies, for example check point inhibitors (CPIs).
Push ahead with the clinical development programs for TG01, TG02, and ONCOS-102 The Group is currently conducting one Phase I/II clinical trial with TG01 in resected pancreatic cancer and is initiating five Phase I/II clinical trials in multiple cancer types with high unmet medical need during 2016, including Anti-PD1 refractory melanoma, mesothelioma, ovarian and prostate cancer with ONCOS-102 and colorectal cancer with TG02. Three of these new studies are sponsored by Targovax while the other two are sponsored by the CRI and Sotio.
Evaluate the combination of ONCOS-102 and check point inhibitors (CPIs) in non-responding CPI patients Evaluate the combination of ONCOS-102 and check point inhibitors (CPIs) in patients who show a poor or no response to CPI based therapy to improve outcomes in current target indications for CPIs. This would potentially expand immunotherapy treatment into larger populations of patients. The majority of patients who receive a CPI do not respond to such therapy and may benefit from the additional immune priming and activation of T cells that ONCOS- 102 induces.
Optimize the Group’s manufacturing capabilities to ensure later stage clinical trials and commercial supply The Group plans to optimize the manufacture, supply and quality systems for its therapeutic candidates to ensure its manufacturing capability is sufficient for later stage clinical trials and commercial supply.
Expand its intellectual property profile The Group intends to continue building its technology platforms, comprised of intellectual property and know how in the field of targeted therapeutic cancer vaccines. These assets form the foundation for its ability to successfully strengthen, defend and expand its position.
Selectively pursue partnerships and clinical trial collaborations The Group intends to build on its existing strong relationship with well-known research centers in Europe and the US to identify new opportunities and position the Group in the field of targeted therapeutic cancer vaccines. The Group will pursue partnerships with leading pharmaceutical companies in the immuno-oncology field to maximize commercial opportunities. The Company is not actively pursuing out-licensing opportunities prior to Proof-of-Concept, but is ready to react opportunistically to prospects with good terms to maximize shareholder value. In the near term, the primary focus of Targovax business development efforts will be to secure clinical trial collaborations with pharmaceutical companies in order to conduct joint clinical trials and thus create more clinical data. The Company believes that clinical
34 Two patents expire prior to 2029: One in 2016 and one in 2019, see Section 8.8.6 “Patents and patent applications”.
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trial collaborations have the potential to drive significant value through combined capabilities.
Progress further targeted therapeutic cancer vaccine candidates to the product development stage The Group currently has four research programs on potential therapeutic cancer vaccines candidates. The Group intends to advance these research programs into preclinical and clinical development as a soon as practicable. The Group’s most advanced research candidate, ONCOS-402 containing a CD40L transgene, may enter clinical development already in 2017.
Explore the combination of the Group’s peptide therapeutic cancer vaccines for RAS mutations together with its viral therapeutic cancer vaccines The Group will explore the combination of its peptide therapeutic cancer vaccines for RAS mutations together with its viral therapeutic cancer vaccine as it is likely to generate a more powerful and broad immune response than either product alone.
8.4 History and important events The table below provides an overview of key events in the history of the Group:
Year Event
1993 ...... First patient (ever) treated with RAS peptide. As a result of the research collaboration between Oslo University Hospital (Nw. Rikshospitalet) and Norsk Hydro, the first clinical trial with RAS peptide vaccination was initiated. The trial was sponsored by Oslo University Hospital and the founders of the Company were central in conducting the study.
1998 ...... First patient treated with TG01. After the first clinical trial in 1993, Norsk Hydro initiated commercial development of RAS peptide vaccines and TG01. Norsk Hydro was sponsor for several exploratory clinical trials with RAS peptide vaccines and the first trial with TG01. The founders of the Company were central in conducting the research and the clinical programs.
2008 ...... First administration of ONCOS-102 in hospital exemption use setting by Akseli Hemminki and his university group.
2009 ...... Oncos (now Targovax Oy) was established by Akseli Hemminki (scientific founder), Pekka Simula, Antti Vuolanto, Mikko Salo and Mark Roth
2010 ...... The Company was established by inventors of the RAS-targeted technology and the Norwegian Radium Hospital Research Foundation
2011 ...... Orphan Drug status granted in EU and US for TG01 GMP production established for TG01 and ONCOS-102
2012 ...... Securing immune stimulator GM-CSF for Phase I/II clinical development of TG01 EMA advice supporting the clinical development plan for TG01 Regulatory approval for Phase I/II clinical trial with TG01 in combination with gemcitabine in resected pancreatic cancer Phase I clinical trial initiated for ONCOS-102, an adenovirus 5/3 with a GM-CSF transgene
2013 ...... First patient treated for TG01 in combination with gemcitabine Completed recruitment of 12 patients in Phase I clinical trial for ONCOS-102 Orphan Drug Designation granted in EU and the US for ONCOS-102 in soft tissue sarcoma
2014 ...... The Company is registered on the N-OTC Phase I part of Phase I/II clinical trial successfully completed for TG01 in combination with gemcitabine with RAS specific immune response in 6/6 patients Phase II clinical trial initiated for TG01 in combination with gemcitabine Phase I clinical trial for ONCOS-102 completed with demonstration of systemic anti-tumor immune response in two patients, immune activation at lesional level in 11/12 patients and 40% stable disease (SD) Orphan Drug Designation granted in EU and the US for ONCOS-102 in ovarian cancer and malignant plural mesothelioma Appointment of Gunnar Gårdemyr as Chief Executive Officer of the Company and Magnus Jäderberg as Chief Medical Officer of Oncos (now Targovax Oy)
2015 ...... Completed recruitment of 18 patients in the Phase I/II clinical trial investigating TG01 in combination with gemcitabine in resected pancreatic cancer Pre-clinical toxicology studies completed for TG02 Manufactured study medication for TG02 Phase I/II trial due in 2016 Cloned ONCOS-402, an adenovirus 5/3 with a CD40L transgene, ready for pre-clinical testing due in 2016 Phase I clinical study for ONCOS-102 published in (Journal of ImmunoTherapy for Cancer) Appointment of Øystein Soug as new Chief Financial Officer and Peter Skorpil as Head of Business Development Targovax presented interim data from the ongoing Phase I/II clinical study at ASCO 2015 and Oncos presented Phase I
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immunoactivation data The Company and Oncos successfully complete the Combination Successful completion of a NOK 200 million private placement Signed collaboration with Cancer Research Institute (CRI) and Ludwig Institute for Cancer Research (LICR) Signed collaboration agreement with Sotio Submitted two clinical trials to competent authorities 2016 ...... Announced interim survival analysis of a first cohort of the ongoing open label, Phase I/II of TG01 and standard of care chemotherapy in patients with resected pancreatic cancer Announced interim DTH immunological data of a second cohort of the same trial Targovax has received approval in Australia to conduct a Phase I clinical trial of TG02 and pembrolizumab in patients with locally recurrent, RAS mutated rectal cancer. Targovax has received approval in Spain to conduct a Phase I/II clinical trial of ONCOS-102 and standard of care chemotherapy in advanced refractory malignant pleural mesothelioma.
8.5 Overview of the Group’s science 8.5.1 Background to immuno-oncology Cancer has historically been treated with surgery, radiation, chemotherapy, or hormone therapy. Over the last few decades, the understanding of the immune system’s role in cancer has increased and has led to immunotherapy becoming an important additional treatment option. Initially, new immunotherapies for cancer were nonspecific in their activation of the immune system which meant limited efficacy and/or significant toxicity while newer immunotherapies are able to activate specific immune cells leading to improved targeting of cancer cells, efficacy and safety. There are various categories of immune therapies including cytokines, antibodies, adoptive cell therapies and peptide as well as virus based vaccines.
Cytokines Interferon-alfa, a cytokine, was the first to be approved for cancer patients in the 1980s. A recent example of cytokines in oncology is Interleukin-2 (IL-2). Cytokines are proteins produced by a number of different cells including T-cell and B-cells. They play an important role in cell signaling, and, in the immune system, cytokines modulate the balance between humoral and cell-based immune responses.
Antibodies The 1990s saw a number of antibodies introduced such as Rituxan, later followed by Herceptin and Avastin in the 2000s. In the 2000s, we saw antibodies that target T cell check point inhibitors (CPIs) being developed with Yervoy, being the first check point inhibitor (CPI), launched in 2011 for the treatment of advanced melanoma. Yervoy was followed by Keytruda and Opdivo in 2014, now approved for both advanced melanoma and lung cancer. However, despite the advances of check point inhibitors (CPIs), there remains a significant unmet medical need in that the majority of patients with cancer, including advanced melanoma, do not respond to check point inhibitors (CPIs). Major tumor types such as pancreas, prostate, colon and ovarian as well as patient groups within responsive tumors often do not respond to current immunotherapy approaches. One theory to explain this non-responsiveness is that certain tumors require direct immune stimulation and recent studies have shown how the absence of the right type of cytotoxic T cells at the tumor is correlated with poor prognosis. Thus, immune therapies that target immune activation at the site of the tumor (lesional level), are suitably placed to be combined with check point inhibitors (CPIs) as well as other anti-cancer therapies such as chemotherapy. This has led to the development of a number of targeted immune therapies.
Adoptive cell therapies Examples include adoptive T cell therapies where T cells are extracted from patients, then activated in a laboratory after which they are given back to the patient.
Peptide and oncolytic virus vaccines Other approaches to activate tumor lesions include administration of peptide vaccines or oncolytic viruses – both being part of the Targovax offering. By having two different immune platforms that target local immune activation, the Group believes it to be well positioned to develop combination therapies that can contribute towards revolutionizing oncology.
8.5.2 Background to the immune system and T cells The immune system is constantly monitoring any external threats to the body. It recognizes danger signals such as foreign bodies, bacteria and cancer cells. It can be described as having two lines of defense: (i) a first line non-specific
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defense named the innate immune system and (ii) a second line defense named the adaptive immune system. The adaptive immune system is composed of highly specific, targeted cells which provide long-term recognition and protection from infectious agents or abnormal processes such as cancer. The adaptive immune system is further subdivided into humoral or anti-body based immune response and into cellular immune response which includes T cell based immune responses.
T cells are the most important immune cells as they are both involved in sensing and killing abnormal cells as well as coordinating the activation of other cells in an immune response. They are grouped into two major types, CD4+ T cells and CD8+ T cells. The CD4+ T cells are primarily helper T cells involved in immune cell co-ordination while CD8+ T cells are cytotoxic and can directly attack and kill cancer cells. Initial activation of T cells takes place in the lymph nodes and is assisted by antigen presenting cells ("APC"). Small disease (cancer) related protein fragments named peptides are presented to the T cells in complex with human leukocyte antigen ("HLA") molecules on the surface of the APCs followed by production of sub-populations of T cells that recognize and destroy cancer cells displaying the same peptides. This way T cells learn to distinguish between "normal self" and "foreign" peptides and are thus able to mobilize an attack when appropriate.
Although the immune system is designed to identify "foreign" or "abnormal", this process is often defective in cancer patients. The cancer "takes over" by, for example, hiding from the immune system or down regulating the immune system which results in an immune suppressive tumor environment – an environment where immune cells have limited or no opportunity to be effective. Consequently, drugs that can change the micro tumor environment from immune suppressive to immune susceptible are likely to offer clinical benefits.
Cancer immunotherapies are combined to maximize efficacy.
Source: Company websites, press releases and filings, FactSet.
8.6 ONCOS-102’s and TG01’s differentiating features 8.6.1 Introduction Targovax is developing two different types of immune activating vaccines. ONCOS-102 is based on the common cold virus Adenovirus 5. This virus is known to be immunogenic, meaning that it is effective in creating an immune response. In order to increase its use in treating cancers, it has been modified in three ways. Firstly, an Adenovirus 3 knob has been added in order to enhance adhesion and thus infectivity of cancer cells. Secondly, in order to ensure selective replication in cancer cells, it has an E1A 24Bp deletion which means that it can only replicate in cancer cells leaving normal cells unaffected. Thirdly, it is engineered with a transgene in another part of the Adenovirus 5 backbone called the E3 region where granulocyte macrophage colony stimulating factor ("GM-CSF"), a powerful immune stimulator, is inserted. As ONCOS-102 is administered into the tumor, (i) a local danger signal is created upon administration of the virus; (ii) which starts replicating, expressing and releasing GM-CSF to attract innate immune cells; (iii) viral replication results in cancer cells lysis with release of cancer antigens, the unique signal of cancer cells, that strengthens the danger signal and (iv) APCs (antigen presenting cells) such as dendritic cells ("DC"), pick up tumor antigens. DC’s transport tumor antigens to the lymph nodes where the DC’s present the tumor antigens to 46
immature T cells. Matured CD8+ T cells that specifically recognize the antigens in question, will then be produced, find and kill tumor cells expressing the specific antigens. As part of this process, "educated" CD8+ (killer) T cells will scan the entire body for the cancer cells. ONCOS-102 is also a Toll Like Receptor ("TLR") 9 agonist – TLRs are small proteins expressed by innate immune cells such as macrophages and DCs and stimulation of these cells represents another mechanism for immune activation.
Targovax’ viral vaccines (including ONCOS-102) are either directly injected into the tumor or are administered by intraperitoneal infusion, but not by systemic administration via intravenous infusion. The mode of administration accordingly limits the range of cancer types / tumors that can potentially be treated with Targovax’ viral vaccines.
The TG01 vaccine has a slightly different mechanism of action. It consists of seven peptides that mimic cancer specific antigens arising from oncogenic mutations in exon 2 of the RAS gene. The RAS mutations are only present in cancer cells and TG01 can be used to educate T cells to specifically recognize and target cancer cells harboring such mutations. TG01 is administered into the skin by intra-dermal injection together with a second product, the immune stimulator GM-CSF that is needed since peptides are not immunogenic by themselves. After administration into the skin GM-CSF attracts and activates local DCs to become mature antigen presenting cells. The TG peptides are taken up by the activated DCs and transported to the lymph nodes. There, T cells learn to recognize and target cancer cells harboring the RAS mutations. Subsequently, "educated" T cells will scan the entire body for cancer cells with the specific RAS mutation and kill them. This anti-cancer effect is caused by both directly killing by the T-cells produced in response to the TG vaccination but also by activation of T cells recognizing other cancer antigens presented as a result of killed tumor cells thus providing a broader anti-cancer activity (in situ bystander activity). Both TG01 and GM-CSF are necessary components of the peptide vaccine platform and will be produced and developed as an investigational product by Targovax.
Below is a schematic representation of the two unique and complementary technologies:
Illustration of the Group’s technology
Source: Ranki et al OncoImmunology 2014; Vassilev et al OncoImmunology 2015.
8.6.2 ONCOS-102 Below is an overview of the distinctive features of ONCOS-102 in comparison to its known competitors included in Section 8.7 "Competition" below.
• ONCOS-102 is an oncolytic virus that can both prime and boost immune responses35: ONCOS-102 is an adenovirus that activates CD8+ T cells via TLR 9. In contrast, oncolytic viruses based on herpes simplex virus ("HSV") have less optimal immune activation being agonists of TLR 2 and 436. Furthermore,
35 Draper and Heeney, 2010, Mat Rev Microbiol 36 Villalba et al, 2012, Med Microbiol Immunol
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HSV can hide from the immune system37 and has a specific mechanism to inhibit T cell responses38. Vaccinia virus based cancer vaccines are less effective in priming T cell responses39.
• The benefits association with intra-tumoral administration: Intra-tumoral administration provides immune activation at the site of the tumor without being deactivated by systemic neutralizing anti-bodies nor is there a need to expose patients to high intravenous viral concentrations/doses that in some cases have been associated with toxicity after intravenous administration.
• ONCOS-102 is the oncolytic virus with the most comprehensively mapped mechanism of action: In a Phase I study of 12 treatment refractory cancer patients with different solid tumors, ONCOS-102 was given intra tumorally nine times for six months. The main objectives were safety, dose finding and preliminary signals of efficacy. Three cohorts were studied in a 3+3 design and patients were monitored for adverse events, disease progression by CT/PET and immune activation in lesions and blood by analyses of biopsies and PBMC at baseline, 1 month and 2 months.
Safety: There were no dose limiting toxicities ("DLT"). Most adverse events were grade 1 – 2 (fever, chills, fatigue, injection site pain, decreased appetite, gastro intestinal symptoms, weight loss and anemia) and six patients had grade 3 adverse events (gastro intestinal symptoms, fever, fatigue, peripheral oedema and increased ALP/ASAT) of which one (peripheral oedema) was possibly related to study drug. ALP and ASAT are laboratory biomarkers of liver function where increases over a certain level indicates reduced liver function. Such can be due to drugs but also common in patients with cancer. There were no grade 4 or 5 adverse events. As can be seen, the most common adverse events were symptoms of viral infection (e.g. fever, chills, fatigue and decreased appetite) and are characteristic of patients with late stage carcinoma (e.g. fatigue, decreased appetite and weight loss). The safety profile was similar to that seen in the advanced therapy access program (ATAP) described below.
Immunology: Uniquely, the Group has gathered baseline biopsies of tumor lesions that allow for assessment of vaccine induced immune cell increases (delta) by comparing to post treatment biopsies. Such immune cell increases are believed to be an important predictor of a positive clinical outcome. Indeed, in this Phase I study, ONCOS-102 was able to activate the innate immune system in 11/12 patients with a positive correlation to overall survival:
In the same study, 11/12 patients had infiltration of cytotoxic CD8+ T cells at lesional level as can be seen in the graph below where patients had significant and in some cases several fold log increases meaning up to 131 (patient 14) and 1,451 (patient 19) times increases to baseline. The adaptive immune system activation was also positively correlated with overall survival:
37 Raftery et al, 1999, J Exp Med 38 Barcy et al, 2001, J Immunol 39 Bart et al, 2014, J Clin Invest
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Anti-tumor cellular immune response was seen systemically in two patients and the Company believes it to be the only oncolytic virus research group to have shown such. In a patient with malignant pleural mesothelioma, induction of CD8+ T cells specific to the tumor antigen MAGE-A3 after treatment was seen. Similarly, ONCOS-102 induced CD8+ T cells specific to the tumor antigens NY-ESO-1, MAGE-A1, MAGE-A3 and mesothelin in the blood of a patient with ovarian cancer. These findings, coupled with the increase of CD8+ T cells in a non-injected lesion (see patient 15 in the orange boxes and bar in the above graph), shows how ONCOS-102 is able to induce a systemic and tumor specific immune activation in treatment refractory patients with solid tumors.
• Orphan drug status in a number of indications: ONCOS-102 has orphan drug status in mesothelioma, ovarian cancer and soft tissue sarcoma.
• Promising clinical Phase I data: ONCOS-102 has promising clinical Phase I data showing stabile disease in 40% of patients and examples of patients with late partial response and prolonged survival. As can be seen below, a patient with treatment refractory malignant pleural mesothelioma (patient 14) had a close to 50% reduction of its tumor mass on PET scan 6 weeks after the last ONCOS-102 vaccination. Malignant pleural mesothelioma is a type of lung cancer associated with exposure to asbestosis. It is highly malignant, and, with only one product, pemetrexed, licensed to date, it represents an area of huge medical need. Patient 19 below, who had undergone seven different types of chemotherapy, surgery and radiation, entered the study, received all nine vaccinations and had stabile disease ("SD"). After finishing the study, the patient responded to chemotherapy which had not been the case before the study, and an assessment 17 months later showed that the patient’s cancer was still stable (SD). Similarly remarkable was the detection of specific T cells to the tumor antigen NY-ESO-1 in the patient’s blood. Put together, this information suggests that ONCOS-102 vaccinations were able to provide stabilization of disease, possibly sensitizing the patient to subsequent chemotherapy while ensuring immunological memory a long time after the last vaccination:
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1 Response Evaluation Criteria In Solid Tumors (RECIST) is a set of internationally agreed rules that define when tumors in cancer patients improve/respond, stay the same/stabilize or worsen/progress during treatment. Complete response= all tumor disappeared, Partial response= >30% disappeared, Stabile disease= neither disappeared or progressed, Progressive disease= >20% increase Source: Internal data on file
• Reassuring safety data from large scale advanced therapy access program ("ATAP"): This was an individualized treatment program conducted in Finland within the European Directive described as ATAP regulations. It was not a study with a protocol of predetermined treatments and monitoring. 290 patients were treated with different types and combinations of adenoviruses given intra-tumourally, intravenously or intra-peritoneally with or without immune stimulatory transgenes. All patients had advanced solid tumor disease and were refractory to standard of care chemotherapy. 115 patients received ONCOS-102. Positive clinical responses in individual patients and lack of any detectable serious side effects formed the basis for continued development of ONCOS-102 and the Phase I study described above. Most adverse events were grade 1 – 2 (fever, fatigue and nausea in less than 50% of patients, 29% with grade 3 and 5% with grade 4 – 5 (none drug related) adverse events. Adverse events in studies are grade 1 – 5: 1 (mild), 2 (moderate), 3 (severe), 4 (life threatening or disabling) and 5 (death).
8.6.3 TG01 Below is an overview of the distinctive features of TG01 in comparison to its known competitors included in Section 8.7 "Competition".
Cancer specific peptide vaccine: Oncogenic mutations in the RAS genes are uniquely found in cancer cells and consequently mutated RAS proteins are also unique for cancer cells. The mutations in the RAS proteins are immunological markers that can serve as targets for immunological attack by T cells. Synthetic peptides (small proteins) mimicking protein fragments encompassing the RAS mutations can be used as vaccines to activate RAS mutation specific T cells. TG01 consists of seven synthetic peptides that mimic seven of the most common RAS exon 2 mutations found in many types of cancers. It has been demonstrated that TG01 activates RAS mutation specific T cells, both when used as mono-therapy and in combination with chemotherapy. Cancer specific immune response reduces greatly the risk of cross- reactivity and unacceptable damage of healthy tissues. The peptides are designed to prevent induction of non-mutation (non-cancer specific) immune response. In contrast, vaccines based on allogenic cancer cell lines engineered to produce immune stimulating molecules (e.g. alpha (1,3) galactosyltransferase (α-GT), GM-CSF) induce immune responses against cancer associated antigens also shared by healthy cells and tissues40,41.
Therapeutic cancer vaccine targeting "undruggable" RAS mutations: Oncogenic RAS mutations are drivers for development of cancer and have for a long time been considered as an "undruggable" target for
40 Rossie G.R. et al 2013 41 Le D.T et al 2013, J Immunother. 2013 September;36(7),382-389
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therapy42. However, the Targovax developed TG peptides vaccine has been shown to activate long lasting RAS mutation specific T cell responses in cancer patients43. Compositions of heat-inactivated S. cerevisiae yeast expressing combinations of RAS mutations are less effective in priming T cells44.
Peptide vaccine, but no need for tissue typing of patients: Peptides must be able to bind to HLA class II molecules for activation of CD4+ T cells and to HLA class I molecules for activation of CD8+ cells. The HLA repertoire (i.e. tissue type) defines an individual’s tissue type and it varies between individuals. General population coverage is secured for TG01 by the design of the peptides. The peptides are designed to bind all three major sub-groups of HLA class II molecules DR, DP and DQ, either directly or after antigen processing by APCs. In addition, the seventeen amino acids long TG peptides allow processing of natural HLA class I epitopes nested around the RAS mutation (HLA class I epitopes are normally nine amino acids). The immunological efficacy of TG01 has been confirmed by clinical testing.
Cocktail of peptides covering seven common RAS mutations: TG01 covers 99% of the most common RAS mutations found in pancreas cancer. Oncogenic mutations in the RAS genes occur as single base alterations resulting in only one amino acid substitution in the expressed protein. In total 12 different amino acid substitutions are found for RAS exon 2 mutations and usually only one mutation is present in a tumor. Traditionally, development of vaccines targeting the different mutations individually require knowledge of (thus screening of) the patients’ specific mutation and the need for several products to be developed simultaneously. This, taken together with the fact that the mutation pattern vary greatly between cancer indications making recruitment of patients to clinical studies and clinical practice very complicated, and therefore not considered commercially viable. The one product TG01 covers more than 99% of the common RAS mutations found in pancreas cancer.
GM-CSF is a very powerful immune stimulator for peptide vaccines: Peptides are not immunogenic by themselves and there is a need for an immune stimulator. Recombinant human GM-CSF expressed in E- coli (molgramostim) has proven to be a very efficient immune stimulator for TG01. Using GM-CSF also avoids problems like T cell sequestering caused by traditional adjuvants creating an antigen depot (primed T cells return to the depot at the vaccination site instead of tumor). Different micro-organisms used for production result in different GM-CSF molecules, with large variation in potency. Targovax has selected the non-glycosylated molecule produced in E-coli for development together with TG01. The potency of this molecule is about the double of that of a glycosylated molecule produced in yeast. All results obtained for TG01 in patients are from using non-glycosylated as immune stimulator.
TG peptides induce both cancer specific CD4+ and CD8+ T cells capable of specific killing of cancer cells: TG peptides combined with GM-CSF activates both CD4+ and CD8+ T cells that can specifically recognize and kill autologous cancer cells and cell lines harboring corresponding RAS mutations (examples below).
42 Adrienne D. Cox et al. 2014, Nature Reviews Drug Discovery13,828–851(2014) 43 Wedén S et al 2011, Int J Cancer. 2011 Mar 1;128(5):1120-8 44 D.Richards et al 2012, Annals of Oncology 23 (Supplement4): iv5-iv18, 2012
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Tumour specific CD4+ T cells kill cancer cells from one vaccinated patient CD4+ T cell clone from a RAS peptide vaccinated patient that recognize the same mutation (12V) as found in the patient’s tumor, can lyse and kill cancer cells (CPE) from the same patient (in vitro)45.
Tumour specific CD8+ T cells kill cancer cells from one vaccinated patient HLA B35 (tissue type) restricted CD8+ T cell clone from a RAS peptide vaccinated patient that recognize the same mutation (12V) as found in the patient’s tumor, can lyse and kill cancer cells (CPE) from the same patient (in vitro)46.
Tumour specific T cell infiltration: After vaccination with four different TG RAS peptides only T cells reactive against the RAS mutation present in the tumor were enriched in the tumor.
CD4+ T cells with same T cell receptor clonality (TCR Vb17), and recognizing the same mutation (12R) as found in the patient’s tumor, were found in both blood (PBMC) and tumor biopsy (TIL) from vaccinated patient. T cells specific for other RAS mutations than 12R were found in PBMC from patient but not in tumor47.
Encouraging long-term survival for patients with resected pancreatic cancer after treatment with TG01 or TG peptides: Long-term follow up after end of study of two clinical trials with TG01 or TG peptide mono-therapy, conducted by Norsk Hydro in the period 1994 – 2000, showed 28 months median survival
45 Gjertsen et al 1997, Int.J.Cancer: 72,784-790(1997) 46 Gjertsen et al 1997, Int.J.Cancer: 72,784-790(1997) 47 Gjertsen et al 2001, Int. J. Cancer:92,441-450(2001)
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and 20% ten years survival for the combined study populations of totally 20 patients48. Reported median survival for historical controls is 20.2 months and 7.7% ten year survival49,50. Patients were treated with either a single TG peptides (9 patients) or TG01 (11 patients).
Retrospective survival analysis of two clinical trials with TG01 or single TG peptide vaccination
Encouraging one year survival in the interim analysis of ongoing TG01 clinical study showing 14 of 15 evaluable patients being alive: In March 2016, Targovax conducted a pre-determined interim survival analysis of the first cohort indicating promising survival data. Of the 19 patients included in the cohort, 15 patients provided consent to be followed up for survival and four patients did not. 1-year survival data showed that 14 out of these 15 patients were alive and one passed away due to pneumonia assessed by the investigator as unrelated to the patients underlying cancer. The regimen was generally well tolerated. In April 2016 Targovax reviewed interim data for immune activation (DTH responses) in the modified vaccination cohort, assessing early immune activation. 4 of the 5 first recruited patients (of a total of up to 13 patients) showed an 8-week immune response. These results were in line with an analysis of the first cohort (in March 2015) where 18 out of 19 patients were eligible for immune response assessment and 15 patients had established a detectable early immune response. The next analysis of survival will be at two years, i.e. in the first half of 2017.
Immunological response to TG01 signaling increased survival in both resected and advanced pancreatic cancer: Below are results from clinical study CTN RAS 9801051:
Resected pancreatic cancer Median survival 5 year survival TG01/GM-CSF (mono-therapy) Evaluable patients (from resection) (from resection)
Detected immune response 11/11 (100%) 26.5 months 2/11 (18%)53 (Historical (Historical controls 20.2 controls 10.4%54 months52) Not detected immune response 0 N/A N/A
Advanced pancreatic cancer Median survival 1 year survival TG01/GM-CSF (mono-therapy) Number of patients (from 1st vaccination) (from 1st vaccination)
Detected immune response 14/25 (56%) 156 days 3/25 (21%) Not detected immune response 11/25 (44%) 109 days 1/11 (9%)
Preliminary immunological results from ongoing clinical study CT TG01-01 in resectable pancreatic cancer
48 Wedén S et al 2011, Int J Cancer. 2011 Mar 1;128(5):1120-8 49 Oettle H et al. JAMA 2007, vol 297 no 3 50 Oettle H et al. JAMA 2013 vol 310, no 14 51 Clinical study report CTN RAS 98010 on file 52 Oettle H et al. JAMA 2007, vol 297 no 3 53 Wedén S et al 2011, Int J Cancer. 2011 Mar 1;128(5):1120-8 54 Oettle H et al. JAMA 2013 vol 310, no 14
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show so far that a TG01 specific immune response (DTH) was seen in 14 of 17 patients after combining TG01 with gemcitabine chemotherapy (ASCO 2015). The TG01/GM-CSF regimen was generally well tolerated with related events being those expected (local reactions and flu like symptoms). There were four related allergic reactions to vaccination, three of which occurred only after gemcitabine treatment and of which two were severe.
TG01 can be used to both prime and boost anti-cancer T cell responses: TG01 can be administered repeatedly without being deactivated by systemic neutralizing anti-bodies.
Low cost of goods – simple to produce, stable and uncomplicated logistics: TG peptides are produced by state of the art chemical synthesis and GM-CSF by recombinant expression in E.coli bacteria. TG01 is a stable lyophilized product presented in glass vials.
8.7 Competition The standard of care treatment of cancers is constantly being improved by the use of new biomarkers, new medical technologies, and new chemotherapies. Immuno-oncology in general and the cancer vaccine field in particular are rapidly evolving as the biotechnological and pharmaceutical industries are dedicating tremendous efforts and resources to the advancement of novel, proprietary therapies. Targovax competes not only with other immuno-oncology treatments, but also with the existing standard of care therapies in the Group’s target indications. The Group’s main competitors include (indication and development phase of most advanced drug candidate in brackets):
Cancer vaccines: DanDrit Biotech A/S (metastatic colorectal cancer, Phase III), Bavarian Nordic, A/S (prostate cancer, Phase III), GlobeImmune, Inc. (pancreatic cancer, Phase II), Aduro Biotech, Inc. (pancreatic cancer, Phase II), Immunovative Therapies, Ltd. (metastatic colorectal cancer, Phase II), Immodulon Therapeutics, Ltd. (pancreatic cancer, metastatic colorectal cancer, Phase II), and Vaximm AG (pancreatic cancer, Phase I).55
Oncolytic viruses: Amgen, Inc. (melanoma, registred in the US October 2015), Advantagene, Inc. (prostate cancer, Phase III), Transgene SA (hepatocellular carcinoma, Phase II), PsiOxus Therapeutics, Ltd. (colorectal cancer, Phase II), Cold Genesys, Inc. (bladder cancer, Phase III), ORCA Therapeutics B.V. (prostate cancer, Phase II), Oncolytics Biotech, Inc. (head and neck cancer, Phase III), SillaJen, Inc. (liver cancer, Phase III), Viralytics, Ltd. (melanoma, Phase II) and DNAtrix, Inc (ovarian cancer, glioma, Phase I).56
The Group’s competitive landscape is rapidly changing, with several different compounds currently being trialed for the Group’s target indications. Looking solely at ongoing Phase I and Phase II studies, there are approximately 200 different compounds within pancreas, approximately 40 different compounds within mesothelioma, approximately 80 different compounds within melanoma and approximately 200 compounds within colorectal. It is worth noting that only a minority of these compounds are immune-oncology treatments. As a result of these ongoing studies, as well as new combinations with CPIs, the standard of care landscape may look different upon and in the event of a market entry of any of the Group’s compounds.57
Additionally, with recent clinical successes in both the cancer vaccine and oncolytic virus fields, the Company expects several early stage companies to emerge with the potential to become significant competitors.
The side effect profiles of peptide or virus based immunotherapies vary, but are of relatively mild nature. Generally speaking, peptide or virus based immunotherapies tend to have considerably less severe side effect profiles than classical chemotherapies. It is unlikely that competing peptide or virus based immunotherapies can distinguish themselves favorably from the Group’s immunotherapies only based on a superior side effect profile.
The Group believes that its RAS-mutated therapeutic cancer vaccines have a high likelihood to succeed because it has avoided the pitfalls that plagued many previous attempts at therapeutic cancer vaccination: (i) selection of antigens that are not cancer-specific, (ii) failure to induce CD4+ T helper cells along with CD8+ cytotoxic T cells, (iii) complex logistics, (iv) inefficient adjuvant and (v) sub-optimal patient selection.
55 GlobalData, 2015, and the respective websites of the competitors. 56 GlobalData, 2015, and the respective websites of the competitors. 57 GlobalData, 2015.
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Likewise, the Company believes that its oncolytic viruses have a high likelihood to succeed. The immunologic mechanism of action of ONCOS-102 has been demonstrated in the Group’s Phase I clinical study. The Group’s oncolytic viruses appear to kill cancer cells selectively, manufacturing and logistics are simple, and administration is safe and targeted by intra-tumoral injection.
Many of the Group’s current or potential future competitors have substantially greater financial, technical and human resources than the Group presently does. The field of immuno-oncology is an area of very intense investment by both biotechnological and pharmaceutical companies, and it has seen a tremendous, and constantly increasing, deal-making activity over the past couple of years. New M&A or licensing deals may create significant new competitors in the future. These current or potential new competitors also compete with the Group for patient recruitment into clinical trials, for establishing clinical study sites, for acquiring complementary technologies to its own programs and for recruiting and retaining top R&D and management personnel.
8.8 Research and development, patents and licenses 8.8.1 Research and development The research goals of Targovax are to:
(i) develop process and produce ONCOS-402 for preclinical studies
(ii) complete animal studies to make ONCOS-402, a CD40L coding adenovirus 5/3, ready for clinical studies;
(iii) complete research on RAS exon 3 and 4 mutated peptides to make TG03 ready for pre-clinical and clinical studies;
(iv) complete process development and manufacturing of TG01 ready for the next phase of clinical studies;
(v) complete process development and manufacturing of TG02 ready for the next phase of clinical studies;
(vi) complete process development and manufacturing of GM-CSF ready for the next phase of clinical studies of TG01, TG02 and TG03;
(vii) complete process development and manufacturing of ONCOS-102 ready for Phase III clinical studies; and
(viii) complete manufacturing of ONCOS-402 ready for Phase I/II clinical studies.
The development goals of Targovax are to:
(i) approve TG01 in combination with GM-CSF as an adjuvant treatment in resected pancreas cancer;
(ii) approve TG02 in combination with GM-CSF, as a treatment for patients with unresectable advanced colorectal cancer in combination with standard of care chemotherapy or checkpoint inhibitor;
(iii) approve ONCOS-102 in combination with first line standard of care chemotherapy in patients with malignant pleural mesothelioma;
(iv) approve ONCOS-102 in check point inhibitor (CPI) refractory patients with advanced melanoma;
(v) explore intra-peritoneal administration of ONCOS-102 in combination with check point inhibitor (CPI) in ovarian cancer and other peritoneal malignancies; and
(vi) explore ONCOS-102 in combination with autologous dendritic cell therapy in advanced prostate cancer.
The development goals are supported by the following clinical trial program for the period 2016 – 2018.
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Clinical trial program 2016 – 2018
** A sponsor is the the company or institution that submit the application for a clinical study to the regulatory authorities and that is responsible for conducting and reporting the study in compliance with the regional regulatory legislations and guidelines.
The below tables include details regarding the Group’s studies:
8.8.1.1 Study 1 – TG01 in resected pancreatic cancer
Description Study design
• Phase I/II trial of TG01 and Gemcitabine as adjuvant • Single arm open label study therapy for treating patients with resected • Stage I or II disease with confirmed R0 and R1 resection adenocarcinoma of the pancreas • CT scan at baseline (if possible), then every 6 month from start • 19 patients (cohort 1) and up to 13 patients (cohort 2) of vaccination or when clinically indicated and at end of study • 5 sites in Norway, UK and Spain. visits • Cohort 1; Start TG01/GM-CSF vaccination prior to/same time as start of chemotherapy, TG01/GM-CSF treatment during the course of chemotherapy, continue TG01/GM-CSF post chemo • DTH immune reaction at weeks 1, 2, 3, 4, 6, 8, 10, 52 • PBMC for TG01 specific T cell response at baseline, week 11, week 52 and end of study • Cohort 2; Start TG01/GM-CSF vaccination prior to chemotherapy, stop TG01/GM-CSF after 6 weeks and reinitiate post-chemo • DTH immune reaction at week 1, 6, 8, week 8 post chemo • PBMC for in vitro assessment of TG01 specific T cell response at baseline, week 8, week 4 post chemo, week 52 and end of study Objectives and endpoints Timeline
Primary objectives • First patient first visit (cohort 1) Q1 2013 • Safety of TG01/GM-CSF vaccination combined with • Cohort 1 completed recruitment Q1 2015 chemotherapy • First patient first visit (cohort 2) in Q3 2015 • Immune response to TG01/GM-CSF and effect of adjuvant • Last patient first visit (cohort 2) in H1 2016 chemotherapy combined with TG01/GM-CSF after tumor resection Expected news flow: Secondary objectives • 24 months survival data of the first cohort expected in 1H2017. • Clinical efficacy at 2 years 24 months survival data of the second cohort expected in Explorative objectives 1H2018 • Relationship of KRAS status to recurrence • Monitor CA 19-9 levels Efficacy endpoints Safety: Adverse events and laboratory assessment Immune responses: DTH and proliferative T-cell response Efficacy at 2 years: Disease free survival, overall survival Exploratory: Relationship of KRAS status to recurrence, monitor CA 19-9 levels
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8.8.1.2 Study 2 – ONCOS-102 in mesothelioma
Description Study design
• A randomized Phase II open label study with a Phase I • Open labelled study with a safety lead in cohort followed by safety lead in cohort of ONCOS-102 and randomised Phase II. pemetrexed/cisplatin in patients with unresectable • The safety group (six patients) and the experimental arm (14 malignant pleural mesothelioma patients) in Phase 2: ONCOS-102 at 3X10to11 VPs and • 30 patients (6 patients (safety cohort) + 24 patients pemetrexed 500mg/m2 plus cisplatin 75mg/m2. ONCOS-102 • (Phase II) given at day 1, 4, 8, 36, 78 and 120 – clophosphamide i.v. bolus • Up to 10 sites in Spain, UK and others (TBD) of 300mg prior day 1 and 78. Chemo will be given at 21 day cycles for 6 cycles. • Control group (10 patients); pemetrexed 500mg/m2 plus cisplatin 75mg/m2. Chemo given at 21 day cycles for 6 cycles. • CT/PET at baseline day 64 (control arm: day 43) and day 148 (control arm: day 127). • Biopsies at baseline and day 36 • PBMC at baseline, day 1, 43, 85, 127 plus 9 and 12 months Objectives and endpoints Timeline
Primary objectives • First patient in H2 2016 • Safety and tolerability • Last patient in H2 2017 Secondary objectives • Tumour-specific immune activation in blood (PBMC) and Expected news flow: tumour tissue • Safety data of first six patients (lead in cohort) • Overall response rate and progression-free survival • Interim immune activation date in H1 2018 • Overall survival • Immune activation and clinical data in H2 2018 Efficacy endpoints • Cellular and humoral immune responses in blood and tumour tissue • Overall response rate and progression-free survival • Overall survival
8.8.1.3 Study 3 – ONCOS-102 in melanoma
Description Study design
• A pilot study of sequential ONCOS-102 and a checkpoint • Open-label single-arm inhibitor in patients with advanced and unresectable • ONCOS-102 given i.t. at 3x10to11 day 1, 4 and 8. melanoma progressing after PD1 blockade. • CPI given according to the established schedule from day 22 for • 12 patients 24 weeks • 1 site in the US • CT/PET at baseline and day 64 • Biopsies at baseline, day 22 and day 64 • PBMC at baseline, day 22, day 64 and day 127. Objectives and endpoints Timeline
Primary objectives • First patient in H2 2016 • Safety and tolerability • Last patient in H2 2017 Secondary objectives • Objective response rate (ORR) Expected news flow: • Change in immune cell subsets • Interim immune activation date in H2 2017 Explorative objectives • Immune activation and clinical data in H1 2018 • Mutational and neoepitope burden in tumours • Changes in T cell receptor clonality in infiltrating and circulating t cells • Gene expression changes in the tumour microenvironment and blood Efficacy endpoints • Objective response rate and Progression Free survival • Correlation of TILs and objective response rate • Clinical benefit rate at 6 months • Changes in infiltration of various immune cell subsets in tumour tissue and blood over time
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8.8.1.4 Study 4 – TG02 in colorectal cancer to assess immune activation
Description Study design
An explorative open-label study to determine anti-tumor Open label single-arm Phase I study immune activation and clinical response of TG02 in TG02/GMCSF on week 1,2,3,4 and 6 patients with colorectal cancer with progressive disease CT/PET at baseline and 8 weeks waiting for surgery of pelvic mass resection. Biopsies at baseline and by surgery (8-14 weeks) 20 patients PBMC at baseline, 4 and 8 weeks and if surgery delayed, as close 2 sites in EU as possible to surgery
Objectives and endpoints Timeline
Primary objectives • First patient in H2 2016 • Safety and tolerability • Last patient in H2 2018 • Immune activation in blood and biopsies Secondary objectives News flow: • Changes in immunological and pathological markers in • Interim immune activation data H2 17 (part 1) tumor tissue • Immune activation and clinical data in H2 2018 (part 1 and 2) • Changes in FDG PET_CT images • Changes in CEA Efficacy endpoints • Presence of TG02 specific T-cells in blood • TG02-specific DTH-reaction • Changes in intra-tumoural lymphocytes
8.8.1.5 Study 5 – ONCOS-102 in various indications, including ovarian The study is a combination study with the Cancer Research Institute of the U.S. and Ludwig Cancer Research Institute who sponsor and manage the study, the details of which are not public as of the date of this Prospectus. A first data readout is expected during H2 2017.
8.8.1.6 Study 6 – ONCOS-102 in prostate cancer, a partner study where SOTIO a.s. is the sponsor and responsible for the management of the study.
Description Study design
• A Phase I single arm clinical trial to evaluate safety and Details not public immune activation of the combination of DCVAC/pca (dendritic cells activated ex-vivo by allogenic prostate cancer cells) and ONCOS-102 in amen dvanced metastatic castration-resistant prostate cancer Objectives and endpoints Timeline
Primary objectives • First patient in H2 2016 • Safety and tolerability • Last patient in H2 2017 Secondary objectives • Details are not public News flow: Explorative objectives • Interim immune activation date in H1 2017 • Details not public • Immune activation and clinical data in H2 2018 Efficacy endpoints • Details not public
8.8.2 Regulatory strategy Targovax has one ongoing Phase I/II study in resected pancreas and five new Phase I/II studies to start in 2016, two of which will be sponsored and managed by the Targovax collaborating organisations CRI/Ludwig and Sotio. These should all be regarded as proof of concept studies and as such will determine subsequent regulatory pathway when immune activation, clinical efficacy and safety data have been analyzed. Depending on the strength of Phase II data, the Company will consider breakthrough/fast track designation with the FDA. In terms of subsequent programs:
TG01 in resected pancreas: 1) Conduct a pivotal study of TG01 plus gemcitabine versus gemcitabine with PFS and OS as endpoints while target PFS as first data set for filing and registration. 2) Start a neoadjuvant Phase I/II study.
ONCOS-102 in mesothelioma: Conduct a pivotal study of ONCOS-102 plus pemetrexed / Cisplatin versus Pemetresxed / Cisplatin with PFS and OS as endpoints while target PFS as first data set for filing and registration.
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ONCOS-102 in melanoma: 1) Conduct pivotal monotherapy study in CPI refractory patients with response rate (RR) and OS as endpoints while file on RR. 2) Start a 1st line Phase I/II study in combination with check point inhibitor (CPI).
TG02 in CRC: Conduct Phase I/II study of TG02 versus SOC tbd followed by pivotal study.
ONCOS-102 in peritoneal cancer: Conduct a pivotal study in combination with check point inhibitor (CPI).
ONCOS-102 in metastatic prostate: Conduct a Phase I/II study in combination with best supportive care versus best supportive care followed by pivotal study.
8.8.3 Collaborative research and development agreements 8.8.3.1 Agreement with Cancer Research Institute of the U.S. and Ludwig Cancer On 18 November 2015, Targovax entered into an agreement with Ludwig Cancer Research (LICR) and the Cancer Research Institute (CRI) in New York to evaluate ONCOS-102 in early phase clinical trials, testing the virotherapy in combination with other, potentially synergistic immunotherapies such as checkpoint inhibitors.
Through this collaboration, Targovax will gain access to the well-known expertise and network of CRI and Ludwig Cancer Research, which provides new opportunities for combinatorial research. The focus will be on mechanistic synergies with clinical impact combining ONCOS-102 with other immune therapies. The publication of exact indications and commencement of a trial is expected during 2016.
Cost sharing is an aspect of the collaboration. The Group has some optionality with respect to the timing of costs, which may affect the share capital requirement of the Group. The cash flow effect of conducting the collaboration trial is expected to be small for Targovax.
8.8.3.2 Agreement with SOTIO a.s. In November 2015, Targovax entered into an agreement with the biotech company SOTIO a.s. to design and run a collaboration study combining ONCOS-102 and SOTIO a.s.’ dendritic cell therapy DCVAC/PCa to evaluate the safety and tolerability of the combination therapy in the treatment of advanced prostate cancer. The plan is to recruit the first patient in first half 2016.
The design of the planned study with SOTIO a.s.is subject to regulatory approvals in the Czech Republic and Finland. Cost sharing is an aspect of the collaboration. The cash flow effect of conducting the collaboration trial is expected to be small for Targovax.
8.8.3.3 Other collaborative research and development agreements Entering into collaborative research and development agreements with partners is a part of the Group’s strategy. The Group is consequently involved in discussions with other potential partners on an ongoing basis. If any such discussions were to materialize into firm agreements, this may affect the share capital requirement of the Group.
8.8.4 Research and development expenses Below is an overview of the research and development ("R&D") expenses of the Group for the three months ended 31 March 2016, the year ended 31 December 2015 and the year ended 31 December 2014.
Three months ended Year ended Year ended In TNOK 31 March 31 December 31 December
2016 2015 2014
(unaudited) (audited) (audited)
External R&D expenses ...... 10,818 25,231 7,766 Payroll and related expense ...... 5,323 13,497 4,752 156 384 2,276 Other operating expense ......
Total ...... 16,298 39,111 14,794
All expenditure on research activities is recognized as an expense in the period in which it is incurred.
8.8.5 Grants The Company and Oncos have received the following grants as of 31 December 2015: 59
(i) NOK 800,000 from Innovation Norway to establish Targovax for the years 2011 to 2012. Up until the date of this Prospectus, all requirements and milestones related to the grant have been met.
(ii) NOK 9,000,000 from Innovation Norway to develop TG01, the therapeutic cancer vaccine targeting RAS positive cancer cells, for the years 2011 to 2014. Up until the date of this Prospectus, all requirements and milestones related to the grant have been met.
(iii) NOK 9,308,000 from the Research Council of Norway to develop GM-CSF as immunomodulator for cancer vaccine TG01 and novel RAS peptide formulations for the years 2013 to 2016. Up until the date of this Prospectus, all requirements and milestones related to the grant have been met.
(iv) NOK 8,982,000 from SkatteFunn tax reduction scheme related to development of cancer vaccines TG01 and TG02 consisting of three approved projects. One of the projects was completed in 2013 and the two remaining projects will be completed in 2016. Up until the date of this Prospectus, all requirements and milestones related to the grant have been met.
(v) EUR 1,041,796 for preparations of clinical trials and for business development of a young innovative company and EUR 34,353 in R&D grant, both from Tekes for the years 2009 to 2012. As of the date of the Prospectus, no obligations remain related to these grants.
(vi) EUR 15,000 from ELY-keskus (Finland’s Centre for Economic Development, Transport and the Environment) for initiating company activities for the year 2009. As of the date of the Prospectus, no obligations remain related to these grants.
(vii) EUR 223,363 from EU to hire one scientist into EU project "ADVance". The EU project was terminated in November 2015. Up until the date of the Prospectus, all requirements and milestones related to the grant have been met. The remaining last payment trance of EUR 39,417 will be paid by EU to the Company likely during the second half of 2016.
In addition, Oncos has received three R&D loans from Tekes under loan agreements dated September 2010, January 2012 and December 2013, respectively, in the total outstanding amount of EUR 5,842,312 as of 31 March 2016. Pursuant to IFRS, these loans have a grant element due to the low interest rate they carry. The loan periods of the R&D loans are 10 years, of which the first 5 years are free of repayment.58 The loans are repaid in equal annual installments during the latter 5 years. Annual interest is paid yearly throughout the entire loan period. The applicable interest rate under the R&D loans is the European Central Bank’s steering rate less 3 percentage points per annum, although not less than 1%. The Company has issued an on-demand guarantee in favor of Tekes for the repayment obligation of Oncos under the R&D loans.
Pursuant to the terms and conditions of the R&D loans from Tekes, there is a change of control provision which accelerate the repayment obligation under the R&D loans in the event of a change of control in Oncos.
8.8.6 Patents and patent applications Below is an overview of the Group’s patents and patent applications.
Patent / patent Priority application date Status Area covered Geographic area Expiry date
EP15172418.4 16 June Pending New peptides targeting RAS exon 4 Currently EPO1, but 16 June 2035 2015 mutations and mixtures of defined RAS- will proceed to mutated peptides can be used as a vaccine international against, or treatment for RAS mutated cancers. In addition, mixtures of T cells specific for RAS-mutations in individual patients can be administered to those patients, with or without RAS-mutated peptides, and RAS mutation specific T cell receptors can be used to engineer chimeric antigen receptor T cells (CART) that can be administered as treatment to patients with RAS mutated cancer.
58 The repayment free period of the loan from September 2010 has been extended with three years.
60
Patent / patent Priority application date Status Area covered Geographic area Expiry date
WO2015/169804 6 May Pending The administration of a mixture of RAS- International 6 May 2034 2014 mutated peptides together with an anti- metabolite chemotherapeutic agent such as gemcitabine leads to a stronger immune response than the administration of the peptide mixture alone. WO2015/086590 9 Pending A mixture of at least two defined RAS- International 9 December (A2) December mutated peptides can be used as a vaccine 2033 2013 against, or treatment for, over 99% of all RAS mutated cancers. In addition, mixtures of T cells specific for RAS-mutations in individual patients can be administered to those patients, with or without RAS- mutated peptides. If granted, this patent application would cover TG02 and TG03. WO 0066153 (A1) 30 April Granted Method of vaccinating humans with a Norway 30 April 2019 1999 mixture of RAS-mutated peptides to elicit a RAS-specific T cell immune response (therapeutic and prophylactic use).
This patent covers TG01. USP 5961978 26 Granted Peptides and method of vaccinating USA 5 October February humans with RAS-mutated peptides to 2016 1991 elicit a RAS mutation-specific T cell immune response (therapeutic and prophylactic use).
This patent covers the TG0X technology in general. WO2013076374 25 Granted / Composition of matter and method of use Granted in Finland. 25 November (A1) November pending of oncolytic adenoviruses having several Pending in EPO and 2031 2011 different characteristics. USA. This patent describes ONCOS-402. EP 15186798.3 25 Pending ONCOS-402 composition of matter and Pending in EPO / USA 25 November US 14/866,582 November method of treating patients (divisional 2031 2011 application of WO2013076374 (A1)) This patent covers ONCOS-402 US 24 Granted / Composition of matter and method of use Granted in Finland, 24 2013323205 (A1) September pending of viral constructs in which the viral South Africa and September WO 2010 replication is under hTERT gene activated Australia. Allowed in 2031 2012038607 (A1) by telomerase activity found in cancer China. Pending in cells. Viral construct include the use of Canada, EPO, South CD40L transgene. Korea, Singapore, This patent covers several viral and USA. constructs containing the CD40L transgene, but not ONCOS-402. WO 2010072900 22 Granted / ONCOS-102 viral construct and its uses. Granted in USA For most (A1) December pending Composition of matter for Ad5/3-D24- Finland, Russia, territories; 2008 GMCSF. Method of treating patients Singapore and South 22 December suffering from various cancer indications Africa. 2029. For using the virus alone or in combination Pending in Australia, Finland; 28 with chemotherapeutics. Brazil, Canada, April 2029; China, EPO1, Hong For Russia; 22, This patent covers ONCOS-102. Kong, India, Japan and South Korea. December 2034
1 Member states of the European Patent Organisation.
The ownerships of the above mentioned patents and patent applications are held by the Group. Except from the above, the Group does not hold or license any patents that are business-critical.
The Group’s success will depend significantly on its ability to obtain and maintain patent and other proprietary 61
protection for commercially important technology, inventions and know-how related to its business, defend and enforce its patents, preserve the confidentiality of the Group’s trade secrets and operate without infringing the valid and enforceable patents and other proprietary rights of third parties. The Group also relies on know-how and continuing technological innovation to develop, strengthen, and maintain its proprietary position in the field of cancer treatment. See Section 2.1 "Risks related to the Group and the industry in which the Group operates" for more information on the risks associated with the Group’s patents.
The costs of the patents, depending upon the nationality of the patent application, are usually comprised of a one-time application fee, a yearly maintenance fee, and costs for prosecution and issuance of the patent. The maintenance fee of patents is currently approximately NOK 191,000 per year for the current patent portfolio (expected to increase in line with any new patent granted).
The patent positions of biopharmaceutical companies are generally uncertain and involve complex legal, scientific and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Consequently, the Company does not know whether its product candidate and future candidates will be protectable or remain protected by enforceable patents in all relevant countries. The Company cannot predict whether the pending patent applications the Group is currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Any patents that the Group holds may be challenged, circumvented or invalidated by third parties. See Section 2.1 "Risks related to the Group and the industry in which the Group operates" for more information on the risks associated with third parties limiting the Group’s freedom to operate.
Two of the Group’s patents expire in 2016 and 2019, respectively. USP 5961978 (USA), which expires in October 2016, relates to peptides and methods of vaccinating humans with RAS position 12 and position 13 mutated peptides to elicit a RAS mutation-specific T cell immune response. Indirectly, the patent is also believed to provide protection for TG01 and TG02. However, TG01 is protected in the U.S. by its orphan drug designation and TG02 is specifically protected by WO2015/086590 with expiry date 9 December 2033. Consequently, the Company does not believe that the expiry of USP 596178 will be of importance to Targovax with respect commercial development of the two vaccines comprising position 12 and position 13 mutated RAS peptides. The expiry of the U.S. patent will by no means have any consequences outside the U.S. Patent no. WO 0066153, which expires in 2019, relates to TG01. TG01 has obtained orphan drug designation in both Europe and the USA. Consequently, the expiry of the Norwegian granted patent is not considered to have any negative effect on Targovax.
The Company also rely on trade secret protection for its confidential and proprietary information.
8.8.7 License agreements The Group’s virus platform uses a cell line licensed from the US National Institute of Health in the GMP manufacturing of ONCOS-102 and ONCOS-402. The license covers the use of the cell line for commercial purposes. The license fee is in total USD 20,000 over the 10 year term of the agreement. The license agreement terminates in 2024.
8.9 Material contracts No company in the Group has entered into any material contract outside the ordinary course of business for the two years prior to the date of this Prospectus. Further, no company in the Group has entered into any other contract outside the ordinary course of business which contains any provision under which any member of the Group has any obligation or entitlement.
8.10 Dependency on contracts, patents and licenses etc. It is the Company’s opinion that the Group’s existing business or profitability is not dependent upon any contracts. It is further the opinion of the Company that the Group’s existing business or profitability is not dependent on any patents or licenses other than the patent and patent application as further described in Section 8.8.6 "Patents and patent application".
8.11 Legal proceedings From time to time, the Company may become involved in litigation, disputes and other legal proceedings arising in the normal course of business, principally personal injury, property casualty and cargo claims. The Company expects that these claims would be covered by insurance, subject to customary deductibles. Such claims, even if lacking merit, could result in the expenditure of significant financial and managerial resources.
The Group is, nor has been during the course of the preceding 12 months, involved in any legal, governmental or arbitration proceedings which may have, or has had in the recent past, significant effects on the Group’s and/or the 62
Group’s financial position or profitability, and the Group is not aware of any such proceedings which are pending or threatened.
8.12 Information technology The Group has outsourced the IT functions, including network, servers, set up and support of printers and PCs. The services are based on a centralized operations/support model.
8.13 Office leases The Group rents premises in Oslo, Norway for office purposes. The annual rent is approximately NOK 1,568,000 (excl VAT). The Company is in addition to this amount charged for a proportionate share of common variable costs related to building management.
The Group also rents premises in Helsinki, Finland for office and laboratory purposes. The rent is approximately EUR 228,000 per annum (excl VAT). As part of the lease, the landlord agreed to finance the construction works and machinery and equipment purchases made by Oncos in 2010 – 2012 pertaining to the premises (approximately EUR 1.4 million excl VAT). The Group is now repaying such investment as part of the rent. The rental agreement may be terminated by the Group in August 2020 and by the landlord in August 2025. Should the lease be terminated by the Group prematurely (i.e. before August 2020), the Group would be liable to pay liquidated damages to the landlord (amounting to 1/150 of the landlord’s total investment per month of premature termination).
There are no environmental issues that may affect the Group’s utilization of the tangible fixed assets.
The Group does not own any assets which are necessary for production.
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9 CAPITALISATION AND INDEBTEDNESS The information presented below should be read in conjunction with the information included elsewhere in this Prospectus, including Section 10 "Selected Financial and Other Information" and the Financial Information and related notes, included in Appendix B and C to this Prospectus.
This Section provides information about the Company’s unaudited capitalization and net financial indebtedness on an actual basis as at 31 March 2016 and, in the "As adjusted 31 March 2016" columns, the Company’s unaudited capitalization and net financial indebtedness as at 31 March 2016, on an adjusted basis to give effect to the following transactions as if these transactions had happened on 31 March 2016:
That the Company's cash balance has been reduced with approximately NOK 38 million in the period from 31 March 2016 to the contemplated date of Listing on 8 July 2016.
That the Company has raised net proceeds of NOK 103.6 million in June 2016 through the Private Placement.
Other than set forth above, there has been no material change to the Company’s capitalization and net financial indebtedness (on an unconsolidated basis) since 31 March 2016.
9.1 Capitalization
Adjustment for Adjustment for In TNOK As of reduced cash the Private As adjusted 31 March 2016 balance Placement 31 March 2016
(unaudited) (unaudited) (unaudited) (unaudited) Indebtedness Total current debt: Guaranteed ...... - - - - Secured ...... - - - - Unguaranteed/unsecured ...... 23,544 - - 23,544
Total non-current debt: Guaranteed1 ...... 37,995 - - 37,995 Secured ...... - - - -
Unguaranteed/unsecured ...... 57,431 - - 57,431
Total indebtedness ...... 118,970 - - 118,970
Shareholders’ equity Share capital ...... 2,688 - 1,469 4,157 Legal reserves ...... 522,502 - 102,169 624,671 Other reserves2 ...... -135,965 -38,000 - -173,965 389,226 -38,000 103,638 454,863 Total shareholders’ equity ......
Total capitalization ...... 508,196 -38,000 103,638 573,833
1 The Company has issued an on-demand guarantee in favor of Tekes for the repayment obligation of Oncos related to this non-current debt. 2 Contains other reserves (NOK 11,502), retained earnings (NOK -162,524) and translation differences (NOK 15,057).
9.2 Net financial indebtedness
Adjustment for Adjustment for In TNOK As of reduced cash the Private As adjusted 31 March 2016 balance Placement 31 March 2016
(unaudited) (unaudited) (unaudited) (unaudited) Net indebtedness (A) Cash ...... 140,885 -38,000 103,638 206,523 (B) Cash equivalents ...... - - -
(C) Interest bearing receivables ...... - - - 140,885 -38,000 103,638 206,523 (D) Liquidity (A)+(B)+(C) ......
15,341 - - 15,341 (E) Current financial receivables ......
(F) Current bank debt ...... - - - - (G) Current portion of non-current debt ...... - - - -
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Adjustment for Adjustment for In TNOK As of reduced cash the Private As adjusted 31 March 2016 balance Placement 31 March 2016
(unaudited) (unaudited) (unaudited) (unaudited)
(H) Other current financial debt ...... 23,544 - - 23,544 23,544 - - 23,544 (I) Current financial debt (F)+(G)+(H) ...
(J) Net current financial indebtedness (I)-(E)-(D) ...... -132,682 38,000 -103,638 -198,320
(K) Non-current bank loans ...... - - - - (L) Bonds issued ...... - - - -
(M) Other non-current loans...... 37,995 - - - (N) Non-current financial indebtedness (K)+(L)+(M) ...... 37,995 - - 37,995
-94,687 38,000 -103,638 -160,325 (O) Net financial indebtedness (J)+(N) ...
9.3 Working capital statement The Group is of the opinion that the working capital available is sufficient for the Group’s present requirements for the period covering at least 12 months from the date of this Prospectus.
9.4 Contingent and indirect indebtedness As at 31 March 2016 and as at the date of the Prospectus, the Group did not have any contingent or indirect indebtedness.
