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Overcoming Chemotherapy Resistance Annual Report 2020

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Overcoming Chemotherapy Resistance Annual Report 2020 OVERCOMING CHEMOTHERAPY RESISTANCE ANNUAL REPORT 2020 Scandion Oncology A/S – www.scandiononcology.com – CVR No. 38613391 XXX XXXXX ANNUAL REPORT 2020 1 SCANDION ONCOLOGY IN BRIEF THE COMPANY THE THERAPY Scandion Oncology is a Danish Phase II Biotech Almost all cancer patients with metastatic company developing first-in-class medicines disease fail their cancer treatment – largely due that reverse anti-cancer drug resistance. to their cancer cells either being resistant already from the time of the primary diagnosis or because One of the most significant challenges in the cancer cells acquire resistance during anti- modern oncology is how to treat tumors that cancer treatment. As a result, the cancer continues are or have become resistant to the prescribed to grow despite treatment and without any other anti-cancer drugs. effective drugs, the patients are left to fight the growing cancer on their own. Scandion Oncology’s most advanced innovative drug, SCO-101, is an oral drug that in preclinical Therefore, drug resistance is a major threat studies has been documented to reverse resi- to cancer patients and a huge burden on the stance towards some of the most commonly health care systems. It also presents a significant used anti-cancer drugs. commercial opportunity for Scandion Oncology. OUR VISION SCO-101 is now in clinical Phase Ib and Phase II The global market for chemotherapy has a To overcome cancer trials in cancer patients. Safety of SCO-101 has value of 37bn USD and is estimated to grow drug resistance in previously been established in healthy volunteers. by 12% (CAGR) annually for the next 5 years. order to improve lives Scandion Oncology is currently developing their An add-on therapy such as SCO-101 would be for cancer patients pipeline with SCO-101 in different indications. able to tap into a portion of this market and reach In addition, Scandion Oncology is extending peak sales fast. and their families the pipeline with additional compounds. The Company is not aware of any drugs that are All with the aim to become the Cancer Drug registered for blocking anti-cancer drug resistance. Resistance Company. SCANDION ONCOLOGY IN BRIEF ANNUAL REPORT 2020 2 SCANDION ONCOLOGY IS SETTING THE PACE TABLE OF CONTENTS FOR THE FUTURE CEO LETTER Scandion Oncology in Brief . 2 PAGE 6 Key figures & Highlights . 4 CEO Letter . 6 Priorities 2021 . 8 SCANDION ONCOLOGY Pipeline and Strategy . 9 IS PURSUING A MAJOR Clinical Pipeline . 10 CORIST. .11 UNMET NEED IN PANTAX . 12 CANCER TREATMENT Biomarker Strategy . 13 Preclinical Pipeline . 14 INTERVIEW WITH Interview with Dr. Richard Schilsky . .16 DR. RICHARD SCHILSKY PAGE 16 Financial Review for 2020 . 17 Risk Management . 18 Corporate Governance . 20 Board of Directors . 22 Management . 24 THE BOARD HAS Shareholder Information . 26 Financial Statements. .28 TAKEN THE INITIATIVE Notes . 34 TO STRENGTHEN THE Accounting Policies. .36 Statement by Management on the Annual Report . 38 GOVERNANCE Auditor’s Report . 39 CORPORATE GOVERNANCE In this document, the following definitions shall apply unless otherwise specified: PAGE 20 “the Company” or “Scandion Oncology” refers to Scandion Oncology A/S, CVR No. 38613391. Page 2 – 27 constitute the Management Commentary. TABLE OF CONTENTS ANNUAL REPORT 2020 3 TABLE OFannual CONTENTS report 2020 3 KEY FIGURES & HIGHLIGHTS TDKK 2020 2019 Net sales 0 0 Profit/loss before financial items (EBIT) -22,888 -15,399 Profit/loss for the period -16,269 -12,184 Total assets 186,408 19,902 Cash position 5,814* 15,421 HIGHLIGHTS AFTER END OF THE PERIOD Equity ratio 84% 92% ON JANUARY 19, Scandion Oncology ON JANUARY 28, Scandion Oncology announced that the Company had announced that the Company had No. of shares end of the period 32,135,544 19,052,241 applied for and received approval for submitted an amendment to the Danish admission to trading on Nasdaq First Medicines Agency regarding the PANTAX Average number of shares 19,610,995 15,048,130 North Growth Market Sweden. The first study. The amendment is based on the day of trading was February 3, 2021. learnings obtained from treating the first Earnings per share (DKK) -0.83 -0.81 12 patients in the CORIST study and will ON JANUARY 23, Scandion Oncology contribute to an optimization of the * Cash position is increased in January 2021 by the net proceeds of the announced that the Company had PANTAX clinical trials. Rights Issue in 2020 amounting to 145.9 MDKK. completed the first 12 patient cohort in part 1 of the ongoing clinical Phase II Equity ratio: Shareholders’ equity as a proportion of total assets. The processing time for the amendment, study (CORIST) with SCO-101. Earnings per share: Profit/loss for the period divided by the average number of shares. on top of the current impact of the COVID-19 pandemic could delay The Company