10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________________ to __________________

Commission file number: 001-39421

ORCHESTRA BIOMED HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware	92-2038755
(State or other jurisdiction of incorporation or organization)	(IRS Employer Identification No.)

150 Union Square Drive

New Hope, Pennsylvania 18938

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (215) 862-5797

Securities registered pursuant to Section 12(b) of the Act

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.0001 per share	OBIO	The Nasdaq Global Market

Indicate 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 ☐

Indicate 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 ☐

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 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.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

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 revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 8, 2025, the registrant had 53,955,085 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents

		Page
PART I. FINANCIAL INFORMATION		1
Item 1.	Financial Statements	1
	Unaudited Condensed Consolidated Financial Statements:
	Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2025 and 2024	2
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Six Months Ended June 30, 2025 and 2024	3
	Condensed Consolidated Statements of Cash Flows for Six Months Ended June 30, 2025 and 2024	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	29
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	47
Item 4.	Controls and Procedures	47
PART II. OTHER INFORMATION		47
Item 1.	Legal Proceedings	47
Item 1A.	Risk Factors	48
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	48
Item 3.	Defaults Upon Senior Securities	48
Item 4.	Mine Safety Disclosures	48
Item 5.	Other Information	48
Item 6.	Exhibits	49
Signatures		50

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This 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.

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 these terms or other similar expressions. Forward-looking statements contained in this report include, but are not limited to, statements about:

● our ability to raise financing in the future, including our ability to borrow additional funds under our current debt financing arrangement;

● our receipt of committed capital, including the payment of the Second Installment under the Revenue Purchase and Sale Agreement (each as defined herein) and the timing of the funding 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 or directors;

● our ability and/or the ability of third-party vendors and partners to manufacture our product candidates;

● our ability to source critical components or materials for the manufacture of our product candidates;

● 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 development activities, including, among other things, the date by which we expect to complete enrollment of our BACKBEAT global pivotal study;

● market acceptance of our product candidates, if approved;

● our ability to compete successfully with larger companies in a highly competitive industry;

● changes in our operating results, which make future operations results difficult to predict;

● serious adverse events, undesirable side effects that could halt the clinical development, regulatory approval or certification, of our product candidates;

● our ability to manage growth or control costs related to growth;

● economic conditions that may adversely affect our business, financial condition and stock price;

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● our reliance on third parties to drive successful marketing and sale of our initial product candidates, if approved;

● our reliance on third parties to manufacture and provide important materials and components for our products and product candidates;

● our and our partners’ abilities to obtain necessary regulatory approvals and certifications for our product candidates in an uncomplicated and inexpensive manner;

● our ability to maintain compliance with regulatory and post-marketing requirements;

● adverse medical events, failure or malfunctions in connection with our product candidates and possible subjection to regulatory sanctions;

● healthcare costs containment pressures and legislative or administrative reforms which affect coverage and reimbursement practices of third-party payors;

● our ability to protect or enforce our intellectual property, unpatented trade secrets, know-how and other proprietary technology;

● our ability to obtain necessary intellectual property rights from third parties;

● our ability to protect our trademarks, trade names and build our names recognition;

● our ability to maintain the listing of our common stock on The Nasdaq Stock Market LLC (“Nasdaq”);

● the success of our licensing agreements; and

● our public securities’ liquidity and trading.

We 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, 2024 (the “2024 10-K”), and “Item 1A. Risk Factors” in Part II of this Quarterly Report, 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.

In 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.

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

ORCHESTRA BIOMED HOLDINGS, INC.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(Unaudited)

	June 30,		December 31,
	2025		2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	18,749	$	22,261
Marketable securities		15,175		44,551
Accounts receivable, net		83		92
Inventory		185		173
Prepaid expenses and other current assets		1,690		2,094
Total current assets		35,882		69,171
Property and equipment, net		1,366		1,384
Right-of-use assets		1,806		2,103
Strategic investments		2,495		2,495
Deposits and other assets		1,276		1,020
TOTAL ASSETS	$	42,825	$	76,173
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable	$	5,308	$	5,134
Accrued expenses and other liabilities		6,650		6,084
Operating lease liability, current portion		642		550
Deferred revenue, current portion		4,461		4,439
Total current liabilities		17,061		16,207
Deferred revenue, less current portion		9,568		10,989
Loan payable		14,384		14,292
Operating lease liability, less current portion		1,328		1,687
Other long-term liabilities		189		40
TOTAL LIABILITIES		42,530		43,215
STOCKHOLDERS’ EQUITY
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at June 30, 2025 and December 31, 2024.		—		—
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 38,643,553 and 38,194,442 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively.		4		4
Additional paid-in capital		348,271		342,780
Accumulated other comprehensive income		16		52
Accumulated deficit		(347,996)		(309,878)
TOTAL STOCKHOLDERS’ EQUITY		295		32,958
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	42,825	$	76,173

The accompanying notes are an integral part of these condensed consolidated financial statements.

1

ORCHESTRA BIOMED HOLDINGS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)

	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Revenue:
Partnership revenue	$	667	$	628	$	1,399	$	1,125
Product revenue		169		150		305		273
Total revenue		836		778		1,704		1,398
Expenses:
Cost of product revenues		46		44		90		78
Research and development		13,853		11,126		27,335		20,238
Selling, general and administrative		6,264		6,467		12,527		12,364
Total expenses		20,163		17,637		39,952		32,680
Loss from operations		(19,327)		(16,859)		(38,248)		(31,282)
Other (expense) income:
Interest (expense) income, net		(36)		902		130		1,918
Loss on fair value of strategic investments		—		(23)		—		(68)
Other expense		—		—		—		(11)
Total other (expense) income		(36)		879		130		1,839
Net loss	$	(19,363)	$	(15,980)	$	(38,118)	$	(29,443)
Net loss per share
Basic and diluted	$	(0.50)	$	(0.45)	$	(0.99)	$	(0.82)
Weighted-average shares used in computing net loss per share, basic and diluted		38,392,716		35,800,273		38,314,936		35,789,137
Comprehensive loss
Net loss	$	(19,363)	$	(15,980)	$	(38,118)	$	(29,443)
Unrealized loss on marketable securities		(21)		(15)		(36)		(13)
Comprehensive loss	$	(19,384)	$	(15,995)	$	(38,154)	$	(29,456)

The accompanying notes are an integral part of these condensed consolidated financial statements.

2

ORCHESTRA BIOMED HOLDINGS, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(in thousands, except share and per share data)

(Unaudited)

						Accumulated				Total
				Additional		Other				Stockholders’
	Common Stock			Paid-in		Comprehensive		Accumulated		Equity
	Shares	Amount		Capital		(Loss) Income		Deficit		(Deficit)
Balance, January 1, 2025	38,194,442	$	4	$	342,780	$	52	$	(309,878)	$	32,958
Unrealized loss on marketable securities	—		—		—		(15)		—		(15)
Stock-based compensation	—		—		2,965		—		—		2,965
Restricted stock unit vesting	95,958		—		(387)		—		—		(387)
Exercise of stock options	22,112		—		91		—		—		91
Net loss	—		—		—		—		(18,755)		(18,755)
Balance, March 31, 2025	38,312,512	$	4	$	345,449	$	37	$	(328,633)	$	16,857
Unrealized loss on marketable securities	—		—		—		(21)		—		(21)
Stock-based compensation	—		—		3,250		—		—		3,250
Restricted stock unit vesting	331,041		—		(428)		—		—		(428)
Net loss	—		—		—		—		(19,363)		(19,363)
Balance, June 30, 2025	38,643,553	$	4	$	348,271	$	16	$	(347,996)	$	295

						Accumulated				Total
				Additional		Other				Stockholders’
	Common Stock			Paid-in		Comprehensive		Accumulated		Equity
	Shares	Amount		Capital		(Loss) Income		Deficit		(Deficit)
Balance, January 1, 2024	35,777,412	$	4	$	316,903	$	(10)	$	(248,854)	$	68,043
Unrealized gain on marketable securities	—		—		—		2		—		2
Stock-based compensation	—		—		2,588		—		—		2,588
Exercise of stock options	7,585		—		18		—		—		18
Net loss	—		—		—		—		(13,463)		(13,463)
Balance, March 31, 2024	35,784,997	$	4	$	319,509	$	(8)	$	(262,317)	$	57,188
Unrealized loss on marketable securities	—		—		—		(15)		—		(15)
Stock-based compensation	—		—		2,761		—		—		2,761
Restricted stock unit vesting	2,000		—		—		—		—		—
Exercise of stock options	37,574		—		171		—		—		171
Net loss	—		—		—		—		(15,980)		(15,980)
Balance, June 30, 2024	35,824,571	$	4	$	322,441	$	(23)	$	(278,297)	$	44,125

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

ORCHESTRA BIOMED HOLDINGS, INC.

Condensed Consolidated Statements of Cash Flows

(in thousands, except share and per share data)

(Unaudited)

	Six Months Ended June 30,
	2025		2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(38,118)	$	(29,443)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		164		148
Stock-based compensation		6,215		5,349
Loss on fair value of strategic investments		—		68
Accretion and interest related to marketable securities		(161)		(914)
Non-cash lease expense		297		224
Amortization of deferred financing fees		92		—
Other		—		11
Changes in operating assets and liabilities:
Accounts receivable		9		19
Inventory		(11)		76
Prepaid expenses and other assets		148		53
Accounts payable, accrued expenses and other liabilities		888		2,449
Operating lease liabilities – current and non-current		(267)		(235)
Deferred revenue		(1,399)		(1,125)
Net cash used in operating activities		(32,143)		(23,320)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment		(146)		(115)
Sales of marketable securities		32,403		58,788
Purchases of marketable securities		(2,902)		(42,388)
Net cash provided by investing activities		29,355		16,285
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of stock options		91		189
Restricted stock units withheld for tax		(815)		—
Net cash (used in) provided by financing activities		(724)		189
Net decrease in cash and cash equivalents		(3,512)		(6,846)
Cash and cash equivalents, beginning of the period		22,261		30,559
Cash and cash equivalents, end of the period	$	18,749	$	23,713
Supplemental Disclosures of Cash Flow Information
Cash paid during the six months ended June 30:
Interest	$	722	$	—
Supplemental disclosure of noncash activities
Non-cash investing activities:
Increase in accounts payable, accrued expenses and other liabilities related to fixed assets	$	23	$	—

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

ORCHESTRA BIOMED HOLDINGS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

1. Organization and Basis of Presentation

Orchestra BioMed Holdings, Inc. (collectively, with its subsidiaries, “Orchestra” or the “Company”) (formerly known as Health Sciences Acquisitions Corporation 2) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. The Company’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. The Company’s flagship product candidates are atrioventricular interval modulation (“AVIM”) therapy (formerly referred to as BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”)), for the treatment of hypertension (“HTN”), a significant risk factor for death worldwide, and Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide.

Prior to January 26, 2023, the Company was a special purpose acquisition company formed for the purpose of entering into a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. On January 26, 2023 (the “Closing”), the Company consummated the business combination contemplated by the Agreement and Plan of Merger, dated as of July 4, 2022 (as amended by Amendment No. 1 to Agreement and Plan of Merger, dated July 21, 2022, and Amendment No. 2 to Agreement and Plan of Merger, dated November 21, 2022, the “Merger Agreement”) by and among Health Sciences Acquisitions Corporation 2, a special purpose acquisition company incorporated as a Cayman Islands exempted company in 2020 (“HSAC2”), HSAC Olympus Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of HSAC2 (“Merger Sub”), and Orchestra BioMed, Inc. (“Legacy Orchestra”). Pursuant to the Merger Agreement, (i) HSAC2 deregistered in the Cayman Islands in accordance with the Companies Act (2022 Revision) (As Revised) of the Cayman Islands and domesticated as a Delaware corporation in accordance with Section 388 of the Delaware General Corporation Law (the “Domestication”) and (ii) Merger Sub merged with and into Legacy Orchestra, with Legacy Orchestra as the surviving company in the merger and, after giving effect to such merger, continuing as a wholly owned subsidiary of Orchestra (the “Merger” and, together with the Domestication and the other transactions contemplated by the Merger Agreement, the “Business Combination”). As part of the Domestication, the Company’s name was changed from “Health Sciences Acquisitions Corporation 2” to “Orchestra BioMed Holdings, Inc.” On January 27, 2023, our common stock (“Company Common Stock”) began trading on the Nasdaq Global Market under the symbol “OBIO.”

Legacy Orchestra, the Company’s wholly owned subsidiary, was incorporated in Delaware in January 2017 and was formed to acquire operating and other assets as well as to raise capital conducted through private placements. In May 2018, Legacy Orchestra concurrently completed its formation mergers (the “Formation Mergers”) with Caliber Therapeutics, Inc., a Delaware corporation, BackBeat Medical, Inc., a Delaware Corporation, and FreeHold Surgical, Inc., a Delaware corporation. Legacy Orchestra completed the conversions of BackBeat Medical, Inc. to BackBeat Medical, LLC (“BackBeat”), a Delaware limited liability company, of FreeHold Surgical, Inc. to FreeHold Surgical, LLC (“FreeHold”) and of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC (“Caliber”), a Delaware limited liability company, in 2019.

Caliber

Caliber Therapeutics, Inc. was incorporated in Delaware in October 2005 and began development of its lead product Virtue SAB in 2008. Virtue SAB is a patented drug/device combination product candidate for the treatment of artery disease that delivers a proprietary extended release formulation of sirolimus called SirolimusEFR to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need for leaving a permanent implant such as a stent in the artery. In 2019, Legacy Orchestra entered into a distribution agreement with Terumo Corporation and Terumo Medical Corporation (collectively “Terumo”) for global development and commercialization of Virtue SAB (the “Terumo Agreement”) (See Note 3 – “Terumo Agreement”).

5

BackBeat

BackBeat Medical, Inc. was incorporated in Delaware in January 2010 and began development of its lead product AVIM therapy that same year. AVIM therapy is a patented implantable cardiac stimulation-based treatment for HTN that is designed to immediately, substantially and persistently lower blood pressure while simultaneously modulating autonomic nervous system responses that normally drive and maintain blood pressure higher. Refer to Note 4 for details regarding the Exclusive License and Collaboration Agreement, dated as of June 30, 2022, by and among, Legacy Orchestra, BackBeat and Medtronic, Inc. (an affiliate of Medtronic plc) (the “Medtronic Agreement”).

FreeHold

FreeHold Surgical, Inc. was incorporated in Delaware in May 2010 and began development of its hands-free, intracorporeal retractor device for minimally invasive surgery in 2012. FreeHold is engaged in the development, sales and marketing of its retractor products that provide optimized visual and total surgeon control during laparoscopic and robotic procedures.

Basis of Presentation and Liquidity

The accompanying unaudited interim condensed consolidated financial statements have been prepared pursuant to the rules and regulation of the U.S. Securities and Exchange Commission (“SEC”) for interim financial reporting. These condensed statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary to fairly present the results of the interim periods. The condensed consolidated balance sheet at December 31, 2024 has been derived from the audited financial statements at that date. Operating results and cash flows for the six months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025 or any other future period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been omitted in accordance with the rules and regulations for interim reporting of the SEC. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025 together with the related notes thereto.

The Company has a limited operating history and the sales and income potential of its businesses and markets are unproven. As of June 30, 2025, the Company had an accumulated deficit of $348.0 million and has experienced net losses each year since its inception. The Company expects to incur substantial operating losses in future periods and will require additional capital as it seeks to advance its products to commercialization. The Company is subject to a number of risks and uncertainties similar to those of other companies of the same size within the biomedical device industry, such as uncertainty of clinical trial outcomes, uncertainty of additional funding, and history of operating losses.

The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements — Going Concern, which requires management to assess the Company’s ability to continue as a going concern within one year after the date the financial statements are issued.

Based on the available balance of cash and cash equivalents and marketable securities as of June 30, 2025, and subsequent proceeds received (see Note 16 – “Subsequent Events”), management has concluded that sufficient capital is available to fund its operations and meet cash requirements through the one-year period subsequent to the issuance date of these financial statements. Management may consider plans to raise capital through the one-year period subsequent to the issuance date of these financial statements through issuance of equity securities, debt securities, and/or additional development and commercialization partnerships for other products within the Company’s development pipeline. The source, timing and availability of any future financing will depend principally upon market conditions and on the progress of the Company’s research and development programs.

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2. Summary of Significant Accounting Policies

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Areas where significant estimates exist include, but are not limited to, the fair value of stock-based compensation, research and development costs incurred, and the estimated costs to complete the combined performance obligation pursuant to the Terumo Agreement (See Note 3 – “Terumo Agreement” for additional information).

Cash and Cash Equivalents

Cash and cash equivalents are held in banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.

Marketable Securities

The Company accounts for its marketable securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. These investments represent debt investments in corporate or government securities that are designated as available-for-sale and are carried at fair value, with unrealized gains and losses reported in stockholders’ equity as accumulated other comprehensive income (loss). The disclosed fair value related to the Company’s investments is based on market prices from a variety of industry standard data providers and generally represent quoted prices for similar assets in active markets or have been derived from observable market data.

Strategic Investments

Management has made investments in affiliated companies and assesses whether the Company exerts significant influence over its strategic investments. The Company considers the nature and magnitude of its investment, any voting and protective rights it holds, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationships. To date, the Company has concluded that it does not have the ability to exercise significant influence over its strategic investments.

The Company’s strategic investments consist of preferred shares of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party. The investments in Vivasure do not have readily determinable fair values and are recorded at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer. Additionally, as the investments in Vivasure are not readily marketable, the Company categorized the investments as non-current assets. As of June 30, 2025 and December 31, 2024, the carrying value of the investments in Vivasure was $2.5 million.

Fair Value of Financial Instruments

The Company applies ASC 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s

7

judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances.

The carrying value of the Company’s cash and cash equivalents, accounts receivable, prepaid expense, accounts payable, and accrued expenses approximate fair value because of the short-term maturity of these financial instruments. In addition, the Company records its investment in marketable securities at fair value. See Note 5 – “Financial Instruments and Fair Value Measurements” for additional information regarding fair value measurements.

The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:

Level 1  —  Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities.

Level 2  —  Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.

Level 3  —  Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities.

Accounts Receivable and Allowance for Doubtful Accounts

Accounts receivable represent amounts due from customers. The allowance for doubtful accounts is recorded for estimated losses by evaluating various factors, including relative creditworthiness of each customer, historical collections experience and aging of the receivable. As of June 30, 2025 and December 31, 2024, an allowance for doubtful accounts was not deemed necessary.

Inventory

Inventory is stated at the lower of standard cost (which approximates actual cost on a first-in, first-out basis) and net realizable value. Net realizable value represents the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The Company analyzes its inventory levels and writes down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value or inventory quantities in excess of expected requirements. Excess requirements are determined based on comparison of existing inventories to forecasted sales, with consideration given to inventory shelf life. Expired inventory is disposed of, and the related costs are recognized in cost of goods sold. As of June 30, 2025 and December 31, 2024, an impairment charge as a result of obsolete inventory was not deemed necessary.

Research and Development Prepayments, Accruals and Related Expenses

The Company incurs costs of research and development activities conducted by its third-party service providers, which include the conduct of preclinical and clinical studies. The Company is required to estimate its prepaid and accrued research and development costs at each reporting date. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with the Company’s service providers. The Company determines the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel and outside service providers, as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with the third parties and the agreed upon fee to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by the Company or the services are performed. Accruals are recorded for the amounts of services provided that have not yet been invoiced.

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Property and Equipment

Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are amortized over the lesser of their useful life or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Maintenance and repairs are charged to operations as incurred.

Asset category	Depreciable life
Manufacturing equipment	10 years
Office equipment	3 – 7 years
Research and development equipment	7 years

Leases

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the terms of the arrangement. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets.

The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the condensed consolidated statements of operations and comprehensive loss.

Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset.

The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

Debt Discount and Debt Issuance Costs

Debt discounts and debt issuance costs incurred in connection with the issuance of debt are capitalized and reflected as a reduction to the related debt liability. The costs are amortized to interest expense over the term of the debt using the effective-interest method.

Impairment of Long-Lived Assets

The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparing the carrying amount to the future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. The Company has not identified any such impairment losses to date.

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Revenue Recognition

The Company recognizes revenue under the core principle according to ASC 606, Revenue from Contracts with Customers (“ASC 606”), to depict the transfer of control to the Company’s customers in an amount reflecting the consideration the Company expects to be entitled to. In order to achieve that core principle, the Company applies the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when a performance obligation is satisfied.

The Company’s revenues are currently comprised of partnership revenues from the Terumo Agreement related to the development and commercialization of Virtue SAB, and product revenue from the sale of FreeHold’s intracorporeal organ retractors.

Partnership Revenues

To date, the Company’s partnership revenues have related to the Terumo Agreement as further described in Note 3. In future periods, partnership revenues may also include revenues related to the Medtronic Agreement as discussed in Note 4.

The Company assessed whether the Terumo Agreement fell within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) based on whether the arrangement involved joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. The Company determined that the Terumo Agreement did not fall within the scope of ASC 808. The Company then analyzed the arrangement pursuant to the provisions of ASC 606 and determined that the arrangement represents a contract with a customer and is therefore within the scope of ASC 606.

The promised goods or services in the Terumo Agreement include (i) license rights to the Company’s intellectual property, and (ii) research and development services. The Company also has optional additional items in the Terumo Agreement which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct in the Terumo Agreement, the Company considered factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available.

The Company estimates the transaction price for the Terumo Agreement performance obligations based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration includes both fixed consideration and variable consideration. At the inception of the Terumo Agreement, as well as at each reporting period, the Company evaluates the amount of potential payments and the likelihood that the payments will be received. The Company utilizes either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method better predicts the amount expected to be received. If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price.

The Terumo Agreement contains development and regulatory milestone payments. At contract inception and at each reporting period, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect partnership revenues and earnings in the period of adjustment.

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The Terumo Agreement also includes sales-based royalties and the license is deemed to be the predominant item to which the royalties relate. Accordingly, the Company will recognize royalty revenue when the related sales occur. To date, the Company has not recognized any royalty revenue under the arrangement.

The Company has determined that intellectual property licensed to Terumo and the research and development services to be provided to support the premarket approval by the U.S. Food and Drug Administration (the “FDA”) for the in-stent restenosis (“ISR”) indication represent a combined performance obligation that is satisfied over time, and that the appropriate method of measuring progress for purposes of recognizing revenues relates to a proportional performance model that measures the proportional performance based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the performance obligation. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

The Company receives payments from Terumo based on billing schedules established in the contract. Such billings for milestone related events have 10-day terms from the date the milestone is achieved, royalty payments are 20-day terms after the close of each quarter, any optional services are 20 days after receipt of an invoice and any sales of the SirolimusEFR are within 30 days after receipt of the shipping invoices. Upfront payments are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the right to consideration is unconditional.

Product Revenues

Product revenues related primarily to sales of FreeHold’s intracorporeal organ retractors are recognized at a point-in-time upon the shipment of the product to the customer, and there are no significant estimates or judgments related to estimating the transaction price. The product revenues consist of a single performance obligation, and the payment terms are typically 30 days. Product revenues are recognized solely in the United States.

Stock-Based Compensation

The Company applies ASC 718-10, Compensation — Stock Compensation, which requires the measurement and recognition of compensation expenses for all stock-based payment awards made to employees and directors including employee stock options under the Company’s stock plans based on estimated fair values (see Note 10 – “Stock-Based Compensation”). Each award vests over the subsequent period during which the recipient is required to provide service in exchange for the award (the vesting period). The cost of each award is recognized as an expense in the financial statements over the respective vesting period on a straight-line basis.

Under the requirements of ASU 2018-07, the Company accounts for stock-based compensation to nonemployees under the fair value method, which requires all such compensation to be calculated based on the fair value at the measurement date (generally the grant date) and recognized in the Company’s condensed consolidated statements of operations and comprehensive loss over the requisite service period. The Company accounts for forfeitures of stock-based awards as they occur.

Net Loss Per Share

Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Since the Company was in a loss position for the periods presented, basic net loss is the same as diluted net loss since the effects of potentially dilutive securities are antidilutive. Potentially dilutive securities include all outstanding warrants, stock options, Earnout Consideration (see Note 15 – “Net Loss Per Share”), unvested restricted stock awards and restricted stock units. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares (as defined in Note 15)) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. In periods in which there is net income, the Company would apply the two-class method to compute net income per share. Under this method, earnings are allocated to common stock and participating securities based on their respective rights to receive dividends, as if all undistributed earnings for the period were distributed. The two-class method does not apply in periods in which a net loss is reported.

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Income Taxes

The Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740, Income Taxes (“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and liabilities of a change in tax rate is recognized in the period that includes the enactment date. A valuation allowance is recorded if it is more-likely-than-not that some portion or all the deferred tax assets will not be realized in future periods. At June 30, 2025 and December 31, 2024, the Company recorded a full valuation allowance on its deferred tax assets.

The Company follows the guidance in ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties related to tax positions in income tax expense as applicable.

Defined Contribution Plan

The Company has a defined retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Effective January 1, 2023, the Company participates in a matching safe harbor 401(k) Plan with a Company contribution of up to 3.5% of each eligible participating employee’s compensation. Safe harbor contributions vest immediately for each participant. During the three and six months ended June 30, 2025, the Company made $119,000 and $239,000, respectively, in contributions under this safe harbor 401(k) Plan. During the three and six months ended June 30, 2024, the Company made $135,000 and $222,000, respectively, in contributions under this safe harbor 401(k) Plan.

Comprehensive Loss

Comprehensive loss is comprised of net loss and changes in unrealized gains and losses on the Company’s available-for-sale investments.

Segment Reporting

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in one segment. For further discussion on Segment Reporting, see Note 14 - “Segment Disclosures.”

New Accounting Standards

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires additional income tax disclosures in the annual consolidated financial statements. The amendments in ASU 2023-09 are intended to enhance the transparency and decision usefulness of income tax disclosures. For public entities, ASU 2023-09 is effective for annual periods beginning after December 15, 2024, with early adoption permitted. As an emerging growth company that has not opted out of the extended transition period for complying with new or revised financial accounting standards, the amendments in ASU 2023-09 are effective for the Company for fiscal years beginning after December 15, 2025, with early adoption permitted.

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In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“ASU 2024-03”) to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026. Early adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2024-03 on its condensed consolidated financial statements.

3. Terumo Agreement

In June 2019, Legacy Orchestra entered into the Terumo Agreement, pursuant to which Terumo secured global commercialization rights for Virtue SAB in coronary and peripheral vascular indications. Under the Terumo Agreement, Legacy Orchestra received an upfront payment of $30 million and an equity commitment of up to $5 million of which $2.5 million was invested in June 2019 as part of the Legacy Orchestra Series B-1 financing and $2.5 million was invested in June 2022 as part of the Legacy Orchestra Series D-2 financing. The Company was initially eligible to receive up to $65 million in additional payments based on the achievement of certain development and regulatory milestones and is also eligible to earn royalties on future sales by Terumo based on royalty rates ranging from 10 – 15%. Of these milestone payments, $35 million relate to achieving certain milestones by specified target achievement dates. As of June 30, 2025, the target achievement dates for three $5 million milestone payments have already passed. In addition, due to delays in the Company’s Virtue SAB program resulting from the COVID-19 pandemic, supply chain issues and unexpected changes to regulatory requirements, including increased testing and other activities related to chemistry, manufacturing, and control, increased nonclinical and good laboratory practice preclinical data requirements, including biocompatibility, as well as a requirement to repeat good laboratory practice preclinical studies already performed based on changes to source of component materials and a change in manufacturing site, the Company will not be able to complete the remaining time-based milestones by the specified target achievement dates to earn the remaining $20 million in time-based milestone payments pursuant to the Terumo Agreement.

As previously disclosed, the Company is in a mediation procedure with Terumo pursuant to the Terumo Agreement and the International Mediation Rules of the International Centre for Dispute Resolution (“ICDR”). The mediation is intended to assist in potentially resolving disagreements and facilitating the completion of negotiations related to restructuring, replacing or terminating the Terumo Agreement. The Terumo Agreement provides that matters that are not resolved through mediation are to be resolved by binding arbitration conducted under the auspices of the ICDR in accordance with its International Arbitration Rules. If the mediation does not lead to a timely agreement or resolution, or, if applicable, the Company does not prevail in arbitration, or if the Terumo Agreement is terminated, the Company’s commercialization plans for Virtue SAB may be adversely impacted. However, any termination of the Terumo Agreement in the context of mediation, an arbitration or otherwise would allow the Company to pursue an alternative strategic collaboration or other transaction with a different partner. The Company currently expects the formal mediation to be completed by the end of the third quarter of 2025. Regardless of the mediation process with Terumo, the Company intends to initiate enrollment of the Virtue SAB trial, its pivotal study of Virtue SAB for coronary in-stent restenosis in the United States during the second half of 2025, as well as to continue other product development efforts related to Virtue SAB.