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10 SELECTED FINANCIAL AND OTHER INFORMATION 10.1 Introduction and basis for preparation The following selected financial information has been extracted from the Company’s unaudited interim financial statements as of and for the three month period ended 31 March 2016, with comparable figures as of and for the three month period ended 31 March 2015 (the Interim Financial Statements) and the Company’s audited financial statements as of and for the year ended 31 December 2015, with comparable figures as of and for the year ended 31 December 2014 (the Financial Statements). The Financial Statements, included in Appendix B, have been prepared in accordance with IFRS, while the Interim Financial Statements, included in Appendix C, have been prepared in accordance with IAS 34.
For pro Forma Financial Information, see Section 11 "Unaudited Pro Forma Financial Information".
The selected financial information included herein should be read in connection with, and is qualified in its entirety by reference to the Financial Information included in Appendix B and Appendix C of this Prospectus.
10.2 Summary of accounting policies and principles For information regarding accounting policies and the use of estimates and judgments, please refer to note 2 of the Financial Statements included in this Prospectus as Appendix B.
10.3 Statement of profit or loss The table below sets out selected data from the Company’s unaudited condensed interim statements of profit or loss for the three month periods ended 31 March 2015 and 2014 and from the Company’s audited statement of profit or loss for the years ended 31 December 2015 and 2014.
Three months ended Year ended In TNOK 31 March 31 December
2016 2015
(unaudited) (unaudited) 2015 2014
Other revenue ...... - - 146 72 Total revenue ...... - - 146 72 External R&D expenses ...... -10,818 -1,517 -25,231 -7,766 Payroll and related expenses ...... -13,198 -2,975 -35,431 -5,367 Other operating expenses ...... -6,960 -2,228 -29,100 -4,509 Total operating expenses ...... -30,976 -6,720 -89,762 -17,642 Operation profit/loss (-) ...... -30,976 -6,720 -89,616 -17,570 Financial income ...... 281 211 2,339 343 Financial expenses ...... -836 -242 -2,608 -420 Net financial items ...... -555 -31 -269 -77 Loss before income tax ...... -31,531 -6,751 -89,885 -17,646 Income tax ...... 74 0 -1,930 - Loss for the period ...... -31,457 -6,751 -91,816 -17,646 Earnings/loss (-) per share Basic and dilutive earnings/loss (-) per share (in NOK) ...... -1.17 -0.72 -5.06 -2.50
10.4 Statement of other comprehensive income The table below sets out selected data from the Company’s unaudited condensed interim statements of other comprehensive income for the three month periods ended 31 March 2015 and 2014 and from the Company’s audited statement of other comprehensive income for the years ended 31 December 2015 and 2014.
In TNOK Three months ended Year ended 31 March 31 December
2016 2015 (unaudited) (unaudited) 2015 2014
Income/loss(-) -31,457 -6,751 -91,816 -17,646 Exchange differences arising from the translation of -6,735 0 21,793 - foreign operations ...... Total comprehensive income/loss -38,192 -6,751 -70,023 -17,646
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(-) for the period ......
Income/loss (-) for the period attributable to owners .. -38,192 -6,751 -70,023 -17,646 Total comprehensive income/loss (-) for the period ...... -38,192 -6,751 -70,023 -17,646
10.5 Statement of financial position The table below sets out selected data from the Company’s unaudited condensed interim statement of financial position as at 31 March 2016 and from the Company’s audited statement of financial position as of 31 December 2015 and 2014.
As of As of In TNOK 31 March 31 December
2016
(unaudited) 2015 2014 Assets Intangible assets ...... 350,457 358,070 - 1,512 1,590 150 Office furniture ......
Total non-current assets ...... 351,969 359,659 150 Receivables ...... 15,341 11,557 4,660 140,885 173,898 62,552 Cash and cash equivalents ......
Total current assets ...... 156,226 185,455 67,213
Total assets ...... 508,196 545,114 67,362 Equity and liabilities Equity Share capital ...... 2,688 2,688 943 Share premium reserve ...... 552,502 522,502 97,792 Other reserves ...... 11,502 6,957 780
Retained earnings ...... -162,524 -131,067 -38,842
Translation differences ...... 15,057 21,793 -
Total equity ...... 389,226 422,873 60,673 Long term liabilities Interest-bearing loans and borrowings ...... 37,995 38,112 - Deferred tax ...... 57,431 58,709 - Total long term liabilities ...... 95,426 96,821 - Short term liabilities Accounts payable and other current liabilities ...... 10,611 6,307 2,564.4 Accrued public charges ...... 1,390 1,826 780.6
Other short-term liabilities ...... 11,542 17,287 3,344.3
Total short term liabilities ...... 23,544 25,420 6,689.3 508,196 545,114 67,362.3 Total equity and liabilities......
10.6 Statement of cash flow The table below sets out selected data from the Company’s unaudited condensed interim statements of cash flow for the three month periods ended 31 March 2016 and 2015 and from the Company’s audited statements of cash flows for the years ended 31 December 2015 and 2014.
Three months ended Year ended In TNOK 31 March 31 December
2016 2015
(unaudited) (unaudited) 2015 2014 Cash flows from operating activities Loss ...... -31,531 -6,571 -89,885 -17,646 Adjustments for: Interest income ...... -281 -211 -2,339 -288 Interest and other finance expense ...... 836 242 2,608 81 Share option expense ...... 4,545 602 5,717 147 Depreciation...... 69 8 148 11 Change in receivables ...... -3,783 -1,670 -3,026 1,166
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Three months ended Year ended In TNOK 31 March 31 December
2016 2015
(unaudited) (unaudited) 2015 2014
Change in other current liabilities ...... -2,812 -579 5,887 2,694
Net cash flow from operating activities ...... -32,958 -8,359 -80,890 -13,835
Cash flows from investing activities Investment in office furniture ...... -19 0 -158 -160 0 0 1,313 - Purchase of intangible assets ......
Net cash flow from investing activities -19 0 1,155 -160
Cash flows from financing activities Net interest income ...... - -2 1,009 287 Interest paid ...... - - -526 - Other finance expense ...... -213 - - -5 Share issue expense - Aquisition of Oncos OY ...... - - -260 - Share issue expense – Private placement ...... - - -9,207 -4,604 Proceeds from issuance of shares – Private Placement ...... - - 200,000 72,500 - - 188 - Proceeds from exercise of options ......
Net cash flow from financing activities ...... -213 -2 191,204 68,178
Total cash flow ...... -33,190 -8,361 111,468 54,182 Net exchange gain/loss on cash and cash equivalents ...... 178 -0 -123 -
Cash and cash equivalents at beginning of period ...... 173,898 62,552 62,552 8,370
Cash and cash equivalents at end of period ...... 140,885 54,191 173,898 62,552
10.7 Statement of changes in equity The table below sets out selected data from the Company’s audited statements of changes in equity for the years ended 31 December 2015 and 2014 and from the Company’s unaudited condensed interim statements of changes in equity for the three month period ended 31 March 2016.
Retained
In TNOK earnings Share Share Other Translation (accumulat Total capital premium reserves differences ed losses) equity
Balance at 1 January 2014 470 20,368 633 - -21,195 276
Loss for the period ...... - - - - -17,646 17,646 Other comprehensive income/loss, net of ------tax ...... Total comprehensive income for the year ...... - - - - 17,646 17,646 Recognition of share-based payments ...... - - 147 - - 147 Issue of ordinary shares – capital 473 77,424 - - - 77,896 increase ...... 943 97,792 780 - -38,841 60,673 Balance at 31 December 2014 ...... Loss for the period ...... - - - - -6,751 -6,751 Total comprehensive income for the period ...... - - - - -6,751 -6,751 Recognition of share-based payments ...... - - 602 602 Balance at 31 March 2015 (unaudited) . 943 97,792 1,381 - -45,592 54,524 Loss for the period ...... - - - - -85,065 -85,065 Exchange differences arising from the translation of foreign operations ...... - - - 21,793 - 21,793 Other comprehensive income/loss, net of ------tax ...... Total comprehensive income for the - - - 21,793 -85,065 -63,272 period ...... Issue of ordinary shares - Acquiring Oncos Therapeutics OY ...... 943 234,792 - - - 235,735 Transaction costs - Oncos Therapeutics - -260 - - - -260 68
Retained
In TNOK earnings Share Share Other Translation (accumulat Total capital premium reserves differences ed losses) equity
OY ...... Issue of ordinary shares - Capital increase - Private ...... 800 199,200 - - - 200,000 Transaction costs – 2015 Private Placement ...... - -9,207 - - - -9,207 Share issuance, employee share options ... 3 185 - - - 188 Reclassification of share-based payment Oncos...... - - 410 -410 - Recognition of share-based payments ...... - - 5,166 - - 5,166 2,688 522,502 6,957 21,793 -131,067 422,873 Balance at 31 December 2015 ...... Loss for the period ...... - - - - -31,457 -31,457 Exchange differences arising from the translation of foreign operations ...... - - - -6,735 - -6,735 Other comprehensive income/loss, net of tax ...... - - - -6,735 31,457 -38,192 Total comprehensive income for the - - - 6,735 31,457 -38,192 period ......
Recognition of share-based payments ...... - - 4,545 - - 4,545
Balance at 31 March 2016 (unaudited) . 2,688 522,502 11,502 15,057 -162,524 389,226
10.8 Auditor The Company’s auditor is Ernst & Young AS (EY), Dronning Eufemias gate 6, P.O. Box 20, Oslo Atrium, N-0051 Oslo, Norway. EY’s partners are members of The Norwegian Institute of Public Accountants (Nw.: Den Norske Revisorforening). EY has been the Company’s auditor since 30 October 2014. Prior to this, Lundes Revisjonskontor DA was the Company’s auditor. Lundes Revisjonskontor DA and its auditors are members of The Norwegian Institute of Public Accountants with mainly SME clients in Norway. As a consequence of the Company’s ambitions to grow its development activities, capital needs and international expansion going forward, the Company decided to change its auditor to one of the global multi discipline audit firms. The Company chose to appoint EY which is a full scale audit and advisory firm with international network and extensive experience from biotech and listed companies. The Financial Statements for the year ended 31 December 2014 with comparable figures for the year ended 31 December 2013 and the Financial Statements for the year ended 31 December 2015, with comparable figures for the year ended 31 December 2014 have been audited by EY, and the auditor’s report is included together with the Financial Statements for the year ended 31 December 2015 in Appendix B.
With respect to the unaudited Pro Forma Financial Information included in the Prospectus, EY has applied assurance procedures in accordance with the International Standard on Assurance Engagements 3420, "Assurance Engagements to Report on the Compilation of Pro Forma Financial Information Included in a Prospectus" in order to express an opinion as to whether the unaudited Pro Forma Financial Information has been properly compiled on the basis stated, and that such basis is consistent with the accounting policies of the Company. EY’s report on the unaudited Pro Forma Financial Information is included in Appendix D.
PricewaterhouseCoopers Oy has audited the Oncos Oy Financial Statements as of and for the year ended 31 December 2014. The following emphasis of matter was included in their report:
"We draw attention to Note 3 to the accompanying report of the Board of Directors, according to which the Company generated a loss of 3,446,227.24 euros during the financial year ended 31 December 2014. This circumstance, along with other matters raised on the report of the Board of Directors, refers to such material uncertainty that may cast significant doubt upon the company’s ability to continue its operations. Our opinion is not qualified in respect of this matter."
Further, the following remark was included in their report:
"As a remark we present that the company’s equity during the end of the financial year was negative. The Board of Directors has made a register notification in accordance to the Companies Act, Chapter 20 § 23 on 28th of April 2014. Our opinion is not qualified in respect of this matter."
To align Targovax Oy to the Group's auditor, EY was elected to do the audit for Targovax Oy for the year ended 31
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December 2015.
Neither EY nor PwC has audited, reviewed or produced any report on any other information provided in this Prospectus.
10.9 Financial review 10.9.1 Liquidity and capital resources 10.9.1.1 Sources of liquidity The Group’s principal sources of liquidity are cash flows from equity issues and governmental grants. The Company primarily uses cash for development of immuno-oncology drug candidates and necessary working capital. As of 31 March 2016, cash and cash equivalents amounted to NOK 140.9 million.
The Company believes that the same general combination of funds provided by governmental grants and equity issues will be sufficient to meet the Company’s working capital and capital expenditure requirements for the foreseeable future. Based on the Company’s current estimates, it believes that the cash balance following the Private Placement will be sufficient to cover the Company’s activities until year-end of 2017.
10.9.1.2 Restrictions on use of capital There are currently no restrictions on the use of the Company’s capital resources that have materially affected or could materially affect, directly or indirectly, the Company’s operations. The Company does not have any debt covenants, and is therefore not in breach and does not expect to be in breach of such covenants. The Company does not believe that there are significant obstacles or barriers to transfers of funds to it from its subsidiaries. There are certain requirements and milestones related to the grants the Group has received, see Section 8.8.5 "Grants".
10.9.1.3 Summarized cash flow information The following table summarizes the Company’s historical cash flows, and is extracted from the Company’s unaudited interim cash flow statements as of and for the three month period ended 31 March 2016 and 2015, and the Company’s audited cash flow statement as of and for the year ended 31 December 2015 and 2014:
Three months ended Year ended In TNOK 31 March 31 December
2016 2015 2015 2014
(unaudited) (unaudited)
Cash flow from operating activities ...... -32,958 -8,359 -80,890 -13,835 Cash flow from investing activities ...... -19 0 1,155 -160 Cash flow from financing activities ...... -213 -2 191,204 68,178 Net change in cash and cash equivalents ...... 33,190 -8,361 111,468 54,182 Cash and cash equivalents at end of period ...... 140,885 54,191 173,898 62,522
10.9.1.4 Cash flows from operating activities Three months ended 31 March 2016 compared to the three months ended 31 March 2015 Net cash outflow from operating activities for the three months ended 31 March 2016 was NOK 33.0 million compared to NOK 8.4 million for the three months ended 31 March 2016, an increase of NOK 24.6 million. The increase was primarily attributable to the combination with Oncos Therapeutics with effect from 2 July 2015 and increased activity in general.
Year ended 31 December 2015 compared to year ended 31 December 2014 Net cash outflow from operating activities for the year ended 31 December 2015 was NOK 80.9 million compared to NOK 13.8 million for the year ended 31 December 2014, an increase of NOK 67.1 million. The increase was primarily attributable to increased operating expenses of NOK 72.1 million due to increased development activities in the Company, and increased net cash flow to the company from change in current receivables and liabilities.
10.9.1.5 Cash flows from investing activities Three months ended 31 March 2016 compared to the three months ended 31 March 2015 Net cash outflow from investing activities for the three months ended 31 March 2016 was NOK 0 million compared to NOK 0 million for three months ended 31 March 2015, an increase of NOK 0 million.
Year ended 31 December 2015 compared to year ended 31 December 2014
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Net cash outflow from investing activities for the year ended 31 December 2015 was NOK 1.2 million compared to NOK 0.2 million for the year ended 31 December 2014, an increase of NOK 1 million. The increase was primarily attributable to office equipment acquired in 2015.
10.9.1.6 Cash flows from financing activities Three months ended 31 March 2016 compared to the three months ended 31 March 2015 Net cash outflow from financing activities for the three months ended 31 March 2016 was NOK 0.2 million compared to NOK 0 million for the three months ended 31 March 2015, an increase of NOK 0.2 million. The increase was primarily attributable to net finance expenses.
Year ended 31 December 2015 compared to year ended 31 December 2014 Net cash inflow from financing activities for the year ended 31 December 2015 was NOK 191.2 million compared to NOK 68.2 million for the year ended 31 December 2014, an increase of NOK 123 million. The increase was primarily attributable to net proceeds from equity issue. Net proceed from equity issue was NOK 191.0 million in 2015 compared to NOK 77.9 million in 2014.
10.9.2 Results of operations Three months ended 31 March 2016 compared to the three months ended 31 March 2015 Revenues were NOK 0 million in the three months ended 31 March 2016, compared to NOK 0 million in the three months ended 31 March 2015. Operating expenses amounted to NOK 31.0 million in the three months ended 31 March 2016, compared to NOK 6.8 million in the three months ended 31 March 2015. The operating expenses are presented net of governmental grants. The governmental grants during the three months ended 31 March 2016 amounted to NOK 3.6 million, compared to NOK 2.0 million in the three months ended 31 March 2015. The increase in other operating costs for the three months ended 31 March 2016 reflects the combination with Oncos and more activities in all areas.
The net loss for the three months ended 31 March 2016 amounted to NOK -31.5 million, compared to NOK -6.8 million for the three months ended 31 March 2015.
Year ended 31 December 2015 compared to the year ended 31 December 2014 Revenues were NOK 0.2 million in the year ended 31 December 2015, compared to NOK 0.1 million in the year ended 31 December 2014. Revenues mainly concern sale of services. Operating expenses amounted to NOK 89.8 million in the year ended 31 December 2015, compared to NOK 17.6 million in the year ended 31 December 2014. The increase in 2015 compared to 2014 reflects increased development activities. The operating expenses have been reduced through the receipt of public funding, which amounted to NOK 9.1 million for the year ended 31 December 2015 compared to NOK 8.0 million in the year ended 31 December 2014. After financial items, the loss for the year amounted to NOK 89.6 million in 2015 compared to NOK 17.6 million in 2014.
10.9.3 Financial position As of 31 March 2016 compared to as of 31 March 2015 As of 31 March 2016, cash and cash equivalents amounted to NOK 140.9 million, compared to NOK 54.2 million as of 31 March 2015. Total equity amounted to NOK 389.2 million as of 31 March 2016 compared to NOK 54.5 as of 31 March 2015. Other receivables amounted to NOK 15.3 million as of 31 March 2016 compared to NOK 6.3 million as of 31 March 2015. Despite increase in operational activities for the three months ended 31 March 2016 compared to the three months 31 March 2015, both the cash position and equity position were strengthened due to the capital increase in July 2015 with net proceed of NOK 191 million. The equity was further strengthened due to the transaction with Oncos also in July 2015.
As of 31 December 2015 compared to as of 31 December 2014 As of 31 December 2015, cash and cash equivalents amounted to NOK 173,898 million compared to NOK 62.5 million as of 31 December 2014. Net proceed from capital increase in 2015 was NOK 191.0 million. Other receivables amounts to NOK 11.6 million as of 31 December 2015 compared to NOK 4.7 million as of 31 December 2014. Total assets amounts to NOK 545,114 million as of 31 December 2015 compared to NOK 67.4 million as of 31 December 2014. Total equity amounted to NOK 422.9 million as of 31 December 2015 compared to NOK 60.7 million as of 31 December 2014. Despite increase in operational activities the for year ended 31 December 2015 compared to the year ended 31 December 2014, both the cash position and equity position were strengthened due to the capital increase in July 2015 with net proceed of NOK 191 million. The equity strengthened further more due to the transaction with Oncos also in July 2015.
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For a financial review of the three months ended as of 31 March 2016 compared to the three months ended 31 March 2016, see page 6 of the Interim Financial Statements included in Appendix C hereto.
10.10 Borrowings, contractual cash obligations and other commitments The Company does not have any material contractual cash obligations or other commitments as of the date of this Prospectus. However, Oncos has received funding from Tekes in the forms of R&D loans in the principal outstanding amount of EUR 5,842,312 as of 30 June 2016. See Section 8.8.5 "Grants" for further description of the grants and R&D loans.
10.11 Investments 10.11.1 Principal investment in progress and planned principal investments There are no significant capital expenditure investments in progress. Costs associated with the development of the Group’s product candidates are ordinary R&D expenses, expensed as they are incurred. See Section 8.8.4 "Research and development expenses".
The Company does not have any other investment plans, firm commitments or obligations to make significant future investments in tangible or intangible assets, or financial assets. However, the Company may modify its plans in the future to address, among others, changes in market conditions for its products and changes in the competitive conditions.
10.11.2 Principal historical investments Historical investments relate to R&D expenses in connection with the development of the product candidates. Costs of obtaining and maintaining patents are also included in the R&D expenses. For further details regarding the R&D expenses, see Section 8.8.4 "Research and development expenses".
The table below shows the principal historical capital expenditures and investments of the Company for the three month period ended 31 March 2016 and the years ended 31 December 2015 and 2014, derived from the Company’s Interim Financial Statements and Financial Statements.
Three months Year ended In TNOK ended 31 March 31 December
2016 2015 2014
(unaudited)
Office equipment etc...... 19 158 160
Total ...... 19 158 160
All research and development costs were for the three month period ended 31 March 2016 and the years ended 31 December 2015 and 2014 expensed and amounted to NOK 16.3 million, NOK 39.1 million and NOK 14.8 million, respectively.
There have been no principal investments since the date of the Interim Financial Statements as of and for the three month period ended 31 March 2016.
10.12 Related party transactions The Company is not a party to any related party transactions.
10.13 No off-balance sheet arrangements The Company has not entered into and is not a party of any off-balance sheet arrangements.
10.14 Trend information The Company has not experienced any changes or trends that are significant to the Company between 31 March 2015 and the date of this Prospectus, nor is the Company aware of such changes or trends that may or are expected to be significant to the Company for the current financial year.
10.15 Significant changes There have been no significant changes in the financial or trading position of the Company since date of the Financial Information, which have been included in this Prospectus.
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10.16 Recent developments The recent developments in the period from 31 March 2016 to the date of this Prospectus are in accordance with plan. Targovax has received approval in Australia to conduct a Phase I clinical trial of TG02 and pembrolizumab in patients with locally recurrent, RAS mutated rectal cancer and received approval in Spain to conduct a Phase I/II clinical trial of ONCOS-102 and standard of care chemotherapy in advanced refractory malignant pleural mesothelioma. Targovax's operational focus is to plan for the start of clinical trials with:
ONCOS-102 in melanoma
ONCOS-102 in mesothelioma
TG02 in colorectal cancer
Furthermore, Targovax, together with its clinical trial collaborators LCR/CRI and Sotio, is planning to start trials in various solid tumor indications and advanced prostate cancer, respectively. In addition, the company continues the existing trial of TG01 in resected pancreatic cancer.
The total cash burn for the period is approximately NOK 42 million, mainly relating to research and development activities.
On 20 June 2016, the Company announced the intention to launch the Private Placement. The application period lasted from 20 June 2016 and until 21 June 2016. On the basis of the applications made, the Board of Directors allocated 14,685,000 new Shares at a price of NOK 7.50 per Share, raising approximately NOK 110 million in gross proceeds, subject to the approval of the general meeting. The general meeting of the Company approved the Private Placement on 6 July 2016. See Section 16.1 "The Private Placement" for more information regarding the Private Placement.
Except from the above mentioned matters, there have been no significant changes in the financial or trading position of the Company since date of the Interim Financial Information, which have been included in this Prospectus.
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11 UNAUDITED PRO FORMA FINANCIAL INFORMATION 11.1 Introduction As discussed elsewhere in this Prospectus, on 2 July 2015, the Company completed the acquisition of all the shares in Oncos pursuant to a share purchase agreement (the "SPA") dated 10 June 2015 (the Combination). As a result thereof, Oncos became a wholly-owned subsidiary of the Company. As consideration for the shares in Oncos, the Company issued 9,429,404 new Shares, each with a nominal value of NOK 0.10, to the sellers. The Company further assumed the transaction costs related to the transaction. On 9 July 2015, the Company completed a private placement raising gross proceeds to the Company of NOK 200 million (the 2015 Private Placement). The net proceeds from the 2015 Private Placement were NOK 190.8 million. 8,000,000 new Shares were issued by the Company in the 2015 Private Placement, increasing the share capital of the Company with NOK 800,000, from NOK 1,885,880.80 to NOK 2,685,880.80. The Combination and the 2015 Private Placement were mutually conditional upon each other. The Combination triggers the requirement to include pro forma financial information in the Prospectus.
For a description of the legal structure of the Group, please see Section 13.2 "Legal structure".
11.2 General information and purpose of the unaudited condensed pro forma financial information The unaudited condensed pro forma financial information (the "unaudited Pro Forma Financial Information") set out below has been prepared by the Company for illustrative purposes to show how the Combination might have affected the Company’s statement of profit or loss and other comprehensive income for the year ended 31 December 2015 as if the Company had acquired Oncos on 1 January 2015.
The Combination is fully reflected in the statement of financial position as at 31 December 2015 and 31 March 2016. The Company has accordingly not prepared a pro forma statement of financial position.
The Pro Forma Financial Information is based on certain management assumptions and adjustments. These assumptions might not necessarily have applied had Oncos been consolidated into the Company for the purposes of financial reporting in such periods. Because of its nature, the Pro Forma Financial Information included herein addresses a hypothetical situation and, therefore, does not represent the actual financial results for the Company for the periods presented. The Pro Forma Financial Information does not purport to present what the Company’s results of operations would actually have been had the Combination occurred on 1 January 2015, and is not representative of the results of operations for any future periods. Investors are cautioned against placing undue reliance on this unaudited Pro Forma Financial Information.
The Pro Forma Financial Information has been compiled in connection with the Listing and the Subsequent Offering to comply with the Norwegian Securities Trading Act and the EU Prospectus Directive. It should be noted that the Pro Forma Financial Information is not prepared in connection with an offering registered with the U.S. Securities and Exchange Commission ("SEC") under the U.S. Securities Act and consequently is not compliant with the requirements of Regulation S-X presentation of pro forma financial information. As such, a U.S. investor should not place undue reliance on the Pro Forma Financial Information included in this Prospectus.
The assumptions underlying the pro forma adjustments and IFRS adjustments, for purpose of deriving the unaudited Pro Forma Financial Information, are described in the notes to the unaudited Pro Forma Financial Information. Neither these adjustments nor the resulting unaudited Pro Forma Financial Information have been audited in accordance with Norwegian or United States generally accepted auditing standards. Each reader should carefully consider the Financial Information of the Company and the Oncos Oy Financial Statements and the notes thereto and the notes to the unaudited Pro Forma Financial Information.
The unaudited Pro Forma Financial Information does not include all of the information required for financial statements under IFRS and should be read in conjunction with the Financial Information of the Company included in Appendix to this Prospectus.
11.3 Basis of preparation 11.3.1 General With respect to the unaudited Pro Forma Financial Information included in this Prospectus, EY has applied assurance procedures in accordance with International Standards on Assurance Engagements 3420, Assurance Engagements to Report on the Compilation of Pro Forma Financial Information Included in a Prospectus, in order to express an opinion as to whether the unaudited Pro Forma Financial Information has been properly compiled on the basis stated, and that such basis is consistent with the accounting policies of the Group. EY’s report is included in Appendix D to this Prospectus. 74
11.3.2 Basis and source for the Pro Forma Financial Information The Pro Forma Financial Information has been prepared in a manner consistent with the accounting policies of the Company (IFRS as adopted by EU) applied in 2015. The Company has not adopted any new policies in the first quarter of 2016. Please refer to the Financial Statement for the year ended 31 December 2015 for a description of the Company’s accounting policies. Differences between the accounting principles adopted by the Company and those adopted by Oncos have been analyzed. Please refer to Section 11.4.2 "Notes to the unaudited condensed pro forma financial information for the year ended 31 December 2015" for further information.
The Pro Forma Financial Information has been prepared under the assumption of going concern.
The Pro Forma Financial Information is based on and derived from:
The Company’s Financial Statements as of and for the year ended 31 December 2015 (prepared in accordance with IFRS), included as Appendix C to the Prospectus;
The Oncos Oy Trial Balances as of and for the six months ended 30 June 2015 (prepared based on the principles of FGAAP);
The Oncos AG Trial Balances as of and for the six months ended 30 June 2015 (prepared based on the principles of SGAAP).
The unaudited condensed Pro Forma Financial Information is presented in NOK, which is also the parent company’s functional currency and presentation currency. For purposes of the unaudited condensed Pro Forma Financial Information the statement profit or loss and other comprehensive income have been translated from the relevant functional currencies to NOK based on the average exchange rate for the period.
The following exchange rates have been used to convert the financial information for Oncos Oy and Oncos AG into NOK for the purposes of the Pro Forma Financial Information presented below:
Currency Average 2015 EUR/NOK ...... 8.9410 CHF/NOK ...... 8.3768
11.4 Unaudited condensed pro forma financial information for the year ended 31 December 2015 11.4.1 Unaudited condensed pro forma statement of profit or loss for the year ended 31 December 2015 The table below sets out the unaudited condensed pro forma statement of profit or loss and other comprehensive income for the Company for the year ended 31 December 2015, as if the Combination had occurred on 1 January 2015.
Historical Historical consolidated consolidated financial financial information of IFRS Pro forma NOK thousand information of Oncos adjustments Pro forma financial the Company YTD 30 June of Oncos adjustment information YTD 31 2015 YTD 30 June YTD 30 June YTD 31 December 2015 (unaudited, 2015 2015 December 2015 (audited, IFRS) FGAAP) (unaudited) (unaudited) (unaudited) Other revenue ...... 146.0 - - - 146.0 Total revenue ...... 146.0 - - - 146.0 Cost of manufacturing for R&D ...... -9,013.4 -123.7 - - -9,137.0 Payroll and related expenses ...... -35,430.9 -6,545.9 -160.9 (b) - -42,137.8 Depreciation ...... -147.7 -101.6 - - -249.3 Other operating expenses ...... -45,170.0 -1,803.9 364.0 (a) - -46,610.0 Total operating expenses ...... -89,762.0 -8,575,1 203.0 - -98,134.1 Operation profit/loss (-) ...... -89,616.0 -8,575.1 203.0 - -97,988.1
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Historical Historical consolidated consolidated financial financial information of IFRS Pro forma NOK thousand information of Oncos adjustments Pro forma financial
the Company YTD 30 June of Oncos adjustment information YTD 31 2015 YTD 30 June YTD 30 June YTD 31 December 2015 (unaudited, 2015 2015 December 2015 FGAAP) (audited, IFRS) (unaudited) (unaudited) (unaudited) Financial income ...... 2,338.9 33.9 - - 2,372.8
Financial expenses ...... -2,608.4 -2,410.3 -4,119.3 (a),(c),(d) 5,293.8 (e) -3,844.2
Net financial items ..... -269.5 -2,376.4 -4,119.3 5,293.8 -1,471.4 Loss before income tax ...... -89,885.5 -10,951.5 -3,916.3 5,293.8 -99,459.4 Income tax...... -1,930.0 - - - -1,930.0 Loss for the period ..... -91,815.5 -10,951.5 -3,916.3 5,293.8 -101,389.4
The unaudited unadjusted historical financial information for Oncos Oy and Oncos AG are presented in the table below for the period ended 30 June 2015. Eliminations of inter-company revenues and expenses between Oncos Oy and Oncos AG in the period are presented in a separate column, and are taken into account in the column "Historical consolidated financial information of Oncos". No differences were identified between FGAAP and SGAAP for the Oncos companies. The financial information of Oncos has been translated using the exchange rates as described in Section 11.3.2 "Basis and source for the condensed unaudited pro forma financial information" above.
Historical Historical Historical Historical Historical consolidated consolidated financial financial financial Eliminations financial financial information information information of information information of Six month period of Oncos of Oncos AG of Oncos AG intercompany of Oncos Oncos ended 30 June 2015 (unaudited, (unaudited, (unaudited, transaction (unaudited, (unaudited, FGAAP) SGAAP) SGAAP) (unaudited) FGAAP) FGAAP) TEUR TCHF TEUR TEUR TEUR TNOK
Other revenue ...... - 503.7 483.7 -483.7 - - Total revenue ...... - 503.7 483.7 -483.7 - - Cost of manufacturing for R&D ...... -14.3 - - - -14.3 -123.7 Payroll and related expenses ...... -358.9 -414.1 -397.6 - -756.6 -6,545.9 Depreciation ...... -11.7 - - - -11.7 -101.6 Other operating expenses ...... -594.0 -102.3 -98.2 483.7 -208.5 -1,803.9 Total operating expenses ...... -978.9 -516.4 -495.9 483.7 -991.1 -8,575.1 Operation profit/loss (-) ...... -978.9 -12.7 -12.2 - -991.1 -8,575.1 Financial income ...... - 4.3 3.9 - 3.9 33.9 Financial expenses ...... -278.6 -0.3 - - -278.6 -2,410.3 Net financial items ...... -278.6 4.1 3.9 - -274.7 -2,376.4 Loss before income tax ...... -1,257.5 -8.6 -8.3 - -1,265.7 -10,951.5 Income tax...... ------Loss for the period ...... -1,257.5 -8.6 -8.3 - -1,265.7 -10,951.5
11.4.2 Notes to the unaudited condensed pro forma financial information for the year ended 31 December 2015 Since the Oncos Oy and Oncos AG Trial Balances for the six months ended 30 June 2015 have been prepared based on the principles of FGAAP and SGAAP, the Management has assessed that certain adjustments were necessary for this financial information to be in compliance with IFRS for use in Section 11.4.1 "Unaudited condensed pro forma statement of profit or loss for the year ended 31 December 2015".
Since the acquisition of Oncos was completed on 2 July 2015 and Oncos has been consolidated from that date, IFRS adjustments and pro forma adjustments relate to the six month period in 2015 up to the completion of the acquisition.
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The IFRS adjustments and pro forma adjustments presented in the table above are specified as follows:
(a) Tekes loans – IFRS adjustments Tekes is a publicly financed funding agency that finances research and development activities in Finland. Tekes loans have been granted by governmental institution at a very low interest rate. Interest charged is 1% while market rate is assessed to be 8%. Under IFRS carrying amount of the liability is recognised at fair value. Fair value is determined by discounting future cash flows applying the 8 % interest rate. The fair value adjustment on initial recognition of the liability is in accordance with IAS 20, recognized as government grant. The government grant is recorded as a reduction to other operating expenses in the period when the loans have been granted. IFRS adjustment for the grant component of loan received in the six month period ended 30 June 2015 amounts to TNOK 364.0.
Interest expense is calculated by using the effective interest rate method and the interest expenses for the six month period ended 30 June 2015 is increased by TNOK 552.6. The adjustment will have a continuing effect going forward.
(b) Payroll and related expenses – IFRS adjustments
Arrangements held by key employees at Oncos contain share based payment compensation. IFRS require recognition of shared based payment transaction while FGAAP does not require such recognition. The share based compensation arrangement is valued using the Black-Scholes in accordance with IFRS 2. The IFRS adjustment for the six month period ended 30 June 2015 is TNOK 160.9 in increased payroll expense.
The share based compensation program for Oncos has been replaced by a new share based compensation program for Targovax in the in fourth quarter 2015.
The adjustment will have a continuing effect going forward.
(c) Convertible bridge loans – IFRS adjustments Oncos has been financed by bridge loans since 2012 and no repayments have been made on the loans. The lenders had a right and obligation to convert the full amount and accumulated interest into preference shares. Annual coupon rate for the loans was 8%. Under FGAAP, carrying value of convertible bridge loans amounted to NOK 73.7 million as of 30 June 2015. In addition the lenders were entitled to subscribe common shares at a below market rate (discount). Under IFRS, the convertible bridge loans are recognized at amortized cost net of the implied fair value of the conversion right at initial recognition. The increased interest expense calculated using the effective interest method amounts to TNOK 2,528.2 for the six month period ended 30 June, 2015. Total interest expense on the convertible bridge loans under IFRS amounts to TNOK 4,876.8 for the six month period ended 30 June 2015.
Since the bridge loans were converted to equity as of 1 July 2015, the loans will not have any impact on the financial statement going forward.
(d) Series A Shares – IFRS adjustments Oncos had two shares series: Series K (common shares) and Series A. Series A shares had preferences related to dividends and asset sharing. Series A shares are classified as debt under IFRS while it is classified as equity under FGAAP. The holders of the Series A shares, had based on the shareholders agreement, right to claim payment of 6% interest. Under IFRS the interest expenses of 6% for the period ended 30 June 2015 amounts to TNOK 1,038.5.
The Company is now owner of all the Series A shares. Consequently, the liability and interest expenses are eliminated in the Group unaudited condensed pro forma financial information and will have no impact on the financial statement going forward.
(e) Financial expenses – pro forma adjustments The bridge loans were converted to equity prior to completion of the acquisition and the preference shares and common shares issued were part of the SPA. The Series A shares were also part of the SPA. In the unaudited condensed pro forma statement of profit or loss and other comprehensive income, interest expenses on the bridge loans and Series A shares are eliminated, resulting in reduced interest expenses of TNOK 4,876.8 and TNOK 1,038.5 respectively. As the bridge loans were converted to equity and the Series A shares were part of the SPA, no interest expenses are charged in the second half of 2015 and going forward.
For the IFRS adjustment of the Tekes loans described in a) above the Company applied the transitional exemptions for first time adopters under IFRS 1. As a consequence, Tekes loans granted prior to 1 January 2013 were not adjusted to fair value. In the purchase price allocation these loans have been adjusted to fair value by discounting future cash 77
flows using the 8 % interest rate, resulting in a fair value adjustment of TNOK 9,283.9 and a carrying amount of TNOK 33,584.0 in the statement of financial position at the acquisition date. Based on the effective interest rate method, an increase in interest expense of TNOK 621.5 has been recorded as a pro forma adjustment in the unaudited condensed pro forma statement of profit or loss and other comprehensive income. The pro forma adjustment will have continuing impact going forward.
The total pro forma adjustment is TNOK 5,293.8.
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12 BOARD OF DIRECTORS, MANAGEMENT, EMPLOYEES AND CORPORATE GOVERNANCE 12.1 Introduction The General Meeting is the highest authority of the Company. All shareholders in the Company are entitled to attend and vote at General Meetings of the Company and to table draft resolutions for items to be included on the agenda for a General Meeting.
The overall management of the Company is vested in the Company’s Board of Directors and the Company’s Management. In accordance with Norwegian law, the Board of Directors is responsible for, among other things, supervising the general and day-to-day management of the Company’s business ensuring proper organization, preparing plans and budgets for its activities ensuring that the Company’s activities, accounts and assets management are subject to adequate controls and undertaking investigations necessary to perform its duties.
The Board of Directors has three sub-committees: an audit committee, a remuneration committee and a corporate governance committee. In addition, the Company’s Articles of Association provides for a nomination committee.
The Management is responsible for the day-to-day management of the Company’s operations in accordance with Norwegian law and instructions set out by the Board of Directors. Among other responsibilities, the Company’s chief executive officer (the "CEO"), is responsible for keeping the Company’s accounts in accordance with existing Norwegian legislation and regulations and for managing the Company’s assets in a responsible manner. In addition, the CEO must according to Norwegian law, brief the Board of Directors about the Company’s activities, financial position and operating results at a minimum of one time per month.
12.2 The Board of Directors 12.2.1 Overview of the Board of Directors The Company’s Articles of Association provide that the Board of Directors shall consist of eight Board Members. The current Board of Directors consist of eight Board Members, as listed in the table below.
Pursuant to the Norwegian Code of Practice for Corporate Governance dated 30 October 2014 (the "Norwegian Corporate Governance Code"), (i) the majority of the shareholder-elected members of the Board of Directors should be independent of the Company’s executive management and material business contacts, (ii) at least two of the shareholder-elected members of the Board of Directors should be independent of the Company’s main shareholders (shareholders holding more than 10% of the Shares in the Company), and (iii) no members of the Company’s executive management should be on the Board of Directors.
All Board Members are independent of the Company’s executive management and material business contacts and no members of the Company’s executive management serves on the Board of Directors. Except from Per Samuelsson and Johan Christenson who are not considered independent of HealthCap V L.P. and Jónas Einarsson and Bente-Lill Bjerkelund Romøren who are not considered independent of the Norwegian Radium Hospital Research Foundation, all Board Members are independent of the Company’s main shareholders (shareholders holding more than 10% of the Shares in the Company).
The Company’s registered office address at Lilleakerveien 2 C, 0283 Oslo, Norway serves as c/o addresses for the Board Members in relation to their directorships of the Company.
As at the date of this Prospectus, none of the members of the Board of Directors hold any options or other rights to acquire Shares, other than Robert Burns who holds 21,235 share options in the Company. See Section 12.5 "Share option program".
12.2.2 The Board of Directors The names and positions of the Board Members are set out in the table below.
Name Position Served since Term expires Shares
Jónas Einarsson ...... Chairperson October 2010 AGM 2017 - Bente-Lill Bjerkelund Romøren ... Board member May 2012 AGM 2017 - Johan Christenson ...... Board member July 2015 AGM 2017 - Lars Lund-Roland ...... Board member July 2015 AGM 2017 - Per Samuelsson ...... Board member July 2015 AGM 2017 - Robert Burns ...... Board member July 2015 AGM 2017 29,063 Eva-Lotta Coulter ...... Board member September 2015 AGM 2016 - Diane Mellett ...... Board member September 2015 AGM 2016 - 79
12.2.3 Brief biographies of the Board Members Set out below are brief biographies of the Board Members, including their relevant management expertise and experience, an indication of any significant principal activities performed by them outside the Company and names of companies and partnerships of which a Board Member is or has been a member of the administrative, management or supervisory bodies or partner the previous five years.
Jónas Einarsson, Chairperson Jónas Einarsson is the CEO of the Norwegian Radium Hospital Research Foundation. The Norwegian Radium Hospital Research Foundation is an experienced pre-seed investor and project developer focused on cancer. Mr Einarsson sits on the board of directors of several Norwegian biotech companies and was one of the initiators behind Oslo Cancer Cluster and the Oslo Cancer Cluster Innovation Park. Mr Einarsson is a Norwegian citizen, and resides in Norway.
Current directorships and senior management positions ... The Norwegian Radium Hospital Research Foundation (CEO), Ultimovacs AS (board member), Biomolex AS (board member) and OCC Innovation Park (board member). Previous directorships and senior management positions last five years ...... Nordic Nanovector ASA (board member), Oslo Cancer Cluster (OCC) (CEO and chairman) and The Norwegian School of Veterinary Science (board member).
Bente-Lill Bjerkelund Romøren, Board member Bente-Lill Bjerkelund Romøren is a consultant with 40 years of experience gained from national and international management positions in the pharmaceutical industry. She was formerly CEO of Novo Nordisk Scandinavia. Her experience spans senior management, marketing, sales, business development, licensing, market access, public affairs, clinical trials and lifecycle management. Ms Bjerkelund Romøren has good knowledge of the health care system as well as regulations and framework for the pharmaceutical market. She has board member experience from private and public sector (health care). She holds a MSc degree in chemistry from the Norwegian Institute of Technology in Trondheim. Ms Bjerkelund Romøren is a Norwegian citizen, and resides in Norway.
Current directorships and senior management positions ... The Norwegian Radium Research Foundation (board member), Farmastat (chairman), Photocure ASA (chairman) and the Norwegian Ski Federation (chairman of the ski jumping committee, board member of Skistyret). Previous directorships and senior management positions last five years ...... Novo Nordisk Scandinavia AS (general manager Norway) and Nordic Nanovector ASA (board member).
Johan Christenson, Board member Dr. Johan Christenson has been a Partner at HealthCap since 2001. He has been in the life science sector covering science, medicine, drug development and venture investments since 1981. Prior to joining HealthCap, Dr Christenson was with SEB Företagsinvest (the venture capital arm of SEB) to supervise the health care portfolio. He was Global Product Director and member of the global therapy area management team of Pain and Inflammation at AstraZeneca. He has a MD degree and a PhD in basic neuroscience from Karolinska Institute. He held a position as Assistant Dean at the Karolinska Institute Graduate School for two years. Dr. Christenson has four years of clinical specialist training in paediatrics and paediatric neurology. Dr Christenson is a Swedish citizen, and resides in Sweden.
Current directorships and senior management positions ... Trimb Healthcare AB (board member), Oncopeptides AB (board member), Glinova AB (board member), BeneChill, Inc. (board member), Nexstim Oy (board member), Ibid AB (board member), Ancilla AB (board member), HealthCap 1999 GP AB (board member), HealthCap Annex Fund I-II GP AB (board member), HealthCap IV GP AB (board member), HealthCap III Sidefund GP AB (board member), HealthCap GbR ORX Holding AB (board member), HealthCap 1999 ORX Holding AB (board member), HealthCap Sidefund ORX Holding AB (board member), HealthCap Holdings GB AB (board member), HealthCap Annex Fund I-II Bis GP AB (board member), HealthCap Aero Holdings GP AB (board member) and HealthCap Orx Holdings GP AB (board member). Previous directorships and senior management positions last five years ...... Cerenis Therapeutics SA (board member), Newron Sweden AB (chairman) and Wilson Therapeutics (board member).
Lars-Lund Roland, Board member Lars Lund-Roland has for the last three years been CEO of Bringwell AB (publ), a Nordic health and welfare company listed in Stockholm, that commercialises OTC pharmaceuticals, nutrition and food supplements. Prior to this, he has 80
been Managing Director of MSD Norway (Merck & Co Inc. subsidiary) for 10 years and has gained more than twenty- five years of big-pharma experience from various executive positions within marketing and sales at Merck & Co., Inc. He currently holds board positions at Vaccibody AS and PI Innovation AS and has served as board member of Infodoc AS and Health Tech AS, two Norwegian health technology companies, as well as on the board of the Norwegian Association of Pharmaceutical Manufacturers. He is a Business Economist Graduate from Norwegian Business School BI, has a BSc in Healthcare from Buskerud University College and leadership education from the Sr. Executive program at Columbia Business School and Harvard. Mr. Lund-Roland is a Norwegian citizen, and resides in Norway.
Current directorships and senior management positions ... VacciBody AS (board member), Papirbredden Innovation AS (board member), Bringwell Norge AS (chairman) and AS Anjo (board member). Previous directorships and senior management positions last five years ...... Bringwell AB (CEO and board member), MSD Norge AS (managing director), Health Tech AS (board member,) Infodoc AS (board member) and Papirbredden Innovation AS (chairman).
Per Samuelsson, Board member Per Samuelsson is a partner at Odlander Fredrikson/HealthCap, the life sciences venture capital firm, which he joined in 2000. Prior to this, he gained more than 15 years of investment banking experience, mainly with Aros Securities in Sweden. In his final position with Aros Securities, as a Director in the firm’s corporate finance department, he specialized in the areas of merger transactions, initial public offerings, and equity incentive programs. Prior to this, Mr Samuelsson was Head of Research, also at Aros Securities. He currently holds several Board positions at BioStratum Inc, Nordic Vision Clinics AS, Oncopeptides AB, RSPR Pharma AB, Nordic Nanovector ASA and SwedenBIO. He received his MSc in Engineering from the Institute of Technology in Linköping, Sweden. Mr Samuelsson is a Swedish citizen, and resides in Sweden.
Current directorships and senior management positions ... Nordic Nanovector ASA (board member), Ancilla AB (board member), BioStratum Inc (board member), Cantando AB (board member), Cardoz Incentive AB (chairman), HealthCap AB (board member), Nordic Vision Clinics AS (chairman), Oncopeptides AB (board member), NVC Holding AB (board member), RSPR Pharma AB (board member), SwedenBio Service AB (board member), HealthCap Holdings GP AB (board member), HealthCap Annex Fund I-II Bis GP AB (board member), HealthCap 1999 GP AB (board member), HealthCap Annex Fund I-II GP AB (board member), HealthCap IV GP AB (board member), HealthCap III Sidefund GP AB (board member), HealthCap Aero Holdings GP AB (board member) and HealthCap Orx Holdings GP AB (board member). Previous directorships and senior management positions last five years ...... Algeta ASA (board member), Eksse AB (board member), Rocaer AB (board member), Onxeo SA (board member), Topotarget A/S (board member), Optivy Sweden AB (chairman and board member), Nordic Vision Clinics AS (board member), PSPR Pharma AB (chairman), HealthCap GbR ORX Holding AB (board member), HealthCap Sidefund ORX Holding AB (board member), HealthCap 1999 ORX Holding AB (board member) and NVC Holding AB (chairman).
Robert Burns, Board member Robert Burns is a consultant and advisor to companies developing immune based therapies in cancer. He has experience over more than 30 years in building biotechnology companies focused on immuno-oncology and was a member of the board of directors of Oncos prior to the Combination. He is currently the Chairman of Haemostatix Limited and was previously CEO at Affitech A/S (NASDAQ/OMX) and CEO at Celldex Therapeutics Inc (NASDAQ), both immuno-oncology vaccine and antibody discovery companies. Prior to Celldex Therapeutics, Dr Burns was Director of Technology Licensing at the Ludwig Institute for Cancer Research, an international independently financed not-for- profit research group focused on cancer vaccines and antibody based immunotherapies. He holds a PhD in Chemistry and is a UK citizen, residing in Oxford, UK.
Current directorships and senior management positions ... Haemostatix Limited (chairman) and Alvos Oncology Ltd (managing director). Previous directorships and senior management positions last five years ...... 4-Antibody AG (CEO) and Affitech AS (CEO).
Eva-Lotta Coulter (known as Eva-Lotta Allan), Board member Eva-Lotta Allan is an experienced biotechnology deal-maker with over 25 years of business development experience from the biotechnology and life science industry in both private and public companies. She has significant operational
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and investor relations expertise as well as Board experience. She is Chief Business Officer at Immunocore, an immune-oncology company specializing in the development of soluble T cell receptor based drugs. Immunocore secured Europe’s largest private life sciences financing in July 2015. Ms Allan was previously at Ablynx NV, where she served as Chief Business Officer for close to seven years and brought in multiple strategic partnerships. She has served as a Non-Executive Director of Isconova AB. Prior to Ablynx, Ms Allan served as Senior Director of Business Development and Site Operations (Europe) at Vertex Pharmaceuticals where she was also a Director of the Board of Vertex Europe. Other senior roles held include Oxford Asymmetry (now Evotec) and Oxford GlycoSciences (now UCB). She received her degree in microbiology from the University of Stockholm. Ms Allan is a Swedish citizen, and resides near Oxford, UK.
Current directorships and senior management positions ... Immunocore Ltd (Chief Business Officer). Previous directorships and senior management positions last five years ...... Immunocore Ltd (board member), Ablynx plc (Chief Business Officer) and Isconova AB (board member).
Diane Mellett, Board member Diane Mellett is a consultant to a number of biotech and medical device companies. She has qualified in both US and UK law and advises biotechnology companies in commercial contract and intellectual property matters. She was formerly General Counsel for Cambridge Antibody Technology (CAT) (LSE: NASDAQ) and led the secondary NASDAQ listing of that company as well as serving on the board of directors. During her time at CAT, she led a successful defense of a contractual dispute with Abbott Pharmaceuticals (now Abbvie) covering the company’s major collaboration partnership covering Humira®, the most successful revenue generating antibody therapy in the pharmaceutical industry to date. Ms Mellett is a UK citizen, and resides in France.
Current directorships and senior management positions ... Chevrelles Consulting Ltd (sole director) and Bioxpress S A (board member). Previous directorships and senior management positions last five years ...... Medical Research Council Technology (member of the Board of Governors).
12.3 Management 12.3.1 Overview The Company’s management team consists of 8 individuals. The names of the members of Management as of the date of this Prospectus, and their respective positions, are presented in the table below:
Employed with the Shares (including Private Name Current position within the Company Company since Placement Shares)
Gunnar Gårdemyr ...... Chief Executive Officer January 2015 40,000 Øystein Soug ...... Chief Financial Officer May 2015 100,0001 Jon Amund Eriksen ...... Chief Operating Officer February 2011 724,6502 Magnus Jäderberg ...... Chief Medical Officer The Combination 20,000 Antti Vuolanto ...... Executive Vice President The Combination 61,773 Tina Madsen ...... Vice President, Quality Assurance January 2015 4,800 Anne-Kirsti Aksnes ...... Vice President, Clinical Development January 2015 12,000 Peter Skorpil ...... Vice President, Business Development April 2015 10,000
1 The shares are held through Abakus Invest AS. 2 The shares are held through Timmuno AS.
The Company’s registered office address at Lilleakerveien 2 C, 0283 Oslo, Norway, serves as c/o address for the members of Management in relation to their employment with the Company.
12.3.2 Brief biographies of the members of Management Set out below are brief biographies of the members of Management, including their relevant management expertise and experience, an indication of any significant principal activities performed by them outside the Company and names of companies and partnerships of which a member of Management is or has been a member of the administrative, management or supervisory bodies or partner the previous five years.
Gunnar Gårdemyr – Chief Executive Officer Gunnar Gårdemyr has more than 30 years of senior level international experience in the pharmaceutical and biotech industry, including business development, mergers & acquisitions, global marketing and commercial strategy. Prior to 82
this position, he was Senior Vice President, Corporate Development/M&A, Global Business Development, Nycomed and Senior Vice President, Global Marketing, Takeda in Zurich, Switzerland, where he led the commercial assessment of external business development licensing opportunities, followed by a position as Corporate Advisor for Acino Pharma in Basel, Switzerland. Mr Gårdemyr began his career at Astra, followed by Ferring, Tigran Technologies and Retinalyze. He has a Bachelor of Science in Business Administration and Economics from the University of Lund, Sweden. Mr Gårdemyr is a Swedish citizen, and resides in Sweden.
Current directorships and senior management positions ... None. Previous directorships and senior management positions last five years ...... None.
Øystein Soug – Chief Financial Officer Øystein Soug has experience from 20 years in international banking and industry. The last six years before joining the Company he was CFO of Algeta ASA, where he built up the functions of Finance, IR, Compliance, IT and HR. Mr Soug oversaw Algeta ASA’s launch of Xofigo, capital raisings of some USD 200 million and the sub-sequent USD 2.9 billion sale of Algeta ASA to Bayer. He has experience from positions at Orkla Group as CFO of Sladco, the previous Russian operations of Orkla, and Project Manager in Orkla’s Corporate Development M&A team as well as at the European Bank for Reconstruction and Development (EBRD) in Russia. He has a MSc in Economics and Finance from the University of St. Gallen (lic.oec.HSG). Mr Soug is a Norwegian citizen, and resides in Norway.
Current directorships and senior management positions ... Abakus Invest AS (chairman) and Pharmasum Therapeutics AS (board member). Previous directorships and senior management positions last five years ...... Bionor Pharma ASA (deputy chairman) and Algeta ASA (CFO).
Jon Amund Eriksen – Chief Operating Officer Jon Amund Eriksen is co-founder and co-inventor of the Targovax technology. Mr Eriksen has more than 30 years of experience in the pharmaceutical and biotech industry (Nycomed, Norsk Hydro, GemVax, Pharmexa and Lytix Biopharma). He has previously held several senior positions as scientist, project leader and manager within development of cancer immunotherapy from discovery and early preclinical to Phase III clinical development. He is co- inventor of several patents for peptide cancer vaccines. Mr Eriksen holds a MSc in Chemistry from the University of Oslo. Mr Eriksen is a Norwegian citizen, and resides in Norway.
Current directorships and senior management positions ... Timmuno AS (chairman and CEO). Previous directorships and senior management positions last five years ...... Lytix Biopharma AS (director development oncology).
Magnus Jäderberg – Chief Medical Officer Magnus Jäderberg is a pharmaceutical physician with more than 25 years in various R&D functions including clinical research, medical affairs, pharmacovigilance, strategic product development, health economics and general management. Dr Jäderberg is experienced in all phases of clinical research, including clinical pharmacology, dose finding, registration, post-launch product differentiation and surveillance. His immunotherapy and clinical development expertise includes several medicines such as Rapamune (sirolimus) and Yervoy (ipilimumab). Prior to joining the Group, Mr Jäderberg held roles at national, European and global level at GSK, Pharmacia, Wyeth and most recently as Chief Medical Officer, Bristol Myers Squibb (Europe). He qualified in medicine at Karolinska Institute, Stockholm, Sweden, and is a fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom, and honorary lecturer in drug development at King’s College, London, United Kingdom. Dr Jäderberg is a Swedish citizen, and resides in the United Kingdom.
Current directorships and senior management positions ... None. Previous directorships and senior management positions last five years ...... Bristol Myers Squibb (Europe) (CMO).
Antti Vuolanto – Executive Vice President Antti Vuolanto has more than 10 years of experience in biotechnology business development, product development and commercialization. Prior to this position, he was a management team member responsible for product commercialization, product development and quality at Mobidiag, a company specializing in rapid nucleic acid-based infectious disease diagnostics. Mr Vuolanto was also project manager at Medicel developing bioinformatics infrastructure. He is a Doctor of Science (Technology) in bioprocess engineering from Aalto University in Helsinki. Mr. Vuolanto is a Finnish citizen, and resides in Finland.
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Current directorships and senior management positions ... None. Previous directorships and senior management positions last five years ...... None.
Tina Madsen – Vice President, Quality Assurance Tina Madsen has more than 20 years of experience within research & development and commercial manufacturing in the pharmaceutical and biotech industry, including quality assurance, process development and formulation. She has held managing positions within formulation and process development in Alpharma and QA in GE Healthcare. Before joining Targovax, she was Director of Product Quality Assurance in Algeta ASA (now Bayer AS). Ms Madsen holds a MSc in Pharmacy. Ms Madsen is a Danish citizen, and resides in Norway.
Current directorships and senior management positions ... None. Previous directorships and senior management positions last five years ...... Algeta ASA (Director Product Quality Assurance).
Anne-Kirsti Aksnes – Vice President, Clinical Development Anne-Kirsti Aksnes has more than 20 years of experience within clinical research and development in the pharmaceutical and biotech industry and 10 years of experience working in clinical physiology. Previously, she was VP Clinical Research in Algeta ASA (now Bayer AS), where she had a key role in the strategic, scientific and clinical development as well as in medical communications. She holds a medical doctorate degree (PhD) at Karolinska Institute, Sweden. Mrs Aksnes is a Norwegian citizen, and resides in Norway.
Current directorships and senior management positions ... None. Previous directorships and senior management positions last five years ...... Algeta ASA (vice president clinical development)
Peter Skorpil – Vice President, Business Development Peter Skorpil has extensive experience in licensing, commercial assessments, business intelligence and partnering. Previously, he was Commercial Director in Pronova BioPharma and Business Development Manager for Clavis Pharma where he was responsible for, among other things, out-licensing and managing Clavis partners. Mr Skorpil has also worked as a venture capital analyst at NeoMed Management. He holds an MBA from Brandeis University, Massachusetts, USA and a PhD in molecular biology from University of Geneva, Switzerland. Mr Skorpil is a Swiss citizen, and resides in Norway.
Current directorships and senior management positions ... None. Previous directorships and senior management positions last five years ...... None.
12.4 Remuneration and benefits 12.4.1 Remuneration of the Board of Directors In 2016, the annual general meeting of the Company resolved that all current board members shall receive NOK 200,000 for the period from the annual general meeting in 2015 and until the annual general meeting in 2016. If the current board members has served for a shorter period than since the annual general meeting in 2015, the remuneration shall be pro rata adjusted down (based on the number of days served compared to the full period). The annual general meeting further resolved that Robert Forbes Burns, Eva-Lotta Allan and Diane Mary Mellett in addition shall receive an extraordinary remuneration in the amount of NOK 100,000 in subject to mandatory settlement in restricted stock units ("RSUs"). See section 12.6 "Restricted stock unit program" for more information regarding the RSUs. Three of the board members Jónas Einarsson (chairman), Johan Christenson and Per Samuelsson have decided to waive any remuneration until the Company has sufficient financing in place. In accordance with their wishes, the annual general meeting resolved that no remuneration shall be granted to these board members for the period from the annual general meeting in 2015 to the annual general meeting in 2016.
At the same annual general meeting, it was resolved that for the period from the annual general meeting in 2016 to annual general meeting in 2017, the chairman of the board shall receive NOK 350,000 and all other board members shall receive NOK 200,000 for the period.
The remuneration shall be payable immediately after the annual general meeting in 2017. If a board member has not served for the entire period, the remuneration shall be pro rata adjusted down (based on the number of days served compared to the full period). With respect to Jónas Einarsson (chairman), Johan Christenson and Per Samuelsson, the payment of the remuneration is subject to the Company having sufficient financing in place prior to the annual general meeting in 2017. 84
The following remuneration was paid to the members of the Board of Directors for the period from the annual general meeting in 2015 to the annual general meeting in 2016 and for the period from the annual general meeting in 2016 to the annual general meeting in 2017, respectively:
Prop rata adjustment for the period from AGM Remuneration for the period Remuneration for the period Board member 2015 to AGM 2016 from AGM 2015 to AGM 2016 from AGM 2016 to AGM 2017 Jónas Einarsson (chairman) - NOK 0 NOK 350,000* Bente-Lill Bjerkelund Romøren 100% NOK 200,000 NOK 200,000 Johan Christenson - NOK 0 NOK 200,000* Lars Lund-Roland - NOK 0 NOK 200,000 Per Samuelsson 81%59 NOK 161,667 NOK 200,000* Robert Burns 100% NOK 200,000 (+ NOK 100,000 in NOK 200,000 RSUs) Eva-Lotta Coulter 58% NOK 116,000 (+ NOK 100,000 in NOK 200,000 RSUs) Diane Mellett 58% NOK 116,000 (+ NOK 100,000 in NOK 200,000 RSUs) * Conditional upon the Company having sufficient financing in place prior to the annual general meeting in 2017.
12.4.2 Remuneration of Management The total remuneration to the members of the Management in 2015 was NOK 17.66 million. The table below sets out the remuneration of the Management in 2015.
In TNOK Share-based payments (excl Other Pension social security expensed Name Salary Bonus expense tax) benefits Total
Jon Amund Eriksen (COO)...... 1,435 - 57 376 218 2,086 Gunnar Gårdemyr (CEO)1 ...... 2,247 - - 1,853 153 4,253 Øystein Soug (CFO)2 ...... 821 - 36 1,007 6 1,870 Magnus Jäderberg (CMO)3 ...... 2,588 270 - 641 616 3,845 Anne-Kirsti Aksnes (VP Clinical 924 - 53 263 13 1,253 development) ...... Antti Vuolanto (Executive VP)4...... 1,256 - 313 387 2 1,958 Tina Madsen (VP, Quality Assurance)5 ...... 896 - 51 263 19 1,229 Peter Skorpil (VP, Business Development)6 . 597 - 35 131 9 772 Total ...... 11,156 270 545 4,921 1,036 17,658
1 Gunnar Gårdemyr was employed by the Group in January 2015. 2 Øystein Soug was employed by the Group in May 2015. 3 Magnus Jäderberg became part of the Management as a result of the Combination. 4 Antti Vuolanto became part of the Management as a result of the Combination. 5 Tina Madsen was employed by the Group in January 2015. 6 Peter Skorpil was employed by the Group in April 2015.
