Orchestra BioMed Holdings Inc 2025年季度报告

Securities registered pursuant to Section12(b)of the Act Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of theSecurities Exchange Act of 1934 during the preceding 12months (or for such shorter period that the registrant was required tofile such reports), and (2)has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12months (or for such shorter periodthat 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 smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”“smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section13(a)of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act). Yes☐No☒ As of August 8, 2025, the registrant had53,955,085shares of common stock, $0.0001 par value per share, outstanding. Table of Contents PART I. FINANCIAL INFORMATION Item 1.Financial Statements1Unaudited Condensed Consolidated Financial Statements:Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) andDecember 31, 20241Condensed Consolidated Statements of Operations and Comprehensive Loss for theThree and Six Months Ended June 30, 2025 and 20242Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Threeand Six Months Ended June 30, 2025 and 20243Condensed Consolidated Statements of Cash Flows forSixMonths Ended June 30,2025 and 20244Notes to Unaudited Condensed Consolidated Financial Statements5Item 2.Management’s Discussion and Analysis of Financial Condition and Results ofOperations29Item 3.Quantitative and Qualitative Disclosures About Market Risk47Item 4.Controls and Procedures47 PART II. OTHER INFORMATION 47 Item 1.Legal Proceedings47Item 1A.Risk Factors48Item 2.Unregistered Sales of Equity Securities and Use of Proceeds48Item 3.Defaults Upon Senior Securities48Item 4.Mine Safety Disclosures48Item 5.Other Information48Item 6.Exhibits49Signatures50 SPECIAL NOTEREGARDING FORWARD-LOOKING STATEMENTS ThisQuarterly Report on Form 10-Q(this“Quarterly Report”)contains forward-lookingstatements. All statements other than statements of historical facts contained in this report, includingstatements regarding our future results of operations and financial position, business strategy, productcandidates, planned preclinical studies and clinical trials, results of clinical trials, research anddevelopment costs, regulatory approvals, timing, and likelihood of success, as well as plans andobjectives of management for future operations, are forward-looking statements. These statementsinvolve known and unknown risks, uncertainties, and other important factors that are in some casesbeyond our control and may cause our actual results, performance, or achievements to be materiallydifferent from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,”“should,”“would,”“expect,”“plan,”“anticipate,”“could,”“intend,”“target,”“project,”“contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of theseterms or other similar expressions. Forward-looking statements contained in this report include, butare not limited to, statements about: ●our ability to raise financing in the future, including our ability to borrow additional fundsunder our current debt financing arrangement;●our receipt of committed capital, including the payment of the Second Installment under theRevenue Purchase and Sale Agreement (each as defined herein) and the timing of thefunding of the Medtronic Loan Agreement (as defined herein);●the date of completion of the formal mediation with Terumo (as defined herein);●our success in retaining or recruiting, or changes required in, our officers, key employees ordirectors;●our ability and/or the ability of third-party vendors and partners to manufacture our productcandidates;●our ability to source critical components or materials for the manufacture of our productcandidates;●our ability to achieve and sustain profitability;●our ability to achieve our projected development and commercialization goals;●the rate of progress, costs and results of our clinical studies and research and developmentactiv