Pursuant to the terms of the Terumo Agreement, Legacy Orchestra licensed intellectual property rights to Terumo and the Company is primarily responsible for completing the development of the product in the United States to support premarket approval by the FDA for the ISR indication. These research and development services to be provided by the Company include (i) manufacturing, testing and packaging the drug required for the clinical trials, (ii) supplying Terumo with information related to the design and manufacture of the delivery device and the technology transfer needed for Terumo to ultimately commence manufacture of the delivery device, and (iii) carrying out regulatory activities related to clinical trials in the United States for the ISR indication.

The Company has concluded that the license granted to Terumo is not distinct from the research and development services that will be provided to Terumo through the completion of the development of ISR indication, as Terumo cannot obtain the benefit of the license without the related research and development services. Accordingly, the Company will recognize revenues for this combined performance obligation over the estimated period of research and development services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total estimated costs of the research and development services.

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In 2019, Legacy Orchestra received a total of $32.5 million from Terumo related to the stock purchase and the revenue generating elements of the Terumo Agreement. The Company recorded the estimated fair value of the shares of $2.5 million in stockholders’ equity, as the value paid by Terumo is consistent with the value paid by other third-party stockholders in Legacy Orchestra’s offering of its Series B-1 Preferred Stock. The Company allocated the remaining $30 million to the transaction price of the Terumo Agreement. The Company considers the future potential development and regulatory milestones to be variable consideration, which are fully constrained from the transaction price as of June 30, 2025 and December 31, 2024, as the achievement of such milestone payments are uncertain and highly susceptible to factors outside of the Company’s control. The Company plans to re-evaluate the transaction price at each reporting period and as uncertain events are resolved or other changes in circumstances occur. In addition, the arrangement also includes sales-based royalties on product sales by Terumo subsequent to commercialization ranging from 10 - 15%, none of which have been recognized to date.

The Company recorded the $30 million upfront payment received from Terumo in 2019 within deferred revenue. The following table presents the changes in the Company’s deferred revenue balance from the Terumo Agreement during the six months ended June 30, 2025 and 2024 (in thousands):

Deferred Revenue – December 31, 2024	$	15,428
Revenue recognized		(1,399)
Deferred Revenue – June 30, 2025	$	14,029

Deferred Revenue – December 31, 2023	$	17,433
Revenue recognized		(1,125)
Deferred Revenue – June 30, 2024	$	16,308

The Company’s balance of deferred revenue contains the transaction price from the Terumo Agreement allocated to the combined license and research and development performance obligation, which was partially unsatisfied as of June 30, 2025. The Company expects to recognize approximately $4.5 million of its deferred revenue during the next twelve months and recognize the remaining approximately $9.5 million through the remainder of the performance period, which is currently estimated to be completed in 2029 and may be impacted by the actual clinical and regulatory timelines of the program.

As of each quarterly reporting date, the Company evaluates its estimates of the total costs expected to be incurred through the completion of the combined performance obligation and updates its estimates as necessary. For the three months ended June 30, 2025 and 2024, the expenses incurred related to the Terumo Agreement were approximately $3.3 million and $4.0 million, respectively. For the six months ended June 30, 2025 and 2024, the expenses incurred related to the Terumo Agreement were approximately $6.8 million and $6.9 million, respectively. The estimated total costs associated with the Terumo Agreement through completion were similar as of June 30, 2025, as compared to the estimates as of December 31, 2024, and increased by approximately 2.8% as of June 30, 2024, as compared to the estimates as of December 31, 2023. While the Company believes it has estimated total costs associated with the Terumo Agreement through completion, these estimates encompass a broad range of expenses over a multi-year period and, as such, are subject to periodic changes as new information becomes available. The impact of the changes in estimates resulted in a reduction of partnership revenues of $21,000 and $220,000 for the three months ended June 30, 2025 and 2024, respectively, as compared to the amounts that would have been recorded based on the previous estimates. The impact of the changes in estimates resulted in a reduction of partnership revenues of $27,000 and $382,000 for the six months ended June 30, 2025 and 2024, respectively, as compared to the amounts that would have been recorded based on the previous estimates. The impact of these changes in estimates on the net loss per share attributable to common stockholders, basic and diluted, for the three and six months ended June 30, 2025 were de minimis. The impact of these changes in estimates on the net loss per share attributable to common stockholders, basic and diluted, for the three and six months ended June 30, 2024 was an increase of $0.01.

The Company will also manufacture, or have manufactured, SirolimusEFR and has exclusive rights to sell it on a per unit basis to Terumo for use in the Virtue SAB product. The Company has determined that this promise does not contain a material right as the pricing is based on standalone selling prices. Through June 30, 2025, there have been no additional

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amounts recognized as revenue under the Terumo Agreement other than the recognition of a portion of the upfront payment described above.

4. Medtronic Agreement

In June 2022, Legacy Orchestra, BackBeat and Medtronic entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of anti-hypertensive medications (the “Primary Field”). Under the terms of the Medtronic Agreement, the Company is sponsoring an ongoing multinational pivotal study, to support regulatory approval of AVIM therapy in the Primary Field and be financially responsible for development, clinical and regulatory costs associated with this pivotal study. AVIM therapy has been integrated into the Medtronic top-of-the-line, commercially available dual-chamber pacemaker system specifically for use in the pivotal trial and will provide development, clinical and regulatory resources in support of the pivotal trial, for which the Company will reimburse Medtronic at cost.

Under the terms of the Medtronic Agreement, Medtronic will have exclusive rights to commercialize AVIM-enabled pacing systems globally following receipt of regulatory approval. Medtronic would be entirely responsible for global commercialization following receipt of regulatory approvals, including manufacturing, sales, marketing and distribution costs.

The Company is expected to receive between $500 and $1,600 per AVIM-enabled device sold based on a formula of the higher of (1) a fixed dollar amount per AVIM-enabled device (amount varies materially on a country-by-country basis) or (2) a percentage of the AVIM therapy-generated sales. Procedures using the AVIM-enabled pacemakers are expected to be billed under existing reimbursement codes.

Medtronic has a right of first negotiation through FDA approval of AVIM therapy in the Primary Field, to expand its global rights to AVIM therapy for the treatment of HTN patients not indicated for a pacemaker.

The Company assessed whether the Medtronic Agreement fell within the scope of ASC 808 and concluded that the Medtronic Agreement is a collaboration within the scope of ASC 808. In addition, the Company determined that Medtronic is a customer for a good or service that is a distinct unit of account, and therefore, the transactions in the Medtronic Agreement should be accounted for under ASC 606.

The Company has concluded that the license granted to Medtronic is not distinct from the development and implementation services that will be provided to Medtronic through the completion of the development of HTN indication, as Medtronic cannot obtain the benefit of the license without the related development and implementation services. ASC 606-10-55-65 includes an exception for the recognition of revenue relating to licenses of intellectual property with sales-based or usage-based royalties. Under this exception, royalty revenue is not recorded until the subsequent sale or usage occurs, or the performance obligation has been satisfied, whichever is later.

The Company concluded that the exemption applies and therefore, the royalty revenue associated with these performance obligations will be recognized as the underlying sales occur. Additionally, pursuant to the Medtronic Agreement, expenses incurred by Medtronic in connection with clinical device development and regulatory activities performed will be reimbursed by the Company. The Company will record such expenses as research and development expenses as incurred. During the three and six months ended June 30, 2025, the Company incurred approximately $4.0 million and $7.4 million, respectively, of research and development costs related to these reimbursements pursuant to the Medtronic Agreement, of which $6.2 million is included within accounts payable and accrued expenses in the Company’s June 30, 2025 condensed consolidated balance sheet. During the three and six months ended June 30, 2024, the Company incurred approximately $1.9 million and $3.1 million, respectively, of research and development costs related to these reimbursements pursuant to the Medtronic Agreement. 

Concurrently with the close of the Medtronic Agreement, Legacy Orchestra also received a $40 million investment from Medtronic in connection with Legacy Orchestra’s Series D-2 Preferred Stock financing. The equity was purchased at a fair value consistent with the price paid by other investors at that time, and accordingly, the proceeds received were recorded as an equity investment.

Through June 30, 2025, there have been no amounts recognized as revenue under the Medtronic Agreement.

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On July 31, 2025, the Company, BackBeat and Medtronic entered into an amendment to the Medtronic Agreement, which became effective on August 4, 2025 (see Note 16 – “Subsequent Events”).

5. Financial Instruments and Fair Value Measurements

The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy:

	June 30, 2025
(in thousands)	Level 1		Level 2		Level 3		Total
Assets
Money market fund (included in cash and cash equivalents)	$	9,147	$	—	$	—	$	9,147
Corporate and government debt securities (included in Marketable securities)		—		15,175		—		15,175
Total assets	$	9,147	$	15,175	$	—	$	24,322

	December 31, 2024
(in thousands)	Level 1		Level 2		Level 3		Total
Assets
Money market fund (included in cash and cash equivalents)	$	12,248	$	—	$	—	$	12,248
Corporate and government debt securities (included in Marketable securities)		—		44,551		—		44,551
Total assets	$	12,248	$	44,551	$	—	$	56,799

The Level 2 assets consist of government and corporate debt securities which are valued using market observable inputs, including the current interest rate and other characteristics for similar types of investments, whose fair value may not represent actual transactions of identical securities. There were no transfers between Levels 1, 2 or 3 for the periods presented.

6. Marketable Securities and Strategic Investments

Marketable Securities

The following is a summary of the Company’s marketable securities as of June 30, 2025 and December 31, 2024:

	June 30, 2025
	Amortized		Unrealized		Unrealized		Fair
(in thousands)	Cost Basis		Gains		Losses		Value
Corporate debt securities	$	14,369	$	17	$	(1)	$	14,385
Government debt securities		790		—		—		790
Total	$	15,159	$	17	$	(1)	$	15,175

	December 31, 2024
	Amortized		Unrealized		Unrealized		Fair
(in thousands)	Cost Basis		Gains		Losses		Value
Corporate debt securities	$	43,724	$	57	$	(5)	$	43,776
Government debt securities		775		—		—		775
Total	$	44,499	$	57	$	(5)	$	44,551

The Company believes it is more likely than not that its marketable securities in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has not recorded any allowance for credit losses on its investment securities. The Company determined that the unrealized losses were not attributed to credit risk but were primarily driven by the broader change in interest rates. As of June 30, 2025, $1.3 million of the Company’s marketable securities had maturities of 12 to 36 months while the remaining marketable securities had maturities of less than 12 months.

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For the three and six months ended June 30, 2025 and 2024, the Company did not recognize any realized gains or losses on its marketable securities.

Strategic Investments

The Company’s long-term strategic investments as of June 30, 2025 represent investments made in Vivasure in 2022, 2021 and 2020 that were originally recorded at cost. There were no observable price changes, other than as described below, or impairments identified during the six months ended June 30, 2025 and 2024 related to these investments.

7. Balance Sheet Components

Property and Equipment, Net

Property and equipment, net consists of the following:

	June 30,		December 31,
(in thousands)	2025		2024
Equipment	$	2,231	$	2,084
Office furniture		443		444
Leasehold improvements		159		159
Property and equipment, gross		2,833		2,687
Less accumulated depreciation and amortization		(1,467)		(1,303)
Total Property and equipment, net	$	1,366	$	1,384

Depreciation and amortization expense was $81,000 and $74,000 for the three months ended June 30, 2025 and 2024, respectively. Depreciation and amortization expense was $164,000 and $148,000 for the six months ended June 30, 2025 and 2024, respectively.

Accrued Expenses and Other Liabilities

Accrued expenses and other liabilities consist of the following:

	June 30,		December 31,
(in thousands)	2025		2024
Clinical trial accruals	$	3,796	$	2,893
Accrued compensation		1,975		2,612
Other accrued expenses		879		579
Total Accrued expenses and other liabilities	$	6,650	$	6,084

8. Common and Preferred Stock

Common Stock

The Company is authorized to issue up to 340,000,000 shares of Company Common Stock.

Preferred Stock

The Company is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.0001 per share. The board of directors of the Company (the “Board”) has the authority to issue preferred stock and to determine the rights, privileges, preferences, restrictions, and voting rights of those shares. As of June 30, 2025, no shares of preferred stock were outstanding.

At-the-Market Offering and Shelf Registration Statement

On May 15, 2024, the Company entered into an Open Market Sale Agreement^SM (the “Prior Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company could offer and sell, from time to time through Jefferies, up

17

to $100 million of shares of Company Common Stock (the “Prior ATM Shares”) by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the “Securities Act”).

Also on May 15, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC (the “Shelf Registration Statement”), which contains a base prospectus, covering up to a total aggregate offering price of $300 million of Company Common Stock, preferred stock, debt securities, warrants, right and/or units, and a prospectus supplement that covered the offering, issuance and sale of the Prior ATM Shares, which are included in the $300 million of securities that may be offered, issued and sold by the Company pursuant to the Shelf Registration Statement.

On July 11, 2024, the Company sold 2,000,000 shares of Company Common Stock under the Prior Agreement resulting in aggregate gross proceeds to the Company of approximately $15.5 million and net proceeds to the Company of approximately $15.0 million.

On August 12, 2024, the Company entered into a sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC, as agent (“TD Cowen”), pursuant to which the Company may offer and sell, from time to time through TD Cowen, up to $100 million of shares of Company Common Stock (the “Offering”) by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. The Offering is being made pursuant to the Shelf Registration Statement, filed with the SEC on May 15, 2024 and declared effective on May 24, 2024, a base prospectus, dated May 24, 2024, included as part of the Shelf Registration Statement, and a prospectus supplement, dated August 12, 2024 filed with the SEC pursuant to Rule 424(b)(5) on August 12, 2024. As of June 30, 2025, no sales had been made under the Sales Agreement.

Termination of Prior Agreement

In connection with the entry into the Sales Agreement, on August 12, 2024, the Company terminated the Prior Agreement between the Company and Jefferies (the “Termination”), in accordance with its terms and with the mutual agreement of Jefferies. The purpose of the Termination was to eliminate restrictions under certain SEC rules relating to the publication or dissemination of new research reports on the Company’s business by Jefferies in light of its role as sales agent under the Prior Agreement. The Company had $84.5 million remaining available under the Prior Agreement. The Company cannot make any further sales of Company Common Stock pursuant to the Prior Agreement.

9. Warrants

The Company evaluates its outstanding warrants to determine if the instruments qualify for equity or liability classification.

Non-employee Warrants

On February 28, 2025, the Company issued equity-classified warrants to purchase 60,000 shares of Company Common Stock at an exercise price of $4.69 per share to non-employee consultants. The warrants were issued as consideration for entering into an agreement for future services. As of February 28, 2025, the Company valued the non-employee warrants using the Black-Scholes option-pricing model and determined the fair value at $187,000. The key inputs to the valuation model included the annualized volatility of 110.1% and a risk-free rate of 3.99%.

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Summarized Outstanding Warrants

The following table summarizes outstanding warrants to purchase shares of Company Common Stock as of June 30, 2025 and December 31, 2024:

	Number of Shares
	June 30,	December 31,	Exercise
	2025	2024	Price	Term
Equity-classified Warrants
Legacy Orchestra Warrants	507,841	507,841	$1.08 – $30.11	0.10 – 8.75
Hercules Warrants (Note 13)	52,264	52,264	$5.74	3.50
Avenue Warrants	27,707	27,707	$7.67	2.50
Non-employee Warrants	60,000	—	$4.69	3.12
Private Warrants Held by Sponsor*	750,000	750,000	$11.50	4.32 – 4.57
Private Warrants Held by Employees	660,000	660,000	$11.50	4.32
Total Outstanding	2,057,812	1,997,812

*Sponsor is defined as HSAC2 Holdings, LLC

10. Stock-Based Compensation

As of June 30, 2025, the only equity compensation plan from which the Company may issue new awards is the Company’s 2023 Equity Incentive Plan (the “2023 Plan”), as more fully described below.

Orchestra BioMed Holdings, Inc. 2023 Equity Incentive Plan

At the Closing, the Company adopted the 2023 Plan which permits the granting of incentive stock options, non-qualified options, stock appreciation rights, restricted stock, restricted stock units, performance awards and other stock-based award to employees, directors, and non-employee consultants and/or advisors. As of June 30, 2025, approximately 1.0 million shares of Company Common Stock are authorized for issuance pursuant to awards under the 2023 Plan. The pool of available shares will be automatically increased on the first day of each calendar year, beginning January 1, 2024 and ending January 1, 2032, by an amount equal to the lesser of (i) 4.8% of the outstanding shares of the Company Common Stock determined on a fully-diluted basis as of the immediately preceding December 31 and (ii) 3,036,722 shares of Company Common Stock, and (iii) such number of shares of Company Common Stock determined by the Board or the Compensation Committee prior to January 1st of a given year. Employees, consultants, and directors are eligible for awards granted under the 2023 Plan, which generally have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Board. Vesting generally occurs over a period of not greater than four years.

Stock-based Compensation Expense

Total stock-based compensation related to option issuances was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	666	$	308	$	1,273	$	817
Selling, general and administrative		692		710		1,331		1,191
Total stock-based compensation	$	1,358	$	1,018	$	2,604	$	2,008

As of June 30, 2025, there was approximately $7.8 million of unrecognized stock-based compensation expense associated with the stock options noted above that is expected to be recognized over a weighted average period of approximately 2.8 years.

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Total stock-based compensation related to restricted stock awards and restricted stock units was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	528	$	392	$	993	$	739
Selling, general and administrative		1,036		1,086		1,986		2,073
Total stock-based compensation	$	1,564	$	1,478	$	2,979	$	2,812

As of June 30, 2025, there was approximately $8.3 million of unrecognized restricted stock-based compensation expense associated with the restricted stock noted above that is expected to be recognized over a weighted average period of approximately 2.0 years.

As previously discussed in Note 9, on February 28, 2025, the Company issued equity-classified warrants to purchase 60,000 shares of Company Common Stock at an exercise price of $4.69 per share to non-employee consultants. The warrants were issued as consideration for entering into an agreement for future services. At the grant date, 6,000 became exercisable while the remaining will vest ratably over eight months. Assumptions used were an expected term (in years) of 3.12, expected volatility of 110%, risk-free interest rate of 3.99%, expected dividend yield of 0%, and the fair value of Company Common Stock of $3.12.

Total stock-based compensation related to warrants was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	121	$	121	$	241	$	241
Selling, general and administrative		207		144		391		288
Total stock-based compensation	$	328	$	265	$	632	$	529

As of June 30, 2025, there was approximately $687,000 of unrecognized stock-based compensation expense associated with the warrants noted above that is expected to be recognized over a weighted average period of approximately 0.6 years.

Stock Option Activity

The following table summarizes the stock option activity of the Company under the 2023 Plan:

		Weighted		Weighted
	Shares	Average		Average	Aggregate
	Underlying	Exercise		Remaining	Intrinsic
	Options	Price		Term (years)	Value
Outstanding at January 1, 2025	5,696,845	$	7.17	7.39	$	3,000
Granted	1,438,524		3.06	—		—
Exercised	(28,251)		4.41	—		33,011
Forfeited/canceled	(143,353)		6.69	—		—
Outstanding June 30, 2025	6,963,765	$	6.34	7.56	$	1,770
Exercisable at June 30, 2025	4,072,270	$	7.54	6.36	$	—

The weighted average grant-date fair value of stock options granted during the six months ended June 30, 2025 and 2024 was $2.18 and $3.56 per share, respectively.

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Restricted Equity Awards Activity

The following table summarizes the restricted stock awards and restricted stock units activity of the Company under the Plan:

	Restricted Stock	Weighted Average
	Awards/Units	Grant Date Fair
	Outstanding	Value
Outstanding at January 1, 2025	2,094,584	$	6.54
Granted	682,365		2.85
Vested	(625,414)		6.95
Outstanding June 30, 2025	2,151,535	$	5.26

No performance-based restricted stock awards or units were granted during the six months ended June 30, 2025. The fair value of restricted stock units vested during the three and six months ended June 30, 2025 was $1.4 million and $2.2 million, respectively.  

Determination of Stock Option Awards Fair Value

The estimated grant-date fair value of all the Company’s option awards was calculated using the Black-Scholes option pricing model, based on the following weighted average assumptions:

	Six Months Ended June 30,
	2025			2024
Expected term (in years)		6.08			6.15
Expected volatility		80	%		71	%
Risk-free interest rate		3.92	%		4.44	%
Expected dividend yield		0	%		0	%
Fair value of common stock		3.06			5.29

The fair value of each stock option grant was determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management.

Expected Term — The expected term represents the period that stock-based awards are expected to be outstanding. The Company’s historical share option exercise information is limited due to a lack of sufficient data points and did not provide a reasonable basis upon which to estimate an expected term. The expected term for option grants is therefore determined using the “simplified” method, as prescribed in the Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 107. The simplified method deems the expected term to be the midpoint between the vesting date and the contractual life of the stock-based awards.

Expected Volatility — The Company consummated the Business Combination on January 26, 2023 and lacks sufficient company-specific historical and implied volatility information. Therefore, it derives expected stock volatility using a weighted average blend of historical volatility of comparable peer public companies and its own historical volatility, over a period equivalent to the expected term of the stock-based awards.

Risk-Free Interest Rate — The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the date of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the stock-based awards’ expected term.

Expected Dividend Yield — The expected dividend yield is zero as neither the Company nor Legacy Orchestra has paid, and the Company does not anticipate paying, any dividends on the Company Common Stock in the foreseeable future.

Fair Value of Common Stock — Prior to the Business Combination, as the Legacy Orchestra Common Stock has not historically been publicly traded, its board of directors periodically estimated the fair value of its common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013

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Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Subsequent to the Business Combination, the Company utilizes the price of its publicly-traded Company Common Stock to determine the grant date fair value of awards.

11. Leases

Office Lease

In August 2024, the Company entered into an additional addendum to the lease agreement for office space in New Hope, PA originally entered into by Legacy Orchestra in December 2009 (as amended, the “New Hope Lease”). The New Hope Lease covers 8,052 square feet and will expire in September 2027. Monthly fees under the New Hope Lease will be between $17,000 and $19,000 for the period from the August 2024 addendum through expiration.

In November 2019, Legacy Orchestra entered into a new lease agreement for approximately 5,200 square feet of office space in New York, NY. In November 2022, Legacy Orchestra entered into an amendment for this lease which increased the office space square footage to approximately 7,800 and amended the expiration to April 2028. Monthly fees will be between $28,000 and $40,000 for the period from commencement through expiration.

In September 2024, the Company entered into a new lease for 6,496 square feet of office space in Fort Lauderdale, Florida. The agreement will expire in December 2027. The monthly fees commenced in November 2024, the commencement date of the agreement, and will be between $16,000 and $17,000 for the period from commencement through expiration.  

Operating cash flow supplemental information for the six months ended June 30, 2025:

Cash paid for amounts included in the present value of operating lease liabilities was $503,000 during the six months ended June 30, 2025 compared to $454,000 during the six months ended June 30, 2024.

As of June 30, 2025:
Weighted average remaining lease term – operating leases, in years	2.63
Weighted average discount rate – operating leases	9.92	%

Operating Leases

Rent/lease expense for office and lab space was approximately $274,000 and $224,000 for the three months ended June 30, 2025 and 2024, respectively. Rent/lease expense for office and lab space was approximately $533,000 and $443,000 for the six months ended June 30, 2025 and 2024, respectively. Variable lease costs were $19,000 and $38,000 for the three months ended June 30, 2025 and 2024, respectively. Variable lease costs were $50,000 and $100,000 for the six months ended June 30, 2025 and 2024, respectively. Variable lease costs consist primarily of common area maintenance costs, insurance and taxes which are paid based upon actual costs incurred by the lessor. The table below shows the future minimum rental payments, exclusive of taxes, insurance, and other costs, under the leases as of June 30, 2025:

	Operating
	Leases
Year ending December 31:	(in thousands)
2025 (remaining six months)	$	373
2026		880
2027		829
2028		159
2029		—
Thereafter		—
Total future minimum lease payments	$	2,241
Imputed interest		(271)
Total liability	$	1,970

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12. Related Party Transactions

Other than transactions and balances related to cash and stock-based compensation to officers and directors, the Company had no transactions or balances with current related parties during the year ended December 31, 2024 and the six months ended June 30, 2025.

13. Debt Financing

2024 Loan and Security Agreement

On November 6, 2024 (the “LSA Closing Date”), the Company and certain of its subsidiaries (together with the Company, the “Borrower”) entered into a Loan and Security Agreement, by and among the Borrower, the several banks and other financial institutions or entities party thereto, as lenders (collectively, the “Hercules Lenders”), and Hercules Capital, Inc. (“Hercules”), as administrative agent and collateral agent for itself and the Hercules Lenders, as amended by that certain First Amendment to Loan and Security Agreement dated as of December 30, 2024 (as amended, the “2024 LSA”). The 2024 LSA provided a secured term loan facility of up to $50.0 million available in up to four tranches (collectively, the “Term Loans”), with the first tranche of $15.0 million drawn on the LSA Closing Date, and a second and third tranche of up to an aggregate of $15.0 million were available upon achievement of certain performance and financing milestones. Additionally, the Company had access to a fourth tranche of $20.0 million subject to future approval. On July 31, 2025, the Borrower, the Hercules Lenders and Hercules entered into that certain second amendment (the “LSA Amendment”) to the 2024 LSA, which became effective on August 4, 2025 (see Note 16 – “Subsequent Events”).

The Term Loans accrue interest at a floating per annum rate equal to the greater of (i) (x) the “prime rate” as reported in The Wall Street Journal plus (y) 2.0%, and (ii) 9.50%. The repayment terms of the Term Loans include monthly payments over a 4-year period, consisting of an initial two-year interest-only period, followed by 24 monthly principal payments plus interest, although the interest-only period can be extended for six months under certain circumstances set forth in the 2024 LSA. At the Company’s option, the Company may prepay all or a portion of the outstanding Term Loans, subject to a prepayment premium equal to (a) 3.0% of the Term Loans being prepaid if the prepayment occurs during the twelve months following the LSA Closing Date, (b) 2.0% of the Term Loans being prepaid if the prepayment occurs after 12 months following the LSA Closing Date but on or prior to 24 months following the LSA Closing Date, and (c) 1.0% of the Term Loans being prepaid if the prepayment occurs after 24 months following the LSA Closing Date and prior to the maturity date. In addition, the Company will pay an end of term charge of 6.35% of the principal amount of the Term Loans upon the prepayment or repayment of the Term Loans and a facility charge of 0.75% upon any draws of the Term Loans.

In connection with the entry into the 2024 LSA, on the LSA Closing Date, the Company issued each of the Hercules Lenders a warrant to purchase Company Common Stock (each a “Hercules Warrant” and, collectively, the “Hercules Warrants”). Pursuant to the terms of the Hercules Warrants, each Hercules Lender could purchase that number of shares of Company Common Stock equal to (i)(x) 0.02, multiplied by (y) the aggregate principal amount of all Term Loan Advances (as defined in the 2024 LSA) made to the Company by the applicable Lender, divided by (ii) $5.74, which was the exercise price of the Hercules Warrants. Each Hercules Warrant is exercisable for seven years from the LSA Closing Date. In connection with the LSA Amendment, on July 31, 2025, the Company entered into amendments to the Hercules Warrants (see Note 16 – “Subsequent Events”).

The 2024 LSA includes customary affirmative and negative covenants and representations and warranties, including a covenant against the occurrence of a “change in control,” financial reporting obligations, and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, transfers, mergers or acquisitions, taxes, corporate changes, and bank accounts. The 2024 LSA also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the 2024 LSA, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, Hercules may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the 2024 LSA.

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The Company must maintain Qualified Cash (as defined in the 2024 LSA) in an amount greater than or equal to (x) the outstanding principal amount of the Term Loan Advances, multiplied by (y) (1) prior to December 1, 2025, 35% or (2) on and after December 1, 2025, (A) if the Performance Milestone Date (as defined in the 2024 LSA) has not occurred on or prior to December 1, 2025, 50% until the date on which the Performance Milestone Date has occurred and (B) on and after the Performance Milestone Date, 35% (the “Minimum Cash Covenant”). The Minimum Cash Covenant will be waived if the Company’s Market Capitalization (as defined in the 2024 LSA) exceeds $500.0 million.

 The following table shows the amount of principal payments due pursuant to the Term Loans by year:

	Principal
	Payments
Year ending December 31:	(in thousands)
2025 (remaining six months)	$	—
2026		570
2027		7,187
2028		7,243
Total	$	15,000

Total interest expense recorded on this facility during the three and six months ended June 30, 2025 was approximately $466,000 and $928,000, respectively. There was no interest expense recorded during the six months ended June 30, 2024.

14. Segment Disclosures

The Company has one reportable segment, which consists of the development of clinical and preclinical product candidates through risk-reward sharing partnerships with leading medical device companies. The Company’s CODM, its Chief Executive Officer, manages the Company's operations on a consolidated basis for the purpose of assessing performance and allocating resources based on net loss that also is reported on the condensed consolidated statement of operations and comprehensive loss as consolidated net loss. Net loss is used by the CODM to make key strategic and operational decisions. To date, the Company has not generated material revenues. However, the majority of that revenue is attributed to one of its two collaboration agreements to accelerate and commercialize high-impact technologies. The measure of segment assets is reported on the condensed consolidated balance sheets as total consolidated assets. The majority of the Company's long-lived assets are held in the United States.