12.5 Share option programs The Company has granted share options under its long term incentive program (the "LTI Option Program"). As of the date of this Prospectus, there are in total 2,463,263 outstanding options under the LTI Option Program.
Under the current plan, share options have been granted to all employees upon joining the Company. Additional grants have been made to senior employees on a discretionary basis. Certain former investors, employees and former and current board members have also been granted options under the LTI Option Program as replacement for historical option holdings.
All employees, including new employees, will be eligible for an option award on a discretionary basis in 2016. The Board of Directors will exercise discretion as to who will receive an equity award in any given year, based on recommendations made by the Nomination Committee.
Granted share options vest over a four-year period as follows: 25 percent of the options vest on the first anniversary of the grant date; and the remaining 75 percent of the options vest in equal monthly tranches over the next 36
59 Calculated with effect from 22 June 2015 where the General Meeting electing the Board Member took place.
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months. Options expire seven years after the grant date.
At the date of prospectus the range of exercise price and weighted average remaining contractual life of the options were as follows:
Outstanding options Vested options
Outstanding Weighted Average Weighted Average Options Per 1 July Remaining Remaining Years Weighted Avgerage Vested options per Exercise price 2016 Contractual Life Until Vesting Exercise Price 10 May 2016
0.00-7.50 148,170 3.65 1.72 4.05 105,636 7.51-15.04 25,000 6.46 1.61 14.46 - 15.05-21.50 506,000 4.68 0.86 21.25 171,700 21.51-31.00 1,683,079 5.10 0.96 25.00 339,471 31.01-40.00 101,014 5.75 0.03 37.60 95,316 Grand Total: 2,463,263 4.97 0.95 23.38 712,123
The following members of the Management participate in the LTI Option Program:
Option holder Number of options Expiry date Exercise price (NOK)
12 July 2020: 300,000 options NOK 21.5: 300,000 options Gunnar Gårdemyr (CEO) 500,000 2 July 2022: 200,000 options) NOK 25: 200,000 options 11 November 2010: 300,000 options Øystein Soug (CFO) 390,000 2 July 2022: 90,000 options NOK 25 Jon Amund Eriksen (COO) 160,000 2 July 2022 NOK 25 12 February 2021: 133,265 options Magnus Jäderberg (CMO) 390,000 2 July 2022: 256,735 options NOK 25 1 January 2021: 11,510 options Antti Vuolanto (EVP) 170,742 2 July 2022: 159,232 options NOK 25 Anne-Kirsti Aksnes (VP CD) 53,000 1 January 2022 NOK 21.5 Tina Madsen (VP QA) 53,000 1 January 2022 NOK 21.5 Peter Skorpil (VP BC) 45,000 8 April 2022 NOK 25
12.6 Restricted stock unit program At the annual general meeting of the Company in 2016, the general meeting resolved to establish a program for the members of the board of directors pursuant to which the members of the board of directors may choose to receive their remuneration, or parts thereof, in the form of restricted stock units (RSUs). The RSUs will be non-transferrable and each RSU will give the right and obligation to acquire shares in Targovax ASA (at nominal value) subject to satisfaction of the applicable vesting conditions.
Each member of the board of directors has three alternatives when the remuneration to the board members is resolved by the general meeting: a) Receive 100% of the board remuneration in the form of RSUs; b) Receive 1/3 of the board remuneration in cash and 2/3 in the form of RSUs; or c) Receive 2/3 of the board remuneration in cash and 1/3 in the form of RSUs;
The number of RSUs to be granted is calculated as the NOK amount of the RSU selected portion of total remuneration to the board member, divided by the market price for the Targovax share. The market price shall be calculated as the volume weighted average share price for the 10 trading days prior to the grant date (i.e. the date of the general meeting which the corresponding board remuneration was resolved, the "GM Date")). The RSU program will apply to the remuneration proposed by the board of directors in Section 12.4.1 "Remuneration of the Board of Directors", and for future periods unless otherwise resolved by the general meeting (including remuneration for the period from the annual general meeting in 2016 to the annual general meeting in 2017 which was resolved by the annual general meeting in 2016).
As a main rule, the vesting of the RSUs will be subject to (i) the grantee being a member of the board of directors at the vesting date, and (ii) the grantee not having notified the company prior to the vesting date of the grantee's intention to step down from the board of directors. If any of the above events occur prior to vesting, then the number
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of RSUs that vest shall be equal to the total number of RSUs granted multiplied by a fraction in which the numerator is equal to the number of calendar days in the period from grant and until the date on which the event occurs, and the denominator is equal to 365. The remaining RSUs shall will lapse without compensation.
The RSUs will vest on the first anniversary of the GM Date unless otherwise determined by the nomination committee. With respect to the RSU's granted for the period from the annual general meeting in 2015 to the annual general meeting in 2016, the RSU shall be fully vested at the time of grant (i.e. at the GM Date in 2016). When the RSUs have vested, the participant must in the following three-year period select when to take delivery of the shares. The participants will on a quarterly basis have the opportunity to: a) Receive all shares b) Receive all shares and sell a proportion of the shares immediately (shares may be sold to cover tax)
The RSUs will be honored by the issue of new Targovax ASA shares or by the delivery of shares held in treasury. The board member must for each share pay the nominal value of a Targovax ASA share of NOK 0.10.
Based on the election made by each member of the Board of Directors (i.e. the allocation between RSUs and cash remuneration as described above), and the volume weighted average share price for the 10 business days prior to the date of grant (13 April 2016) which was NOK 12.20 per share, the members of the Board of Directors currently hold the following number of RSUs:
Number of RSUs for Number of RSUs for the period AGM 2015 the period AGM 2016 Vesting Total RSU holder Grant date – AGM 2016 Vesting date – AGM 2017 date RSUs Jónas Einarsson ------Bente-Lill Bjerkelund Romøren 13 April 2016 5,464 13 April 2016 5,465 13 April 2017 10,929 Johan Christenson ------Lars Lund-Roland 13 April 2016 4,417 13 April 2016 16,394 13 April 2017 20,811 Per Samuelsson ------Robert Burns 13 April 2016 24,590 13 April 2016 16,394 13 April 2017 40,984 Eva-Lotta Coulter 13 April 2016 17,704 13 April 2016 5,465 13 April 2017 23,169 Diane Mellett 13 April 2016 17,704 13 April 2016 16,394 13 April 2017 34,098 Total 129,991
12.7 Benefits upon termination Gunnar Gårdemyr (CEO) and Magnus Jäderberg (CMO)are entitled to severance pay equal to 12 months' salary in the event of termination of his employment. Apart from this, no employee, including any member of Management, has entered into employment agreements which provide for any special benefits upon termination. None of the Board Members or members of the nomination committee have service contracts and none will be entitled to any benefits upon termination of office.
12.8 Pensions and retirement benefits For the year ended 31 December 2015, the costs of pensions for members of Management were NOK 544,000. The Company has no pension or retirement benefits for its Board Members.
12.9 Loans and guarantees The Company has not granted any loans, guarantees or other commitments to any of its Board Members or to any member of Management.
12.10 Employees As of the date of this Prospectus, the Group had 27 employees. The table below shows the development in the numbers of full-time employees over the last two years (including both the employees of the Company and Oncos (now Targovax Oy) and its subsidiary).
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As of the date of the Year ended Prospectus 31 December
2015 2014 27 26 20 Total Group ...... By legal entity: - Targovax ASA (Norway) ...... 18 15 6 - Targovax Oy (Finland)...... 9 10 13 - Targovax AG (Switzerland) ...... 0 1 1
By main category of activity: - Management ...... 8 7 6 - Functional Heads ...... 2 4 2 - Functional employees ...... 13 12 10 - Administrative ...... 4 3 2
12.11 Nomination committee The Company’s Articles of Association provide for a nomination committee composed of three members. The current members of the nomination committee are Ludvik Sandnes (chairperson), Anders Tuv and Johan Christenson. The nomination committee shall give recommendations for the shareholder-elected Board Members and the members of the nomination committee and make recommendations for remuneration to the Board Members and the members of the nomination committee.
12.12 Remuneration committee The Board of Directors has established a remuneration committee composed of Board Members. The current members of the remuneration committee are Per Samuelsson, Lars Lund-Roland and Robert Burns. The primary purpose of the remuneration committee is to assist and facilitate the decision making of the Board of Directors in matters relating to the remuneration of the executive management of the Group, reviewing recruitment policies, career planning and management development plans, and prepare matters relating to other material employment issues in respect of the executive management.
The remuneration committee reports and makes recommendations to the Board of Directors, but the Board of Directors retains responsibility for implementing such recommendations.
12.13 Audit committee The Board of Directors has established an audit committee composed of Board Members. The current members of the audit committee are Jónas Einarsson, Per Samuelsson and Lars Lund-Roland. The primary purposes of the audit committee are to:
assist the Board of Directors in discharging its duties relating to the safeguarding of assets, the operation of adequate system and internal controls, the control processes and the preparation of accurate financial reporting and statements in compliance with applicable legal requirements, corporate governance and accounting standards; and
provide support to the Board of Directors on the risk profile and risk management of the Group.
The audit committee reports and makes recommendations to the Board of Directors, but the Board of Directors retains responsibility for implementing such recommendations.
12.14 Corporate governance committee The Board of Directors has established a corporate governance committee composed of Board Members. The current members of the corporate governance committee are Johan Christenson, Bente-Lill Bjerkelund Romøren, Diane Mellett and Eva-Lotta Coulter. The primary purposes of the corporate governance committee are to monitor the Company’s compliance with the Norwegian Corporate Governance Code. The corporate governance committee reports and makes recommendations to the Board of Directors, but the Board of Directors retains responsibility for implementing such recommendations.
12.15 External scientific and clinical advisors The following internationally renowned scientific experts support Targovax’ research and development:
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Oncolytic viruses Pancreatic cancer Colorectal cancer
Name Institution Name Institution Name Institution
Kapil Dingra ...... KAPital Consulting Jordan Berlin ...... Vanderbilt University Al Benson ...... Lurie Comp Cancer Munchen, Germany Center Center of Northwestern Nashville, USA University, Division of Hematology / Oncology Chicago, IL, USA Mikael von Euler .. Karolinska Daniel Haller ...... Abramson Cancer Michal Ducreux ..... Institute Gustave Roussy Development Center at the Perelman Villejuif, France Stockholm, Sweden School of Medicine at the University of Pennsylvania, USA Hani Gabra ...... Imperial College Manuel Hidalgo ..... Centro Nacional de Richard Goldberg .. OSUCCC-James Cancer London, UK Investgaciones Hospital, Columbus Oncológicas OH, USA Madrid, Spain Eva Galanis ...... Mayo Clinic Eileen O’Reilly...... Memorial Sloan- Daniel Haller ...... Abramson Cancer Center Rochester, USA Kettering Cancer at the Perelman School Center, New York, USA of Medicine at the University of Pennsylvania, USA Luca Gianni ...... San Raffaele Hospital Margaret Eric van Cutsem .... Leuven Cancer Institute, Milano, Italy Tempero ...... Helen Diller Family UZ Comprehensive Center, Leuven, Belgium San Francisco, USA Kevin The Rotyal Marsden Eric van Cutsem.... Leuven Cancer John Zalckberg ..... School of Public Health Harrington ...... Hospital Institute, UZ and Preventive Medicine, London, UK Department of Epidemiology, Monash University Melbourne, Australia Elke Jager ...... Nordwest Krankenhaus Frankfurt, Germany Lee Helman ...... The National Cancer Institute Bethesda, USA
12.16 Corporate governance The Company has adopted and implemented a corporate governance policy based on the Norwegian Corporate Governance Code. The Company's corporate governance policy deviates from the Norwegian Corporate Governance Code on the following points:
• Deviation from Section 6 "General meetings": The Company does not have an arrangement in place to ensure independent chairing of the General Meeting. However, the Board of Directors will on an ad hoc basis evaluate independent chairing when necessary. Historically, it has not been deemed necessary to have independent chair.
Although Targovax encourages the Board Members and the member of the nomination committee to be present at the annual general meeting, their attendance is not always possible as the majority of the members live abroad and have competing work and travel commitments.
• Deviation from Section 7 "Nomination committee": Johan Christenson is currently member of both the Board of Directors and the nomination committee and offered himself for re-election, and was re-elected, as a Board Member and a member of the nomination committee at the annual general meeting in 2016.
12.17 Conflicts of interests etc. Per Samuelsson was a member of the board of directors of Eksse AB and Rocaer AB (two fund administration companies for liquidated HealthCap funds). These companies were liquidated in the ordinary course of business in 2012. Other than this, no Board Member or member of the Management has, or had, as applicable, during the last five years preceding the date of the Prospectus:
any convictions in relation to fraudulent offences;
received any official public incrimination and/or sanctions by any statutory or regulatory authorities (including designated professional bodies) or was disqualified by a court from acting as a member of the 89
administrative, management or supervisory bodies of a company or from acting in the management or conduct of the affairs of any company; or
been declared bankrupt or been associated with any bankruptcy, receivership or liquidation in his or her capacity as a founder, member of the administrative body or supervisory body, director or senior manager of a company; or
been selected as a member of the administrative, management of supervisory bodies or member of senior management of the Company’s major shareholders, customers, suppliers or others.
There are currently no other actual or potential conflicts of interest between the Company and the private interests or other duties of any of the Board Members and the members of the Management, including any family relationships between such persons.
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13 CORPORATE INFORMATION AND DESCRIPTION OF SHARE CAPITAL The following is a summary of certain corporate information and material information relating to the Shares and share capital of the Company and certain other shareholder matters, including summaries of certain provisions of the Company’s Articles of Association and applicable Norwegian law in effect as of the date of this Prospectus. The summary does not purport to be complete and is qualified in its entirety by the Company’s Articles of Association and applicable law.
13.1 Company corporate information The Company’s legal and commercial name is Targovax ASA. The Company is a publicly limited company organized and existing under the laws of Norway pursuant to the Norwegian Public Limited Companies Act. The Company’s registered office and domicile is in the municipality of Oslo, Norway. The Company was incorporated in Norway on 8 October 2010 and converted into a public limited company on 29 September 2015. The Company’s organization number in the Norwegian Register of Business Enterprises is 996 162 095, and the Shares are registered in book-entry form with the VPS under ISIN NO0010689326. The Company’s register of shareholders in VPS is administrated by Nordea Bank Norge ASA, Securities Services – Issuer Services, Middelthuns gate 17, P.O. Box 1166 Sentrum, N-0107 Oslo, Norway. The Company’s registered office is located at Lilleakerveien 2 C, 0283 Oslo, Norway and the Company’s main telephone number at that address is +47 21 39 88 10. The Company’s website can be found at www.targovax.com. The content of www.targovax.com is not incorporated by reference into and does not otherwise form part of this Prospectus.
13.2 Legal structure The Company is a public limited company incorporated and domiciled in Norway. The Company is the parent company in the Group. The Group’s operations are carried out by the Company and its wholly-owned subsidiary Targovax Oy. Targovax AG, a wholly owned subsidiary of Targovax Oy has no operations other than being the employing entity of one of the employees of the Group. Targovax Oy is incorporated in Finland and Targovax AG is incorporated in Switzerland. The Company does not have any other subsidiaries. The Company is the holder of the TG technology while Targovax Oy is the holder of the ONCOS-102 technology.
As at the date of this Prospectus, the Company is of the opinion that its holding in Targovax Oy is likely to have a significant effect on the assessment of its own assets and liabilities, financial condition or profit and losses.
13.3 Share capital and share capital history As of the date of this Prospectus, the Company’s share capital is NOK 4,159,036.70 divided into 41,590,367 Shares, with each Share having a nominal value of NOK 0.10. All the Shares have been created under the Norwegian Public Limited Companies Act, and are validly issued and fully paid.
The Company has one class of shares. Other than the share options and RSUs described in Section 12.5 "Share option program" and Section 12.6 "Restricted stock unit program", there are no share options or other rights to subscribe for or acquire Shares from the Company. Neither the Company nor any of its subsidiaries directly or indirectly owns Shares in the Company.
The table below shows the development in the Company’s share capital for the period from 8 October 2010 to the date hereof:
Change in share Nominal value New number New share Date of registration Type of change capital (NOK) (NOK) of Shares capital (NOK)
8 October 2010 Incorporation 100,000.00 1,000 100 100,000.00 6 April 2011 Share capital increase 66,000.00 1,000 166 166,000.00 13 September 2011 Share capital increase 34,000.00 1,000 200 200,000.00 23 February 2012 Share capital increase 170,300.00 0.10 1,703,000 370,300.00 19 April 2013 Share capital increase 100,000.00 0.10 4,703,000 470,300.00 21 January 2014 Share capital increase 147,059.00 0.10 6,173,590 617,359.00 13 June 2014 Share capital increase 325,581.40 0.10 9,429,404 942,940.40 2 July 2015 Share capital increase 942,940.40 0.10 18,858,808 1,885,880.80 9 July 2015 Share capital increase 800,000.00 0.10 26,858,808 2,685,880.80 17 December 2015 Share capital increase 2,500 0.10 26,883,808 2,688,380.80 (exercise of options) 9 May 2016 Share capital increase 2,155.9 0.10 26,905,367 2,690,536.70 (exercise of options) 7 July 2016 Share capital increase 1,468,500.00 0.10 14,685,000 4,159,036.70 (private placement) 91
Change in share Nominal value New number New share Date of registration Type of change capital (NOK) (NOK) of Shares capital (NOK)
*) The nominal value of the shares was changed from NOK 1,000 to NOK 0,1 between the September 2011 and February 2012 share issue. For comparable figures nominal value of 0,1 NOK are assumed for all years.
Except for the issuance of 9,429,404 consideration shares, each with a nominal value of NOK 0.10, in connection with the Combination completed on 2 July 2015, no share capital has been paid for with assets other than cash in the period from the incorporation of the Company to the date of this Prospectus. See Section 8.1 "Overview" for further details regarding the Combination.
13.4 Admission to trading The Company has applied for admission to trading of its Shares on Oslo Axess and the board of directors of the Oslo Stock Exchange approved the listing application of the Company on 5 July 2016, subject to certain condition being met. All such conditions have been met as of the date of this Prospectus.
The Company currently expects commencement of trading in the Shares (excluding the Offer Shares) on Oslo Axess on or about 8 July 2016. The Company has not applied for admission to trading of the Shares on any other stock exchange or regulated market.
13.5 Ownership structure As of 28 June 2016, the Company had 211 shareholders. The Company’s 20 largest shareholders as of the same date are shown in the table below.
# Shareholders Number of Shares1 Percent
1 Handelsbanken Stockholm Clients AC2 ...... 8,488,918 31.55% 2 Radiumhospitalets Forskningsstift...... 3,410,589 12.68% 3 Datum Invest AS ...... 2,462,000 9.15% 4 Arctic Funds PLC ...... 907,000 3.37% 5 Timmuno AS ...... 724,650 2.69% 6 Prieta AS ...... 720,000 2.68% 7 Portia AS ...... 599,561 2.23% 8 Danske Bank A/S ...... 587,971 2.19% 9 Nordnet Bank AB ...... 569,022 2.11% 10 Verdipapirfondet KLP Aksjenorge ...... 460,000 1.71% 11 Eltek Holding AS ...... 442,000 1.64% 12 Statoil Pensjon ...... 433,716 1.61% 13 Storebrand Vekst...... 426,000 1.58% 14 Pactum AS ...... 400,000 1.49% 15 Birk Venture AS ...... 378,980 1.41% 16 OP-Europe Equity Fund ...... 357,869 1.33% 17 Tobech Invest AS ...... 286,449 1.06% 18 Viola AS ...... 280,000 1.04% 19 Kommunal Landspensjonskasse ...... 270,000 1.00% 20 Verdipapirfondet DNB Grønt Norden ...... 250,919 0.93% Others ...... 4,449,723 16.54%
Total ...... 26,905,367 100%
1 Excluding the Private Placement Shares
2 Nominee account of Healthcap V LP / OFP V Advisor AB
There are no differences in voting rights between the shareholders.
Shareholders owning 5% or more of the Shares have an interest in the Company’s share capital which is notifiable pursuant to the Norwegian Securities Trading Act. See Section 14.7 "Disclosure obligations" for a description of the disclosure obligations under the Norwegian Securities Trading Act. As of the date of this Prospectus, no shareholder, other than HealthCap V L.P. (approximately 31%), The Norwegian Radium Hospital Research Foundation (approximately 13%) and Datum Invest AS (approximately 9%) holds more than 5% or more of the issued Shares.
To the extent known to the Company, there are no persons or entities that, directly or indirectly, jointly or severally, exercise or could exercise control over the Company. The Company is not aware of any arrangements the operation of which may at a subsequent date result in a change of control of the Company.
The Company’s Articles of Association do not contain any provisions that would have the effect of delaying, deferring or preventing a change of control of the Company. The Shares have not been subject to any public takeover bids 92
during the current or last financial year.
13.6 Authorization to increase the share capital and to issue Shares The Board of Directors has been granted an authorization to increase the share capital by up to NOK 268,838.08, to be used in connection with the share based incentive programs for the Group’s employees. The authorization is valid until the annual general meeting in 2017. See Section 12.5 "Share option program" for more information regarding the share option programs.
The Board of Directors has been granted an authorization to increase the share capital by up to NOK 30,000, to be used in connection with the RSU Program for the Board of Directors. The authorization is valid until the annual general meeting in 2017. See Section 12.6 "Restricted stock unit program" for more information regarding the share option programs.
The preferential rights of the existing shareholders to subscribe for the new shares pursuant to Section 10-4 of the Norwegian Public Limited Companies Act may be deviated from with respect to both authorizations. The authorizations do not permit share capital increases against contribution in kind or in connection with mergers.
13.7 Other financial instruments Except for the share options described in Section 12.5 "Share option programs" and the RSUs described under Section 12.6 "Restricted stock unit program", neither the Company nor any of its subsidiaries have issued any options, warrants, convertible loans or other instruments that would entitle a holder of any such instrument to subscribe for any shares in the Company or its subsidiaries. Furthermore, neither the Company nor any of its subsidiaries has issued subordinated debt or transferable securities other than the Shares and the shares in its subsidiaries which will be held, directly or indirectly, by the Company.
13.8 Shareholder rights The Company has one class of Shares in issue, and in accordance with the Norwegian Public Limited Companies Act, all Shares in that class provide equal rights in the Company, including the right to any dividends. Each of the Shares carries one vote. The rights attaching to the Shares are described in Section 13.9 "The Articles of Association and certain aspects of Norwegian law".
13.9 The Articles of Association and certain aspects of Norwegian law 13.9.1 The Articles of Association The Company’s Articles of Association are set out in Appendix A to this Prospectus. Below is a summary of provisions of the Articles of Association.
Objective of the Company The objective of the Company comprises sale and development of biomedical products and services. See Section 3 in the Company’s Articles of Association.
Registered office The Company’s registered office is in the municipality of Oslo, Norway. See Section 2 in the Company’s Articles of Association.
Share capital and nominal value The Company’s share capital is NOK 4,159,036.70 divided into NOK 41,590,367 Shares, each Share with a nominal value of NOK 0.10. The Shares are registered with the VPS. See Section 4 in the Company’s Articles of Association.
Board of Directors The Company’s Board of Directors shall consist of 8 Board Members. See Section 5 in the Company’s Articles of Association.
Restrictions on transfer of Shares The Articles of Association do not provide for any restrictions on the transfer of Shares, or a right of first refusal for the Company. Share transfers are not subject to approval by the Board of Directors.
General meetings Documents relating to matters to be dealt with by the General Meeting, including documents which by law shall be 93
included in or attached to the notice of the General Meeting, do not need to be sent to the shareholders if such documents have been made available on the Company’s website. A shareholder may nevertheless request that documents which relate to matters to be dealt with at the General Meeting are sent to him/her. See Section 8 in the Company’s Articles of Association. The shareholders may cast their votes in writing, including through electronic communication, in a period prior to the General Meeting. The Board of Directors can establish specific guidelines for such advance voting. The established guidelines must be stated in the notice of the General Meeting. The Board of Directors may decide that shareholders who want to participate in the General Meeting must notify the Company thereof within a specific deadline that cannot expire earlier than three days prior to the General Meeting.
Nomination committee The Company shall have a nomination committee. See Section 12.11 "Nomination committee" and Section 6 in the Company’s Articles of Association.
13.9.2 Certain aspects of Norwegian corporate law General meetings Through the general meeting, shareholders exercise supreme authority in a Norwegian company. In accordance with Norwegian law, the annual general meeting of shareholders is required to be held each year on or prior to 30 June. Norwegian law requires that written notice of annual general meetings setting forth the time of, the venue for and the agenda of the meeting be sent to all shareholders with a known address no later than 21 days before the annual general meeting of a Norwegian public limited company listed on a stock exchange or a regulated market shall be held, unless the articles of association stipulate a longer deadline, which is not currently the case for the Company.
A shareholder may vote at the general meeting either in person or by proxy appointed at their own discretion. Although Norwegian law does not require the Company to send proxy forms to its shareholders for General Meetings, the Company plans to include a proxy form with notices of General Meetings. All of the Company’s shareholders who are registered in the register of shareholders maintained with the VPS as of the date of the General Meeting, or who have otherwise reported and documented ownership to Shares, are entitled to participate at General Meetings.
Apart from the annual general meeting, extraordinary general meetings of shareholders may be held if the Board of Directors considers it necessary. An extraordinary general meeting of shareholders must also be convened if, in order to discuss a specified matter, the auditor or shareholders representing at least 5% of the share capital demands this in writing. The requirements for notice and admission to the annual general meeting also apply to extraordinary general meetings. However, the annual general meeting of a Norwegian public limited company may with a majority of at least two-thirds of the aggregate number of votes cast as well as at least two-thirds of the share capital represented at a general meeting resolve that extraordinary general meetings may be convened with a 14 day notice period until the next annual general meeting provided the Company has procedures in place allowing shareholders to vote electronically.
Voting rights – amendments to the Articles of Association Each of the Shares carries one vote. In general, decisions that shareholders are entitled to make under Norwegian law or the Articles of Association may be made by a simple majority of the votes cast. In the case of elections or appointments, the person(s) who receive(s) the greatest number of votes cast are elected. However, as required under Norwegian law, certain decisions, including resolutions to waive preferential rights to subscribe in connection with any share issue in the Company, to approve a merger or demerger of the Company, to amend the Articles of Association, to authorize an increase or reduction in the share capital, to authorize an issuance of convertible loans or warrants by the Company or to authorize the Board of Directors to purchase Shares and hold them as treasury shares or to dissolve the Company, must receive the approval of at least two-thirds of the aggregate number of votes cast as well as at least two-thirds of the share capital represented at a general meeting. Norwegian law further requires that certain decisions, which have the effect of substantially altering the rights and preferences of any shares or class of shares, receive the approval by the holders of such shares or class of shares as well as the majority required for amending the Articles of Association.
Decisions that (i) would reduce the rights of some or all of the Company’s shareholders in respect of dividend payments or other rights to assets or (ii) restrict the transferability of the Shares, require that at least 90% of the share capital represented at the general meeting in question vote in favor of the resolution, as well as the majority required for amending the Articles of Association.
In general, only a shareholder registered in the VPS is entitled to vote for such Shares. Beneficial owners of the Shares that are registered in the name of a nominee are generally not entitled to vote under Norwegian law, nor is any person who is designated in the VPS register as the holder of such Shares as nominees. Investors should note that there are 94
varying opinions as to the interpretation of the right to vote on nominee registered shares. In the Company’s view, a nominee may not meet or vote for Shares registered on a nominee account ("NOM-account"). A shareholder must, in order to be eligible to register, meet and vote for such Shares at the General Meeting, transfer the Shares from such NOM-account to an account in the shareholder’s name.
There are no quorum requirements that apply to the general meetings.
Additional issuances and preferential rights If the Company issues any new Shares, including bonus share issues, the Articles of Association must be amended, which requires the same vote as other amendments to the Articles of Association. In addition, under Norwegian law, the Company’s shareholders have a preferential right to subscribe for new Shares issued by the Company. Preferential rights may be derogated from by resolution in a General Meeting passed by the same vote required to amend the Articles of Association. A derogation of the shareholders’ preferential rights in respect of bonus issues requires the approval of all outstanding Shares.
The General Meeting may, by the same vote as is required for amending the Articles of Association, authorize the Board of Directors to issue new Shares, and to derogate from the preferential rights of shareholders in connection with such issuances. Such authorization may be effective for a maximum of two years, and the nominal value of the Shares to be issued may not exceed 50% of the registered par share capital when the authorization is registered with the Norwegian Register of Business Enterprises.
Under Norwegian law, the Company may increase its share capital by a bonus share issue, subject to approval by the Company’s shareholders, by transfer from the Company’s distributable equity or from the Company’s share premium reserve and thus the share capital increase does not require any payment of a subscription price by the shareholders. Any bonus issues may be affected either by issuing new shares to the Company’s existing shareholders or by increasing the nominal value of the Company’s outstanding Shares.
Issuance of new Shares to shareholders who are citizens or residents of the United States upon the exercise of preferential rights may require the Company to file a registration statement in the United States under United States securities laws. Should the Company in such a situation decide not to file a registration statement, the Company’s U.S. shareholders may not be able to exercise their preferential rights. If a U.S. shareholder is ineligible to participate in a rights offering, such shareholder would not receive the rights at all and the rights would be sold on the shareholder’s behalf by the Company.
Minority rights Norwegian law sets forth a number of protections for minority shareholders of the Company, including, but not limited to, those described in this paragraph and the description of General Meetings as set out above. Any of the Company’s shareholders may petition Norwegian courts to have a decision of the Board of Directors or the Company’s shareholders made at the General Meeting declared invalid on the grounds that it unreasonably favors certain shareholders or third parties to the detriment of other shareholders or the Company itself. The Company’s shareholders may also petition the courts to dissolve the Company as a result of such decisions to the extent particularly strong reasons are considered by the court to make necessary dissolution of the Company.
Minority shareholders holding 5% or more of the Company’s share capital have a right to demand in writing that the Company’s Board of Directors convene an extraordinary general meeting to discuss or resolve specific matters. In addition, any of the Company’s shareholders may in writing demand that the Company place an item on the agenda for any General Meeting as long as the Company is notified in time for such item to be included in the notice of the meeting. If the notice has been issued when such a written demand is presented, a renewed notice must be issued if the deadline for issuing notice of the General Meeting has not expired.
Rights of redemption and repurchase of Shares The share capital of the Company may be reduced by reducing the nominal value of the Shares or by cancelling Shares. Such a decision requires the approval of at least two-thirds of the aggregate number of votes cast and at least two-thirds of the share capital represented at a General Meeting. Redemption of individual Shares requires the consent of the holders of the Shares to be redeemed.
The Company may purchase its own Shares provided that the Board of Directors has been granted an authorization to do so by a General Meeting with the approval of at least two-thirds of the aggregate number of votes cast and at least two-thirds of the share capital represented at the meeting. The aggregate nominal value of treasury shares so acquired, and held by the Company must not exceed 10% of the Company’s share capital, and treasury shares may 95
only be acquired if the Company’s distributable equity, according to the latest adopted balance sheet, exceeds the consideration to be paid for the shares. The authorization by the General Meeting of the Company’s shareholders cannot be granted for a period exceeding 18 months.
Shareholder vote on certain reorganizations A decision of the Company’s shareholders to merge with another company or to demerge requires a resolution by the General Meeting passed by at least two-thirds of the aggregate votes cast and at least two-thirds of the share capital represented at the General Meeting. A merger plan, or demerger plan signed by the Board of Directors along with certain other required documentation, would have to be sent to all the Company’s shareholders, or if the Articles of Association stipulate that, made available to the shareholders on the Company’s website, at least one month prior to the General Meeting to pass upon the matter.
Liability of members of the Board of Directors Board Members owe a fiduciary duty to the Company and its shareholders. Such fiduciary duty requires that the Board Members act in the best interests of the Company when exercising their functions and exercise a general duty of loyalty and care towards the Company. Their principal task is to safeguard the interests of the Company.
Board Members may each be held liable for any damage they negligently or willfully cause the Company. Norwegian law permits the General Meeting to discharge any such person from liability, but such discharge is not binding on the Company if substantially correct and complete information was not provided at the General Meeting passing upon the matter. If a resolution to discharge the Company’s Board Members from liability or not to pursue claims against such a person has been passed by a General Meeting with a smaller majority than that required to amend the Articles of Association, shareholders representing more than 10% of the share capital or, if there are more than 100 shareholders, more than 10% of the shareholders may pursue the claim on the Company’s behalf and in its name. The cost of any such action is not the Company’s responsibility but can be recovered from any proceeds the Company receives as a result of the action. If the decision to discharge any of the Company’s Board Members from liability or not to pursue claims against the Company’s Board Members is made by such a majority as is necessary to amend the Articles of Association, the minority shareholders of the Company cannot pursue such claim in the Company’s name.
Indemnification of Directors Neither Norwegian law nor the Articles of Association contains any provision concerning indemnification by the Company of the Board of Directors. The Company is permitted to purchase insurance for the Board Members against certain liabilities that they may incur in their capacity as such.
Distribution of assets on liquidation Under Norwegian law, the Company may be wound-up by a resolution of the Company’s shareholders at the General Meeting passed by at least two-thirds of the aggregate votes cast and at least two-thirds of the share capital represented at the meeting. In the event of liquidation, the Shares rank equally in the event of a return on capital.
13.9.3 Shareholders’ agreements To the knowledge of the Company, there are no shareholders’ agreements related to the Shares.
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14 SECURITIES TRADING IN NORWAY Set out below is a summary of certain aspects of securities trading in Norway. The summary is based on the rules and regulations in force in Norway as at the date of this Prospectus, which may be subject to changes occurring after such date. The summary does not purport to be a comprehensive description of securities trading in Norway. Shareholders who wish to clarify the aspects of securities trading in Norway should consult with and rely upon their own advisors.
14.1 Introduction The Oslo Stock Exchange was established in 1819 and is the principal market in which shares, bonds and other financial instruments are traded in Norway. As of 31 December 2015, the total capitalization of companies listed on the Oslo Stock Exchange amounted to approximately NOK 1,839 billion. Shareholdings of non-Norwegian investors as a percentage of total market capitalization as at 31 December 2015 amounted to approximately 36.8%.
The Oslo Stock Exchange has entered into a strategic cooperation with the London Stock Exchange group with regards to, inter alia, trading systems for equities, fixed income and derivatives.
14.2 Trading and settlement Trading of equities on the Oslo Stock Exchange is carried out in the electronic trading system Millennium Exchange. This trading system is in use by all markets operated by the London Stock Exchange, including the Borsa Italiana, as well as by the Johannesburg Stock Exchange.
Official trading on the Oslo Stock Exchange takes place between 09:00 hours (CET) and 16:20 hours (CET) each trading day, with pre-trade period between 08:15 hours (CET) and 09:00 hours (CET), closing auction from 16:20 hours (CET) to 16:25 hours (CET) and a post-trade period from 16:25 hours (CET) to 17:30 hours (CET). Reporting of after exchange trades can be done until 17:30 hours (CET).
The settlement period for trading on the Oslo Stock Exchange is two trading days (T+2). This means that securities will be settled on the investor’s account in the VPS two days after the transaction, and that the seller will receive payment after two days.
Oslo Clearing ASA, a wholly-owned subsidiary of SIX x-clear AG, a company in the SIX group, has a license from the Norwegian FSA to act as a central clearing service, and has from 18 June 2010 offered clearing and counterparty services for equity trading on the Oslo Stock Exchange.
Investment services in Norway may only be provided by Norwegian investment firms holding a license under the Norwegian Securities Trading Act, branches of investment firms from an EEA member state or investment firms from outside the EEA that have been licensed to operate in Norway. Investment firms in an EEA member state may also provide cross-border investment services into Norway.
It is possible for investment firms to undertake market-making activities in shares listed in Norway if they have a license to this effect under the Norwegian Securities Trading Act, or in the case of investment firms in an EEA member state, a license to carry out market-making activities in their home jurisdiction. Such market-making activities will be governed by the regulations of the Norwegian Securities Trading Act relating to brokers’ trading for their own account. However, such market-making activities do not as such require notification to the Norwegian FSA or the Oslo Stock Exchange except for the general obligation of investment firms that are members of the Oslo Stock Exchange to report all trades in stock exchange listed securities.
14.3 Information, control and surveillance Under Norwegian law, the Oslo Stock Exchange is required to perform a number of surveillance and control functions. The Surveillance and Corporate Control unit of the Oslo Stock Exchange monitors all market activity on a continuous basis. Market surveillance systems are largely automated, promptly warning department personnel of abnormal market developments.
The Norwegian FSA controls the issuance of securities in both the equity and bond markets in Norway and evaluates whether the issuance documentation contains the required information and whether it would otherwise be unlawful to carry out the issuance.
Under Norwegian law, a company that is listed on a Norwegian regulated market, or has applied for listing on such market, must promptly release any inside information directly concerning the company. Inside information means precise information about financial instruments, the issuer thereof or other matters which are likely to have a
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significant effect on the price of the relevant financial instruments or related financial instruments, and which are not publicly available or commonly known in the market. A company may, however, delay the release of such information in order not to prejudice its legitimate interests, provided that it is able to ensure the confidentiality of the information and that the delayed release would not be likely to mislead the public. The Oslo Stock Exchange may levy fines on companies violating these requirements.
14.4 The VPS and transfer of Shares The Company’s principal share register is operated through the VPS. The VPS is the Norwegian paperless centralized securities register. It is a computerized book-keeping system in which the ownership of, and all transactions relating to, Norwegian listed shares must be recorded. The VPS and the Oslo Stock Exchange are both wholly-owned by Oslo Børs VPS Holding ASA.
All transactions relating to securities registered with the VPS are made through computerized book entries. No physical share certificates are, or may be, issued. The VPS confirms each entry by sending a transcript to the registered shareholder irrespective of any beneficial ownership. To give effect to such entries, the individual shareholder must establish a share account with a Norwegian account agent. Norwegian banks, Norges Bank (being, Norway’s central bank), authorized securities brokers in Norway and Norwegian branches of credit institutions established within the EEA are allowed to act as account agents.
As a matter of Norwegian law, the entry of a transaction in the VPS is prima facie evidence in determining the legal rights of parties as against the issuing company or any third party claiming an interest in the given security. A transferee or assignee of shares may not exercise the rights of a shareholder with respect to such shares unless such transferee or assignee has registered such shareholding or has reported and shown evidence of such share acquisition, and the acquisition is not prevented by law, the relevant company’s articles of association or otherwise.
The VPS is liable for any loss suffered as a result of faulty registration or an amendment to, or deletion of, rights in respect of registered securities unless the error is caused by matters outside the VPS’ control which the VPS could not reasonably be expected to avoid or overcome the consequences of. Damages payable by the VPS may, however, be reduced in the event of contributory negligence by the aggrieved party.
The VPS must provide information to the Norwegian FSA on an ongoing basis, as well as any information that the Norwegian FSA requests. Further, Norwegian tax authorities may require certain information from the VPS regarding any individual’s holdings of securities, including information about dividends and interest payments.
14.5 Shareholder register – Norwegian law Under Norwegian law, shares are registered in the name of the beneficial owner of the shares. As a general rule, there are no arrangements for nominee registration and Norwegian shareholders are not allowed to register their shares in the VPS through a nominee. However, foreign shareholders may register their shares in the VPS in the name of a nominee (bank or other nominee) approved by the Norwegian FSA. An approved and registered nominee has a duty to provide information on demand about beneficial shareholders to the company and to the Norwegian authorities. In case of registration by nominees, the registration in the VPS must show that the registered owner is a nominee. A registered nominee has the right to receive dividends and other distributions, but cannot vote in general meetings on behalf of the beneficial owners.
14.6 Foreign investment in shares listed in Norway Foreign investors may trade shares listed on the Oslo Stock Exchange through any broker that is a member of the Oslo Stock Exchange, whether Norwegian or foreign.
14.7 Disclosure obligations If a person’s, entity’s or consolidated group’s proportion of the total issued shares and/or rights to shares in a company listed on a regulated market in Norway (with Norway as its home state, which will be the case for the Company) reaches, exceeds or falls below the respective thresholds of 5%, 10%, 15%, 20%, 25%, 1/3, 50%, 2/3 or 90% of the share capital or the voting rights of that company, the person, entity or group in question has an obligation under the Norwegian Securities Trading Act to notify the Oslo Stock Exchange and the issuer immediately. The same applies if the disclosure thresholds are passed due to other circumstances, such as a change in the company’s share capital.
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14.8 Insider trading According to Norwegian law, subscription for, purchase, sale or exchange of financial instruments that are listed, or subject to the application for listing, on a Norwegian regulated market, or incitement to such dispositions, must not be undertaken by anyone who has inside information, as defined in Section 3-2 of the Norwegian Securities Trading Act. The same applies to the entry into, purchase, sale or exchange of options or futures/forward contracts or equivalent rights whose value is connected to such financial instruments or incitement to such dispositions.
14.9 Mandatory offer requirement The Norwegian Securities Trading Act requires any person, entity or consolidated group that becomes the owner of shares representing more than one-third of the voting rights of a company listed on a Norwegian regulated market (with the exception of certain foreign companies not including the Company) to, within four weeks, make an unconditional general offer for the purchase of the remaining shares in that company. A mandatory offer obligation may also be triggered where a party acquires the right to become the owner of shares that, together with the party’s own shareholding, represent more than one-third of the voting rights in the company and the Oslo Stock Exchange decides that this is regarded as an effective acquisition of the shares in question.
The mandatory offer obligation ceases to apply if the person, entity or consolidated group sells the portion of the shares that exceeds the relevant threshold within four weeks of the date on which the mandatory offer obligation was triggered.
When a mandatory offer obligation is triggered, the person subject to the obligation is required to immediately notify the Oslo Stock Exchange and the company in question accordingly. The notification is required to state whether an offer will be made to acquire the remaining shares in the company or whether a sale will take place. As a rule, a notification to the effect that an offer will be made cannot be retracted. The offer and the offer document required are subject to approval by the Oslo Stock Exchange before the offer is submitted to the shareholders or made public.
The offer price per share must be at least as high as the highest price paid or agreed by the offeror for the shares in the six-month period prior to the date the threshold was exceeded. If the acquirer acquires or agrees to acquire additional shares at a higher price prior to the expiration of the mandatory offer period, the acquirer is obliged to restate its offer at such higher price. A mandatory offer must be in cash or contain a cash alternative at least equivalent to any other consideration offered.
In case of failure to make a mandatory offer or to sell the portion of the shares that exceeds the relevant threshold within four weeks, the Oslo Stock Exchange may force the acquirer to sell the shares exceeding the threshold by public auction. Moreover, a shareholder who fails to make an offer may not, as long as the mandatory offer obligation remains in force, exercise rights in the company, such as voting in a general meeting, without the consent of a majority of the remaining shareholders. The shareholder may, however, exercise his/her/its rights to dividends and pre-emption rights in the event of a share capital increase. If the shareholder neglects his/her/its duty to make a mandatory offer, the Oslo Stock Exchange may impose a cumulative daily fine that runs until the circumstance has been rectified.
Any person, entity or consolidated group that owns shares representing more than one-third of the votes in a company listed on a Norwegian regulated market (with the exception of certain foreign companies not including the Company) is obliged to make an offer to purchase the remaining shares of the company (repeated offer obligation) if the person, entity or consolidated group through acquisition becomes the owner of shares representing 40%, or more of the votes in the company. The same applies correspondingly if the person, entity or consolidated group through acquisition becomes the owner of shares representing 50% or more of the votes in the company. The mandatory offer obligation ceases to apply if the person, entity or consolidated group sells the portion of the shares which exceeds the relevant threshold within four weeks of the date on which the mandatory offer obligation was triggered.
Any person, entity or consolidated group that has passed any of the above mentioned thresholds in such a way as not to trigger the mandatory bid obligation, and has therefore not previously made an offer for the remaining shares in the company in accordance with the mandatory offer rules is, as a main rule, obliged to make a mandatory offer in the event of a subsequent acquisition of shares in the company.
14.10 Compulsory acquisition Pursuant to the Norwegian Public Limited Companies Act and the Norwegian Securities Trading Act, a shareholder who, directly or through subsidiaries, acquires shares representing 90% or more of the total number of issued shares in a Norwegian public limited liability company, as well as 90% or more of the total voting rights, has a right, and each remaining minority shareholder of the company has a right to require such majority shareholder, to effect a 99
compulsory acquisition for cash of the shares not already owned by such majority shareholder. Through such compulsory acquisition the majority shareholder becomes the owner of the remaining shares with immediate effect.
If a shareholder acquires shares representing more than 90% of the total number of issued shares, as well as more than 90% of the total voting rights, through a voluntary offer in accordance with the Securities Trading Act, a compulsory acquisition can, subject to the following conditions, be carried out without such shareholder being obliged to make a mandatory offer: (i) the compulsory acquisition is commenced no later than four weeks after the acquisition of shares through the voluntary offer, (ii) the price offered per share is equal to or higher than what the offer price would have been in a mandatory offer, and (iii) the settlement is guaranteed by a financial institution authorized to provide such guarantees in Norway.
A majority shareholder who effects a compulsory acquisition is required to offer the minority shareholders a specific price per share, the determination of which is at the discretion of the majority shareholder. However, where the offeror, after making a mandatory or voluntary offer, has acquired more than 90% of the voting shares of a company and a corresponding proportion of the votes that can be cast at the general meeting, and the offeror pursuant to Section 4-25 of the Norwegian Public Limited Companies Act completes a compulsory acquisition of the remaining shares within three months after the expiry of the offer period, it follows from the Norwegian Securities Trading Act that the redemption price shall be determined on the basis of the offer price for the mandatory/voluntary offer unless specific reasons indicate another price.
Should any minority shareholder not accept the offered price, such minority shareholder may, within a specified deadline of not less than two months, request that the price be set by a Norwegian court. The cost of such court procedure will, as a general rule, be the responsibility of the majority shareholder, and the relevant court will have full discretion in determining the consideration to be paid to the minority shareholder as a result of the compulsory acquisition.
Absent a request for a Norwegian court to set the price or any other objection to the price being offered, the minority shareholders would be deemed to have accepted the offered price after the expiry of the specified deadline.
14.11 Foreign exchange controls There are currently no foreign exchange control restrictions in Norway that would potentially restrict the payment of dividends to a shareholder outside Norway, and there are currently no restrictions that would affect the right of shareholders of a company that has its shares registered with the VPS who are not residents in Norway to dispose of their shares and receive the proceeds from a disposal outside Norway. There is no maximum transferable amount either to or from Norway, although transferring banks are required to submit reports on foreign currency exchange transactions into and out of Norway into a central data register maintained by the Norwegian customs and excise authorities. The Norwegian police, tax authorities, customs and excise authorities, the National Insurance Administration and the Norwegian FSA have electronic access to the data in this register.
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15 TAXATION Set out below is a summary of certain Norwegian tax matters related to an investment in the Company. The summary regarding Norwegian taxation is based on the laws in force in Norway as at the date of this Prospectus, which may be subject to any changes in law occurring after such date. Such changes could possibly be made on a retrospective basis.
The following summary does not purport to be a comprehensive description of all the tax considerations that may be relevant to a decision to purchase, own or dispose of the shares in the Company. Shareholders who wish to clarify their own tax situation should consult with and rely upon their own tax advisors. Shareholders resident in jurisdictions other than Norway and shareholders who cease to be resident in Norway for tax purposes (due to domestic tax law or tax treaty) should specifically consult with and rely upon their own tax advisors with respect to the tax position in their country of residence and the tax consequences related to ceasing to be resident in Norway for tax purposes.
Please note that for the purpose of the summary below, a reference to a Norwegian or non-Norwegian shareholder refers to the tax residency rather than the nationality of the shareholder.
15.1 Norwegian taxation 15.1.1 Taxation of dividends Norwegian Personal Shareholders Dividends received by shareholders who are individuals resident in Norway for tax purposes ("Norwegian Personal Shareholders") are taxable as ordinary income in Norway for such shareholders at an effective rate of 28.75% to the extent the dividend exceeds a tax-free allowance; i.e. dividends received, less the tax free allowance, shall be multiplied by 1.15 which are then included as ordinary income taxable at a flat rate of 25%, increasing the effective tax rate on dividends received by Norwegian Personal Shareholders to 28.75%.
The allowance is calculated on a share-by-share basis. The allowance for each share is equal to the cost price of the share multiplied by a risk free interest rate based on the effective rate after tax of interest on treasury bills (Nw.: statskasseveksler) with three months maturity. The allowance is calculated for each calendar year, and is allocated solely to Norwegian Personal Shareholders holding shares at the expiration of the relevant calendar year.
Norwegian Personal Shareholders who transfer shares will thus not be entitled to deduct any calculated allowance related to the year of transfer. Any part of the calculated allowance one year exceeding the dividend distributed on the share ("excess allowance") may be carried forward and set off against future dividends received on, or gains upon realization, of the same share. Any excess allowance will also be included in the basis for calculating the allowance on the same share in the following years.
Norwegian Corporate Shareholders Dividends distributed from the Company to shareholders who are limited liability companies (and certain similar entities) resident in Norway for tax purposes ("Norwegian Corporate Shareholders"), are effectively taxed at rate of 0.75% (3% of dividend income from such shares is included in the calculation of ordinary income for Norwegian Corporate Shareholders and ordinary income is subject to tax at a flat rate of 25%).
Non-Norwegian Personal Shareholders Dividends distributed to shareholders who are individuals not resident in Norway for tax purposes ("Non-Norwegian Personal Shareholders"), are as a general rule subject to withholding tax at a rate of 25%. The withholding tax rate of 25% is normally reduced through tax treaties between Norway and the country in which the shareholder is resident. The withholding obligation lies with the company distributing the dividends and the Company assumes this obligation.
Non-Norwegian Personal Shareholders resident within the EEA for tax purposes may apply individually to Norwegian tax authorities for a refund of an amount corresponding to the calculated tax-free allowance on each individual share (please see "Taxation of dividends – Norwegian Personal Shareholders" above). However, the deduction for the tax- free allowance does not apply in the event that the withholding tax rate, pursuant to an applicable tax treaty, leads to a lower taxation on the dividends than the withholding tax rate of 25% less the tax-free allowance.
If a Non-Norwegian Personal Shareholder is carrying on business activities in Norway and the shares are effectively connected with such activities, the shareholder will be subject to the same taxation of dividends as a Norwegian Personal Shareholder, as described above.
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Non-Norwegian Personal Shareholders who have suffered a higher withholding tax than set out in an applicable tax treaty may apply to the Norwegian tax authorities for a refund of the excess withholding tax deducted.
Non-Norwegian Corporate Shareholders Dividends distributed to shareholders who are limited liability companies (and certain other entities) not resident in Norway for tax purposes ("Non-Norwegian Corporate Shareholders"), are as a general rule subject to withholding tax at a rate of 25%. The withholding tax rate of 25% is normally reduced through tax treaties between Norway and the country in which the shareholder is resident.
Dividends distributed to Non-Norwegian Corporate Shareholders resident within the EEA for tax purposes are exempt from Norwegian withholding tax provided that the shareholder is the beneficial owner of the shares and that the shareholder is genuinely established and performs genuine economic business activities within the relevant EEA jurisdiction.
If a Non-Norwegian Corporate Shareholder is carrying on business activities in Norway and the shares are effectively connected with such activities, the shareholder will be subject to the same taxation of dividends as a Norwegian Corporate Shareholder, as described above.
Non-Norwegian Corporate Shareholders who have suffered a higher withholding tax than set out in an applicable tax treaty may apply to the Norwegian tax authorities for a refund of the excess withholding tax deducted.
Nominee registered shares will be subject to withholding tax at a rate of 25% unless the nominee has obtained approval from the Norwegian Tax Directorate for the dividend to be subject to a lower withholding tax rate. To obtain such approval the nominee is required to file a summary to the tax authorities including all beneficial owners that are subject to withholding tax at a reduced rate.
The withholding obligation in respect of dividends distributed to Non-Norwegian Corporate Shareholders and on nominee registered shares lies with the company distributing the dividends and the Company assumes this obligation.
15.1.2 Taxation of capital gains on realization of shares Norwegian Personal Shareholders Sale, redemption or other disposal of shares is considered a realization for Norwegian tax purposes. A capital gain or loss generated by a Norwegian Personal Shareholder through a disposal of shares is taxable or tax deductible in Norway. Such capital gain or loss is included in or deducted from the Norwegian Personal Shareholder’s ordinary income in the year of disposal. The effective tax rate on gain or loss related to shares realised by Norwegian Personal Shareholders is currently 28.75%; i.e. capital gains (less the tax free allowance) and losses shall be multiplied by 1.15 which are then included in or deducted from the Norwegian Personal Shareholder’s ordinary income in the year of disposal. Ordinary income is taxable at a flat rate of 25%, increasing the effective tax rate on gains/losses realised by Norwegian Personal Shareholders to 28.75%.
The gain is subject to tax and the loss is tax deductible irrespective of the duration of the ownership and the number of shares disposed of.
The taxable gain/deductible loss is calculated per share as the difference between the consideration for the share and the Norwegian Personal Shareholder’s cost price of the share, including costs incurred in relation to the acquisition or realization of the share. From this capital gain, Norwegian Personal Shareholders are entitled to deduct a calculated allowance provided that such allowance has not already been used to reduce taxable dividend income. Please refer to Section 15.1.1 "Taxation of dividends – Norwegian Personal Shareholders" above for a description of the calculation of the allowance. The allowance may only be deducted in order to reduce a taxable gain, and cannot increase or produce a deductible loss, i.e. any unused allowance exceeding the capital gain upon the realization of a share will be annulled.
If the Norwegian Personal Shareholder owns shares acquired at different points in time, the shares that were acquired first will be regarded as the first to be disposed of, on a first-in first-out basis.
Norwegian Corporate Shareholders Norwegian Corporate Shareholders are exempt from tax on capital gains derived from the realization of shares qualifying for participation exemption, including shares in the Company. Losses upon the realization and costs incurred in connection with the purchase and realization of such shares are not deductible for tax purposes.
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Gains from the sale or other disposal of shares by a Non-Norwegian Personal Shareholder will not be subject to taxation in Norway unless the Non-Norwegian Personal Shareholder holds the shares in connection with business activities carried out or managed from Norway.
Non-Norwegian Corporate Shareholders Capital gains derived by the sale or other realization of shares by Non-Norwegian Corporate Shareholders are not subject to taxation in Norway.
15.1.3 Net wealth tax The value of shares is included in the basis for the computation of net wealth tax imposed on Norwegian Personal Shareholders. Currently, the marginal net wealth tax rate is 0.85% of the value assessed. The value for assessment purposes for listed shares is equal to the listed value as of 1 January in the year of assessment (i.e. the year following the relevant fiscal year).
Norwegian Corporate Shareholders are not subject to net wealth tax.
Shareholders not resident in Norway for tax purposes are not subject to Norwegian net wealth tax. Non-Norwegian Personal Shareholders can, however, be taxable if the shareholding is effectively connected to the conduct of trade or business in Norway.
15.1.4 VAT and transfer taxes No VAT, stamp or similar duties are currently imposed in Norway on the transfer or issuance of shares.
15.1.5 Inheritance tax A transfer of shares through inheritance or as a gift does not give rise to inheritance or gift tax in Norway.
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16 THE COMPLETED PRIVATE PLACEMENT AND THE SUBSEQUENT OFFERING This Section provides information regarding the Private Placement completed on 7 July 2016 and the Subsequent Offering. Please note that the Shares in the Private Placement have already been subscribed, paid for and issued as the date of this Prospectus.
16.1 The Private Placement 16.1.1 Overview At the extraordinary general meeting of the Company held on 6 July 2016, it was inter alia resolved to increase the share capital of the Company with NOK 1,468,500, through the issuance of 14,685,000 Private Placement Shares, at a subscription price of NOK 7.50 per Private Placement Share, in the Private Placement directed towards (i) investors in Norway and internationally where the minimum subscription and allocation amount was set to the NOK equivalent of EUR 100,000 and (ii) employees of the Company and its respective subsidiaries, the 100 largest shareholders in the Company as registered in the VPS on 17 June 2016 and other potential investors constituting less than 150 potential investors in total, with a minimum subscription and allocation amount of NOK 10,500.
The shareholders' preferential right to subscribe for and be allocated the Private Placement Shares pursuant to Section 10-4 of the Norwegian Public Limited Companies Act was accordingly deviated from. The reason for this is as follows:
• The Company has for a period of time worked with alternative structures for a share issue to secure financing which enables the Company to conduct the planned clinical studies, CMC to support such clinical studies and for other corporate purposes. Based on this work and feedback from existing shareholders and potential investors, the elected transaction structure (the Private Placement combined with the Subsequent Offering) is the structure that best preserves the interest of the Company and the shareholders as a whole.
• The Company will through the Private Placement obtain a larger shareholder base, which will be in the Company's interest upon later capital needs.
• It was proposed to carry out the Subsequent Offering pursuant to which existing shareholders who were not part of the pre-sounding for or were allocated shares in the Private Placement are given the opportunity to subscribe for shares on the same terms as investors in the Private Placement.
The Private Placement was subject to applicable exemptions from relevant prospectus and other registration requirements, and, as a result, no prospectus was prepared in connection with the Private Placement.
The Company and the Joint Bookrunners discussed the potential Private Placement with larger shareholders and other investors prior to announcing the contemplated transaction on 20 June 2016 in order to determine whether to launch the transaction and also to determine the terms of the transaction. The feed-back received in this pre-sounding indicated that investors were valuing the Company using other parameters than the Share price based on trades in the Shares as registered on the NOTC. On the basis of the investor feed-back, it was decided that a substantial discount to such price would be required in order to complete the Private Placement. In consultation with the Joint Bookrunners, the Board of Directors resolved to set the subscription price at NOK 7.50 when launching the Private Placement. The subscription price was approved by the extraordinary general meeting of the Company on 6 July 2016.
The Private Placement Shares issued in the Private Placement were placed by the Joint Bookrunners to selected investors in the application period from 20 June 2016 to 14:00 hours (CET) on 22 June 2016. The successful bookbuilding of the Private Placement was announced through an announcement made by the Company on 23 June 2016. The share capital increase relating to the issuance of the Private Placement Shares was registered with the Norwegian Register of Business Enterprises on 7 July 2016, and the new Shares were issued to the VPS accounts of the investors participating in the Private Placement on the same date.
The percentage of immediate dilution resulting from the Private Placement for the Company’s shareholders who did not participate in the Private Placement was approximately 35.3%.
A lock-up agreement was entered into between the Joint Bookrunners and certain shareholders, members of the Board of Directors and the Management and the Company in connection with the Private Placement. Please see Section 16.5 "Lock-up" for more information regarding the lock-up undertakings.
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16.1.2 Resolution to issue the Private Placement Shares On 6 July 2016, the extraordinary general meeting of the Company passed the following resolution to increase the Company's share capital by NOK 1,468,500 in connection with the issuance of the Private Placement Shares (translated from Norwegian):
(i) "The share capital shall be increased by NOK 1,468,500 by issuance of 14,685,000 new shares, each having a nominal value of NOK 0.10. The subscription price is NOK 7.50 per share.
(ii) The new shares shall be subscribed for by investors that have entered into an application agreement with the Company and that have been allocated shares in the private placement, as attached to the minutes as appendix 1. The shareholders of the Company shall accordingly not have any preferential rights to subscribe or be allocated the new shares (cf. Section 10-4 of the Norwegian Public Limited Companies Act).
(iii) The shares shall be subscribed for in a separate subscription form within 6 July 2016.
(iv) Payment shall be made to the Company's share settlement account on 7 July 2016.
(v) The new shares carry rights to dividends and other rights in the Company from the registration of the share capital increase in the Norwegian Register of Business Enterprises.
(vi) The Company's expenses in relation to the share capital increase are estimated to approximately NOK 6.5 million. In addition, the Company has incurred expenses related to the contemplated listing on Oslo Axess.
(vii) The resolution is conditional upon the approval of the resolution in item 4 above by the extraordinary general meeting.
(viii) Section 4 of the Articles of Association is amended to read as follows:
"The company’s share capital is NOK 4,159,036.70 divided between 41,590,367 shares, each with a nominal value of NOK 0.10. The company’s shares shall be registered in the Norwegian Central Securities Depository (VPS).""
16.2 The Subsequent Offering 16.2.1 Overview The Subsequent Offering consists of an offer by the Company to issue up to 2,666,667 Offer Shares at a subscription price of NOK 7.50 per Offer Share, being equal to the subscription price in the Private Placement. Subject to all Offer Shares being issued, the Subsequent Offering will result in approximately NOK 20 million in gross proceeds to the Company.
Eligible Shareholders, being shareholders of the Company as of 21 June 2016 (as registered in the VPS on 23 June 2016 pursuant to the two days’ settlement procedure in VPS (the Record Date)), other than shareholders who were part of the pre-sounding for or were allocated shares in the Private Placement and shareholders in jurisdictions other than Norway where an offer to participate in the Subsequent Offering is not allowed or would require approval or registration of a prospectus or similar measures, will be granted non-transferable Subscription Rights that, subject to applicable law, will give preferential right to subscribe for, and be allocated, Offer Shares at the Subscription Price. In order to allow existing shareholders of the Company who were not a part of the pre-sounding for or were allocated shares in the Private Placement the opportunity to subscribe for Shares on the same terms as the investors in the Private Placement, the general meeting resolved that the shareholders' preferential right to subscribe for the Offer Shares pursuant to Section 10-4 of the Norwegian Public Limited Liability Companies Act was deviated from.
The Eligible Shareholders will be granted 0.42939 Subscription Rights for each existing Share registered as held by such Eligible Shareholders as of the Record Date, rounded down to the nearest whole Subscription Right. Each whole Subscription Right provides a preferential right to subscribe for, and be allocated, one Offer Share at the Subscription Price, subject to applicable securities laws. Oversubscription (i.e., subscription for more Offer Shares than the number of Subscription Rights held by the subscriber entitles the subscriber to be allocated) and subscription without Subscription Rights is permitted.
All offers and sales in the United States will be made only to QIBs as defined in Rule 144A or in other transactions exempt from registration requirements under the U.S. Securities Act. All offers and sales outside the United States will be made in compliance with Regulation S. 105
This Prospectus does not constitute an offer of, or an invitation to purchase, the Offer Shares in any jurisdiction in which such offer or sale would be unlawful. For further details, see "Important Notice" and Section 17 "Selling and Transfer Restrictions".
