Orchestra BioMed Holdings Inc 2025年度报告

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 Section 15(d) of the Act. Yes☐ No ☒ Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of the Securities Exchange Act of 1934 during thepreceding 12months (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 past90days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T(§232.405 of this chapter) during the preceding 12months (or for such shorter period that the registrant 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, a smaller reporting company, or an emerging growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section13(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 effectiveness of its internal control over financialreporting under Section 404(b) of the Sarbanes‐Oxley Act (15 U.S.C. 7262(b)) by the registered public 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 the registrant included in the filing reflect thecorrection 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‐based compensation received by any of theregistrant’s executive officers during the relevant recovery period pursuant to §240.10D‐1(b).☐ The aggregate market value of the registrant’s common stock held by non-affiliates as of June 30, 2025 the last business day of the registrant’s most recently completedsecond fiscal quarter was approximately $63.4 million as computed by reference to the closing price of the common stock on the Nasdaq Global Market on that date.As of March 10, 2026, the registrant had 58,520,901 shares of common stock, $0.0001 par value per share, outstanding. DOCUMENTS INCORPORATED BY REFERENCEPart III of this report incorporates information by reference from the Company's definitive proxy statement, which proxy statement is due to be filed with the Securities and Exchange Commission not later than 120 days after December 31, 2025. Table of Contents PagePART I1 Item 1Business1Item 1ARisk Factors77Item 1BUnresolved Staff Comments130Item 1CCybersecurity131Item 2Properties132Item 3Legal Proceedings132Item 4Mine Safety Disclosures132 PART II132 Item 5Market for Registrant’s Common Equity, Related Shareholder Matters and IssuerPurchases of Equity Securities132Item 6[Reserved]133Item 7Management’s Discussion and Analysis of Financial Condition and Results of Operations134Item 7AQuantitative and Qualitative Disclosures About Market Risk148Item 8Financial Statements and Supplementary Data149Item 9Changes in and Disagreements with Accountants on Accounting and FinancialDisclosure188Item 9AControls and Procedures189Item 9BOther Information190Item 9CDisclosure Regarding Foreign Jurisdictions That Prevent Inspections190 Item 10Directors, Executive Officers and Corporate Governance191Item 11Executive Compensation191Item 12Security Ownership of Certain Beneficial Owners and Management and RelatedShareholder Matters191Item 13Certain Relationships and Related Transactions, and Director Independence191Item 14Principal Accountant Fees and Services191 Unless the context indicates otherwise, references in this Annual Report on Form 10-K to the“Company,” “Orchestra,” “we,” “us,” “our” and similar terms refer to Orchestra BioMed Holdings, Inc., aDelaware corporation formerly known as Health Sciences Acquisitions Corporation 2, and its consolidatedsubsidiaries. Certain information contained in this Annual Report on Form 10-K relates to or is based on studies,publications, surveys and other data obtained from third-party sources and our own internal estimates andresearch. While we believe these third-party sources to be reliable as of the date of this Annual Report onForm 10-K, we have not independently verified the market and industry data contained in this AnnualReport on Form 10-K or the underlying assumptions relied