方舟生物医药 2025年度报告

FORM 10-K OR Commission File Number 000-22873 Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES☐NO☒ Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES☐NO☒ Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports),and (2) has been subject to such filing requirements for the past 90 days. YES☒NO☐ Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theRegistrant was required to submit such files). YES☒NO☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reportingcompany,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Accelerated filer☐Smaller reporting company☒ Large accelerated filerNon-accelerated filerEmerging growth company If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectivenessof its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registeredpublic accounting firm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of theregistrant included in the filing reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-basedcompensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES☐NO☒ The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant as of June 30, 2025,was approximately $371.5 million based on the closing price of the Registrant’s shares of common stock on The Nasdaq CapitalMarket on such date. The number of shares of the Registrant’s common stock outstanding as of February 28, 2026 was 49,542,691. Table of Contents PagePART IItem 1.Business1Item 1A.Risk Factors37Item 1B.Unresolved Staff Comments65Item 1C.Cybersecurity65Item 2.Properties65Item 3.Legal Proceedings65Item 4.Mine Safety Disclosures65PART IIItem 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of EquitySecurities66Item 6.[Reserved]66Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations67Item 7A.Quantitative and Qualitative Disclosures About Market Risk78Item 8.Financial Statements and Supplementary Data79Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure110Item 9A.Controls and Procedures110Item 9B.Other Information111Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections111PART IIIItem 10.Directors, Executive Officers and Corporate Governance112Item 11.Executive Compensation112Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters112Item 13.Certain Relationships and Related Transactions, and Director Independence112Item 14.Principal Accounting Fees and Services112PART IVItem 15.Exhibits, Financial Statement Schedules113Item 16.Form 10-K Summary115Signatures116 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, or Annual Report, contains “forward-looking statements” within the meaning of Section 27Aof the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).These forward-looking statements reflect the current views of Oruka Therapeutics, Inc. (“Oruka”, the “Company”, “we”, or “us”) withrespect to future events and are based on assumptions and subject to known and unknown risks and uncertainties and other factors thatmay cause our actual results, performance, time frames or achievements to be materially different from any future results,performance, time frames or achievements