16.2.2 Resolution relating to the Subsequent Offering and the issue of the Offer Shares On 6 July 2016, the extraordinary general meeting of the Company passed the following resolution to increase the share capital by minimum NOK 0.10 and maximum NOK 266,666.70 by the issuance of minimum 1 and maximum 2,666,667 new Shares by adopting the following resolution (translated from Norwegian):
(i) The share capital shall be increased by minimum NOK 0.10 and maximum NOK 266,666.70, by issuance of minimum 1 and maximum 2,666,667 new shares, each having a nominal value of NOK 0.10. The final number of shares to be issued shall be determined by the Company's board of directors based on the number of shares subscribed during the subscription period.
(ii) The subscription price is NOK 7.50 per share.
(iii) The Company's existing shareholders as of 21 June 2016 (as registered in the Norwegian Central Securities Depository (VPS) on 23 June 2016) who did not participate in the pre-sounding for or were allocated shares in the share capital increase referred to above in item 4, subject to applicable restrictions in the relevant jurisdictions of such shareholders (Eligible Shareholders) shall have a preferential right to subscribe for the new shares. The shareholders of the Company shall accordingly not have any preferential rights to subscribe or be allocated the new shares (cf. Section 10 4 of the Norwegian Public Limited Companies Act). Eligible Shareholders shall receive non-transferable subscription rights corresponding to their shareholding in the Company as of 21 June 2016 as registered in the Company's shareholder register in the VPS as of expiry of 23 June 2016. The number of subscription rights to be issued to each shareholder will be rounded down to the nearest whole subscription right. Each subscription right will entitle to subscribe for one new share. Over-subscription and subscription without subscription rights will be allowed.
(iv) The Company shall publish a prospectus approved by the Financial Supervisory Authority of Norway in connection with the share capital increase. Unless the board of directors decides otherwise, the prospectus shall not be registered with, or approved by, any other foreign prospectus authority. The new shares cannot be subscribed for by investors in jurisdictions in which it is not permitted to offer new shares with such registration or approval.
(v) The subscription period shall commence on 11 July 2016 and end on 8 August 2016 at 16:30 hours (CET). However, if the prospectus is not approved by the Financial Supervisory Authority of Norway in time for the subscription period to commence on 11 July 2016, the subscription period shall commence on the first trading day on Oslo Axess after such approval has been obtained and end at 16:30 hours (CET) four weeks thereafter.
(vi) The due date for payment of the new shares is 12 August 2016, or the fourth trading day on Oslo Axess after the expiry of the subscription period if the subscription period is postponed in accordance with sub- item (v) above. When subscribing for shares, each subscriber with a Norwegian bank account must grant a one-time power of attorney to debit a stated bank account for the subscription amount corresponding with the number of allocated shares. Upon allocation, the allocated amount will be debited the subscriber's account. The debit will take place on or around the due date for payment. Payment of the subscription amount by subscribers without a Norwegian bank account shall be made pursuant to the instructions in the subscription form.
(vii) The following allocation criteria shall apply:
a) Allocation will be made to subscribers in accordance with the (allocated) subscription rights used to subscribe new shares in the subscription period. Each subscription right will give the right to subscribe for and be allocated one (1) new share.
b) If not all subscription rights are used in the subscription period, subscribers having used their subscription rights and who have over-subscribed will be allocated remaining new shares on a pro rata basis based on the number of subscription rights exercised. In the event that pro rata allocation is not possible due to the number of remaining new shares, the Company will determine the allocation by lot drawing.
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c) Any remaining new shares not allocated pursuant to the criteria in items a) and b) above will be allocated to subscribers not holding subscription rights. Allocation will be sought made pro rata based on the relevant subscription amounts, however so that allocations may be rounded down to the nearest 100 shares.
(viii) The new shares carry rights to dividends and other rights in the Company from the registration of the share capital increase in the Norwegian Register of Business Enterprises.
(ix) The Company's expenses in relation to the share capital increase are estimated to approximately NOK 1.5 million assuming that all the shares are subscribed for.
(x) Section 4 of the Articles of Association shall be amended to state the total share capital and number of shares following the share capital increase.
(xi) The resolution is conditional upon the approval of the resolution in item 4 above by the extraordinary general meeting.
16.2.3 Timetable The timetable set out below provides certain indicative key dates for the Subsequent Offering:
The date of the extraordinary general meeting ...... 6 July 2016 Record Date (i.e. the date on which the Eligible Shareholders and their shareholding appear in the VPS) ...... 23 June 2016 Subscription Period commences ...... 11 July 2016 at 09:00 hours (CET) Subscription Period ends...... 8 August 2016 at 16:30 hours (CET) Allocation of the Offer Shares ...... On or about 9 August 2016 Distribution of allocation letters ...... On or about 9 August 2016 Payment Date ...... On or about 12 August 2016 Delivery date of the Offer Shares ...... On or about 17 August 2016
16.2.4 Subscription Price The Subscription Price in the Subsequent Offering is NOK 7.50 per Offer Share, being the same as the subscription price in the Private Placement. No expenses or taxes are charged to the subscribers in the Subsequent Offering by the Company or the Joint Bookrunners.
16.2.5 Subscription Period The Subscription Period will commence on 11 July 2016 and end on 8 August 2016 at 16:30 hours (CET). The Subscription Period may not be revoked, extended or shortened prior to the end of the Subscription Period.
16.2.6 Subscription Rights Eligible Shareholders will be granted non-transferable Subscription Rights giving a preferential right to subscribe for, and be allocated, Offer Shares in the Subsequent Offering. Each Eligible Shareholder will, subject to applicable securities laws, be granted 0.42939 Subscription Rights for each Share registered as held by such Eligible Shareholder on the Record Date, rounded down to the nearest whole Subscription Right. Each whole Subscription Right will, subject to applicable securities laws, give the right to subscribe for and be allocated one Offer Share in the Offering.
The Subscription Rights will be credited to and registered on each relevant Eligible Shareholder’s VPS account on or about 8 July 2016 under ISIN NO0010769250. The Subscription Rights will be distributed free of charge. The Subscription Rights are non-transferable and will accordingly not be listed on any regulated market place.
The Subscription Rights may be used to subscribe for Offer Shares in the Subsequent Offering before the expiry of the Subscription Period on 8 August 2016 at 16:30 hours (CET).
The Subscription Rights must be used to subscribe for Offer Shares before the end of the Subscription Period (i.e., 8 August 2016 at 16:30 hours (CET)). Subscription Rights which are not exercised before 8 August 2016 at 16:30 hours (CET) will have no value and will lapse without compensation to the holder. Holders of Subscription Rights should note that subscriptions for Offer Shares must be made in accordance with the procedures set out in this Prospectus. The Subscription Rights are non-transferable.
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Subscription Rights of Eligible Shareholders resident in jurisdictions where the Prospectus may not be distributed and/or with legislation that, according to the Company’s assessment, prohibits or otherwise restricts subscription for Offer Shares (the "Ineligible Shareholders") will initially be credited to such Ineligible Shareholders’ VPS accounts. Such credit specifically does not constitute an offer to Ineligible Shareholders to subscribe for Offer Shares. The Company will instruct the Joint Bookrunners to, as far as possible, withdraw the Subscription Rights from such Ineligible Shareholders’ VPS accounts with no compensation to the holder.
16.2.7 Subscription procedures Subscribers in the Subsequent Offering who are residents of Norway with a Norwegian personal identification number are recommended to apply for Offer Shares through the VPS online subscription system by following the link to such online application system on the following websites: www.abgsc.no, www.arctic.com and www.dnb.no/emisjoner. Subscribers in the Subsequent Offering not having access to the VPS online application system must apply using the Subscription Form attached to this Prospectus as Appendix E "Subscription Form". Subscription Forms, together with this Prospectus, can be obtained from the Company, the Company’s website www.targovax.com, the Joint Bookrunners’ websites listed above or the subscription offices set out below. Subscriptions made through the VPS online application system must be duly registered during the Subscription Period. Please note that the VPS online subscription system is only available for individual persons and is not available for legal entities; legal entities must thus submit a Subscription Form in order to subscribe for Offer Shares.
The subscription offices for physical subscriptions in the Subsequent Offering are:
ABG Sundal Collier Arctic Securities DNB Markets Registrars Department Munkedamsveien 45E Haakon VIIs gate 5 Dronning Eufemias gate 30 P.O. Box 1444 Vika P.O. Box 1833 Vika P.O. Box 1600 Sentrum N-0115 Oslo N-0123 Oslo N-0021 Oslo Norway Norway Norway Tel: +47 22 01 60 00 Tel: +47 21 01 30 40 Tel: +47 23 26 81 01
Fax: +47 22 01 60 62 Fax: +47 21 01 31 36 E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] Website: www.abgsc.no Website: www.arctic.com Website: www.dnb.no/emisjoner
All subscriptions will be treated in the same manner regardless of which of the above Joint Bookrunners the applications are placed with. Further, all subscriptions will be treated in the same manner regardless of whether they are submitted by delivery of a Subscription Form or through the VPS online subscription system.
Subscription Forms that are incomplete or incorrectly completed, electronically or physically, or that are received after the expiry of the Subscription Period, may be disregarded without further notice to the subscriber. Properly completed Subscription Forms must be received by one of the subscription offices listed above or registered electronically through the VPS application system by 16:30 hours (CET) on 8 August 2016. None of the Company or any of the Joint Bookrunners may be held responsible for postal delays, unavailable fax lines, internet lines or servers or other logistical or technical matters that may result in subscriptions not being received in time or at all by any subscription office.
Subscriptions are binding and irrevocable, and cannot be withdrawn, cancelled or modified by the subscriber after having been received by the Joint Bookrunners, or in the case of subscriptions through the VPS online subscription system, upon registration of the subscription. The subscriber is responsible for the correctness of the information filled into the Subscription Form. By signing and submitting a Subscription Form, the subscribers confirm and warrant that they have read this Prospectus and are eligible to subscribe for Offer Shares under the terms set forth herein.
There is no minimum subscription amount for which subscriptions in the Subsequent Offering must be made. Oversubscription (i.e., subscription for more Offer Shares than the number of Subscription Rights held by the subscriber entitles the subscriber to be allocated) and subscription without Subscription Rights is permitted. Multiple subscriptions (i.e., subscriptions on more than one Subscription Form) are allowed. Please note, however, that two separate Subscription Forms submitted by the same subscriber with the same number of Offer Shares subscribed for on both Subscription Forms will only be counted once unless otherwise explicitly stated in one of the Subscription Forms. A Subscription Form shall also only be sent to one (and not several) of the applications offices stated above. If the same Subscription form is received by more than one of the application offices, the subscription may be counted more than once. In the case of multiple subscriptions through the VPS online subscription system or subscriptions made both on a Subscription Form and through the VPS online subscription system, all subscriptions will be counted.
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16.2.8 Mandatory anti-money laundering procedures The Subsequent Offering is subject to applicable anti-money laundering legislation, including the Norwegian Money Laundering Act of 6 March 2009 no. 11 and the Norwegian Money Laundering Regulations of 13 March 2009 no. 302 (collectively, the "Anti-Money Laundering Legislation").
Applicants who are not registered as existing customers of any of the Joint Bookrunners must verify their identity to the Manager in which the order is placed in accordance with the requirements of the Anti-Money Laundering Legislation, unless an exemption is available. Applicants who have designated an existing Norwegian bank account and an existing VPS account on the Subscription Form are exempted, unless verification of identity is requested by any of the Joint Bookrunners. Applicants who have not completed the required verification of identity prior to the expiry of the Application Period may not be allocated Offer Shares.
16.2.9 Financial intermediaries General All persons or entities holding Shares or Subscription Rights through financial intermediaries (e.g., brokers, custodians and nominees) should read this Section. All questions concerning the timeliness, validity and form of instructions to a financial intermediary in relation to the exercise, sale or purchase of Subscription Rights should be determined by the financial intermediary in accordance with its usual customer relations procedure or as it otherwise notifies each beneficial shareholder.
The Company is not liable for any action or failure to act by a financial intermediary through which Shares are held.
Subscription Rights If an Eligible Shareholder holds Shares registered through a financial intermediary, the financial intermediary will, subject to the terms of the agreement between the Eligible Shareholder and the financial intermediaries, customarily give the Eligible Shareholder details of the aggregate number of Subscription Rights to which it will be entitled and the relevant financial intermediary will customarily supply each Eligible Shareholder with this information in accordance with its usual customer relations procedures. Eligible Shareholders holding Shares through a financial intermediary should contact the financial intermediary if they have received no information with respect to the Subsequent Offering.
Eligible Shareholders who hold their Shares through a financial intermediary and who are Ineligible Shareholders will not be entitled to exercise their Subscription Rights.
Subscription Period The time by which notification of exercise instructions for subscription of Offer Shares must validly be given to a financial intermediary may be earlier than the expiry of the Subscription Period. Such deadline will depend on the financial intermediary. Eligible Shareholders who hold their Shares through a financial intermediary should contact their financial intermediary if they are in any doubt with respect to deadlines.
Subscription Any Eligible Shareholder who is not an Ineligible Shareholder and who holds its Subscription Rights through a financial intermediary and wishes to exercise its Subscription Rights, should instruct its financial intermediary in accordance with the instructions received from such financial intermediary. The financial intermediary will be responsible for collecting exercise instructions from the Eligible Shareholders and for informing the Manager of their exercise instructions.
Please refer to Section 17 "Selling and Transfer Restrictions" for a description of certain restrictions and prohibitions applicable to the exercise of Subscription Rights in certain jurisdictions outside Norway.
Method of Payment Any Eligible Shareholder who holds its Subscription Rights through a financial intermediary should pay the Subscription Price for the Offer Shares that are allocated to it in accordance with the instructions received from the financial intermediary. The financial intermediary must pay the Subscription Price in accordance with the instructions in the Prospectus. Payment by the financial intermediary for the Offer Shares must be made to the Manager no later than the Payment Date. Accordingly, financial intermediaries may require payment to be provided to them prior to the Payment Date.
16.2.10 Allocation of Offer Shares Allocation of the Offer Shares will take place on or about 9 August 2016 in accordance with the following criteria: 109
(i) Allocation will be made to subscribers in accordance with Subscription Rights used to subscribe Offer Shares in the Subscription Period. Each Subscription Right will give the right to subscribe for and be allocated one (1) Offer Share.
(ii) If not all Subscription Rights are used in the Subscription Period, subscribers having used their Subscription Rights and who have over-subscribed will be allocated remaining new shares on a pro rata basis based on the number of Subscription Rights exercised. In the event that pro rata allocation is not possible due to the number of remaining Offer Shares, the Company will determine the allocation by lot drawing.
(iii) Any remaining Offer Shares not allocated pursuant to the criteria in items (i) and (ii) above will be allocated to subscribers not holding Subscription Rights. Allocation will be sought made pro rata based on the relevant subscription amounts, however so that allocations may be rounded down to the nearest 100 Offer Shares.
No fractional Offer Shares will be allocated. The Company may round off, reject or reduce any subscription for Offer Shares not covered by Subscription Rights in accordance with the allocation criteria. Allocation of fewer Offer Shares than subscribed for by a subscriber will not impact on the subscriber’s obligation to pay for the number of Offer Shares allocated.
The result of the Subsequent Offering is expected to be published on or about 9 August 2016 in the form of a stock exchange notification from the Company through the Oslo Stock Exchange's information system. Notifications of allocated Offer Shares and the corresponding subscription amount to be paid by each subscriber are expected to be distributed on or about 9 August 2016.
16.2.11 Payment for the Offer Shares Payment due date The payment for Offer Shares allocated to a subscriber falls due on the Payment Date (12 August 2016). Payment must be made in accordance with the requirements set out below in this Section.
Subscribers who have a Norwegian bank account Subscribers who have a Norwegian bank account must, and will by signing the Subscription Form or by registering a subscription through the VPS online subscription system, provide ABG Sundal Collier (on behalf of the Joint Bookrunners) with a one-time irrevocable authorisation to debit a specified bank account with a Norwegian bank for the amount payable for the Offer Shares which are allocated to the subscriber.
The specified bank account is expected to be debited on or about the Payment Date and there must be sufficient funds in the stated bank account from and including the date falling two banking days prior to the Payment Dat.. The Joint Bookrunners are only authorised to debit such account once, but reserves the right to make up to three debit attempts, and the authorisation will be valid for up to seven working days after the Payment Date.
The subscriber furthermore authorises the Joint Bookrunners to obtain confirmation from the subscriber’s bank that the subscriber has the right to dispose over the specified account and that there are sufficient funds in the account to cover the payment.
If there are insufficient funds in a subscriber’s bank account or if it for other reasons is impossible to debit such bank account when a debit attempt is made pursuant to the authorisation from the subscriber, the subscriber’s obligation to pay for the Offer Shares will be deemed overdue.
Payment by direct debiting is a service that banks in Norway provide in cooperation. In the relationship between the subscriber and the subscriber’s bank, the standard terms and conditions for "Payment by Direct Debiting – Securities Trading", which are set out on page 2 of the Subscription Form, will apply, provided, however, that subscribers who subscribe for an amount exceeding NOK 5 million by signing the Subscription Form provide the Joint Bookrunners with a one-time irrevocable authorisation to manually debit the specified bank account for the entire subscription amount.
Subscribers who do not have a Norwegian bank account Subscribers who do not have a Norwegian bank account must ensure that payment with cleared funds for the Offer Shares allocated to them is made on or before the Payment Date.
Prior to any such payment being made, the subscriber must contact one of the Joint Bookrunners for further details and instructions.
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Overdue payments Overdue payments will be charged with interest at the applicable rate under the Norwegian Act on Interest on Overdue Payment of 17 December 1976 No. 100; 8.5% per annum as of the date of the Prospectus. If the subscriber fails to comply with the terms of payment or should payments not be made when due, the subscriber will remain liable for payment of the Offer Shares allocated to it and the Offer Shares allocated to such subscriber will not be delivered to the subscriber. In such case the Company and the Joint Bookrunners reserve the right to, at any time and at the risk and cost of the subscriber, re-allot, cancel or reduce the subscription and the allocation of the allocated Offer Shares, or, if payment has not been received by the third day after the Payment Date, without further notice sell, assume ownership to or otherwise dispose of the allocated Offer Shares in accordance with applicable law. If Offer Shares are sold on behalf of the subscriber, such sale will be for the subscriber’s account and risk and the subscriber will be liable for any loss, costs, charges and expenses suffered or incurred by the Company and/or the Joint Bookrunners as a result of, or in connection with, such sales. The Company and/or the Joint Bookrunners may enforce payment for any amounts outstanding in accordance with applicable law.
16.2.12 Delivery of the Offer Shares Subject to timely payment of the entire subscription amount in the Subsequent Offering, the Company expects that the share capital increase pertaining to the Subsequent Offering will be registered with the Norwegian Register of Business Enterprises on or about 17 August 2016 and that the Offer Shares will be delivered to the VPS accounts of the subscribers to whom they are allocated on or about the same day. The final deadline for registration of the share capital increase pertaining to the Subsequent Offering with the Norwegian Register of Business Enterprises, and, hence, for the subsequent delivery of the Offer Shares, is, pursuant to the Norwegian Public Limited Companies Act, three months from the expiry of the Subscription Period (i.e. 8 November 2016).
16.2.13 Listing of the Offer Shares The Shares (including the Private Placement Shares, but excluding the Offer Shares) will be listed on Oslo Axess under ISIN NO0010689326 and ticker code "TRVX" on or about 8 July 2016. The Offer Shares will be listed on Oslo Axess as soon as the share capital increase pertaining to the Subsequent Offering has been registered with the Norwegian Register of Business Enterprises and the Offer Shares have been registered in the VPS. This is expected to take place on or about 17 August 2016.
The Offer Shares may not be transferred or traded before they are fully paid and said registrations in the Norwegian Register of Business Enterprises and the VPS have taken place.
The Shares are not listed, and no application has been filed for listing, on any other stock exchange or regulated market than Oslo Axess.
16.2.14 The rights conferred by the Offer Shares The Offer Shares to be issued in the Subsequent Offering will be ordinary Shares in the Company with a nominal value of NOK 0.10 each, and will be issued electronically in registered form in accordance with the Norwegian Public Limited Companies Act.
The Offer Shares will rank pari passu in all respects with the existing Shares in the Company and will carry full shareholder rights from the time of registration of the share capital increase pertaining to the Subsequent Offering with the Norwegian Register of Business Enterprises. The Offer Shares will be eligible for any dividends which the Company may declare after such registration. All Shares, including the Offer Shares, will have voting rights and other rights and obligations which are standard under the Norwegian Public Limited Companies Act, and are governed by Norwegian law. See Section 13 "Corporate Information and Description of Share Capital" for a more detailed description of the Shares.
16.2.15 VPS registration The Offer Shares will be registered in the VPS with the same International Securities Identification Number as the Shares, being ISIN NO0010689326. The Company's registrar with the VPS is Nordea Bank Norge ASA (the VPS Registrar), Essendrops gate 7, N-0368 Oslo, Norway, telephone number +47 24 01 34 27.
16.3 Dilution The dilutive effect following the Private Placement and the Subsequent Offering (assuming subscription of the maximum number of Offer Shares) is summarised in the table below:
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Prior to the Subsequent to the Private Subsequent to the Private Private Placement Placement (for a Placement and the Subsequent and the shareholder not Offering (for a shareholder Subsequent participating in the Private participating neither in the Private Offering Placement) Placement nor in the subsequent offering, assuming maximum number of shares are allocated) Number of Shares each with a nominal value of NOK 0.10 ...... 26 905 367 41,590,367 44,257,034 % dilution ...... 35.3% 39.2%
16.4 Expenses of the Private Placement, the Subsequent Offering and the Listing The gross proceeds from the Private Placement and the Subsequent Offering to the Company will be approximately NOK 130 million and the Company’s total costs and expenses of, and incidental to, the Private Placement, the Listing and the Subsequent Offering are estimated to amount to approximately NOK 10 million (excluding VAT) based on the assumption that the maximum number of Offer Shares are applied for and allocated in the Subsequent Offering.
Under the mandate agreement entered into among the Company and the Joint Bookrunners in connection with the Private Placement and the Subsequent Offering, the Company will pay a commission calculated on the basis of the gross proceeds from the Private Placement and the Subsequent Offering. The commission is 2.5% for shares allocated to certain existing shareholders, and 5% for shares allocated to others.
No expenses or taxes will be charged by the Company or the Joint Bookrunners to the applicants in the Subsequent Offering.
16.5 Lock-up 16.5.1 The Company Pursuant to a lock up undertaking, the Company has undertaken that it will not and will procure that none of its respective subsidiaries nor any other party acting on its behalf (other than the Joint Bookrunners) will, without the prior written consent of the Joint Bookrunners: (1) directly or indirectly, issue, offer, pledge, sell, or contract to issue or sell any Shares, or (2) (i) directly or indirectly, issue, offer, pledge, sell or contract to issue or sell any securities convertible into or exercisable or exchangeable for Shares or (ii) enter into any swap or any other agreement or any transaction that has an equivalent effect to paragraph (i) above, whether any such swap or transaction described in paragraph (i) or (ii) above is to be settled by delivery of such securities, in cash or otherwise.
The lock up undertaking will remain in force for a period of 12 months following the completion of the Private Placement. The lock-up undertaking does not apply to the sale and issue of the Offer Shares in the Subsequent Offering, or any issuance of options, shares or other similar instruments as part of the existing duly approved option scheme and RSU scheme.
16.5.2 Major shareholders Pursuant to a lock up undertaking, three of the major shareholders of the company, HealthCap V L.P., Norwegian Radium Hospital Research Foundation and Prieta AS, have undertaken to not offer, sell, pledge, lend or otherwise dispose of any Shares or resolve to do any of the foregoing without the prior written consent of the Joint Bookrunners. The obligation applies correspondingly to any sale of or other disposition of options, warrants, convertible bonds or other securities convertible or exchangeable into Shares. The shareholders have also undertaken not to enter into any swap or other agreement or transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of Shares, whether any such swap or transaction is to be settled by delivery of Shares or other securities, in cash or otherwise or resolve to do any of the foregoing, without the prior written consent of the Joint Bookrunners.
The undertaking does not apply to (i) acceptance (including pre-acceptance) of any bona fide offer for all the Shares, (ii) any direct or indirect transfer of Shares to a company controlled by the shareholder or entity controlling the shareholder provided that such company or entity prior to the transfer has signed a lock-up undertaking in the same form as this lock-up undertaking or (iii) Shares acquired following the completion of the Private Placement.
The lock up undertaking will remain in force for six months after the completion of the Private Placement.
16.5.3 Members of the Board of Directors and the Management Pursuant to a lock up undertaking, all members of the Board of Directors and the Management have undertaken to: (1) not offer, sell, pledge, lend or otherwise dispose of any Shares or resolve to do any of the foregoing without the
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prior written consent of the Joint Bookrunners. The obligation applies correspondingly to any sale of or other disposition of options, warrants, convertible bonds or other securities convertible or exchangeable into Shares. The members of the Board of Directors and the Management have also undertaken not to enter into any swap or other agreement or transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of Shares, whether any such swap or transaction is to be settles by delivery of Shares or other securities, in cash or otherwise or resolve to do any of the foregoing, without the prior written consent of the Joint Bookrunners.
The undertaking does not apply to (i) acceptance (including pre-acceptance) of any bona fide offer for all the Shares, (ii) any direct or indirect transfer of Shares to a company controlled by the shareholder or entity controlling the shareholder provided that such company or entity prior to the transfer has signed a lock-up undertaking in the same form as this lock-up undertaking, (iii) the sale of Shares subscribed under the Company's share option program, (iv) the sale of Shares to finance the strike price for share options exercised and any tax triggered by such sale or the exercise of share options, or (v) Shares acquired following the completion of the Private Placement.
The lock up undertaking shall remain in force for 12 months after the completion of the Private Placement.
16.6 Disclosure regarding subscription of shares by the members of the Management and the Board of Directors outside the Subsequent Offering In the 2015 Private Placement completed on 2 July 2015, Gunnar Gårdemyr (CEO), Magnus Jäderberg (CMO), Peter Skorpil (VP, Business Development), Tina Madsen (VP, Quality Assurance) and Øystein Soug (CFO) (though his holding company Abakus Invest AS) subscribed for shares in the Company at a subscription price of NOK 25 per Share. This is NOK 17.50 higher than the Subscription Price in the Subsequent Offering.
On 29 April 2016, Antti Vuolanto (executive vice president) and other employees in the Company who participated in the Company’s share incentive programme, purchased shares in the Company for a price of NOK 0.51 per Share. This is NOK 6.99 lower than the Subscription Price in the Subsequent Offering.
In respect of the RSU program described in Section 12.6 "Restricted stock unit program", the number of RSUs granted to the members of the Board of Directors was calculated on the basis of the volume weighted average share price for the 10 business days prior to the date of grant (13 April 2016) of NOK 12.20 per share. This is NOK 4.70 higher than the Subscription Price in the Subsequent Offering.
In the Private Placement, Gunnar Gårdemyr (CEO), Øystein Soug (CFO) (though his holding company Abakus Invest AS), Peter Skorpil (VP, Business Development), Tina Madsen (VP, Quality Assurance) and Anne-Kirsti Aksnes (VP Clinical development) subscribed for Shares in the Company at a subscription price of NOK 7.50 per Share. This is the same price as the Subscription Price in the Subsequent Offering.
16.7 Interest of natural and legal persons involved in the Subsequent Offering The Joint Bookrunners or their affiliates have provided from time to time, and may provide in the future, investment and commercial banking services to the Company and its affiliates in the ordinary course of business, for which they may have received and may continue to receive customary fees and commissions and may come to have interests that may not be aligned or could potentially conflict with the interests of the Company and investors in the Company. The Joint Bookrunners do not intend to disclose the extent of any such investments or transactions otherwise than in accordance with any legal or regulatory obligation to do so.
The Joint Bookrunners will receive a management fee in connection with the Private Placement and the Subsequent Offering and, as such, have an interest in the Subsequent Offering. See Section 16.4 "Expenses of the Private Placement, the Subsequent Offering and the Listing" for information on fees to the Joint Bookrunners in connection with the Subsequent Offering.
Beyond the above-mentioned, the Company is not aware of any interest, including conflicting ones, of any natural or legal persons involved in the Subsequent Offering.
16.8 Participation of major existing shareholders and members of the Management, supervisory and administrative bodies in the Subsequent Offering The Company is not aware of whether any major shareholders of the Company or members of the Management, supervisory or administrative bodies intend to apply for Offer Shares in the Subsequent Offering, or whether any person intends to apply for more than 5% of the Offer Shares.
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16.9 Publication of information in respect of the Subsequent Offering In addition to press releases which will be posted on the Company’s website, the Company will use the Oslo Stock Exchange’s information system to publish information relating to the Subsequent Offering.
16.10 Governing law and jurisdiction This Prospectus, the Subscription Form and the terms and conditions of the Subsequent Offering shall be governed by and construed in accordance with Norwegian law, and the Offer Shares will be issued pursuant to, the Norwegian Public Limited Companies Act. Any dispute arising out of, or in connection with, this Prospectus, the Subscription Form or the Subsequent Offering shall be subject to the exclusive jurisdiction of the courts of Norway, with the Oslo District Court as the legal venue.
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17 SELLING AND TRANSFER RESTRICTIONS 17.1 General The grant of Subscription Rights and issue of Offer Shares upon exercise of Subscription Rights to persons resident in, or who are citizens of countries other than Norway, may be affected by the laws of the relevant jurisdiction. Investors should consult their professional advisors as to whether they require any governmental or other consents or need to observe any other formalities to enable them to exercise Subscription Rights or purchase Offer Shares.
The Subscription Rights and Offer Shares have not been and will not be registered under the U.S. Securities Act or under the securities laws of any state or jurisdiction of the United States, and may not be offered, sold, pledged, resold, granted, delivered, allocated, taken up, transferred or delivered, directly or indirectly, within the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the U.S. Securities Act and in compliance with the applicable securities laws of any state or jurisdiction of the United States. Receipt of this Prospectus will not constitute an offer in those jurisdictions in which it would be illegal to make an offer and, in those circumstances, this Prospectus is for information only and should not be copied or redistributed. Except as otherwise disclosed in this Prospectus, if an investor receives a copy of this Prospectus in any territory, such investor may not treat this Prospectus as constituting an invitation or offer to it, nor should the investor in any event deal in the Offer Shares, unless, in the relevant jurisdiction, such an invitation or offer could lawfully be made to that investor, or the Offer Shares could lawfully be dealt in without contravention of any unfulfilled registration or other legal requirements. Accordingly, if an investor receives a copy of this Prospectus, the investor should not distribute or send the same, or transfer Offer Shares to any person or in or into any jurisdiction where to do so would or might contravene local securities laws or regulations. If the investor forwards this Prospectus into any such territories (whether under a contractual or legal obligation or otherwise), the investor should direct the recipient’s attention to the contents of this Section.
Except as otherwise noted in this Prospectus and subject to certain exceptions: (i) the Subscription Rights and Offer Shares being granted or offered, respectively, in the Subsequent Offering may not be offered, sold, resold, transferred or delivered, directly or indirectly, in or into, Member States of the EEA that have not implemented the Prospectus Directive, Australia, Canada, Japan, the United States or any other jurisdiction in which it would not be permissible to offer the Subscription Rights and/or the Offer Shares (the “Ineligible Jurisdictions”); (ii) this Prospectus may not be sent to any person in any Ineligible Jurisdiction; and (iii) the crediting of Subscription Rights to an account of an Ineligible Shareholder or other person who is a resident of an Ineligible Jurisdiction (referred to as “Ineligible Persons”) does not constitute an offer to such persons of the Subscription Rights or the Offer Shares. Ineligible Persons may not exercise Subscription Rights.
If an investor takes up Subscription Rights, exercises Subscription Rights to obtain Offer Shares or trades or otherwise deals in the Offer Shares pursuant to this Prospectus, unless the Company in its sole discretion determines otherwise on a case-by-case basis, that investor will be deemed to have made or, in some cases, be required to make, the following representations and warranties to the Company and any person acting on the Company’s or its behalf:
(i) the investor is not located in an Ineligible Jurisdiction;
(ii) the investor is not an Ineligible Person;
(iii) the investor is not acting, and has not acted, for the account or benefit of an Ineligible Person;
(iv) the investor acknowledges that the Company is not taking any action to permit a public offering of the Subscription Rights or the Offer Shares (pursuant to the exercise of the Subscription Rights or otherwise) in any jurisdiction other than Norway; and
(v) the investor may lawfully be offered, take up, subscribe for and receive Subscription Rights and Offer Shares in the jurisdiction in which it resides or is currently located.
The Company and the Joint Bookrunners and their affiliates and others will rely upon the truth and accuracy of the above acknowledgements, agreements and representations, and agree that, if any of the acknowledgements, agreements or representations deemed to have been made by its purchase of Offer Shares is no longer accurate, it will promptly notify the Company and the Joint Bookrunners. Any provision of false information or subsequent breach of these representations and warranties may subject the investor to liability.
If a person is acting on behalf of a holder of Subscription Rights (including, without limitation, as a nominee, custodian or trustee), that person will be required to provide the foregoing representations and warranties to the Company with 115
respect to the exercise of Subscription Rights on behalf of the holder. If such person cannot or is unable to provide the foregoing representations and warranties, the Company will not be bound to authorize the allocation of any of the Subscription Rights and Offer Shares to that person or the person on whose behalf the other is acting. Subject to the specific restrictions described below, if an investor (including, without limitation, its nominees and trustees) is located outside Norway and wishes to exercise Subscription Rights and/or deal in or subscribe Offer Shares, the investor must satisfy itself as to full observance of the applicable laws of any relevant territory including obtaining any requisite governmental or other consents, observing any other requisite formalities and paying any issue, transfer or other taxes due in such territories.
The information set out in this Section is intended as a general guide only. If the investor is in any doubt as to whether it is eligible to exercise its Subscription Rights or subscribe for the Offer Shares, such investor should consult its professional advisor without delay.
Subscription Rights will initially be credited to financial intermediaries for the accounts of all shareholders who hold Shares registered through a financial intermediary on the Record Date. Subject to certain exceptions, financial intermediaries, which include brokers, custodians and nominees, may not exercise any Subscription Rights on behalf of any person in the Ineligible Jurisdictions or any Ineligible Persons and may be required in connection with any exercise of Subscription Rights to provide certifications to that effect.
Subject to certain exceptions, financial intermediaries are not permitted to send this Prospectus or any other information about the Offering into any Ineligible Jurisdiction or to any Ineligible Persons. Subject to certain exceptions, exercise instructions or certifications sent from or postmarked in any Ineligible Jurisdiction will be deemed to be invalid and Offer Shares will not be delivered to an addressee in any Ineligible Jurisdiction. The Company reserves the right to reject any exercise (or revocation of such exercise) in the name of any person who provides an address in an Ineligible Jurisdiction for acceptance, revocation of exercise or delivery of such Subscription Rights and Offer Shares, who is unable to represent or warrant that such person is not in an Ineligible Jurisdiction and is not an Ineligible Person, who is acting on a non-discretionary basis for such persons, or who appears to the Company or its agents to have executed its exercise instructions or certifications in, or dispatched them from, an Ineligible Jurisdiction. Furthermore, the Company reserves the right, with sole and absolute discretion, to treat as invalid any exercise or purported exercise of Subscription Rights which appears to have been executed, effected or dispatched in a manner that may involve a breach or violation of the laws or regulations of any jurisdiction.
Notwithstanding any other provision of this Prospectus, the Company reserves the right to permit a holder to exercise its Subscription Rights if the Company, in its absolute discretion, is satisfied that the transaction in question is exempt from or not subject to the laws or regulations giving rise to the restrictions in question. Applicable exemptions in certain jurisdictions are described further below. In any such case, the Company does not accept any liability for any actions that a holder takes or for any consequences that it may suffer as a result of the Company accepting the holder’s exercise of Subscription Rights.
No action has been or will be taken by the Joint Bookrunners to permit the possession of this Prospectus (or any other offering or publicity materials or application form(s) relating to the Offering) in any jurisdiction where such distribution may lead to a breach of any law or regulatory requirement.
Neither the Company nor the Joint Bookrunners, nor any of their respective representatives, is making any representation to any offeree, subscriber or purchaser of Subscription Rights and/or Offer Shares regarding the legality of an investment in the Subscription Rights and/or the Offer Shares by such offeree, subscriber or purchaser under the laws applicable to such offeree, subscriber or purchaser. Each investor should consult its own advisors before subscribing for or purchasing Offer Shares. Investors are required to make their independent assessment of the legal, tax, business, financial and other consequences of a subscription for or a purchase of Offer Shares.
A further description of certain restrictions in relation to the Subscription Rights and the Offer Shares in certain jurisdictions is set out below.
17.2 Selling restrictions 17.2.1 United States The Offer Shares have not been and will not be registered under the U.S. Securities Act, and may not be offered or sold except: (i) within the United States to QIBs as defined in Rule 144A or in other transactions exempt from registration requirements under the U.S. Securities Act; or (ii) to certain persons in offshore transactions in compliance with Regulation S, and in accordance with any applicable securities laws of any state or territory of the United States or any other jurisdiction. Transfer of the Offer Shares will be restricted and each purchaser of the Offer
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Shares in the United States will be required to make certain acknowledgements, representations and agreements, as described under Section 17.3.1 "United States".
Any offer or sale in the United States will be made through affiliates of the Joint Bookrunners who are broker-dealers registered under the U.S. Exchange Act. In addition, until 40 days after the commencement of the Subsequent Offering, an offer or sale of Offer Shares within the United States by a dealer, whether or not participating in the Subsequent Offering, may violate the registration requirements of the U.S. Securities Act if such offer or sale is made otherwise than in accordance with Rule 144A or pursuant to another exemption from the registration requirements of the U.S. Securities Act, and in each case any applicable state securities laws. The Joint Bookrunners and/or their affiliates who are broker-dealers registered under the U.S. Exchange Act may in accordance with their own policies, in connection with any offer or sale in the United States require the investor to make certain acknowledgements, representations and agreements.
17.2.2 United Kingdom Each United Kingdom applicant confirms that it understands that the Subsequent Offering in the United Kingdom has only been communicated or caused to be communicated and will only be communicated or caused to be communicated ) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order) or (iii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as Relevant Persons). The Offer Shares are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such Shares will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.
17.2.3 European Economic Area In relation to each Relevant Member State, with effect from and including the date on which the EU Prospectus Directive is implemented in that Relevant Member State (the "Relevant Implementation Date"), an offer to the public of any Offer Shares which are the subject of the offering contemplated by this Prospectus may not be made in that Relevant Member State, other than the offering in Norway as described in this Prospectus, once the Prospectus has been approved by the competent authority in Norway and published in accordance with the EU Prospectus Directive (as implemented in Norway), except that an offer to the public in that Relevant Member State of any Offer Shares may be made at any time with effect from and including the Relevant Implementation Date under the following exemptions under the EU Prospectus Directive, if they have been implemented in that Relevant Member State:
a) to legal entities which are qualified investors as defined in the EU Prospectus Directive;
b) to fewer than 100, or, if the Relevant Member State has implemented the relevant provisions of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified investors as defined in the EU Prospectus Directive), as permitted under the EU Prospectus Directive, subject to obtaining the prior consent of the Joint Bookrunners for any such offer, or
c) in any other circumstances falling within Article 3(2) of the EU Prospectus Directive; provided that no such offer of Offer Shares shall require the Company any Manager to publish a prospectus pursuant to Article 3 of the EU Prospectus Directive or supplement a prospectus pursuant to Article 16 of the EU Prospectus Directive.
For the purposes of this provision, the expression an "offer to the public" in relation to any Offer Shares in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any Securities to be offered so as to enable an investor to decide to purchase any Offer Shares, as the same may be varied in that Member State by any measure implementing the EU Prospectus Directive in that Member State the expression "EU Prospectus Directive" means Directive 2003/71/EC (and amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member State), and includes any relevant implementing measure in each Relevant Member State and the expression "2010 PD Amending Directive" means Directive 2010/73/EU.
This EEA selling restriction is in addition to any other selling restrictions set out in this Prospectus.
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17.2.4 Additional jurisdictions 17.2.4.1 Switzerland The Offer Shares may not be publicly offered in Switzerland and will not be listed on the Swiss Exchange ("SIX") or on any other stock exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses under article 652a or article 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under article 27 ff of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or marketing material relating to the Offer Shares or the Subsequent Offering may be publicly distributed or otherwise made publicly available in Switzerland. Neither this document nor any other offering or marketing material relating to the Subsequent Offering, the Company or the Shares have been or will be filed with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the Subsequent Offering will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA, and the Subsequent Offering has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes ("CISA"). The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of shares.
17.2.4.2 Canada This Prospectus is not, and under no circumstance is to be construed as, a prospectus, an advertisement or a public offering of the Offer Shares in Canada or any province or territory thereof. Any offer or sale of the Offer Shares in Canada will be made only pursuant to an exemption from the requirements to file a prospectus with the relevant Canadian securities regulators and only by a dealer properly registered under applicable provincial securities laws or, alternatively, pursuant to an exemption from the dealer registration requirement in the relevant province or territory of Canada in which such offer or sale is made.
17.2.4.3 Hong Kong The Offer Shares may not be offered or sold in Hong Kong by means of any document other than (i) in circumstances which do not constitute an offer to the public within the meaning of the Companies Ordinance (Cap. 32) of Hong Kong, or (ii) to "professional investors" within the meaning of the Securities and Futures Ordinance (Cap. 571) of Hong Kong and any rules made there under, or (iii) in other circumstances which do not result in the document being a "prospectus" within the meaning of the Companies Ordinance (Cap. 32) of Hong Kong, and no advertisement, invitation or document relating to the Offer Shares may be issued or may be in the possession of any person for the purposes of issue (in each case whether in Hong Kong or elsewhere), which is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to Offer Shares which are or are intended to be disposed of only to persons outside Hong Kong or only to "professional investors" within the meaning of the Securities and Futures Ordinance (Cap. 571) of Hong Kong and any rules made there under.
17.2.4.4 Other jurisdictions The Offer Shares may not be offered, sold, resold, transferred or delivered, directly or indirectly, in or into, Japan, Australia, South Africa or any other jurisdiction in which it would not be permissible to offer the Offer Shares.
In jurisdictions outside the United States and the EEA where the Subsequent Offering would be permissible, the Offer Shares will only be offered pursuant to applicable exceptions from prospectus requirements in such jurisdictions.
17.3 Transfer restrictions 17.3.1 United States The Offer Shares have not been and will not be registered under the U.S. Securities Act and may not be offered or sold within the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and applicable state securities laws. Terms defined in Rule 144A or Regulation S shall have the same meaning when used in this section.
Each purchaser of the Offer Shares outside the United States pursuant to Regulation S will be deemed to have acknowledged, represented and agreed that it has received a copy of this Prospectus and such other information as it deems necessary to make an informed decision and that:
The purchaser is authorized to consummate the purchase of the Offer Shares in compliance with all applicable laws and regulations.
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The purchaser acknowledges that the Offer Shares have not been and will not be registered under the U.S. Securities Act, or with any securities regulatory authority or any state of the United States, and are subject to significant restrictions on transfer.
The purchaser is, and the person, if any, for whose account or benefit the purchaser is acquiring the Offer Shares was, located outside the United States at the time the buy order for the Offer Shares was originated and continues to be located outside the United States and has not purchased the Offer Shares for the benefit of any person in the United States or entered into any arrangement for the transfer of the Offer Shares to any person in the United States.
The purchaser is not an affiliate of the Company or a person acting on behalf of such affiliate, and is not in the business of buying and selling securities or, if it is in such business, it did not acquire the Offer Shares from the Company or an affiliate thereof in the initial distribution of such Shares.
The purchaser is aware of the restrictions on the offer and sale of the Offer Shares pursuant to Regulation S described in this Prospectus.
The Offer Shares have not been offered to it by means of any "directed selling efforts" as defined in Regulation S.
The Company shall not recognize any offer, sale, pledge or other transfer of the Offer Shares made other than in compliance with the above restrictions.
The purchaser acknowledges that the Company, the Joint Bookrunners and their respective advisers will rely upon the truth and accuracy of the foregoing acknowledgements, representations and agreements.
Each purchaser of the Offer Shares within the United States pursuant to Rule 144A will be deemed to have acknowledged, represented and agreed that it has received a copy of this Prospectus and such other information as it deems necessary to make an informed investment decision and that:
The purchaser is authorized to consummate the purchase of the Offer Shares in compliance with all applicable laws and regulations.
The purchaser acknowledges that the Offer Shares have not been and will not be registered under the U.S. Securities Act or with any securities regulatory authority of any state of the United States and are subject to significant restrictions to transfer.
The purchaser (i) is a QIB (as defined in Rule 144A), (ii) is aware that the sale to it is being made in reliance on Rule 144A or another exemption from the registration requirements under the U.S. Securities Act and (iii) is acquiring such Offer Shares for its own account or for the account of a QIB, in each case for investment and not with a view to any resale or distribution to the Offer Shares, as the case may be.
The purchaser is aware that the Offer Shares are being offered in the United States in a transaction not involving any public offering in the United States within the meaning of the U.S. Securities Act.
If, in the future, the purchaser decides to offer, resell, pledge or otherwise transfer such Offer Shares, as the case may be, such Shares may be offered, resold, pledged or otherwise transferred only (i) to a person whom the beneficial owner and/or any person acting on its behalf reasonably believes is a QIB in a transaction meeting the requirements of Rule 144A, (ii) in accordance with Regulation S, (iii) in accordance with Rule 144 (if available), (iv) pursuant to any other exemption from the registration requirements of the U.S. Securities Act, subject to the receipt by the Company of an opinion of counsel or such other evidence that the Company may reasonably require that such sale or transfer is in compliance with the U.S. Securities Act or (v) pursuant to an effective registration statement under the U.S. Securities Act, in each case in accordance with any applicable securities laws of any state or territory of the United States or any other jurisdiction.
The purchaser is not an affiliate of the Company or a person acting on behalf of such affiliate, and is not in the business of buying and selling securities or, if it is in such business, it did not acquire the Offer Shares from the Company or an affiliate thereof in the initial distribution of such Shares.
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The Offer Shares are "restricted securities" within the meaning of Rule 144(a)(3) and no representation is made as to the availability of the exemption provided by Rule 144 for resales of any Offer Shares, as the case may be.
The Company shall not recognize any offer, sale pledge or other transfer of the Offer Shares made other than in compliance with the above-stated restrictions.
The purchaser acknowledges that the Company, the Joint Bookrunners and their respective advisers will rely upon the truth and accuracy of the foregoing acknowledgements, representations and agreements.
17.3.2 European Economic Area Each person in a Relevant Member State (other than, in the case of paragraph (a), persons receiving offers contemplated in this Prospectus in Norway) who receives any communication in respect of, or who acquires any Offer Shares under, the offers contemplated in this Prospectus will be deemed to have represented, warranted and agreed to and with each Manager and the Company that: a) It is a qualified investor as defined in the EU Prospectus Directive; and b) in the case of any Offer Shares acquired by it as a financial intermediary, as that term is used in Article 3(2) of the EU Prospectus Directive, (i) the Offer Shares acquired by it in the offer have not been acquired on behalf of, nor have they been acquired with a view to their offer or resale to, persons in any Relevant Member State other than qualified investors, as that term is defined in the Prospectus Directive, or in circumstances in which the prior consent of the Joint Bookrunners has been given to the offer or resale; or (ii) where Offer Shares have been acquired by it on behalf of persons in any Relevant Member State other than qualified investors, the offer of those Shares to it is not treated under the EU Prospectus Directive as having been made to such persons.
For the purposes of this representation, the expression an "offer" in relation to any Offer Shares in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any Offer Shares to be offered so as to enable an investor to decide to purchase or subscribe for the Offer Shares, as the same may be varied in that Relevant Member State by any measure implementing the EU Prospectus Directive in that Relevant Member State and the expression "EU Prospectus Directive" means Directive 2003/71/EC (and amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member State), and includes any relevant implementing measure in each Relevant Member State and the expression "2010 PD Amending Directive" means Directive 2010/73/EU.
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18 ADDITIONAL INFORMATION 18.1 Auditor and advisors The Company’s independent auditor is Ernst & Young AS with registration number 976 389 387, and business address Dronning Eufemias gate 6, N-0191 Oslo, Norway. The partners of EY are members of Den Norske Revisorforening (The Norwegian Institute of Public Accountants). The Company’s financial statements as of and for the year ended 31 December 2015, with comparable figures as of and for the year ended 31 December 2014 as included in Appendix B to this Prospectus were audited by Ernst & Young. With respect to the Pro Forma Financial Information as provided in section 11 "Unaudited pro forma financial information", Ernst & Young AS has issued an independent assurance report on the unaudited pro forma condensed financial information included as Appendix D to this Prospectus.
ABG Sundal Collier (Munkedamsveien 45E Vika Atrium N-0250 Oslo, Norway), Arctic Securities AS (Haakon VIIs gate 5, N-0161, Oslo, Norway) and DNB Markets (Dronning Eufemias gate 30, N-0021 Oslo, Norway) are acting as Joint Bookrunners for the Private Placement and the Subsequent Offering.
Advokatfirmaet Thommessen AS (Haakon VII’s gate 10, N-0161 Oslo, Norway) is acting as legal counsel to the Company.
Advokatfirmaet Wiersholm AS (Dokkveien 1, N-0250 Oslo, Norway) is acting as legal counsel to the Joint Bookrunners.
18.2 Documents on display Copies of the following documents will be available for inspection at the Company’s offices at Lilleakerveien 2 C, 0283 Oslo, Norway, during normal business hours from Monday to Friday each week (except public holidays) for a period of twelve months from the date of this Prospectus:
The Company’s certificate of incorporation and Articles of Association;
All reports, letters, and other documents, historical financial information, valuations and statements prepared by any expert at the Company’s request any part of which is included or referred to in this Prospectus;
The historical financial information of the Company and its subsidiary undertakings for each of the two financial years preceding the publication of this Prospectus; and
This Prospectus.
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19 DEFINITIONS AND GLOSSARY In the Prospectus, the following defined terms have the following meanings:
2010 PD Amending Directive ...... Directive 2010/73/EU amending the EU Prospectus Directive. 2015 Private Placement ...... The private placement completed on 9 July 2015 with gross proceeds of NOK 200 million, in which 8,000,000 new Shares, each with a nominal value of NOK 0.10, were issued by the Company. ABG Sundal Collier ...... ABG Sundal Collier Norge ASA. AA ...... Accelerated approval. ALP ...... Alkaline phosphatase antibody ...... Immune defense molecule recognizing antigens on cell surfaces. Antigen ...... A substance that the immune system recognizes as foreign to the body and that the immune system can mount an immune response against Anti-Money Laundering Legislation .. The Norwegian Money Laundering Act of 6 March 2009 no. 11 and the Norwegian Money Laundering Regulations of 13 March 2009 no. 302, collectively. AoA ...... The U.S. Department of Health and Human Services; Administration for Community Living. APC...... Antigen presenting cells. ARC ...... Antibody radionuclide conjugate. Arctic Securities ...... Arctic Securities AS. ASAT ...... Aspartate amino transferase Articles of Association...... The Company’s articles of association. Board Members ...... The members of the Board of Directors. Board of Directors ...... The board of directors of the Company. CAGR ...... Compound annual growth rate CA 19-9 ...... Blood levels of Cancer Antigen 19-9 are used to differentiate pancreatic cancer from other cancers and serve to monitor treatment response as well as recurrence. CD4+ T helper cells ...... CD4 positive T helper lymphocytes. CD8+ cytotoxic T cells ...... CD8 positive cytotoxic T lymphocytes. CEO ...... The Company’s chief executive officer. CET ...... Central European Time. CHF ...... Swiss franc, the lawful currency of Switzerland. CISA ...... The Swiss Federal Act on Collective Investment Schemes. CMO ...... Contract manufacturing organization. Combination ...... The share for share acquisition of 100% of the shares in Oncos by the Company by issuing 9,429,404 new shares to the shareholders of Oncos as consideration, completed on 2 July 2015. Company ...... Targovax ASA. CT ...... Computed tomography. DC ...... Dendritic cell. DNB Markets ...... DNB Markets, a part of DNB Bank ASA. DHT ...... Delayed-type hypersensitivity. A test performed on the skin to measure T-cell mediated immunity against specific antigens. DLT ...... Dose limiting toxicities. EEA ...... The European Economic Area. Epitope ...... An epitope is the specific part of an antigen that is recognized by the immune system. T-cells and antibodies recognize and attack specific epitopes. An antigen can have several different epitopes. EMA ...... The European Medicines Agency. EU ...... The European Union. EU Prospectus Directive ...... Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003, and amendments thereto, including the 2010 PD Amending Directive to the extent implemented in the Relevant Member State. EUR ...... The lawful common currency of the EU member states who have adopted the Euro as their sole national currency. exon ...... Gene fragment being expressed to protein. EY ...... Ernst & Young AS, the Company’s auditor. FDA ...... The U.S. Food and Drug Administration. FGAAP ...... Finnish Generally Accepted Accounting Principles.
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Financial Information ...... The Financial Statements and the Interim Financial Statements. Financial Statements ...... The audited financial statements for the Company as of and for the year ended 31 December 2015, with comparable figures as of and for the year ended 31 December 2014. Gemcitabine ...... A generic chemotherapy drug used to treat cancer since 1995, which has become standard of care in various cancer indications. Gemcitabine is a nucleoside analog that becomes incorporated into the DNA of replicating cells, thereby killing the cells. General Meeting ...... The general meeting of the shareholders in the Company. GM-CSF ...... Granulocyte macrophage colony stimulating factor (non glycosylated human GM-CSF expressed in e-coli). GMP ...... Good manufacturing practice. Group...... The Company and its consolidated subsidiaries following completion of the Combination. HLA...... Human leukocyte antigen. HRAS ...... A form of the RAS gene that is highly expressed in the brain, muscles, and skin HSV ...... Herpes simplex virus. IAS 34 ...... International Accounting Standard 34. IFRS ...... International Financial Reporting Standards as adopted by the EU. IMM ...... Irreversible morbidity or mortality. Interim Financial Statements...... The unaudited condensed financial statements of the Company as of and for the three and nine month periods ended 31 March 2016. Intralesional Infiltration ...... The penetration of T-cells called Tumor-Infiltrating Lymphocytes (TILs) into a tumor Joint Bookrunners ...... ABG Sundal Collier, Arctic Securities and DNB Markets, collectively. KRAS ...... A form of the RAS gene that is highly expressed in the gut, lung, and thymus. Listing ...... The listing of the Shares on Oslo Axess. Management ...... The senior management team of the Company. Member States ...... The participating member states of the European Union. NDA ...... New drug application. New Shares ...... New shares to be issued by the Company in the Subsequent Offering. NOK ...... Norwegian Kroner, the lawful currency of Norway. NOM-account ...... Nominee account. Non-Norwegian Corporate Shareholders ...... Shareholders who are limited liability companies (and certain other entities) not resident in Norway for tax purposes. Neoepitope ...... An epitope that is created through a genetic mutation in cancer cells. Neoepitopes are much stronger stimulators of the immune system than epitopes that are merely over-expressed in cancer cells compared to normal cells, but which are not structurally altered themselves. Non-Norwegian Personal Shareholder ...... Shareholders who are individuals not resident in Norway for tax purposes. Non-randomized Clinical Trial ...... All enrolled patients receive the same treatment regimen in the clinical trial. The outcome of the trial is compared to historical data. Non-randomized Phase of a Clinical Trial ...... In the first part of the clinical trial, the non-randomized phase, all enrolled patients receive the same treatment. In the second part of the clinical trial, the randomized phase, all enrolled patients are randomly assigned to one of the treatment regimens that are compared in the clinical trial. A clinical trial can be non-randomized or randomized, or it can contain a non- randomized and a randomized phase. Nordea ...... Nordea Bank Norge ASA. Norwegian Act on Overdue Payment ...... The Norwegian Act on Overdue Payment of 17 December 1976 no. 100 (Nw.: forsinkelsesrenteloven). Norwegian Corporate Governance Code ...... The Norwegian Code of Practice for Corporate Governance dated 30 October 2014. Norwegian Corporate Shareholders . Shareholders who are limited liability companies and certain similar corporate entities resident in Norway for tax purposes. Norwegian FSA ...... The Financial Supervisory Authority of Norway (Nw.: Finanstilsynet). Norwegian Personal Shareholder..... Shareholders who are individuals resident in Norway for tax purposes. Norwegian Public Limited Companies Act ...... The Norwegian Public Limited Companies Act of 13 June 1997 no. 45 (Nw.: allmennaksjeloven). Norwegian Securities Trading Act .... The Norwegian Securities Trading Act of 29 June 2007 no. 75 (Nw.: verdipapirhandelloven).
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NOTC ...... Norwegian OTC is an information system for unlisted shares (it is not a regulated stock exchange). NRAS ...... A form of the RAS gene that is highly expressed in the testis and thymus. Offer Shares ...... The shares offered in the Subsequent Offering. Oncos...... Oncos Therapeutics Oy, a wholly owned subsidiary of the Company. Oncos AG ...... Oncos Therapeutics AG, a wholly owned subsidiary of Oncos. Oncos AG Trial Balances ...... Oncos AG’s unaudited trial balances as of and for year ended 31 December 2014 and as of and for the nine month period ended 30 September 2015. Oncos Oy Financial Statements...... Oncos’ audited financial statements as of and for the year ended 31 December 2014. Oncos Oy Trial Balances ...... Oncos’ unaudited trial balances as of and for the nine month period ended 30 September 2015. Open Label Study ...... Both the patients and the physicians know what kind of treatment a patient gets in such a clinical trial. This is opposed to a placebo-controlled clinical trial in which neither the patients nor the physicians know if a patient gets the active treatment or the placebo Order ...... The Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended. Oslo Axess ...... A Norwegian regulated stock exchange operated by Oslo Børs ASA. Oslo Stock Exchange ...... Oslo Børs ASA, or, as the context may require, Oslo Børs, a Norwegian regulated stock exchange operated by Oslo Børs ASA. Payment Date ...... The payment date for the Offer Shares under the Subsequent Offering, expected to be on 12 August 2016. PBMC ...... Peripheral blood mononuclear cells. PET ...... Positron emission tomography. Pivotal Study ...... A clinical trial that is intended to directly lead to the market approval of a drug. Private Placement ...... The private placement completed on 7 July 2016 with gross proceeds of approximately NOK 110 million, in which 14,685,000 new Shares, each with a nominal value of NOK 0.10, were issued by the Company. Pro Forma Financial Information ..... Unaudited condensed pro forma financial information showing how the Combination and the 2015 Private Placement could have affected the Company’s statement of profit or loss and other comprehensive income for the year ended 31 December 2015 as if the transactions had taken place on 1 January 2015. Prospectus ...... This Prospectus dated 7 June 2016. QIBs ...... Qualified institutional buyers as defined in Rule 144A. Randomized and Non-randomized In the first part of the clinical trial, the non-randomized phase, all enrolled patients receive the Phase of a Clinical Trial ...... same treatment. In the second part of the clinical trial, the randomized phase, all enrolled patients are randomly assigned to one of the treatment regimens that are compared in the clinical trial. A clinical trial can be non-randomized or randomized, or it can contain a non- randomized and a randomized phase. Randomized Clinical Trial ...... Enrolled patients are randomly assigned to one of the treatment regimens that are compared in the clinical trial. RAS ...... RAS genes and expressed RAS protein. RAS mutation ...... Defined change in exon 2 codon 12 or 13 in RAS genes and the corresponding expressed RAS protein with amino acid substitutions in sequence position 12 and 13. Regulation S ...... Regulation S under the U.S. Securities Act. Relevant Member State ...... Each Member State of the European Economic Area which has implemented the EU Prospectus Directive. Relevant Persons ...... Persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Order or (ii) high net worth entities, and other persons to whom the Prospectus may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. R Resections ...... A system of classification of pancreatic cancer surgery to define the extent of the resection. R0 Resection ...... The pancreatic tumor has been completely resected and there are no signs of tumor cells around the edges of the resected tumor mass. There may or may not be lymph node metastases. R1 Resection ...... The pancreatic tumor has been completely resected but there are signs of tumor cells around the edges of the resected tumor mass. This indicates that probably not all tumor cells were resected R2 Resection ...... The pancreatic tumor could not be completely resected and visible tumor mass was left behind Randomized Clinical Trial ...... Enrolled patients are randomly assigned to one of the treatment regimens that are compared in the clinical trial Rule 144A ...... Rule 144A under the U.S. Securities Act. SD ...... Stabile disease. SGAAP...... Swiss Generally Accepted Accounting Principles. Share(s) ...... Means the shares of the Company, each with a nominal value of NOK 0.10, or any one of them.
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SIX ...... The Swiss Exchange. SPA ...... The share purchase agreement dated 10 June 2015 relating to the Company’s acquisition of all the shares in Oncos. Subscription Form ...... The Subscription Form to be used to apply for Offer Shares in the Subsequent Offering, attached to this Prospectus as Appendix E. Subscription Period ...... The subscription period for the Subsequent Offering which will take place from 09:00 hours (CET) on 11 July 2016 to 16:30 hours (CET) on 8 August 2016, unless shortened or extended. Subscription Price ...... The subscription price of NOK 7.50 per Offer Share. Subsequent Offering ...... The offering of up to 2,666,667 Offer Shares on the terms and conditions set out in this Prospectus Targovax ...... The Company and its consolidated subsidiaries. T cell ...... T lymphocyte. Tekes ...... Finnish Funding Agency for Technology and Innovation. TG ...... TG includes GM-CSF unless explicitly stated. TLR ...... Toll Like Receptor, small proteins expressed by innate immune cells such as macrophages and dendritic cells and stimulation of these cells represents another mechanism for immune activation. Transaction ...... The Combination and the 2015 Private Placement. transgene ...... e Virus with extra gene(s) inserted. UK ...... United Kingdom. U.S. or United States ...... The United States of America. U.S. Exchange Act ...... The U.S. Securities Exchange Act of 1934, as amended. U.S. Securities Act ...... The U.S. Securities Act of 1933, as amended. USD or U.S. Dollar ...... United States Dollars, the lawful currency of the United States. VPS ...... The Norwegian Central Securities Depository (Nw.: Verdipapirsentralen). VPS account ...... An account with VPS for the registration of holdings of securities. WHO ...... The World Health Organisation.
