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of Contents](#TOC)\n\n​\n\n​\n\n**UNITED STATES**\n\n**SECURITIES AND EXCHANGE COMMISSION**\n\n**WASHINGTON, DC 20549**\n\n​\n\n**FORM ****10-Q**\n\n​\n\n​\n\n**(Mark One)**\n\n**☒********QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n**For the quarterly period ended****March 31, 2026**\n\n**OR**\n\n**☐********TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n**For the transition period from __________________ to __________________**\n\n**Commission file number:****001-39421**\n\n​\n\n**ORCHESTRA BIOMED HOLDINGS, INC.**\n\n**(Exact name of registrant as specified in its charter)**\n\n**Delaware**\n\n  ​ ​\n\n**92-2038755**\n\n**(State or other jurisdiction of**\n**incorporation or organization)**\n\n \n\n**(IRS Employer**\n**Identification No.)**\n\n​\n\n**150 Union Square Drive**\n\n**New Hope****,****Pennsylvania********18938**\n\n**(Address of principal executive offices, including zip code)**\n\n**Registrant’s telephone number, including area code: (****215****)****862-5797**\n\nSecurities registered pursuant to Section 12(b) of the Act\n\n**Title of each class**\n\n  ​ ​ ​\n\n**Trading Symbol(s)**\n\n  ​ ​ ​\n\n**Name of each exchange on which registered**\n\nCommon stock, par value $0.0001 per share\n\n \n\nOBIO\n\n \n\nThe Nasdaq Stock Market LLC\n\n​\n\nIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange 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 ☐\n\nIndicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐\n\nIndicate 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 growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.\n\nLarge accelerated filer\n\n☐\n\nAccelerated filer\n\n☐\n\nNon-accelerated filer\n\n☒\n\nSmaller reporting company\n\n☒\n\n​\n\n​\n\nEmerging growth company\n\n☐\n\n​\n\nIf 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 revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐\n\nIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒\n\nAs of May 8, 2026, the registrant had 59,880,715 shares of common stock, $0.0001 par value per share, outstanding.\n\n​\n\n​\n\n​\n\n​\n\n​\n\n[Table of Contents](#TOC)\n\n**Table of Contents**\n\n​\n\n​\n\n**Page**\n\n[**PART I. FINANCIAL INFORMATION**](#PARTIFINANCIALINFORMATION_947780)\n\n1\n\n​\n\n​\n\n​\n\n[Item 1.](#Item1FinancialStatements_676566)\n\n[Financial Statements](#Item1FinancialStatements_676566)\n\n1\n\n​\n\nUnaudited Condensed Consolidated Financial Statements:\n\n​\n\n​\n\n[Condensed Consolidated Balance Sheets as of March 31, 2026 (Unaudited) and December 31, 2025](#CondensedConsolidatedBalanceSheets_10989)\n\n1\n\n​\n\n[Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2026 and 2025](#CondensedConsolidatedStatementsofOperati)\n\n2\n\n​\n\n[Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three Months Ended March 31, 2026 and 2025](#CondensedConsolidatedStatementsofStockho)\n\n3\n\n​\n\n[Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2026 and 2025](#CondensedConsolidatedStatementsofCashFlo)\n\n4\n\n​\n\n[Notes to Unaudited Condensed Consolidated Financial Statements](#NOTESTOCONDENSEDCONSOLIDATEDFINANCIALSTA)\n\n5\n\n[Item 2.](#Item2ManagementsDiscussionandAnalysisofF)\n\n[Management’s Discussion and Analysis of Financial Condition and Results of Operations](#Item2ManagementsDiscussionandAnalysisofF)\n\n29\n\n[Item 3.](#Item3QuantitativeandQualitativeDisclosur)\n\n[Quantitative and Qualitative Disclosures About Market Risk](#Item3QuantitativeandQualitativeDisclosur)\n\n40\n\n[Item 4.](#Item4ControlsandProcedures_214683)\n\n[Controls and Procedures](#Item4ControlsandProcedures_214683)\n\n40\n\n​\n\n​\n\n​\n\n[**PART II. OTHER INFORMATION**](#PARTIIOTHERINFORMATION_491535)\n\n40\n\n​\n\n​\n\n​\n\n[Item 1.](#Item1LegalProceedings_728134)\n\n[Legal Proceedings](#Item1LegalProceedings_728134)\n\n40\n\n[Item 1A.](#_Item_1A._Risk)\n\n[Risk Factors](#_Item_1A._Risk)\n\n40\n\n[Item 2.](#Item2UnregisteredSalesofEquitySecurities)\n\n[Unregistered Sales of Equity Securities and Use of Proceeds](#Item2UnregisteredSalesofEquitySecurities)\n\n41\n\n[Item 3.](#Item3DefaultsUponSeniorSecurities_590897)\n\n[Defaults Upon Senior Securities](#Item3DefaultsUponSeniorSecurities_590897)\n\n41\n\n[Item 4.](#Item4MineSafetyDisclosures_710534)\n\n[Mine Safety Disclosures](#Item4MineSafetyDisclosures_710534)\n\n41\n\n[Item 5.](#Item5OtherInformation_169053)\n\n[Other Information](#Item5OtherInformation_169053)\n\n41\n\n[Item 6.](#Item6Exhibits_566689)\n\n[Exhibits](#Item6Exhibits_566689)\n\n42\n\n[Signatures](#SIGNATURES_191271)\n\n43\n\n​\n\n​\n\n​\n\n​\n\ni\n\n[Table of Contents](#TOC)\n\nSPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS\n\nThis Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing, and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that are in some cases beyond our control and may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.