The following table presents selected financial information, including significant expenses regularly reviewed by the CODM, about the Company’s single operating segment for the three and six months ended June 30, 2025, and 2024:

	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
(in thousands)
Partnership revenue	$	667	$	628	$	1,399	$	1,125
Product revenue		169		150		305		273
Expenses:
Cost of product revenues		46		44		90		78
Non-clinical development costs		4,607		4,648		9,072		7,947
Clinical development costs		2,633		1,504		5,575		2,547
Personnel and consulting costs		7,002		5,913		13,666		11,407
Stock-based compensation		3,250		2,761		6,215		5,349
Depreciation expense		81		74		164		148
Other segment expenses(1)		2,544		2,716		5,170		5,283
Interest income (expense), net		36		(902)		(130)		(1,918)
Net Loss	$	(19,363)	$	(15,980)	$	(38,118)	$	(29,443)

¹Other segment expenses primarily include general and administrative costs not presented in other line items.

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15. Net Loss Per Share

Basic net loss per share of Company Common Stock is computed by dividing net loss by the weighted-average number of shares of Company Common Stock. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. In connection with the Business Combination, HSAC2 Holdings, LLC (the “Sponsor”) agreed that 25% or 1,000,000 of the shares of Company Common Stock held by the Sponsor will be forfeited to the Company on the first business day following the fifth anniversary of the Closing unless, as to 500,000 shares, the volume-weighted average price of the Company Common Stock is greater than or equal to $15.00 per share over any 20 trading days within any 30-trading day period (the “Initial Milestone Event”), and as to the remaining 500,000 shares, the volume-weighted average price of the Company Common Stock is greater than or equal to $20.00 per share over any 20 trading days within any 30-trading day period (the “Final Milestone Event”).

In connection with the Business Combination, existing Legacy Orchestra stockholders had the opportunity to elect to participate in an earnout (the “Earnout”) pursuant to which such each electing stockholder (each, an “Earnout Participant”) may receive a portion of additional contingent consideration of up to 8,000,000 shares of Company Common Stock (the “Earnout Consideration”). Each Earnout Participant agreed to extend their applicable lock-up period from 6 months to 12 months after the Closing, pursuant to an Earnout Election Agreement and such Earnout Participants will collectively be entitled to receive: (i) 4,000,000 shares of the Earnout Consideration, in the event that, from the time beginning immediately after the Closing until the fifth anniversary of the Closing (the “Earnout Period”), the Initial Milestone Event occurs; and (ii) an additional 4,000,000 shares of the Earnout Consideration, in the event that, during the Earnout Period, the Final Milestone Event occurs. Approximately 91% of Legacy Orchestra stockholders elected to participate in the Earnout. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding). Additionally, 500,000 of the Forfeitable Shares are no longer subject to forfeiture as a result of the Initial Milestone Event.

Diluted net loss per share of Company Common Stock includes the effect, if any, from the potential exercise or conversion of securities, such as stock options, Legacy Orchestra Warrants and Private Warrants, and Forfeitable Shares and Earnout Consideration, which would result in the issuance of incremental shares of Company Common Stock, unless their effect would be anti-dilutive.

The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2025 and June 30, 2024, as their effect is anti-dilutive:

	Three and Six Months Ended June 30,
	2025	2024
Stock options	6,963,765	5,164,962
Company common stock warrants	2,057,812	1,945,548
Unvested restricted stock equity awards	2,151,535	2,475,786
Forfeitable shares	500,000	500,000
Earnout consideration	4,000,000	4,000,000
Total	15,673,112	14,086,296

16. Subsequent Events

Ligand Pharmaceuticals Incorporated Revenue Participation Right Purchase and Sale Agreement and Purchase of Shares

On July 31, 2025, the Company entered into a revenue participation right purchase and sale agreement (the “Revenue Purchase and Sale Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”). Under the terms of the Revenue Purchase and Sale Agreement, in exchange for payment of $35.0 million (the “Investment Amount”), less certain reimbursable expenses, Ligand acquired from the Company the right to receive tiered revenue payments (the “Revenue Interest”) with respect to revenue (including certain licensing revenue) received by the Company in a calendar year in connection with worldwide net product sales, or other product revenue received by, by the Company and its licensees

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(“Annual Net Sales”) of (a) AVIM therapy (the “Primary Product”) and (b) Virtue SAB (the “Secondary Product” and together with the Primary Product, the “Products”) in the field of coronary artery treatment.

Subject to the Performance Ratchet (as defined below), Revenue Interest rates are based on the Annual Net Sales of the Products. The Applicable Purchaser Revenue Interest Rate is 17.0% for Annual Net Sales less than or equal to $100 million, in any field. The Applicable Purchaser Revenue Interest Rate is 4.0% for Annual Net Sales of greater than or equal to $100 million, only in the fields described above.

Pursuant to the Revenue Purchase and Sale Agreement, the Investment Amount shall be paid in two tranches: (i) $20.0 million was paid on August 4, 2025 (the “Ligand Closing”) and (ii) $15.0 million is payable on May 1, 2026 (the “Second Installment”), provided certain conditions have been met. In accordance with the terms of the Revenue Purchase and Sale Agreement, the Applicable Purchaser Revenue Interest Rates set forth above will incrementally increase from 17.0% and 4.0% up to 20.0% and 7.0%, respectively, if the Company does not achieve certain enrollment milestones relating to the BACKBEAT clinical study through January 1, 2027 (the “Performance Ratchet”).

The Revenue Interest in respect of Annual Net Sales of the Products will end on the date in which no Product is being developed or commercialized by or on behalf of the Company, any of its affiliates, or any of its or their licensees or distributors and Ligand has received the last Revenue Interest payment payable under the terms of the Revenue Purchase and Sale Agreement. The obligations arising under the Revenue Purchase and Sale Agreement are secured by security interests in, and pledges over, the Revenue Interest, the Revenue Participation Right (as defined in the Revenue Purchase and Sale Agreement) and the Company’s interests in the Products and associated intellectual property rights, subject to certain agreed security principles, permitted liens and other customary exceptions and qualifications, and the security interests in the Products and associated intellectual property rights of the Company are subordinate in right of payment to the prior payment in full of the outstanding indebtedness under the 2024 LSA. The Revenue Purchase and Sale Agreement contains customary representations, warranties and indemnities of the Company and Ligand, and customary covenants on the part of the Company. The Ligand Closing occurred on August 4, 2025. 

In connection with the sale of the Revenue Interest, and pursuant to the terms of the Revenue Purchase and Sale Agreement, on August 4, 2025, the Company issued to Ligand a warrant (the “Ligand Warrant”) to purchase up to 2,000,000 shares of the Company Common Stock (and, such shares underlying the Ligand Warrant, the “Ligand Warrant Shares”), at an exercise price equal to $3.67 per share. The exercise price of the Ligand Warrant and the number of Ligand Warrant Shares issuable upon exercise of the Ligand Warrant are subject to adjustments for stock splits, combinations, stock dividends or similar events. Pursuant to the terms of the Ligand Warrant, the Ligand Warrant Shares shall vest and become exercisable as follows: (i) 1,142,857 of the Ligand Warrant Shares (the “First Tranche”) vested upon issuance; however, the Ligand Warrant may not be exercised for six months after the issuance of the Ligand Warrant and (ii) 857,143 of the Ligand Warrant Shares will vest on the date of payment of the Second Installment. In the event that the Second Installment is not paid, the Ligand Warrant shall only be exercisable with respect to the First Tranche. The Ligand Warrant is exercisable for ten years from the date of issuance.

Concurrent with the execution of the Revenue Purchase and Sale Agreement, Ligand also agreed to purchase $5.0 million of shares of Company Common Stock (the “Ligand Private Placement Shares”) pursuant to a stock purchase agreement, dated as of July 31, 2025, between the Company and Ligand (the “Ligand Stock Purchase Agreement”), at a purchase price per share equal to the public offering price per share in the Company’s next public offering of its equity securities. Pursuant to the Ligand Stock Purchase Agreement, Ligand purchased 1,818,181 shares of Company Common Stock at a purchase price of $2.75 per share on August 4, 2025 in connection with the closing of the Public Offering (as defined below).

Purchase of Shares by Medtronic and Loan Agreement with Medtronic

On July 31, 2025, the Company and its wholly-owned subsidiaries, Legacy Orchestra and BackBeat, entered into a Loan Agreement (the “Medtronic Loan Agreement”) with Medtronic, pursuant to which Medtronic agreed to extend a convertible loan to the Company in the aggregate original principal amount of $20.0 million (the “Medtronic Loan”). The Medtronic Loan is evidenced by a secured subordinated convertible promissory note (the “Medtronic Note”) of the

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Company. The issuance of the Medtronic Note to Medtronic and the funding of the Medtronic Loan will take place on April 27, 2026 subject to certain closing conditions as described in the Medtronic Loan Agreement.

The Medtronic Note will accrue simple interest at a rate of 11% per annum. The Medtronic Note does not allow for prepayment without the prior consent of Medtronic. Unless earlier converted, or redeemed, the Medtronic Note will mature on April 27, 2031 (the “Repayment Date”). In addition, the payment or other satisfaction of the obligations set forth in the Medtronic Loan Agreement are subordinate in right of payment to the prior payment in full of the senior obligations. The obligations arising under the Medtronic Loan Agreement and the Medtronic Note are secured by security interests in, and pledges over, the Company’s assets, subject to certain agreed security principles, permitted liens and other customary exceptions and qualifications.

The principal balance of the Medtronic Note, together with all accrued and unpaid interest thereon (collectively, the “Balance”) will automatically convert into a revenue share (the “Revenue Share Credit”), if FDA approval of a Medtronic device incorporating AVIM is achieved prior to the Repayment Date. Upon conversion of the then outstanding Balance the Company shall pay to Medtronic the Revenue Share Credit, which shall equal 15% of the revenue share amounts that the Company receives under the Medtronic Agreement, until such time as the total Revenue Share Credit payments equal $40.0 million.

The Medtronic Loan Agreement contains customary representations, warranties and affirmative and negative covenants. In addition, the Medtronic Loan Agreement contains customary events of default that entitle Medtronic to cause the Company’s indebtedness under the Note to become immediately due and payable, and to exercise remedies against the Company and the collateral securing the Loan. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 2.0% per annum may apply to all obligations owed under the Loan Agreement.

In addition, in connection with the closing of the Public Offering on August 4, 2025, Medtronic, through its affiliate Covidien Group S.à.r.l. (“Covidien”), purchased 4,077,427 shares of Company Common Stock (together with the Ligand Private Placement Shares, the “Private Placement Shares”) pursuant to a stock purchase agreement, dated as of July 31, 2025 and amended on August 1, 2025, between the Company and Covidien (as amended, the “Medtronic Stock Purchase Agreement” and, together with the Ligand Stock Purchase Agreement, the “Stock Purchase Agreements”), at a purchase price of $2.75 per share. In addition, pursuant to the terms and subject to the conditions of the Medtronic Stock Purchase Agreement, if the underwriters in the Public Offering (as defined below) exercise their option to purchase an additional 2,182,500 shares of Company Common Stock, Medtronic will be obligated to purchase an additional 132,282 shares of Company Common Stock at a purchase price of $2.75 per share.

Amendment of Exclusive License and Collaboration Agreement

On July 31, 2025, the Company, BackBeat and Medtronic entered into an amendment to the Medtronic Agreement, which became effective on August 4, 2025 (the “Medtronic Agreement Amendment”), to provide, among other things, a development and commercialization framework for future AVIM-therapy integration into a dual-chamber leadless pacemaker. Pursuant to the Medtronic Agreement Amendment, the Company will, among other things, be required to reimburse Medtronic for certain expenses incurred in connection with the integration of AVIM-therapy into Medtronic’s dual-chamber leadless pacemaker, up to a specified cap.  

Amendments to Hercules Loan and Security Agreement and Warrant Agreements

On July 31, 2025, the Borrower, the Hercules Lenders and Hercules entered into the LSA Amendment to the 2024 LSA, which, among other things, amended the existing 2024 LSA to (i) delay the initial date upon which the Company has to begin amortizing term loans under the 2024 LSA from (a) December 1, 2026 (with amortization payments delayed to as late December 1, 2027 if certain conditions were met) to (b) July 1, 2027 (with amortization payments delayed to as late as January 1, 2028 if certain conditions are met); and (ii) increase by $15.0 million (from $20.0 million to $35.0 million) the amount that that may be borrowed by the Company in the discretion of the lender’s investment committee’s and (iii) eliminate the Company’s ability to draw up to $15.0 million if certain milestones are achieved. The LSA Amendment became effective on August 4, 2025.

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Under the 2024 LSA as amended by the LSA Amendment (the “Amended 2024 LSA”), beginning on December 1, 2025, the Borrower must maintain Qualified Cash (as defined in the Amended 2024 LSA) in an amount greater than or equal to (x) the outstanding principal amount of the Term Loan Advances, multiplied by (y) the applicable Cash Coverage Percentage (as defined in the Amended 2024 LSA), which percentage ranges from a minimum of 60% to a maximum of 100% of Term Loan Advances, depending upon the amount of Qualified Cash.

 In addition, on July 31, 2025, the Company entered into amendments to the Hercules Warrants with the Hercules Lenders (the “Warrant Agreement Amendments”). As a result of the Warrant Agreement Amendments, among other things:

● the exercise price under the Hercules Warrants is now $3.58 (“Exercise Price”); and

● the number of shares issuable upon exercise of the Hercules Warrants is equal to 4% of aggregate principal amount of Term Loan Advances divided by the Exercise Price.

Registration Rights Agreement

In connection with the Stock Purchase Agreements and the Ligand Warrant, on August 4, 2025, the Company, Ligand and Medtronic entered into a Registration Rights Agreement (the “Registration Rights Agreement”), pursuant to which the Company has agreed to file a shelf registration statement providing for the resale of the Private Placement Shares and the Ligand Warrant Shares within 90 calendar days of the closing of the Stock Purchase Agreements, to use its commercially reasonable efforts to cause such registration statement to be declared effective after its filing at the earliest possible date, but no later than the earlier of (i) the 180^th calendar day following the issuance of the Private Placement Shares, if the SEC notifies the Company that it will “review” such registration statement and (ii) the 5^th business day after the date the Company is notified by the SEC that such registration statement will not be “reviewed” or will be subject to no further review, and to maintain the effectiveness of such registration statement until the date as of which there are no longer any Registrable Securities (as such term is defined in the Registration Rights Agreement).

Public Offering

On August 4, 2025, the Company closed an underwritten public offering of 9,413,637 shares of Company Common Stock at a price to the public of $2.75 per share and pre-funded warrants to purchase 5,136,363 shares of Company Common Stock at a price to the public of $2.7499 per pre-funded warrant, which represents the per share public offering price for the shares of Company Common Stock less the $0.0001 per share exercise price for each pre-funded warrant, for total gross proceeds of approximately $40.0 million, before deducting underwriting discounts and commissions and estimated offering expenses (the “Public Offering”). In addition, as part of the Public Offering, the Company granted the underwriters a 30-day option to purchase up to an additional 2,182,500 shares of Company Common Stock at the public offering price per share, less underwriting discounts and commissions.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Unless otherwise indicated or the context otherwise requires, references to “Orchestra,” “Orchestra’s,” “the Company,” “we,” “its” and “our” refer to Orchestra BioMed Holdings, Inc. and its consolidated subsidiaries. All references to years, unless otherwise noted, refer to the Company’s fiscal years, which end on December 31.

The following discussion should be read together with “Special Note Regarding Forward-Looking Statements” and the Company’s unaudited condensed consolidated financial statements, together with the related notes thereto, included elsewhere in this Quarterly Report on Form 10-Q (the “Consolidated Financial Statements”), and the Company’s audited consolidated financial statements, together with the related notes thereto, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025.

Closing of Business Combination

Prior to January 26, 2023, the Company was a special purpose acquisition company formed for the purpose of entering into a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. On January 26, 2023, we consummated the business combination contemplated by the Agreement and Plan of Merger, dated as of July 4, 2022 (as amended by Amendment No. 1 to Agreement and Plan of Merger, dated July 21, 2022, and Amendment No. 2 to Agreement and Plan of Merger, dated November 21, 2022, the “Merger Agreement”) by and among Health Sciences Acquisitions Corporation 2, a special purpose acquisition company incorporated as a Cayman Islands exempted company in 2020 and Orchestra’s predecessor (“HSAC2”), HSAC Olympus Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of HSAC2 (“Merger Sub”), and Orchestra BioMed, Inc. (“Legacy Orchestra”). Pursuant to the Merger Agreement, (i) HSAC2 deregistered in the Cayman Islands in accordance with the Companies Act (2022 Revision) (As Revised) of the Cayman Islands and domesticated as a Delaware corporation in accordance with Section 388 of the Delaware General Corporation Law (the “Domestication”) and (ii) Merger Sub merged with and into Legacy Orchestra, with Legacy Orchestra as the surviving company in the merger and, after giving effect to such merger, continuing as a wholly owned subsidiary of Orchestra (the “Merger” and, together with the Domestication and the other transactions contemplated by the Merger Agreement, the “Business Combination”). As part of the Domestication, we changed our name from “Health Sciences Acquisitions Corporation 2” to “Orchestra BioMed Holdings, Inc.” On January 27, 2023, our common stock (“Company Common Stock”) began trading on the Nasdaq Global Market under the symbol “OBIO.”

Overview

We are a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Our partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products we develop. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Our business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by our founding team.

Our flagship product candidates are atrioventricular interval modulation (“AVIM”) therapy (formerly referred to as BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”)), for the treatment of hypertension (“HTN”), a significant risk factor for death worldwide, and Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. We have an exclusive license and collaboration agreement with Medtronic, Inc. for the development and commercialization of AVIM therapy for the treatment of HTN in patients indicated for a cardiac pacemaker. We are conducting a double-blind, randomized study (the “BACKBEAT study”) that is expected to enroll a total of 500 patients who have previously received a Medtronic dual-chamber pacemaker. We currently estimate completion of enrollment of the BACKBEAT study in mid-2026; however, there is no assurance that our current operating plan will be achieved. We have a strategic collaboration with Terumo Medical Corporation (“Terumo”) for the development and commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease. We recently received FDA approval for an amended FDA investigational device exemption (“IDE”) to conduct a U.S. pivotal study in coronary ISR randomizing Virtue SAB vs. Boston Scientific Corporation’s

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AGENT™ drug coated balloon (“DCB”) and are currently targeting initiation of enrollment of this study in the second half of 2025.

Since Legacy Orchestra’s inception, we have devoted the substantial majority of our resources to performing research and development and clinical activities in support of our product development and collaboration efforts. We have funded our operations primarily through the issuance of convertible preferred stock and proceeds from the Business Combination, as well as through proceeds from our distribution agreement with Terumo (the “Terumo Agreement”), borrowings under debt arrangements and, to a lesser extent, from product revenue from our subsidiary, FreeHold Surgical, LLC. (“FreeHold”). Through June 30, 2025, we have raised a cumulative $252.3 million in gross proceeds through the issuance of convertible preferred stock, proceeds from the Business Combination and other equity sales, and have received $30.0 million from the Terumo Agreement. We have incurred net losses each year since inception. Our net losses were $38.1 million and $29.4 million for the six months ended June 30, 2025 and 2024, respectively. We expect to continue to incur significant losses for the foreseeable future. As of June 30, 2025, we had an accumulated deficit of $348.0 million.

Legacy Orchestra, our wholly owned subsidiary, was incorporated in Delaware in 2017 and completed a recapitalization and mergers with Caliber Therapeutics, Inc., a Delaware corporation that has, among other things, the rights to the Virtue SAB product candidate and BackBeat Medical, Inc., a Delaware Corporation that has, among other things, the rights to the AVIM therapy product candidate, in 2018. Legacy Orchestra completed the conversions of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC, a Delaware limited liability company, and BackBeat Medical, Inc. to BackBeat Medical, LLC, a Delaware limited liability company, in 2019.

Recent Developments

Ligand Pharmaceuticals Incorporated Revenue Participation Right Purchase and Sale Agreement and Purchase of Shares

On July 31, 2025, we entered into a revenue participation right purchase and sale agreement (the “Revenue Purchase and Sale Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”). Under the terms of the Revenue Purchase and Sale Agreement, in exchange for payment of $35.0 million (the “Investment Amount”), less certain reimbursable expenses, Ligand acquired from us the right to receive tiered revenue payments (the “Revenue Interest”) with respect to revenue (including certain licensing revenue) received by us in a calendar year in connection with worldwide net product sales, or other product revenue received by, by us and our licensees (“Annual Net Sales”) of (a) AVIM therapy (the “Primary Product”) and (b) Virtue SAB (the “Secondary Product” and together with the Primary Product, the “Products”) in the field of coronary artery treatment.

Pursuant to the Revenue Purchase and Sale Agreement, the Investment Amount shall be paid in two tranches: (i) $20.0 million was paid on August 4, 2025 and (ii) $15.0 million is payable on May 1, 2026 (the “Second Installment”), provided certain conditions have been met. For further information, see Note 16 to the Consolidated Financial Statements, “Subsequent Events.”

In connection with the sale of the Revenue Interest, and pursuant to the terms of the Revenue Purchase and Sale Agreement, on August 4, 2025, we issued to Ligand a warrant (the “Ligand Warrant”) to purchase up to 2,000,000 shares of the Company Common Stock (and, such shares underlying the Ligand Warrant, the “Ligand Warrant Shares”), at an exercise price equal to $3.67 per share. The exercise price of the Ligand Warrant and the number of Ligand Warrant Shares issuable upon exercise of the Ligand Warrant are subject to adjustments for stock splits, combinations, stock dividends or similar events. Pursuant to the terms of the Ligand Warrant, the Ligand Warrant Shares shall vest and become exercisable as follows: (i) 1,142,857 of the Ligand Warrant Shares (the “First Tranche”) vested upon issuance; however, the Ligand Warrant may not be exercised for six months after the issuance of the Ligand Warrant, and (ii) 857,143 of the Ligand Warrant Shares will vest on the date of payment of the Second Installment. In the event that the Second Installment is not paid, the Ligand Warrant shall only be exercisable with respect to the First Tranche. The Ligand Warrant is exercisable for ten years from the date of issuance.

Concurrent with the execution of the Revenue Purchase and Sale Agreement, Ligand also agreed to purchase $5.0 million of shares of Company Common Stock (the “Ligand Private Placement Shares”) pursuant to a stock purchase agreement, dated as of July 31, 2025, between the Company and Ligand (the “Ligand Stock Purchase Agreement”), at a

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purchase price per share equal to the public offering price per share in our next public offering of our equity securities. Pursuant to the Ligand Stock Purchase Agreement, Ligand purchased 1,818,181 shares of Company Common Stock a purchase price of $2.75 per share on August 4, 2025 in connection with the closing of the Public Offering (as defined below).

Purchase of Shares by Medtronic and Loan Agreement with Medtronic

On July 31, 2025, we and our wholly-owned subsidiaries, Legacy Orchestra and BackBeat, entered into a Loan Agreement (the “Medtronic Loan Agreement”) with Medtronic, pursuant to which Medtronic agreed to extend a convertible loan to us in the aggregate original principal amount of $20.0 million (the “Medtronic Loan”). The Medtronic Loan is evidenced by a secured subordinated convertible promissory note (the “Medtronic Note”) of us. The issuance of the Medtronic Note to Medtronic and the funding of the Medtronic Loan will take place on April 27, 2026 subject to certain closing conditions as described in the Loan Agreement. For further information, see Note 16 to the Consolidated Financial Statements, “Subsequent Events.”

In addition, in connection with the closing of the Public Offering, on August 4, 2025, Medtronic, through its affiliate Covidien Group S.à.r.l. (“Covidien”), purchased 4,077,427 shares of Company Common Stock at a purchase price of $2.75 per share (the “Medtronic Private Placement Shares” and, together with the Ligand Private Placement Shares, the “Private Placement Shares”) pursuant to a stock purchase agreement, dated as of July 31, 2025 and amended on August 1, 2025, between us and Covidien (as amended, the “Medtronic Stock Purchase Agreement” and,  together with the Ligand Stock Purchase Agreement, the “Stock Purchase Agreements”). In addition, pursuant to the terms and subject to the conditions of the Medtronic Stock Purchase Agreement, if the underwriters in the Public Offering (as defined below) exercise their option to purchase an additional 2,182,500 shares of Company Common Stock, Medtronic will be obligated to purchase an additional 132,282 shares of Company Common Stock at a purchase price of $2.75 per share.

Amendment of Exclusive License and Collaboration Agreement

On July 31, 2025, we, BackBeat and Medtronic entered into an amendment to the Medtronic Agreement, which became effective on August 4, 2025 (the “Medtronic Agreement Amendment”), to provide, among other things, a development and commercialization framework for future AVIM-therapy integration into a dual-chamber leadless pacemaker. Pursuant to the Medtronic Agreement Amendment, the Company will, among other things, be required to reimburse Medtronic for certain expenses incurred in connection with the integration of AVIM-therapy into Medtronic’s dual-chamber leadless pacemaker, up to a specified cap.

Amendments to Hercules Loan and Security Agreement and Warrant Agreements

On July 31, 2025, we, certain of our subsidiaries, the Hercules Lenders (as defined below) and Hercules (as defined below) entered into that certain second amendment (the “LSA Amendment”) to the 2024 LSA (as defined below), which, among other things, amended the existing 2024 LSA to (i) delay the initial date upon which we are to begin amortizing term loans under the 2024 LSA from (a) December 1, 2026 (with amortization payments delayed to as late December 1, 2027 if certain conditions were met) to (b) July 1, 2027 (with amortization payments delayed to as late as January 1, 2028 if certain conditions are met); and (ii) increase by $15.0 million (from $20.0 million to $35.0 million) the amount that that may be borrowed by us in the discretion of the lender’s investment committee’s and (iii) eliminate our ability to draw up to $15.0 million if certain milestones are achieved.

Under the 2024 LSA as amended by the LSA Amendment (the “Amended 2024 LSA”), beginning on December 1, 2025, the Borrower (as defined below) must maintain Qualified Cash (as defined in the Amended 2024 LSA) in an amount greater than or equal to (x) the outstanding principal amount of the Term Loan Advances, multiplied by (y) the applicable Cash Coverage Percentage (as defined in the Amended 2024 LSA), which percentage ranges from a minimum of 60% to a maximum of 100% of Term Loan Advances, depending upon the amount of Qualified Cash.

In addition, concurrently with the effectiveness of the LSA Amendment, we entered into amendments to the warrant agreements dated November 6, 2024 (the “Hercules Warrants”) with the Hercules Lenders under the 2024 LSA (the “Warrant Agreement Amendments”). As a result of the Warrant Agreement Amendments, among other things:

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● the exercise price under the Hercules Warrants is now $3.58 (“Exercise Price”); and

● the number of shares issuable upon exercise of the Hercules Warrants is equal to 4% of aggregate principal amount of Term Loan Advances divided by the Exercise Price.

Registration Rights Agreement

In connection with the Stock Purchase Agreements and the Ligand Warrant, we, Ligand and Medtronic entered into a Registration Rights Agreement, pursuant to which we have agreed to file a shelf registration statement providing for the resale of the Private Placement Shares and the Ligand Warrant Shares within 90 calendar days of the closing of the Stock Purchase Agreements. For further information, see Note 16 to the Consolidated Financial Statements, “Subsequent Events.”

Public Offering

On August 4, 2025, we closed an underwritten public offering of 9,413,637 shares of Company Common Stock at a price to the public of $2.75 per share and pre-funded warrants to purchase 5,136,363 shares of Company Common Stock at a price to the public of $2.7499 per pre-funded warrant, which represents the per share public offering price for the shares of Company Common Stock less the $0.0001 per share exercise price for each pre-funded warrant, for total gross proceeds of approximately $40.0 million, before deducting underwriting discounts and commissions and estimated offering expenses (the “Public Offering”). In addition, as part of the Public Offering, we granted the underwriters a 30-day option to purchase up to an additional 2,182,500 shares of Company Common Stock at the public offering price per share, less underwriting discounts and commissions.

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Registration Statement

Due to the significant number of redemptions of HSAC2’s ordinary shares in connection with the Business Combination, there was a significantly lower number of HSAC2 ordinary shares that converted into shares of Company Common Stock in connection with the Business Combination. Pursuant to the Amended and Restated Registration Rights Agreement we entered into in connection with the closing of the Business Combination and certain warrant agreements, we filed a registration statement (the “Resale Registration Statement”), which was declared effective on May 9, 2024, that registers, among other things, the resale of an aggregate of 18,586,201 shares of Company Common Stock, which constitutes approximately 34% of the outstanding Company Common Stock as of August 8, 2025. Additionally, some of the shares of the Company Common Stock being registered for resale were originally purchased by selling stockholders pursuant to investments in Legacy Orchestra or HSAC2 at prices considerably below the current market price of the Company Common Stock. These selling stockholders may realize a positive rate of return on the sale of their shares of Company Common Stock covered by the Resale Registration Statement and therefore will have an incentive to sell their shares. Public shareholders may not experience a similar rate of return on shares of Company Common Stock they purchased. This discrepancy in purchase prices may have an impact on the market perception of the Company Common Stock’s value and could increase the volatility of the market price of the Company Common Stock or result in a significant decline in the public trading price of the Company Common Stock. The registration of these shares of Company Common Stock for resale creates the possibility of a significant increase in the supply of the Company Common Stock in the market. The increased supply, coupled with the potential disparity in purchase prices, may lead to heightened selling pressure, which could negatively affect the public trading price of the Company Common Stock.