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APPENDIX A:
ARTICLES OF ASSOCIATION
A - 1 (OFFICE TRANSLATION)
VEDTEKTER ARTICLES OF ASSOCIATION
for for
TARGOVAX ASA TARGOVAX ASA
Sist endret 6. juli 2016 Last amended 6 July 2016
§ 1 Foretaksnavn § 1 The name of the company Selskapets navn er Targovax ASA. The company’s name is Targovax ASA. Selskapet er et allmennaksjeselskap. The company is a public limited liability company.
§ 2 Forretningskontor § 2 Registered office Selskapets forretningskontor er i Oslo The company’s registered office is in kommune. Oslo municipality.
§ 3 Virksomhet § 3 Object Selskapets virksomhet skal omfatte The business of the company shall salg og utvikling av biomedisinske comprise the sale and development of produkter og tjenester. Formålet kan biomedical products and services. This fremmes ved deltakelse i eller object can be pursued through samarbeid med andre foretak i inn- og participation in or collaboration with utland. other enterprises in Norway and abroad.
§ 4 Aksjekapital § 4 Share capital Selskapets aksjekapital er kr The company’s share capital is NOK 4 159 036,70 fordelt på 41 590 367 4,159,036.70 divided between aksjer hver pålydende kr 0,10. 41,590,367 shares, each with a Selskapets aksjer skal være registrert nominal value of NOK 0.10. The i VPS. company’s shares shall be registered in the Norwegian Central Securities Depository (VPS).
§ 5 Styre § 5 Board of directors Selskapets styre består av inntil 8 The company’s board of directors shall styremedlemmer etter consist of up to 8 members as decided generalforsamlingens nærmere by the general meeting. beslutning.
§ 6 Valgkomité § 6 Nomination committee Selskapet skal ha en valgkomité. The company shall have a nomination Komiteen skal bestå tre medlemmer. committee. The nomination committee Flertallet av medlemmene skal være shall consist of three members. A uavhengig av styret og den daglige majority of the members shall be ledelse. Valgkomiteens medlemmer, independent of the board of directors herunder valgkomiteens leder, velges and the management. The members av generalforsamlingen for ett år av of the nomination committee, gangen. including the chairperson, will be elected by the general meeting for a
A - 2 term of one year.
Valgkomiteen avgir innstilling til The nomination committee shall give generalforsamlingen til valg av recommendations for the election of aksjonærvalgte medlemmer til styret shareholder elected members of the og medlemmer til valgkomiteen, samt board of directors and the members of godtgjørelse til styrets medlemmer og the nomination committee, and valgkomiteens medlemmer. remuneration to the members of the Godtgjørelse til medlemmene av board of directors and the members of valgkomiteen fastsettes av the nomination committee. The generalforsamlingen. remuneration to the members of the Generalforsamlingen kan fastsette nomination committee is determined instruks for valgkomiteen. by the general meeting. The general meeting may adopt instructions for the nomination committee.
§ 7 Signatur §7 Signature Selskapets firma tegnes av styrets The chair of the board and one leder og et styremedlem i fellesskap. member of the board are jointly Styret kan meddele prokura. authorised to sign on behalf of the company. The board may grant powers of procuration.
§ 8 Generalforsamling § 8 General meeting Dokumenter som gjelder saker som Documents relating to matters to be skal behandles i selskapets dealt with by the company’s general generalforsamling, herunder meeting, including documents which dokumenter som etter lov skal inntas i by law shall be included in or attached eller vedlegges innkallingen til to the notice of the general meeting, generalforsamlingen, trenger ikke do not need to be sent to the sendes til aksjonærene dersom shareholders if such documents have dokumentene er tilgjengelige på been made available on the company’s selskapets hjemmeside. En aksjonær website. A shareholder may kan likevel kreve å få tilsendt nevertheless request that documents dokumenter som gjelder saker som which relates to matters to be dealt skal behandles på with at the general meeting, are sent generalforsamlingen. to him/her.
På den ordinære generalforsamlingen The annual general meeting shall skal følgende spørsmål behandles og address and resolve the following avgjøres: matters:
1. Godkjennelse av årsregnskapet og 1. Approval of the annual report and årsberetningen, herunder utdeling accounts, including distribution of av utbytte. dividend 2. Andre saker som etter loven eller 2. Any other matters which are vedtektene hører under referred to the general meeting generalforsamlingen. by law or the articles of association.
A - 3 Aksjonærer kan avgi sin stemme The shareholders may cast their votes skriftlig, herunder ved bruk av in writing, including through electronic elektronisk kommunikasjon, i en communication, in a period prior to periode før generalforsamlingen. the general meeting. The board of Styret kan fastsette nærmere directors can establish specific retningslinjer for slik guidelines for such advance voting. forhåndsstemming. Det skal fremgå The established guidelines must be av generalforsamlingsinnkallingen stated in the notice of the general hvilke retningslinjer som er fastsatt. meeting.
Styret kan beslutte at aksjonærer som The board of directors may decided vil delta på generalforsamlingen må that shareholders who want to meddele dette til selskapet innen en participate in the general meeting bestemt frist som ikke kan utløpe must notify the company thereof tidligere enn tre dager før within a specific deadline that cannot generalforsamlingen. expire earlier than three days prior to the general meeting.
A - 4 APPENDIX B:
FINANCIAL STATEMENTS FOR TARGOVAX ASA FOR THE YEAR ENDED 31 DECEMBER 2015, WITH COMPARABLE FIGURES FOR THE YEAR ENDED 31 DECEMBER 2014
B - 1 Content
______ ______ ______ Strategy and strategic focus areas ______5
Business and technology platforms ______6
Clinical development programs ______7
Important events in 2015 ______8
Important events after balance sheet date ______10
Key figures in the consolidated accounts ______10
Going concern ______11
Risk factors and risk management ______11
Market developments ______14
External environment ______16
Corporate social responsibility ______16
Personnel and organisation ______17
Health, Safety and Environment ______17
Corporate governance and ethics ______18
ANNUAL REPORT Shareholder information ______18 2015 Remuneration to management ______19 Financial results and allocation of profits in Targovax ASA ______20
Outlook ______20
Responsibility Statement from the Board of Directors and the Managing Director _____ 22
______ ! " # ______ $ % ______ Implementation and reporting ______32
Business ______34
Equity and dividends ______35
Equal treatment of shareholders and transactions with close associates ______36
Freely negotiable shares ______38
General meetings ______39
B - 2 Content Content
Nomination Committee ______41 11. Related parties and Management ______78
Board; composition and independence______43 12. Share-based compensation ______90
The work of the Board ______45 13. Other operating expenses ______94
Risk management and internal control ______48 14. Financial items ______94
Remuneration of the board ______49 15. Tax ______96
Remuneration of executive personnel ______50 16. Intangible assets and impairment test ______98
Information and communication ______51 17. Property, plant and equipment ______101
Take-overs ______53 18. Lease ______101
Auditor ______54 19. Receivables ______103
" & M ______ ( 20. Cash and cash equivalents ______103
Consolidated statement of profit or loss ______56 21. Share capital and shareholder information ______104
Consolidated Statement of other comprehensive income ______56 22. Interest-bearing debt ______106
Consolidated statement of financial position ______57 23. Current liabilities ______107
Consolidated statement of changes in equity ______59 24. Events after the reporting date ______108
Consolidated statement of cashflow ______60 " ______ )* Notes to the financial statements M Targovax Group ______61 Statement of profit or loss - Targovax ASA ______109
1. General information ______61 Statement of comprehensive income M Targovax ASA ______109
2. Summary of significant accounting principles ______61 Statement of financial position M Targovax ASA ______110
2.1 Basis for preparation of the annual accounts ______62 Statement of changes in equity M Targovax ASA ______112
2.2 Accounting principles ______63 Statement of cashflow M Targovax ASA ______113
2.3 Adoption of new and revised IFRS standards ______63 Notes to the financial statements M Targovax ASA ______114
2.4 Basis of consolidation ______63 1. General information ______114
2.5 Business combinations and intangible assets______65 2. Summary of significant accounting principles/Critical accounting estimates and judgments ______114 2.6 Going concern ______66 2.1 Basis for preparation of the annual accounts ______115 3. Important accounting estimates and discretionary assessments ______66 2.2 Accounting principles ______115 4. Acquisition of Oncos Therapeutics ______67 2.3 Adoption of new and revised IFRS standards ______116 5. Segments ______70
6. Financial instruments and risk management objectives and policies ______71 2.4 Going concern ______116
7. Revenuerecognition ______74 3. Important accounting estimates and discretionary assessments ______116 4. Acquisition of Oncos Therapeutics ______117 8. Research and development expenses ______75 5. Segments ______120 9. Government grants ______76 6. Financial instruments and risk management objectives and policies ______120 10. Payroll and related expenses ______77
B - 3 Content P. 01 About Targovax
7. Revenuerecognition ______123 8. External research and development expenses ______124 About Targovax 9. Government grants ______124 Targovax is a clinical stage immuno-oncology group developing targeted immunotherapy 10. Payroll and related expenses ______125 treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio 11. Related parties and Management ______126 and aims to become a leader in its area. The group is currently developing two complementary and highly targeted approaches to immuno-oncology: 12. Share-based compensation ______127
13. Other operating expenses ______131 ONCOS-102 is part of a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This 14. Financial items ______132 treatment may reinstate the immune system's capacity to recognize and attack cancer cells. 15. Tax ______133 TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to 16. Property, plant and equipment ______134 treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancers 17. Lease ______135 and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will 18. Investments in subsidiaries ______136 prolong time to cancer progression and increase survival.
19. Receivables ______136 The product candidates will be developed in combination with multiple treatments, including 20. Cash and cash equivalents ______137 checkpoint inhibitors, in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in early stage of development. 21. Share capital and shareholder information ______137
22. Current liabilities ______140
23. Events after the reporting date ______140
" R ______ , # ______ , . # ______ ,
Please visitt www.targovax.comg m for more information about Targovax
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TG01 is being developed for the treatment of resected pancreatic cancer and is the most CEO Statement advanced program, currently in Phase II development. Other exciting clinical studies planned include ONCOS-102 in melanoma and TG02 in colorectal cancer.
FOCUS ON COMBINATION STUDIES Let me elaborate on the melanoma trial for a moment: Targovax is continuously making progress in Many solid cancers respond only partially 7 8 7 9 :; < 7 R developing highly targeted immunotherapy cancer manage to hide from the immune system. For example, 50 per cent of melanoma treatments for cancer patients. Further development patients are non-responders in combination studies with CPIs. of our comprehensive clinical program will be our most important task in 2016. However, in a phase I study, Targovax demonstrated how ONCOS-102 is able to induce tumour specific CD8+ T-cells in solid tumours suggesting that ONCOS-102 may increase Successful integration response rates in melanoma patients when combined with CPIs. In 2015, by far the most important event was the Our next step will be to conduct a trial where CPI refractory melanoma patients will receive merger of Targovax and Oncos Therapeutics, ONCOS-102 and then be re-treated with a CPI. The objective is to show that ONCOS-102 effective from 2 July. The merger created a group that can trigger immune recognition of 7 R urs, leading to subsequent response focuses on two unique complementary technologies clinically on retreatment with a CPI. that aim to activate the immune system to recognize We are eager to pursue the opportunity to be the first immunotherapy treating CPI refractory cancer as a threat and mobilize T-cells to attack melanoma. cancer cells via: The trial will include 12 patients in the US and will commence in the second half of 2016. An adenovirus-based immunotherapy platform, and A peptide-based immunotherapy platform International partnerships The group has three targeted immunotherapy products in development, four orphan drug Last November, Targovax announced an agreement with US based Ludwig Cancer Research designations and will start five clinical combination studies in 2016. Through the merger, (LCR) and the Cancer Research Institute (CRI) to conduct a trial to evaluate ONCOS-102 in Targovax has reached critical mass concerning pipeline and organization, which has made combination with other immunotherapies such as checkpoint inhibitors. the group more visible to investors and potential partners. The Executive director of technology development at LCR stated: I am pleased to state that integration so far has been successful. The organization is experiencing positive synergistic effects from a joint management and team through shared “We believe oncolytic virotherapy—in which engineered viruses are deployed against cancer and extended competences as well as exchange of experiences. In addition, pipeline cells—holds considerable promise, especially for boosting the efficacy and expanding the applicability of compatible immunotherapies.” synergies will be explored during the next few years. 67 / 7 " # ;R / / / " # " "=
“Our partnership between Targovax and Ludwig is an important step forward in efforts to Strong pipeline discover and develop optimally effective immunotherapy treatment regimens.” The clinical portfolio /. Q " " R5 6 have a broad and
diversified pipeline of several promising product candidates targeting multiple indications: Also in November, Targovax entered into an agreement with the biotech company Sotio to conduct a combination trial between ONCOS- ) " R " " // 7 . /
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the safety and tolerability in the treatment of advanced prostate cancer. The plan is to recruit the first patient in the second half 2016. Directors Report 2015 was an eventful year for Targovax ASA (The company), both organizationally and In both partnership agreements, Targovax will have access to well-known expertise and operationally. In June, the company acquired all the shares in the Finnish company networks that will provide us with new opportunities for exciting research. Oncos Therapeutics OY, creating a Nordic leading immuno-oncology group (The We are delighted with the partnerships and excited at what may come of them. Group), with multiple assets in research and development and a strong internationally experienced management team.
The year ahead Following the merger, the company raised NOK 200 million through a private placement, securing funding of ongoing operations and development programs Last year was an important step in creating a Nordic leader within immuno-oncology. I am through the second half of 2016. proud of the Targovax team for bringing us here, and I am grateful to you, our shareholders, for your continued support. On the operational side, the combined group experienced significant advances within both the peptide based cancer vaccine platform (TG), and the oncolytic virus platform Going forward we will give full attention to advancing our clinical programs preparing for (ONCOS), entering agreements for collaboration with leading international research multiple data read-outs in 2017. At the same time, we will endeavour to expand the institutions in Europe and the US. shareholder base and explore additional research and development collaborations.
Targovax wants to create a new future for cancer patients, our industry, and our company. I Strategy and strategic focus areas hope you share the excitement about our path and our corporate goal: To secure a front-line Targovax is a clinical stage immuno-oncology group, committed to developing, manufacturing position in the immuno-oncology space by arming the patients’ immune system to fight cancer. and delivering innovative and targeted first-in-class therapeutic cancer vaccines to extend and transform the lives of cancer patients with solid tumors.
The Group aims to become a leading immuno-oncology development group with a broad and Gunnar Gårdemyr diversified portfolio of immunotherapy candidates in multiple cancer indications5 Rs CEO Targovax Group cancer vaccines under development are ideally positioned to be combined with standard of care chemotherapies as well as other types of immunotherapies, for example check point inhibitors.
To achieve this vision, the business will focus particularly on the following:
Rapidly advancing current targeted therapeutic product candidates (TG01 and ONCOS- 102) into phase II clinical trials Evaluate the combination of ONCOS-102 and check point inhibitors (CPIs) patients who do not respond to CPI treatment Progress further candidates to the product development stage / 7 # 7 % R " 7 # mutations together with its viral therapeutic cancer vaccines 7 % R # / / / / / " commercial supply Expand 7 % R intellectual property profile Selectively pursue partnerships and collaborations
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Business and technology platforms pancreatic cancer and TG02 for colorectal cancer. RAS mutated cancer are difficult to treat and found in approximately 85% of pancreatic cancers, 50% of colorectal cancers and 20- Targovax is developing two complementary approaches to cancer immunotherapy: 30% of all cancers. A virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors (ONCOS Clinical development programs platform) A peptide-based, targeted immunotherapy platform for patients with RAS-mutated ONCOS-102 Mesothelioma cancers (TG platform) This trial will be a randomized phase I/II open label trial with a Phase Ib safety lead-in of ! 7 7 7 7 R @ . # 7 5 ONCOS-102 and standard of care chemotherapy in patients with unresectable malignant pleural mesothelioma. The trial is planned to include 6 patients in the safety cohort and R virus-based oncolytic immunotherapeutic technology has a targeted mechanism approximately 24 patients in the randomized phase II part. Clinical trial documentation for of action, making tumors visible to the immune system and educating the immune system to ethical and regulatory assessment was finalized in January 2016 and the trial will be initiated recognize and attack patient specific tumor cells. The technology is based on adenoviruses second half of 2016. engineered to kill tumor cells, primarily via activation of a systemic, patient-specific, tumor- targeted immune response. The lead product candidate is ONCOS- ) 5 R & ONCOS-102 Melanoma immunotherapy technology is designed to stimulate the immune system in several ways in " " 7 . C " # 7 5 D /.E @7 R This trial will be an explorative open-label trial to determine anti-tumor immune activation and clinical response of ONCOS-102 given with an immune checkpoint inhibitor in patients with adenovirus infects and kills tumor cells, it makes small peptide fragments of the tumor (tumor- advanced melanoma who have stopped responding to previoustreatment with immune check specific neoantigens) visible to the immune system by causing them to be released from the point inhibitors. The trial is planned to include approximately 12 patients in the US and will killed tumor cells 7 # // 9 : < @7 7 Q" / .R 7 commence in the second half of 2016. fragments to other immune cells such as T-cells which are then activated to target and kill the tumor. Secondly, ONCOS-102 contains the transgene for GM-CSF (granulocyte-macrophage colony-stimulating factor). GM-CSF helps alert immune cells to the presence of the newly TG01 Pancreatic Cancer released neoantigens. Thirdly, in addition to stimulating new T cell responses against the This trial is an ongoing open label, phase I/II of TG01/GM-CSF treatment and gemcitabine as tumor, ONCOS-102 is also strengthening already existing T cell responses against the tumor adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas. In the because the sheer presence of adenovirus in a tumor attracts T cells to the tumor. A second first cohort, 19 patients have received the combined treatment. Of the 18 patients eligible for virus product candidate, ONCOS-402, could be ready to enter clinical development as early immune response assessment, 15 (83%) have established a detectable immune response. as 2017. The regimen was generally well tolerated, with events related to TG01 being those expected for a peptide vaccine (local reactions and flu-like symptoms). Grade 3/4 reactions were The TG immunotherapy platform is designed with activate immune responses to peptides primarily related to gemcitabine. There were four related allergic reactions to vaccination, two fragments that are recognized by both MHC (major histocompatibility complex) class II of which were severe, representing dose limiting toxicity (DLT). This has led to study a slightly complexes as well as MHC class I complexes. The TG product candidates are therefore able different regimen. A modified vaccination regiment has been introduced and up to 13 patients to activate both CD8+ cytotoxic T cells and CD4+ helper T cells. Peptides are not will be included in this new cohort. The trial centers are open and actively recruiting patients. immunogenic by themselves and need an adjuvant to attract immune cells to the peptides and enhance the ability of that stimulates the immune system to recognize the peptides and to TG02 Colorectal Cancer process them. Targovax has selected GM-CSF as its adjuvant for peptide vaccination. Targovax is working towards demonstrating that the TG vaccines can prolong time to cancer This trial will be an open label, non-randomized, phase Ib exploratory trial of TG02 in progression and increase survival by inducing immune responses in cancer patients with RAS combination with pembrolizumab, an immune checkpoint inhibitor (fully humanized mutations. Currently, two TG product candidates are being developed: TG01 for resected programmed cell death 1 (PD-1) blocking antibody) to determine safety and anti-tumor
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immune activation of TG02 in patients with colorectal cancer with progressive disease waiting immuno-oncology player with a more extensive clinical portfolio. Combining the companies for pelvic mass resection. Immune activation will be measured through skin DTH-test, PBCM resulted in a strong senior management team, a portfolio of multiple assets in research and (cancer antigen specific T-cells) and resected tumor material (cytotoxic T-cells). The trial is development, and a broad shareholder base including reputable institutional investors. planned to include approximately 20 patients at sites in Australia. The submission and Furthermore, the combination of two highly competent and complementary organizations will approval process has been initiated and trial start up is planned for second half of 2016. promote a more efficient execution and accelerated development of ongoing and future programs. Settlement for the acquisition of Oncos was in Targovax shares, and after the transaction, the former shareholders of Oncos held 50 per cent of Targovax. Clinical studies with external parties In November 2015, Targovax entered into an agreement with the US institutions Ludwig Following the Oncos transaction, Targovax issued 8,000,000 new shares in a private Cancer Research (LCR) and the Cancer Research Institute (CRI) to evaluate ONCOS-102 in placement, raising NOK 200 million to secure funding for ongoing and planned studies. early phase clinical trials, testing this immunotherapy in combination with other, potentially Following the private placement, HealthCap and the Norwegian Radium Hospital Research synergistic immunotherapies such as checkpoint inhibitors. The publication of exact Foundation became the two largest shareholders of the company, holding 32 and 13 per cent indications and commencement of the trial is expected during 2016. respectively of the total shares outstanding. The Private Placement was also directed towards Through this collaboration, Targovax will gain access to the well-known expertise and network 24 employees of Targovax and Oncos, their respective subsidiaries, and companies of CRI and LCR, which provides new opportunities for combinatorial research. The focus will controlled by any such employees. be on mechanistic synergies with clinical impact combining ONCOS-102 with other immune therapies. At the extraordinary general meeting held 22 June, a new Board of directors was elected, consisting of Jónas Einarsson (chair), Bente-Lill Romøren, Lars Lund-Roland, Per Also in November, Targovax and the biotech company Sotio agreed to design and run a Samuelsson, Robert Burns and Johan Christenson. At the extraordinary general meeting held collaboration trial combining ONCOS- ) " R " " // 7 . G H: 14 September, Eva-Lotta Allan and Diane Mellett were elected to the Board of directors, and evaluate the safety and tolerability of the combination therapy in the treatment of advanced it was decided to convert the company from a Norwegian private limited company into a prostate cancer. The plan is to recruit the first patient in second half of 2016. Norwegian public limited company (ASA). The design of the planned trial with Sotio is subject to regulatory approvals in the Czech Republic and UK. In November, Targovax entered into an agreement with Ludwig Cancer Research (LCR) and the Cancer Research Institute (CRI) in New York to evaluate ONCOS-102 in combination with Both of these collaborations involve cost sharing between the parties. The cash flow effect of other immunotherapies such as checkpoint inhibitors. Also in November, Targovax entered conducting these collaboration trials is expected to be modest for Targovax. into a collaboration with the Czech biotech company Sotio to run a clinical trial combining ONCOS-102 an" R " " // 7 . / 7 # . " / / . 7 Important events in 2015 treatment of advanced prostate cancer. Both trials will commence in 2016. On 1 June 2015, Targovax presented interim data from the ongoing phase I/II clinical trial of TG01 at the annual meeting of American Society of Clinical Oncology (ASCO 2015). The trial At the SITC (Society for Immunotherapy of Cancer) conference in Washington DC in / " # Rs therapeutic cancer vaccine TG01 in combination with November, Targovax presented immune biomarker data from a phase I trial, suggesting that gemcitabine, in patients with resected pancreatic cancer. The regimen was generally well local immunotherapy with ONCOS-102 has the potential to activate immunologically silent tolerated and RAS specific T-cell immune responses were induced and enhanced during the tumours, and reduce local immune suppression in advanced tumou 5 ; 7 @ /"R treatment phase. leading member-driven organization specifically dedicated to professionals working in the field of cancer immunology and immunotherapy. Also in June, Targovax entered into an agreement with the shareholders of Oncos Therapeutics Oy to acquire the shares of Oncos, creating a larger and more visible Nordic
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Important events after balance sheet date Financial position In January 2016, Targovax submitted a trial protocol to the regulatory authorizes in Spain to As at 31 December 2015, Targovax had total assets of NOK 545 million, compared to NOK assess its ONCOS-102 product in combination with chemotherapy in patients with malignant 67 million by the end of 2014. pleural mesothelioma (MPM), a rare type of lung cancer associated with exposure to asbestos.
Total current assets amounted to NOK 185 million (NOK 67m), of which cash and cash In March 2016, Targovax reported encouraging interim survival results from its ongoing phase equivalents amounted to NOK 174 million (NOK 63m). I/II trial of TG01 in resected pancreatic cancer. In this 19 patients trial, 15 patients provided consent to be followed up of which 14 patients were alive after one year. Total non-current assets were NOK 360 million (NOK 0.2m), of which intangible assets Key figures in the consolidated accounts amounted to NOK 358 million (NOK 0m). Income statement (2014 figures in brackets) Booked equity amounted to NOK 423 million, increased from NOK 61 million in 2014. The In 2015 Targovax had revenues related to a non-core service fee amounted to NOK 0.1 million equity ratio amount to 77.6 percent compared to 90.1 percent in 2014. (NOK 0m).
Total operating expenses for 2015 amounted to NOK 90 million (NOK 18m), of which payroll Going concern and related expenses amounts to NOK 35 million (NOK 5m). The operating expenses are The financial statements for 2015 have been prepared under the going concern assumption, reported net of governmental grants, which amounted to NOK 9 million in the period (NOK / " 5 # 7 & @ 5 6 7 # 7 % R 8m). The higher operating expenses reflects the combination with Oncos and more activities financial results, financial position and forecasts for years to come, it is hereby confirmed that in all areas of the business. grounds for this assumption do exist.
Operating loss amounted to NOK 90 million in 2015 (NOK 18m). Risk factors and risk management Financial income amounted to NOK 2 million or the year (NOK 0.3m). The group has financial Targovax is subject to a number of operational and financial risk factors and uncertainties expenses of NOK 3 million (NOK 0.4m). which may affect parts or all the activities in the group. The Group proactively manages such risks and management and the Board of Directors regularly analyse operations and potential Taxes amounted to NOK 2 million (NOK 0m), leaving the loss for the 2015 at NOK 92 million risk factors to take measures to reduce risk exposure. (NOK 18m). Operational risk Cash flow R Net cash was NOK 174 million at the end of the year, compared to NOK 63 million at the end s activity is development of pharmaceutical medications. Development of of 2014.The change in net cash level was driven by the NOK 200 million capital increase pharmaceuticals normally goes through several stages before commercialisation and risk for undertaken in July offset primarily by operating activities. failure is generally inherent throughout the process.
The group is in an early phase, with one clinical trial ongoing and several clinical studies Net cash outflow for the year was negative NOK 81 million from operating activities (NOK planned to start in 2016. As the results from these studies are yet to be revealed, the 14m), and positive NOK 191 million from financing activities (NOK 68m). The difference uncertainty related to the outcome of these may be regarded as the most important risk factor. between the operating loss and negative cash flow from operating activities is due to activities completed in 2015 not yet invoiced at 31 December 2015. The increase in cash flow from Also, delays in the work with ongoing, or in the preparations of new clinical studies, are financing activities has led to the opportunity to expand the operational activities, hence the important risk factors. Targovax is currently in the preparation-phase of drug substance outflow from operational activities have increased.
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production, and unforeseen incidents and delays may have impact on the progress of ongoing improvement opportunities are followed up and corrective measures implemented and planned clinical studies. continuously.
As many studies depend on both funding and technology from external partners for Funding of ongoing operations is and will be for some time depending on external sources, completion, uncertainties append 7 R @ // . 7 " 7 75 mainly equity contributions. Significant changes to financial market conditions, may affect the / # " " / " Rs IPO plans in particular. Development of pharmaceuticals is highly time consuming and costly and as Targovax depend on third parties to conduct its clinical trials, delays or other unforeseen discrepancies " " 7 .R # / " outside Targova Rs control may occur. Such delays in trials might increase the cost of the trial risk capital when needed, The Targovax management continuously promote and present the and additional capital requirements might arise group through road shows and participation on industry- and investor seminars.
Targovax also conduct clinical trials in combination with third-party products. Limited access Interest rate fluctuations may 7 # ## 7 % R E # / " E or any other constraints in terms of use of such products may adversely impact the progress results of operations, cash flows, time to market and prospects. Currently, the Group has no / / " / # Rs trials and products. long-term debt other than its debt to Tekes. The debt to Tekes carry an annual interest equal 7 / ! 8R / E / To secure progress according to plans and budgets, Targovax has implemented and execute than 1 per cent. The current interest is 1 per cent per annum. routines and practises, including monitoring, evaluation and reporting, to secure planned and approved project developments. D/ 7 /" ## 7 % R cash flow and financial condition. The currency exposure include both transaction risk and risk related to translation of operating The clinical trials also include volunteer patients and Targovax put great emphasis on the expenses. safety of these as well as general regulatory framework of the development of pharmaceuticals. Transaction risk arises when future commercial transactions or recognized assets or liabilities are denominated i . 7 7 .R # / .5 7 % 7 % R / " " " " E %) " & -102, are currently in clinical phase undertakes various transactions in foreign currencies and is consequently exposed to II and phase I, respectively. fluctuations in exchange rates. The exposure arises largely from research expenses. The The success, competitive position and future revenues will depend in part on Targovax´s group is mainly exposed to fluctuations in EUR, GBP, and CHF. Translation risk in the ability to protect its intellectual property and know-how. To date, Targovax holds certain company arises when amounts denominated in foreign currencies are converted to NOK, the exclusive patent rights and has filed several patent applications, however, there will always .R " # / .5 # 7 % R " 7 K exist uncertainties related to predicting the degree and range of the protection from patents. reporting and functional currency, while another has CHF.
Financial risks Targovax has costs and payments in several currencies, EUR the most prominent but also USD, CHF and other. Cash inflow takes place in NOK through capital increases. Targovax Being an early phase research and development group, Targovax is accumulating financial manages currency risk by matching expected outflows with holdings in all major currencies. losses. Operating losses are expected to persist during the development phases of the G R products, and potentially cash generating operations are not expected until of one or more of the R products are commercialised.
General monitoring of risks related to the financial development is secured through control of financial reporting. This is achieved through day-to-day follow-up by management, supervised by the Board of Directors, through periodical reporting and evaluation. Non-conformances and
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Market developments Types of cancer treatment Pharmaceutical market overall The cancer therapy (oncology) market is a broad market, and the optimal treatment depends During the last decade, the global pharmaceutical industry has demonstrated an annual 7 . " # 7 E @ // 7 R // physical condition. A 1 growth of 6.4 per cent. The world pharmaceutical market was estimated to USD 850 billion . R / . # . " ## E // " " 7 For the coming 5-year period, the annual growth rate is expected to drop slightly below 5 per situation. Some cancer patients suffer from extreme pain and want to increase their life quality cent. for the remaining part of their lives, while others being cured is the target. Among the most common treatments are: surgery, chemotherapy, radiation therapy, hormonal therapy and The largest single market is North America, in 2014 accounting for 38 per cent, compared to targeted therapy. Europe accounting for 23 per cent. However, the main driver behind the growth in recent years has been emerging markets, and in the 2009-2014 period growth in Asia, Africa and Latin Immunotherapy America was around twice the global growth. Doctors and scientists agree that the immune system can be used to fight cancer, and have in recent years managed to design therapies which uses R @ . The cancer market # 7 5 ; 7 . # # 7 . " " R General system in the fight against cancer. The immune system can be utilised in several ways, but The market for cancer therapeutics has experienced lower growth than anticipated in recent 7 O P 7 . " / years. Following a period (2003-08) with an annual growth-rate above 14 per cent, growth fell the cancer cells as foreign bodies that are to be removed. This is normally achieved by giving to 5.4 per cent in the following five-year period. In 2013 worldwide spending on cancer drugs patients antibodies, vaccines or non-specific cancer immunotherapies and adjuvants. passed USD 90 billion. The slowdown is partly explained by fewer major breakthroughs. Immunotherapy is now an important form of treatment in the fight against many types of However in the last 12-18 months there has been a rise in activity in the equity markets, with cancer. numerous companies applying for a listing in the US and Europe. Based on the total pipeline and news flow communicated by these various companies, this may, depending on the Within immunotherapy there are several different variations and approaches. One approach success of clinical development, result in more products reaching market and could alter the is to inject a virus directly into the tumor, which subsequently kills some of the cancer cells growth rate going forward. through a process in which 7 // 8 " @ 9 # # " OP. P<5 When the cell membrane is broken down, unique tumor antigens are released and the immune The Cancer Epidemiology system learns 7 Q // # 7 5 / E 7 R 7 6 /" M / 7 9O6M P< 7 " # 7 $ immune cells (eg. T cells) will start to find and kill cancer cells. million deaths in 2012 globallyE @7 7 8 7 @ /"R " "/. " 5 7 year, more than 32 million individuals lived with a five-year cancer diagnosis, while 14 million Another approach focus on a family of proteins called RAS. These proteins are ubiquitously new cases of cancer were reported. Today, cancer accounts for about one in every seven expressed in all cell lineages and play an important role in regulating cell growth and division. deaths worldwide and by 2030, the American Cancer Society expects the number of new Mutation of RAS can cause sustained cell division and thus drive cancer development. RAS- incidents of cancer to be close to 22 million per year, and that the number of deaths by cancer mutation is an early cancer marker present in up to 30 per cent of all cancers2 and one will increase to 13 million.
2 Fernandez-Medarde, A. and Santos, E.; RAS in cancer and Developmental Diseases 1 Key Data 2013, European Federation of Pharmaceutica Industries and Associations (efpia) Genes & Cancer. 2011, 2(3): 344-358
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therapeutic technique is to use peptide-based cancer vaccine candidates that target RAS- activities from developing products, gaining approval by relevant authorities, working with mutations. These peptides are injected into the skin of the patient and subsequently the patient organizations and hospitals and finally getting the products to the market. immune system learns to recognise the RAS-mutations and activate T cells to kill the cancer cells with RAS-mutated proteins. The group is developing two complementary and highly targeted approaches in immuno- oncology: a peptide-based immunotherapy platform for patients with RAS-mutated cancers External environment and a virus-based immunotherapy platform based on engineered oncolytic viruses armed with The group does not pollute the external environment more than what is considered normal for potent immune-stimulating transgenes for patients with solid tumours. Both treatment this industry. All production and distribution is outsourced. When selecting suppliers, Targovax 7 7 7 R @ . # 7 5 / 7 " " R 7 / " / " / " E health and safety policy. Personnel and organisation The group has a policy to outsource non-core operations and highly specialised services. The Corporate social responsibility Board consider the work environment within the group to be good. No accidents or injuries Targovax is a clinical stage immuno-oncology group dedicated to the development of highly resulting in absence was registered in 2015. Absence due to illness in the group was 0.8 targeted immunotherapies for cancer patients. percent in 2015, considerably lower than the industry standard.
We believe that creating value for patients, customers and society strengthens our business As at 31 December 2015, Targovax had a total of 27 employees, compared with 6 employees and provides value for shareholders, and that our commitment to corporate social at the end of 2014. responsibility will enhance this by building strong relationships with our stakeholders. Health, Safety and Environment Our commitment to corporate social responsibility is driven by our values, trust, quality, Targovax aims to be a workplace with equal opportunities in all areas. The group has teamwork and innovation and is reflected in Targovax focus to develop innovative traditionally recruited from environments where the number of women and men is relatively immunotherapies to fight cancer, human resources, environment, governance and ethics. equally represented. In terms of gender equality, 38 per cent of board members are women, as are 22 per cent of the senior management team. Working time arrangements at the group Targovax has a set of Corporate Social Responsibility principles agreed by the Board on 3 are independent of gender. September 2015. They consist of principles related to: Social commitment Rs policy is to promote equal human rights and opportunities and prevent Business conduct discrimination because of gender, ethnicity, nationality, ancestry, colour or religion. Targovax Anti-corruption is working actively to promote the anti-discrimination act in our business. The activities include Human rights Labour rights and work conditions recruitment, salary and working conditions, promotion, professional development and Whistleblowing protection against harassment. Environmental responsibility Targovax aims to be a workplace where there is no discrimination because of disability. 7 .R @ The complete content of the principles is published Targovax works actively to design and facilitate the physical environment so that the G R www.targovax.com. various functions can be used by as many as possible.
Targovax conducts social commitment through its mission to extend and transform the lives of cancer patients with highly targeted immunotherapies. This mission encompasses all
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Corporate governance and ethics Shareholder # shares % HEALTHCAP 8,488,918 32 % Ensuring good governance practices involves all people in Targovax. This includes RADIUMHOSPITALETS FORSKNINGSSTIFT. 3,410,589 13 % governance as documented in the guidelines for corporate governance, ethical conduct and DATUM INVEST AS 2,4620,00 9 % ARCTIC FUNDS PLC 907,000 3 % anti-corruption based on the Targovax values and respect for human rights. Targovax supplier TIMMUNO AS 724,650 3 % requirements in terms of adherence to our practices, guidelines and values are an integral PRIETA AS 720,000 3 % part of all stages of the procurement process including selection and auditing. PORTIA AS 631,945 2 % DANSKE BANK A/S 587,971 2 % NORDNET BANK AB 570,022 2 % Our values set out our expectation for everyone to behave ethically in everything they do. Our VERDIPAPIRFONDET KLP AKSJENORGE 460,000 2 % values are trust, quality, teamwork and innovation ELTEK HOLDING AS 442,000 2 % STATOIL PENSJON 433,716 2 % STOREBRAND VEKST 426,000 2 % Targovax considers solid corporate governance as a prerequisite to creating value for PACTUM AS 400,000 1 % shareholders and gaining the confidence of investors. Targovax will strive to comply with the BIRK VENTURE AS 378,980 1 % OP-EUROPE EQUITY FUND 357,869 1 % generally accepted principles of good corporate governance through its internal controls and TOBECH INVEST AS 286,449 1 % management structure. Targovax believes that its current guidelines for corporate governance VIOLA AS 280,000 1 % are in line with the latest version of the Norwegian Code of Practice for Corporate Governance, KOMMUNAL LANDSPENSJONSKASSE 270,000 1 % VERDIPAPIRFONDET DNB GRØNT NORDEN 250,919 1 % and a description of this is given at the end of the Annual report. A complete description of the TOTAL 20 LARGEST SHAREHOLDERS 22,489,028 84 % recommendation is available at the Norwegian Corporate Governance Board (NCGB) web OTHER SHAREHOLDERS (176) 4,394,780 16 % pages (www.nues.no). TOTAL ALL SHAREHOLDERS 26,883,808 100 %
For further details, please see the section entitled Corporate Governance in this Annual Report Remuneration to management and on the R homepage. 7 # 7 " " 7 % R " / . Shareholder information attract and retain the most qualified management team members and to provide solid basis for succession planning. During 2015 the Targovax share was traded in the NOK 12.00 M 36.00 range. During 2015, some 1.87 million shares were traded, with a total value of NOK 45 million. Closing price on The Compensation Committee submits recommendations on compensation policy and 31 December was NOK 17.00 per share, corresponding to a market-value of NOK 457 million. adjustments in remuneration of the management team members for the approval of the Board of Directors. The remuneration of the management team may consist of fixed salary and As of 1 March 2016, there were 26,883,808 shares outstanding in Targovax, distributed to supplements, incentive programs and pension schemes. Subject to individual agreement, 196 shareholders. HealthCap is the largest shareholder, holding about 32 percent of total members of the management team are also entitled to other fixed benefits. shares outstanding. The 20 largest shareholders control 84 percent of total shares outstanding. Information about the work in the Compensation Committee and applied and proposed compensation principles for the management team in 2015 and 2016 respectively are in the Key management and members of the board holds a total of 885 086 shares in the company, Compensation Report submitted in note 11 to the Annual Accounts. representing some 3.3% of total shares outstanding
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Financial results and allocation of profits in Targovax ASA Oslo, 16 March 2016 The Board of Directors of Targovax ASA Targovax ASA is the holding company in the Targovax group. Targovax ASA reported a loss before tax of NOK 61 million (NOK 18m). Total cash amount to NOK 166 million at the end of 2015 compared to NOK 63 million at the end of 2014. Equity at the end of 2015 amount to NOK 430 million compared to NOK 61 million at the end of 2014.
Targovax ASA´s annual result amounted to a loss of NOK 61 million. The Board of Directors proposed that the loss is transferred to accumulated loss.
Outlook Rs focus during the next 12 months will be to starting previously described trials with: ONCOS-102 in melanoma ONCOS-102 in mesothelioma TG02 in colorectal cancer
Furthermore, Targovax, together with its collaborators Sotio and LICR/CRI, are planning to start trials in advanced prostate cancer and other solid tumor indications. In addition, the group will continue the ongoing trials of TG01 in resected pancreatic cancer.
In the first half of 2016, the group intends to publish immune data for the second cohort of patients in the TG01 trial in pancreatic cancer which will help the group to design subsequent trials with drug candidates from the TG-platform.
Targovax is continuously working to improve and strengthen its organization and infrastructure to meet its objectives. Access to capital is vital to this development. A part of the strategy is to expand its investor relations outreach.
According to current plans, the group has funds to finance its activities until the end of 2016. Targovax has retained flexibility in its cost structure and has the possibility to change prioritizations and thereby enable the cash position to last into early 2017.
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Responsibility Statement from the Board of Directors and the Management Managing Director 7 .R # nine individuals. Set out below are brief We confirm, to the best of our knowledge that the financial statements for the period 1 January biographies of the members of Management. Holdings of shares and share options as at 16 to 31 December 2015 have been prepared in accordance with current applicable accounting March 2015. standards, and give a true and fair view of the assets, liabilities, financial position and profit or loss of the entity and the group taken as a whole5 6 / # 7 7 ! " # R Gunnar Gårdemyr M Chief Executive Officer Report includes a true and fair view of the development and performance of the business and Gunnar Gårdemyr has more than 30 years of senior level the position of the entity and the group, together with a description of the principal risks and international experience in the pharmaceutical and biotech industry, uncertainties facing the entity and the group. including business development, mergers & acquisitions, global marketing and commercial strategy. Prior to this position, he was Oslo, 16 March 2016 Senior Vice President, Corporate Development/M&A, Global The Board of Directors of Targovax ASA Business Development, Nycomed and Senior Vice President, Global Marketing, Takeda in Zurich, Switzerland, where he led the commercial assessment of external business development licensing opportunities, followed by a position as Corporate Advisor for Acino Pharma in Basel, Switzerland. Mr Gårdemyr began his career at Astra, followed by Ferring, Tigran Technologies and Retinalyze. He has a Bachelor of Science in Business Administration and Economics from the University of Lund, Sweden. Mr Gårdemyr is a Swedish citizen, and resides in Switzerland. Shares 20 000 Share options 500 000
Øystein Soug M Chief Financial Officer Øystein Soug has experience from 20 years in international banking, industry and biotech. The last six years before joining the Company he was CFO of Algeta ASA, where he built up the functions of Finance, IR, Compliance, IT and HR. Mr Soug @ / R / 7 # R # E / # USD 200 million and the subsequent USD 2.9 billion sale of Algeta to Bayer. He has experience from positions at Orkla Group as CFO of its the previous Russian operations, and Project Manager in 8/ R / S @ // 7 ! 8 # Reconstruction and Development (EBRD) in Russia. He has a MSc in Economics and Finance from the University of St. Gallen (lic.oec.HSG). Mr Soug is a Norwegian citizen, and resides in Norway. Shares 25 600 Share options 390 000
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Jon Amund Eriksen M Chief Operating Officer Antti Vuolanto M Executive Vice President Jon Amund Eriksen is co-founder and co-inventor of the Targovax Antti Vuolanto has more than 10 years of experience in technology. Mr Eriksen has more than 30 years of experience in the biotechnology business development, product development and pharmaceutical and biotech industry (Nycomed, Norsk Hydro, commercialization. Prior to this position, he was a management GemVax, Pharmexa and Lytix Biopharma). He has previously held team member responsible for product commercialization, product several senior positions as scientist, project leader and manager development and quality at Mobidiag, a company specializing in within development of cancer immunotherapy from discovery and rapid nucleic acid-based infectious disease diagnostics. Mr early preclinical to phase III clinical development. He is co-inventor Vuolanto was also project manager at Medicel developing of several patents for peptide cancer vaccines. Mr Eriksen holds a bioinformatics infrastructure. He is a Doctor of Science (Technology) MSc in Chemistry from the University of Oslo. Mr Eriksen is a in bioprocess engineering from Aalto University in Helsinki. Mr. Vuolanto is a Finnish citizen, Norwegian citizen, and resides in Norway. and resides in Finland. Shares 724 650 Shares 61 773 Share options 160 000 Share options 181 000
Magnus Jäderberg M Chief Medical Officer Tina Madsen M Vice President, Quality Assurance Magnus Jäderberg is a pharmaceutical physician with more than Tina Madsen has more than 20 years of experience within research 25 years in various R&D functions including clinical research, & development and commercial manufacturing in the medical affairs, pharmacovigilance, strategic product pharmaceutical and biotech industry, including quality assurance, development, health economics and general management. Dr process development and formulation. She has held managing Jäderberg is experienced in all phases of clinical research, positions within formulation and process development in Alpharma including clinical pharmacology, dose finding, registration, post- and QA in GE Healthcare. Before joining Targovax, she was launch product differentiation and surveillance. His Director of Product Quality Assurance in Algeta ASA (now Bayer immunotherapy and clinical development expertise includes AS). Ms Madsen holds a MSc in Pharmacy. Ms Madsen is a Danish several medicines such as Rapamune (sirolimus) and Yervoy (ipilimumab). Prior to joining the citizen, and resides in Norway. Group, Mr Jäderberg held roles at national, European and global level at GSK, Pharmacia, Shares 800 Wyeth and most recently as Chief Medical Officer, Bristol Myers Squibb (Europe). He qualified Share options 53 000 in medicine at Karolinska Institute, Stockholm, Sweden, and is a fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom, and 7 . / " " / T R // E P " n, United Kingdom. Dr Jäderberg is a Swedish citizen, and resides in the United Kingdom. Shares 20 000 Share options 390 000
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Anne Kirsti Aksnes M Vice President, Clinical Peter Skorpil M Vice President, Business Development Development Peter Skorpil has extensive experience in licensing, commercial Anne Kirsti Aksnes has more than 20 years of experience within assessments, business intelligence and partnering. Previously, he clinical research and development in the pharmaceutical and was Commercial Director in Pronova BioPharma and Business biotech industry and 10 years of experience working in clinical Development Manager for Clavis Pharma where he was responsible physiology. for, among other things, out-licensing and managing Clavis partners. Mr Skorpil has also worked as a venture capital analyst at NeoMed Previously, she was VP Clinical Research in Algeta ASA (now Management. He holds an MBA from Brandeis University, Bayer AS), where she had a key role in the strategic, scientific Massachusetts, USA and a PhD in molecular biology from University of Geneva, Switzerland. and clinical development as well as in medical communications. Mr Skorpil is a Swiss citizen, and resides in Norway. She holds a medical doctorate degree (PhD) at Karolinska Institute, Sweden. Mrs Aksnes is a Norwegian citizen, and resides in Norway. Shares 4 000 Share options 45 000 Shares 4 000 Share options 53 000
Nikolaj Knudtzon M Head of HR Nikolaj Knudtzon is a HR Strategic Business Partner with more than 15 years of experience within development and implementation of strategic HR in close cooperation with business and executives. He has experience as a trusted member of top management teams and responsible for all aspects of HR in large international organisations. Mr Knudtzon has strong expertise in transformational changes of organisations in regions worldwide. He has a Master in Law from Copenhagen University and a Certificate in Business Administration from AVT in association with Harvard Business School. Mr Knudtzon is a Danish citizen, and resides in Switzerland. Shares 0 Share options 0
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Board of Directors Johan Christenson, Board member Dr. Johan Christenson has been a Partner at HealthCap since Set out below are brief biographies of the Board Members. 2001. He has been in the life science sector covering science, medicine, drug development and venture investments since 1981. Jónas Einarsson, Chairperson Prior to joining HealthCap, Dr Christenson was with SEB Jónas Einarsson is the CEO of the Norwegian Radium Hospital Företagsinvest (the venture capital arm of SEB) to supervise the Research Foundation. The Norwegian Radium Hospital Research health care portfolio. He was Global Product Director and member Foundation is an experienced pre-seed investor and project of the global therapy area management team of Pain and developer focused on cancer. Mr Einarsson sits on the board of Inflammation at AstraZeneca. He has a MD degree and a PhD in directors of several Norwegian biotech companies and was one of basic neuroscience from Karolinska Institute. He held a position as Assistant Dean at the the initiators behind Oslo Cancer Cluster and the Oslo Cancer Karolinska Institute Graduate School for two years. Dr. Christenson has four years of clinical Cluster Innovation Park. Mr Einarsson is a Norwegian citizen, and specialist training in paediatrics and paediatric neurology. Dr Christenson is a Swedish citizen, resides in Norway. and resides in Sweden. Shares 0 Shares 0 Share options 0 Share options 0
Lars-Lund Roland, Board member Bente-Lill Bjerkelund Romøren, Board member Lars Lund-Roland has for the last three years been CEO of Bente-Lill Bjerkelund Romøren is a consultant with 40 years of Bringwell AB (publ), a Nordic health and welfare company listed in experience gained from national and international management Stockholm, that commercialises OTC pharmaceuticals, nutrition positions in the pharmaceutical industry. She was formerly CEO of and food supplements. Prior to this, he has been Managing Director Novo Nordisk Scandinavia. Her experience spans senior of MSD Norway (Merck & Co Inc. subsidiary) for 10 years and has management, marketing, sales, business development, licensing, gained more than twenty-five years of big-pharma experience from market access, public affairs, clinical trials and lifecycle various executive positions within marketing and sales at Merck & management. Ms Bjerkelund Romøren has good knowledge of the Co., Inc. He currently holds board positions at Vaccibody AS and health care system as well as regulations and framework for the PI Innovation AS and has served as board member of Infodoc AS and Health Tech AS, two pharmaceutical market. She has board member experience from private and public sector Norwegian health technology companies, as well as on the board of the Norwegian (health care). She holds a MSc degree in chemistry from the Norwegian Institute of Association of Pharmaceutical Manufacturers. He is a Business Economist Graduate from Technology in Trondheim. Ms Bjerkelund Romøren is a Norwegian citizen, and resides in Norwegian Business School BI, has a BSc in Healthcare from Buskerud University College Norway. and leadership education from the Sr. Executive program at Columbia Business School and Shares 0 Harvard. Mr. Lund-Roland is a Norwegian citizen, and resides in Norway. Share options 0 Shares 0 Share options 0
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Per Samuelsson, Board member Eva-Lotta Coulter (known as Eva-Lotta Allan), Board member Per Samuelsson is a partner at Odlander Fredrikson/HealthCap, the Eva-Lotta Allan is an experienced biotechnology deal-maker with life sciences venture capital firm, which he joined in 2000. Prior to over 25 years of business development experience from the this, he gained more than 15 years of investment banking experience, biotechnology and life science industry in both private and public mainly with Aros Securities in Sweden. In his final position with Aros companies. She has significant operational and investor relations E 7 # R #inance department, expertise as well as Board experience. She is Chief Business Officer he specialized in the areas of merger transactions, initial public at Immunocore, an immune-oncology company specializing in the offerings, and equity incentive programs. Prior to this, Mr Samuelsson development of soluble T cell receptor based drugs. Immunocore was Head of Research, also at Aros Securities. He currently holds several Board positions at " R / / # # U /y 2015. Ms Allan was previously BioStratum Inc, Nordic Vision Clinics AS, Oncopeptides AB, RSPR Pharma AB, Nordic at Ablynx NV, where she served as Chief Business Officer for close to seven years and Nanovector ASA and SwedenBIO. He received his MSc in Engineering from the Institute of brought in multiple strategic partnerships. She has served as a Non-Executive Director of Technology in Linköping, Sweden. Mr Samuelsson is a Swedish citizen, and resides in Isconova AB. Prior to Ablynx, Ms Allan served as Senior Director of Business Development Sweden. and Site Operations (Europe) at Vertex Pharmaceuticals where she was also a Director of the Shares 0 Board of Vertex Europe. Other senior roles held include Oxford Asymmetry (now Evotec) and Share options 0 Oxford GlycoSciences (now UCB). She received her degree in microbiology from the University of Stockholm. Ms Allan is a Swedish citizen, and resides in the UK. Robert Burns, Board member Shares 0 Robert Burns is a consultant and advisor to companies developing Share options 0 immune based therapies in cancer. He has experience over more than 30 years in building biotechnology companies focused on immuno-oncology and was a member of the board of directors of Diane Mellett, Board member Oncos prior to the Combination. He is currently the Chairman of Diane Mellett is a consultant to a number of biotech and medical Haemostatix Limited and was previously CEO at 4-Antibody AG, device companies. She has qualified in both US and UK law and Affitech A/S (NASDAQ/OMX) and Celldex Therapeutics Inc advises biotechnology companies in commercial contract and (NASDAQ), each immuno-oncology vaccine and antibody discovery companies. Prior to intellectual property matters. She was formerly General Counsel for Celldex Therapeutics, Dr Burns was Director of Technology Licensing at the Ludwig Institute Cambridge Antibody Technology (CAT) (LSE: NASDAQ) and led the for Cancer Research, an international independently financed not-for-profit research group secondary NASDAQ listing of that company as well as serving on focused on cancer vaccines and antibody based immunotherapies. He holds a PhD in the board of directors. During her time at CAT, she led a successful Chemistry and is a UK citizen, residing in Oxford, UK. defense of a contractual dispute with Abbott Pharmaceuticals (now Abbvie) covering the Shares 29 063 .R V // 7 ng Humira®, the most successful revenue Share options 23 235 generating antibody therapy in the pharmaceutical industry to date. Ms Mellett is a UK citizen, and resides in France. Shares 0 Share options 0
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The Board adopted its Corporate Governance Policy on 3 September 2015. It is in all material Corporate Governance Report respects based on the Code of Practice, to which the Board has resolved that the Company 9 7 O .P " 7 @ 7 " E 7 O% P< " " shall adhere. corporate governance to be a prerequisite for value creation and trustworthiness and for access to capital. The Board adheres to good corporate governance standards and ensures that the Company at all times has sound corporate governance. In order to secure strong and sustainable corporate governance, it is important that the Group The following report covers each point of the Norwegian Code and describes Targovax ensure good and healthy business practices, reliable financial reporting and an environment compliance efforts. of compliance with legislation and regulations. Corporate Social Responsibility principles were adopted by the Board on 3 September 2015 7 & @ % ! " 9& %! &K < 7 # .R / " to ensure sound corporate social responsibility. These formalized corporate responsibility Oslo Børs and Oslo Axess issued O 7 & @ " # : # principles include principles related to the protection of basic human rights, labor and social % P /. " ) ) , 9 7 O " # : P<5 7 " # issues, environmental responsibility, and business conduct and anti-corruption. The : / / @@@5 5 5 7 " # : " O /. / / # / / . / 7 % R " .-to-day / P @7 . / " panies must comply with the Code of Practice or explain why operations, its business strategies and towards various stakeholders is further described at in they have chosen an alternative approach. How the Company has adapted to this Code of the Board of directors report 2015. : " " 7 .R % : / .5 7 7 represents the 15 topics in the Code of Practice. It starts with a text box with the Internal policies also include a Code of Conduct that defines expectations and ethical recommendations, explains how the policy is followed up by the Company, and finally behaviour for all employees and Members of the Board. The Targovax Code of Conduct concludes with any deviations from the Code of Practice. provides the ethical framework for operations and interaction with society and various stakeholders. Implementation and reporting Targovax requires Members of the Board and employees to observe high standards of business and personal ethics in the conduct of their duties and responsibilities. They must practice fair dealing, honesty and integrity in every aspect in dealing with other employees, business relations and customers, the public, the business community, shareholders, suppliers, competitors and government authorities.
Deviations from the recommendation: None
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Business Equity and dividends
In accordance with common practice for Norwegian incorporated companies, 7 .R business activities are not precisely defined in the articles of incorporation. However, the fundamental objectives and strategy of the Company is to achieve substantial total returns for shareholders by (i) rapidly advance TG01 and ONCOS-102 into phase II clinical trials, (ii) progress further targeted therapeutic cancer vaccines candidates to the product development E 9 < / 7 # 7 % R " 7 # mutations together with its viral therapeutic cancer vaccines, (iv) evaluate the combination of ONCOS-102 and check point inhibitors (CPIs) in non-responding check point inhibitor (CPI) patients, (v) optimiz 7 % R # / / / / / and commercial supply (vi) expand its intellectual property profile and (vii) selectively pursue The Company shall have an equity capital that is suitable for its objectives, strategy and risk partnerships and collaborations. # / 5 " " R 9 7 O% R P< Q . ) @ & T 425 million, which corresponds to an equity ratio of 78%. The Board of Directors regards the 7 .R / # / / www.targovax.com. Q . " " " 7 .R V E . and risk profile. Moreover, for biotech companies at a relatively early stage, like Targovax, Deviations from the recommendation: None access to debt is usually restricted and not available outside of government support structures.
7 .R / -term objectives include making distributions of net income in the form of dividends but Targovax has paid no dividend to date. The Group is focusing its resources on the development of its immuno-oncology platforms and does not anticipate paying any cash dividend in the foreseeable future.
" " 7 ! " 7 .R 7 / 7 // " defined purposes. If the general meeting is to consider mandates to the Board for the issue of shares for different purposes, each mandate shall be considered separately by the meeting. Mandates granted to the Board shall be limited in time to no later than the date of the next
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annual general meeting. This shall also apply to mandates granted to the Board for the General information Company to purchase its own shares. The Company has only one class of shares. Each share in the Company carries one vote, and all shares carry equal rights, including the right to participate in general meetings. All ; @ 7 7 .R 7 " 7 shareholders shall be treated on an equal basis, unless there is just cause for treating them 10-14 of the Norwegian Limited Companies Act, the Board is granted an authorisation to differently. Shareholders who are registered in the Norwegian Central Securities Depository 7 .R 7 / . up to the lower of (a) NOK 500 000 and (b) 10% of (VPS) may vote in person or by proxy. Invitations are sent to the shareholders or to the the share capital of the Company. bank/broker where the shareholder's securities account is held.
Deviations from the recommendation: None Share issues without pre-emption rights for existing shareholders Any decision to waive the pre-emption rights of existing shareholders to subscribe for shares Equal treatment of shareholders and transactions with close in the event of an increase in the share capital shall be justified. Where the Board resolves to associates carry out a share issue without pre-emption rights for existing shareholders, then the justification shall be publicly disclosed in an announcement issued in connection with the share issue.
Approval of agreements with shareholders and other closely- related parties The Board shall arrange for a valuation to be obtained from an independent third party in the event of a not immaterial transaction between the Company and its shareholders, a 7 7 /" R .E # 7 ! "E / /.- related parties of any such parties. An independent valuation shall also be carried out in the event of transactions between companies within the same group where any of the companies involved have minority shareholders.
Members of the Board and executive management must notify the Board if they have a significant, direct or indirect, interest in any transaction carried out by the Company other than by virtue of their position within the Company. The Company has no such significant agreements present.
Transactions with own shares Any transactions the Company carries out in its own shares shall be carried out either through the Oslo Stock Exchange or at prevailing stock exchange prices if carried out in another way. If there is limited liquidity in the C .R 7 E 7 . 7 // " 7 @ . ensure equal treatment of all shareholders. The Company has not conducted trades in its own shares.
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General meetings Deviations from the recommendation: None
Freely negotiable shares
The Company's constituting documents do not impose any transfer restrictions on the .W 7 " 7 .R 7 # /. # / E V . restrictions that may exist under applicable securities laws.
Deviations from the recommendation: None
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Exercising rights Nomination Committee The Board takes reasonable steps to ensure that as many shareholders as possible can 7 7 7 .R / " 7 7 / are an effective forum for the views of shareholders and the Board. Among other things, the Board ensures that: The notice and the supporting documents and information on the resolutions to be " " 7 / / / 7 .R @ / 7 21 days prior to the date of the general meeting; The resolutions and supporting documentation, if any, are sufficiently detailed to allow shareholders to understand and form a view on matters that are to be considered at the general meeting; The registration deadline, if any, for shareholders to participate at the general meeting is set as closely as practically possible to the date of the general meeting and pursuant to the provisions in the articles of association; The Board and the person who chairs the meeting shall ensure that the shareholders have The opportunity to vote separately on each candidate nominated for election to the Board and committees, if applicable; Representatives of the Board shall be present at general meetings, while representatives of the nomination committee as well as the auditor should be present at general meetings where matters of relevance for such committees/persons are on the agenda;
Participation without being present Shareholders who cannot be present at the general meeting are given the opportunity to vote using proxies. The Company provide in this respect: Information about the procedure for attending via proxy; A person who will be available to vote on behalf of a shareholder as their proxy; and Proxy form which shall, insofar as this is possible, be formulated in such a manner that the shareholder has the option to vote on each item that is to be addressed and vote for each of the candidates that are nominated for election.
Deviations from the recommendation: The Company does not have an arrangement in place to ensure independent chairing of the General Meeting. However, the Board will on an ad hoc basis evaluate independent chairing when necessary. Historically it has not been deemed necessary to have independent chair. The largest shareholder is represented in the Board.