\n\nIn 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 these terms or other similar expressions. Forward-looking statements contained in this report include, but are not limited to, statements about:\n\n●our ability to raise financing in the future, including our ability to borrow additional funds under our current debt financing arrangements;\n\n●our success in retaining or recruiting, or changes required in, our officers, key employees or directors;\n\n●our ability and/or the ability of third-party vendors and partners to manufacture our product candidates;\n\n●our ability to source critical components or materials for the manufacture of our product candidates;\n\n●our ability to achieve and sustain profitability;\n\n●our ability to achieve our projected development and commercialization goals;\n\n●the rate of progress, costs and results of our clinical studies and research and development activities, including, among other things, the date by which we expect to complete enrollment of our BACKBEAT Global Pivotal Trial and our Virtue Trial;\n\n●market acceptance of our product candidates, if approved;\n\n●our ability to compete successfully with larger companies in a highly competitive industry;\n\n●changes in our operating results, which make future operations results difficult to predict;\n\n●serious adverse events, undesirable side effects that could halt the clinical development, regulatory approval or certification, of our product candidates;\n\n●our ability to manage growth or control costs related to growth;\n\n●economic conditions that may adversely affect our business, financial condition and stock price;\n\n●our reliance on third parties to drive successful marketing and sale of our initial product candidates, if approved;\n\n●our reliance on third parties to manufacture and provide important materials and components for our products and product candidates;\n\n●our and our partners’ abilities to obtain necessary regulatory approvals and certifications for our product candidates in an uncomplicated and inexpensive manner;\n\nii\n\n[Table of Contents](#TOC)\n\n●our ability to maintain compliance with regulatory and post-marketing requirements;\n\n●adverse medical events, failure or malfunctions in connection with our product candidates and possible subjection to regulatory sanctions;\n\n●healthcare costs containment pressures and legislative or administrative reforms which affect coverage and reimbursement practices of third-party payors;\n\n●our ability to protect or enforce our intellectual property, unpatented trade secrets, know-how and other proprietary technology;\n\n●our ability to obtain necessary intellectual property rights from third parties;\n\n●our ability to protect our trademarks, trade names and build our name recognition;\n\n●our ability to maintain the listing of our common stock on The Nasdaq Stock Market LLC (“Nasdaq”);\n\n●the success of our licensing agreements; and\n\n●our public securities’ liquidity and trading.\n\nWe have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations, and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this report and are subject to a number of risks, uncertainties, and assumptions described under the headings “Item 1A. Risk Factors” in Part I of our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 10-K”) filed with SEC on March 12, 2026 as well as elsewhere in this Quarterly Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We do not plan to publicly update or revise any forward-looking statements contained herein whether as a result of any new information, future events, or otherwise, except as required by law.\n\nIn addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.\n\n​\n\n​\n\niii\n\n[Table of Contents](#TOC)\n\nPART I—FINANCIAL INFORMATION"}