Components of Our Results of Operations

Partnership Revenue

To date, our partnership revenues have related to the Terumo Agreement described below. In future periods, partnership revenues may also include revenues related to the Exclusive License and Collaboration Agreement, dated as of June 30, 2022, by and among, Legacy Orchestra, BackBeat Medical, LLC and Medtronic, Inc. (an affiliate of Medtronic plc) (the “Medtronic Agreement”), discussed in Note 4 to the Consolidated Financial Statements.

Legacy Orchestra entered into the Terumo Agreement in June 2019, and has determined that the arrangement represents a contract with a customer and is therefore in scope of ASC 606, Revenues from Contracts with Customers (“ASC 606”). Under the Terumo Agreement, Legacy Orchestra received an upfront payment of $30.0 million in 2019 and an equity commitment of up to $5 million of which $2.5 million was invested in June 2019 as part of the Legacy Orchestra Series B-1 financing and $2.5 million was invested in June 2022 as part of the Legacy Orchestra Series D-2 financing.

Under the Terumo Agreement, we were initially eligible for certain milestone payments in the amount of $65 million from Terumo upon completion of certain minimum enrollments in clinical studies, making certain filings and submissions, and obtaining certain regulatory approvals and certifications, and are also eligible to earn royalties on future sales by Terumo based on royalty rates ranging from 10 - 15%. Of these milestone payments, $35 million relate to achieving certain milestones by specified target achievement dates. As of June 30, 2025, the target achievement dates for three $5 million milestone payments have already passed, in each case, without achieving the related milestones. In addition, due to delays in our Virtue SAB program resulting from the COVID-19 pandemic, supply chain issues and unexpected changes to regulatory requirements, including increased testing and other activities related to chemistry, manufacturing, and control, increased nonclinical and good laboratory practice preclinical data requirements, including biocompatibility, as well as a requirement to repeat good laboratory practice preclinical studies already performed based on changes to source of component materials and a change in manufacturing site, that caused us to amend our original project plan, we will not be able to complete the remaining time-based milestones by the specified target achievement dates to earn the remaining $20 million in time-based milestone payments pursuant to the Terumo Agreement.

As previously disclosed, we are in a mediation procedure with Terumo pursuant to the Terumo Agreement and the International Mediation Rules of the International Centre for Dispute Resolution (“ICDR”). The mediation is intended to assist in potentially resolving disagreements and facilitating the completion of negotiations related to restructuring, replacing or terminating the Terumo Agreement. The Terumo Agreement provides that matters that are not resolved

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through mediation are to be resolved by binding arbitration conducted under the auspices of the ICDR in accordance with its International Arbitration Rules. If the mediation does not lead to a timely agreement or resolution, or, if applicable, we do not prevail in arbitration, or if the Terumo Agreement is terminated, our commercialization plans for Virtue SAB may be adversely impacted. However, any termination of the Terumo Agreement in the context of mediation, an arbitration or otherwise would allow us to pursue an alternative strategic collaboration or other transaction with a different partner. We currently expect the formal mediation to be completed by the end of the third quarter of 2025. Regardless of the mediation process with Terumo, we intend to initiate enrollment of the Virtue SAB trial, our pivotal study of Virtue SAB for coronary in-stent restenosis in the U.S. during the second half of 2025, as well as to continue other product development efforts related to Virtue SAB.

We recorded the $30.0 million upfront payment received in 2019 from Terumo within deferred revenue and are recognizing the upfront payment over time based on a proportional performance model based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the development of the Coronary ISR indication, for which we are primarily responsible. We have recognized $16.0 million in cumulative partnership revenues from 2019 through June 30, 2025. There were no other proceeds received pursuant to the Terumo Agreement from 2019 through June 30, 2025.

In June 2022, Legacy Orchestra entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of anti-hypertensive medications. We have determined that the arrangement is a collaboration within the scope of ASC 808, Collaborative Arrangements (“ASC 808”). In addition, we concluded that Medtronic, Inc., an affiliate of Medtronic plc (“Medtronic”), is a customer for a good or service that is a distinct unit of account, and therefore, the transactions in the Medtronic Agreement should be accounted for under ASC 606. Through June 30, 2025, there have been no amounts recognized as revenue under the Medtronic Agreement.

Product Revenue

Product revenues related to sales of FreeHold’s intracorporeal organ retractors and such revenues are recognized at a point-in-time upon the shipment of the product to the customer given payment terms are typically 30 days. FreeHold products are currently only sold in the United States.

Cost of Product Revenue and Gross Margin

Cost of product revenue consists primarily of costs of finished goods components for use in FreeHold’s products and assembled, warehoused and inventoried by a third-party vendor. We expect the cost of finished goods product revenue to increase in absolute terms as our revenue grows.

Our gross margin has been, and will continue to be, affected by a variety of factors, including finished goods manufactured component parts, as well as the cost to assemble and warehouse the FreeHold product finished goods inventory.

Research and Development Expenses

Research and development expenses consist of applicable personnel, consulting, materials and clinical study expenses. Research and development expenses include:

● Certain personnel-related expenses, including salaries, benefits, bonus, travel and stock-based compensation;

● Cost of clinical studies to support new products and product enhancements, including expenses for clinical research organizations and site payments;

● Product device materials and drug supply, and manufacturing used for internal research and development, and clinical activities;

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● Allocated overhead including facilities and information technology expenses; and

● Cost of outside consultants who assist with device and drug development, regulatory affairs, clinical affairs and quality assurance.

Research and development costs are expensed as incurred. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical studies. In the future, we expect research and development expenses to increase in absolute dollars as we continue to develop new products, enhance existing products and technologies, initiate clinical studies, manufacture drug supply for internal research and development and clinical trial supply and perform activities related to obtaining additional regulatory approvals. We do not track expenses by product candidate, unless tracking such expenses is required pursuant to the revenue recognition model for a collaborative arrangement.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist of personnel-related expenses, including salaries, benefits, bonus, travel and stock-based compensation. Other selling, general and administrative expenses include professional services fees, including legal, audit, investor/public relations, and insurance costs, outside consultants costs, employee recruiting and training costs, and non-income taxes. Moreover, we incur and expect to continue to incur additional expenses associated with operating as a public company, including legal, accounting, insurance, exchange listing and U.S. Securities and Exchange Commission (“SEC”) compliance, and investor relations expenses. We expect quarterly selling, general and administrative expenses to continue to increase as we conduct additional clinical trials and expand our operations as a public company.

Interest (Expense) Income, Net

Interest (expense) income, net reflects the income generated from marketable securities during the year. Interest expense is attributable to loan interest.

On November 6, 2024 (the “LSA Closing Date”), we and certain of our subsidiaries (together, the “Borrower”) entered into a Loan and Security Agreement, by and among the Borrower, the several banks and other financial institutions or entities party thereto, as lenders (collectively, the “Hercules Lenders”), and Hercules Capital, Inc. (“Hercules”), as administrative agent and collateral agent for itself and the Hercules Lenders, as amended by that certain First Amendment to Loan and Security Agreement dated as of December 30, 2024 (as amended, the “2024 LSA”). The 2024 LSA provided a secured term loan facility of up to $50.0 million available in up to four tranches (collectively, the “Term Loans”), with the first tranche of $15.0 million drawn on the LSA Closing Date, and a second and third tranche of up to an aggregate of $15.0 million were available upon achievement of certain performance and financing milestones. Additionally, the Company had access to a fourth tranche of $20.0 million subject to future approval. The Term Loan has a maturity date of November 6, 2028 and accrues interest at a floating per annum rate equal to the greater of (i) (x) the “prime rate” as reported in The Wall Street Journal plus (y) 2.0%, and (ii) 9.50%. Refer to Note 13 – “Debt Financing” to our Consolidated Financial Statements. On July 31, 2025, the Borrower, the Hercules Lenders and Hercules entered into the LSA Amendment, which became effective on August 4, 2025. See “Overview—Amendments to Hercules Loan and Security Agreement and Warrant Agreements” above in this Item 2.

Loss on Fair Value of Strategic Investments

The loss on fair value of strategic investments represents a change in the preferred shares and convertible notes of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party, and fair value of our investment in common stock holdings of a previously publicly-held company. The investments in Vivasure do not have readily determinable fair values and are recorded at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer. The common stock held represented equity securities with a readily determinable fair value and were required to be measured at fair value at each

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reporting period using readily determinable pricing available on a securities exchange, in accordance with the provisions of ASU 2016-01.

Results of Operations

Comparison of the Six Months Ended June 30, 2025 and 2024

The following table presents our statement of operations data for the six months ended June 30, 2025 and 2024, and the dollar and percentage change between the two periods (in thousands):

	Six Months Ended June 30,
	2025		2024		Change $		Change %
Revenue:
Partnership revenue	$	1,399	$	1,125	$	274		24	%
Product revenue		305		273		32		12	%
Total revenue		1,704		1,398		306		22	%
Expenses:
Cost of product revenues		90		78		12		15	%
Research and development		27,335		20,238		7,097		35	%
Selling, general and administrative		12,527		12,364		163		1	%
Total expenses		39,952		32,680		7,272		22	%
Loss from operations		(38,248)		(31,282)		(6,966)		(22)	%
Other income (expense):
Interest income, net		130		1,918		(1,788)		(93)	%
Loss on fair value of strategic investments		—		(68)		68		100	%
Other expense		—		(11)		11		100	%
Total other income		130		1,839		(1,709)		(93)	%
Net loss	$	(38,118)	$	(29,443)	$	(8,675)		(29)	%

Partnership Revenue

Partnership revenue increased by $274,000, or approximately 24%, to $1.4 million in the six months ended June 30, 2025 from $1.1 million for the six months ended June 30, 2024. Partnership revenue relates to the recognition of the combined performance obligation for the license granted to Terumo and the ongoing research and development services over the estimated performance period for the Virtue SAB coronary ISR indication, using a proportional performance model, based on the costs incurred relative to the total estimated costs of the research and development services. As of each quarterly reporting date, we evaluate our estimates of the total costs expected to be incurred through the completion of the combined performance obligation and update our estimates as necessary.

For the six months ended June 30, 2025 and 2024, the expenses incurred related to the Terumo Agreement were approximately $6.8 million and $6.9 million, respectively. The estimated total costs associated with the Terumo Agreement through completion were similar as of June 30, 2025 compared to the estimates as of December 31, 2024, and increased by approximately 2.8% as of June 30, 2024, as compared to the estimates as of December 31, 2023.

While we believe we have estimated total costs associated with the Terumo Agreement through completion, these estimates encompass a broad range of expenses over a multi-year period and, as such, are subject to periodic changes as new information becomes available.

Product Revenue

Product revenue increased by $32,000, or approximately 12%, to $305,000 in the six months ended June 30, 2025 from $273,000 for the six months ended June 30, 2024.

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Product revenue primarily consisted of the sale of FreeHold Duo and Trio intracorporeal organ retractors and revenue is recognized when product is shipped to customers. The increase in product revenue was due to an increase in the purchase volume. There were no changes to the per unit sale price between the periods presented.

Cost of Product Revenue

Cost of product revenue increased by $12,000, or approximately 15%, to $90,000 in the six months ended June 30, 2025 from $78,000 for the six months ended June 30, 2024. The increase was primarily due to higher production costs per unit of FreeHold Duo and Trio intracorporeal organ retractors.

Research and Development Expenses

The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024 (in thousands):

	Six Months Ended June 30,
	2025		2024
Personnel and consulting costs	$	12,544	$	9,616
Non-clinical development costs		9,216		8,075
Clinical development costs		5,575		2,547
Total research and development expenses	$	27,335	$	20,238

Research and development expenses increased by $7.1 million, or approximately 35%, to $27.3 million for the six months ended June 30, 2025 from $20.2 million for the six months ended June 30, 2024. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT study and to advance Virtue SAB into a planned pivotal study. The increase included an increase of $3.0 million in clinical development costs, an increase in personnel-related expenses of $2.2 million due to increased headcount and consulting costs, an increase of $1.1 million in non-clinical development costs associated with research and development program costs, supplies, and testing, and an increase in stock-based compensation of $710,000.  

The total research and development expenses summarized above include $6.8 million for the six months ended June 30, 2025 and 2024 related to the Terumo Agreement. The consistency in expense is due to a similar level of expense activity related to the Terumo Agreement during the six months ended June 30, 2025 compared to the same period in 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by $163,000, or approximately 1%, to $12.5 million for the six months ended June 30, 2025, from $12.4 million of expense for the six months ended June 30, 2024. The increase primarily resulted from an increase in stock-based compensation of $157,000.

Interest Income, Net

Interest income, net, decreased by $1.8 million, or approximately 93%, to $130,000 of income for the six months ended June 30, 2025, from $1.9 million of income for the six months ended June 30, 2024. The net interest income in the 2025 period consisted primarily of interest earned from marketable securities partially offset by monthly interest expense resulting from the 2024 LSA. The net interest income in the 2024 period consisted primarily of interest earned from marketable securities. The decrease in net interest income resulted from lower amounts of marketable securities held during the 2025 period.

Loss on Fair Value of Strategic Investments

No gain or loss on fair value of strategic investments was recognized for the six months ended June 30, 2025. The loss of $68,000 for the six months ended June 30, 2024 related to the change in fair value in our common stock holdings of a previously publicly-held company.

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Comparison of the Three Months Ended June 30, 2025 and 2024

The following table presents our statement of operations data for the three months ended June 30, 2025 and 2024, and the dollar and percentage change between the two periods (in thousands):

	Three Months Ended June 30,
	2025		2024		Change $		Change %
Revenue:
Partnership revenue	$	667	$	628	$	39	$	6	%
Product revenue		169		150		19		13	%
Total revenue		836		778		58		7	%
Expenses:
Cost of product revenues		46		44		2		5	%
Research and development		13,853		11,126		2,727		25	%
Selling, general and administrative		6,264		6,467		(203)		(3)	%
Total expenses		20,163		17,637		2,526		14	%
Loss from operations		(19,327)		(16,859)		(2,468)		(15)	%
Other (expense) income:
Interest (expense) income, net		(36)		902		(938)		(104)	%
Loss on fair value of strategic investments		—		(23)		23		100	%
Total other (expense) income		(36)		879		(915)		(104)	%
Net loss	$	(19,363)	$	(15,980)	$	(3,383)	$	(21)	%

Partnership Revenue

Partnership revenue increased by $39,000, or approximately 6%, to $667,000 in the three months ended June 30, 2025 from $628,000 for the three months ended June 30, 2024. Partnership revenue relates to the recognition of the combined performance obligation for the license granted to Terumo and the ongoing research and development services over the estimated performance period for the Virtue SAB Coronary ISR indication, using a proportional performance model, based on the costs incurred relative to the total estimated costs of the research and development services. As of each quarterly reporting date, we evaluate our estimates of the total costs expected to be incurred through the completion of the combined performance obligation and update our estimates as necessary.

For the three months ended June 30, 2025 and 2024, the expenses incurred related to the Terumo Agreement were approximately $3.3 million and $4.0 million, respectively. The estimated total costs associated with the Terumo Agreement through completion were similar as of June 30, 2025 as compared to the estimates as of March 31, 2025, and increased by approximately 1.6% as of June 30, 2024, as compared to the estimates as of March 31, 2024.

While we believe we have estimated total costs associated with the Terumo Agreement through completion, these estimates encompass a broad range of expenses over a multi-year period and, as such, are subject to periodic changes as new information becomes available.

Product Revenue

Product revenue increased by $19,000, or approximately 13%, to $169,000 in the three months ended June 30, 2025 from $150,000 for the three months ended June 30, 2024.

Product revenue primarily consisted of the sale of FreeHold Duo and Trio intracorporeal organ retractors and revenue is recognized when product is shipped to customers. The increase in product revenue was primarily due to an increase in the purchase volume. There were no changes to the per unit sale price in either period presented.

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Cost of Product Revenue

Cost of product revenue increased by $2,000, or approximately 5%, to $46,000 in the three months ended June 30, 2025 from $44,000 for the three months ended June 30, 2024. The increase was primarily due to higher production costs per unit of FreeHold Duo and Trio intracorporeal organ retractors.

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended June 30, 2025 and 2024 (in thousands):

	Three Months Ended June 30,
	2025		2024
Personnel and consulting costs	$	6,542	$	4,909
Non-clinical development costs		4,678		4,713
Clinical development costs		2,633		1,504
Total research and development expenses	$	13,853	$	11,126

Research and development expenses increased by $2.7 million, or approximately 25%, to $13.9 million for the three months ended June 30, 2025, from $11.1 million for the three months ended June 30, 2024. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT study and to advance Virtue SAB into a planned pivotal study. The increase included an increase in personnel-related expenses of $1.1 million due to increased headcount and consulting costs, an increase of $1.1 million in clinical development costs, and an increase in stock-based compensation of $494,000.  

The total research and development expenses summarized above include $3.3 million for the three months ended June 30, 2025 and $4.0 million for the three months ended June 30, 2024 related to the Terumo Agreement. The decrease of $724,000 is due to decreased expense activity related to the Terumo Agreement during the three months ended June 30, 2025 compared to the same period in 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses decreased by $203,000, or approximately 3%, to $6.3 million for the three months ended June 30, 2025, from $6.5 million of expense for the three months ended June 30, 2024. The decrease was primarily due to a decrease in professional fees.

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Interest (Expense) Income, Net

Interest (expense) income, net, decreased by $938,000, or approximately 104%, to $36,000 of net interest expense for the three months ended June 30, 2025, from $902,000 of net interest income for the three months ended June 30, 2024. The net interest expense in the 2025 period consisted primarily of monthly interest expense resulting from the 2024 LSA partially offset by interest earned from marketable securities. The net interest income in the 2024 period consisted primarily of interest earned from marketable securities. The decrease in net interest income resulted from lower amounts of marketable securities held during the 2025 period.

Loss on Fair Value of Strategic Investments

No gain or loss on fair value of strategic investments was recognized for the three months ended June 30, 2025. The loss in fair value of strategic investments was $23,000 for the three months ended June 30, 2024 related to the change in fair value in our common stock holdings of a previously publicly-held company.

Liquidity and Capital Resources

Overview

From inception through June 30, 2025, we have incurred significant operating losses and negative cash flows from our operations. Our net losses were $38.1 million and $29.4 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $348.0 million. We have funded our operations primarily through the issuance of convertible preferred stock, proceeds from the Business Combination and other equity sales, as well as through proceeds from the Terumo Agreement, borrowings under debt arrangements and, to a lesser extent, from FreeHold product revenue. Through June 30, 2025, we have raised a cumulative $252.3 million in gross proceeds through the issuance of convertible preferred stock, proceeds from the Business Combination and other equity sales, and have received $30.0 million under the Terumo Agreement. We had $33.9 million in cash and cash equivalents and marketable securities at June 30, 2025, comprised of $18.7 million in cash and cash equivalents and $15.2 million in marketable securities. Cash and cash equivalents consisted primarily of bank deposits and money market funds while short-term marketable securities consisted primarily of our investments in corporate debt securities. On August 4, 2025, we received $76.2 million as a result of concurrent equity offerings and strategic transactions, which included $16.2 million in proceeds from an equity private placement with Medtronic and Ligand, $40.0 million from a public equity offering, and $20.0 million related to entering into the Revenue Purchase and Sale Agreement with Ligand. Future committed cash receipts expected in April 2026 from the same strategic transactions include $20.0 million from the Medtronic Loan Agreement, and an additional $15.0 million from Ligand under the Revenue Purchase and Sale Agreement.

Funding Requirements  

While we continue to prioritize spending on our AVIM therapy program and the execution of our BACKBEAT study, we are planning to increase spending to support our planned U.S. pivotal clinical trial initiation for our Virtue SAB program. We expect operating expenses to increase to support (1) clinical study costs as well as additional research and development expenses in support of future potential regulatory approval and commercialization of AVIM-enabled Medtronic pacemakers; and (2) our Virtue SAB program, which will be primarily focused on initiating enrollment of our planned Virtue Trial, a U.S. pivotal clinical trial for the treatment of coronary ISR comparing Virtue SAB to Boston Scientific Corporation’s AGENT™ DCB, for which we have received FDA full IDE approval and anticipate launching in the second half of 2025.

Based on internally prepared budget estimates that reflect our operating priorities, we anticipate that our cash, cash equivalents, marketable securities, expected future proceeds from contractual financing commitments and other potential future proceeds described below are sufficient to fund our operations into the second half of 2027. The amount and timing of our future funding requirements may change from this current estimate and are dependent on many factors, including the cost and pace of execution of clinical studies and research and development activities, the strength of results from clinical studies and other research, development and manufacturing efforts, as well as the receipt of payments under the Revenue Purchase and Sale Agreement and the Medtronic Loan Agreement, and the realization of cash from the sale of

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some or all of our strategic holdings, most notably, Vivasure Medical. There are no assurances that any of these factors will be favorable to us, and we may need to seek additional sources of liquidity to meet our funding requirements earlier than current estimates, including the issuance of new equity, and/or other financing structures. In this regard, as of the date of this Quarterly Report on Form 10-Q, we may sell up to $100.0 million of shares of Company Common Stock under the sales agreement we entered into with TD Securities (USA) LLC (the “Sales Agreement”), subject to the provisions of the lock-up agreement executed in connection with the Public Offering, which, prohibits us from selling shares of Company Common Stock pursuant to the Sales Agreement until October 31, 2025.

Our future viability is dependent on our ability to raise additional capital to finance our operations. Our inability to raise capital as and when needed could have a negative impact on our financial condition and ability to pursue our business strategies. There can be no assurance that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.

As noted above, the sale of Company Common Stock pursuant to the Resale Registration Statement may result in a decline in the value of the Company Common Stock, which may make it more difficult and more dilutive to the existing holders of Company Common Stock to raise funds from the sale of our equity securities.

Cash Flows

The following table summarizes our cash flow data for the periods indicated (in thousands):

	Six Months Ended June 30,
	2025		2024
Net cash used in operating activities	$	(32,143)	$	(23,320)
Net cash provided by investing activities		29,355		16,285
Net cash (used in) provided by financing activities		(724)		189
Net decrease in cash and cash equivalents	$	(3,512)	$	(6,846)

Comparison of the Six Months Ended June 30, 2025 and 2024

Net Cash Flows from Operating Activities

Net cash used in operating activities for the six months ended June 30, 2025 was $32.1 million and primarily consisted of our net loss of $38.1 million and changes in net operating assets and liabilities of $632,000, partially offset by non-cash charges of $6.6 million. Our non-cash charges primarily consisted of stock-based compensation of $6.2 million, partially offset by $161,000 related to accretion and interest of marketable securities. The net change in operating assets and liabilities was primarily due to a decrease in deferred revenue of $1.4 million offset by a decrease in accounts payable, accrued expenses and other liabilities of $888,000.

Net cash used in operating activities for the six months ended June 30, 2024 was $23.3 million and primarily consisted of our net loss of $29.4 million, which was partially offset by changes in net operating assets and liabilities of $1.2 million, and non-cash charges of $4.9 million. Our non-cash charges primarily consisted of stock-based compensation of $5.3 million, partially offset by $914,000 related to accretion and interest of marketable securities. The net change in operating assets and liabilities was primarily due to an increase in accounts payable and accrued expenses of $2.4 million and a decrease in deferred revenue of $1.1 million.

Net Cash Flows from Investing Activities

Net cash provided by investing activities for the six months ended June 30, 2025 was $29.4 million, which primarily consisted of the sale of $32.4 million of marketable securities, partially offset by the purchase of $2.9 million of marketable securities.

Net cash provided by investing activities for the six months ended June 30, 2024 was $16.3 million, which primarily consisted of the sale of $58.8 million of marketable securities, partially offset by the purchase of $42.4 million of

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marketable securities.

Net Cash Flows from Financing Activities

Net cash used by financing activities of $724,000 for the six months ended June 30, 2025 was primarily due to $815,000 used to settle taxes associated with restricted stock vesting, partially offset by proceeds of $91,000 related to the exercise of stock options.

Net cash provided by financing activities of $189,000 for the six months ended June 30, 2024 was primarily attributable to exercises of stock options.

Contractual Obligations and Commitments

The following table summarizes our contractual obligations and commitments as of June 30, 2025 (in thousands):

	Payments Due by Period
			Less than		1-3		3-5		More than
	Total		1 Year		Years		Years		5 Years
Operating lease obligations	$	2,241	$	806	$	1,435	$	—	$	—
Debt, principal and interest(1)		19,555		1,445		13,691		4,419		—
Total	$	21,796	$	2,251	$	15,126	$	4,419	$	—

(1) In November 2024, we entered into the 2024 LSA with Hercules. The 2024 LSA will mature in November 2028. Refer to Note 13 to the Consolidated Financial Statements for additional information.

We enter into agreements in the normal course of business with clinical research organizations for work related to clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are cancelable at any time by us, generally upon 30 days prior written notice. These payments are not included in the above table of contractual obligations and commitments.

Critical Accounting Policies and Estimates

Our financial statements are prepared in accordance with U.S. GAAP. The preparation of the financial statements in conformity with U.S. GAAP requires our management to make a number of estimates and assumptions relating to the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the period. We evaluate our significant estimates on an ongoing basis, including estimates related to the total costs expected to be incurred though the completion of the combined performance obligation of the Terumo Agreement, research and development prepayments, accruals and related expenses and stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.

We believe that the accounting policies described below involve a significant degree of judgment and complexity. Accordingly, we believe these are the most critical to aid in fully understanding and evaluating our financial condition and results of operations. For further information, see Note 2 to the Consolidated Financial Statements – “Summary of Significant Accounting Policies.”

Revenue Recognition

We recognize revenue under the core principle according to ASC 606 to depict the transfer of control to our customers in an amount reflecting the consideration we expect to be entitled to. In order to achieve that core principle, we apply the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when a performance obligation is satisfied.

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Our revenues are currently comprised of partnership revenues under the Terumo Agreement related to the development and commercialization of Virtue SAB, and product revenue from the sale of FreeHold’s intracorporeal organ retractors.

Partnership Revenues

To date, our partnership revenues have related to the Terumo Agreement described below. In future periods, partnership revenues may also include revenues related to the Medtronic Agreement, discussed in Note 4 to the Consolidated Financial Statements.

Legacy Orchestra entered into the Terumo Agreement as further described in Note 3 to the Consolidated Financial Statements. We assessed whether the Terumo Agreement fell within the scope of ASC 808 based on whether the arrangement involved joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. We determined that the Terumo Agreement did not fall within the scope of ASC 808. We then analyzed the arrangement pursuant to the provisions of ASC 606 and determined that the arrangement represents a contract with a customer and is therefore within the scope of ASC 606.

The promised goods or services in the Terumo Agreement include (i) license rights to our intellectual property and (ii) research and development services. We also have optional additional items in the Terumo Agreement, which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct in the Terumo Agreement, we considered factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available.

We estimate the transaction price for the Terumo Agreement performance obligations based on the amount expected to be received for transferring the promised goods or services pursuant to the Terumo Agreement. The consideration includes both fixed consideration and variable consideration. At the inception of the Terumo Agreement, as well as at each reporting period, we evaluate the amount of potential payment and the likelihood that the payments will be received. We utilize either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method better predicts the amount expected to be received. If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price.

The Terumo Agreement contains development and regulatory milestone payments. At contract inception and at each reporting period, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect partnership revenues and earnings in the period of adjustment.

The Terumo Agreement also includes sales-based royalties and the license is deemed to be the predominant item to which the royalties relate. Accordingly, we will recognize royalty revenue when the related sales occur. To date, we have not recognized any royalty revenue under the arrangement.

We have determined that intellectual property licensed to Terumo and the research and development services to be provided to support the premarket approval by the FDA for the ISR indication represent a combined performance obligation that is satisfied over time, which is currently estimated to be completed in 2029, and that the appropriate method of measuring progress for purposes of recognizing revenues relates to a proportional performance model that measures the proportional performance based on the costs incurred to date relative to the total costs expected to be incurred through the

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completion of the performance obligation. We evaluate the measure of progress at each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

In the six months ended June 30, 2025, we updated our estimates of the total costs expected to be incurred through the completion of the combined performance obligation. The impact of the changes in estimates resulted in a reduction in partnership revenues of $27,000, which resulted in a de minimis effect on net loss per share, basic and diluted. In the six months ended June 30, 2024, the impact of the changes in estimates resulted in a reduction of partnership revenues of $382,000, which resulted in a $0.01 effect on net loss per share, basic and diluted.

We receive payments from Terumo based on billing schedules established in the contract. Such billings for milestone related events have 10-day terms from the date the milestone is achieved, royalty payments are 20-day terms after the close of each quarter, any optional services are 20 days after receipt of an invoice and sales of SirolimusEFR are within 30 days after receipt of the shipping invoices. Upfront payments are recorded as deferred revenue upon receipt or when due until we perform our obligations under these arrangements. Amounts are recorded as accounts receivable when the right to consideration is unconditional.