Although Targovax encourages the members of the Board and the Nomination Committee to be present at the Annual General Meeting, their attendance is not always possible as the The Company has a Nomination Committee consisting of three members: Johan Christenson majority of the members live abroad and have competing work and travel commitments. 9 7 B - 24 P. 42 Corporate Governance Report P. 43 Corporate Governance Report remuneration. The current Nomination Committee was elected at the general meeting 14 Board; composition and independence September 2015. 7 & 7 // 7 .R @ / 7 7 /" E registered in the VPS on 1 November each year, and request such shareholders to each propose a candidate to be appointed as a member of the Nomination Committee. If any candidates are proposed by such shareholders, the Nomination Committee shall include those candidates among the three candidates in the recommendation to the general meeting for election of members to the Nomination Committee. Two out of three of the members of the Nomination Committee are independent of the .R ! " " 5 @ # 7 / ot member of the Board. Neither the CEO nor others of the executive management team are members of the Nomination Committee. The objectives, duties and functions of the Nomination Committee are described in the .R O 7 # 7 & P @7 7 @ " " . the general meeting 14 September 2015. Deviations from the recommendation: Johan Christenson is currently member of both the Board and the Nomination Committee. The Board of Directors consists of eight members, and currently has the following composition: Jònas Einarsson (Chair), Per Samuelsson, Bente-Lill Romøren, Johan B - 25 P. 44 Corporate Governance Report P. 45 Corporate Governance Report Christenson, Lars Lund-Roland, Robert Burns, Eva-Lotta Allan and Diane Mellett. The current Deviations from the recommendation: None Board was elected at the general meeting 14 September 2015. Participation on Board meetings and Board committee meetings during 2015: The work of the Board Participation in Board Audit Compensation Governance meetings Meetings Committee committee Committee Jònas Einarsson 14 2 Bente-Lill Romøren 13 1 Johan Christenson 7 1 Lars Lund-Roland 7 2 3 Robert Burns 7 3 Eva-Lotta Allan 3 1 Diane Mellett 2 1 Per Samuelsson 7 2 3 Hans Ivar Robinson 7 Tom Thorsen 6 Harald Arnet 7 7 # 7 .R ! " " " 7 7 7 7 /" R "E " 7 7 .R " # " # " " " Board with sufficient capacity is in place. The Board members represent a combination of expertise, capabilities and experience from the pharmaceutical industry and finance business. The composition of the Board ensures that it can act independently of any special interests. All of the shareholder-elected members of the Board are inde " # 7 .R executive personnel and material business connections. In addition, five of the members of 7 ! " " " " " # 7 .R V 7 7 /" 9 <5 V shareholder means in this connection a shareholder that owns or controls 10% or more of the .R 7 E " " " 7 // / 7 7 relations that may be expected to be able to influence independent assessments of the person in question. The Board does not include executive personnel. The Chairperson of the Board is elected by General the general meeting. / / # 7 ! "R @ 8 " "E @ 7 / 7 V E The term of office for members of the Board of Directors are no longer than one year at the strategy and implementation. The Board Handbook adopted by the Board 3 September 2015 time. Members of the Board of Directors may be re-elected. includes a set of instructions and policies instructions for its own work, as well as for the For further information about the members of the Board, including amount of shares and who executive personnel, with particular emphasis on clear allocation of internal responsibilities are considered independent, see note11 in 7 .R / . and duties. B - 26 P. 46 Corporate Governance Report P. 47 Corporate Governance Report The Board, working with the Corporate Governance Committee, will, starting 2016, carry out Compensation committee an annual evaluation of its own performance and expertise and presents the evaluation report The members of the Compensation Committee are Per Samuelsson, Lars Lund-Roland and to the Nomination Committee. Robert Burns. The composition of the committee meets the requirements of the Norwegian The Board of Directors has established three permanent Board Committees, which is Code of Practice for Corporate Governance as regards independence, and all the committee described in further detail below. The current members of the committees were elected at members are considered to be independent of Executive Management. The mandate of the the Board meeting 25 September 2015. The members of the committee are appointed for committee is set out in the Charter for the Compensation Committee and is in brief as follows: one year. These committees do not pass resolutions, but supervise the work of the company The role of the committee shall be to oversee the Group's compensation policy for its management on behalf of the Board and prepare matters for Board consideration within their CEO, Management, employees and consultants, recommend changes to the Group's specialized areas. In this preparatory process, the committees have the opportunity to draw compensation policy to the Board as and when appropriate and prepare matters for final on company resources, and to seek advice and recommendations from sources outside the decision by the Board. Recommendations and proposals for compensation to members company. The Board also establishes ad hoc sub-committees as needed, e.g. research, of the Board shall be the responsibility of the Nomination Committee. development, finance, manufacturing and in connection with M&A activities. Three meetings were held in 2015. Audit Committee Corporate Governance Committee The members of the Audit Committee are Jònas Einarsson, Per Samuelsson and Lars The members of the Corporate Governance Committee are Johan Christenson, Diane Lund- / "5 7 D # 7 . 7 R .5 7 composition Mellett, Eva-Lotta Allan and Bente-Lill Romøren. The composition of the committee meets of the committee meets the requirements of the Norwegian Code of Practice for Corporate the requirements of the Norwegian Code of Practice for Corporate Governance as regards Governance as regards independence, and all the committee members are considered to independence, and all the committee members are considered to be independent of be independent of Executive Management. The mandate of the committee is set out in the Executive Management. The mandate of the committee is set out in the Charter for the Charter for the Audit Committee and is in brief as follows: Governance Committee and is as follows: Prepare for the Board a report describing its supervision of the financial reporting process, including review of implementation of accounting principles and policies. Develop and review the Groups policies and practices for corporate Monitor the ## # 7 .R / / " 8 governance, and annually recommend changes to such policies and systems, noting any deficiencies and monitor management in remedying any such practices, if any, to the Board. deficiencies. P " 7 ! " / @ # 7 ! "R performance Have regular contact with the external auditor regarding the annual and consolidated Monitor the functioning of the Board committees and sub-groups and make accounts. recommendations to the Board with regard to the composition of Board committees Review and monitor the independence of the statutory auditor, ref. the Norwegian and sub-groups. Auditors Act, chapter 4 and in particular whether services other than audits delivered P " 7 ! " / @ # 7 R performance. . 7 . " 7 " # 7 7 . " R independence. The committee supervises implementation of and compliance with the .R 7 " # " " 7 .R / One meeting was held in 2015. activities relating to corruption as further described in the provisions herein. Deviations from the recommendation: None 2 meetings were held in 2015. B - 27 P. 48 Corporate Governance Report P. 49 Corporate Governance Report Risk management and internal control Remuneration of the board To manage the Company specific risks and risk inherent in the industry, and to comply with international and national regulations, the Company will, starting 2016, implement a periodic review process to identify, analyze and handle the main risk factors facing the Group. The Audit Committee will periodically receive written reports, highlighting the main risks and proposed actions to address these as well as any significant weaknesses in the internal control regime. . 7 ! " @ // @ " " 7 .R 8 " 7 / " The compensation of the Board and its sub-committees is decided by the Annual General internal control regime. Meeting, based on a recommendation from the Nomination Committee. Separate rates are set for the Board's chair and other members, respectively. Separate rates are also adopted 8 # 7 " " " O R PE 7 8 . for the Board's sub-committees, with similar differentiation between the Chair and the other members of each committee. Deviations from the recommendation: None The Board receives its compensation by cash payment. The cash compensation is not linked 7 .R # / 5 & # 7 ! " 7 / agreement concerning pay after termination of their office with the company. Robert Burns, Board member of the Company, was granted share options in Oncos Therapeutics Oy when he was a Board member of that company. By virtue of the combination with Oncos on 2 July 2015, these share options were converted into share options in Targovax ASA. The details of his options are set out in Note 12 to the consolidated financial statements. He is the only Board member with share options in the Company. There are no plans to issue new options to Board members going forward. In 2016, the Company intends to lay the grounds for an equity program, compensating Board members in part with restricted share units (vesting shares). B - 28 P. 50 Corporate Governance Report P. 51 Corporate Governance Report Information about all compensation paid to each member of the Board of Directors is is subject to an absolute limit (while there is no upside limit on granted share options nor on presented in Note 11 to the consolidated financial statements. granted share units). Deviations from the recommendation: None Deviations from the recommendation: None Remuneration of executive personnel Information and communication General information The Company shall provide timely and precise information about the Company and its operations to its shareholders, the stock exchange when applicable and the financial markets in general. Such information will be given in the form of annual reports, quarterly reports, press The Board has establish guidelines for the remuneration of the executive personnel. Such releases, notices to relevant market place exchange as well as investor presentations in guidelines set out the main principles applied in determining the salary and other remuneration accordance with what is deemed most suitable. The Company shall seek to clarify its long- of the executive personnel and in order to contribute to aligning the interests of shareholders term potential, including strategies, value drivers and risk factors. and executive management. These guidelines shall be communicated to the annual general meeting. As a rule, the Company will promptly disclose inside information (as defined by the Norwegian Performance-related remuneration of the executive personnel in the form of share option Securities Trading Act) on an on-going basis. grants, bonus programs or similar are linked to value creation for shareholders over time. Such arrangementsR intention is to incentivise performance and be based on quantifiable factors over which the employee in question can have influence. Performance-related remuneration B - 29 P. 52 Corporate Governance Report P. 53 Corporate Governance Report Information to shareholders Take-overs The Company has procedures for establishing discussions with shareholders to enable the Company to develop a balanced understanding of the circumstances and focus of shareholders. Such discussions will always be in compliance with the principle of equal # 7 .R 7 7 /" 5 Deviations from the recommendation: None In the event of a take- E 7 ! " " 7 .R 7 7 " " / / . 7 7 .R 7 7 /" " Q //. " 7 7 .R /. interrupted. The Board has a particular responsibility in ensuring that the shareholders have sufficient information and time B - 30 P. 54 Corporate Governance Report P. 55 Corporate Governance Report to form a view on the offer. No take overs have happened after the implementation of the current corporate governance policy. 7 " R # E " & 11 to the consolidated financial statements, have stated # 7 / # " " 7 5 7 " R # " " Deviations from the recommendation: None the Annual General Meeting. Auditor Deviations from the recommendation: None The auditor attends at least one meeting each year with the Board and the Audit Committee @7 7 7 .R "5 ; "" E 7 " at meetings of the Board that approves the annual accounts. At least once a year, the Audit Committee will meet @ 7 7 " " 7 " R @ 7 % R principles, risk areas and internal control procedures. The Audit Committee receives an annual summary from the external auditor of services other than auditing that have been provided to the Company. During 2016, the Company will / 7 " / # 7 R # 7 / " # 7 7 auditing. B - 31 P. 56 Accounts and Notes M Targovax group P. 57 Accounts and Notes M Targovax group Accounts and Notes M Targovax group Consolidated statement of financial position (Amounts in NOK thousands) Note 31.12.2015 31.12.2014 Consolidated statement of profit or loss ASSETS Intangible assets 16 358 070 - (Amounts in NOK thousands except per share data) Note 2015 2014 Property, plant, and equipment 17 1 590 150 Total non-current assets 359 659 150 Other revenues 7 146 72 Total revenue 146 72 Receivables 19 11 557 4 660 External R&D expenses 8 -25 231 -7 766 Cash and cash equivalents 20 173 898 62 552 Payroll and related expenses 9,10,11,12 -35 431 -5 367 Total current assets 185 455 67 213 Other operating expenses 13 -29 100 -4 509 Total operating expenses -89 762 -17 642 TOTAL ASSETS 545 114 67 362 Operating profit/ loss (-) -89 616 -17 570 Financial income 14 2 339 343 Financial expenses 14 -2 608 -420 EQUITY AND LIABILITIES Net financial items -269 -77 Shareholders equity Loss before income tax -89 885 -17 646 Share capital 21 2 688 943 Share premium reserve 522 502 97 792 Income tax expense 15 -1 930 Other reserves 6 957 780 Loss for the period -91 816 -17 646 Retained earnings -131 067 -38 841 Translation differences 21 793 Earnings/ loss (-) per share Basic and dilutive earnings/ loss (-) per share 21 -5.06 -2.50 Total equity 422 873 60 673 Non-current liabilities The Notes on pages 61 to 108 are an integral part of these consolidated financial statements. Interest-bearing liabilities 22 38 112 - Deferred tax 15 58 709 - Total non-current liabilities 96 821 - Current liabilities Consolidated Statement of other comprehensive income Accounts payable and other current liabilities 23 6 307 2 564 Accrued public charges 23 1 826 781 Other short-term liabilities 23 17 287 3 344 (Amounts in NOK thousands except per share data) 2015 2014 Total current liabilities 25 420 6 689 Income / loss (-) for the period -91 816 -17 646 TOTAL EQUITY AND LIABILITIES 545 114 67 362 Items that may be reclassified to profit or loss: Exchange differences arising from the translation of foreign operations 21 793 - Total comprehensive income/ loss (-) for the period -70 023 -17 646 The Notes on pages 61 to 108 are an integral part of these consolidated financial statements. Total comprehensive income/ loss (-) for the period attributable to owners -70 023 -17 646 The Notes on pages 61 to 108 are an integral part of these consolidated financial statements. B - 32 P. 58 Accounts and Notes M Targovax group P. 59 Accounts and Notes M Targovax group Oslo, 16 March 2016 Consolidated statement of changes in equity The Board of directors of Targovax ASA Retained Share Share Other Translation earnings (Amounts in NOK thousands) Note Total equity capital premium reserves differences (Accumulated losses) Balance at 1 January 2014 470 20 368 633 -21 195 276 Loss for the period -17 646 -17 646 Other comprehensive income/loss, net of tax Total comprehensive income for the period -17 646 -17 646 Recognition of share-based payments 12 147 147 Issue of ordinary shares - Capital increase 21 473 77 424 77 896 Audited balance at 31 December 2014 943 97 792 780 -38 841 60 673 Balance at 1 January 2015 943 97 792 780 -38 841 60 673 Loss for the period -91 816 -91 816 Exchange differences arising from the translation of foreign operations 21 793 21 793 Other comprehensive income/loss, net of tax Total comprehensive income for the period 21 793 -91 816 -70 023 Issue of ordinary shares - Aquiring Oncos Therapeutics OY 21 943 234 792 235 735 Transaction costs - Oncos Therapeutics OY 21 -260 -260 Issue of ordinary shares - Capital increase - Private 21 800 199 200 200 000 Transaction costs - Private Placement 21 -9 207 -9 207 Share issuance, employee share options 21 3 185 188 Reclassification of share-based payment Oncos 12 410 -410 Recognition of share-based payments 21 5 768 5 768 Balance at 31 December 2015 2 688 522 502 6 957 21 793 -131 067 422 873 The Notes on pages 61 to 108 are an integral part of these consolidated financial statements. B - 33 P. 60 Accounts and Notes M Targovax group P. 61 Accounts and Notes M Targovax group Consolidated statement of cashflow Notes to the financial statements M Targovax Group (Amounts in NOK thousands) Note 2015 2014 Cash flow from operating activities 1. General information Loss before income tax -89 885 -17 646 The Company is a public limited liability company incorporated and domiciled in Norway. The address of the registered office is Lilleakerveien 2C, 0283 Oslo, Norway. Adjustments for: Finance income 14 -2 339 -288 Targovax ASA ("the Company") and its subsidiaries (together the Group) is a clinical stage Finance expense 14 2 608 81 immuno-oncology company dedicated to the development of targeted immunotherapy Share option expense 12 5 717 147 treatments for cancer patients. Depreciation 13 148 11 Change in receivables 19 -3 026 1 166 The Group is targeting complementary approaches to cancer immunotherapy: A cancer Change in other current liabilities 23 5 887 2 694 vaccine platform developed for patients with RAS-mutated cancers and an immunotherapy Net cash flow from /(used in) operating activities -80 890 -13 835 platform based on engineered oncolytic viruses armed with potent immune-stimulating 5 ! 7 7 7 7 R Cash flow from investing activities transgenes for patients with solid tumor Purchases of property, plant, and equipment (PPE) 17 -158 -160 own immune system to fight the cancer. Purchases of intangible assets 16 Aquisition of subsidiary, net of cash acquired 4 1 313 These financial statements have been approved for issue by the Board of Directors on 16 Net cash received from/(paid in) investing activities 1 155 -160 March 2016, and are subject to approval by the Annual General Meeting in April 2016. Cash flow from financing activities Interest received 14 1 009 287 2. Summary of significant accounting principles Interest paid 14 -526 Other finance expense 14 -5 The principal accounting policies applied in the preparation of these consolidated financial Share issue expense - Aquisition of Oncos OY 21 -260 statements are described in the respective note, or if not, set out below. These policies have Share issue expense - Private Placement 21 -9 207 -4 604 been consistently applied to all the years presented, unless otherwise stated. Proceeds from issuance of shares -Private Placement 21 200 000 72 500 Proceeds from exercise of options 21 188 The Group have changed the way of presenting the operating expenses in the Consolidated Statement of profit and loss. This change has been applied for the years 2015 and 2014. The Net cash generated from financing activities 191 204 68 178 f 7 # 7 # 7 O # # # S P O / S P5 7 @ "" O # # # S P Net increase/(decrease) in cash and cash equvivalents 111 468 54 182 including all external R&D expenses previously included in the cost item O 7 Net exchange gain/loss on cash and cash equivalents -123 P5 7 " 7 7 7 O P @ / " " 7 Cash and cash equivalents at beginning of period 62 552 8 370 O 7 P5 Cash and cash equivalents at end of period 173 898 62 552 Amounts are in thousand Norwegian kroner unless stated otherwise. The Notes on pages 61 to 108 are an integral part of these consolidated financial statements. B - 34 P. 62 Accounts and Notes M Targovax group P. 63 Accounts and Notes M Targovax group Functional currency 2.2 Accounting principles The functional currency is determined in each entity in the Group based on the currency within Foreign exchange the entity's primary economic environment. Transactions in foreign currency are translated to The Group record transactions at initial recognition based on the average month exchange functional currency using the exchange rate at the date of the transaction. At the end of each rate in the month of transaction. The date of a transaction is the date on which the transaction reporting period foreign currency monetary items are translated using the closing rate, non- first qualifies for recognition in accordance with International Financial Reporting Standards. monetary items that are measured in terms of historical cost are translated using the exchange However, if exchange rates fluctuate significantly, the use of the average rate for a period may rate at the date of the transaction and non-monetary items that are measured at fair value in be inappropriate and an exchange rate closer to transaction date is used. a foreign currency are translated using the exchange rates at the date when the fair value was measured. Changes in the exchange rate are recognized continuously in the accounting period. Any exchange differences are recognized in profit or loss under financial items in the period in which they arise. Presentation currency 7 % R . & T5 7 / 7 .R # / 2.3 Adoption of new and revised IFRS standards currency. The statement of financial position figures of entities with a different functional Standards and interpretations affecting amounts reported in the current period currency are translated at the exchange rate prevailing at the end of the reporting period for All relevant new and revised IFRSs and IFRIC interpretations that are mandatory for periods balance sheet items, including goodwill, and the exchange rate at the date of the transaction commencing 1 January 2015 and earlier have been adopted for all periods presented in these for profit and loss items. The monthly average exchange rates are used as an approximation of the transaction exchange rate. Exchange differences are recognized in other financial statements. 7 9O ;P<5 Standards and interpretations in issue but not yet adopted When investments in foreign subsidiaries are sold, the accumulated translation differences IFRS15 Revenue from Contracts with Customers: relating to the subsidiary attributable to the equity holders of the parent are recognized in the The Group is in the research and development phase and the IFRS 15, will not have an statement of comprehensive income. When a loss of control, significant influence or joint material effect on the financial statements control is present the accumulated exchange differences related to investments allocated to controlled interests is recognized in profit and loss. IFRS 16 Lease : IFRS 16 replaces existing IFRS leases requirements, IAS 17 Leases. IFRS 16 sets out the When a partial disposal of a subsidiary (not loss of control) is present the proportionate share principles for the recognition, measurement, presentation and disclosure of leases for both of the accumulated exchange differences is allocated to non-controlling interests. parties to a contract, i.e. 7 9Q/ R< " 7 / 9Q/ R<5 7 @ / standard requires lessees to recognize assets and liabilities for most leases, which is a 2.1 Basis for preparation of the annual accounts significant change from current requirements. The effective date of the standard is January 1 2019, but it is not yet approved by the EU. The consolidated financial statements of Targovax ASA have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union, The Group has not made any assessment of any impact IFRS 16 will have on the financial as well as Norwegian disclose requirements listed in the Norwegian Accounting Act. statements. The consolidated financial statements are based on historical cost. The consolidated financial statements have been prepared on the basis of uniform accounting 2.4 Basis of consolidation principles for similar transactions and events under otherwise similar circumstances. The consolidated financial statements comprise the financial statements of the Company and its subsidiaries as at 31 December 2015. The subsidiaries include Oncos Therapeutics OY, B - 35 P. 64 Accounts and Notes M Targovax group P. 65 Accounts and Notes M Targovax group located at Helsinki, Finland and Oncos Therapeutics AG, Meggen, Switzerland, all 100% flows relating to transactions between members of the Group are eliminated in full on owned and controlled subsidiaries. Oncos Therapeutics OY is the parent company of Oncos consolidation. Therapeutics AG. A change in the ownership interest of a subsidiary, without a loss of control, is accounted for Control is achieved when the Group is exposed, or has rights, to variable returns from its as an equity transaction. involvement with the investee and has the ability to affect those returns through its power over the investee. If the Group loses control over a subsidiary, it ceases to recognize the related assets (including goodwill), liabilities, non-controlling interest and other components of equity, while any Specifically, the Group controls an investee if, and only if, the Group has: resultant gain or loss is recognize d in profit or loss. Any investment retained is recognized at fair value. # Power over the investee (i.e. existing rights that give it the current ability to direct the relevant activities of the investee) The functional currency of the subsidiaries is the local currency in the country in which they # Exposure, or rights, to variable returns from its involvement with the investee are domiciled. All transactions in foreign currency are translated to functional currency on the # The ability to use its power over the investee to affect its returns date of transaction. Monetary items denominated in foreign currency are translated to the functional currency using the exchange rate at the reporting date. All exchange differences In general, there is a presumption that a majority of voting rights results in control. To support are recognized in profit or loss. this presumption and when the Group has less than a majority of the voting or similar rights of 7 % R . & TE @7 7 / 7 .R # / an investee, the Group considers all relevant facts and circumstances in assessing whether it currency. has power over an investee, including: On consolidation of foreign subsidiaries that have a functional currency other than NOK, items # The contractual arrangement(s) with the other vote holders of the investee # " / " 7 % R . 7 # Rights arising from other contractual arrangements exchange rate for the period. The assets and liabilities of these entities are translated into the # 7 % R 7 " / 7 % R . the exchange rate at the reporting date. Currency differences arising on translation of foreign subsidiaries are attributed to equity and presented as other The Group re-assesses whether or not it controls an investee if facts and circumstances comprehensive income in the consolidated condensed statement of profit or loss and other indicate that there are changes to one or more of the three elements of control. Consolidation comprehensive income. On disposal of a subsidiary, accumulated translation differences of a subsidiary begins when the Group obtains control over the subsidiary and ceases when associated with the subsidiary are charged to profit or loss. the Group loses control of the subsidiary. Assets, liabilities, income and expenses of a subsidiary acquired or disposed of during the year are included in the consolidated financial 2.5 Business combinations and intangible assets statements from the date the Group gains control until the date the Group ceases to control Business combinations are accounted for using the acquisition method. The cost of an the subsidiary. acquisition is measured as the aggregate of the consideration transferred, which is measured at acquisition date fair value, and the amount of any non-controlling interests in the acquiree. Profit or loss and each component of OCI are attributed to the equity holders of the parent of For each business combination, the Group elects whether to measure the non-controlling the Group and to the non-controlling interests, even if this results in the non-controlling 7 Q # / 7 7 # 7 Q R " # / interests having a deficit balance. When necessary, adjustments are made to the financial net assets. Acquisition-related costs are expensed as incurred and included in administrative # " 7 / / @ 7 7 % R expenses. accounting policies. All intra-group assets and liabilities, equity, income, expenses and cash B - 36 P. 66 Accounts and Notes M Targovax group P. 67 Accounts and Notes M Targovax group When the Group acquires a business, it assesses the financial assets and liabilities assumed market authorization the intangible assets will be amortized using the straight-line method to for appropriate classification and designation in accordance with the contractual terms, allocate their cost to their residual values over their estimated useful lives. economic circumstances and pertinent conditions as at the acquisition date. This includes the Acquired intangible assets related to development of the ONCOS-102 platform are recognized separation of embedded derivatives in host contracts by the acquiree. in the financial position, amounting to 358 MNOK. The value is tested for impairment 31 December 2015. Due to the nature of the intangible assets there are uncertainties in Any contingent consideration to be transferred by the acquirer will be recognized at fair value estimating the value in the impairment test. This is further described in Note 16. at the acquisition date. Contingent consideration classified as an asset or liability that is a financial instrument and within the scope of IAS 39 Financial Instruments: Recognition and Measurement, is measured at fair value with the changes in fair value recognize d in the Estimated value of share-based payments statement of profit or loss. At each balance sheet date, the Group revises its estimates of the number of options that are expected to vest. It recognizes the impact of the revision to original estimates, if any, in the Intangible assets comprises the patented technology were recognized at fair value at the date income statement, with a corresponding adjustment to equity. The estimated turnover rate for of acquisition of Oncos 2 July 2015. Until the development of the patented technology is unvested share options is five percent for all share option plans. See Note 12 Share-based finalized no depreciation is recorded and the carrying amount will be tested for impairment at compensation. least once a year, or more often if there are indicators of impairment. When finalized, the patented technology will be depreciated by the straight-line method over Deferred tax the estimated useful life. The Group cannot render probable future taxable income large enough to justify recognizing a deferred tax asset in the balance sheet. However, this assumption must be continually 2.6 Going concern assessed and changes could lead to a significant asset being recognized in the future. This As a result of the private placement in the third quarter 2015 and the current liquidity situation, assumption requires significant management judgment. See Note 15 Taxes. Directors have an expectation that the Group has available financial resources sufficient for the planned activities in the next 12 months as of 31 December 2015. The Group therefore 4. Acquisition of Oncos Therapeutics continues to adopt the going concern basis in preparing its consolidated financial statements. On 2 July 2015, the Company acquired all the shares in Oncos Therapeutics Oy ("Oncos"), an unlisted privately funded company based in Finland. Oncos is a clinical-stage 3. Important accounting estimates and discretionary biotechnology company, which also is focusing on the design and development of targeted assessments cancer immunotherapy. The transaction was structured as a share for share exchange whereby Targovax ASA issued 9 429 404 new shares to the shareholders of Oncos as Management makes estimates and assumptions that affect the reported amounts of assets " # 7 7 9 7 O Q P<5 and liabilities within the next financial year. Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future Following the Oncos Acquisition, Oncos is a wholly-owned subsidiary of the Company at the events that are believed to be reasonable under the circumstances. closing date of the agreement 2 July 2015 (the "Acquisition date"). Following the share capital increase registered on July 2 2015, the share capital of Targovax is NOK 1 885 880.80, divided into 18 858 808 shares, each with a nominal value of NOK 0.10. Impairment of intangible assets Where a finite useful life of the acquired intangible asset cannot be determined, the asset is The combination of Targovax and Oncos complementary technologies creates a unique not subject to amortization, but is tested when indication, or at least annually for impairment. platform for the development of cutting-edge vaccines and immunotherapies. The combined Acquired intangible assets will not be subject to amortization until market authorization is group of Targovax and Oncos is positioned as a leading immuno-oncology company with obtained with the regulatory authorities and the intangible assets are available for use. After B - 37 P. 68 Accounts and Notes M Targovax group P. 69 Accounts and Notes M Targovax group clinical experience to date validates safety and mechanism of action of both technology mesothelioma, ovarian cancer, and soft tissue sarcoma. The other products and patents platforms. developed by Oncos are still at a discovery stage and invested capital in these products is insignificant. No excess value is allocated to other products than ONCOS-102. The main drivers for Oncos are the patented technology and mainly the product technology for the ONCOS-102 product. The allocation of value to the patented technology is done by a Deferred tax cost based valuation approach, analyzing the total fund invested in the intangible assets and Deferred tax is calculated on temporary differences on intangible assets. The value of the additional value created as part of the product development. identified intangible assets acquired amounts to TNOK 327 409. Net tax value of assets No residual value of the purchase price is recognized as goodwill, and no other excess values capitalized for tax purposes amounts to TNOK 67 649, resulting in a temporary difference of than patented technology is identified as part of the transaction. TNOK 261 058 and a deferred tax of TNOK 51 952 using statutory tax rate in Finland of 20%. The deferred tax will be calculated on the same basis going forward. Total transaction costs related to the acquisition are NOK 4 million. No contingent consideration arrangements are identified as part of the acquisition. In addition, recognition of deferred tax asset has been assessed in the purchase price // 5 / " / # R K $5 // # The fair values of the identifiable assets and liabilities of Oncos, as at the date of acquisition, 31 December 2014. With a current tax rate in Finland of 20%, the corresponding deferred tax as a result of the preliminary purchase price allocation were: asset is EUR 1.6 million. Oncos has not recognized any deferred taxes under FGAAP. Tax losses in Finland can be carried forward and offset against taxable income in ten years for tax purposes. Oncos has not generated taxable income in prior years and is not expected to (Amounts in NOK/EUR thousands) NOK EUR generate taxable income in the nearest future. Due to the uncertainty for future taxable profit Assets Intangible assets 327 409 37 227 within the ten years limitation of use, the company has assessed that it cannot be considered Tangible assets 1 298 148 as probable that future taxable profit can be used against the tax losses carried forward. No Other current assets 6 324 719 deferred tax asset is recognized in the purchase price allocation. Cash and cash equivalents 1 313 149 Total assets 336 344 38 243 Other non-current liabilities Liability Oncos Therapeutics OY has received funding from Tekes in the forms of R&D loans in the Deferred tax 51 952 5 907 principal outstanding amount of EUR 5 842 312 for the commercialisation of ONCOS-102. Other non-current liabilities 33 584 3 819 Other current liabilities 15 073 1 714 Tekes is a publicly financed funding agency that finances research and development activities Total liabilities 100 609 11 439 for young innovative companies in Finland. See Note 22. TOTAL CONSIDERATION (THE "PURCHASE PRICE") 235 735 26 803 Three separate R&D loans with special terms have been granted before acquisition date by governmental institution at a very low interest rate. Interest charged is 1% while market rate Intangible assets is assessed to be 8%. Under IFRS carrying amount of the liability is recognized at fair value. Intangible assets of NOK 327 409 083 comprises the patented technology, which was a key Fair value is determined by discounting future cash flows applying the 8 % interest rate. The value driver for Oncos. The patented technology consists mainly of the product technology for fair value adjustment on initial recognition of the liability is in accordance with IAS 20, the ONCOS-102 product. ONCOS-102 has shown promising results in cellular immune recognized as government grant. The government grant is recorded as a reduction to other response stimulation. The product has succeeded in passing phase I in the development cycle operating expenses in the period when the loans have been granted. Interest expense is and is ready to start phase II in several solid tumor indications. In addition, ONCOS-102 has calculated by using the effective interest rate method. been designated orphan drug status both in Europe and the US for the indications B - 38 P. 70 Accounts and Notes M Targovax group P. 71 Accounts and Notes M Targovax group The loans usually have a 10-year duration, of which the first five years are free of repayment. 6. Financial instruments and risk management objectives However, one of the three loans has a term of 13-year duration with 8 years free of repayment. and policies Repayment shall be made in equal annual instalments during the latter five years, while The Group's financial assets and liabilities comprise cash in banks, receivables and trade interest is paid annually throughout the entire loan period. The applicable interest rate under creditors that originate from its operations. All financial assets and liabilities are carried at the R&D loans is the European C / ! 8R / amortized cost. All financial assets and liabilities are short-term and their carrying value annum, although no less than 1 percent. approximates fair value. Should the project fail, it is possible to get a remission on part of the debt in accordance with the EU competition legislation. The final amount of the non-recovered part of the principal depends on factors such as the time and the materialized interest rate trend. The final sum The Group does currently not use financial derivatives. The Group is subject to market risk, credit risk and liquidity risk. will be determined when an eventual decision on non-recovery is made. Targovax Group has issued an on-demand guarantee in favor of Tekes for the repayment obligation of Oncos Market risk ; #/ /" 7 # //. " " /. ## 7 % R Therapeutics OY under the R&D loans. The loan agreements include no financial covenants. business, financial condition, results of operations, cash flows, time to market and prospects. From the acquisition date, Oncos Therapeutics OY has contributed NOK 146 021 of revenue and NOK 27 469 050 to the loss before tax of the Group. If the acquisition had taken place at Currently, the Group has no long-term debt other than its debt to Tekes. The debt to Tekes . / Q / 7 / ! 8R / the beginning of the year, revenue of the Group would have been NOK 146 021 for the full year 2015 and the loss before tax would have been NOK 44 096 230. points, but in no event less than 1%. The current interest is 1% per annum. The Group may in the future be exposed to interest rate risk primarily in relation to any future interest bearing debt issued at floating interest rates and to variations in interest rates of bank deposits. 5. Segments Consequently, movements in interest rates could have a material and adverse effect on the % R E # / " E / # E 7 #/ @ E 8 " The Group's activities during 2015 have been to continue the development and implementation of a strategy with the aim of developing highly targeted immunotherapy prospects. treatments for cancer patients. 7 # // @ / " 7 % R . 1 percent change in interest rates There was increased operational activity in Finland and Norway after the acquisition of Oncos on cash and cash equivalents and interest-bearing borrowings at 31 December 2015 and % R Therapeutics OY. The lead product has not yet obtained regulatory approval. For 2014. management purposes, the Group is organized as one business unit and the internal 2015 2014 reporting is structured in accordance with this. The Group is thus currently organized in one (Amounts in NOK thousands) 1% point 1% point 1% point 1% point increase decrease increase decrease operating segment. Loss before income tax effect 1 358 -1 358 626 -626 Foreign currency risk D/ 7 /" ## 7 % R 7 #/ @ " # / " The Group has currency exposure to both transaction risk and translation risk related to its operating expenses. Transaction risk arises when future commercial transactions or recognized assets or liabilities are denominated in a currency that is different # 7 % R presentation currency. The Group undertakes various transactions in foreign currencies and B - 39 P. 72 Accounts and Notes M Targovax group P. 73 Accounts and Notes M Targovax group is consequently exposed to fluctuations in exchange rates. The exposure arises largely from 2015 2014 (Amounts in NOK thousands) Carrying Carrying research expenses. The Group is mainly exposed to fluctuations in EUR, GBP and CHF. Fair value Fair value amounts amounts Receivables 11 557 11 557 4 660 4 660 7 # // @ / " 7 % R . . monetary assets Cash and cash equivalents 173 898 173 898 62 552 62 552 and liabilities in the loss before income tax and other comprehensive income at 31 December Total financial assets 185 455 185 455 67 213 67 213 2015 and 2014. Interest-bearing borrow ings 38 112 38 112 - - Deferred tax 56 674 56 674 - - Accounts payable and other current liabilities 6 307 6 307 2 564 2 564 % R . )Y increase/decrease in EUR against NOK Accrued public charges 1 826 1 826 781 781 2015 2014 (Amounts in NOK thousands) Other short-term liabilities 17 287 17 287 3 344 3 344 10% increase 10% decrease 10% increase 10% decrease Total financial liabilities 120 206 120 206 6 689 6 689 Loss before income tax effect -261 261 -38 38 Other comprehensive income -3 519 3 519 - - The table below analyses financial instruments carried at fair value, by valuation method. The % R . )Y H" MD & T different levels have been defined as follows: 2015 2014 (Amounts in NOK thousands) 10% increase 10% decrease 10% increase 10% decrease Loss before income tax effect -139 139 -108 108 Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities Other comprehensive income 41 -41 - - Level 2: Inputs other than quoted prices including Level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) Level 3: Inputs in asset or liability that are not based on observable market data (that is, % R . )Y H" %!: & T unobservable inputs) 2015 2014 (Amounts in NOK thousands) 10% increase 10% decrease 10% increase 10% decrease (Amounts in NOK thousands) Level 1 Level 2 Level 3 Total Loss before income tax effect -219 219 -163 163 Other comprehensive income -10 10 - - Interest-bearing borrow ings - - 38 112 38 112 Total financial instruments at fair value - - 38 112 38 112 Credit risk Credit risk is the risk of a counterparty defaulting. The Group has limited credit risk. At the end of year 2014 there were no financial instruments carried at fair value to measure. Outstanding receivables are limited and primarily government grants receivable from various government agencies. No impairment has been recognized. The carrying value of the assets Liquidity risk represents the Group's maximum exposure to credit risk. The Group manages liquidity risk by estimating and monitoring cash and liquidity needs on an on- going basis, and maintaining adequate reserves and banking facilities. The Group has Cash at bank: sufficient cash available to meet its obligations as at 31 December 2015. All liabilities, other 2015 2014 than the debt to Tekes, at year-end are short term and fall due within one year of the reporting (Amounts in NOK thousands) Rating (S&P) Amount In % Amount In % date, their carrying value approximates their fair value. Nordea Bank Norge ASA 165 868 95 % 62 552 100 % AA- Danske Bank Abp 7 148 4 % - 0 % A The Group is properly funded for its current activities, but will need new funding for the next Credit Suisse AG 881 1 % - 0 % A- Total 173 898 100 % 62 552 100 % phases of the development program. The funding strategy and development strategy are directly connected. There will be no cash flow commitments related to the development Fair value of financial instruments program before properly commitments to funding is in place. The carrying value of receivables, cash and cash equivalents, borrowings, deferred tax, and other short term payables and accrued liabilities are assessed to approximate fair value. B - 40 P. 74 Accounts and Notes M Targovax group P. 75 Accounts and Notes M Targovax group 7 # // @ / /. 7 % R " -current financial liabilities, at 31 8. Research and development expenses December 2015 and 2014 respectively, into relevant maturity groupings based on the remaining period at the balance sheet date to the contractual maturity date. The amounts Expenditure on research activities is recognized as an expense in the period in which it disclosed in the tables are the financial undiscounted cash flows. is incurred. Internal development costs related to the Group's development of products are At 31 December 2015 Less than 3 3 to 12 recognized in the income statement in the year incurred unless it meets the asset On demand 1 to 5 years > 5 years Total (Amounts in NOK thousands) months months recognition criteria of IAS 38 "lntangible Assets". Interest-bearing borrow ings - 220 342 28 917 29 871 59 350 Accounts payable and other current liabilities - 6 307 - - - 6 307 Accrued public charges - 1 826 - - - 1 826 Uncertainties related to the regulatory approval process and other factors generally means Other short-term liabilities - 17 287 - - - 17 287 that the criteria are not met until the time when the marketing authorization is obtained with - 25 640 342 28 917 29 871 84 770 the regulatory authorities. This assessment requires significant management discretion and estimations. At 31 December 2014 Less than 3 3 to 12 On demand 1 to 5 years > 5 years Total (Amounts in NOK thousands) months months Interest-bearing borrow ings ------Accounts payable and other current liabilities - 2 564 - - - 2 564 The Group is developing new products. Uncertainties related to the regulatory approval Accrued public charges - 781 - - - 781 Other short-term liabilities - 3 344 - - - 3 344 process and results from ongoing clinical trials, generally indicate that the criteria for asset - 6 689 - - - 6 689 recognition is not met until the time when marketing authorization is obtained from relevant regulatory authorities. 7. Revenue recognition The following external research and development expenditures have been expensed: Revenue comprises the fair value of consideration received or due consideration for the (Amounts in NOK thousands) 2015 2014 sale of services in regular business activities. Revenue is presented net of value added tax. Cost of manufacturing for R&D 9 597 7 735 Patent expenses 651 336 Revenue is recognized when the service is performed. Other 21 874 5 730 Government grants -6 891 -6 034 Total external research and development expenses 25 231 7 766 (Amounts in NOK thousands) 2015 2014 The following research and development expenditures have been expensed: Other revenue 146 72 Total operating revenue 146 72 (Amounts in NOK thousands) 2015 2014 Total R&D Total R&D The Group's products are still in the research and development phase, and it has no revenue External R&D expenses 25 231 25 231 7 766 7 766 Payroll and related expenses 35 431 13 497 5 367 4 752 from sales of products yet. Other revenue in 2015 arises from a non-core service fee and in Other operating expenses 29 100 384 4 509 2 276 2014 from consulting services carried out in Norway. Total 89 762 39 111 17 642 14 794 B - 41 P. 76 Accounts and Notes M Targovax group P. 77 Accounts and Notes M Targovax group 9. Government grants Three separate R&D loans with special terms have been granted before acquisition date by governmental institution at a very low interest rate. Interest charged is 1% while market rate Government grants are recognized at the value of the contributions at the transaction is assessed to be 8%. Under IFRS carrying amount of the liability is recognized at fair value. date. Grants are not recognized until it is probable that the conditions attached to the Fair value is determined by discounting future cash flows applying the 8 % interest rate. The contribution will be achieved. The grant is recognized in the income statement in the same fair value adjustment on initial recognition of the liability is in accordance with IAS 20, period as the related costs, and are presented net. recognized as government grant. The government grant is recorded as a reduction to other operating expenses in the period when the loans have been granted. Interest expense is Government grants are normally related to either reimbursements of employee costs and calculated by using the effective interest rate method. classified as a reduction of payroll and related expenses or related to other operating activities Grants receivables as at 31 December are detailed as followed: and thus classified as a reduction of other operating expenses. (Amounts in NOK thousands) 2015 2014 Grants Research Counsil 1 491 512 Government grants have been recognized in profit or loss as a reduction of the related Grants from SkatteFUNN 4 361 3 236 expense with the following amounts: Total grants 5 852 3 749 (Amounts in NOK thousands) 2015 2014 External R&D expenses 6 891 6 034 Payroll and related expenses 2 225 2 003 10. Payroll and related expenses Total 9 115 8 038 Payroll and related expenses are recognized in the income statement in the period in R&D projects have been approved for SkatteFunn for the period 2011 through 2016. For the which the related costs are incurred or services are provided. full year 2015 the Group has recognized NOK 4 361 331 (2014: 3 236 368) as cost reduction Defined contribution plans in Payroll and related expenses and Other Operating expenses. Targovax ASA has a defined contribution pension plan as required by the Norwegian Law and For the period 2013 through 2016, the Group has been awarded a grant from The Research as well an applicable contribution pension plan as required by Finnish Law for all employees Council (program for user-managed innovation arena (BIA)) of NOK 12 361 000 in total. For employed in Targovax OY. These pension plans apply to all employees of Targovax ASA and the full year ended 31 December 2015, the Group has recognized NOK 4 473 000 (4 712 435) Targovax OY respectively. Currently, members of the Management team with residence as cost reduction in External R&D expenses and Payroll and related expenses. " & @ . " D / " # 7 .R / / 5 The company pays these executives an annual amount in addition to base salary in lieu of 7 % 7 @ " " # K " 7 K V O G P # K their participation in a company scheme. For defined contribution pension plans, contributions 223 363 and the Group has for the full year 2015 recognized NOK 280 859 as cost reduction are paid to pension insurance plans and charged to the income statement in the period to in External R&D expenses. which the contributions relate. The Group has been awarded EUR 1,041,796 for preparations of clinical trials and for business development of a young innovative company and EUR 34,353 in R&D grant, both Bonus scheme from Tekes for the years 2009 to 2012. As of 31 December 20151, no obligations remain Bonuses are based on the corporate objectives as well as individual objectives. The Group related to these grants. recognizes a liability and an expense for bonuses based on a short-term incentive plan for employees linked to achievement of specific targets determined by the Board. See note 11. The Group has been awarded EUR 15,000 from ELY-8 8 9D / "R # Development, Transport and the Environment) for initiating company activities for the year 2009. As of the date of the Prospectus, no obligations remain related to these grants. B - 42 P. 78 Accounts and Notes M Targovax group P. 79 Accounts and Notes M Targovax group Total payroll and related expenses for the Group are: Last year was a year of transformation for Targovax. Through the merger in July 2015 between Oncos and Targovax, a solid strategic foundation was established. Other significant (Amounts in NOK thousands) 2015 2014 developments in 2015 were: Salaries ad bonus 26 154 5 767 / . R / 3 278 1 080 Private placement of NOK 200m in July Share-based compensation1 M & 5 875 147 Conception of a new clinical trial program with five new trials starting during 2016 - : M " # " / 1 723 257 progressing as planned towards multiple readouts in 2016-18 Other 626 119 Hiring of Gunnar Gårdemyr as new CEO in January and establishment of a new Governmental grants -2 225 -2 003 management team during the summer and fall Initiation of collaborations with Ludwig Cancer Research/Cancer Research Institute and Total payroll and related expenses 35 431 5 367 Sotio a.s. in November 1) Share-based compensation has no cash effect. Number of employees calculated on a full-time basis as at 31 December 26,5 5,5 As per end 2015, the initiation of several new trials with ONCOS-102 and TG02 and Number of employees as at 31 December 27 6 the ongoing clinical trial in phase II for TG01 have first priority. The outcomes of these trials represent the foundation on which Targovax will build its future value. Targovax ASA has a defined contribution pension scheme that complies with requirements of Targovax is a clinical stage company with a broad portfolio of opportunities in immuno- Norwegian occupational pension legislation (OTP). The contribution is expensed when it is oncology. The total compensation philosophy reflects this in that equity incentives play an accrued. Oncos Therapeutics OY has a defined contribution pension scheme that complies important role in compensating, motivating, and retaining the work force. Moreover, the with requirements of Finnish law. / 7 / 7 / # R is aligned with the # R 7 7 /" 5 7 O" P # 7 C " particular key employees is essential to reach the milestones that will bring Targovax forward 11. Related parties and Management and underpin value creation. To make this journey successful, Targovax needs to attract and retain senior and talented individuals that are willing to build lasting careers with the company. Targovax Compensation Report During the year the Compensation Committee has engaged closely with Management in order to ensure a shared view of the compensation policy and discuss and give feedback to the This report describes the compensation programs developed and established during the year essential tools necessary to fulfil the needs of the company. Long-term incentive has been the for Targovax. It is intended to describe programs for senior executives and to explain how most critical tool to ensure this close collaboration. The Compensation Committee is they were compensated in 2015 and will be in 2016. See Note 10 and 12 for accounting convinced that the suggested compensation policy will support and fulfil the essential needs principle for payroll and related expenses and equity-settled share-based payments.. of sustainable engagement and value creation. Section 1: Introduction by the Chairman of the Compensation Committee The Committee will continue to measure and monitor the effectiveness of the compensation policies and return with further amendments when needed. Dear Shareholder, Per Samuelson, Robert Burns, Lars Lund-Roland It is our pleasure to present Targovax Compensation Report for the year 2015 or to be more Targovax Compensation Committee, 16 March 2016 precise for the second half of 2015, after the formation of our newly merged company, and represent the situation at the end of 2015. We encourage all shareholders to read the entire Compensation Report before attending the Annual General meeting in April 2016. B - 43 P. 80 Accounts and Notes M Targovax group P. 81 Accounts and Notes M Targovax group Section 2 – Compensation Committee activity Section 3 – Overview of the compensation policy The Compensation Committee The compensation policy The Board of Directors with the assistance of the Compensation Committee determines the The compensation policy applied in 2015 is as follows: compensation policy for Targovax. The Committee is of the view that compensation practices Principle Summary must support the strategic aims of the business and enable the recruitment, motivation, and Targovax offers market competitive reward # @ // 8 . / . 5 R 8 Market competitive opportunities on a level to enable to attract, retain, and compensation account the views of regulatory and governance bodies and the expectations of shareholders motivate the talent needed to achieve our vision and and the wider employee population. The Board of Directors approves the total compensation business objectives. We balance the need to provide market competitive levels of reward against a desire to of the CEO, which is communicated to the shareholders through the Annual General Meeting. be cost-effective when determining reasonable and The Board of Directors has final approval of the compensation of the Management team, upon responsible reward outcomes. recommendation of the CEO and the Compensation Committee An appropriate proportion of the reward package is Pay for commitment performance- based for top executives to ensure Committee activity reward is linked to the achievement of key [nancial The committee was established and met in the second half of 2015 after the merger was and non-[ / V @ 7 / # 7 and long term performance components but with concluded. The CEO and the CFO attended selected meetings, providing input and assisting priority to the long term commitment of key with specific queries. They did not participate in conversations regarding their own level of employees. Compensation programs are designed and compensation. Transparency communicated in a manner that reinforces the linkage between business objectives, our vision, and culture. The committee covered the following matters during the year: Establishment of a post-merger retention tool Compensation decisions are made within an Salary anomaly corrections post-merger Business alignment and international framework to ensure local practices are consistency Establishment of a new option plan, including transformation and modification of old aligned and consistent with our principles and Oncos options into Targovax options policies. Our compensation practices will remain Recommendation of the new Targovax long term equity strategy and practices \exible enough to evolve as the business priorities of Approval of the new Targovax long term strategy and the terms and conditions of Targovax change. the proposed option plan Our compensation programs will align the interests of Shareholder alignment Review of the total package of the CEO all employees in driving value creation for our shareholders. We will share the success of the company wherever possible with our employees. Together with the Nomination Committee, the Compensation Committee also started work on an equity program for Board members, intended to form part of Board compensation in 2015, 2016 and onward. B - 44 P. 82 Accounts and Notes M Targovax group P. 83 Accounts and Notes M Targovax group post-merger integration. Element Applied Proposed for in 2015 2016 Maximum bonus percentages 2015 Base salary (% of base salary) Short term incentive for top executives: Annual bonus Chief Executive Officer 25% Chief Medical Officer 30% Long term incentive for all employees: Share options CFO 20% Equity as part of Board fee The Committee may, at its discretion, review the operation of the annual bonus plan and make Benefits recommendations to the Board for approval. Any review will take into account the overall impact of the compensation package, the mix between fixed and variable pay, and the balance Pension between short and long term performance measurement. With respect to performance in 2015, the following bonuses will be paid in 2016: Bonus pay-outs 2015 Section 4 – Compensation policy for each element (% of target bonus) The policy for each element of compensation are described below; setting out the policy CEO 96% applied for 2015 and 2016. CMO 94% Base salary CFO 97% Base salaries for individual members of the Management team are reviewed annually by the Committee. The salaries are set by taking into consideration the scope of the role, the level of experience of the individual, the geographical location of the role, internal relativity, and Long term incentives external economic environment. 7 R / # ) ( / " 7 / . / " ) The overall performance rating, employee potential, and current compensation market described below. competitiveness will be combined to assess any proposed salary revision. Short term incentives: annual bonus Long term incentives proposal for 2016 The corporate objectives are set by the Board and determined for and agreed with the CEO. Eligibility The bonus of the CEO is to a large part determined by achievements of corporate objectives. Other Management Team bonuses are based on the corporate objectives as well as individual New employees are eligible for option grants upon joining the company. Employees, will be objectives. eligible for an annual option award on a discretionary basis, taking into account overall performance, work responsibility, importance of retention, organization level, and position. The level of performance achieved and the amount of bonus to be awarded the member of the Management Team is reviewed by the Committee, in discussion with the CEO, and The Board of Directors will exercise discretion as to who will receive an equity award in any approved by the Board. given year, based on recommendations made by the Committee. The system of corporate objectives was introduced during 2015 and in place for the fourth The Board of Directors intends to grant awards under the plan, alongside the existing option quarter. The objectives for both 2015 and 2016 revolve around a) execution of clinical plan b) plan, on an annual basis. establishment of collaborations c) investor relations and preparations for a fund raising and d) B - 45 P. 84 Accounts and Notes M Targovax group P. 85 Accounts and Notes M Targovax group The Board members is not eligible to participate. shares and 10 % of the share capital. The authorization to increase the share capital covers: # Already granted options, vested as well as unvested; and # Planned future grants of options Grant size and exercise price Going forward this cap will be proposed at approximately 10% of outstanding shares and The Compensation Committee shall recommend to the Board the size of the overall option options (i.e. fully diluted). grant. The grant schedule will be determined, and reviewed, on the basis of market competitiveness of the equity component of the compensation package and the overall size of At the end of 2015, 2 545 889 share options were outstanding, of which 443 964 were vested the available share pool approved by shareholders. and exercisable at year-end 2015. Management Team members and Board of Directors held 1 793 235 share options. 426 152 option were held by other employees and the remaining Share option grants will not be subject to any performance-based vesting conditions. 326 502 by previous employees, previous Oncos board members and inventors. By the end of 2015, one Board member who had previously been granted options in legacy The exercise price is determined at grant and reflects the share price on the day of the grant. Oncos, held 21,235 Targovax options converted from these legacy Oncos options. Targovax has never and does not plan to grant options to Board members. Long-term incentives in 2015 Pension In 2015, Targovax granted share options under the current share option plan in which all Targovax ASA has a defined contribution pension plan as required by the Norwegian Law and employees are eligible to participate. as well an applicable contribution pension plan as required by Finnish Law for all employees employed in Targovax OY. These pension plans apply to all employees of Targovax ASA and The share option grants are not subject to any performance-based vesting conditions. Under Targovax OY respectively. the current plan, share options have been granted to employees upon joining the company. Additional grants have been made to senior employees on a discretionary basis taking into Currently, members of the Management team with residence outside Norway and Finland are account the number of options held, overall performance, competitiveness of terms, work not part of 7 .R / / 5 7 . . 7 responsibility, importance of retention, organization level, and position. executives an annual amount in addition to base salary in lieu of their participation in a company scheme. Employee vesting schedule Granted share options vest over a four-year period as follows: 25 percent of the options vest Other benefits on the first anniversary of the grant date; and the remaining 75 percent of the options vest in Benefits to the Management team may comprise certain other items such as healthcare, equal monthly tranches over the next 36 months. Options expire seven years after the grant accident insurance, etc. on customary terms. date. The type of benefit provision, the level of cover, and the coverage formed part of the 2015 In the case of termination of employment, the employee will not vest further share options pension and benefit review. beyond notice of termination. The terminated employee can as a rule exercise vested share options for a maximum period of six months after termination. Severance payment Limits The CEO and the CMO have the right to receive 7 R / . " # 7 of involuntary termination of their employment. The Board of Targovax seeks authorization from shareholders at the Annual General Meeting to issue a maximum number of share options in total for all grants. This authorization is sought every year and at the Extraordinary General Meeting in September 2015, the Board was 7 C " 7 % R 7 / @ 7 7 Board of Directors arrangements to employees, Board members, and consultants by up to the lower of 5 000 000 No Board fee has yet been paid for 2015. The Nominations Committee, however, is reviewing B - 46 P. 86 Accounts and Notes M Targovax group P. 87 Accounts and Notes M Targovax group the compensation for 2015 and 2016. The fees are decided by the Annual General Meeting. remunerations for the year 2015. The Group has recognized as expense NOK 1.3 million, excluding National Insurance Statement for 2015 Contribution, in provision for bonus to Management for 2015 7 ! " # / @ 7 7 " " R " . % / $ / ) # 7 ! " # R / Holding of shares and options for shares as at 31 December 2015: for Management compensation pursuant to Norwegian Public Limited Companies Act section Holding of Granted Holding of 6M16a. With the exception of the principle outlined in Section 3 above, the principles for 2015 (Amounts in NOK thousands) shares as at% ow nership options options as were identical to the principles listed above. 31 Dec. 2015 2015 5 at 31 Dec. 2015 Board of Directors of Targovax ASA: Section 5 – Compensation tables for 2015 and 2014 Jónas Einarsson, Chairperson 1 - 2 Remunerations and other benefits in 2015: Johan Christenson, Board member - Per Samuelsson, Board member 2 - Fixed Bonus Ear ned Pension Benefits Total Robert Burns, Board member 29 063 0,11 % 21 235 21 235 annual earned salary as remunerat Total Board of Directors 29 063 0,11 % 21 235 21 235 (Amounts in NOK thousands) salaries in 2014, expenses in kind at ion Management: 31 Dec. paid in Gunnar Gårdemyr, Chief Executive Officer in 2015 in 2015 in 2015 20 000 0,07 % 500 000 500 000 2015 2015 (appointed 12 January 2015) Management: Øystein Soug, Chief Financial Officer 20 000 0,07 % 390 000 390 000 (appointed 11 May 2015) 3 Gunnar Gårdemyr, Chief Executive Officer 2 310 2 247 153 2 400 4 (appointed 12 January 2015) Jon Amund Eriksen, Chief Operating Officer 724 650 2,70 % 160 000 160 000 Øystein Soug, Chief Financial Officer Magnus Jäderberg, Chief Medical Officer 1 400 821 36 6 863 20 000 0,07 % 390 000 390 000 (appointed 11 May 2015) (appointed 2 July 2015) Antti Vuolanto, Executive Vice President 61 773 0,23 % 181 000 181 000 Jon Amund Eriksen, Chief Operating Officer 1 445 1 435 57 218 1 710 (appointed 2 July 2015) Tina Madsen, VP Quality Assurance 53 000 53 000 Magnus Jäderberg, Chief Medical Officer 1 2 588 2 588 270 616 3 474 Peter Skorpil, VP Business Development (appointed 2 July 2015) 2 000 0,01 % 45 000 45 000 Antti Vuolanto, Executive Vice President2 (appointed 8 April 2015) 1 234 1 256 313 2 1 571 Anne Kirsti Aksnes, VP Clinical Development (appointed 2 July 2015) 53 000 53 000 (appointed 01.01.2016) Tina Madsen, VP Quality Assurance 1 006 896 51 19 967 Total Management 848 423 3,16 % 1 772 000 1 772 000 Peter Skorpil, VP Business Development 940 597 35 9 641 Total 877 486 3,26 % 1 793 235 1 793 235 (appointed 8 April 2015) Anne Kirsti Aksnes, VP Clinical Development 1) Jónas Einarsson, Chairperson of the Board of Directors, is CEO of the Radium Hospital Research Foundation 1 037 924 53 13 989 (appointed 01.01.2016) which owns 3 410 589 shares at 31.12.2015 2) Johan Christenson and Per Samuelsson, both Member of the Board, are partners at HealthCap, HealthCap owns 3 Total Management 11 961 10 764 270 544 1 037 12 615 8 488 918 shares at 31.12.2015 3) The shares are held through Abakus Invest AS Total 11 961 10 764 270 544 1 037 12 615 4) The shares are held through Timmuno AS 5) Granted options to Robert Burns, Magnus Jäderberg and Antti Vuolanto include conversion of Oncos Therapeutics OY's option program to Targovax option program 2 July 2015 1) Fixed annual salary is the annual salary in GBP multiplied by the average exchange rate throughout the year. 2) Fixed annual salary is the annual salary in EUR multiplied by the average exchange rate throughout the year. 3) 7 % R M " # M 7 " / " 7 # / " " 7 / - please refer to the table All amounts in the tables exclude National Insurance Contribution. The Group has recognized Related party transactions as expense NOK 4.9 million in share-based compensation to Management in 2015. The Board of Directors or Management have not exercised options for shares in 2015. There are no There were no remuneration payments to Board members in 2015. NOK 1.3 million, excluding outstanding loans or guarantees made to the Board of Directors or the Management. National Insurance Contribution, was recognized as expense in provision for Board B - 47 P. 88 Accounts and Notes M Targovax group P. 89 Accounts and Notes M Targovax group Remunerations and other benefits in 2014: Fixed Bonus Ear ned Pension Benefits Total Exercise price in NOK 0.51 21.50 25.00 37.60 Total annual earned salary as remunerat (Amounts in NOK thousands) salaries in 2013, expenses in kind at ion Board of Directors of Targovax ASA: 31 Dec. paid in in 2014 in 2014 in 2014 1 2014 2014 Robert Burns, Board member 21 235 21 235 Management: Total Board of Directors - - - 21 235 21 235 Hanne M. D. Kristensen, Chief Executive 1 331 1 331 54 1 017 2 401 Management: Officer (terminated 12 January 2015)2 Gunnar Gårdemyr, Chief Executive Officer Jon Amund Eriksen, Chief Operating Officer 1 399 1 388 54 7 1 449 300 000 200 000 500 000 (appointed 12 January 2015) Øystein Soug, Chief Financial Officer Total Management 2 731 2 720 - 107 1 024 3 850 390 000 390 000 (appointed 11 May 2015) Total 2 731 2 720 - 107 1 024 3 850 Jon Amund Eriksen, Chief Operating Officer 160 000 160 000 1) There was no remuneration to Board members. Magnus Jäderberg, Chief Medical Officer 390 000 390 000 2) The CEO signed an agreement for employee termination 1 December 2014. Her position as CEO was terminated (appointed 2 July 2015) at 12 January 2015, when the new CEO 8 7 5 . # * 7 R / . & T Antti Vuolanto, Executive Vice President 1.007.514, including social security NOK 1.149.573, was accrued as at 31 December 2014. All share options will 10 258 170 742 181 000 (appointed 2 July 2015) be vested at 5 February 2015. Tina Madsen, VP Quality Assurance 53 000 53 000 Peter Skorpil, VP Business Development 45 000 45 000 (appointed 8 April 2015) Holding of shares and options for shares at 31 December 2014: Anne Kirsti Aksnes, VP Clinical Development 53 000 53 000 (appointed 01.01.2016) Holding of Holding of Total Management 10 258 406 000 1 355 742 - 1 772 000 (Amounts in NOK thousands) shares as at% ow nership options as Total 10 258 406 000 1 376 977 21 235 1 793 235 31 Dec. 2014 at 31 Dec. 2014 Board of Directors of Targovax ASA: Hans Ivar Robinsen, Board member 1 438 657 4,65 % - Total outstanding options for shares by range of exercise price at 31 December 2014: Tom A . Thor s en, Boar d member 2 392 465 4,16 % - Total Board of Directors 831 122 8,81 % - Exercise price in NOK 7,5 Total Management: Hanne M. D. Kristensen, Chief Executive 10 160 0,11 % 50 000 Officer (terminated 12 January 2015) Management: 3 Hanne M. D. Kristensen, Chief Executive Jon Amund Eriksen, Chief Operating Officer 724 650 7,69 % - 50 000 50 000 Officer (terminated 12 January 2015) 2 Total Management 734 810 7,79 % 50 000 Total Management 50 000 50 000 Total 1 565 932 16,61 % 50 000 1) Indirect ownership through Birk Venture AS 2) Indirect ownership through Algot Invest AS 3) Indirect ownership through Timmuno AS Management members have not exercised options for shares in 2015 or 2014. Total outstanding options for shares by range of exercise price at 31 December 2015: B - 48 P. 90 Accounts and Notes M Targovax group P. 91 Accounts and Notes M Targovax group Related party transactions: The fair value of the options granted is measured using the Black-Scholes model. 