History, Development and Corporate Structure
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THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE OVERVIEW We are an innovative biopharmaceutical company focused on the discovery and development of novel therapeutics addressing unmet medical needs in respiratory and lung diseases. With a product portfolio covering full disease cycle and patient segmentations, our drug candidates address a unique spectrum of acute and chronic respiratory and lung diseases that currently lack effective treatments. As of the Latest Practicable Date, we had developed a pipeline of nine drug candidates, including a three-asset RSV franchise led by ziresovir, our Core Product and one of our lead assets, and a three-asset anti-fibrotic franchise highlighted by AK3280, our other lead asset. The history of our Group can be traced back to August 2013 when Dr. Wu founded ArkBio Cayman, the predecessor of our Company. Our Company was established in Shanghai as a limited liability company under the PRC Company Law in April 2014 by ArkBio Limited, which was wholly-owned by ArkBio Cayman, and was converted into a joint stock company on March 5, 2021. See “Directors, Supervisors and Senior Management” section in this document for the relevant industry experience of Dr. Wu. KEY MILESTONES The following is a summary of our Group’s key corporate and business development milestones. 2013 ArkBio Cayman was incorporated. 2014 Our Company was established. We in-licensed global rights of ziresovir (AK0529) from Roche. 2015 We completed series A financing. We completed phase I clinical trial for ziresovir (AK0529) in Australia. 2016 We initiated Viral Inhibition in Children for Treatment of RSV (VICTOR) international multiple centers phase II clinical trial for ziresovir (AK0529). 2017 We partnered with California Institute for Biomedical Research of The Scripps Research Institute for the development of AK0705. We completed series A+ financing. 2018 We in-licensed global rights of AK3280 from Genentech, Roche and Intermune. We completed two phase I clinical trials for ziresovir (AK0529) in China and UK, respectively. We completed series B financing. 2019 We completed phase II global clinical trial of ziresovir (AK0529) for treatment of hospitalized pediatric patients and initiated phase III clinical trial in China. We completed phase I drug interaction study of ziresovir (AK0529) in Australia. 2020 We obtained IND approval from FDA for ziresovir (AK0529). – 162 – THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE Our ziresovir (AK0529) received breakthrough designation from the NMPA. We out-licensed China rights of AK0706 to Amoytop. We completed series pre-C and series C financings. 2021 We obtained IND approval from the NMPA for AK3280. We completed phase Ib clinical trial for AK3280 in Sweden. We completed series C+ financing. We filed IND application for AK3287 with the NMPA. ESTABLISHMENT AND MAJOR SHAREHOLDING CHANGES OF OUR GROUP The corporate history and major shareholding changes of our Group are set out below: Incorporation of ArkBio Cayman, ArkBio Limited and our Company On August 19, 2013, ArkBio Cayman was incorporated in the Caymans Islands under the Cayman Companies Act with limited liability. The initial authorized share capital of ArkBio Cayman was US$5,000 divided into 50,000,000 ordinary shares with a par value of US$0.0001 each, of which 1,000,000 ordinary shares were issued to Dr. Wu at par value immediately upon the incorporation. ArkBio Limited was later incorporated in Hong Kong as a direct wholly-owned subsidiary of ArkBio Cayman on November 29, 2013. Our Company was established as a direct wholly-owned subsidiary of ArkBio Limited on April 29, 2014 with an initial registered capital of USD200,000. Since the establishment, our Company has been functioned as the principal operating entity of our Group through which we operate our business operations primarily. Initial Shareholding Changes of ArkBio Cayman before the Restructuring Before the Restructuring, ArkBio Cayman had received several rounds of Pre-[REDACTED] Investments which are summarized in the paragraph headed “—Pre-[REDACTED] Investments.” The following table sets forth the shareholding structure of ArkBio Cayman immediately before the completion of the Restructuring (after the completion of the series B financing and the equity transfer between Morem Limited and Harmony Sky Capital Limited, details of which are set out in “—Pre-[REDACTED] Investments”): Number of Shares of ArkBio Shareholding No. Shareholder Cayman Class of Shares Percentage(1) 1 Profits Excel(2) 889,690 Ordinary shares 37.52% 2 Million Joy(2) 200,000 Ordinary shares 8.43% – 163 – THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE Number of Shares of ArkBio Shareholding No. Shareholder Cayman Class of Shares Percentage(1) 3 Golden Trend Investment Limited 237,509 Ordinary shares 10.02% (“Golden Trend”) 4 Magic Seeds Investment Limited 127,532 Ordinary shares 5.38% (“Magic Seeds”) 5 Qiming Managing Directors Fund 3,526 Series A preferred 0.20% IV, L.P. shares 1,218 Series A+ preferred shares 6 Qiming Managing Directors Fund 3,731 Series B preferred 0.16% VI, L.P. shares 7 Qiming Venture Partners IV, L.P. 111,668 Series A preferred 6.34% shares 38,585 Series A+ preferred shares 8 Qiming Venture Partners VI, L.P. 138,642 Series B preferred 5.85% shares 9 Morningside Venture (I) 86,396 Series A preferred 11.33% Investments Limited shares 39,803 Series A+ preferred shares 142,373 Series B preferred shares 10 SIP Sungent Venture Capital 59,705 Series A+ 2.52% Investment Partnership II (LP) preferred shares (蘇州工業園區新建元二期創業 投資企業(有限合夥), “SIP Sungent”) 11 Suzhou Industrial Park Seed 19,902 Series A+ 0.84% Zhengze Yihao Venture Capital preferred shares Enterprise (Limited Partnership) (蘇州工業園區原 點正則壹號創業投資企業(有限 合夥), “Oriza Seed”) 12 BioTrack AK Limited 42,712 Series B preferred 1.80% shares 13 Harmony Sky Investment Limited 42,712 Series B preferred 1.80% (“Harmony Sky”) shares 14 Harmony Sky Capital Limited(3) 100,000 Ordinary shares 4.22% – 164 – THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE Number of Shares of ArkBio Shareholding No. Shareholder Cayman Class of Shares Percentage(1) 15 Suzhou Juming Zhonghong 42,712 Series B preferred 1.80% Fangren Venture Capital shares Investment Partnership (Limited Partnership) (蘇州聚 明中泓方仁創業投資合夥企業 (有限合夥), “MING Bioventures Fund I”) 16 Pingtan Taige Yingke Venture 42,712 Series B preferred 1.80% Capital Investment Partnership shares (Limited Partnership) (平潭泰 格盈科創業投資合夥企業(有限 合夥), “Taige Yingke”) Total 2,371,128 100.00% Notes: (1) Assuming the preferred shares were converted into ordinary shares on a 1:1 basis. (2) Each of Profits Excel and Million Joy was wholly owned by Dr. Wu. Among the 889,690 ordinary shares held by Profits Excel, 189,690 ordinary shares, representing 8.00% of the then issued share capital of ArkBio Cayman, were reserved for employee incentive purpose. (3) Harmony Sky Capital Limited is an Independent Third Party. Restructuring In order to further optimize our shareholding structure, ArkBio Cayman, ArkBio Limited, our Company, ArkBio Suzhou, ArkBio Australia, Dr. Wu and other then shareholders of ArkBio Cayman entered into a restructuring framework agreement (the “Restructuring Agreement”) on August 1, 2020, pursuant to which we underwent the Restructuring to demolish our overseas shareholding structure. The following chart sets forth a simplified corporate structure of our Group immediately before the Restructuring: ArkBio Cayman (Cayman) 100% ArkBio Limited (HK) 100% 100% 100% ArkBio Australia ArkBio Suzhou Our Company (Australia) (PRC) – 165 – THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE Step 1: Acquisition of ArkBio Suzhou On August 26, 2020, pursuant to the sole shareholder’s resolution of ArkBio Limited, ArkBio Limited transferred the USD10,000,000 registered capital of ArkBio Suzhou held by it, representing the entire equity interest of ArkBio Suzhou, to our Company at the consideration of USD1,431,680, which was determined with reference to an asset valuation report issued by an independent third party valuer, the net asset value of the Company as at April 30, 2020. Upon such transfer, ArkBio Suzhou became a wholly-owned subsidiary of our Company. Step 2: Acquisition of ArkBio Australia On August 3, 2020, ArkBio HK was incorporated in Hong Kong as a direct wholly-owned subsidiary of our Company with an initial share capital of HK$10,000 divided into 10,000 ordinary shares with a par value of HK$1.00 each. On August 28, 2020, ArkBio Limited and ArkBio HK entered into a share transfer agreement pursuant to which ArkBio Limited transferred the entire equity interest in ArkBio Australia held by it to ArkBio HK at nil consideration. The transaction was approved by the Australian Government Foreign Investment Review Board on December 18, 2020. Upon such transfer, ArkBio Australia became an indirect wholly-owned subsidiary of our Company. Step 3: Transfer of equity interest in our Company from ArkBio Limited to the shareholders of ArkBio Cayman Pursuant to the Restructuring Agreement and the equity transfer agreements entered into among ArkBio Limited and the then shareholders of ArkBio Cayman or their designated parties on September 28, 2020 and November 20, 2020, ArkBio Limited transferred the entire equity interest in our Company to the shareholders of ArkBio Cayman or their designated parties in proportion to their respective shareholding in ArkBio Cayman.