In June 2022, Legacy Orchestra, BackBeat Medical, LLC and Medtronic entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of anti-hypertensive medications. We determined that the arrangement is a collaboration within the scope of ASC 808. In addition, we concluded Medtronic is a customer for a good or service that is a distinct unit of account, and therefore the transactions in the Medtronic Agreement should be accounted for under ASC 606. Through June 30, 2025, there have been no amounts recognized as revenue under the Medtronic Agreement.

Product Revenues

Product revenues related to sales of FreeHold’s intracorporeal organ retractors are recognized at a point-in-time upon the shipment of the product to the customer, and there are no significant estimates or judgments related to estimating the transaction price. The product revenues consist of a single performance obligation, and the payment terms are typically 30 days. Product revenues are recognized solely in the United States.

Research and Development Prepayments, Accruals and Related Expenses

We incur costs of research and development activities conducted by our third-party service providers, which include the conduct of preclinical and clinical studies. We are required to estimate our prepaid and accrued research and development costs at each reporting date. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with our service providers. We determine the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel and outside service providers, as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with the third parties and the agreed upon fees to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by us or the services are performed. Accruals are recorded for the amounts of services provided that have not yet been invoiced.

Stock-Based Compensation

We account for share-based payments at fair value. The fair value of stock options is measured using the Black-Scholes option-pricing model and the fair value of restricted stock is measured based on the fair value of the Company Common Stock underlying the award as of the grant date, described further below. For share-based awards that vest subject to the satisfaction of a service requirement, the fair value measurement date for stock-based compensation awards is the date of grant and the expense is recognized on a straight-line basis, over the vesting period. We account for forfeitures as they occur.

Prior to the Business Combination, due to the absence of an active market for Legacy Orchestra’s common stock, Legacy Orchestra utilized methodologies, approaches, and assumptions consistent with the American Institute of Certified

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Public Accountants’ Audit and Accounting Practice Guide: Valuation of Privately-Held Company Equity Securities Issued as Compensation to estimate the fair value of its common stock. The fair value of Legacy Orchestra’s common stock was determined based upon a variety of factors, including valuations of Legacy Orchestra’s common stock performed with the assistance of independent third-party valuation specialists; Legacy Orchestra’s stage of development and business strategy, including the status of research and development efforts of its product candidates, and the material risks related to its business and industry; Legacy Orchestra’s business conditions and projections; Legacy Orchestra’s results of operations and financial position, including its levels of available capital resources; the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies; the lack of marketability of Legacy Orchestra’s common stock as a private company; the prices of Legacy Orchestra’s convertible preferred stock sold to investors in arm’s length transactions and the rights, preferences and privileges of its convertible preferred stock relative to those of its common stock; the likelihood of achieving a liquidity event for the holders of Legacy Orchestra’s common stock, such as an initial public offering or a sale of Legacy Orchestra given prevailing market conditions; trends and developments in its industry; the hiring of key personnel and the experience of management; and external market conditions affecting the life sciences and biotechnology industry sectors. Significant changes to the key assumptions underlying the factors used could result in different fair values of Legacy Orchestra’s common stock at each valuation date. In determining the exercise prices for options granted and fair value of restricted stock, we have considered the fair value of the common stock as of the grant date.

Prior to the Business Combination, valuation analyses were conducted utilizing a probability weighted expected return method, in which the probability of a public company scenario was considered via either an initial public offering or special purpose acquisition company transaction. Subsequent to the Business Combination, fair value was determined by market prices of the Company Common Stock.

We classify stock-based compensation expense in our condensed consolidated statements of operations and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified.

The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is based on the assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management.

● Expected Term — The expected term represents the period that stock-based awards are expected to be outstanding. Our historical share option exercise information is limited due to a lack of sufficient data points and does not provide a reasonable basis upon which to estimate an expected term. The expected term for option grants is therefore determined using the “simplified” method, as prescribed in the SEC’s Staff Accounting Bulletin (SAB) No. 107. The simplified method deems the expected term to be the midpoint between the vesting date and the contractual life of the stock-based awards.

● Expected Volatility — We consummated the Business Combination on January 26, 2023 and lack sufficient company-specific historical and implied volatility information. Therefore, we derived expected stock volatility using a weighted average blend of historical volatility of comparable peer public companies and our own historical volatility, over a period equivalent to the expected term of the stock-based awards.

● Risk-Free Interest Rate — The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the date of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the stock-based awards’ expected term.

● Expected Dividend Yield — The expected dividend yield is zero as neither we nor Legacy Orchestra has paid, and we do not anticipate paying, any dividends on the Company Common Stock in the foreseeable future.

● Common Stock Valuation — Prior to the Business Combination, given the absence of a public trading market for Legacy Orchestra’s common stock, Legacy Orchestra’s board of directors considered numerous subjective and objective factors to determine the best estimate of fair value of Legacy Orchestra’s common stock underlying the stock options granted to its employees and non-employees. In determining the grant date fair value of Legacy

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Orchestra’s common stock, Legacy Orchestra’s board considered, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Following the Business Combination, our board of directors determines the fair value of the Company Common Stock based on the closing price of the Company Common Stock on or around the date of grant.

During the three months ended June 30, 2025 and 2024, stock-based compensation was $3.2 million and $2.8 million, respectively. During the six months ended June 30, 2025 and 2024, stock-based compensation was $6.2 million and $5.3 million, respectively. As of June 30, 2025, we had approximately $16.8 million of total unrecognized stock-based compensation, which we expect to recognize over a weighted-average period of approximately 2.3 years.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “Summary of Significant Accounting Policies,” to the Consolidated Financial Statements.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that an emerging growth company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. We have elected not to opt out of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of our Consolidated Financial Statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

We will remain an emerging growth company until the earliest of (1) the last day of the fiscal year following the fifth anniversary of the closing of the initial public offering of HSAC2, (2) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (3) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of the Company Common Stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of our voting and non-voting Company Common Stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii)(a) our annual revenue is less than

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$100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting Company Common Stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures.

We maintain “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025, the end of the period covered by this Quarterly Report. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2025.

Changes in Internal Control Over Financial Reporting.

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitation on the Effectiveness of Internal Control.

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures, or our internal controls, will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in various claims and legal proceedings that arise in the ordinary course of our business. We are not currently a party to any material legal proceedings and are not aware of any pending or threatened legal proceeding against us that we believe would have a material adverse effect on our business, operating results or financial condition.

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Item 1A. Risk Factors.

For information regarding factors that could affect our results of operations, financial condition and liquidity, see the risk factors discussed in Part I, Item 1A in the 2024 10-K and in Item 1A in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 (the “Q1 2025 Form 10-Q”). Except as set forth in the Q1 2025 Form 10-Q, there have been no material changes to the risk factors previously disclosed in Part I, Item 1A in the 2024 10-K.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Rule 10b5-1 Trading Arrangements

During the three months ended June 30, 2025, no director or officer (as defined in Rule 16a-1(f) of the Exchange Act) informed us of the adoption or termination of a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement”, as each term is defined in Item 408(c) of Regulation S-K.

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Item 6. Exhibits.

Exhibit	Description
3.1	Certificate of Incorporation of Orchestra BioMed Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed with the SEC on January 31, 2023).
3.2	Amended and Restated Bylaws of Orchestra BioMed Holdings, Inc. (incorporated by reference to Exhibit 3.2 to the Quarterly Report on Form 10-Q filed with the SEC on August 12, 2024).
4.1+	Warrant issued to Ligand Pharmaceuticals Incorporated, dated August 4, 2025.
4.2	Form of Amendment No. 1 to Warrants between the Company and each of Hercules Capital, Inc., Hercules Capital IV, L.P., and Hercules SBIC V, L.P. (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed with the SEC on July 31, 2025).
4.3	Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on August 4, 2025)
10.1	Revenue Participation Right Purchase and Sale Agreement, by and between the Company and Ligand Pharmaceuticals Inc., dated July 31, 2025 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on July 31, 2025).
10.2	Stock Purchase Agreement, by and between the Company and Ligand Pharmaceuticals Incorporated, dated July 31, 2025 (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on July 31, 2025).
10.3	Loan Agreement, by and among the Company, Orchestra BioMed, Inc, BackBeat Medical, LLC and Medtronic Inc., dated July 31, 2025 (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed with the SEC on July 31, 2025).
10.4	Form of Secured Subordinated Promissory Note by and among the Company, Orchestra BioMed, Inc, BackBeat Medical, LLC and Medtronic Inc. (incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K filed with the SEC on July 31, 2025).
10.5	Stock Purchase Agreement, by and between the Company and Covidien Group S.à.r.l., dated July 31, 2025 (incorporated by reference to Exhibit 10.5 to the Current Report on Form 8-K filed with the SEC on July 31, 2025).
10.6+	Amendment No. 1 to Stock Purchase Agreement, by and between the Company and Covidien Group S.à.r.l., dated August 1, 2025.
10.7	Second Amendment to Loan and Security Agreement, by and among the Company and certain of its subsidiaries, the lenders named therein and Hercules Capital, Inc., dated July 31, 2025 (incorporated by reference to Exhibit 10.6 to the Current Report on Form 8-K filed with the SEC on July 31, 2025).
10.8+	Registration Rights Agreement, dated August 4, 2025, by and among the Company, Ligand Pharmaceuticals Incorporated and Covidien Group S.à.r.l.
10.9+˄	Amendment No. 1 to Exclusive License and Collaboration Agreement, dated as of August 1, 2025, by and among the Company, BackBeat Medical, LLC and Medtronic, Inc.
31.1+	Certification of Chief Executive Officer, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2+	Certification of Chief Financial Officer, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*	Certification of Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*	Certification of Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS	Inline XBRL Instance Document.
101.SCH	Inline XBRL Taxonomy Extension Schema Document.
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104	Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

+Filed herewith.

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* Furnished herewith. This exhibit shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such exhibit shall not be deemed incorporated into any filing under the Securities Act or the Exchange Act.

 ˄ Certain identified information has been omitted pursuant to Item 601(b)(10) of Regulation S-K because such information is both (i) not material and (ii) information that the Registrant treats as private or confidential. The Registrant hereby undertakes to furnish supplemental copies of the unredacted exhibit upon request by the SEC.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	ORCHESTRA BIOMED HOLDINGS, INC.
Dated: August 12, 2025	/s/ Andrew Taylor
	Andrew Taylor
	Chief Financial Officer
	(Principal Financial Officer)

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EX-4.1

Exhibit 4.1

Execution Version

NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS.

COMMON STOCK PURCHASE WARRANT

ORCHESTRA BIOMED HOLDINGS, INC.

Warrant Shares: 2,000,000	Issue Date: August 4, 2025
	Initial Exercise Date: February 4, 2026

THIS COMMON STOCK PURCHASE WARRANT (this “Warrant”) certifies that, for value received, Ligand Pharmaceuticals, Inc. or its permitted assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Initial Exercise Date and on or prior to 5:00 p.m. (New York City time) on August 4, 2035 (the “Termination Date”) but not thereafter, to subscribe for and purchase from Orchestra Biomed Holdings, Inc., a Delaware corporation (the “Company”), up to 2,000,000 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”) (as subject to adjustment hereunder, the “Warrant Shares”); provided that this Warrant may only be exercised with respect to Warrant Shares that have Vested (as defined in Section 2(d) below). The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b) below. Pursuant to the Registration Rights Agreement between the Company and the Holder, dated of even date herewith (the “RRA”), subject to the terms and conditions of the RRA, the Company expects to file a registration statement on Form S-3 (or, if Form S-3 is not available to the Company, any other form the Company is eligible to use) (as applicable, the “Registration Statement”) to register under the Securities Act of 1933, as amended (the “Securities Act”), the resale of any Warrant Shares issued to the Holder.

Section 1.Agreement. This Warrant is being issued pursuant to that certain Revenue Participation Right Purchase and Sale Agreement, dated August 4, 2025, by and between the Company and Holder (as may be amended or restated from time to time, the “Purchase and Sale Agreement”).

Section 2.Exercise.

(a)Exercise of Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial

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Exercise Date with respect to Warrant Shares that have Vested and on or before the Termination Date by delivery to the Company of a duly executed PDF copy submitted by e-mail (or e-mail attachment) of the Notice of Exercise in the form annexed hereto as Exhibit A (the “Notice of Exercise”). Unless the cashless exercise procedure specified in Section 2(e) below (if available) is specified in the applicable Notice of Exercise, within two (2) Trading Days following the date of exercise as aforesaid, the Holder shall deliver to the Company the aggregate Exercise Price for the Warrant Shares specified in the applicable Notice of Exercise by wire transfer or cashier’s check drawn on a United States bank, and the date on which such Exercise Price is delivered to the Company is an “Exercise Date,” provided that if the cashless exercise procedure specified in Section 2(e) below is specified in the applicable Notice of Exercise, the Exercise Date shall be the date the Notice of Exercise is delivered to the Company. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise be required. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased in connection with such partial exercise. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Trading Day of receipt of such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof. For purposes of this Warrant, “Trading Day” means any day on which the Common Stock is purchased and sold on the principal market on which the Common Stock is listed or quoted (the “Trading Market”).

(b)Exercise Price. The exercise price per share of Common Stock under this Warrant shall be $3.67, subject to adjustment hereunder (the “Exercise Price”).

(c)Mechanics of Exercise.

(i)Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder (the “Exercise Shares”) to be transmitted by its transfer agent to the Holder (i) by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“DWAC”) if the Company is then a participant in such system and there is an effective registration statement permitting the issuance of the Warrant Shares to the Holder and (ii) otherwise by delivering evidence of issuance of the Warrant Shares in book entry with the Company’s transfer agent, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in

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the Notice of Exercise (or, evidence of such book entry issuance to the email address specified in such Notice of Exercise) by the date that is no less than the number of Trading Days comprising the Standard Settlement Period following the Exercise Date. The Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised as of the Exercise Date, irrespective of the date such Warrant Shares are credited to the Holder’s Depository Trust Company account or the date of the book entry positions evidencing such Warrant Shares. For purposes of this Warrant, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, for the Trading Market with respect to the Common Stock that is in effect on the date of delivery of an applicable Exercise Notice, which as of the Issue Date was “T+1.”

(ii)Buy-In. In addition to any other rights available to the Holder, if the Company fails to cause the transfer agent to deliver to the Holder or its designee Exercise Shares in the manner required pursuant to Section 2(c)(i) within the Standard Settlement Period following the Exercise Date (other than a failure caused by incorrect or incomplete information provided by the Holder to the Company) and the Holder or the Holder’s broker on its behalf purchases (in an open market transaction or otherwise) shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”) but did not receive within the Standard Settlement Period, then the Company shall, within two (2) Trading Days after the Holder’s request (i) pay cash to the Holder in an amount equal to the excess (if any) of the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased in the Buy-In, less the product of (A) the number of shares of Common Stock purchased in the Buy-In, times (B) the Closing Sale Price (as defined below) of a share of Common Stock on the Exercise Date and (ii) in the Holder’s sole discretion, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or promptly honor its obligation to deliver to the Holder or its designee the Exercise Shares pursuant to Section 2(c)(i). The Holder shall provide the Company written notice promptly after the occurrence of a Buy-In, including the amounts payable to the Holder in respect of the Buy-In together with applicable confirmations and other evidence reasonably requested by the Company.

(iii)Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.

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(iv)No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the fair market value (based on the Closing Sale Price) for any such fractional shares.

(v)Charges, Taxes and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto as Exhibit B duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The Company shall pay all transfer agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.

(vi)Closing of Books. The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.

(d)Vested Warrants.

(i)The Warrant Shares shall vest as follows (upon such vesting, such Warrants Shares shall be “Vested”): (a) 1,142,857 of the Warrant Shares (the “First Tranche”) shall vest as of the Issue Date and (ii) 857,143 of the Warrant Shares (the “Second Tranche”) shall vest on the date of payment of the Second Installment (as such term is defined in the Purchase and Sale Agreement) pursuant to the terms and conditions of the Purchase and Sale Agreement.

(ii)In the event that the Second Installment is not paid, this Warrant shall only be exercisable with respect to the First Tranche.

(e)Cashless Exercise if Registration Statement Not Available. If, and only if, at the time of exercise of this Warrant the Registration Statement is not effective (or the prospectus contained therein is not available for use) for the resale of all of the Warrant Shares that can be issued pursuant to this Warrant, then the Holder may, in lieu of payment of the Exercise Price in the manner as specified in Section 2(a) above, but otherwise in

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accordance with the requirements of Section 2(a), at its option, exercise this Warrant, in whole or in part, by means of a “cashless exercise” in which the Holder shall be entitled to receive, and the Company shall issue to the Holder, such number of fully paid and non-assessable Warrant Shares determined as follows: X = Y[(A-B)/A] (“Cashless Exercise”), where:

(X)=the number of Warrant Shares to be issued to the Holder;

(A)=the Closing Sale Price (as defined below) of the shares of Common Stock (as of the Trading Day on the date immediately preceding the Exercise Date;

(B)=the Exercise Price of this Warrant, as adjusted hereunder; and

(Y)=the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise pursuant to Section 2(a) rather than a cashless exercise.

For purposes of this Warrant, “Closing Sale Price” means, for any security as of any date, the last trade price for such security on the principal Trading Market for such security, as reported by Bloomberg Financial Markets, or, if such Trading Market begins to operate on an extended hours basis and does not designate the last trade price, then the last trade price of such security prior to 4:00 P.M., New York City time, as reported by Bloomberg Financial Markets, or if the foregoing do not apply, the last trade price of such security in the over-the-counter market on the electronic bulletin board for such security as reported by Bloomberg Financial Markets. If the Closing Sale Price cannot be calculated for a security on a particular date on any of the foregoing bases, the Closing Sale Price of such security on such date shall be the fair market value as mutually determined by the Company and the Holder.

For purposes of Rule 144, it is intended, understood and acknowledged that the Warrant Shares issued in a cashless exercise transaction shall be deemed to have been acquired by the Holder, and the holding period for the Warrant Shares shall be deemed to have commenced, on the date this Warrant was originally issued (provided that the Securities and Exchange Commission (the “Commission”) continues to take the position that such treatment is proper at the time of such exercise).

If Warrant Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the holding period of the Warrant Shares being issued may be tacked on to the holding period of this Warrant. The Company agrees not to take any position contrary to this Section 2(d).

Section 3.Certain Adjustments.

(a)Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend on its Common Stock or otherwise makes a

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distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by reclassification of shares of Common Stock any shares of capital stock of the Company, then in each case the number of Warrant Shares shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately after such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately before such event. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification; provided, however, if an adjustment is made immediately after the record date for the determination of stockholders entitled to receive a dividend or distribution but such dividend or distribution is not so made, the number of Warrant Shares shall be readjusted, effective as of the date the Company’s Board of Directors determines not to make such dividend or distribution, to the number of Warrant Shares issuable upon exercise of this Warrant that would then be in effect at such time had no such adjustment been made.

(b)Rights Upon Distribution of Assets. If, on or after the Issue Date and on or prior to the Termination Date, the Company shall declare or make any dividend or other pro rata distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, stock or other securities, property, options, evidence of indebtedness or any other assets by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction, but, for the avoidance of doubt, excluding any distribution of shares of Common Stock subject to Section 3(a) and any Fundamental Transaction subject to Section 3(c) (a “Distribution”), then, in each such case, the Exercise Price shall be adjusted by multiplying the Exercise Price in effect immediately prior to the record date fixed for determination of stockholders entitled to receive such Distribution by a fraction, of which the denominator shall be the Closing Sale Price determined as of the record date, and of which the numerator shall be such Closing Sale Price on such record date less the then per share fair market value at such record date of the portion of such Distribution so distributed applicable to one outstanding share of the Common Stock as determined by the Board of Directors of the Company in good faith. The adjustment shall be described in a statement provided to the Holder. Such adjustment shall be made whenever any such Distribution is made and shall become effective immediately after the applicable record date.

(c)Fundamental Transactions. If, at any time while this Warrant is outstanding (i) the Company effects any merger or consolidation of the Company with or into another Person, in which the Company is not the surviving entity or in which the stockholders of the Company immediately prior to such merger or consolidation do not own, directly or indirectly, at least 50% of the voting power of the surviving entity immediately after such

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merger or consolidation, (ii) the Company effects any sale to another Person of all or substantially all of its assets in one or a series of related transactions, (iii) pursuant to any tender offer or exchange offer (whether by the Company or another Person), holders of capital stock tender shares representing more than 50% of the voting power of the capital stock of the Company and the Company or such other Person, as applicable, accepts such tender for payment, (iv) the Company consummates a stock purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin off or scheme of arrangement) with another Person whereby such other Person acquires more than 50% of the voting power of the capital stock of the Company (except for any such transaction in which the stockholders of the Company immediately prior to such transaction maintain, in substantially the same proportions, the voting power of such Person immediately after the transaction) or (v) the Company effects any reclassification of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property (other than as a result of a subdivision or combination of shares of Common Stock covered by Section 3(a) above) (in any such case, a “Fundamental Transaction”), then following such Fundamental Transaction the Holder shall have the right to receive, upon exercise of this Warrant, the same amount and kind of securities, cash or property as it would have been entitled to receive upon the occurrence of such Fundamental Transaction if it had been, immediately prior to such Fundamental Transaction, the holder of the number of Vested Warrant Shares then issuable upon exercise of this Warrant(the “Alternate Consideration”). The Company shall not effect any Fundamental Transaction in which the Company is not the surviving entity or the Alternate Consideration includes securities of another Person unless (i) the Alternate Consideration is solely cash and the Company provides for the simultaneous “cashless exercise” of this Warrant pursuant to Section 2(e) above or (ii) prior to or simultaneously with the consummation thereof, any successor to the Company, surviving entity or other Person (including any purchaser of assets of the Company) shall assume the obligation to deliver to the Holder such Alternate Consideration as, in accordance with the foregoing provisions, the Holder may be entitled to receive, and the other obligations under this Warrant. The provisions of this paragraph (d) shall similarly apply to subsequent transactions analogous to a Fundamental Transaction type. For purposes of this Warrant, “Person” shall mean an individual, partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated or unincorporated association, joint venture, government (or an agency or subdivision thereof) or any other entity or organization.

(d)Number of Warrant Shares. Simultaneously with any adjustment to the number of Warrant Shares pursuant to Section 3, the Exercise Price shall be increased or decreased proportionately, so that after such adjustment the aggregate Exercise Price payable hereunder for the increased or decreased number of Warrant Shares shall be the same as the aggregate Exercise Price in effect immediately prior to such adjustment. Notwithstanding the foregoing, in no event may the Exercise Price be adjusted below the par value of the Common Stock then in effect.

(e)Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding as

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of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.

(f)Notice to Holder.

(i)Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by e-mail a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

(ii)Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize any Distribution, (D) the approval of any stockholders of the Company shall be required in connection with any reclassification of the Common Stock, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property or any Fundamental Transaction, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by e-mail to the Holder at its last e-mail address as it shall appear upon the Warrant Register of the Company, at least 20 calendar days prior to the applicable record or effective date hereinafter specified, a notice of such transaction in order to enable the Holder to participate in or vote with respect to such transaction; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. To the extent that any notice provided in this Warrant constitutes, or contains, material, non-public information regarding the Company or any of its subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

Section 4.Representations and Covenants of the Holder. This Warrant has been entered into by the Company in reliance upon the following representations and covenants of the Holder:

(a)Investment Purpose. This Warrant and the Warrant Shares are being acquired for investment and not with a view to the sale or distribution of any part thereof, and the Holder has no present intention of selling or engaging in any public distribution of

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the same except pursuant to a registration under the Securities Act or an exemption from the registration requirements of the Securities Act. Holder is not a registered broker-dealer under Section 15 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or an entity engaged in a business that would require it to be so registered as a broker-dealer.

(b)Private Issue. The Holder understands (i) that the Warrant Shares are not registered under the Securities Act or qualified under applicable state securities laws on the ground that the issuance contemplated by this Warrant will be exempt from the registration and qualifications requirements thereof, and (ii) that the Company’s reliance on such exemption is predicated on the representations set forth in this Section 4.

(c)Risk of No Registration. Without in any way limiting the Company’s obligations under this Warrant, the Holder understands that if the Common Stock is not registered with the Commission pursuant to Section 12 of the Exchange Act or the Company is not required to file reports pursuant to Section 13(a) or Section 15(d) of the Exchange Act, or if a registration statement is not effective under the Securities Act covering the resale of the Warrant Shares when it desires to sell (i) the rights to purchase Common Stock pursuant to this Warrant or (ii) the Warrant Shares, as applicable, it may be required to hold such securities for an indefinite period. The Holder also understands that any sale of (A) its rights hereunder to purchase Warrant Shares or (B) Warrant Shares which might be made by it in reliance upon Rule 144 under the Securities Act may be made only in accordance with the terms and conditions of that Rule.

(d)Restricted Securities. The Holder understands that this Warrant and the Warrant Shares issuable upon exercise hereof have not been registered under the Securities Act or registered or qualified under the securities laws of any state, and are issued in reliance upon specific exemptions therefrom, which exemptions depend upon, among other things, the bona fide nature of the Holder’s investment intent as expressed herein. The Holder understands that the Company is under no obligation to so register or qualify this Warrant or the Warrant Shares, except to the extent provided in the RRA. The Holder understands that this Warrant and any Warrant Shares issued upon any exercise hereof are “restricted securities” within the meaning of Rule 144 promulgated under the Securities Act and must be held indefinitely unless subsequently registered under the Securities Act and registered or qualified under applicable state securities laws, unless exemptions from such registration and qualification are otherwise available.

(e)Accredited Investor. The Holder is, and on each date on which it exercises any portion of this Warrant it will be, an “accredited investor” as defined in Regulation D promulgated under the Securities Act.

Section 5.Transfer of Warrant.

(a)Transferability. This Warrant and the Warrant Shares issued upon exercise hereof may not be transferred or assigned in whole or in part except in compliance with applicable federal and state securities laws by the transferor and the transferee (including, without limitation, the delivery of investment representation letters and legal opinions

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reasonably satisfactory to the Company or its transfer agent, as reasonably requested by the Company or such transfer agent). Subject to the immediately preceding sentence, the Holder may transfer all or part of this Warrant or the Warrant Shares to any transferee; provided, that in connection with any such transfer of this Warrant, Holder will give the Company notice of the portion of the Warrant being transferred, with the name, address and taxpayer identification number of the transferee in accordance with Exhibit B hereto, and the Holder will surrender this Warrant to the Company for reissuance to the transferee(s) (and to the Holder if applicable); and provided further, that any transferee of this Warrant shall make substantially the representations set forth in Section 4 above and shall agree in writing with the Company to be bound by all of the terms and conditions of this Warrant.

(b)New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 5(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the Issue Date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.

(c)Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

(d)Removal of Legends. In connection with any sale or other transfer of Warrant Shares that complies with all applicable securities laws, and subject to the Company’s receipt from the Holder of customary representations and other documentation reasonably acceptable to the Company, the Company shall, within the Standard Settlement Period following any request therefor from the Holder, (A) deliver to the transfer agent irrevocable instructions that the transfer agent shall make a new, unlegended entry for such book entry position Warrant Shares and (B) cause its counsel to deliver to the transfer agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the Securities Act if required by the transfer agent to effect the removal of the legends in accordance with the provisions hereof. The Company shall be responsible for the fees of its transfer agent.

Section 6.Miscellaneous.

(a)No Rights as Stockholder Until Exercise; No Settlement in Cash. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(c). Without limiting the rights of a Holder to receive Warrant Shares on a Cashless Exercise, and to

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receive the cash payments contemplated pursuant to Section 2(c)(iv), in no event will the Company be required to net cash settle an exercise of this Warrant.

(b)Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.

(c)Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Trading Day, then, such action may be taken or such right may be exercised on the next succeeding Trading Day.

(d)Authorized Shares.

The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue).

Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise

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immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.

Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.

(e)Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be governed by and construed and enforced in accordance with the laws of the State of New York, without giving effect to conflict of laws principles thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Warrant (whether brought against a party hereto or their respective affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be brought and enforced in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, State of New York for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Warrant and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If either party shall commence an action, suit or proceeding to enforce any provisions of this Warrant, the prevailing party in such action, suit or proceeding shall be reimbursed by the other party for their reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.

(f)Waiver of Jury Trial. Each party acknowledges and agrees that any controversy which may arise under this Warrant is likely to involve complicated and difficult issues and, therefore, each such party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Warrant or the transactions contemplated hereby.

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(g)Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant will have restrictions upon resale imposed by state and federal securities laws.

(h)Nonwaiver. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies.