2015 2014 Measurement inputs include share price on measurement date, exercise price of the (Amounts in NOK thousands) Payable at 31 Expensed Payable at 31 December Expensed December instrument, expected volatility, weighted average expected life of the instruments, expected Knudtzon 392 92 - - dividends, and the risk-free interest rate. Targovax entered into a consulting agreement with Knudtzon, a Zurich based company, 26 Service and non-market performance conditions attached to the transactions are not taken June 2015. Knudtzon is a related party of Nikolaj Knudtzon, who was elected as a member of into account in determining fair value. Targovax Management Team, Head of HR, in June 2015. Knudtzon is entitled to a consultancy fee of NOK 73,500 per month. When the options are exercised, the Company issues new shares. The proceeds received net of any directly attributable transaction costs are recognized as share capital (nominal value) and share premium reserve. Remuneration to the statutory auditor (excl. VAT): At the end of each reporting period, the group revises its estimates of the number of options (Amounts in NOK thousands) 2015 2014 that are expected to vest. It recognizes the impact of the revision to original estimates, if Statutory audit 268 70 any, in profit or loss, with a corresponding adjustment to equity. Changes to the estimates Other attestation services 979 may significantly influence the expense recognized during a period. Tax services 39 63 Other services 527 Total 1 813 133 At the Extraordinary general meeting in September 2015 the Board was authorized to increase 7 % R 7 / @ 7 7 . 7 / @ of NOK 500 000 and 10% of the Share capital. 12. Share-based compensation The Company has granted 7 " / 9 7 OP ; : P<5 7 : / 7 @ // / . general. Certain former employees and former board members have also been granted Equity-settled share-based payments are measured at the fair value of the equity options under the LTI Option Program. instruments at the grant date. "" //.E 7 . 7 7 " . # 9 7 O;: : P<5 The fair value of the employee services received in exchange for the grant of the options is recognized as an expense, based on the Company's estimate of equity instruments that will The Group operates an equity-settled, share-based compensation plan, under which the entity eventually vest. The total amount to be expensed is determined by reference to the fair value receives services from employees as consideration for equity instruments (options) in of the options granted excluding the impact of any non-market service and performance Targovax ASA. vesting conditions. The grant date fair value of the options granted is recognized as an Each share option converts into one ordinary share of the Company on exercise. Options may employee expense with a corresponding increase in equity, over the period that the be exercised at any time from the date of vesting until expiry. The options generally vest over employees become unconditionally entitled to the options (vesting period). a period of four years: 25 percent of the options vest on the first anniversary of the grant date; B - 49 P. 92 Accounts and Notes M Targovax group P. 93 Accounts and Notes M Targovax group and the remaining 75 percent of the options vest in equal monthly tranches over the next 36 The average fair value of options granted in 2015 was NOK 14.05 per share and NOK 1.48 in months. Options expire seven years after the grant date. 2014. The weighted- average assumptions used to determine the Black Scholes fair value of options granted in 2015 and 2014 were: In general, the exercise price of the options is set at the fair value of the shares at grant date. 2015 2014 There were granted 2 090 062 share options during 2015, no share options were granted Volatility (%) 84.59 58.52 during 2014. As a result of the Oncos transaction 2 July 2015 380 827 share options in Oncos Expected life (in years) 3.78 3.57 were converted into Targovax share options. The outstanding options in Oncos has been Risk-free interest rate (%) 0.84 1.49 converted to options in Targovax. At the convertions the exercise price, lifetime and quantity Share price (NOK) 24.58 143.06 have been adjusted. The adjustments have been made so that fair value of the outstanding Exercise price (NOK) 24.58 145.54 award is equal to the fair value of the outstanding awards after conversion. Hence, there is no incremental value to be expensed after the conversion. The conversion of the share options The expensed share-based compensation, NOK 5.8 million in 2015 and NOK 0.1 million in entailed no added value. 2014, includes management estimate for employee turnover. The estimated turnover rate Certain former employees and former board members have also been granted options under used for the year 2015 was 0 %. the LTI Option Program as replacement for historical option holdings At 31 December 2015, the range of exercise prices and weighted average remaining As of 31 December 2015 , there are in total 2,545,889 outstanding options for all option contractual life of the options were as follows: programs, 2 450 887 options under the LTI Option Program and 95 002 options under the IPR Outstanding options Vested options Option Program. Weighted Weighted Outstanding Weighted average average Vested options Exercise price options per average Fair value of the options has been calculated at grant date. The fair value of the options were remaining exercise 31.12.2015 31.12.2015 exercise price contractual life price calculated using the Black-Scholes model. The expected volatility for options issued in 2015 is estimated at average of 0.8459, based on the volatility of comparable listed companies. The 0.51 102 234 6.51 0.51 52 195 0.51 7.50 75 000 1.85 7.50 75 000 7.50 volume weighted average interest rate applied to the share options grants in first half of 2015 15.04 20 000 6.92 15.04 0 0 is 0.84%. 21.50 486 000 5.11 21.50 7 810 21.50 25.00 1 761 641 5.64 25.00 216 967 25.00 The following table shows the changes in outstanding options in 2015 and 2014: 37.60 101 014 6.25 37.60 91 992 37.60 Total 2 545 889 5.50 23.25 443 964 21.71 2015 2014 Weighted avg. Weighted avg. At 31 December 2014, the range of exercise prices and weighted average remaining No. of options excercise price No. of options excercise price contractual life of the options were as follows: (in NOK) (in NOK) Outstanding at 1 January 100 000 7.5 100 000 7.5 Outstanding options Vested options Granted during the period 1 2 090 062 24.09 - - Weighted Weighted 2 Outstanding Weighted Exercised during the period -25 000 7.5 - average average Vested options Exercise price options per average remaining exercise 31.12.2015 Convertion of Oncos option program 2/7-2015 380 827 21.77 - - 31.12.2015 exercise price contractual life price Outstanding no. of options at 31 December 2 545 889 23.25 100 000 7.5 7.50 100 000 2.85 7.50 67 500 7.50 1) See Note 11 Related parties and Executive Management for further information on granted share options to Total 100 000 2.85 7.50 67 500 7.50 Executive Management. 2) Weighted average exercise price on the exercised share options during the period was NOK 7.50 in 2015. B - 50 P. 94 Accounts and Notes M Targovax group P. 95 Accounts and Notes M Targovax group 13. Other operating expenses and fees or costs that are an integral part of the EIR. The EIR amortization is included as finance costs in the statement of profit or loss. Expenditure on other operating expenses is recognized in the income statement as an expense in the period in which it is incurred Financial assets; The Group's financial assets are initially measured at fair va lue. Transaction costs that are directly attributable to the acquisition of financial assets are added to the fair value of the asset. The assets are subsequently measured at amortized cost using the (Amounts in NOK thousands) 2015 2014 effective interest method, less any impairment losses. Financial assets are derecognized / .E " R " ; 21 408 2 314 when the rights to receive cash flows from the investments have expired or have been Travel expenses 1 961 358 Facilities expenses 1 946 541 transferred and the Group has transferred substantially all risks and rewards of ownership to IT services and IT-related accessories 1 275 387 another party. Financial assets are assessed for indicators of impairment at the end of the Conferences and training 295 99 reporting period and are considered impaired when there is objective evidence that, as a Other 2 068 800 result of one or more events that occurred after the initial recognition of the financial asset, Depreciation 147,715 11 Total other operating expenses 29 100 4 509 the estimated future cash flows of the investment have been affected. Loans and borrowings This is the category most relevant to the Group. After initial recognition, interest-bearing loans 14. Financial items and borrowings are subsequently measured at amortized cost using the EIR method. Gains Financial income consist of interest income and foreign exchange gain. Financial and losses are recognized in profit or loss when the liabilities are derecognized as well as expense mainly consist of interest expense and exchange loss. through the EIR amortization process. Amortized cost is calculated by taking into account any discount or premium on acquisition and fees or costs that are an integral part of the EIR. The Debt and equity instruments are classified as either financial liabilities or as equity in EIR amortization is included as finance costs in the statement of profit or loss. accordance with the substance of the contractual arrangements and the definitions of a financial liability and an equity instrument. The Group's financial assets consist of receivables and cash. Management determines the Finance income and expense classification of its financial assets at initial recognition, and the classification of financial assets All finance income and finance expense, except for foreign exchange income/expense, are depends on the nature and purpose of the financial assets. related to financial assets and financial liabilities carried at amortized cost. Financial liabilities; The Group's financial liabilities consist of accounts payable, other current Financial income are: liabilities and interest-bearing liabilities. Accounts payable are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts (Amounts in NOK thousands) 2015 2014 Interest income on bank deposit 993 274 payable and other current liabilities are recognized initially at fair value net of directly Interest income on tax repaid 16 14 attributable transaction costs. Currency gain - other operating items 1 329 55 Other finance income After initial recognition, interest-bearing liabilities are subsequently measured at amortized Total finance income 2 339 343 cost using the Effective Interest (EIR) method. Gains and losses are recognized in profit or loss when the liabilities are derecognized as well as through the EIR amortization process. Amortized cost is calculated by taking into account any discount or premium on acquisition B - 51 P. 96 Accounts and Notes M Targovax group P. 97 Accounts and Notes M Targovax group Financial expenses are: changes could lead to significant deferred tax asset being recognized in the future. This assumption requires significant management judgment. (Amounts in NOK thousands) 2015 2014 Interest expense - Convertible Loan 75 Interest expense - Tekes Loan 514 The Group is in the research phase of its product development and has incurred significant tax Amortized interest costs - Tekes loan 1 327 losses related to its operations. Targovax ASA has a total tax loss carried forward of NOK 212 Other interest expense -2 1 Currency loss - other operating items 765 338 million at 31 December 2015 (31 December 2014: NOK 51 million). Other finance expense 45 Total finance expenses 2 608 420 / " / # R K $5 // # December 2014. With a current tax rate in Finland of 20%, the corresponding deferred tax asset is EUR 1.6 million. Oncos has not recognized any deferred taxes under FGAAP. Tax Financial assets losses in Finland can be carried forward and offset against taxable income in ten years for tax Currently, all the Group's financial assets are categorized as receivables. The Group does not purposes. Oncos has not generated taxable income in prior years and is not expected to have any trade receivables and at 31 December 2015 and 2014 the receivables mainly consist generate taxable income in the nearest future. Due to the uncertainty for future taxable profit of grants receivables and receivables related to VAT. The Group has currently not recognized within the ten years limitation of use, the company has assessed that it cannot be considered any non-current financial assets. as probable that future taxable profit can be used against the tax losses carried forward. However, the Group has recognized a deferred tax liability on temporary differences on the 15. Tax acquired intangible assets, ref. Note 4, per 31 December 2015 of NOK 59 million. Income tax expense comprise current income tax (tax payable) and deferred tax. No current or deferred tax charge or liability has been recognized for 2014. Deferred taxes are recognized based on temporary differences between the carrying amounts of assets and liabilities in the financial statements and the corresponding tax bases used in (Amounts in NOK thousands) 2015 2014 the computation of taxable profit. Deferred tax assets arising from deductible temporary Tax loss carried forward -212 310 -50 937 differences are recognized to the extent that it is probable that taxable profits will be available Fixed assets 286 299 21 Borrowings 9 449 - so temporary differences can be utilized. Other current liabilities -13 305 - Share options -79 -224 Deferred tax liabilities and assets are measured at the tax rates that are expected to apply in Temporary differences 31.12 70 054 -51 140 the period in which the liability is settled or the asset realized, based on tax rates that have Deferred tax asset (25%) 10 690 -13 808 been enacted or substantively enacted by the end of the reporting period. Deferred tax asset not recognized 48 019 - Deferred tax liablity 31.12 58 709 - The tax losses can be carried forward indefinitely in Norway and in Finland it can be carried forward and offset against taxable income in ten years for tax purposes. The Group considers that a deferred tax asset related to accumulated tax losses cannot be recognized in the statement of financial position until the product under development has been approved for marketing by the relevant authorities. However, this assumption is continually assessed and B - 52 P. 98 Accounts and Notes M Targovax group P. 99 Accounts and Notes M Targovax group (Amounts in NOK thousands) Statutory income tax rate 25 % 0,27 Tax effect of income / loss (-) -22 423 -4 765 Recognized intangible assets in the Group amounts to NOK 358 million as of 31.12.2015. The Tax effect permanent differences -1 878 -2 055 intangible assets is derived from the acquisition of Oncos Therapeutics OY which was Tax effect different tax rates - completed in July 2015 (see Note 4). Change in deferred tax not recognized 22 372 6 820 Tax expense -1 930 - The intangible assets are related to the development of ONCOS-102, which is a virus-based immunotherapy platform. Intangible assets are tested for impairment at least annually, or when there are indications of 16. Intangible assets and impairment test impairment. This is the first impairment test since the intangible assets were acquired in July 2015. Intangible assets Intangible assets that relate to intellectual property rights acquired through licensing or The intangible assets are still under development and therefore currently difficult to calculate the value based on a pure discounted cash flow model without significant risk of estimation assigning patents and know-how are carried at historical cost less accumulated amortization, errors. Hence the valuation is based on an alternative approach. The value is estimated based where the useful life is finite and the asset is likely to generate economic benefits exceeding on combination of a discounted cash flows method and a method based on a hypothetical costs. Where a finite useful life of the acquired intangible asset cannot be determined, the sales transaction. asset is not subject to amortization, but is when indication, or at least tested annually for The valuation is sensitive to many assumptions. There are significant uncertainties to time to impairment. Acquired intangible assets will not be subject to amortization until market market and the commercial results of biotech products in a development phase such as authorization is obtained with the regulatory authorities and the intangible assets are available ONCOS-102. The results from the valuation in this impairment test is limited to ensure for use. Depreciation on items of Intangible assets will be depreciated using the straight-line sufficient certainty for the recognized amount in the financial statement, and should not be method to allocate their cost to their residual values over their estimated useful lives. considered as a complete valuation of the full potential of ONCOS-102. Assumptions Research costs are recognized in the income statement as incurred. Internal development / " 7 % R " / # " recognized in the income statement The forthcoming plan for ONCOS-102 is to be tested on four indications: in the year in which they are incurred unless they meet the recognition criteria of IAS 38, # O; / 5P K / " 7 / . / " 7 # Malignant mesotheliom # Melanoma generally means that the criteria are not met until the time when the marketing authorization # Ovarian # is obtained with the regulatory authorities. Advanced Prostate The impairment test is limited to assumptions on commercialization of these indications. Impairment of non-financial assets Assets that are subject to amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An / C " # 7 . @7 7 7 R . " / 5 7 / 7 7 7 # R # / / costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). Non-financial assets other than goodwill that suffered impairment are reviewed for possible reversal of the impairment at each reporting date. B - 53 P. 100 Accounts and Notes M Targovax group P. 101 Accounts and Notes M Targovax group Other assumptions: The impairment test is most sensitive to ONCOS-102 probability to succeed in the marked. If the product does not succeed the valuation will be 0. If the product succeeds the value will Input to model Assumptions increase significantly other assumptions unchanged. Assumed probability to succeed is based Price per treatment 48-65 000 USD dependent on geography Royalty (% on gross 20% 7 " R 7 " / 5 revenues) Patient base Currently 25 000 M 175 000 patients growing between 1-3% annually dependent of indication, Peak penetration 5%-50% dependent of indication 17. Property, plant and equipment Years to launch 5 years Property, Plant and equipment (non-current assets) are carried at cost less Years from launch to peak 5 years Years on peak 5 years (no cash flows estimated after last year at peak) accumulated depreciation and accumulated impairment losses. Acquisition cost includes Probability of success 5% - 10% dependent of indication expenditures that are directly attributable to the acquisition of the individual item. Other Discount factor 15% non-current assets is depreciated on a straight-line basis over the expected useful life of the asset. lf significant individual parts of the assets have different useful lives, they are An estimate of discounted expenses to assumed time to licensing of the product are deducted recognized and depreciated separately. Depreciation commences when the assets are ready the value. for their intended use. The assumptions are based on professional judgment, but should due the nature of the At the end of each reporting period, the Group reviews the carrying amounts of its assets to business be considered with significant uncertainty. determine whether there is any indication that those assets have suffered an impairment loss. Results and sensitive analysis Property, plant and equipment consist of: The impairment test indicated that the value of the intangible assets is NOK 384 million, which Office equipment acquired during 2015 and 2014. The estimated useful lives of the assets exceeds the book value with NOK 26 million. are 5 years, and accumulated depreciation as at 31 December 2015 is NOK 148 thousand and NOK 11 thousands in 2014. No impairment losses have been recognized. The value is however based on key assumptions. If these key assumptions are developing unfavorable going forward it may cause a need for impairment. For example if the discount # R / # ## D / "E 7 / "/ " " # 7 construction works and machinery and equipment purchases made by Oncos in 2010 M rate increase to 16%, assumed royalty decrease with 1%-points or assumed probability of 2012 pertaining to the premises (approximately EUR 1.4 million exclusive VAT). The success decreases with 1%-.points the intangible assets will be impaired if other assumptions Group is now repaying such investment as part of the rent. The rental agreement may be are unchanged. terminated by the Group in August 2020 and by the landlord in August 2025. Should the lease be terminated by the Group prematurely (i.e. before August 2020), the Group would The table below shows how the recoverable amount of intangible assets will be affected by / / . / Q " " " 7 / "/ " 9 H ) # 7 / "/ "R total investment per month of premature termination). changes in various assumptions, given that the remainders of the assumptions are constant. Assumptions Sensitivity Changes in recoverable amount Discount rate +/- 1% point -53 MNOK/+59 MNOK 18. Lease Royalty +/- 1% point +31 MNOK/-31 MNOK Probability of success +/- 1% point +89 MNOK/-89 MNOK A lease is classified at the inception date as a finance lease or an operating lease. A lease that transfers substantially all the risks and rewards incidental to ownership to the Group is classified as a finance lease. The determination of whether an arrangement is (or B - 54 P. 102 Accounts and Notes M Targovax group P. 103 Accounts and Notes M Targovax group contains) a lease is based on the substance of the arrangement at the inception of the lease. 19. Receivables To understand if the lease is a finance lease or an operating lease depends on the substance of the transaction rather than the form of the contract Receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are included in current assets, except for maturities Lease payments under operating leases are recognized as an expense on a straight-line basis greater than 12 months after the balance sheet date. These are classified as non-current 5 7 % R / /. " # ## / E " over the lease term. Incentives received on negotiating or renewing operating leases are also amortized on a straight-line basis over the lease terms. Any prepaid lease payments are and government grants in the Statement of financial position, see Note 9 for further information recognized in the balance sheet and amortized over the lease term on a straight-line basis. of the recognition of grants in the income statement. Any contingent rentals arising under operating leases are recognized as an expense in the period in which they are incurred. (Amounts in NOK thousands) 2015 2014 Receivable government grants 5 871 3 749 VAT receivable 814 549 The Group has not entered into any finance lease arrangements . The only significant agreement Other prepayments 4 873 362 classified as operating lease is the rental agreement for premises: Total receivables 11 557 4 660 The Group rents premises in Oslo, Norway for office purposes. The rental agreement, initiated at 18 December 2015 and which Targovax ASA was located as at 31 December 2015, expires 20. Cash and cash equivalents on 31 December 2020. The agreement is non-cancellable and expected minimum payment in 2016 is NOK 1 568 000 (excl VAT). The Company is in addition to this amount charged for a Cash and short-term deposits in the Statement of financial position comprise cash at proportionate share of common variable costs related to building management. Recognized bank and other short-term highly liquid investments with original maturities of three months lease expenses for 2015 is NOK 622 301 and for 2014 it was 329 889. or less. The Group also rents premises in Helsinki, Finland for office and laboratory purposes. The rent is approximately EUR 228,000 per annum (excl VAT). As part of the lease, the landlord At 31 December 2015 and 2014 the Group only held cash deposits. agreed to finance the construction works and machinery and equipment purchases made by (Amounts in NOK thousands) 2015 2014 Bank deposits 173 898 62 552 Oncos in 2010 M 2012 pertaining to the premises (approximately EUR 1.4 million excl VAT). Total cash and cash equivalents 173 898 62 552 The Group is now repaying such investment as part of the rent. The rental agreement may be terminated by the Group in August 2020 and by the landlord in August 2025. Should the lease be terminated by the Group prematurely (i.e. before August 2020), the Group would be liable Restricted cash specification: to pay liquidated damages to the la "/ " 9 H ) # 7 / "/ "R / ( Amount s i n NO K t housa nds) 2015 2014 investment per month of premature termination). Income tax w ithholding from employee compensation 1 842 307 Rent deposits 2 429 7 /. / 7 . ## 7 % R / C # 7 Other 242 tangible fixed assets. The Group does not own any assets which are necessary for production. Total restricted cash 4 513 307 B - 55 P. 104 Accounts and Notes M Targovax group P. 105 Accounts and Notes M Targovax group 21. Share capital and shareholder information The Group had 88 shareholders as at 31 December 2014: Share capital as at 31 December 2015 is 2 688 381 (31 December 2014: 942 940) being 26 Shareholder # shares % Radiumhospitalets Forskningsstiftelse 3 410 589 36,2 % 883 808 ordinary shares at nominal value NOK 0.10 (31 December 2014: 9 429 404 at NOK Datum Invest AS 1 162 000 12,3 % 0.10). All shares carry equal voting rights. Timmuno AS 724 650 7,7 % Prieta AS 720 000 7,6 % The movement in the number of shares during the period was as follows: Birk Venture AS 438 657 4,7 % 2015 2014 Algot Invest AS 392 465 4,2 % Ordinary shares at beginning of period 9 429 404 4 703 000 Portia AS 300 000 3,2 % Share issuance - private placement 8 000 000 4 726 404 Trygve Schiørbecks Eftf. AS 286 449 3,0 % Aquisition of Oncos Therapeutics OY 9 429 404 - Arctic Funds PLC 182 000 1,9 % Op-Europe Equity Fund 157 869 1,7 % Share issuance, employee share options 25 000 - 10 largest shareholders 7 774 679 82,5 % Ordinary shares at end of period 26 883 808 9 429 404 Other shareholders (78) 1 654 724 17,5 % Total shareholders 9 429 403 100,0 % The Group had 193 shareholders as at 31 December 2015: Shareholder # shares % HealthCap 8 488 918 31,6 % Earnings per share Radiumhospitalets Forskningsstiftelse 3 410 589 12,7 % Trojan AS 2 462 000 9,2 % Earnings per share are calculated by dividing the profit or loss attributable to ordinary Arctic Funds PLC 907 000 3,4 % shareholders of the Company by the weighted average number of ordinary shares Timmuno AS 724 650 2,7 % outstanding during the period. Prieta AS 720 000 2,7 % Portia AS 631 945 2,4 % Danske Bank A/S 587 971 2,2 % Diluted earnings per share is calculated as profit or loss attributable to ordinary shareholders Nordnet Bank AB 570 022 2,1 % of the Company, adjusted for the effects of all dilutive potential options. KLP Aksje Norge VPF 460 000 1,7 % Eltek Holding AS 442 000 1,6 % Statoil Pensjon 433 716 1,6 % Storebrand Vekst 425 000 1,6 % Pactum AS 400 000 1,5 % Amounts in NOK thousand 2015 2014 Birk Venture AS 378 980 1,4 % Loss for the period -89 781 -17 646 Op-Europe Equity Fund 357 869 1,3 % Average number of outstanding shares during the period 18 150 7 066 Trygve Schiørbecks Eftf. AS 286 449 1,1 % Viola AS 280 000 1,0 % Earnings/ loss per share - basic and diluted -4,95 -2,50 Kommunal Landspensjonskasse 270 000 1,0 % Verdipapirfondet DNB Grønt NORDEN 250 919 0,9 % Share options issued have a potential dilutive effect on earnings per share. No dilutive effect 20 largest shareholders 22 488 028 83,6 % Other shareholders (173) 4 395 780 16,4 % has been recognized as potential ordinary shares only shall be treated as dilutive if their Total shareholders 26 883 808 100,0 % conversion to ordinary shares would decrease earnings per share or increase loss per share from continuing operations. As the Group is currently loss-making an increase in the average HealthCap, Radiumhospitalets Forskningsstiftelse, Timmuno AS and Prieta AS have entered into lock- up agreements for their shares for the period until the earliest of: number of shares would have anti-dilutive effects. (1) completion of an initial public offering (2) the day falling 12 Months after the completion of the private placement 9 July 2015 B - 56 P. 106 Accounts and Notes M Targovax group P. 107 Accounts and Notes M Targovax group " 7 S / 7 / ! 8Rs steering rate less 3 percentage points 22. Interest-bearing debt per annum, although not less than 1%. Interest-bearing liabilities have been granted by governmental institution with For the IFRS adjustment of the Tekes loans described above the Company applied the special terms such as a low interest rate (1% currently), hence the loans shall be divided to transitional exemptions for first time adopters under IFRS 1. As a consequence, Tekes loans financial liability and government grant components. granted prior to 1 January 2013 were not adjusted to fair value. In the purchase price allocation these loans have been adjusted to fair value by discounting future cash flows using the 8 % The financial liability shall be initially recognized at fair value and subsequently at amortized interest rate, resulting in a fair value adjustment of TNOK 9,283.9 and a carrying amount of cost using effective interest method. The grant component shall be recognized as income on TNOK 33,584.0 in the statement of financial position at the acquisition date. Based on the a systematic basis over the periods in which the entity recognizes as expenses the related effective interest rate method, an increase in interest expense of TNOK 726,2 has been costs for which the grants are intended to compensate. The interest rate used to discount the recorded in the statement of profit or loss and other comprehensive income as at 31 December cash flows of the loans should reflect the market rate of interest for the Company at the time 2015. when the tranches have been withdrawn. However, as per management, Targovax could only raise finance from the owners or/and from venture capitalists at 8% rate or from the Should the project fail, it is possible to get a remission on part of the debt in accordance with % Y 5 7 /. 7 @ Q/ 8 R5 7 # " the EU competition legislation. The final amount of the non-recovered part of the principal limits also set restrictions to the estimation of the fair market rate that shall be used to discount depends on factors such as the time and the materialized interest rate trend. The final sum the cash flows. Further, there is no proper peer group for life science companies, hence there will be determined when an eventual decision on non-recovery is made. Targovax Group has is no comparable yield curve available in Europe. Any other interest rate than in the bridge issued an on-demand guarantee in favor of Tekes for the repayment obligation of Oncos loan interest will be highly judgmental due to the very tight credit status of the company (cannot Therapeutics OY under the R&D loans. The loan agreements include no financial covenants. provide any collateral). Therefore, the 8% bridge loan interest represents managements best and only estimate of a market rate interest and is used in separating the government grant component from the Tekes loans. The additional interest expense resulting from recognizing 23. Current liabilities the loan by using the effective interest method, is booked as addition to interest expenses in the p&l. The separated government grant is booked as other operating income in the p&l in 7 % R # / / / # " " . / " 7 the period when it has been received. liabilities as withholding taxes and accrued expenses, and are classified as "current liabilities". Trade and accounts payable are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Trade and accounts payable are The Group has received three R&D loans, for the commercialization of ONCOS-102, from classified as current liabilities if payment is due within one year or less (or in the normal Tekes under loan agreements dated September 2010, January 2012 and December 2013, operating cycle of the business if longer). If not, they are presented as non-current liabilities. respectively, in the total outstanding amount of EUR 5,842,312 as of 31 December 2015. Accounts payable and other financial liabilities are recognized initially at fair value and Tekes is a publicly financed funding agency that finances research and development activities subsequently measured at amortized cost using the effective interest method. for young innovative companies in Finland. Pursuant to IFRS, these loans have a grant element due to the low interest rate they carry. The loan periods of the R&D loans are 10 years, of which the first five years are free of repayment. However, one of the three loans has a term of 13-year duration with 8 years free of repayment. The loans are repaid in equal annual installments during the latter five years. Annual interest is paid yearly throughout the entire loan period. The applicable interest rate B - 57 P. 108 Accounts and Notes M Targovax group P. 109 Accounts and notes Targovax ASA Current liabilities consist of: Accounts and notes Targovax ASA (Amounts in NOK thousands) 2015 2014 Trade and other payables 6 307 2 564 Withholding taxes and social security payables 1 826 781 Statement of profit or loss - Targovax ASA Accruals for expenses 17 287 3 344 FY 2015 FY2014 Total current liabilities 25 420 6 689 (Amounts in NOK thousands except per share data) Note 2015 2014 Other revenues 7 1 152 72 Total revenue 1 152 72 External R&D expenses 8 -19 807 -7 766 24. Events after the reporting date Payroll and related expenses 9,10,11,12 -21 973 -5 367 Other operating expenses 13 -22 437 -4 509 During the first two months of 2016 the Group granted 25 000 new share options to other Total operating expenses -64 217 -17 642 employees (see note 12). Operating profit/ loss (-) -63 065 -17 570 Financial income 14 2 339 343 In January 2016, Targovax submitted a trial protocol to the regulatory authorizes in Spain to Financial expenses 14 -676 -420 Net financial items 1 663 -77 assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of lung cancer associated with exposure to asbestos. Loss before income tax -61 402 -17 646 Income tax expense 15 Loss for the period -61 402 -17 646 In March 2016, Targovax reported encouraging interim survival results from its ongoing phase Total income / loss (-) for the period attributable to I/II trial of TG01 in resected pancreatic cancer. In this 19 patients trial, 15 patients provided owners: -61 402 -17 646 consent to be followed up of which 14 patients were alive after one year. Earnings/ loss (-) per share Basic and dilutive earnings/ loss (-) per share 21 -3.38 -2.50 Statement of comprehensive income M Targovax ASA (Amounts in NOK thousands except per share data) 2015 2014 Income / loss (-) for the period -61 402 -17 646 Items that may be reclassified to profit or loss: - - Exchange differences arising from the translation of foreign operations - - Total comprehensive income/ loss (-) for the period -61 402 -17 646 Total comprehensive income/ loss (-) for the period attributable to owners -61 402 -17 646 The Notes on pages 114 to 140 are an integral part of these financial statements. B - 58 P. 110 Accounts and notes Targovax ASA P. 111 Accounts and notes Targovax ASA Statement of financial position M Targovax ASA Oslo, 16 March 2016 The Board of directors of Targovax ASA (Amounts in NOK thousands) Note 31.12.2015 31.12.2014 ASSETS Property, plant, and equipment 16 269 150 Investment in subsidiaries 18 273 134 Total non-current assets 273 403 150 Receivables 19 7 846 4 660 Cash and cash equivalents 20 165 868 62 552 Total current assets 173 715 67 213 TOTAL ASSETS 447 118 67 362 EQUITY AND LIABILITIES Shareholders equity Share capital 21 2 688 943 Share premium reserve 522 502 97 792 Other reserves 5 256 780 Retained earnings -100 244 -38 841 Total equity 430 203 60 673 Current liabilities Accounts payable and other current liabilities 22 4 915 2 564 Accrued public charges 22 1 588 781 Other short-term liabilities 22 10 413 3 344 Total current liabilities 16 915 6 689 TOTAL EQUITY AND LIABILITIES 447 118 67 362 The Notes on pages 114 to 140 are an integral part of these financial statements. B - 59 P. 112 Accounts and notes Targovax ASA P. 113 Accounts and notes Targovax ASA Statement of changes in equity M Targovax ASA Statement of cashflow M Targovax ASA Retained (Amounts in NOK thousands) Note 2015 2014 Share Share Other earnings (Amounts in NOK thousands) Note Total equity Cash flow from operating activities capital premium reserves (Accumulated losses) Loss before income tax -61 402 -17 646 Balance at 1 January 2014 470 20 368 633 -21 195 276 Loss for the period -17 646 -17 646 Adjustments for: Other comprehensive income/loss, net of tax Total comprehensive income for the period -17 646 -17 646 Finance income 14 -2 339 -343 Finance expense 14 676 420 Recognition of share-based payments 12 147 147 Issue of ordinary shares - Capital increase 21 473 77 424 77 896 Share option expense 12 4 476 147 Audited balance at 31 December 2014 943 97 792 780 -38 841 60 673 Depreciation 13 39 11 Balance at 1 January 2015 943 97 792 780 -38 841 60 673 Change in receivables 19 -3 185 1 166 Loss for the period -61 402 -61 402 Change in other current liabilities 22 10 886 2 412 Other comprehensive income/loss, net of tax Total comprehensive income for the period -61 402 -61 402 Net cash flow from /(used in) operating activities -50 849 -13 834 Issue of ordinary shares - Aquiring Oncos Therapeutics OY 21 943 234 792 235 735 Transaction costs - Oncos Therapeutics OY 21 -260 -260 Issue of ordinary shares - Capital increase - Private 21 800 199 200 200 000 Cash flow from investing activities Transaction costs - Private Placement 21 -9 207 -9 207 Share issuance, employee share options 21 3 185 188 Purchases of property, plant, and equipment (PPE) 16 -158 -160 Recognition of share-based payments 21 4 476 4 476 Investment in subsidiary 18 -37 399 Audited balance at 31 December 2015 2 688 522 502 5 256 -100 244 430 203 Net cash received from/(paid in) investing activities -37 557 -160 The Notes on pages 114 to 140 are an integral part of these financial statements. Cash flow from financing activities Interest received 14 1 009 287 Interest paid 14 -7 -1 Other finance expense 14 -5 Share issue expense - Aquisition of Oncos OY 21 -260 Share issue expense - Private Placement 21 -9 207 -4 604 Proceeds from issuance of shares -Private Placement 21 200 000 72 500 Proceeds from exercise of options 21 188 Net cash generated from financing activities 191 722 68 176 Net increase/(decrease) in cash and cash equvivalents 103 316 54 182 Cash and cash equivalents at beginning of period 62 552 8 370 Cash and cash equivalents at end of period 165 868 62 552 The Notes on pages 114 to 140 are an integral part of these financial statements. B - 60 P. 114 Accounts and notes Targovax ASA P. 115 Accounts and notes Targovax ASA Notes to the financial statements M Targovax ASA Functional currency The functional currency of the Company is NOK. Transactions in foreign currency are 1. General information translated to functional currency using the exchange rate at the date of the transaction. At the end of each reporting period foreign currency monetary items are translated using the closing The Company is a public limited liability company incorporated and domiciled in Norway. The rate, non-monetary items that are measured in terms of historical cost are translated using the address of the registered office is Lilleakerveien 2C, 0283 Oslo, Norway. exchange rate at the date of the transaction and non-monetary items that are measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair Targovax ASA ("the Company") is a clinical stage immuno-oncology company dedicated to value was measured. Changes in the exchange rate are recognized continuously in the the development of targeted immunotherapy treatments for cancer patients. accounting period. The Company is targeting complementary approaches to cancer immunotherapy: A peptide Presentation currency vaccine platform developed for patients with RAS-mutated cancers and an immunotherapy 7 .R . & T5 7 / 7 .R # / platform based on engineered oncolytic viruses armed with potent immune-stimulating currency. # @ 7 / " 5 ! 7 7 7 7 R own immune system to fight the cancer. 2.1 Basis for preparation of the annual accounts These financial statements have been approved for issue by the Board of Directors on 16 The financial statements of Targovax ASA have been prepared in accordance with March 2016, and are subject to approval by the Annual General Meeting in April 2016. International Financial Reporting Standards (IFRS) as adopted by the European Union, as well as Norwegian disclose requirements listed in the Norwegian Accounting Act. The financial statements are based on historical cost. 2. Summary of significant accounting principles/Critical accounting estimates and judgments The financial statements have been prepared on the basis of uniform accounting principles for similar transactions and events under otherwise similar circumstances. The principal accounting policies applied in the preparation of these financial statements are described in the respective note, or if not, set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. 2.2 Accounting principles Foreign exchange The Company have changed the way of presenting the operating expenses in the Statement The Company record transactions at initial recognition based on the average month exchange of profit and loss. This change has been applied for the years 2015 and 2014. The first change rate in the month of transaction. The date of a transaction is the date on which the transaction consist of the rename # 7 O # # # S P O / S first qualifies for recognition in accordance with International Financial Reporting Standards. P5 7 @ "" O # # # S P / " // However, if exchange rates fluctuate significantly, the use of the average rate for a period may / S /. / " " 7 O 7 P5 7 be inappropriate and an exchange rate closer to transaction date is used. s " 7 7 7 O P @ / " " 7 O 7 Any exchange differences are recognized in profit or loss under financial items in the period P5 in which they arise. Amounts are in thousand Norwegian kroner unless stated otherwise. B - 61 P. 116 Accounts and notes Targovax ASA P. 117 Accounts and notes Targovax ASA 2.3 Adoption of new and revised IFRS standards and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. 2.3.1 Standards and lnterpretations affecting amounts reported in the current period Estimated value of share-based payments All relevant new and revised IFRSs and IFRIC interpretations that are mandatory for periods At each balance sheet date, the Company revises its estimates of the number of options that commencing 1 January 2015 and earlier have been adopted for all periods presented in these are expected to vest. It recognizes the impact of the revision to original estimates, if any, in financial statements. the income statement, with a corresponding adjustment to equity. The estimated turnover rate for unvested share options is five percent for all share option plans. See Note 12 Share-based 2.3.2 Standards and lnterpretations in issue but not yet adopted compensation. IFRS15 Revenue from Contracts with Customers: The Company is in the research and development phase and the IFRS 15, will not have a Deferred tax material effect on the financial statements The Company cannot render probable future taxable income large enough to justify recognizing a deferred tax asset in the balance sheet. However, this assumption must be IFRS 16 Lease: continually assessed and changes could lead to a significant asset being recognized in the IFRS 16 replaces existing IFRS leases requirements, IAS 17 Leases. IFRS 16 sets out the future. This assumption requires significant management judgment. See Note 15 Taxes. principles for the recognition, measurement, presentation and disclosure of leases for both E 7 9Q/ R< " 7 / 9Q/ R<5 7 @ / standard requires lessees to recognize assets and liabilities for most leases, which is a 4. Acquisition of Oncos Therapeutics significant change from current requirements. The effective date of the standard is January 1 On 2 July 2015, the Company acquired all the shares in Oncos Therapeutics Oy ("Oncos"), 2019, but it is not yet approved by the EU. an unlisted privately funded company based in Finland. Oncos was a clinical-stage biotechnology company, which focused on the design and development of targeted cancer The Company has not made any assessment of any impact IFRS 16 will have on the financial immunotherapy. The transaction was structured as a share for share exchange whereby statements. Targovax ASA issued 9 429 404 new shares to the shareholders of Oncos as consideration # 7 7 9 7 O Q P<5 2.4 Going concern As a result of the private placement in the third quarter 2015 and the current liquidity situation, Following the Oncos Acquisition, Oncos is a wholly-owned subsidiary of the Company at the Directors have an expectation that the Company has available financial resources sufficient closing date of the agreement 2 July 2015 (the "Acquisition date"). Following the share capital for the planned activities in the next 12 months as of 31 December 2015. The Company increase registered on July 2 2015, the share capital of Targovax was NOK 1 885 880.80, therefore continues to adopt the going concern basis in preparing its financial statements. divided into 18 858 808 shares, each with a nominal value of NOK 0.10. The combination of Targovax and Oncos complementary technologies creates a unique platform for the development of cutting-edge vaccines and immunotherapies. The combined 3. Important accounting estimates and discretionary group of Targovax and Oncos is positioned as a leading immuno-oncology company with assessments clinical experience to date validates safety and mechanism of action of both technology platforms. Management makes estimates and assumptions that affect the reported amounts of assets and liabilities within the next financial year. Estimates and judgments are continually evaluated The main value driver for Oncos was the patented technology and mainly the product technology for the ONCOS-102 product. The allocation of value to the patented technology is B - 62 P. 118 Accounts and notes Targovax ASA P. 119 Accounts and notes Targovax ASA done by a cost based valuation approach, analyzing the total fund invested in the intangible Deferred tax assets and additional value created as part of the product development. Deferred tax is calculated on temporary differences on intangible assets. The value of the identified intangible assets acquired amounts to TNOK 327 409. Net tax value of assets No residual value of the purchase price is recognized as goodwill, and no other excess values capitalized for tax purposes amounts to TNOK 67 649, resulting in a temporary difference of than patented technology is identified as part of the transaction. TNOK 261 058 and a deferred tax of TNOK 51 952 using statutory tax rate in Finland of 20%. Total transaction costs related to the acquisition is NOK 4 million. The deferred tax will be calculated on the same basis going forward. No contingent consideration arrangements are identified as part of the acquisition. In addition, recognition of deferred tax asset has been assessed in the purchase price // 5 / " / # R K $5 // # The fair values of the identifiable assets and liabilities of Oncos, as at the date of acquisition, as a result of the preliminary purchase price allocation were: 31 December 2014. With a current tax rate in Finland of 20%, the corresponding deferred tax asset is EUR 1.6 million. Oncos has not recognized any deferred taxes under FGAAP. Tax (Amounts in NOK/EUR thousands) NOK EUR losses in Finland can be carried forward and offset against taxable income in ten years for tax Assets purposes. Oncos has not generated taxable income in prior years and is not expected to Intangible assets 327 409 37 227 generate taxable income in the nearest future. Due to the uncertainty for future taxable profit Tangible assets 1 298 148 Other current assets 6 324 719 within the ten years limitation of use, the company has assessed that it cannot be considered Cash and cash equivalents 1 313 149 as probable that future taxable profit can be used against the tax losses carried forward. No Total assets 336 344 38 243 deferred tax asset is recognized in the purchase price allocation. Liability Deferred tax 51 952 5 907 Other non-current liabilities Other non-current liabilities 33 584 3 819 Oncos Therapeutics OY has received funding from Tekes in the forms of R&D loans in the Other current liabilities 15 073 1 714 Total liabilities 100 609 11 439 principal outstanding amount of EUR 5 842 312 for the commercialization of ONCOS-102. Tekes is a publicly financed funding agency that finances research and development activities TOTAL CONSIDERATION (THE "PURCHASE PRICE") 235 735 26 803 for young innovative companies in Finland. Intangible assets Three separate R&D loans with special terms have been granted before acquisition date by Intangible assets of NOK 327 409 083 comprises the patented technology, which is a key governmental institution at a very low interest rate. Interest charged is 1% while market rate value driver for Oncos. The patented technology consists mainly of the product technology for is assessed to be 8%. Under IFRS carrying amount of the liability is recognized at fair value. the ONCOS-102 product. ONCOS-102 has shown promising results in cellular immune Fair value is determined by discounting future cash flows applying the 8 % interest rate. The response stimulation. The product has succeeded in passing the critical phase I in the fair value adjustment on initial recognition of the liability is in accordance with IAS 20, development cycle and is ready to start phase II in several solid tumor indications. In addition, recognized as government grant. The government grant is recorded as a reduction to other ONCOS-102 has been designated orphan drug status both in Europe and the US for the operating expenses in the period when the loans have been granted. Interest expense is indications mesothelioma, ovarian cancer, and soft tissue sarcoma. The other products and calculated by using the effective interest rate method. patents developed by Oncos are still at a discovery stage and invested capital in these products is insignificant. No excess value is allocated to other products than ONCOS-102. The loans usually have a 10-year duration, of which the first five years are free of repayment. However, one of the three loans has a term of 13-year duration with 8 years free of repayment. Repayment shall be made in equal annual instalments during the latter five years, while interest is paid annually throughout the entire loan period. The applicable interest rate under B - 63 P. 120 Accounts and notes Targovax ASA P. 121 Accounts and notes Targovax ASA the R&D loans is the European / ! 8R / interest rates and to variations in interest rates of bank deposits. Consequently, movements annum, although no less than 1 percent. in interest rates could have a material and adverse effect on 7 .R E # / condition, results of operations, cash flows, time to market and prospects. Should the project fail, it is possible to get a remission on part of the debt in accordance with the EU competition legislation. The final amount of the non-recovered part of the principal depends on factors such as the time and the materialized interest rate trend. The final sum will be determined when an eventual decision on non-recovery is made. Targovax Group has issued an on-demand guarantee in favor of Tekes for the repayment obligation of Oncos Therapeutics OY under the R&D loans. The loan agreements include no financial covenants. 5. Segments Foreign currency risk D/ 7 /" ## 7 .R cash flow and financial condition The Company's activities during 2015 have been to continue the development and The Company has currency exposure to both transaction risk and translation risk related to its implementation of a strategy with the aim of developing highly targeted immunotherapy operating expenses. Transaction risk arises when future commercial transactions or treatments for cancer patients recognized assets or liabilities are denomin " . 7 7 .R # / currency. The Company undertakes various transactions in foreign currencies and is The .R lead product has not yet obtained regulatory approval. For management consequently exposed to fluctuations in exchange rates. The exposure arises largely from purposes, the Company is organized as one business unit and the internal reporting is research expenses. The Company is mainly exposed to fluctuations in EUR, GBP and CHF. structured in accordance with this. The Company is thus currently organized in one operating Translation risk arises due to the conversion of amounts denominated in foreign currencies to segment. & TE 7 .R functional currency. The following tables demonstrate the .R currency rate sensitivity on financial assets 6. Financial instruments and risk management objectives and liabilities at 31 December 2015 and 2014. and policies 7 .R . )Y H" K & T The Company's financial assets and liabilities comprise cash in banks, receivables borrowings and trade creditors that originate from its operations. All financial assets and liabilities are carried at amortized cost. All financial assets and liabilities are short-term and their carrying value approximates fair value. 7 .R . )Y H" MD & T The Company does currently not use financial derivatives. The Company is subject to market risk, credit risk and liquidity risk. Market risk ; #/ /" 7 # //. " " /. ## 7 .R 7 .R sensitivity to a 10% increase/decrease in GBP against NOK business, financial condition, results of operations, cash flows, time to market and prospects. Currently, the Company has no long-term debt. The Company may in the future be exposed Credit risk to interest rate risk primarily in relation to any future interest bearing debt issued at floating B - 64 P. 122 Accounts and notes Targovax ASA P. 123 Accounts and notes Targovax ASA Credit risk is the risk of a counterparty defaulting. The Company has limited credit risk. directly connected. There will be no cash flow commitments related to the development Outstanding receivables are limited and primarily government grants receivable from various program before properly commitments to funding is in place. government agencies. No impairment has been recognized. The carrying value of the assets represents the Company's maximum exposure to credit risk. 7 # // @ / /. 7 % R " -current financial liabilities, at 31 December 2015 and 2014 respectively, into relevant maturity groupings based on the The credit quality of financial assets can be assessed by reference to credit ratings. remaining period at the balance sheet date to the contractual maturity date. The amounts disclosed in the tables are the financial undiscounted cash flows. Cash at bank: Fair value of financial instruments The carrying value of receivables, cash and cash equivalents, borrowings, deferred tax, and other short term payables and accrued liabilities are assessed to approximate fair value. 7. Revenue recognition Revenue comprises the fair value of consideration received or due consideration for the sale of services in regular business activities. Revenue is presented net of value added tax. Revenue is recognized when the service is performed. At the end of year 2015 and 2014 there were no financial instruments carried at fair value to measure. (Amounts in NOK thousands) 2015 2014 Revenue from subsidiary 1 152 - Liquidity risk Other revenue - 72 The Company manages liquidity risk by estimating and monitoring cash and liquidity needs Total operating revenue 1 152 72 on an on-going basis, and maintaining adequate reserves and banking facilities. The Company has sufficient cash available to meet its obligations as at 31 December 2015. All liabilities at year-end are short term and fall due within one year of the reporting date, their carrying value 7 .R " // 7 7 " " / 7 E " 7 approximates their fair value. revenue from sales of products yet. Other revenue in 2014 from consulting services carried out in Norway. The Company is properly funded for its current activities, but will need new funding for the next phases of the development program. The funding strategy and development strategy are B - 65 P. 124 Accounts and notes Targovax ASA P. 125 Accounts and notes Targovax ASA 8. External research and development expenses contribution will be achieved. The grant is recognized in the income statement in the same period as the related costs, and are presented net. Expenditure on research activities is recognized as an expense in the period in which it is incurred. Internal development costs related to the Company's development of products Government grants are normally related to either reimbursements of employee costs and are recognized in the income statement in the year incurred unless it meets the asset classified as a reduction of payroll and related expenses or related to other operating activities recognition criteria of IAS 38 "lntangible Assets". and thus classified as a reduction of other operating expenses. Uncertainties related to the regulatory approval process and other factors generally means that the criteria are not met until the time when the marketing authorization is obtained with Government grants have been recognized in profit or loss as a reduction of the related the regulatory authorities. This assessment requires significant management discretion and expense with the following amounts: estimations. (Amounts in NOK thousands) 2015 2014 External R&D expenses 6 610 6 034 Payroll and related expenses 2 225 2 003 The Company is developing new products. Uncertainties related to the regulatory approval Total 8 834 8 038 process and results from ongoing clinical trials, generally indicate that the criteria for asset recognition is not met until the time when marketing authorization is obtained from relevant R&D projects have been approved for SkatteFunn for the period 2011 through 2016. For the regulatory authorities. full year 2015 the Company has recognized NOK 4 361 331 (2014: 3 236 368) as cost reduction in Payroll and related expenses and Other Operating expenses. The following external research and development expenditures have been expensed: For the period 2013 through 2016, the Company has been awarded a grant from The (Amounts in NOK thousands) 2015 2014 Research Council (program for user-managed innovation arena (BIA)) of NOK 12 361 000 in Cost of manufacturing for R&D 4 191 7 735 Patent expenses 352 336 total. For the full year ended 31 December 2015, the Company has recognized NOK 4 473 Other 21 874 5 730 000 (4 712 435) as cost reduction in External R&D expenses and Payroll and related Government grants -6 610 -6 034 expenses. Total external research and development expenses 19 807 7 766 Grants receivables as at 31 December are detailed as followed: The following research and development expenditures have been expensed: (Amounts in NOK thousands) 2015 2014 (Amounts in NOK thousands) 2015 2014 Grants Research Counsil 1 491 512 Total R&D Total R&D Grants from SkatteFUNN 4 361 3 236 External R&D expenses 19 807 19 807 7 766 7 766 Total grants 5 852 3 749 Payroll and related expenses 21 973 8 936 5 367 4 752 Other operating expenses 22 437 384 4 509 2 276 Total 64 217 29 127 17 642 14 794 10. Payroll and related expenses 9. Government grants Payroll and related expenses are recognized in the income statement in the period in Government grants are recognized at the value of the contributions at the transaction which the related costs are incurred or services are provided. date. Grants are not recognized until it is probable that the conditions attached to the B - 66 P. 126 Accounts and notes Targovax ASA P. 127 Accounts and notes Targovax ASA / . " . R " " 7 .E / & / " Defined contribution plans " 7 % R /idated financial statements. See Targovax ASA has a defined contribution pension plan as required by the Norwegian Law. Note 10 and 12 for accounting principle for payroll and related expenses and equity-settled This pension plan apply to all employees of Targovax ASA. Currently, members of the share- " . 7 .R # / 5 Management team with residence " & @ . # 7 .R national pension plans. The company pays these executives an annual amount in addition to Related party transactions: base salary in lieu of their participation in a company scheme. For defined contribution pension plans, contributions are paid to pension insurance plans and charged to the income statement 2015 2014 in the period to which the contributions relate. (Amounts in NOK thousands) Receivable/(payable Receivable/(payable Revenue/(expense) at 31 December Revenue/(expense) at 31 December Bonus scheme Knudtzon 392 92 - - Bonuses are based on the corporate objectives as well as individual objectives. The Company Subsidiaries: recognizes a liability and an expense for bonuses based on a short-term incentive plan for M / " " -835 - - - employees linked to achievement of specific targets determined by the Board. See note 11. M / / " " 317 - - M / " " 1 152 - - Total payroll and related expenses for the Company are: Targovax entered into a consulting agreement with Knudtzon, a Zurich based company, 26 (Amounts in NOK thousands) 2015 2014 Salaries ad bonus 15 226 5 767 June 2015. Knudtzon is a related party of Nikolaj Knudtzon, who was elected as a member of / . R / 2 247 1 080 Targovax Management Team, Head of HR, in June 2015. Knudtzon is entitled to a Share-based compensation1 M & 4 476 147 consultancy fee of NOK 73,500 per month. : M " # " / 629 257 Other 1 619 119 Remuneration to the statutory auditor (excl. VAT): Governmental grants -2 225 -2 003 Total payroll and related expenses 21 973 5 367 (Amounts in NOK thousands) 2015 2014 1) Share-based compensation has no cash effect. Statutory audit 160 70 Other attestation services 979 Number of employees calculated on a full-time basis as at 31 December 15,5 5,5 Tax services 40 63 Number of employees as at 31 December 16 6 Other services 527 Total 1 706 133 Targovax ASA has a defined contribution pension scheme that complies with requirements of Norwegian occupational pension legislation (OTP). The contribution is expensed when it is accrued. 11. Related parties and Management 12. Share-based compensation Equity-settled share-based payments are measured at the fair value of the equity As the only difference between the Group and the Company concerning Executive instruments at the grant date. management remunerations is that Antti Vuolanto, EVP, and Magnus Jäderberg, CMO, are B - 67 P. 128 Accounts and notes Targovax ASA P. 129 Accounts and notes Targovax ASA The Company operates an equity-settled, share-based compensation plan, under which the The fair value of the employee services received in exchange for the grant of the options is entity receives services from employees as consideration for equity instruments (options) in recognized as an expense, based on the Company's estimate of equity instruments that will Targovax ASA. eventually vest. The total amount to be expensed is determined by reference to the fair value of the options granted excluding the impact of any non-market service and performance Each share option converts into one ordinary share of the Company on exercise. Options may vesting conditions. The grant date fair value of the options granted is recognized as an be exercised at any time from the date of vesting until expiry. The options generally vest over employee expense with a corresponding increase in equity, over the period that the a period of four years: 25 percent of the options vest on the first anniversary of the grant date; employees become unconditionally entitled to the options (vesting period). and the remaining 75 percent of the options vest in equal monthly tranches over the next 36 months. Options expire seven years after the grant date. The fair value of the options granted is measured using the Black-Scholes model. In general, the exercise price of the options is set at the fair value of the shares at grant date. Measurement inputs include share price on measurement date, exercise price of the instrument, expected volatility, weighted average expected life of the instruments, expected There were granted 2 090 062 share options during 2015, no share options were granted dividends, and the risk-free interest rate. during 2014. As a result of the Oncos transaction 2 July 2015 380 827 share options in Oncos were converted into Targovax share options. The outstanding options in Oncos has been Service and non-market performance conditions attached to the transactions are not taken converted to options in Targovax. At the convertions the exercise price, lifetime and quantity into account in determining fair value. have been adjusted. The adjustments have been made so that fair value of the outstanding award is equal to the fair value of the outstanding awards after conversion. Hence, there is no When the options are exercised, the Company issues new shares. The proceeds received net incremental value to be expensed after the conversion. The conversion of the share options of any directly attributable transaction costs are recognized as share capital (nominal value) entailed no added value. The conversion of the share options entailed no added value. and share premium reserve. During the first two months of 2016, additional 25 000 share options were granted to other employees. At the end of each reporting period, the Company revises its estimates of the number of options that are expected to vest. It recognizes the impact of the revision to original estimates, As of 31 December 2015, there are in total 2,545,889 outstanding options for all option if any, in profit or loss, with a corresponding adjustment to equity. Changes to the estimates programs, 2 450 887 options under the LTI Option Program and 95 002 options under the IPR may significantly influence the expense recognized during a period. Option Program. Fair value of the options has been calculated at grant date. The fair value of the options were calculated using the Black-Scholes model. The expected volatility for options issued in 2015 At the Extraordinary general meeting in September 2015 the Board was authorized to increase is estimated at average of 0.8459, based on the volatility of comparable listed companies. The 7 .R 7 / connection with share incentive arrangements by up to the volume weighted average interest rate applied to the share options grants in first half of 2015 lower of NOK 500 000 and 10% of the Share capital. is 0.84%. 7 . 7 " 7 " / 9 7 OP ; : P<5 7 : / 7 ent as well to employees in general. Certain former employees and former board members have also been granted options under the LTI Option Program. "" //.E 7 . 7 7 " . # 9 7 O;: Option ProgramP<5 B - 68 P. 130 Accounts and notes Targovax ASA P. 131 Accounts and notes Targovax ASA The following table shows the changes in outstanding options in 2015 and 2014: At 31 December 2015, the range of exercise prices and weighted average remaining contractual life of the options were as follows: 2015 2014 Weighted avg. Weighted avg. No. of options excercise price No. of options excercise price (in NOK) (in NOK) Outstanding at 1 January 100 000 7.5 100 000 7.5 Granted during the period 1 2 090 062 24.09 - - Exercised during the period 2 -25 000 7.5 - Convertion of Oncos option program 2/7-2015 380 827 21.77 - - Outstanding no. of options at 31 December 2 545 889 23.25 100 000 7.5 1) See Note 11 Related parties and Executive Management for further information on granted share options to Executive Management. 2) Weighted average exercise price on the exercised share options during the period was At 31 December 2014, the range of exercise prices and weighted average remaining NOK 7.50 in 2015. contractual life of the options were as follows: The average fair value of options granted in 2015 was NOK 14.93 per share, no options was Outstanding options Vested options granted in 2014. The weighted- average assumptions used to determine the Black Scholes Weighted Weighted Outstanding Weighted average average Vested options Exercise price options per average fair value of options granted in 2015 and 2014 were: remaining exercise 31.12.2015 31.12.2015 exercise price contractual life price 7.50 100 000 2.85 7.50 67 500 7.50 2015 2014 Total 100 000 2.85 7.50 67 500 7.50 Volatility (%) 84.59 58.52 Expected life (in years) 3.78 3.57 Risk-free interest rate (%) 0.84 1.49 Share price (NOK) 24.58 143.06 13. Other operating expenses Exercise price (NOK) 24.58 145.54 Expenditure on other operating expenses is recognized in the income statement as an expense in the period in which it is incurred The expensed share-based compensation of NOK 4.5 million in 2015 and the NOK 1.6 million share-based compensation allocated to the investment in Targovax OY in 2015 includes management estimate for employee turnover, hence totaling NOK 6.1 million share-based (Amounts in NOK thousands) 2015 2014 compensation in the Company. / .E " R " ; 17 338 2 314 Travel expenses 1 311 358 The estimated turnover rate used for the year 2015 was 0 %. Facilities expenses 867 541 IT services and IT-related accessories 990 387 Conferences and training 198 99 Other 1 695 800 Depreciation 39 11 Total other operating expenses 22 437 4 509 B - 69 P. 132 Accounts and notes Targovax ASA P. 133 Accounts and notes Targovax ASA 14. Financial items Finance income and expense All finance income and finance expense, except for foreign exchange income/expense, are Financial income consist of interest income and foreign exchange gain. Financial related to financial assets and financial liabilities carried at amortized cost. expense mainly consist of interest expense and exchange loss. Financial income are: Debt and equity instruments are classified as either financial liabilities or as equity in (Amounts in NOK thousands) 2015 2014 accordance with the substance of the contractual arrangements and the definitions of a Interest income on bank deposit 993 274 financial liability and an equity instrument. Interest income on tax repaid 16 14 Currency gain - other operating items 1 329 55 The Company's financial assets consist of receivables and cash. Management determines the Other finance income Total finance income 2 339 343 classification of its financial assets at initial recognition, and the classification of financial assets depends on the nature and purpose of the financial assets. Financial expenses are: Financial liabilities; The .Rs financial liabilities consist of accounts payable and other (Amounts in NOK thousands) 2015 2014 Interest expense - Convertible Loan 75 current liabilities. Accounts payable are obligations to pay for goods or services that have Other interest expense 71 been acquired in the ordinary course of business from suppliers. Accounts payable and other Currency loss - other operating items 668 338 financial liabilities are recognized initially at fair va lue and in the case of loans and borrowings Other finance expense 5 and payables, net of directly attributable transaction costs. Total finance expenses 676 420 Eq uity instruments; An equity instrument is any contract that evidences a residual interest Financial assets in the assets of an entity after deducting all of its liabilities. Equity instruments issued by a Currently, all the .Rs financial assets are categorized as receivables. The Company company are recognized at the proceeds received, net of any issue costs. Transaction costs does not have any trade receivables and at 31 December 2015 and 2014 the receivables directly attributable to the issue of equity are recognized directly in equity, net of tax mainly consist of grants receivables and receivables related to VAT. The Company has currently not recognized any non-current financial assets. Financial assets; The Company's financial assets are initially measured at fair va lue. Transaction costs that are directly attributable to the acquisition of financial assets are added 15. Tax to the fair value of the asset. The assets are subsequently measured at amortized cost using the effective interest method, less any impairment losses. Financial assets are derecognized Income tax expense comprise current income tax (tax payable) and deferred tax. when the rights to receive cash flows from the investments have expired or have been transferred and the Company has transferred substantially all risks and rewards of ownership Deferred taxes are recognized based on temporary differences between the carrying to another party. Financial assets are assessed for indicators of impairment at the end of the amounts of assets and liabilities in the financial statements and the corresponding tax reporting period and are considered impaired when there is objective evidence that, as a bases used in the computation of taxable profit. Deferred tax assets arising from deductible result of one or more events that occurred after the initial recognition of the financial asset, temporary differences are recognized to the extent that it is probable that taxable profits will the estimated future cash flows of the investment have been affected. be available so temporary differences can be utilized. Deferred tax liabilities and assets are measured at the tax rates that are expected to apply in the period in which the liability is settled or the asset realized, based on tax rates that have been enacted or substantively enacted by the end of the reporting period. B - 70 P. 134 Accounts and notes Targovax ASA P. 135 Accounts and notes Targovax ASA The tax losses can be carried forward indefinitely. The Company considers that a deferred At the end of each reporting period, the Company reviews the carrying amounts of its assets tax asset related to accumulated tax losses cannot be recognized in the statement of to determine whether there is any indication that those assets have suffered an impairment financial position until the product under development has been approved for marketing by loss. the relevant authorities. However, this assumption is continually assessed and changes could lead to significant deferred tax asset being recognized in the future. This assumption requires significant management judgment. Property, plant and equipment consist of Office equipment acquired during 2015 and 2014. The estimated useful lives of the assets are 5 years, and accumulated depreciation as at 31 December 2015 is NOK 148 thousand and NOK 11 thousands in 2014. No impairment losses has The Company is in the research phase of its product development and has incurred significant been recognized. tax losses related to its operations. Targovax ASA has a total tax loss carried forward of NOK 119 ,626, 840 at 31 December 2015 (31 December 2014: NOK 50.937.285). No development costs have been recognized as assets as per 31 December 2015. No current or deferred tax charge or liability has been recognized for 2015. 