received the green the planned readout from the study light from the Data Safety Monitoring Board to move forward with the next into Q4, 2021. treatment cohorts. KEY FIGURES & HIGHLIGHTS ANNUAL REPORT 2020 4 TABLE OFannual CONTENTS report 2020 3 HIGHLIGHTS 2020 Q4 Q3 Q2 Q1 ON OCTOBER 7, Scandion Oncology ON JULY 31, Scandion Oncology repor- ON MAY 27, Scandion Oncology announ- ON FEBRUARY 19, Scandion Oncology announced modified timelines for the ted on data from the first patients from ced that the first patient has received announced that the Company has clinical Phase II colorectal cancer study cohort I of the first part of the clinical treatment with SCO-101 and FOLFIRI obtained a grant of 5 MDKK from Inno- (CORIST) and the Phase Ib study for phase II study enrolling chemotherapy and no unexpected SCO-101-related vation Fund Denmark for the clinical pancreatic cancer (PANTAX). The updated resistant colorectal cancer patients adverse events had been observed. development of SCO-101 in inoperable timelines came as a result of the spread treated with SCO-101 and chemotherapy SCO-101 caused the expected changes pancreatic cancer. of COVID-19. (FOLFIRI). All patients had completed at of the exposure biomarker bilirubin least one treatment cycle (14 days). The levels, demonstrating that SCO-101 ON MARCH 9, Scandion Oncology infor- ON OCTOBER 28, Scandion Oncology main observation was that a 150 mg daily was present in the body in an effective med about a delay in the clinical phase announced that its second clinical study oral dose SCO-101 potentiates the effects concentration. II study with SCO-101 in drug resistant with SCO-101 had been initiated. The of chemotherapy (FOLFIRI). colorectal cancer. The delay was due to Phase Ib study (PANTAX) enrolls meta- ON JUNE 4, Scandion Oncology an- external events outside the influence of static pancreatic cancer patients who will ON SEPTEMBER 16, Scandion Oncology nounced the signing of a collaboration Scandion Oncology and is unrelated to receive SCO-101 together with 1st line appointed Bo Rode Hansen as new agreement with Alligator Bioscience AB, the treatment with SCO-101. standard chemotherapy (Nab-paclitaxel President & CEO in order to strengthen Sweden. The two companies have agreed plus gemcitabine) in cohorts of three. executive leadership, and secure corpo- to explore the anti-tumor efficacy of the ON MARCH 23, Scandion Oncology The primary endpoints of this study are rate- and pipeline development towards CD40 antibody mitazalimab (Alligator together with its clinical partners at the safety and efficacy. upcoming value inflection points for Bioscience) in combination with SCO- hospitals decided to continue the colo- Scandion Oncology. 101 (Scandion Oncology) as an addition rectal cancer study with FOLFIRI resistant ON DECEMBER 15, Scandion Oncology to chemotherapy in resistant preclinical patients despite the COVID-19 pandemic. announced the result of its Rights Issue, ON SEPTEMBER 28, Scandion Oncology tumor models. However, due to this pandemic, Scandion which provided the Company with announced that the Company had Oncology is unable to predict patient proceeds amounting to approximately received final approval from the Danish ON JUNE 9, Scandion Oncology announ- recruitment rates the next couple of 236 MSEK before issue costs. Medicines Agency and Ethical Committee ced that the Clinical Trial Application for months. Enrolment into the study will to initiate a clinical trial with the drug a pancreatic cancer study with chemothe- be solely based on the discretion of the candidate SCO-101 in combination rapy and SCO-101 has been submitted clinical investigators. with first line chemotherapy in patients to the Danish Medicines Agency and the with inoperable or metastatic pancreatic Ethical Committee. cancer. This is the second clinical trial with SCO-101 that commenced in 2020. HIGHLIGHTS 2020 ANNUAL REPORT 2020 5 TABLE OFannual CONTENTS report 2020 3 SCANDION ONCOLOGY IS SETTING THE PACE FOR THE FUTURE President & CEO Bo Rode Hansen Serving the patients to understand the safety and tolerability. The study is sums up 2020 and looks ahead – with platform and personalized medicine expected to continue into the effect study part immedia- Our clinical development is aimed at making a difference tely after the interim data read-out. in oncology treatment. I want to extend my unconditional Looking back on 2020, it was undoubtedly a historic year gratitude to the patients who are involved in our studies. Later in 2021, we expect to obtain results from the of change in the name of COVID-19, and we all had to ac- One of the biggest challenges in oncology treatment is first part of the PANTAX study, where the objective is to cept and adapt to the situation. For Scandion Oncology’s cancer drug resistance which leads to almost 9 million optimize the dose for the treatment of pancreatic cancer part, we managed to navigate through the crisis in the lost lives every year.
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