(i)Notices. Any and all notices or other communications or deliveries to be provided by the Holder hereunder including, without limitation, any Notice of Exercise, shall be in writing and delivered personally, by e-mail, or sent by a nationally recognized overnight courier service, addressed to the Company, at Orchestra Biomed Holdings, Inc., 150 Union Square Drive, New Hope, Pennsylvania 18938, Attention: Chief Financial Officer, e-mail address: ataylor@orchestrabiomed.com, or such other number, e-mail address or address as the Company may specify for such purposes by written notice to the Holder. Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by e-mail, or sent by a nationally recognized overnight courier service addressed to the Holder at the e-mail address or address of such Holder appearing on the signature page to this Warrant or to such other address as the Holder may designate for itself by notice given in accordance with this Section 6(i). Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the time of transmission, if such notice or communication is delivered via e-mail at the e-mail address set forth in this Section 6(i) prior to 5:30 p.m. (New York City time) on any date, (ii) the next Trading Day after the time of transmission, if such notice or communication is delivered via e-mail at the e-mail address set forth in this Section 6(i) on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given.

(j)Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

(k)Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.

(l)Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and

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permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.

(m)Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company, on the one hand, and the Holder, on the other hand.

(n)Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.

(o)Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

********************

(Signature Page Follows)

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IN WITNESS WHEREOF, the parties hereto have caused this Warrant to be executed by their respective officers thereunto duly authorized as of the date first above indicated.

ORCHESTRA BIOMED HOLDINGS, INC.
By:	/s/ Andrew Taylor
Name:	Andrew Taylor
Title:	Chief Financial Officer
HOLDER
LIGAND PHARMACEUTICALS, INC.
By:	/s/ Todd C. Davis
Name:	Todd C. Davis
Title:	Chief Executive Officer
Address of Holder:
Ligand Pharmaceuticals Inc.
555 Heritage Drive, Suite 200
Jupiter, Florida 33458
Attention: Paul Hadden; Andrew Reardon
Email of Holder: [Omitted Pursuant to Item 601(a)(6)];
[Omitted Pursuant to Item 601(a)(6)]

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EXHIBIT A

NOTICE OF EXERCISE

TO:ORCHESTRA BIOMED HOLDINGS, INC.

(1)The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant, and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.

(2)Payment shall take the form of (check applicable box):

☐in lawful money of the United States; or

☐the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in Section 2(d) of the Warrant, to exercise the Warrant with respect to the cashless exercise procedure set forth in Section 2(d) of the Warrant.

(3)Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

The Warrant Shares (or the direct registration statement with respect to the Warrant Shares) shall be delivered to the following [DWAC Account Number][address and email]:

(4)The undersigned is an “accredited investor” as defined in Regulation D promulgated under the Securities Act of 1933, as amended.

HOLDER

Signature of Authorized Signatory of Holder:

Name of Authorized Signatory:

Title of Authorized Signatory:

Date:

EXHIBIT B

ASSIGNMENT FORM

(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.)

FOR VALUE RECEIVED, the certain Warrant, dated August [·], 2025, issued by the Company to the Holder, and all rights evidenced thereby [with respect to [·] Warrant Shares] are hereby assigned to

Name:
		(Please Print)
Address:
		(Please Print)
Taxpayer Identification Number
Phone Number:
Email Address:
Dated:	,
Holder’s Signature:
Holder’s Address:

EX-10.6

Exhibit 10.6

Execution Version

AMENDMENT TO STOCK PURCHASE AGREEMENT

This Amendment to Stock Purchase Agreement (this “Amendment”) is made and entered into as of August 1, 2025 by and between Orchestra BioMed Holdings, Inc., a Delaware corporation (the “Issuer”) and Covidien Group S.à.r.l., a private limited liability company (société à responsabilité limitée), incorporated under the laws of the Grand Duchy of Luxembourg (the “Investor”).

RECITALS

WHEREAS, the Issuer and Investor are parties to that certain Stock Purchase Agreement, dated as of July 31, 2025 (the “Stock Purchase Agreement”);

WHEREAS, pursuant to Section 6.5 of the Stock Purchase Agreement, the Stock Purchase Agreement may be amended by written instrument executed by the Issuer and Investor; and

WHEREAS, the Issuer and Investor wish to amend the terms of the Stock Purchase Agreement pursuant to the terms of this Amendment.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and by their signatures to this Amendment, the Issuer and Investor hereby amend the Stock Purchase Agreement in the following manner:

1.Definitions.  Unless otherwise indicated herein, words and terms which are defined in the Stock Purchase Agreement shall have the same meaning where used in this Amendment.

2.Amendments to the Stock Purchase Agreement.

(a)The second WHEREAS clause of the Stock Purchase Agreement shall be amended and restated in its entirety as follows:

“WHEREAS, the Investor, wishes to purchase, and the Issuer wishes to issue and sell, upon the terms and conditions stated in this Agreement, an aggregate of up to $12,000,000 of shares of the Issuer’s common stock, par value $0.0001 per share (“Common Stock”), consisting of (i) $10,000,000 of shares of Common Stock (the “Initial Shares”) and (ii) additional shares of Common Stock (the “Additional Shares” and, together with the Initial Shares, the “Shares”) up to $2,000,000, at a purchase price per share at which the Common Stock is sold to the public in the Issuer’s next underwritten public offering of its Common Stock and pre-funded warrants pursuant to an effective registration statement under the Securities Act (the “Subsequent Offering”), as set forth on the cover page of the prospectus filed in connection with the Subsequent Offering, and such purchase will occur immediately following and shall be conditioned upon, the closing of the Subsequent Offering (the “Closing”);”.

(b)Section 1.2 of the Stock Purchase Agreement shall be amended and restated in its entirety as follows:

“1.2Additional Shares. Subject to the terms and conditions of this Agreement, the Investor agrees to purchase such dollar amount of Additional Shares on a proportional basis equal to 0.06061 multiplied by the amount of gross proceeds raised in the Subsequent Offering in excess of $20,000,000, up to a cap of $2,000,000.”

3.Continued Validity of Stock Purchase Agreement.  Each of the parties to this Amendment hereby (i) affirms the terms of the Stock Purchase Agreement as modified by this Amendment, and (ii) agrees that the terms and conditions of the Stock Purchase Agreement as modified by this Amendment shall continue in full force and effect.  Any reference to the Stock Purchase Agreement contained in any notice, request or other document executed concurrently with or after the execution and delivery of this Amendment shall be deemed to refer to the Stock Purchase Agreement as modified by this Amendment unless the context shall otherwise require.

4.Governing Law.  THIS AMENDMENT AND THE RIGHTS AND OBLIGATIONS OF THE PARTIES UNDER THIS AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUED AND INTERPRETED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK, WITHOUT REGARD TO PRINCIPLES OF CONFLICTS OF LAW. EACH OF THE PARTIES HERETO IRREVOCABLY AND UNCONDITIONALLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK OR, IF SUCH COURT WILL NOT ACCEPT JURISDICTION, THE SUPREME COURT OF THE STATE OF NEW YORK OR ANY COURT OF COMPETENT CIVIL JURISDICTION SITTING IN NEW YORK COUNTY, NEW YORK FOR THE PURPOSE OF ANY ACTION OR JUDGMENT RELATING TO OR ARISING OUT OF THIS AMEDMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY AND TO THE LAYING OF VENUE IN SUCH COURT. EACH OF THE PARTIES HEREBY WAIVES THE DEFENSE OF AN INCONVENIENT FORUM TO THE MAINTENANCE OF ANY SUCH ACTION OR PROCEEDING IN SAID COURTS.

5.Waiver of Trial by Jury. TO THE EXTENT PERMITTED BY APPLICABLE LAW, EACH PARTY HERETO IRREVOCABLY WAIVES ALL RIGHT OF TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM, ARISING OUT OF OR IN CONNECTION WITH THIS AMENDMENT OR ANY MATTER ARISING HEREUNDER.

6.Counterparts. This Amendment may be executed in any number of counterparts, each of which shall be deemed an original, but all such counterparts shall together constitute but one and the same instrument. Electronic signatures complying with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other applicable law will be deemed original signatures for purposes of this Amendment.

[Signature Page Follows]

IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the date first above written.

ORCHESTRA BIOMED HOLDINGS INC.
By:	/s/ David P. Hochman
	Name:	David P. Hochman
	Title:	CEO
COVIDIEN GROUP S.À.R.L.
By:	/s/ Chris Eso
	Name:	Chris Eso
	Title:	VP, Corporate
	Development & Ventures

[Signature Page to Amendment to Stock Purchase Agreement]

EX-10.8

Exhibit 10.8

REGISTRATION RIGHTS AGREEMENT

THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of August 4, 2025, is entered into by and among Orchestra BioMed Holdings, Inc., a Delaware corporation (the “Company”), and the investors listed on the signature pages hereto (each, an “Investor” and collectively, the “Investors”). Certain capitalized terms used herein and not otherwise defined have the meaning given to them in Section 9(a) hereof.

W I T N E S S E T H:

WHEREAS, in connection with:

● the Revenue Participation Right Purchase and Sale Agreement, dated as of July 31, 2025 (the “Purchase and Sale Agreement”), by and among the Company and Ligand Pharmaceuticals Incorporated, a Delaware corporation (“Ligand”), the Company has agreed, upon the terms and subject to the conditions of the Purchase and Sale Agreement, to issue and deliver to Ligand a warrants (the “Warrants”) to purchase shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock” and such shares of Common Stock, the “Warrant Shares”);

● the Stock Purchase Agreement, dated as of July 31, 2025, by and between the Company and Ligand (the “Ligand Stock Purchase Agreement”), pursuant to which, Ligand agreed to purchase from the Company and the Company agreed to sell to Ligand, $5,000,000 of Common Stock (the “Ligand PIPE Shares”), subject to the terms and conditions of the Ligand Stock Purchase Agreement; and

● the Stock Purchase Agreement, dated as of July 31, 2025, by and between the Company and Covidien Group S.à.r.l. (“Medtronic”), a private limited liability company (société à responsabilité limitée), incorporated under the laws of the Grand Duchy of Luxembourg (the “Medtronic Stock Purchase Agreement” and, together with the Ligand Stock Purchase Agreement, the “Stock Purchase Agreements”), pursuant to which, Medtronic agreed to purchase from the Company and the Company agreed to sell to Medtronic, up to $12,000,000 of Common Stock (the “Medtronic PIPE Shares” and, together with the Ligand PIPE Shares, the “PIPE Shares”), subject to the terms and conditions of the Medtronic Stock Purchase Agreement.

WHEREAS, the Investors have requested, and the Company has agreed to provide, certain rights with respect to the registration of the resale of the Warrant Shares and the PIPE Shares, subject to the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained, the parties hereto hereby agree as follows:

Section 1.Shelf Registration.

(a)On or prior to the Filing Deadline, the Company shall prepare and file with the SEC a registration statement under the Securities Act covering the resale of all of the Registrable Securities for an offering to be made on a continuous basis pursuant to Rule 415 on Form S-3 (or any successor short form registration statement available for such resale that permits incorporation by reference at least to the same extent as such form) (“Form S-3”) or, if Form S-3 is not then available to the Company, on such form of registration statement as is then available to effect a registration for resale of the Registrable Securities

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(together with the Form S-3, the “Registration Statement”). The Registration Statement shall contain (except if otherwise required pursuant to written comments received from the SEC upon a review of such Registration Statement) a “Plan of Distribution” in substantially the form attached hereto as Exhibit A and a “Selling Stockholder” section in substantially the form attached hereto as Exhibit B; provided, however, that no Investor shall be named as an “underwriter” in the Registration Statement without such Investor’s prior written consent, except that an Investor may be named as a “statutory underwriter” if such Investor is, or is affiliated with, a broker-dealer and states such fact in its Selling Stockholder Questionnaire. The Registration Statement also shall cover, to the extent allowable under the Securities Act and the rules promulgated thereunder (including Rule 416), such indeterminate number of additional shares of Common Stock resulting from stock splits, stock dividends or similar transactions with respect to the Registrable Securities registered under such Registration Statement. Such Registration Statement shall not include any shares of Common Stock or other securities for the account of any other holder of securities of the Company without the prior written consent of the Investors.

(b)The Company shall use its commercially reasonable efforts to cause the Registration Statement to be declared effective after its filing at the earliest possible date, but no later than the earlier of (i) the one hundred and eightieth (180^th) calendar day following the issuance of the PIPE Shares, if the SEC notifies the Company that it will “review” the Registration Statement and (ii) the fifth (5^th) Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that the Registration Statement will not be “reviewed” or will be subject to no further review. Subject to Section 8, the Company shall use its commercially reasonable efforts to keep the  Registration Statement effective under the Securities Act until the date as of which there are no longer any Registrable Securities  registered thereunder (the “Effectiveness Period”). The Company shall promptly, and in any event within 24 hours, notify the Investors of the effectiveness of each Registration Statement and shall promptly, and in no event later than the second Business Day after the Company receives notice of the effectiveness of each Registration Statement, file a final prospectus with the SEC, as required by Rule 424(b).

(c)Subject to Section 8, in the event that Form S-3 is not available for the registration of the resale of Registrable Securities hereunder, the Company shall (i) register the resale of the Registrable Securities on another appropriate form and (ii) undertake to register the Registrable Securities on Form S-3 promptly after such form is available, provided, that the Company shall maintain the effectiveness of the registration statement then in effect until such time as a registration statement on Form S-3 covering the Registrable Securities has been declared effective by the SEC.

(d)In the event that the Registration Statement ceases to be effective for any reason at any time (other than because all Registrable Securities registered thereunder shall have been sold pursuant thereto or shall have otherwise ceased to be Registrable Securities), the Company shall, subject to Section 8, use its reasonable best efforts to obtain the prompt withdrawal of any order suspending the effectiveness thereof or file a subsequent Registration Statement covering all of the securities that, as of the date of such filing or designation, are Registrable Securities.

(e)If a Registration Statement is then effective, subject to Section 3, an Investor may sell Registrable Securities available for sale by it pursuant to such Registration Statement, and the Company shall pay all Registration Expenses in connection therewith (other than discounts and commissions payable in connection with the sale of such Investor’s securities thereunder).

(f)Notwithstanding anything to the contrary contained herein, Ligand’s sole recourse against the Company for failing to have the Registration Statement available for the resale of the Warrant Shares is to exercise the Warrants by Cashless Exercise (as such term is defined in the Warrants), and the Company shall have no liability to Ligand for failing to have the Registration Statement available for the resale of the Warrant Shares.

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Section 2.Registration Procedures; Commercially Reasonable Efforts.  In connection with any registration contemplated hereunder, the Company shall:

(a)At least ten (10) Business Days before filing the Registration Statement pursuant to Section 1 hereof, the Company will furnish to the Investors notice of the proposed filing date of such Registration Statement (the “Proposed Filing Date”) and a copy of a draft of the Registration Statement.  Each Investor shall review and approve the Selling Stockholder and Plan of Distribution sections of the Registration Statement, which approval shall not be unreasonably withheld or delayed. Any objections to the draft Registration Statement must be lodged within two (2) Business Days of such Investor’s receipt thereof. The Company shall (a) use commercially reasonable efforts to address the comments of each Investor or its counsel reasonably proposed by the Investor, and (b) not file the Registration Statement containing information regarding an Investor to which such Investor reasonably objects, unless management of the Company, after consulting with Company counsel, determines, in its sole discretion, such information is required to comply with any applicable law or regulation. Other than any Investor that indicates to the Company in writing that it does not wish to be named as a “selling stockholder” in such Registration Statement, each Investor agrees to furnish to the Company a completed questionnaire in the form attached hereto as Exhibit C (a “Selling Stockholder Questionnaire”) on a date that is not less than five (5) Business Days prior to the Proposed Filing Date;

(b)Notify immediately the Investors of any stop order threatened or issued by the SEC and take all actions reasonably required to prevent the entry of a stop order or if entered to have it rescinded or otherwise removed;

(c)Use its commercially reasonable best efforts to prepare and file with the SEC such amendments and supplements to the Registration Statement necessary to keep the Registration Statement effective under the Securities Act for the Effectiveness Period and comply with the provisions of the Securities Act with respect to the disposition of all securities covered by the Registration Statement during each period in accordance with the Investors’ intended methods of disposition as set forth in the Registration Statement; provided, that least three (3) Business Days before filing any such amendments or supplements to the Registration Statement, the Company will furnish to the Investors notice of the proposed filing date of such amendment or supplement and a copy of a draft of such amendment or supplement to the Registration Statement for review by the Investors. The Company shall (a) use commercially reasonable efforts to address the comments of the Investors or their counsel reasonably proposed by the Investors, and (b) not file any amendment or supplement to the Registration Statement containing information regarding an Investor to which such Investor reasonably objects, unless management of the Company, after consulting with Company counsel, determines, in its sole discretion, such information is required to comply with any applicable law or regulation;

(d)Furnish to the Investors a sufficient number of copies of the Registration Statement and such other documents as each Investor may reasonably request to facilitate the disposition of its Registrable Securities; provided, that the Company shall have no obligation to provide any document pursuant to this clause that is available on the EDGAR system;

(e)Use its commercially reasonable efforts to register or qualify the Registrable Securities subject to registration under securities or blue sky laws of jurisdictions in the United States of America as any Investor requests and will do any and all other acts and things that may be necessary or advisable to enable such Investor to consummate the disposition of its Registrable Securities; provided that the Company shall not be required to qualify to do business or to file a general consent to service of process in any such jurisdictions, unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities Act;

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(f)Use its commercially reasonable efforts to cause the Registrable Securities covered by the Registration Statement to be registered with or approved by those governmental agencies or authorities necessary to enable the Investors to consummate the disposition of its Registrable Securities;

(g)Promptly (but in no event later than 24 hours) notify the Investors, at any time when a prospectus is required to be delivered under the Securities Act, of any event as a result of which the prospectus or any document incorporated therein by reference contains an untrue statement of a material fact or omits to state any material fact necessary to make the statements therein not misleading, and will promptly prepare a supplement or amendment to the prospectus or any such document incorporated therein by reference so that thereafter the prospectus will not contain an untrue statement of a material fact or omit to state any material fact necessary to make the statements therein not misleading;

(h)Use its commercially reasonable efforts to cause all Registrable Securities to be listed on the same securities exchange, with the same CUSIP, and with the same transfer agent, as similar securities issued by the Company are then listed; and

Section 3.Suspension Period.

(a)The Company may suspend the use of a prospectus that is part of a Registration Statement for up to an aggregate sixty (60) days on no more than two (2) occasions in any given twelve (12)-month period, and therefore suspend sales of Registrable Securities available for sale pursuant to such Registration Statement (such period, the “Suspension Period”) by providing written notice to the Investors if the Company’s board of directors determines in its reasonable good faith judgment that such suspension is in the best interests of the Company.

(b)In the case of an event that causes the Company to suspend the use of a Registration Statement as set forth in Section 3(a) above (a “Suspension Event”), the Company shall promptly (but in no event later than 24 hours) give a written notice to the Investors (a “Suspension Notice”) to suspend sales of the Registrable Securities (but shall not contain any material non-public information concerning the Company) and that such suspension shall continue only for so long as the Suspension Event is continuing. An Investor shall not effect any sales of the Registrable Securities pursuant to such Registration Statement (or such filings) at any time after it has received a Suspension Notice from the Company and prior to receipt of an End of Suspension Notice (as defined below). Each Investor agrees that such Investor shall treat as confidential the receipt of the Suspension Notice and shall not disclose the information contained in such Suspension Notice without the prior written consent of the Company until such time as the information contained therein is or becomes available to the public generally, other than as a result of disclosure by such Investor in breach of the terms of this Agreement; provided, that the foregoing will not prohibit the Investor from trading in the Registrable Securities solely by virtue of having received a Suspension Notice and the information contained therein.  An Investor may recommence effecting sales of the Registrable Securities pursuant to the Registration Statement (or such filings) following further written notice to such effect (an “End of Suspension Notice”) from the Company, which End of Suspension Notice shall be given by the Company to the Investor promptly (but in no event later than 24 hours) following the conclusion of any Suspension Event.

Section 4.Registration Expenses.  All expenses incident to the Company’s performance of or compliance with this Agreement, including, without limitation, all registration, qualification and filing fees, fees and expenses of compliance with securities or blue sky laws, printing expenses, messenger and delivery expenses, fees and disbursements of custodians, and fees and disbursements of counsel for the Company and all independent certified public accountants  and other persons retained by the Company (all such expenses being herein called “Registration Expenses”) shall be borne by the Company. The Investors shall

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be responsible for the payment of all discounts and commissions incurred in connection with sales of Registrable Securities.

Section 5.Obligations of the Investors.

(a)From time to time, the Company may require each Investor to furnish to the Company information regarding the distribution of the Registrable Securities held by it, as shall be reasonably required to effect the registration of such Registrable Securities.

(b)The Investors, by such Investors’ acceptance of the Registrable Securities, agrees to cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of any Registration Statement hereunder.

(c)Each Investor agrees that, upon receipt of a Suspension Notice pursuant to Section 3(b), such Investor will immediately discontinue disposition of Registrable Securities pursuant to any Registration Statement(s) covering such Registrable Securities until such Investor’s receipt of the End of Suspension Notice.

(d)Each Investor covenants and agrees that it will comply with the prospectus delivery requirements of the Securities Act as applicable to it or an exemption therefrom in connection with sales of Registrable Securities pursuant to the Registration Statement.

(e)Each Investor agrees that, upon receipt of any written notice from the Company of any event as a result of which the prospectus or any document incorporated therein by reference contains an untrue statement of material fact or omits to state any material fact necessary to make the statements therein not misleading, such Investor will discontinue the distribution of Registrable Securities pursuant to any such prospectus until such Investor receives copies of a supplemented or amended prospectus from the Company. In addition, if the Company requests in writing, each Investor will deliver to the Company (at the Company’s expense) all copies, other than permanent file copies then in its possession, of the prospectus covering the Registrable Securities current at the time of receipt of the notice. Each Investor agrees not to use any free writing prospectus unless consented to by the Company.

Section 6.Indemnification.

(a)To the full extent permitted by law, the Company agrees to indemnify and hold harmless each Investor, its officers, directors, members, employees, agents, and each person who controls such Investor (within the meaning of the Securities Act and the Exchange Act) against all losses, claims, damages, liabilities, and expenses to which any of such persons may become subject in connection with any claims arising out of or resulting from any untrue or allegedly untrue statement of material fact contained in any Registration Statement, prospectus, preliminary prospectus, final prospectus or any amendment or supplement thereof, or any omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading or any violation or alleged violation by the Company of the Securities Act, the Exchange Act or any rule or regulation thereunder applicable to the Company and relating to the action or inaction of the Company in connection with any registration, qualification or compliance, except to the extent the untrue statement or omission resulted from information that such Investor furnished in writing to the Company specifically for use in such Registration Statement or prospectus and was reviewed and approved in writing by such Investor; or any violation or alleged violation by the Company of any of the Securities Act or the Exchange Act or any applicable state securities laws, or any rules promulgated under any such acts or laws; provided, however, that the Company shall not be liable to any Investor in any such case to the extent that such loss, claim, damage, liability or expense is related to the use by an Investor of an outdated or defective prospectus after such party has received written

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notice from the Company that such prospectus is outdated or defective. As to any person entitled to indemnity under this Section 6(a), such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such person and shall survive the transfer of the Registrable Securities by an Investor.

(b)Each Investor will furnish to the Company in writing the information that the Company reasonably requests for use in connection with any Registration Statement or prospectus and such Investor agrees to indemnify, to the fullest extent permitted by law, the Company, its directors and officers, and each person who controls the Company (within the meaning of the Securities Act and the Exchange Act) against all losses, claims, damages, liabilities and expenses to which any of such persons may become subject under the Securities Act or the Exchange Act resulting from any untrue or allegedly untrue statement of material fact contained in any Registration Statement, prospectus, preliminary prospectus, final prospectus or any amendment or supplement thereof, or any omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, but only to the extent that the untrue statement or omission results from a statement contained in or omitted from any information such Investor furnished in writing to the Company through an instrument duly executed by such Investor specifically stating that it is for use in the preparation of such Registration Statement, prospectus or preliminary prospectus and was reviewed and approved in writing by such Investor, it being understood that Exhibit A hereto and the Selling Stockholder Questionnaire have been approved for such purpose; provided, however, that the obligations of any Investor hereunder shall be limited to an amount equal to the net proceeds actually received by such Investor from the sale of securities pursuant to the Registration Statement as contemplated herein; provided, further, however, that the obligations of an Investor shall not apply to amounts paid in settlement of any claim if such settlement is effected without the prior written consent of such Investor, which consent shall not be unreasonably withheld, conditioned or delayed. As to any person entitled to indemnity under this Section 6(b), such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such person.

(c)Any person entitled to indemnification under this Section 6 will (x) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification  (provided, that the failure to give prompt notice shall not impair any person’s or entity’s right to indemnification hereunder to the extent such failure has not materially prejudiced the indemnifying party) and (y) unless in the indemnifying party’s reasonable judgment a conflict of interest may exist between the indemnified and indemnifying parties with respect to the claim, permit the indemnifying party to assume the defense of the claim with counsel reasonably satisfactory to the indemnified party. The indemnifying party will not be liable for any settlement made without its written consent, which consent shall not be unreasonably withheld, conditioned or delayed. No indemnifying party will consent to entry of any judgment or will enter into any settlement that does not include as an unconditional term the claimant’s or plaintiffs release of the indemnified party from all liability concerning the claim or litigation. An indemnifying party who is not entitled to or elects not to assume the defense of a claim will not be obligated to pay the fees and expenses of more than one counsel for all parties indemnified by the indemnifying party with respect to the claim. Each indemnified party shall furnish such information regarding itself or the claim in question as an indemnifying party may reasonably request in writing and as shall be reasonably required in connection with defense of such claim and litigation resulting therefrom.

(d)If for any reason the indemnification provided for in the preceding paragraphs (a) and (b) is unavailable to an indemnified party or insufficient to hold it harmless, other than as expressly specified therein, then the indemnifying party shall contribute to the amount paid or payable by the indemnified party as a result of such loss, claim, damage or liability in such proportion as is appropriate to reflect the relative fault of the indemnified party and the indemnifying party, as well as any other relevant equitable considerations; provided, however, that an Investor will not be required to contribute any amount in excess of the net proceeds actually received by such Investor from the sale of securities pursuant to the Registration

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Statement as contemplated herein. The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact was made by, or relates to information supplied by, the indemnifying party or the indemnified party, and the indemnifying party’s or the indemnified party’s relative intent, knowledge, access to information and opportunity to correct or prevent such action. The amount paid or payable by a party as a result of the losses, claims, damages, liabilities and expenses referred to above shall be deemed to include, subject to the limitations set forth in this Agreement, any legal or other fees, charges or expenses reasonably incurred by such party in connection with any investigation or proceeding. The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 6(d) were determined by pro rata allocation or by any other method of allocation which does not take account of the equitable considerations referred to in this Section 6(d). No person or entity guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any person or entity who was not guilty of such fraudulent misrepresentation.

Section 7.Rule 144; Company Obligations.  With a view to making available to the Investors the benefits of Rule 144 promulgated under the Securities Act or any other similar rule or regulation of the SEC that may at any time permit the Investors to sell securities of the Company to the public without registration, the Company agrees to use reasonable best efforts, during the Effectiveness Period to:

(a)Make and keep public information available, as those terms are understood and defined in Rule 144;

(b)File with the SEC in a timely manner (without giving effect to any extensions pursuant to Rule 12b-25 under the Exchange Act) all reports and other documents required of the Company under the Exchange Act so long as the Company remains subject to such requirements and the filing of such reports and other documents is required for the applicable provisions of Rule 144; and

(c)So long as an Investor owns Registrable Securities, promptly upon request, furnish to such Investor (i) a written statement by the Company that it has complied with the reporting requirements of the Exchange Act as required for applicable provisions of Rule 144, (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company and (iii) such other information as may be reasonably requested to permit such Investor to sell such Registrable Securities pursuant to Rule 144 without registration; provided, however, that the Company shall have no obligation to provide any document pursuant to this Section 7(c) that is available on the EDGAR system.

(d)Subject to the limitations contained herein, the Company shall use commercially reasonable efforts to facilitate the disposition by the Investors of the Registrable Securities pursuant to the Registration Statement.

Section 8.[Reserved.]

Section 9.Interpretation of this Agreement.

(a)Terms Defined.  As used in this Agreement, the following terms have the respective meaning set forth below:

“Agreement” is defined in the recitals.

“Business Day” shall mean any day other than a Saturday, a Sunday or a day on which commercial banks in New York City are required or authorized to be closed, on which the SEC is open and accepts

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filings, provided that any reference to “days” (unless Business Days are specified) shall mean calendar days.

“Closing Date” shall have the meaning set forth in the Purchase and Sale Agreement.

“Common Stock” is defined in the recitals.

“Company” is defined in the recitals.

“Effectiveness Period” is defined in Section 1(b).

“End of Suspension Notice” is defined in Section 3(b).

“Exchange Act” shall mean the Securities Exchange Act of 1934, as amended.

“Filing Deadline” shall mean ninety (90) days after issuance of the PIPE Shares.

“Form S-3” is defined in Section 1(a).

“Ligand” is defined in the recitals.

“Ligand PIPE Shares” is defined in the recitals.

“Ligand Stock Purchase Agreement” is defined in the recitals.

“Medtronic PIPE Shares” is defined in the recitals.

“Medtronic Stock Purchase Agreement” is defined in the recitals.

“Investor” and “Investors” are defined in the recitals.