17. Lease (Amounts in NOK thousands) 2015 2014 A lease is classified at the inception date as a finance lease or an operating lease. A Tax loss carried forward -119 627 -50 937 lease that transfers substantially all the risks and rewards incidental to ownership to the Fixed assets 68 21 Company is classified as a finance lease. The determination of whether an arrangement is (or Share options -79 -224 contains) a lease is based on the substance of the arrangement at the inception of the lease. Temporary differences 31.12 -119 638 -51 140 To understand if the lease is a finance lease or an operating lease depends on the substance Deferred tax asset (25%) -29 910 -13 808 of the transaction rather than the form of the contract. (Amounts in NOK thousands) Statutory income tax rate 27 % 27 % Lease payments under operating leases are recognized as an expense on a straight-line basis Tax effect of income / loss (-) -16 664 -4 765 over the lease term. Incentives received on negotiating or renewing operating leases are also Tax effect permanent differences -1 871 -2 055 amortized on a straight-line basis over the lease terms. Any prepaid lease payments are Change in deferred tax not recognized 18 535 6 820 recognized in the balance sheet and amortized over the lease term on a straight-line basis. Tax expense - - Any contingent rentals arising under operating leases are recognized as an expense in the period in which they are incurred. 16. Property, plant and equipment Property, Plant and equipment (non-current assets) are carried at cost less accumulated The Company has not entered into any finance lease arrangements. The only significant depreciation and accumulated impairment losses. Acquisition cost includes expenditures that agreement classified as operating lease is the rental agreement for premises: are directly attributable to the acquisition of the individual item. Other non-current assets is depreciated on a straight-line basis over the expected useful life of the asset. lf significant The Company rents premises in Oslo, Norway for office purposes. The rental agreement, individual parts of the assets have different useful lives, they are recognized and depreciated initiated at 18 December 2015 and which Targovax ASA was located as at 31 December separately. Depreciation commences when the assets are ready for their intended use. 2015, expires on 31 December 2020. The agreement is non-cancellable and expected minimum payment in 2016 is NOK 1 568 000 (excl VAT). The Company is in addition to this amount charged for a proportionate share of common variable costs related to building B - 71 P. 136 Accounts and notes Targovax ASA P. 137 Accounts and notes Targovax ASA management. Recognized lease expenses for 2015 is NOK 622 301 and for 2014 it was 329 (Amounts in NOK thousands) 2015 2014 889. Receivable government grants 5 871 3 749 Receivable from subsidiaries 317 - VAT receivable 814 549 There a /. / 7 . ## 7 .R / C # 7 Other prepayments 845 362 tangible fixed assets. Total receivables 7 846 4 660 The Company does not own any assets which are necessary for production. 20. Cash and cash equivalents 18. Investments in subsidiaries Cash and short-term deposits in the Statement of financial position comprise cash at bank and other short-term highly liquid investments with original maturities of three months Shares and investments intended for long-term ownership are reported in the .R or less. statement of financial position as non-current asets and valued at cost. The Company determines at each reporting date whether there is any objective indication that the investment At 31 December 2015 and 2014 the Company only held cash deposits. in the subsidiary is impaired. If this is the case, the amount of impairment is calculated as the difference between the recoverable amount of the subsidiary and its carrying value and (Amounts in NOK thousands) 2015 2014 recognizes the amount in the income statement. Any realized and unrealized losses and any Bank deposits 165 868 62 552 write downs relating to these investments will be included in the .R statement of Total cash and cash equivalents 165 868 62 552 comprehensive income as financial items. Restricted cash specification: (Amounts in NOK thousands) 2015 2014 (Amounts in thousands) Location Year incorp. Share capital Ow nership Income tax w ithholding from employee compensation 1 842 307 Subsidiary: Rent deposits 40 - Targovax OY (prev. Oncos Therapeutics OY) Helsinki, Finland 2015 EUR 8 211 100 % Total restricted cash 1 882 307 M 7 % Meggen, Sw itzerland 2015 CHF 100 100 % 21. Share capital and shareholder information 19. Receivables Share capital as at 31 December 2015 is 2 688 381 (31 December 2014: 942 940) being Receivables are non-derivative financial assets with fixed or determinable payments that 26 883 808 ordinary shares at nominal value NOK 0.10 (31 December 2014: 9 429 404 at are not quoted in an active market. They are included in current assets, except for maturities NOK 0.10). All shares carry equal voting rights. greater than 12 months after the balance sheet date. These are classified as non-current 5 7 % R / mainly comprise deposit for office leases, prepaid expenses and government grants in the Statement of financial position, see Note 9 for further information of the recognition of grants in the income statement. B - 72 P. 138 Accounts and notes Targovax ASA P. 139 Accounts and notes Targovax ASA The movement in the number of shares during the period was as follows: Shareholder # shares % 2015 2014 Radiumhospitalets Forskningsstiftelse 3 410 589 36,2 % Ordinary shares at beginning of period 9 429 404 4 703 000 Datum Invest AS 1 162 000 12,3 % Share issuance - private placement 8 000 000 4 726 404 Timmuno AS 724 650 7,7 % Aquisition of Oncos Therapeutics OY 9 429 404 - Prieta AS 720 000 7,6 % Birk Venture AS 438 657 4,7 % Share issuance, employee share options 25 000 - Algot Invest AS 392 465 4,2 % Ordinary shares at end of period 26 883 808 9 429 404 Portia AS 300 000 3,2 % Trygve Schiørbecks Eftf. AS 286 449 3,0 % Arctic Funds PLC 182 000 1,9 % The Company had 193 shareholders as at 31 December 2015: Op-Europe Equity Fund 157 869 1,7 % 10 largest shareholders 7 774 679 82,5 % Shareholder # shares % HealthCap 8 488 918 31,6 % Other shareholders (78) 1 654 724 17,5 % Radiumhospitalets Forskningsstiftelse 3 410 589 12,7 % Total shareholders 9 429 403 100,0 % Trojan AS 2 462 000 9,2 % Arctic Funds PLC 907 000 3,4 % Timmuno AS 724 650 2,7 % Earnings per share Prieta AS 720 000 2,7 % Portia AS 631 945 2,4 % Earnings per share are calculated by dividing the profit or loss attributable to ordinary Danske Bank A/S 587 971 2,2 % shareholders of the Company by the weighted average number of ordinary shares Nordnet Bank AB 570 022 2,1 % outstanding during the period. KLP Aksje Norge VPF 460 000 1,7 % Eltek Holding AS 442 000 1,6 % Diluted earnings per share is calculated as profit or loss attributable to ordinary shareholders Statoil Pensjon 433 716 1,6 % of the Company, adjusted for the effects of all dilutive potential options. Storebrand Vekst 425 000 1,6 % Pactum AS 400 000 1,5 % Birk Venture AS 378 980 1,4 % Amounts in NOK thousand 2015 2014 Op-Europe Equity Fund 357 869 1,3 % Trygve Schiørbecks Eftf. AS 286 449 1,1 % Loss for the period -61 402 -17 646 Viola AS 280 000 1,0 % Average number of outstanding shares during the period 18 150 7 066 Kommunal Landspensjonskasse 270 000 1,0 % Earnings/ loss per share - basic and diluted -3,38 -2,50 Verdipapirfondet DNB Grønt NORDEN 250 919 0,9 % 20 largest shareholders 22 488 028 83,6 % Share options issued have a potential dilutive effect on earnings per share. No dilutive effect Other shareholders (173) 4 395 780 16,4 % has been recognized, as potential ordinary shares only shall be treated as dilutive if their Total shareholders 26 883 808 100,0 % conversion to ordinary shares would decrease earnings per share or increase loss per share HealthCap, Radiumhospitalets Forskningsstiftelse, Timmuno AS and Prieta AS have entered into lock- from continuing operations. As the Company is currently loss-making, an increase in the up agreements for their shares for the period until the earliest of: average number of shares would have anti-dilutive effects. (1) completion of an initial public offering (2) the day falling 12 Months after the completion of the private placement 9 July 2015 The Company had 88 shareholders as at 31 December 2014: B - 73 P. 140 Accounts and notes Targovax ASA P. 141 AuditoR 22. Current liabilities AuditorR report 7 .R # / / / # " " . / " 7 current liabilities as withholding taxes and accrued expenses, and are classified as "current liabilities". Trade and accounts payable are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Trade and accounts payable are classified as current liabilities if payment is due within one year or less (or in the normal operating cycle of the business if longer). If not, they are presented as non-current liabilities. Accounts payable and other financial liabilities are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. Current liabilities consist of: (Amounts in NOK thousands) 2015 2014 Trade and other payables 4 915 2 564 Withholding taxes and social security payables 1 588 781 Accruals for expenses 10 413 3 344 Total current liabilities 16 915 6 689 23. Events after the reporting date During the first two months of 2016 the Company granted 25 000 new share options to other employees in the Company and its subsidiaries (see note 12). In January 2016, Targovax submitted a trial protocol to the regulatory authorizes in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of lung cancer associated with exposure to asbestos. In March 2016 , Targovax reported encouraging interim survival results from its ongoing phase I/II trial of TG01 in resected pancreatic cancer. In this 19 patients trial, 15 patients provided consent to be followed up of which 14 patients were alive after one year. B - 74 P. 142 R P. 143 Contact information Contact information Gunnar Gårdemyr Øystein Soug CEO CFO Ph. +41 798 340 585 Ph. +47 906 56 525 [email protected] [email protected] Company information Targovax ASA Oslo office: Lilleakerveien 2 C, 0283 Oslo, Phone: +47 21 39 88 10 Helsinki office: Saukonpaadenranta 2, FI-00180 Helsinki, Phone: +358 10 279 4000 www.targovax.com B - 75 APPENDIX C: INTERIM FINANCIAL STATEMENTS FOR TARGOVAX ASA FOR THE THREE MONTH PERIOD ENDED 31 MARCH 2016 C - 1 QUARTERLY REPORT Q1 2016 C - 2 Interim Report first quarter 2016 Arming the patient’s immune system to fight cancer Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a world leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology. ONCOS - 102 is a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment is designed to reactivate the immune system's capacity to recognize and attack cancer cells. TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancer and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival. These product candidates will be developed in combination with multiple treatments, including checkpoint inhibitors in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in the early stages of development. Highlights In March, Targovax conducted an interim survival analysis of a first cohort of the ongoing open label, phase I/II of TG01/GM-CSF and gemcitabine in patients with resected pancreatic cancer. Of the 19 patients included in the cohort, 15 patients provided consent to be followed up for survival. 1-year survival data showed that 14 of these 15 patients were still alive at the time of analysis In April, Targovax conducted an interim DTH immunological response of a second cohort of the same trial, assessing early immune activation. Four of the five first recruited patients (of a total of up to 13 patients) showed an 8-week immune response. These results were in line with the analysis of the first cohort (in March 2015) where 15 of 18 eligible patients showed a detectable immune response suggesting that immune activation can be achieved with lower vaccine doses Targovax progressed the preparation of a further five new combination clinical trials, according to plan. All studies are in the process of being set up. Submissions to competent authorities and ethical committees have been initiated. C - 3 Key figures: Amounts in NOK thousands 1Q 2016 1Q 2015 2015 Total operating revenues - -146 Total operating expenses -30 976 -6 720 -89 762 Operating profit/loss -30 976 -6 720 -89 616 Net financial items -555 -31 -269 Income tax 74 - -1 930 Net profit/loss -31 457 -6 751 -91 816 Basic and diluted EPS (NOK/share) -1.17 -0.72 -5.06 Net change in cash -33 012 -8 361 111 345 Cash and cash equivalents start of period 173 898 62 552 62 552 Cash and cash equivalents end of period 140 885 54 191 173 898 Operational Review Following the merger between Targovax A broad and diversified pipeline and Oncos in July 2015, the combined Since the merger in 2015, Targovax has company has several product lines based progressed its clinical plan according to on two different technology platforms, and schedule. Management has actively the company has reached critical mass worked to increase company visibility in the concerning pipeline and organization. investor community and towards potential future partners among pharmaceutical Currently, Targovax has: companies. one ongoing trial During the first quarter of 2016, Targovax two technology platforms continued the development of its different three product candidates in product lines, both through its own clinical development trials and through collaborations. four orphan drug indications five combination trials starting in 2016, two with scientific collaboration partners six cancer indications and six additional efficacy read-outs anticipated by the end of 2017. C - 4 Indication(s) Program Discovery Pre-Clinical Phase I Phase II Phase III Pancreatic cancer* TG01 Mesothelioma* ONCOS-102 Melanoma ONCOS-102 Development Colorectal cancer* TG02 Ovarian cancer* ONCOS-102 Prostate cancer ONCOS-102 Exploratory TG03 ONCOS-402 Discovery ONCOS-802 Discovery ONCOS-902 * Orphan drug status Clinical development TG01 Pancreatic Cancer Targovax has an ongoing open label, vaccination cohort. Four of the five first phase I/II clinical trial of TG01/GM-CSF recruited patients (of a total of up to 13 treatment and gemcitabine (chemotherapy) patients) showed an 8-week immune as adjuvant therapy for treating patients response. These results were in line with with resected adenocarcinoma of the the analysis of the first cohort (which had pancreas. The trial is structured as a first received a more frequent vaccination cohort of 19 patients and a second cohort schedule) where 18 out of 19 patients were on a modified and reduced vaccination eligible for immune response assessment schedule. The modified cohort will have up and 15 of those had established a to 13 patients and is currently ongoing. In detectable immune response. 2015, Targovax showed that TG01/GM- CSF, administered in combination with The modified vaccination schedule seems gemcitabine induced RAS specific T-cell to generate similar 8-week immune immune responses. responses in patients with pancreatic cancer as seen in the initial cohort. In March, Targovax conducted a 1-year pre-determined interim survival analysis of The TG01 trial will conclude with an the first cohort. Of the 19 patients included analysis of 2-year survival data for the in the cohort, 15 patients provided consent respective cohorts in 2017 and 2018. to be followed up for survival and four patients did not. The 1-year survival data TG02 Colorectal Cancer showed that 14 out of these 15 patients This is an open label, non-randomized, were alive and one had passed away due phase Ib exploratory trial to determine to pneumonia assessed by the investigator safety and anti-tumor immune activation as unrelated to the patient’s underlying generated by TG02/GM-CSF, first as cancer. The regimen was generally well monotherapy, then in combination with a tolerated. checkpoint inhibitor, in patients with locally recurrent rectal cancer scheduled to have In April, Targovax reviewed interim data for surgery. early (8-week) immune activation (by measuring DTH responses) in the modified C - 5 Currently, the trial is planned to include Through these collaborations, Targovax approximately 20 patients at sites in gains access in a highly cost-effective Australia. The trial is on track to start during manner to leading expertise and extensive the second half of 2016. clinical trial networks. ONCOS-102 Mesothelioma The joint trial with LCR and CRI includes This trial is a randomized phase Ib/II open testing and evaluation of ONCOS-102 in label trial with a Phase Ib safety lead-in of combination with other synergistic ONCOS-102 and standard of care immunotherapies, such as checkpoint chemotherapy in patients with unresectable inhibitors, in various oncology indications. malignant pleural mesothelioma. The trial is The objective of the Sotio collaboration is to planned to include six patients in a safety study safety and tolerability when cohort to evaluate the safety of the combining ONCOS-102 and Sotio’s combination treatment. This will be followed dendritic cell therapy DCVAC/PCa in by a randomized phase II section of the trial prostate cancer patients. in approximately 24 patients to compare the In both cases, the sponsor of the trial will be tumor targeted immune activation of the Targovax’s collaboration partner. The plan combination treatment with the standard of is to recruit the first patients into both these care chemotherapy alone. In February trials during the second half of 2016, after 2016, Targovax announced the submission this more detailed information about the of the trial protocol to the regulatory trials and combination products will be authorities in Spain. According to plan, the available. trial is intended to commence during the second half of 2016. IPR / Market exclusivity ONCOS-102 Melanoma Targovax owns a patent portfolio protecting This trial is an exploratory open-label phase its pipeline with different families of patents Ib trial designed to determine anti-tumor and patent applications covering its product immune activation and clinical response to candidates in development as well as ONCOS-102 given with a checkpoint potential future product candidates. The inhibitor in patients with advanced or company is working continuously to unresectable melanoma who have had strengthen its patent portfolio. disease progression following treatment The company has Orphan Drug status for with checkpoint blockade. The goal of the ONCOS-102 within mesothelioma, ovarian trial is to investigate whether these patients cancer, and soft tissue sarcoma1 in the EU will respond to a checkpoint inhibitor after and USA, ensuring 10 and 7 years of ONCOS-102 priming treatment. The trial is market protection respectively from the planned to include approximately 12 date of market approval. Orphan Drug patients in the US and is intended to status has also been granted for TG01 in commence in the second half of 2016. pancreatic cancer in the EU and USA. Clinical trials with collaboration partners Experienced team In late 2015, Targovax entered into two Targovax has a highly experienced separate agreements with US-based management team with backgrounds from Ludwig Cancer Research (LCR) and the successful biotech companies as well as Cancer Research Institute (CRI), and the large pharmaceutical companies. Czech biotech company Sotio. The intention of these two collaborations is to execute joint clinical trials. 1 Soft tissue sarcoma is an indication currently not being pursued by Targovax C - 6 Management team Financial position and cash flow Net cash was NOK 141m at the end of the Name Position first quarter compared to NOK 174m at the Gunnar Gårdemyr CEO end of 2015. The change in the net cash Øystein Soug CFO level was primarily driven by operating Jon Amund Eriksen COO activities. Net cash outflow in the quarter Magnus Jäderberg CMO was NOK 33m from operating activities. Antti Vuolanto EVP Anne-Kirsti Aksnes VP Clinical The company had the equivalent of NOK Tina Madsen VP QA 38m in interest bearing debt, all to Tekes, Peter Skorpil VP BD the Finnish Funding Agency for Technology and Innovation. Board of Directors The Board consists of highly skilled Shareholder information professionals with a broad range of relevant On 14 April 2016, there were 26 883 808 competences. shares outstanding, distributed to approx. Name Position 200 shareholders. The 20 largest shareholders controlled some 84 percent of Jónas Einarsson Chairman Eva-Lotta Allan Member the shares. Robert Burns Member During the first quarter 2016, Targovax Johan Christenson Member shares traded in the NOK 12.00-17.00 Diane Mellett Member range. During the quarter, approx. 163 000 Lars Lund-Roland Member shares were traded, with a total value of Bente-Lill Romøren Member NOK 2m. The closing price on 31 March Per Samuelsson Member 2016 was NOK 14.00 per share, corresponding to a market capitalization of Financial Review NOK 376 million. Since Targovax merged with the Finnish company Oncos on 2 July 2015, the figures in this report include the combined Shareholders # shares % businesses only from the second half of HealthCap 8 488 918 31,6 % 2015. Figures in parentheses are from the RadForsk 3 410 589 12,7 % Trojan AS 2 462 000 9,2 % comparable pre-merger period in 2015. Arctic Funds PLC 907 000 3,4 % Timmuno AS 724 650 2,7 % Results first quarter 2016 Prieta AS 720 000 2,7 % As a pre-commercial R&D-focused biotech Portia AS 626 845 2,3 % company, Targovax does not have Danske Bank A/S 587 971 2,2 % revenue. Nordnet Bank AB 569 022 2,1 % KLP Aksje Norge VPF 460 000 1,7 % Operating expenses amounted to NOK Eltek Holding AS 442 000 1,6 % 31m (NOK 7m) in the quarter. The Statoil Pensjon 433 716 1,6 % operating expenses are reported net of Storebrand Vekst 426 000 1,6 % Pactum AS 400 000 1,5 % governmental grants, which amounted to Birk Venture AS 378 980 1,4 % NOK 4m in the period (NOK 2m). The Op-Europe Equity Fund 357 869 1,3 % higher operating expenses reflect the Trygve Schiørbecks Eftf. 286 449 1,1 % combination with Oncos and the resulting Viola AS 280 000 1,0 % increase in activities in all areas of the KLP 270 000 1,0 % DNB Grønt NORDEN 250 919 0,9 % business. 20 largest shareholders 22 482 928 83,6 % The net loss amounted to NOK 31m in the Other shareholders 4 400 880 16,4 % Total shareholders 26 883 808 100,0 % quarter. C - 7 Subsequent events Furthermore, Targovax, together with its In April, Targovax announced that the clinical trial collaborators LCR/CRI and company has conducted an interim DTH Sotio, is planning to start trials in various immunological response evaluation solid tumor indications and advanced assessing early immune activation prostate cancer, respectively. In addition, following administration of TG01 in the company will continue the existing trial combination with gemcitabine in the of TG01 in resected pancreatic cancer. ongoing Phase I/II trial. The results show Simultaneously, Targovax is working that the modified and reduced vaccination continuously to improve its organization schedule generate similar 8-week immune and expanding its investor relation responses in patients with pancreatic outreach. cancer as seen in the initial cohort. According to current plans, the company Outlook has funds to finance its activities until the Targovax’s focus during the next 12 months end of 2016. Targovax has retained will be to start clinical trials outlined here flexibility in its cost structure to enable with: changes in prioritizations if required to ONCOS-102 in melanoma extend the cash position to last into early ONCOS-102 in mesothelioma 2017. TG02 in colorectal cancer C - 8 First quarter accounts 2016 Condensed consolidated statement of profit and loss Unaudited Unaudited (Amounts in NOK thousands except per share data) Note 1Q 2016 1Q 2015 2015 Other revenues - -146 Total revenue 146 External R&D expenses 3,4 -10 818 -1 517 -25 231 Payroll and related expenses 5,11 -13 198 -2 975 -35 431 Other operating expenses -6 960 -2 228 -29 100 Total operating expenses -30 976 -6 720 -89 762 Operating profit/ loss (-) -30 976 -6 720 -89 616 Financial income 281 211 2 339 Financial expenses 7 -836 -242 -2 608 Net financial items -555 -31 -269 Loss before income tax -31 531 -6 751 -89 885 Income tax expense 74 - -1 930 Loss for the period -31 457 -6 751 -91 816 Earnings/ loss (-) per share Basic and dilutive earnings/ loss (-) per share 10 -1.17 -0.72 -5.06 Consolidated statement of other comprehensive income / loss (-), net of income tax (Amounts in NOK thousands except per share data) 1Q 2016 1Q 2015 2015 Income / loss (-) for the period -31 457 -6 751 -91 816 Items that may be reclassified to profit or loss: Exchange differences arising from the translation of foreign operations -6 735 - 21 793 Total comprehensive income/ loss (-) for the period -38 192 -6 751 -70 023 Total comprehensive income/ loss (-) for the period attributable to owners -38 192 -6 751 -70 023 C - 9 Condensed consolidated statement of financial position Unaudited Unaudited (Amounts in NOK thousands) Note 31.03.2016 31.03.2015 31.12.2015 ASSETS Intangible assets 6 350 457 - 358 070 Property, plant, and equipment 1 512 142 1 590 Total non-current assets 351 969 142 359 659 Receivables 15 341 6 330 11 557 Cash and cash equivalents 140 885 54 191 173 898 Total current assets 156 226 60 521 185 455 TOTAL ASSETS 508 196 60 663 545 114 EQUITY AND LIABILITIES Shareholders equity Share capital 9 2 688 943 2 688 Share premium reserve 522 502 97 792 522 502 Other reserves 11 502 1 381 6 957 Retained earnings -162 524 -45 592 -131 067 Translation differences 15 057 - 21 793 Total equity 389 226 54 524 422 873 Non-current liabilities Interest-bearing liabilities 7 37 995 - 38 112 Deferred tax 57 431 - 58 709 Total non-current liabilities 95 426 - 96 821 Current liabilities Accounts payable and other current liabilities 10 611 1 844 6 307 Accrued public charges 1 390 804 1 826 Other short-term liabilities 11 542 3 491 17 287 Total current liabilities 23 544 6 139 25 420 TOTAL EQUITY AND LIABILITIES 508 196 60 663 545 114 C - 10 Condensed consolidated statement of changes in equity Retained Share Share Other Translation earnings (Amounts in NOK thousands) Note Total equity capital premium reserves differences (Accumulated losses) Balance at 1 January 2015 943 97 792 780 -38 841 60 673 Loss for the period -6 751 -6 751 Total comprehensive income for the period -6 751 -6 751 Recognition of share-based payments 602 602 Balance at 31 March 2015 943 97 792 1 381 -45 592 54 524 Loss for the period -85 065 -85 065 Exchange differences arising from the translation of foreign operations 21 793 21 793 Other comprehensive income/loss, net of tax - Total comprehensive income for the period 21 793 -85 065 -63 272 Issue of ordinary shares - Acquiring Oncos Therapeutics OY 943 234 792 235 735 Transaction costs - Oncos Therapeutics OY -260 -260 Issue of ordinary shares - Capital increase - Private Placement 800 199 200 200 000 Transaction costs - Private Placement -9 207 -9 207 Share issuance, employee share options 3 185 188 Reclassification of share-based payment Oncos Therapeutics OY 410 -410 Recognition of share-based payments 11 5 166 5 166 Balance at 31 December 2015 2 688 522 502 6 957 21 793 -131 067 422 873 Loss for the period -31 457 -31 457 Exchange differences arising from the translation of foreign operations -6 735 -6 735 Other comprehensive income/loss, net of tax - Total comprehensive income for the period -6 735 -31 457 -38 192 Recognition of share-based payments 11 4 545 4 545 Balance at 31 March 2016 2 688 522 502 11 502 15 057 -162 524 389 226 C - 11 Condensed consolidated statement of cash flow (Amounts in NOK thousands) Note Q1 2016 Q1 2015 FY 2015 Cash flow from operating activities Loss before income tax -31 531 -6 751 -89 885 Adjustments for: Finance income -281 -211 -2 339 Finance expense 836 242 2 608 Share option expense 11 4 545 602 5 717 Depreciation 69 8 148 Change in receivables -3 783 -1 670 -3 026 Change in other current liabilities -2 812 -579 5 887 Net cash flow from /(used in) operating activities -32 958 -8 359 -80 890 Cash flow from investing activities Purchases of property, plant, and equipment (PPE) -19 -158 Acquisition of subsidiary, net of cash acquired 1 313 Net cash received from/(paid in) investing activities -19 1 155 Cash flow from financing activities Interest received -2 1 009 Interest paid 7 -213 -526 Share issue expense - Acquisition of Oncos OY -260 Share issue expense - Private Placement -9 207 Proceeds from issuance of shares -Private Placement 200 000 Proceeds from exercise of options 188 Net cash generated from financing activities -213 -2 191 204 Net increase/(decrease) in cash and cash equvivalents -33 190 -8 361 111 468 Net exchange gain/loss on cash and cash equivalents 178 -123 Cash and cash equivalents at beginning of period 173 898 62 552 62 552 Cash and cash equivalents at end of period 140 885 54 191 173 898 C - 12 Notes 1. General information Targovax ASA ("the Company") and its subsidiaries (together the Group) is a clinical stage immuno- oncology company dedicated to the development of targeted immunotherapy treatments for cancer patients. The Group is targeting complementary approaches to cancer immunotherapy: A cancer vaccine platform developed for patients with RAS-mutated cancers and an immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors. Both treatment approaches harness the patient’s own immune system to fight the cancer. The Company is a limited liability company incorporated and domiciled in Norway. The address of the registered office is Lilleakerveien 2C, 0283 Oslo, Norway. The interim figures for the first quarter 2016 report are unaudited. These financial statements were approved for issue by the Board of Directors on 11 May, 2016. 2. Accounting principles The interim condensed consolidated financial statements for the Group are prepared using the same accounting principles and calculation methods as used for the statutory, annual financial statements 2015 for Targovax ASA. The accounting principles used have been consistently applied in all periods presented, unless otherwise stated. Amounts are in thousand Norwegian kroner unless stated otherwise. The functional currency of the Group is NOK (Norwegian kroner). 2.1 Basis of preparation The quarterly financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting, as adopted by the EU. 2.2 Standards and interpretations in issue but not yet adopted At the date of authorization of these quarterly financial statements, there are no Standards or Interpretation that have been issued where the Management considers any material impact. 2.3 Basis of consolidation The consolidated financial statements comprise the financial statements of the Company and its subsidiaries as at 31 March 2016. The subsidiaries include Targovax OY, located at Helsinki, Finland and Oncos Therapeutics AG, Meggen, Switzerland, all 100% owned and controlled subsidiaries. Targovax OY is the parent company of Oncos Therapeutics AG. 2.4 Going concern As a result of the private placement in the third quarter 2015 and the current liquidity situation, Directors have an expectation that the Group has available financial resources sufficient for the planned activities in the next twelve months as of 31 March 2016. The Group therefore continues to adopt the going concern basis in preparing its consolidated financial statements. 3. Research and development expenses The Group is developing new products. Uncertainties related to the regulatory approval process and results from ongoing clinical trials, generally indicate that the criteria for asset recognition is not met until the time when marketing authorization is obtained from relevant regulatory authorities. C - 13 The following research and development expenditures have been expensed: (Amounts in NOK thousands) 1Q 2016 1Q 2015 2015 Total R&D Total R&D Total R&D External R&D expenses 10 818 10 818 1 517 1 517 25 231 25 231 Payroll and related expenses 13 198 5 323 2 975 1 210 35 431 13 497 Other operating expenses 6 960 156 2 228 114 29 100 384 Total 30 976 16 298 6 720 2 840 89 762 39 111 4. Government grants Government grants have been recognized in profit or loss as a reduction of the related expense with the following amounts: (Amounts in NOK thousands) 1Q 2016 1Q 2015 2015 External R&D expenses 2 721 993 6 891 Payroll and related expenses 824 1 033 2 225 Other operating expenses 6 - - Total 3 552 2 025 9 115 For the period 2013 through 2016, the Group has been awarded a grant from The Research Council (program for user-managed innovation arena (BIA)) of NOK 12.4 million in total. For the first quarter 2016, the Group has recognized NOK 1.5 million as cost reduction in External R&D expenses, Payroll and related expenses and Other Operating expenses. R&D projects have been approved for Skatte Funn for the period 2011 through 2016. For the first quarter 2016 the Group has recognized NOK 2 million as cost reduction in External R&D expenses, Payroll and related expenses and Other Operating expenses. 5. Payroll and related expenses Total payroll and related expenses for the Group are: (Amounts in NOK thousands) 1Q 2016 1Q 2015 2015 Salaries and bonus 7 348 2 815 26 154 Employer’s national insurance contributions 880 350 3 278 Share-based compensation 1 4 545 602 5 875 Pension expenses – defined contribution plan 756 120 1 723 Other 494 121 626 Governmental grants -824 -1 033 -2 225 Total payroll and related expenses 13 198 2 975 35 431 1) Share-based compensat ion has no cash ef f ect . Number of employees calculated on a full-time basis as at end of period 27,5 8,5 26,5 Number of employees as at end of period 28 9 27 C - 14 6. Intangible assets Recognized intangible assets in the Group amounts to NOK 350 million as of 31 March 2016. This is a decrease from NOK 358 million due to NOK/EUR foreign exchange fluctuations. The intangible assets are derived from the acquisition of Oncos Therapeutics OY, which was completed in July 2015. The intangible assets are related to the development of ONCOS-102, which is a virus-based immunotherapy platform. Intangible assets are tested for impairment at least annually, or when there are indications of impairment. No indications identified since the last impairment test performed as at 31 December 2015. See note 16 in the Annual Report 2015 for more information. 7. Interest bearing debt (TEKES) The Group has received three R&D loans, for the commercialization of ONCOS-102, from TEKES under loan agreements dated September 2010, January 2012 and December 2013, respectively, in the total outstanding amount of EUR 5 842 312 as of 31 March 2016. TEKES is a publicly financed funding agency that finances research and development activities for young innovative companies in Finland. No new TEKES loans have been issued during the first quarter 2016. Consequently, no grant element is recognized. Amortized interests are charged to financial expenses amounting to NOK 0.7 million during the first quarter 2016. See note 22 in the Annual Report 2015 for more information about the TEKES loans. 8. Fair value of financial instruments The carrying value of receivables, cash and cash equivalents, borrowings, deferred tax, and other short-term payables and accrued liabilities are assessed to approximate fair value. 3M 2016 3M 2015 FY 2015 (Amounts in NOK thousands) Carrying Carrying Carrying Fair value Fair value Fair value amounts amounts amounts Receivables 15 341 15 341 6 330 6 330 11 557 11 557 Cash and cash equivalents 140 885 140 885 54 191 54 191 173 898 173 898 Total financial assets 156 226 156 226 60 521 60 521 185 455 185 455 Interest-bearing borrowings 37 995 37 995 38 112 38 112 Deferred tax 57 431 57 431 58 709 58 709 Accounts payable and other current liabilities 10 611 10 611 1 844 1 844 6 307 6 307 Accrued public charges 1 390 1 390 804 804 1 826 1 826 Other short-term liabilities 11 542 11 542 3 491 3 491 17 287 17 287 Total financial liabilities 118 970 118 970 6 139 6 139 122 241 122 241 The tables below analyses financial instruments carried at fair value, by valuation method. The different levels have been defined as follows: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities Level 2: Inputs other than quoted prices including Level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) Level 3: Inputs in asset or liability that are not based on observable market data (that is, unobservable inputs) C - 15 As at 31 March 2016: (Amounts in NOK thousands) Level 1 Level 2 Level 3 Total Interest-bearing borrowings - - 37 995 37 995 Total financial instruments at fair value - - 37 995 37 995 As at 31 December 2015: (Amounts in NOK thousands) Level 1 Level 2 Level 3 Total Interest-bearing borrowings - - 38 112 38 112 Total financial instruments at fair value - - 38 112 38 112 At the end of first quarter 2015 there were no financial instruments carried at fair value to measure. 9. Share capital and number of shares Share capital as at 31 March 2016 is 2 688 381 (31 March 2015: 942 940) comprising 26 883 808 ordinary shares at nominal value NOK 0.10 (31 March 2015: 9 429 404 at NOK 0.10). All shares carry equal voting rights. The movement in the number of shares during the period was as follows: Q1 2016 Q1 2015 FY 2015 Ordinary shares at beginning of period 26 883 808 9 429 404 9 429 404 Share issuance - private placement 0 0 8 000 000 Acquisition of Oncos Therapeutics OY 0 0 9 429 404 Share issuance, employee share options 0 0 25 000 Ordinary shares at end of period 26 883 808 9 429 404 26 883 808 C - 16 The 20 largest shareholders are as follows at 31 March 2016: Shareholder # shares % HealthCap 8 488 918 31,6 % Radiumhospitalets Forskningsstiftelse 3 410 589 12,7 % Trojan AS 2 462 000 9,2 % Arctic Funds PLC 907 000 3,4 % Timmuno AS 724 650 2,7 % Prieta AS 720 000 2,7 % Portia AS 630 845 2,3 % Danske Bank A/S 587 971 2,2 % Nordnet Bank AB 569 022 2,1 % KLP Aksje Norge VPF 460 000 1,7 % Eltek Holding AS 442 000 1,6 % Statoil Pensjon 433 716 1,6 % Storebrand Vekst 426 000 1,6 % Pactum AS 400 000 1,5 % Birk Venture AS 378 980 1,4 % Op-Europe Equity Fund 357 869 1,3 % Trygve Schiørbecks Eftf. AS 286 449 1,1 % Viola AS 280 000 1,0 % Kommunal Landspensjonskasse 270 000 1,0 % Verdipapirfondet DNB Grønt NORDEN 250 919 0,9 % 20 largest shareholders 22 486 928 83,6 % Other shareholders (180) 4 396 880 16,4 % Total shareholders 26 883 808 100,0 % HealthCap, Radiumhospitalets Forskningsstiftelse, Timmuno AS and Prieta AS have entered into lock-up agreements for their shares for the period until the earliest of: (1) completion of an initial public offering (2) the day falling 12 months after the completion of the private placement 9 July 2015 C - 17 Shareholdings Key management The following table provides the total number of shares owned by the key management of the Group and member of the Board of Directors as of 31 March 2016: No. of shares outstanding Name Position at 31 Mar. 2016 Key management: Gunnar Gårdemyr Chief Executive Officer 20 000 Magnus Jäderberg Chief Medical Officer 20 000 Jon Amund Eriksen Chief Operating Officer 724 650 1) Øystein Soug Chief Financial Officer 26 600 2) Anne-Kirsti Aksnes VP, Clinical Development 4 000 Tina Madsen VP, Quality Assurance 800 Peter Skorpil VP, Business Development 4 000 Antti Vuolanto Executive VP 61 773 Total no. of shares owned by key management of the Group 861 823 Board of directors: Robert Burns Board member 29 063 Total no. of shares owned by the Board of Directors of the Group 29 063 1 The shares are held through Timmuno AS 2 The shares are held through Abakus Invest AS Jonas Einarsson, Chairman of the Board of Directors, is CEO in the Radium Hospital Research Foundation Johan Christenson and Per Samuelsson, both Member of the Board, are partners at HealthCap 10. Earnings per share Amounts in NOK thousand Q1 2016 Q1 2015 FY 2015 Loss for the period -31 457 -6 751 -91 816 Average number of outstanding shares during the period 26 884 9 429 18 150 Earnings/ loss per share - basic and diluted -1,17 -0,72 -5,06 Share options issued have a potential dilutive effect on earnings per share. No dilutive effect has been recognized as potential ordinary shares only shall be treated as dilutive if their conversion to ordinary shares would decrease earnings per share or increase loss per share from continuing operations. As the Group is currently loss-making an increase in the average number of shares would have anti-dilutive effects. 11. Share based payment At the Extraordinary General Meeting in September 2015 the Board was authorized to increase the Group’s share capital in connection with share incentive arrangements by up to 10% of the Share capital. The authorization was renewed at the Ordinary general meeting in April 2106. The Group operates an equity-settled, share-based compensation plan, under which the entity receives services from employees as consideration for equity instruments (options) in Targovax ASA. Each share option converts into one ordinary share of the Company on exercise. Options may be exercised at any time from the date of vesting until expiry. The options generally vest over a period of four years and expire seven years after the grant date. In general, the exercise price of the options is set at the fair value of the shares at grant date. C - 18 During the first quarter of 2016, additional 75 000 share options were granted to other employees. A total of 2 620 889 options were issued at 31 March 2016. The fair value of the options has been calculated at grant date. The fair value of the options was calculated using the Black-Scholes model. The expected volatility for options issued in first quarter 2016 is estimated at average of 83%, based on the volatility of comparable listed companies. The volume weighted average interest rate applied to the share options grants in first quarter 2016 is 0.67%. 3M 2016 FY 2015 Weighted avg. Weighted avg. No. of options excercise price No. of options excercise price (in NOK) (in NOK) Outstanding at 1 January 2 545 889 23.25 100 000 7.50 Granted during the period 75 000 14.20 2 090 062 24.09 Exercised during the period -25 000 7.50 Convertion of Oncos option program 2/7-2015 380 827 21.77 Outstanding no. of options at end of period 2 620 889 23.00 2 545 889 23.25 The following table shows the outstanding and granted options for shares to Key Management of the Group at 31 March 2016: Options Name Position Granted Outstanding 3M 2016 31.03.2016 Key management: Gunnar Gårdemyr Chief Executive Officer - 500 000 Magnus Jäderberg Chief Medical Officer - 390 000 Jon Amund Eriksen Chief Operating Officer - 160 000 Øystein Soug Chief Financial Officer - 390 000 Antti Vuolanto Executive VP - 181 000 Anne Kirsti Aksnes VP, Clinical Development - 53 000 Tina Madsen VP, Quality Assurance - 53 000 Peter Skorpil VP, Business Development - 45 000 Total option for shares to key management of the Group - 1 772 000 Board of directors: - Robert Burns Board member - 21 235 Total option for shares to the Board of Directors of the Group 21 235 No share options have been granted to Key Management in first quarter 2016. C - 19 12. Subsequent events The ordinary general meeting 13 April 2016 decided to remunerate the Board of directors with a combination of cash and Restricted Share Units (RSU). The number of RSUs to be granted to the members of the board of directors is calculated as the NOK amount of the RSU opted portion of total compensation to the board member, divided by the market price for the Targovax ASA share. The market price is calculated as volume weighted average share price the 10 trading days prior to the grant date, NOK 12.20 for the grant at 13 April 2016. . The board members must elect to either (i) receive 100% of the compensation in RSUs, (ii) receive 1/3 of the compensation in cash and 2/3 in RSUs, or (iii) receive 2/3 of the compensation in cash and 1/3 in RSUs. The total compensation to each member of the board of directors for both the period 2015-2016 and 2016-2017 have been set out in the minutes from the ordinary general meeting. A total of 129 991 RSUs have thus been granted. The RSUs granted for the period 2015 – 2016 vested on 13 April 2016, while the RSUs granted for the period 2016- 2017 will vest on 13 April 2017. C - 20 APPENDIX D: INDEPENDENT PRACTITIONER’S ASSURANCE REPORT ON THE COMPILATION OF UNAUDITED PRO FORMA FINANCIAL INFORMATION D - 1 D - 2 D - 3 D - 4 APPENDIX E: SUBSCRIPTION FORM E - 1 TARGOVAX ASA SUBSCRIPTION FORM Subsequent Offering Securities no. ISIN NO0010689326 General information: The terms and conditions of the Subsequent Offering by Targovax ASA (the “Company”) are set out in the prospectus dated 7 July 2016 (the “Prospectus”). Terms defined in the Prospectus shall have the same meaning in this Subscription Form. The notice of, and minutes from, the extraordinary general meeting (with appendices) held 6 July 2016, the Company’s by-laws and annual accounts and annual reports for the last two years are available at the Company’s registered office address Lilleakerveien 2C, 0283 Oslo, Norway. The resolution to increase the share capital by the extraordinary general meeting is included in the Prospectus. All announcements referred to in this Subscription Form will be made through Oslo Børs’ information system under the Company’s ticker “TRVX”. Subscription procedures: The subscription period is from 09:00 hours (CET) on 11 July 2016 to 16:30 hours (CET) on 8 August 2016 (the “Subscription Period”). Correctly completed Subscription Forms must be received by one of the Joint Bookrunners before the end of the Subscription Period at one of the following addresses: ABG Sundal Collier Arctic Securities DNB Markets Registrars Department Munkedamsveien 45E Haakon VIIs gate 5 Dronning Eufemias gate 30 P.O. Box 1444 Vika P.O. Box 1833 Vika P.O. Box 1600 Sentrum N-0115 Oslo N-0123 Oslo N-0021 Oslo Norway Norway Norway Tel: +47 22 01 60 00 Tel: +47 21 01 30 40 Tel: +47 23 26 81 01 Fax: +47 22 01 60 62 Fax: +47 21 01 31 36 E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] Website: www.abgsc.no Website: www.arctic.com Website: www.dnb.no/emisjoner The Subscription Form should only be sent to one of the subscription offices set out above. If the same Subscription Form is sent to several of the subscription offices, it may be counted more than once. The subscriber is responsible for the correctness of the information filled in on the Subscription Form. Subscription Forms that are incomplete or incorrectly completed, or that are received after the end of the Subscription Period, and any subscription that may be unlawful, may be disregarded, at the discretion of the Joint Bookrunners on behalf of the Company. Subscribers who are residents of Norway with a Norwegian personal identification number may also subscribe for Offer Shares through the VPS online subscription system by following the link on any of the following websites: www.arcticsercurities.no, www.abgsc.no or www.dnb.no/emisjoner. Subscriptions made through the VPS online subscription system must be duly registered before the expiry of the Subscription Period. Neither the Company nor any of the Joint Bookrunners may be held responsible for postal delays, unavailable fax lines, internet lines or servers or other logistical or technical problems that may result in subscriptions not being received in time or at all by the Joint Bookrunners. Subscriptions are irrevocable and binding upon receipt and cannot be withdrawn, cancelled or modified by the subscriber after having been received by any of the Joint Bookrunners, or in the case of subscriptions through the VPS online subscription system, upon registration of the subscription. Subscription Price: The Subscription Price in the Subsequent Offering is NOK 7.50 per Offer Share. Subscription Rights: Registered holders of the Company’s shares (the “Eligible Shareholders”) as appearing in the VPS as of 23 June 2016 (the “Record Date”), other than shareholders who were part of the pre-sounding for or were allocated shares in the Private Placement and shareholders in jurisdictions other than Norway where an offer to participate in the Subsequent Offering is not allowed or would require approval or registration of a prospectus or similar measures, will be granted non-transferable subscription rights (the “Subscription Rights”) that, subject to applicable law, will give a preferential right to subscribe for, and be allocated, the Offer Shares at the Subscription Price. Eligible Shareholders will be granted 0.42939 Subscription Rights for every existing share registered as held by such Eligible Shareholder as of the Record Date, rounded down to the nearest whole Subscription Right. Each Subscription Right provides a preferential right to subscribe for, and be allocated, one Offer Share at the Subscription Price, subject to applicable securities laws. Over-subscription and subscription without Subscription Rights is permitted. Subscription Rights not used to subscribe for Offer Shares before the expiry of the Subscription Period will have no value and will lapse without compensation to the holder. Allocation of Offer Shares: The Offer Shares will be allocated to the subscribers based on the allocation criteria set out in the Prospectus. The Company reserves the right to reject or reduce any subscription for Offer Shares not covered by Subscription Rights in accordance with the allocation criteria. The Company will not allocate fractional Offer Shares. Allocation of fewer Offer Shares than subscribed for does not impact on the subscriber’s obligation to pay for the Offer Shares allocated. Notification of allocated Offer Shares and the corresponding subscription amount to be paid by each subscriber is expected to be distributed in a letter from the VPS on or about 9 August 2016. Payment: By signing this Subscription Form, or registering a subscription through the VPS online subscription system, subscribers authorise ABG Sundal Collier (on behalf of the Joint Bookrunners) to debit the subscriber’s Norwegian bank account for the total subscription amount payable for the Offer Shares allocated to the subscriber. Accounts will be debited on or about 12 August 2016 (the “Payment Date”), and there must be sufficient funds in the stated bank account from and including the date falling 2 banking days prior to the Payment Date. Subscribers who do not have a Norwegian bank account must ensure that payment for the allocated Offer Shares is made on or before the Payment Date. Details and instructions can be obtained by contacting ABG Sundal Collier, telephone: + 47 22 01 60 00. ABG Sundal Collier (on behalf of the Joint Bookrunners) is only authorized to debit each account once, but reserves the right (but has no obligation) to make up to three debit attempts through 18 August if there are insufficient funds on the account on the Payment Date. Should any subscriber have insufficient funds in his or her account, should payment be delayed for any reason, if it is not possible to debit the account or if payments for any other reasons are not made when due, overdue interest will accrue and other terms will apply as set out under the heading “Overdue and missing payments” below. PLEASE SEE PAGE 2 OF THIS SUBSCRIPTION FORM FOR OTHER PROVISIONS THAT ALSO APPLY TO THE SUBSCRIPTION DETAILS OF THE SUBSCRIPTION Subscriber’s VPS account: Number of Subscription Rights: Number of Offer Shares subscribed (For broker: consecutive no.): (incl. over-subscription): SUBSCRIPTION RIGHT’S SECURITIES NUMBER: ISIN NO 001 0769250 Subscription Price per Offer Share: Subscription amount to be paid: NOK 7.50 NOK IRREVOCABLE AUTHORIZATION TO DEBIT ACCOUNT (MUST BE COMPLETED BY SUBSCRIBERS WITH A NORWEGIAN BANK ACCOUNT) Norwegian bank account to be debited for the payment for Offer Shares allocated (number of Offer Shares allocated x NOK 7.50). (Norwegian bank account no.) I/we hereby irrevocably (i) subscribe for the number of Offer Shares specified above subject to the terms and conditions set out in this Subscription Form and in the Prospectus, (ii) authorize and instruct each of the Joint Bookrunners (or someone appointed by any of them) acting jointly or severally to take all actions required to transfer such Offer Shares allocate to me/us to the VPS Registrar and ensure delivery of the beneficial interests to such Offer Shares to me/us in the VPS, on my/our behalf, (iii) authorize ABG Sundal Collier to debit my/our bank account as set out in this Subscription Form for the amount payable for the Offer Shares allotted to me/us, and (iv) confirm and warrant to have read the Prospectus and that I/we are eligible to subscribe for Offer Shares under the terms set forth therein. Place and date Binding signature must be dated in the Subscription Period. The subscriber must have legal capacity. When signed on behalf of a company or pursuant to an authorization, documentation in the form of a company certificate or power of attorney must be enclosed. INFORMATION ON THE SUBSCRIBER – ALL FIELDS MUST BE COMPLETED First name Surname/company Street address Post code/district/ country Personal ID number/ organization number Nationality E-mail address Daytime telephone number E - 2 ADDITIONAL GUIDELINES FOR THE SUBSCRIBER Regulatory issues: In accordance with the Markets in Financial Instruments Directive (“MiFID”) of the European Union, Norwegian law imposes requirements in relation to business investments. In this respect, the Joint Bookrunners must categorize all new clients in one of three categories: eligible counterparties, professional clients and non- professional clients. All subscribers in the Subsequent Offering who are not existing clients of one of the Joint Bookrunners will be categorized as non-professional clients. Subscribers can, by written request to a Joint Bookrunner, ask to be categorized as a professional client if the subscriber fulfils the applicable requirements of the Norwegian Securities Trading Act. For further information about the categorization, the subscriber may contact DNB Markets (DNB Markets, KSC - Customer Administration, P.O. Box 7100, NO5020 Bergen, Norway or www.dnb.no/en/mifid), ABG Sundal Collier (Munkedamsveien 45E, P.O. Box 1444 Vika, NO0115 Oslo), Arctic Securities (Haakon VIIs gate 5, P.O. Box 1833 Vika, N-0123 Oslo). The subscriber represents that he/she/it is capable of evaluating the merits and risks of a decision to invest in the Company by subscribing for Offer Shares, and is able to bear the economic risk, and to withstand a complete loss, of an investment in the Offer Shares. Selling Restrictions: The attention of persons who wish to subscribe for Offer Shares is drawn to Section 17 “Selling and transfer restrictions” of the Prospectus. The Company is not taking any action to permit a public offering of the Subscription Rights or the Offer Shares (pursuant to the exercise of the Subscription Rights or otherwise) in any jurisdiction other than Norway. Receipt of this Prospectus will not constitute an offer in those jurisdictions in which it would be illegal to make an offer and, in those circumstances, this Prospectus is for information only and should not be copied or redistributed. Persons outside Norway should consult their professional advisors as to whether they require any governmental or other consent or need to observe any other formalities to enable them to subscribe for Offer Shares. It is the responsibility of any person wishing to subscribe for Offer Shares under the Subsequent Offering to satisfy himself as to the full observance of the laws of any relevant jurisdiction in connection therewith, including obtaining any governmental or other consent which may be required, the compliance with other necessary formalities and the payment of any issue, transfer or other taxes due in such territories. The Subscription Rights and Offer Shares have not been registered, and will not be registered, under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) and may not be offered, sold, taken up, exercised, resold, delivered or transferred, directly or indirectly, within the United States, except pursuant to an applicable exemption from the registration requirements of the U.S. Securities Act and in compliance with the securities laws of any state or other jurisdiction of the United States. The Subscription Rights and Offer Shares have not been and will not be registered under the applicable securities laws of Australia, Canada or Japan and may not be offered, sold, taken up, exercised, resold, delivered or transferred, directly or indirectly, in or into Australia, Canada or Japan or any other jurisdiction in which it would not be permissible to offer the Offer Shares. This Subscription Form does not constitute an offer to sell or a solicitation of an offer to buy Offer Shares in any jurisdiction in which such offer or solicitation is unlawful. A notification of exercise of Subscription Rights and subscription of Offer Shares in contravention of the above restrictions may be deemed to be invalid. By subscribing for the Offer Shares, persons effecting subscriptions will be deemed to have represented to the Company that they, and the persons on whose behalf they are subscribing for the Offer Shares, have complied with the above selling restrictions. Execution Only: The Joint Bookrunners will treat the Subscription Form as an execution-only instruction. The Joint Bookrunners are not required to determine whether an investment in the Offer Shares is appropriate or not for the subscriber. Hence, the subscriber will not benefit from the protection of the relevant conduct of business rules in accordance with the Norwegian Securities Trading Act. Information exchange: The subscriber acknowledges that, under the Norwegian Securities Trading Act and the Norwegian Commercial Banks Act and foreign legislation applicable to the Joint Bookrunners there is a duty of secrecy between the different units of each of the Joint Bookrunners as well as between the Joint Bookrunners and the other entities in the Joint Bookrunners’ respective groups. This may entail that other employees of the Joint Bookrunners or the Joint Bookrunners' respective groups may have information that may be relevant to the subscriber and to the assessment of the Offer Shares, but which the Joint Bookrunners will not have access to in their capacity as Joint Bookrunners for the Subsequent Offering. Information barriers: The Joint Bookrunners are securities firms that offer a broad range of investment services. In order to ensure that assignments undertaken in the Joint Bookrunners' corporate finance departments are kept confidential, the Joint Bookrunners' other activities, including analysis and stock broking, are separated from the respective Joint Bookrunners' corporate finance departments by information walls. Consequently the subscriber acknowledges that the Joint Bookrunners' analysis and stock broking activity may conflict with the subscriber’s interests with regard to transactions in the Shares, including the Offer Shares. VPS account and mandatory anti-money laundering procedures: The Subsequent Offering is subject to the Norwegian Money Laundering Act of 6 March 2009 No. 11 and the Norwegian Money Laundering Regulations of 13 March 2009 No. 302 (collectively, the “Anti-Money Laundering Legislation”). Subscribers who are not registered as existing customers of one of the Joint Bookrunners must verify their identity to one of the Joint Bookrunners in accordance with requirements of the Anti-Money Laundering Legislation, unless an exemption is available. Subscribers who have designated an existing Norwegian bank account and an existing VPS account on the Subscription Form are exempted, unless verification of identity is requested by a Joint Bookrunner. Subscribers who have not completed the required verification of identity prior to the expiry of the Subscription Period will not be allocated Offer Shares. Participation in the Subsequent Offering is conditional upon the subscriber holding a VPS account. The VPS account number must be stated in the subscription form. VPS accounts can be established with authorized VPS registrars, who can be Norwegian banks, authorized securities brokers in Norway and Norwegian branches of credit institutions established within the EEA. Establishment of a VPS account requires verification of identity to the VPS registrar in accordance with the Anti-Money Laundering Legislation. However, non-Norwegian investors may use nominee VPS accounts registered in the name of a nominee. The nominee must be authorized by the Financial Supervisory Authority of Norway. Terms and conditions for payment by direct debiting - securities trading: Payment by direct debiting is a service the banks in Norway provide in cooperation. In the relationship between the payer and the payer’s bank the following standard terms and conditions apply: a) The service “Payment by direct debiting – securities trading” is supplemented by the account agreement between the payer and the payer’s bank, in particular Section C of the account agreement, General terms and conditions for deposit and payment instructions. b) Costs related to the use of “Payment by direct debiting – securities trading” appear from the bank’s prevailing price list, account information and/or information given in another appropriate manner. The bank will charge the indicated account for costs incurred. c) The authorization for direct debiting is signed by the payer and delivered to the beneficiary. The beneficiary will deliver the instructions to its bank that in turn will charge the payer’s bank account. d) In case of withdrawal of the authorization for direct debiting the payer shall address this issue with the beneficiary. Pursuant to the Norwegian Financial Contracts Act the payer’s bank shall assist if the payer withdraws a payment instruction that has not been completed. Such withdrawal may be regarded as a breach of the agreement between the payer and the beneficiary. e) The payer cannot authorize payment of a higher amount than the funds available on the payer’s account at the time of payment. The payer’s bank will normally perform a verification of available funds prior to the account being charged. If the account has been charged with an amount higher than the funds available, the difference shall immediately be covered by the payer. f) The payer’s account will be charged on the indicated date of payment. If the date of payment has not been indicated in the authorization for direct debiting, the account will be charged as soon as possible after the beneficiary has delivered the instructions to its bank. The charge will not, however, take place after the authorization has expired as indicated above. Payment will normally be credited the beneficiary’s account between one and three working days after the indicated date of payment/delivery. g) If the payer’s account is wrongfully charged after direct debiting, the payer’s right to repayment of the charged amount will be governed by the account agreement and the Norwegian Financial Contracts Act. Overdue and missing payments: Overdue payments will be charged with interest at the applicable rate under the Norwegian Act on Interest on Overdue Payment of 17 December 1976 No. 100; 8.5% per annum as of the date of the Prospectus. If the subscriber fails to comply with the terms of payment or should payments not be made when due, the subscriber will remain liable for payment of the Offer Shares allocated to it and the Offer Shares allocated to such subscriber will not be delivered to the subscriber. In such case the Company and the Joint Bookrunners reserve the right to, at any time and at the risk and cost of the subscriber, re-allot, cancel or reduce the subscription and the allocation of the allocated Offer Shares, or, if payment has not been received by the third day after the Payment Date, without further notice sell, assume ownership to or otherwise dispose of the allocated Offer Shares in accordance with applicable law. If Offer Shares are sold on behalf of the subscriber, such sale will be for the subscriber’s account and risk and the subscriber will be liable for any loss, costs, charges and expenses suffered or incurred by the Company and/or the Joint Bookrunners as a result of, or in connection with, such sales. The Company and/ the Joint Bookrunners may enforce payment for any amounts outstanding in accordance with applicable law. E - 3 Registered office and advisors Targovax ASA Lilleakerveien 2 C TARGOVAX ASA 0283 Oslo Norway (A public limited company incorporated under the laws of Norway) Listing of the Company’s Shares on Oslo Axess Offering and listing of up to 2,666,667 Offer Shares with Subscription Rights for Eligible Shareholders at a Subscription Price of NOK 7.50 per Offer Share This prospectus (the "Prospectus") has been prepared in connection with the listing (the "Listing") of the shares (the "Shares") in Targovax ASA (the "Company"), a public limited company incorporated under the laws of Norway (together with its consolidated subsidiaries, "Targovax" or the "Group") on Oslo Axess ("Oslo Axess"), a stock exchange operated by Oslo Børs ASA, and the subsequent offering (the "Subsequent Offering") of up to 2,666,667 new shares in the Company with a nominal value of NOK 0.10 each (the "Offer Shares") at a subscription price of NOK 7.50 per Offer Share (the "Subscription Price") as resolved by the extraordinary general meeting of the Company held Joint Global Coordinators and Joint Bookrunners on 6 July 2016. ABG Sundal Collier Norge ASA Arctic Securities AS DNB Markets Munkedamsveien 45E Vika Atrium Haakon VIIs gate 5 Dronning Eufemias gate 30 The shareholders of the Company as of 21 June 2016 (and being registered as such in the Norwegian Central Securities Depository (the "VPS") on 23 June 2016 pursuant to the two days’ settlement procedure in VPS (the "Record Date")), other than shareholders who were part of the pre- N-0250 Oslo N-0116 Oslo N-0021 Oslo sounding for or were allocated shares in the private placement of 14,685,000 new shares, each with a nominal value of NOK 0.10, (the "Private Norway Norway Norway Placement Shares") completed by the Company on 7 July 2016 (the "Private Placement") and shareholders in jurisdictions other than Norway where an offer to participate in the Subsequent Offering is not allowed or would require approval or registration of a prospectus or similar measures, (the "Eligible Shareholders") will be granted non-transferable subscription rights (the "Subscription Rights") that, subject to applicable law, will give preferential right to subscribe for, and be allocated, Offer Shares at the Subscription Price. Legal Adviser to the Company Legal Adviser to the Joint Global Coordinators and Joint Each Eligible Shareholder will be granted 0.42939 Subscription Rights for each existing Share registered as held by such Eligible Shareholders as Advokatfirmaet Thommessen AS Bookrunners of the Record Date, rounded down to the nearest whole Subscription Right. Each whole Subscription Right will give the right to subscribe for, and Haakon VII’s gate 10 Advokatfirmaet Wiersholm AS be allocated, one Offer Share, subject to applicable securities laws. Over-subscription and subscription without Subscription Rights will be N-0161 Oslo Dokkveien 1 permitted. Norway N-0250 Oslo Norway The subscription period in the Subsequent Offering will commence at 09:00 hours Central European Time ("CET") on 11 July 2016 and expire at 16:30 hours CET, on 8 August 2016 (the "Subscription Period"). Subscription Rights that are not used to subscribe for Offer Shares before the expiry of the Subscription Period will have no value and will lapse without compensation to the holder. The Shares, including the Private Placement Shares, are, and the Offer Shares will be, registered in the Norwegian Central Securities Depository (the "VPS") in book-entry form. All Shares will rank in parity with one another and carry one vote per Share. Except where the context requires otherwise, references in this Prospectus to "Shares" will be deemed to include the existing Shares, including the Private Placement Shares, and the Offer Shares. Investing in the Shares involves a high degree of risk. Prospective investors should read the entire document and, in particular, consider Section 2 "Risk Factors" beginning on page 12 when considering an investment in the Company. The Shares have not been, and will not be, registered under the U.S. Securities Act or with any securities regulatory authority of any state or other jurisdiction in the United States, and are being offered and sold: (i) in the United States only to QIBs as defined in Rule 144A or in other transactions exempt from registration requirements under the U.S. Securities Act; and (ii) outside the United States in compliance with Regulation S. The distribution of this Prospectus and the offer and sale of the Offer Shares in certain jurisdictions may be restricted by law. Persons in possession of this Prospectus are required to inform themselves about and to observe any such restrictions. See Section 17 "Selling and Transfer Restrictions". The due date for the payment of the Offer Shares is expected to be on or about 12 August 2016. Delivery of the Offer Shares is expected to take place on or about 17 August 2016 through the facilities of the VPS. Prior to the Listing, the Shares have not been publicly traded. The Company applied for the Shares (including the Private Placement Shares, but excluding the Offer Shares) to be admitted for trading and listing on Oslo Axess on 30 June 2016, and the board of directors of Oslo Stock Exchange approved the listing application of the Company on 5 July 2016, subject to certain conditions being met. All such conditions have been met as of the date of this Prospectus. Trading in the Shares (including the Private Placement Shares, but excluding the Offer Shares) on Oslo Axess is expected to commence on or about 8 July 2016, under the ticker code "TRVX". Joint Global Coordinators and Joint Bookrunners ABG Sundal Collier Arctic Securities DNB Markets The date of this Prospectus is 7 July 2016 www.kursiv.no