“Permitted Transferee” shall mean, in the event of a transfer or assignment of Registrable Securities by an Investor to such Permitted Transferee, (i) an affiliate, nominee, subsidiary, parent, partner, limited partner, retired partner, member, retired member, shareholder or related party of the Investor; or (ii) after such assignment or transfer, the Permitted Transferee holds all of such assignor or transferor’s shares and rights to shares of Registrable Securities  (subject to appropriate adjustment for stock splits, stock dividends, combinations and other recapitalizations).

“Person” shall mean an individual, a limited liability company, a partnership, a joint venture, a corporation, a trust, an unincorporated organization and a government or any department or agency thereof.

“PIPE Shares” is defined in the recitials.

“Proposed Filing Date” is defined in Section 2(a).

“Purchase and Sale Agreement” is defined in the recitals.

“register,” “registered” and “registration” refer to a registration effected by preparing and filing one or more Registration Statements in compliance with the Securities Act and pursuant to Rule 415 and the declaration or ordering of effectiveness of such Registration Statement(s) by the SEC.

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“Registrable Securities” shall mean (i) the Warrant Shares, (ii) the PIPE Shares and (ii) any other securities of the Company (or any successor or assign of the Company, whether by merger, reorganization, consolidation, sale of assets or otherwise) which may be issued, issuable, with respect to, in exchange for, or in substitution of, Registrable Securities referenced in the foregoing clauses (i) and (ii) by reason of any dividend, distribution or Common Stock split, combination of shares of Common Stock, merger, consolidation, recapitalization, reclassification, reorganization, sale of assets or similar transaction; provided, that a Registrable Security shall cease to be a Registrable Security when it is (x) registered under the Securities Act and disposed of in accordance with the registration statement covering it, (y) sold under Rule 144 (or any similar provisions then in force) under the Securities Act or (z) eligible for sale by the holder thereof without limitations as to volume or manner of sale pursuant to Rule 144.

“Stock Purchase Agreements” is defined in the recitals.

“Registration Expenses” is defined in Section 4.

“Registration Statement” is defined in Section 1(a), and includes the prospectus, amendments and supplements to such registration statement, including pre- and post-effective amendments, all exhibits thereto, and all material incorporated by reference or deemed to be incorporated by reference in such registration statement.

“Rule 144” shall mean Rule 144 promulgated under the Securities Act or any successor rule that may be promulgated by the SEC.

“Rule 415” shall mean Rule 415 promulgated under the Securities Act or any successor rule providing for offering securities on a continuous or delayed basis.

“SEC” shall mean the Securities and Exchange Commission.

“Securities Act” shall mean the Securities Act of 1933, as amended.

“Selling Stockholder Questionnaire” is defined in Section 2(a).

“Shares” is defined in the recitals.

“Suspension Event” is defined in Section 3(b).

“Suspension Notice” is defined in Section 3(b).

“Suspension Period” is defined in Section 3(a).

“Trading Day” shall mean any day on which the Common Stock is traded for any period on the NASDAQ Global Select Market, or if the Common Stock is no longer listed on the NASDAQ Global Select Market, on the other United States securities exchange or market on which the Common Stock is then being principally traded. If the Common Stock is not so listed or traded, then “Trading Day” means a Business Day.

“Warrants” is defined in the recitals.

“Warrant Shares” is defined in the recitals.

(b)Governing Law.  THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE DOMESTIC LAWS OF THE STATE OF NEW YORK WITHOUT

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REGARD TO THE CONFLICTS OF LAWS OR PRINCIPLES THEREOF THAT WOULD CAUSE THE APPLICATION OF THE LAWS OF ANY JURISDICTION OTHER THAN THE STATE OF NEW YORK. WITH RESPECT TO ANY LAWSUIT OR PROCEEDING ARISING OUT OF OR BROUGHT WITH RESPECT TO THIS AGREEMENT, OR ANY TRANSACTION CONTEMPLATED HEREBY, EACH OF THE PARTIES HERETO IRREVOCABLY (a) SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE UNITED STATES FEDERAL AND NEW YORK STATE COURTS LOCATED IN THE COUNTY OF NEW YORK IN THE STATE OF NEW YORK; (b) WAIVES ANY OBJECTION IT MAY HAVE AT ANY TIME TO THE LAYING OF VENUE OF ANY PROCEEDING BROUGHT IN ANY SUCH COURT; (c) WAIVES ANY CLAIM THAT SUCH PROCEEDING HAS BEEN BROUGHT IN AN INCONVENIENT FORUM; AND (d) FURTHER WAIVES THE RIGHT TO OBJECT, WITH RESPECT TO SUCH PROCEEDINGS, THAT SUCH COURT DOES NOT HAVE JURISDICTION OVER SUCH PART.

(c)Section Headings.  The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitute a part thereof.

Section 10.Miscellaneous.

(a)Notices.

(i)Any notices, consents, waivers or other communications required or permitted to be given under the terms of this Agreement must be in writing and will be deemed to have been delivered: (i) upon receipt, when delivered personally; (ii) when sent, if sent by email (provided that such sent email is kept on file (whether electronically or otherwise) by the sending party and the sending party does not receive an automatically generated message from the recipient’s email server that such email could not be delivered to such recipient); or (iii) one (1) Business Day after deposit with a nationally recognized overnight delivery service, in each case properly addressed to the party to receive the same. The addresses and facsimile numbers for such communications shall be:

If to the Company:

Orchestra BioMed Holdings, Inc.

150 Union Square DriveNew Hope, Pennsylvania 18938Attention: Chief Financial Officer

Email: [Omitted Pursuant to Item 601(a)(6)]

with a copy to (which shall not constitute notice):

Paul Hastings LLP

200 Park Avenue

New York, NY 10166

Attention:  Samuel Waxman

Email:  [Omitted Pursuant to Item 601(a)(6)]

If to an Investor, to the address set forth on such Investor’s signature page hereto.

or to such other physical or email address and/or to the attention of such other Person as the recipient party has specified by written notice given to each other party five (5) days prior to the

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effectiveness of such change. Written confirmation of receipt (A) given by the recipient of such notice, consent, waiver or other communication, (B) electronically generated by the sender’s email containing the time, date, recipient email address of such transmission or (C) provided by an overnight courier service shall be rebuttable evidence of personal service, receipt by email or receipt from an overnight courier service in accordance with clause (i), (ii) or (iii) above, respectively.

(b)Reproduction of Documents. This Agreement and all documents relating thereto, including, without limitation, consents, waivers and modifications which may hereafter be executed, documents received by the Investors pursuant hereto and financial statements, certificates and other information previously or hereafter furnished to the Investors, may be reproduced by the Investors by a photographic, photostatic, microfilm, microcard, miniature photographic or other similar process and the Investors may destroy any original document so reproduced. All parties hereto agree and stipulate that any such reproduction shall be admissible in evidence as the original itself in any judicial or administrative proceeding (whether or not the original is in existence and whether or not such reproduction was made by the Investors in the regular course of business) and that any enlargement, facsimile or further reproduction of such reproduction shall likewise be admissible in evidence.

(c)Successors and Assigns.  The Agreement will inure to the benefit of and be binding on the parties hereto and their respective successors and permitted assigns. An Investor may assign its rights and obligations hereunder to any transferee or assignee of its Registrable Securities who is a Permitted Transferee, provided that the Company is, within a reasonable time after such assignment or transfer, furnished with written notice of the name and address of such Permitted Transferee and the Registrable Securities with respect to which such rights and obligations are being assigned, and, provided further, that such Permitted Transferee enters into an agreement to be bound by the terms of this Agreement in the form of the Joinder Agreement attached hereto as Exhibit D. Any such transfer to a Permitted Transferee must be in compliance with the Securities Act and any other applicable securities or blue sky laws. By delivering an executed Joinder Agreement, such Permitted Transferees shall be deemed to be a party hereto and such Joinder Agreement shall be a part of this Agreement.

(d)Entire Agreement; Amendment and Waiver.  This Agreement constitutes the entire understanding of the parties hereto relating to the subject matter hereof and supersedes all prior understandings among such parties. The Agreement may be amended, supplemented or otherwise modified only by a written instrument executed by the Company and the Investors. No waiver of the provisions of the Agreement will be effective unless explicitly set forth in writing and executed by the Company and the Investors. Except as provided in the preceding sentence, no action taken pursuant to the Agreement, including without limitation, any investigation by or on behalf of any party, will be deemed to constitute a waiver by the party taking such action of compliance with any covenants or agreements contained herein. The waiver by any party hereto of a breach of any provision of the Agreement will not operate or be construed as a waiver of any subsequent breach.

(e)Severability.  In the event that any part or parts of this Agreement shall be held illegal or unenforceable by any court or administrative body of competent jurisdiction, such determination shall not affect the remaining provisions of this Agreement which shall remain in full force and effect.

(f)Third Parties.  Except as otherwise set forth herein, the Agreement does not create any rights, claims or benefits inuring to any person that is not a party thereto nor create or establish any third party beneficiary thereto.

(g)Specific Performance.  Without limiting or waiving in any respect any rights or remedies of the parties hereto under the Agreement, each of the parties will be entitled to seek specific performance of

11

the obligations to be performed by the other in accordance with the provisions of the Agreement. The Company and the Investors hereby declare that it is impossible to measure in money the damages which will accrue to the parties hereto by reason of the failure of any party to perform any of its obligations under this Agreement. If any party hereto shall institute any action or proceeding to enforce the provisions hereof, the Company and each of the Investors hereby waive the claim or defense that the party instituting such action or proceeding has an adequate remedy at law.

(h)Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of which together shall be considered one and the same agreement. Electronic signatures complying with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other applicable law will be deemed original signatures for purposes of this Agreement. Transmission by telecopy, electronic mail or other transmission method of an executed counterpart of this Agreement will constitute due and sufficient delivery of such counterpart.

[The remainder of this page is left intentionally blank]

12

IN WITNESS WHEREOF, this Registration Rights Agreement has been executed by the parties as of the date first above written.

THE COMPANY
ORCHESTRA BIOMED HOLDINGS INC.
By:	/s/ Andrew Taylor
	Name:	Andrew Taylor
	Title:	Chief Financial Officer

[Signature Page to Registration Rights Agreement]

INVESTOR:
LIGAND PHARMACEUTICALS INCORPORATED
By:	/s/ Todd C. Davis
	Name:	Todd C. Davis
	Title:	Chief Executive Officer
	Address:
	Ligand Pharmaceuticals, Inc.
	555 Heritage Drive, Suite 200
	Jupiter, Florida 33458
	Email:	[Omitted Pursuant to Item 601(a)(6)];
		[Omitted Pursuant to Item 601(a)(6)]

[Signature Page to Registration Rights Agreement]

INVESTOR:
COVIDIEN GROUP S.À.R.L.
By:	/s/ Harsimran Kaur Virdee
	Name:	Harsimran Kaur Virdee
	Title:	General Manager
c/o Medtronic, Inc.
Medtronic Operational Headquarters
710 Medtronic Parkway
Minneapolis, Minnesota 55432-5604
Attention:		Chris Eso, VP
		Corporate Development
		Peter Shimabukuro, BD Legal
Email:		[Omitted Pursuant to Item 601(a)(6)]
		[Omitted Pursuant to Item 601(a)(6)]
with a copy to (which shall not constitute notice):
Fredrikson & Byron, P.A.
200 South Sixth Street, Suite 4000
Minneapolis, MN 55402
Attention:		[Omitted Pursuant to Item 601(a)(6)]
Email:		[Omitted Pursuant to Item 601(a)(6)]

[Signature Page to Registration Rights Agreement]

EXHIBIT A

PLAN OF DISTRIBUTION

A-1

EXHIBIT B

SELLING STOCKHOLDER

B-1

EXHIBIT C

SELLING STOCKHOLDER NOTICE AND QUESTIONNAIRE

C-1

EXHIBIT D

JOINDER AGREEMENT

D-1

EX-10.9

Exhibit 10.9

EXECUTION COPY

*** Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and is information that the company treats as private or confidential. Such omitted information is indicated by brackets “[***]” in this exhibit. ***

AMENDMENT NO. 1

TO

EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT

This Amendment No. 1 (the “Amendment”) to the Exclusive License and Collaboration Agreement dated as of June 30, 2022 (the “Agreement”) is entered into as of August 1, 2025 (the “Amendment Effective Date”), by and among Orchestra Biomed, Inc., a Delaware corporation (“Orchestra”), BackBeat Medical, LLC, a Delaware limited liability company and wholly-owned subsidiary of Orchestra (“BackBeat”), and Medtronic, Inc., a Minnesota corporation (“Medtronic”).  Orchestra and Medtronic are referred to individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, the Parties entered into the Agreement to integrate the Backbeat CNT Algorithms (also known as Atrioventricular Interval Modulation therapy or AVIM therapy) into Medtronic’s transvenous Pacing System for the treatment of hypertension;

WHEREAS, the Parties now desire to amend the Agreement to provide Medtronic with the option to integrate Backbeat CNT Algorithms into a leadless dual chamber Pacing System (the “Leadless Product”) upon the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, it is agreed that the above Recitals are incorporated as material provisions of this Amendment, and Orchestra and Medtronic hereby further agree as follows:

ARTICLE 1

Definitions

In this Amendment, capitalized terms shall have the meanings ascribed to them in the Agreement, in the Recitals to this Amendment, or the body of this Amendment, or as set forth below:

1.1 “Cap” has the meaning set forth in Section 2.2(b).

1.2 “Clinical Leadless Device” has the meaning set forth in Section 2.3(a).

1.3 “Leadless Device Plan” has the meaning set forth in Section 2.2(a).

1

1.4 “Leadless Election” has the meaning set forth in Section 2.2(a).

1.5 “Leadless Regulatory Plan” has the meaning set forth in Section 2.4.

1.6 “Leadless Product” has the meaning set forth in the Recitals.

ARTICLE 2

Amendments to the Agreement

2.1Revised Definitions. The following definitions of the Agreement shall, upon the Leadless Election, hereby be amended, restated and replaced in their respective entireties as follows:

“1.11 [***]

1.23 “Commercial Device Plan” has the meaning set forth in Section 5.2(a) of the Agreement and includes, upon Medtronic  making the Leadless Election pursuant to Section 2.2 of this Amendment, the Leadless Device Plan.

1.45 “Integration IP” means Collaboration IP that is primarily related to the integration of BackBeat CNT Algorithms with the Device or, upon Medtronic making the Leadless Election pursuant to  Section 2.2 of this Amendment, with the Leadless Product.

1.68 “Pacing System” means the hardware, firmware or software of a pacing system, including implantable cardiac pacemaker (leadless or transvenous), external programmer and remote patient monitor, delivery system and all features and components thereof, other than in each case BackBeat CNT Algorithms that when integrated with a Pacing System comprise a Product.

1.80 “Product” means any Pacing System incorporating or integrating BackBeat CNT Algorithms into the programming software and firmware, including the Leadless Product.”

2.2Leadless Election, Obligations and Effects.

(a)Leadless Election. Following Medtronic’s receipt of Regulatory Approval from the FDA necessary for the commercialization of a transvenous Product in the United States, Medtronic shall have the option, but not the obligation, to elect to develop  and commercialize  the Leadless Product, pursuant to a preliminary plan and budget initially as set forth on Exhibit A hereto and as may be updated per Section 2.2(b) below (the “Leadless Device Plan”), and the terms and conditions of this Amendment (the “Leadless Election”); provided that (i) the Leadless Election shall be made no later than one hundred and eighty (180) days after the receipt of the aforementioned Regulatory Approval, and (ii) Medtronic shall only have the right to make the Leadless Election if, at

2

the time of such election, it is in material compliance with its material obligations under the Agreement and that certain Loan Agreement by and between the Parties dated of even date herewith.

(b)Orchestra Obligation for Leadless Device Plan.  Upon determination by Medtronic to make a Leadless Election, Medtronic shall notify the JSC in writing and shall submit to the JSC an updated Leadless Device Plan. Notwithstanding Section 4.3(b) of the Agreement, the updated Leadless Device Plan shall be subject to review and discussion by the JSC for a period of up to ninety (90) days following Medtronic’s submission of the foregoing notice to the JSC but shall not be subject to approval by the JSC. Orchestra shall, and does hereby agree, that Orchestra shall be obligated to reimburse Medtronic in an amount not to exceed [***] (the “Cap”) for its documented actual expenses as incurred in its conduct of the scope of work defined in the Leadless Device Plan or such other expenses as approved in writing and assigned to the Cap by the JSC. Orchestra shall reimburse Medtronic for such documented actual expenses in accordance with the budget included in the Leadless Device Plan, as incurred in connection with the Leadless Device Plan, and in accordance with the payment terms as defined in the Commercial Device Plan.

(c)Related Development Activities Prior to Leadless Election. It is understood that Orchestra and Medtronic may, with the prior written approval of the JSC, conduct certain development activities in support of the Leadless Device Plan prior to the Leadless Election in accordance with a written budget and development timeline approved in writing by the JSC (“Prior Leadless Development”). Expenses incurred directly by Orchestra or incurred by Medtronic and reimbursed by Orchestra related to Prior Leadless Development shall be documented and included in the calculation of the Cap. The JSC may also approve in writing and assign other development activities that are carried out at Orchestra’s expense to the Cap.

(d)Effect of Leadless Election.

(i)Upon a Leadless Election by Medtronic, the Leadless Product shall be treated as a “Product” under the Agreement, and the provisions of the Agreement that are applicable to the Product thereunder shall, subject to Section 2.5(c), apply mutatis mutandis to the Leadless Product, unless otherwise specified in this Amendment.

(ii)In addition, the Leadless Device Plan shall be an addendum to, and incorporated into, the Commercial Device Plan, and the provisions of the Agreement that are applicable to the Commercial Device Plan shall apply, subject to Section 2.5(c), mutatis mutandis to the Leadless Device Plan, unless otherwise specified herein.

3

(iii)Notwithstanding anything to the contrary herein, in no event shall a Leadless Election diminish Medtronic’s obligations with respect to a transvenous Product pursuant to the Agreement.

2.3 Revised Development Provisions for Leadless Product.

(a)Clinical Development of Leadless Product. As of the Amendment Effective Date, the Parties cannot determine whether development of a clinical device version of the Leadless Product (“Clinical Leadless Device”) will be required in order to obtain any Regulatory Approvals for the Leadless Product. However, if Medtronic determines that a Clinical Leadless Device is required, Medtronic will include such  Device Integration in the Leadless Device Plan submitted to the JSC, and Orchestra shall reimburse for any such costs subject to the Cap, as specified in Section 2.2(b) hereof. In addition, Orchestra will provide the development support set forth in Section 5.1(b)  of the Agreement for any such integration, as applicable, if needed.

(b)Commercial Development of Leadless Product. In the event of a  Leadless Election pursuant to Section 2.2(a) hereof, Medtronic shall perform the development work to integrate and qualify the Leadless Product for commercial sale in accordance with the Leadless Device Plan. For clarity, and in accordance with Section 5.2(b) of the Agreement, Orchestra will provide Medtronic with implementation support for such commercial development work for the Leadless Product as needed.  In addition, the Parties shall use Commercially Reasonable Efforts to complete such commercial development work for the Leadless Product based upon the Leadless Device Plan.

2.4Regulatory Activities for the Leadless Product. Notwithstanding Section 6.1 of the Agreement, a Leadless Product regulatory plan shall be included in the updated Leadless Device Plan submitted to the JSC in connection with a Leadless Election (“Leadless Regulatory Plan”). Such Leadless Regulatory Plan shall specify the countries that are in scope for Regulatory Approval of the Leadless Product. It is the intention of the Parties to seek Regulatory Approval and to use Commercially Reasonable Efforts to engage in each Party’s respective Regulatory Activities in support of obtaining such Regulatory Approvals, in the applicable countries and/or Country Group(s), as applicable, as described in the Leadless Regulatory Plan. For the avoidance of doubt, Sections 6.2 through Section 6.4 of the Agreement shall continue to apply to the Leadless Product and the Leadless Regulatory Plan, as applicable.

2.5Commercialization of the Leadless Product.

(a)Commercialization Conditions and Obligations. Medtronic’s obligations to commercialize the Leadless Product shall be conditioned upon making the Leadless Election as provided in Section 2.2 hereof, and receipt of the Regulatory Approvals for the Leadless Product as set forth in Leadless Regulatory Plan.  Subject to the foregoing, during the Term, Medtronic shall have the exclusive right, and shall use its Commercially Reasonable Efforts, to market, promote, sell, offer for sale, and otherwise commercialize the Leadless Product in the applicable Territories in the Primary Field of Use in accordance with the Leadless Device Plan which will be incorporated into the Commercialization Plan,

4

at its sole cost and expense, in accordance with the actions set forth in Section 7.1(a)-(j) of the Agreement, and pursuant to  Sections 7.2, 7.3 and 7.5 of the Agreement.

(b)Sales Target Thresholds.  For purposes of the sales target thresholds set forth in  Section 7.4 (i) and Section 7.4(ii) of the Agreement, the Parties hereby agree that Medtronic shall be permitted to aggregate actual sales of transvenous Products and  Leadless Products for purposes of determining whether the aforementioned thresholds are met, as applicable.

(c)US Launch Failure of the Leadless Product Not Applicable.  The Parties hereby agree that no aspect of Section 7.6 of the Agreement shall apply to the Leadless Product.

(d)Revenue Sharing for Transvenous Product and Leadless Product. The Parties hereby agree that the Revenue Share Amount shall be calculated separately for each of the Leadless Product and the transvenous Product.  The Revenue Share Amount for the Leadless Product shall be the greater of (i) the Per Device Minimum per unit of Product sold in the applicable Country Group in the Territory, provided that such amount shall not be subject to Section 8.6 of the Agreement, (ii) [***], as calculated in the applicable Fiscal Quarter, in the applicable country in the Territory, subject to Section 8.5 of the Agreement with respect to calculation of the [***], or (iii) [***]. [***], the Revenue Share Amount for the Leadless Product shall be calculated solely with reference to (i) and (ii) of this Section 2.5(d), and all applicable provisions of the Agreement. [***].

2.6No Technical Infeasibility Termination.  The Parties hereby agree that, notwithstanding Section 17.2(e) of the Agreement, neither Party shall have the right to terminate the Agreement based on the basis of Technical Infeasibility of the Leadless Product.

ARTICLE 3

Other Agreements

3.1No Breach for Certain Withholding of Revenue Share. Contemporaneously herewith, Medtronic and Orchestra are executing a Loan Agreement and Second Secured Promissory Note which provide that Medtronic has the right, in the event that Medtronic does not timely receive certain Revenue Share Credit (as defined therein) payments from Orchestra to offset against future payments that may be owed by Medtronic to Orchestra or its Affiliates. If, under such circumstances, Medtronic withholds Revenue Share payments no greater than an amount offsetting such outstanding Revenue Share Credit payments, such withholding shall not be considered a breach of the Agreement. This Section 3.1 shall not be construed to amend, affect or modify the Loan Agreement and Second Secured Promissory Note in any way.

5

3.2Affirmation of Agreement. Except as modified by this Amendment, the Parties hereby ratify the Agreement and agree that the Agreement shall remain unchanged and shall continue in full force and effect. In the event there is any conflict between the terms of the Agreement and the terms set forth in this Amendment, the terms specifically set out in this Amendment shall control.

3.3Multiple Agreements.  Notwithstanding the fact that this Amendment is one of a series of agreements entered into the Parties on the date hereof, the Parties acknowledge and agree that the entry into this Amendment, and the performance hereunder, is not an inducement to enter into any other of such agreements, and that the entry into any other such agreements, or the performance thereunder, is not an inducement to enter into this Amendment.

3.4Miscellaneous. This Amendment contains the entire understanding between the Parties with respect to the matters being amended as contained herein. This Amendment may not be changed or modified orally, but only by an agreement in writing signed by the party against whom enforcement of any waiver, change, or modification is sought. Each of the Parties shall deliver to the other any further instruments or documents which may be reasonably required to establish to the satisfaction of the other party that it has agreed to be bound by and become liable under the terms and conditions of the Agreement and this Amendment.

3.5Counterparts. This Agreement may be executed by any party by PDF file signature, and on one or more counterparts, and by different parties on separate counterparts, each of which shall be deemed to be an original as against any party whose signature appears thereon, all of which together shall constitute but one and the same instrument.

[Remainder of Page Left Intentionally Blank; Signature Page Follows.]

6

IN WITNESS WHEREOF, the Parties have executed this Amendment No. 1 to Exclusive License and Collaboration Agreement as of the Amendment Effective Date.

ORCHESTRA BIOMED, INC.
By:	/s/ David Hochman
Name:	David Hochman
Title:	Chief Executive Officer
BACKBEAT MEDICAL, LLC
By:	/s/ David Hochman
Name:	David Hochman
Title:	Chief Executive Officer
MEDTRONIC, INC.
By:	/s/ Chris Eso
Name:	Chris Eso
Title:	VP, Corporate Development & Ventures

7

Exhibit A

Preliminary Leadless Device Plan

[***]

8

EX-31.1

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, David P. Hochman, certify that:

1.I have reviewed this Quarterly Report on Form 10-Q of Orchestra BioMed Holdings, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Dated: August 12, 2025	/s/ David P. Hochman
	David P. Hochman
	Chief Executive Officer
	(Principal Executive Officer)

EX-31.2

Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Andrew Taylor, certify that:

1.I have reviewed this Quarterly Report on Form 10-Q of Orchestra BioMed Holdings, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Dated: August 12, 2025	/s/ Andrew Taylor
	Andrew Taylor
	Chief Financial Officer
	(Principal Financial Officer)

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. §1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Orchestra BioMed Holdings, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David P. Hochman, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in this Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: August 12, 2025	/s/ David P. Hochman
	David P. Hochman
	Chief Executive Officer
	(Principal Executive Officer)

A signed original of this written statement required by Section 906 has been provided to Orchestra BioMed Holdings, Inc. and will be retained by Orchestra BioMed Holdings, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

EX-32.2

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. §1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Orchestra BioMed Holdings, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Andrew Taylor, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in this Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: August 12, 2025	/s/ Andrew Taylor
	Andrew Taylor
	Chief Financial Officer
	(Principal Financial Officer)

A signed original of this written statement required by Section 906 has been provided to Orchestra BioMed Holdings, Inc. and will be retained by Orchestra BioMed Holdings, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

XML

Document And Entity Information - shares	6 Months Ended
	Jun. 30, 2025	Aug. 08, 2025
Cover Page
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2025
Document Fiscal Year Focus	2025
Document Transition Report	false
Entity File Number	001-39421
Entity Registrant Name	Orchestra BioMed Holdings, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	92-2038755
Entity Address, Address Line One	150 Union Square Drive
Entity Address, City or Town	New Hope
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	18938
City Area Code	215
Local Phone Number	862-5797
Title of 12(b) Security	Common stock, par value $0.0001 per share
Trading Symbol	OBIO
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		53,955,085
Entity Central Index Key	0001814114
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q2
Amendment Flag	false

XML

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Jun. 30, 2025	Dec. 31, 2024
CURRENT ASSETS:
Cash and cash equivalents	$ 18,749	$ 22,261
Marketable securities	15,175	44,551
Accounts receivable, net	83	92
Inventory	185	173
Prepaid expenses and other current assets	1,690	2,094
Total current assets	35,882	69,171
Property and equipment, net	1,366	1,384
Right-of-use assets	1,806	2,103
Strategic investments	2,495	2,495
Deposits and other assets	1,276	1,020
TOTAL ASSETS	42,825	76,173
CURRENT LIABILITIES:
Accounts payable	5,308	5,134
Accrued expenses and other liabilities	6,650	6,084
Operating lease liability, current portion	642	550
Deferred revenue, current portion	4,461	4,439
Total current liabilities	17,061	16,207
Deferred revenue, less current portion	9,568	10,989
Loan payable	14,384	14,292
Operating lease liability, less current portion	1,328	1,687
Other long-term liabilities	189	40
TOTAL LIABILITIES	42,530	43,215
STOCKHOLDERS' EQUITY
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at June 30, 2025 and December 31, 2024.
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 38,643,553 and 38,194,442 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively.	4	4
Additional paid-in capital	348,271	342,780
Accumulated other comprehensive income	16	52
Accumulated deficit	(347,996)	(309,878)
TOTAL STOCKHOLDERS' EQUITY	295	32,958
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 42,825	$ 76,173

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Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares	Jun. 30, 2025	Dec. 31, 2024
Condensed Consolidated Balance Sheets
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized	340,000,000	340,000,000
Common stock, shares issued	38,643,553	38,194,442
Common stock, shares outstanding	38,643,553	38,194,442

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Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024	Jun. 30, 2025	Jun. 30, 2024
Revenue:
Total revenue	$ 836	$ 778	$ 1,704	$ 1,398
Expenses:
Cost of product revenues	46	44	90	78
Research and development	13,853	11,126	27,335	20,238
Selling, general and administrative	6,264	6,467	12,527	12,364
Total expenses	20,163	17,637	39,952	32,680
Loss from operations	(19,327)	(16,859)	(38,248)	(31,282)
Other (expense) income:
Interest (expense) income, net	(36)	902	130	1,918
Loss on fair value of strategic investments		(23)		(68)
Other expense				(11)
Total other (expense) income	(36)	879	130	1,839
Net loss	$ (19,363)	$ (15,980)	$ (38,118)	$ (29,443)
Net loss per share
Basic (in dollars per share)	$ (0.5)	$ (0.45)	$ (0.99)	$ (0.82)
Diluted (in dollars per share)	$ (0.5)	$ (0.45)	$ (0.99)	$ (0.82)
Weighted-average shares used in computing net loss per share, basic (in shares)	38,392,716	35,800,273	38,314,936	35,789,137
Weighted-average shares used in computing net loss per share, diluted (in shares)	38,392,716	35,800,273	38,314,936	35,789,137
Comprehensive loss
Net loss	$ (19,363)	$ (15,980)	$ (38,118)	$ (29,443)
Unrealized gain (loss) on marketable securities	(21)	(15)	(36)	(13)
Comprehensive loss	(19,384)	(15,995)	(38,154)	(29,456)
Partnership revenue
Revenue:
Total revenue	667	628	1,399	1,125
Product revenue
Revenue:
Total revenue	$ 169	$ 150	$ 305	$ 273

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Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Common Stock	Additional Paid-In Capital	Accumulated Other Comprehensive (Loss) Income	Accumulated Deficit	Total
Balance at Dec. 31, 2023	$ 4	$ 316,903	$ (10)	$ (248,854)	$ 68,043
Balance (in shares) at Dec. 31, 2023	35,777,412
Unrealized gain (loss) on marketable securities			2		2
Stock-based compensation		2,588			2,588
Exercise of stock options		18			18
Exercise of stock options (in shares)	7,585
Net Income (Loss)				(13,463)	(13,463)
Balance at Mar. 31, 2024	$ 4	319,509	(8)	(262,317)	57,188
Balance (in Shares) at Mar. 31, 2024	35,784,997
Balance at Dec. 31, 2023	$ 4	316,903	(10)	(248,854)	68,043
Balance (in shares) at Dec. 31, 2023	35,777,412
Unrealized gain (loss) on marketable securities					(13)
Net Income (Loss)					(29,443)
Balance at Jun. 30, 2024	$ 4	322,441	(23)	(278,297)	44,125
Balance (in Shares) at Jun. 30, 2024	35,824,571
Balance at Mar. 31, 2024	$ 4	319,509	(8)	(262,317)	57,188
Balance (in shares) at Mar. 31, 2024	35,784,997
Unrealized gain (loss) on marketable securities			(15)		(15)
Stock-based compensation		2,761			2,761
Restricted stock unit vesting (in shares)	2,000
Exercise of stock options		171			171
Exercise of stock options (in shares)	37,574
Net Income (Loss)				(15,980)	(15,980)
Balance at Jun. 30, 2024	$ 4	322,441	(23)	(278,297)	44,125
Balance (in Shares) at Jun. 30, 2024	35,824,571
Balance at Dec. 31, 2024	$ 4	342,780	52	(309,878)	32,958
Balance (in shares) at Dec. 31, 2024	38,194,442
Unrealized gain (loss) on marketable securities			(15)		(15)
Stock-based compensation		2,965			2,965
Restricted stock unit vesting		(387)			(387)
Restricted stock unit vesting (in shares)	95,958
Exercise of stock options		91			91
Exercise of stock options (in shares)	22,112
Net Income (Loss)				(18,755)	(18,755)
Balance at Mar. 31, 2025	$ 4	345,449	37	(328,633)	16,857
Balance (in Shares) at Mar. 31, 2025	38,312,512
Balance at Dec. 31, 2024	$ 4	342,780	52	(309,878)	32,958
Balance (in shares) at Dec. 31, 2024	38,194,442
Unrealized gain (loss) on marketable securities					(36)
Net Income (Loss)					(38,118)
Balance at Jun. 30, 2025	$ 4	348,271	16	(347,996)	295
Balance (in Shares) at Jun. 30, 2025	38,643,553
Balance at Mar. 31, 2025	$ 4	345,449	37	(328,633)	16,857
Balance (in shares) at Mar. 31, 2025	38,312,512
Unrealized gain (loss) on marketable securities			(21)		(21)
Stock-based compensation		3,250			3,250
Restricted stock unit vesting		(428)			(428)
Restricted stock unit vesting (in shares)	331,041
Net Income (Loss)				(19,363)	(19,363)
Balance at Jun. 30, 2025	$ 4	$ 348,271	$ 16	$ (347,996)	$ 295
Balance (in Shares) at Jun. 30, 2025	38,643,553

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Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (38,118)	$ (29,443)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	164	148
Stock-based compensation	6,215	5,349
Loss on fair value of strategic investments		68
Accretion and interest related to marketable securities	(161)	(914)
Non-cash lease expense	297	224
Amortization of deferred financing fees	92
Other		11
Changes in operating assets and liabilities:
Accounts receivable	9	19
Inventory	(11)	76
Prepaid expenses and other assets	148	53
Accounts payable, accrued expenses and other liabilities	888	2,449
Operating lease liabilities - current and non-current	(267)	(235)
Deferred revenue	(1,399)	(1,125)
Net cash used in operating activities	(32,143)	(23,320)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(146)	(115)
Sales of marketable securities	32,403	58,788
Purchases of marketable securities	(2,902)	(42,388)
Net cash provided by investing activities	29,355	16,285
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of stock options	91	189
Restricted stock units withheld for tax	(815)
Net cash (used in) provided by financing activities	(724)	189
Net decrease in cash and cash equivalents	(3,512)	(6,846)
Cash and cash equivalents, beginning of the period	22,261	30,559
Cash and cash equivalents, end of the period	18,749	$ 23,713
Cash paid during the six months ended June 30:
Interest	722
Supplemental disclosure of noncash activities
Increase in accounts payable, accrued expenses and other liabilities related to fixed assets	$ 23

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Organization and Basis of Presentation

6 Months Ended

Jun. 30, 2025

Organization and Basis of Presentation

Organization and Basis of Presentation

1. Organization and Basis of Presentation

Orchestra BioMed Holdings, Inc. (collectively, with its subsidiaries, “Orchestra” or the “Company”) (formerly known as Health Sciences Acquisitions Corporation 2) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. The Company’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. The Company’s flagship product candidates are atrioventricular interval modulation (“AVIM”) therapy (formerly referred to as BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”)), for the treatment of hypertension (“HTN”), a significant risk factor for death worldwide, and Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide.

Prior to January 26, 2023, the Company was a special purpose acquisition company formed for the purpose of entering into a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. On January 26, 2023 (the “Closing”), the Company consummated the business combination contemplated by the Agreement and Plan of Merger, dated as of July 4, 2022 (as amended by Amendment No. 1 to Agreement and Plan of Merger, dated July 21, 2022, and Amendment No. 2 to Agreement and Plan of Merger, dated November 21, 2022, the “Merger Agreement”) by and among Health Sciences Acquisitions Corporation 2, a special purpose acquisition company incorporated as a Cayman Islands exempted company in 2020 (“HSAC2”), HSAC Olympus Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of HSAC2 (“Merger Sub”), and Orchestra BioMed, Inc. (“Legacy Orchestra”). Pursuant to the Merger Agreement, (i) HSAC2 deregistered in the Cayman Islands in accordance with the Companies Act (2022 Revision) (As Revised) of the Cayman Islands and domesticated as a Delaware corporation in accordance with Section 388 of the Delaware General Corporation Law (the “Domestication”) and (ii) Merger Sub merged with and into Legacy Orchestra, with Legacy Orchestra as the surviving company in the merger and, after giving effect to such merger, continuing as a wholly owned subsidiary of Orchestra (the “Merger” and, together with the Domestication and the other transactions contemplated by the Merger Agreement, the “Business Combination”). As part of the Domestication, the Company’s name was changed from “Health Sciences Acquisitions Corporation 2” to “Orchestra BioMed Holdings, Inc.” On January 27, 2023, our common stock (“Company Common Stock”) began trading on the Nasdaq Global Market under the symbol “OBIO.”

Legacy Orchestra, the Company’s wholly owned subsidiary, was incorporated in Delaware in January 2017 and was formed to acquire operating and other assets as well as to raise capital conducted through private placements. In May 2018, Legacy Orchestra concurrently completed its formation mergers (the “Formation Mergers”) with Caliber Therapeutics, Inc., a Delaware corporation, BackBeat Medical, Inc., a Delaware Corporation, and FreeHold Surgical, Inc., a Delaware corporation. Legacy Orchestra completed the conversions of BackBeat Medical, Inc. to BackBeat Medical, LLC (“BackBeat”), a Delaware limited liability company, of FreeHold Surgical, Inc. to FreeHold Surgical, LLC (“FreeHold”) and of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC (“Caliber”), a Delaware limited liability company, in 2019.

Caliber

Caliber Therapeutics, Inc. was incorporated in Delaware in October 2005 and began development of its lead product Virtue SAB in 2008. Virtue SAB is a patented drug/device combination product candidate for the treatment of artery disease that delivers a proprietary extended release formulation of sirolimus called SirolimusEFR to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need for leaving a permanent implant such as a stent in the artery. In 2019, Legacy Orchestra entered into a distribution agreement with Terumo Corporation and Terumo Medical Corporation (collectively “Terumo”) for global development and commercialization of Virtue SAB (the “Terumo Agreement”) (See Note 3 – “Terumo Agreement”).

BackBeat

BackBeat Medical, Inc. was incorporated in Delaware in January 2010 and began development of its lead product AVIM therapy that same year. AVIM therapy is a patented implantable cardiac stimulation-based treatment for HTN that is designed to immediately, substantially and persistently lower blood pressure while simultaneously modulating autonomic nervous system responses that normally drive and maintain blood pressure higher. Refer to Note 4 for details regarding the Exclusive License and Collaboration Agreement, dated as of June 30, 2022, by and among, Legacy Orchestra, BackBeat and Medtronic, Inc. (an affiliate of Medtronic plc) (the “Medtronic Agreement”).

FreeHold

FreeHold Surgical, Inc. was incorporated in Delaware in May 2010 and began development of its hands-free, intracorporeal retractor device for minimally invasive surgery in 2012. FreeHold is engaged in the development, sales and marketing of its retractor products that provide optimized visual and total surgeon control during laparoscopic and robotic procedures.

Basis of Presentation and Liquidity

The accompanying unaudited interim condensed consolidated financial statements have been prepared pursuant to the rules and regulation of the U.S. Securities and Exchange Commission (“SEC”) for interim financial reporting. These condensed statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary to fairly present the results of the interim periods. The condensed consolidated balance sheet at December 31, 2024 has been derived from the audited financial statements at that date. Operating results and cash flows for the six months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025 or any other future period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been omitted in accordance with the rules and regulations for interim reporting of the SEC. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025 together with the related notes thereto.

The Company has a limited operating history and the sales and income potential of its businesses and markets are unproven. As of June 30, 2025, the Company had an accumulated deficit of $348.0 million and has experienced net losses each year since its inception. The Company expects to incur substantial operating losses in future periods and will require additional capital as it seeks to advance its products to commercialization. The Company is subject to a number of risks and uncertainties similar to those of other companies of the same size within the biomedical device industry, such as uncertainty of clinical trial outcomes, uncertainty of additional funding, and history of operating losses.

The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements — Going Concern, which requires management to assess the Company’s ability to continue as a going concern within one year after the date the financial statements are issued.

Based on the available balance of cash and cash equivalents and marketable securities as of June 30, 2025, and subsequent proceeds received (see Note 16 – “Subsequent Events”), management has concluded that sufficient capital is available to fund its operations and meet cash requirements through the one-year period subsequent to the issuance date of these financial statements. Management may consider plans to raise capital through the one-year period subsequent to the issuance date of these financial statements through issuance of equity securities, debt securities, and/or additional development and commercialization partnerships for other products within the Company’s development pipeline. The source, timing and availability of any future financing will depend principally upon market conditions and on the progress of the Company’s research and development programs.

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Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2025

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Areas where significant estimates exist include, but are not limited to, the fair value of stock-based compensation, research and development costs incurred, and the estimated costs to complete the combined performance obligation pursuant to the Terumo Agreement (See Note 3 – “Terumo Agreement” for additional information).

Cash and Cash Equivalents

Cash and cash equivalents are held in banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.

Marketable Securities

The Company accounts for its marketable securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. These investments represent debt investments in corporate or government securities that are designated as available-for-sale and are carried at fair value, with unrealized gains and losses reported in stockholders’ equity as accumulated other comprehensive income (loss). The disclosed fair value related to the Company’s investments is based on market prices from a variety of industry standard data providers and generally represent quoted prices for similar assets in active markets or have been derived from observable market data.

Strategic Investments

Management has made investments in affiliated companies and assesses whether the Company exerts significant influence over its strategic investments. The Company considers the nature and magnitude of its investment, any voting and protective rights it holds, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationships. To date, the Company has concluded that it does not have the ability to exercise significant influence over its strategic investments.

The Company’s strategic investments consist of preferred shares of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party. The investments in Vivasure do not have readily determinable fair values and are recorded at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer. Additionally, as the investments in Vivasure are not readily marketable, the Company categorized the investments as non-current assets. As of June 30, 2025 and December 31, 2024, the carrying value of the investments in Vivasure was $2.5 million.

Fair Value of Financial Instruments

The Company applies ASC 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s

judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances.

The carrying value of the Company’s cash and cash equivalents, accounts receivable, prepaid expense, accounts payable, and accrued expenses approximate fair value because of the short-term maturity of these financial instruments. In addition, the Company records its investment in marketable securities at fair value. See Note 5 – “Financial Instruments and Fair Value Measurements” for additional information regarding fair value measurements.

The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:

Level 1  —  Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities.

Level 2  —  Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.

Level 3  —  Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities.

Accounts Receivable and Allowance for Doubtful Accounts

Accounts receivable represent amounts due from customers. The allowance for doubtful accounts is recorded for estimated losses by evaluating various factors, including relative creditworthiness of each customer, historical collections experience and aging of the receivable. As of June 30, 2025 and December 31, 2024, an allowance for doubtful accounts was not deemed necessary.

Inventory

Inventory is stated at the lower of standard cost (which approximates actual cost on a first-in, first-out basis) and net realizable value. Net realizable value represents the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The Company analyzes its inventory levels and writes down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value or inventory quantities in excess of expected requirements. Excess requirements are determined based on comparison of existing inventories to forecasted sales, with consideration given to inventory shelf life. Expired inventory is disposed of, and the related costs are recognized in cost of goods sold. As of June 30, 2025 and December 31, 2024, an impairment charge as a result of obsolete inventory was not deemed necessary.

Research and Development Prepayments, Accruals and Related Expenses

The Company incurs costs of research and development activities conducted by its third-party service providers, which include the conduct of preclinical and clinical studies. The Company is required to estimate its prepaid and accrued research and development costs at each reporting date. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with the Company’s service providers. The Company determines the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel and outside service providers, as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with the third parties and the agreed upon fee to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by the Company or the services are performed. Accruals are recorded for the amounts of services provided that have not yet been invoiced.

Property and Equipment

Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are amortized over the lesser of their useful life or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Maintenance and repairs are charged to operations as incurred.

Asset category	Depreciable life
Manufacturing equipment	10 years
Office equipment	3 – 7 years
Research and development equipment	7 years

Leases

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the terms of the arrangement. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets.

The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the condensed consolidated statements of operations and comprehensive loss.

Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset.

The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

Debt Discount and Debt Issuance Costs

Debt discounts and debt issuance costs incurred in connection with the issuance of debt are capitalized and reflected as a reduction to the related debt liability. The costs are amortized to interest expense over the term of the debt using the effective-interest method.

Impairment of Long-Lived Assets

The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparing the carrying amount to the future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. The Company has not identified any such impairment losses to date.

Revenue Recognition

The Company recognizes revenue under the core principle according to ASC 606, Revenue from Contracts with Customers (“ASC 606”), to depict the transfer of control to the Company’s customers in an amount reflecting the consideration the Company expects to be entitled to. In order to achieve that core principle, the Company applies the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when a performance obligation is satisfied.

The Company’s revenues are currently comprised of partnership revenues from the Terumo Agreement related to the development and commercialization of Virtue SAB, and product revenue from the sale of FreeHold’s intracorporeal organ retractors.

Partnership Revenues

To date, the Company’s partnership revenues have related to the Terumo Agreement as further described in Note 3. In future periods, partnership revenues may also include revenues related to the Medtronic Agreement as discussed in Note 4.

The Company assessed whether the Terumo Agreement fell within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) based on whether the arrangement involved joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. The Company determined that the Terumo Agreement did not fall within the scope of ASC 808. The Company then analyzed the arrangement pursuant to the provisions of ASC 606 and determined that the arrangement represents a contract with a customer and is therefore within the scope of ASC 606.

The promised goods or services in the Terumo Agreement include (i) license rights to the Company’s intellectual property, and (ii) research and development services. The Company also has optional additional items in the Terumo Agreement which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct in the Terumo Agreement, the Company considered factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available.

The Company estimates the transaction price for the Terumo Agreement performance obligations based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration includes both fixed consideration and variable consideration. At the inception of the Terumo Agreement, as well as at each reporting period, the Company evaluates the amount of potential payments and the likelihood that the payments will be received. The Company utilizes either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method better predicts the amount expected to be received. If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price.

The Terumo Agreement contains development and regulatory milestone payments. At contract inception and at each reporting period, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect partnership revenues and earnings in the period of adjustment.

The Terumo Agreement also includes sales-based royalties and the license is deemed to be the predominant item to which the royalties relate. Accordingly, the Company will recognize royalty revenue when the related sales occur. To date, the Company has not recognized any royalty revenue under the arrangement.

The Company has determined that intellectual property licensed to Terumo and the research and development services to be provided to support the premarket approval by the U.S. Food and Drug Administration (the “FDA”) for the in-stent restenosis (“ISR”) indication represent a combined performance obligation that is satisfied over time, and that the appropriate method of measuring progress for purposes of recognizing revenues relates to a proportional performance model that measures the proportional performance based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the performance obligation. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

The Company receives payments from Terumo based on billing schedules established in the contract. Such billings for milestone related events have 10-day terms from the date the milestone is achieved, royalty payments are 20-day terms after the close of each quarter, any optional services are 20 days after receipt of an invoice and any sales of the SirolimusEFR are within 30 days after receipt of the shipping invoices. Upfront payments are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the right to consideration is unconditional.

Product Revenues

Product revenues related primarily to sales of FreeHold’s intracorporeal organ retractors are recognized at a point-in-time upon the shipment of the product to the customer, and there are no significant estimates or judgments related to estimating the transaction price. The product revenues consist of a single performance obligation, and the payment terms are typically 30 days. Product revenues are recognized solely in the United States.

Stock-Based Compensation

The Company applies ASC 718-10, Compensation — Stock Compensation, which requires the measurement and recognition of compensation expenses for all stock-based payment awards made to employees and directors including employee stock options under the Company’s stock plans based on estimated fair values (see Note 10 – “Stock-Based Compensation”). Each award vests over the subsequent period during which the recipient is required to provide service in exchange for the award (the vesting period). The cost of each award is recognized as an expense in the financial statements over the respective vesting period on a straight-line basis.

Under the requirements of ASU 2018-07, the Company accounts for stock-based compensation to nonemployees under the fair value method, which requires all such compensation to be calculated based on the fair value at the measurement date (generally the grant date) and recognized in the Company’s condensed consolidated statements of operations and comprehensive loss over the requisite service period. The Company accounts for forfeitures of stock-based awards as they occur.

Net Loss Per Share

Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Since the Company was in a loss position for the periods presented, basic net loss is the same as diluted net loss since the effects of potentially dilutive securities are antidilutive. Potentially dilutive securities include all outstanding warrants, stock options, Earnout Consideration (see Note 15 – “Net Loss Per Share”), unvested restricted stock awards and restricted stock units. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares (as defined in Note 15)) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. In periods in which there is net income, the Company would apply the two-class method to compute net income per share. Under this method, earnings are allocated to common stock and participating securities based on their respective rights to receive dividends, as if all undistributed earnings for the period were distributed. The two-class method does not apply in periods in which a net loss is reported.

Income Taxes

The Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740, Income Taxes (“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and liabilities of a change in tax rate is recognized in the period that includes the enactment date. A valuation allowance is recorded if it is more-likely-than-not that some portion or all the deferred tax assets will not be realized in future periods. At June 30, 2025 and December 31, 2024, the Company recorded a full valuation allowance on its deferred tax assets.

The Company follows the guidance in ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties related to tax positions in income tax expense as applicable.

Defined Contribution Plan

The Company has a defined retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Effective January 1, 2023, the Company participates in a matching safe harbor 401(k) Plan with a Company contribution of up to 3.5% of each eligible participating employee’s compensation. Safe harbor contributions vest immediately for each participant. During the three and six months ended June 30, 2025, the Company made $119,000 and $239,000, respectively, in contributions under this safe harbor 401(k) Plan. During the three and six months ended June 30, 2024, the Company made $135,000 and $222,000, respectively, in contributions under this safe harbor 401(k) Plan.

Comprehensive Loss

Comprehensive loss is comprised of net loss and changes in unrealized gains and losses on the Company’s available-for-sale investments.

Segment Reporting

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in one segment. For further discussion on Segment Reporting, see Note 14 - “Segment Disclosures.”

New Accounting Standards

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires additional income tax disclosures in the annual consolidated financial statements. The amendments in ASU 2023-09 are intended to enhance the transparency and decision usefulness of income tax disclosures. For public entities, ASU 2023-09 is effective for annual periods beginning after December 15, 2024, with early adoption permitted. As an emerging growth company that has not opted out of the extended transition period for complying with new or revised financial accounting standards, the amendments in ASU 2023-09 are effective for the Company for fiscal years beginning after December 15, 2025, with early adoption permitted.

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“ASU 2024-03”) to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026. Early adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2024-03 on its condensed consolidated financial statements.

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Terumo Agreement

6 Months Ended

Jun. 30, 2025

Terumo Agreement.

Terumo Agreement

3. Terumo Agreement

In June 2019, Legacy Orchestra entered into the Terumo Agreement, pursuant to which Terumo secured global commercialization rights for Virtue SAB in coronary and peripheral vascular indications. Under the Terumo Agreement, Legacy Orchestra received an upfront payment of $30 million and an equity commitment of up to $5 million of which $2.5 million was invested in June 2019 as part of the Legacy Orchestra Series B-1 financing and $2.5 million was invested in June 2022 as part of the Legacy Orchestra Series D-2 financing. The Company was initially eligible to receive up to $65 million in additional payments based on the achievement of certain development and regulatory milestones and is also eligible to earn royalties on future sales by Terumo based on royalty rates ranging from 10 – 15%. Of these milestone payments, $35 million relate to achieving certain milestones by specified target achievement dates. As of June 30, 2025, the target achievement dates for three $5 million milestone payments have already passed. In addition, due to delays in the Company’s Virtue SAB program resulting from the COVID-19 pandemic, supply chain issues and unexpected changes to regulatory requirements, including increased testing and other activities related to chemistry, manufacturing, and control, increased nonclinical and good laboratory practice preclinical data requirements, including biocompatibility, as well as a requirement to repeat good laboratory practice preclinical studies already performed based on changes to source of component materials and a change in manufacturing site, the Company will not be able to complete the remaining time-based milestones by the specified target achievement dates to earn the remaining $20 million in time-based milestone payments pursuant to the Terumo Agreement.

As previously disclosed, the Company is in a mediation procedure with Terumo pursuant to the Terumo Agreement and the International Mediation Rules of the International Centre for Dispute Resolution (“ICDR”). The mediation is intended to assist in potentially resolving disagreements and facilitating the completion of negotiations related to restructuring, replacing or terminating the Terumo Agreement. The Terumo Agreement provides that matters that are not resolved through mediation are to be resolved by binding arbitration conducted under the auspices of the ICDR in accordance with its International Arbitration Rules. If the mediation does not lead to a timely agreement or resolution, or, if applicable, the Company does not prevail in arbitration, or if the Terumo Agreement is terminated, the Company’s commercialization plans for Virtue SAB may be adversely impacted. However, any termination of the Terumo Agreement in the context of mediation, an arbitration or otherwise would allow the Company to pursue an alternative strategic collaboration or other transaction with a different partner. The Company currently expects the formal mediation to be completed by the end of the third quarter of 2025. Regardless of the mediation process with Terumo, the Company intends to initiate enrollment of the Virtue SAB trial, its pivotal study of Virtue SAB for coronary in-stent restenosis in the United States during the second half of 2025, as well as to continue other product development efforts related to Virtue SAB.

Pursuant to the terms of the Terumo Agreement, Legacy Orchestra licensed intellectual property rights to Terumo and the Company is primarily responsible for completing the development of the product in the United States to support premarket approval by the FDA for the ISR indication. These research and development services to be provided by the Company include (i) manufacturing, testing and packaging the drug required for the clinical trials, (ii) supplying Terumo with information related to the design and manufacture of the delivery device and the technology transfer needed for Terumo to ultimately commence manufacture of the delivery device, and (iii) carrying out regulatory activities related to clinical trials in the United States for the ISR indication.

The Company has concluded that the license granted to Terumo is not distinct from the research and development services that will be provided to Terumo through the completion of the development of ISR indication, as Terumo cannot obtain the benefit of the license without the related research and development services. Accordingly, the Company will recognize revenues for this combined performance obligation over the estimated period of research and development services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total estimated costs of the research and development services.

In 2019, Legacy Orchestra received a total of $32.5 million from Terumo related to the stock purchase and the revenue generating elements of the Terumo Agreement. The Company recorded the estimated fair value of the shares of $2.5 million in stockholders’ equity, as the value paid by Terumo is consistent with the value paid by other third-party stockholders in Legacy Orchestra’s offering of its Series B-1 Preferred Stock. The Company allocated the remaining $30 million to the transaction price of the Terumo Agreement. The Company considers the future potential development and regulatory milestones to be variable consideration, which are fully constrained from the transaction price as of June 30, 2025 and December 31, 2024, as the achievement of such milestone payments are uncertain and highly susceptible to factors outside of the Company’s control. The Company plans to re-evaluate the transaction price at each reporting period and as uncertain events are resolved or other changes in circumstances occur. In addition, the arrangement also includes sales-based royalties on product sales by Terumo subsequent to commercialization ranging from 10 - 15%, none of which have been recognized to date.

The Company recorded the $30 million upfront payment received from Terumo in 2019 within deferred revenue. The following table presents the changes in the Company’s deferred revenue balance from the Terumo Agreement during the six months ended June 30, 2025 and 2024 (in thousands):

Deferred Revenue – December 31, 2024	$	15,428
Revenue recognized		(1,399)
Deferred Revenue – June 30, 2025	$	14,029

Deferred Revenue – December 31, 2023	$	17,433
Revenue recognized		(1,125)
Deferred Revenue – June 30, 2024	$	16,308

The Company’s balance of deferred revenue contains the transaction price from the Terumo Agreement allocated to the combined license and research and development performance obligation, which was partially unsatisfied as of June 30, 2025. The Company expects to recognize approximately $4.5 million of its deferred revenue during the next twelve months and recognize the remaining approximately $9.5 million through the remainder of the performance period, which is currently estimated to be completed in 2029 and may be impacted by the actual clinical and regulatory timelines of the program.

As of each quarterly reporting date, the Company evaluates its estimates of the total costs expected to be incurred through the completion of the combined performance obligation and updates its estimates as necessary. For the three months ended June 30, 2025 and 2024, the expenses incurred related to the Terumo Agreement were approximately $3.3 million and $4.0 million, respectively. For the six months ended June 30, 2025 and 2024, the expenses incurred related to the Terumo Agreement were approximately $6.8 million and $6.9 million, respectively. The estimated total costs associated with the Terumo Agreement through completion were similar as of June 30, 2025, as compared to the estimates as of December 31, 2024, and increased by approximately 2.8% as of June 30, 2024, as compared to the estimates as of December 31, 2023. While the Company believes it has estimated total costs associated with the Terumo Agreement through completion, these estimates encompass a broad range of expenses over a multi-year period and, as such, are subject to periodic changes as new information becomes available. The impact of the changes in estimates resulted in a reduction of partnership revenues of $21,000 and $220,000 for the three months ended June 30, 2025 and 2024, respectively, as compared to the amounts that would have been recorded based on the previous estimates. The impact of the changes in estimates resulted in a reduction of partnership revenues of $27,000 and $382,000 for the six months ended June 30, 2025 and 2024, respectively, as compared to the amounts that would have been recorded based on the previous estimates. The impact of these changes in estimates on the net loss per share attributable to common stockholders, basic and diluted, for the three and six months ended June 30, 2025 were de minimis. The impact of these changes in estimates on the net loss per share attributable to common stockholders, basic and diluted, for the three and six months ended June 30, 2024 was an increase of $0.01.

The Company will also manufacture, or have manufactured, SirolimusEFR and has exclusive rights to sell it on a per unit basis to Terumo for use in the Virtue SAB product. The Company has determined that this promise does not contain a material right as the pricing is based on standalone selling prices. Through June 30, 2025, there have been no additional

amounts recognized as revenue under the Terumo Agreement other than the recognition of a portion of the upfront payment described above.

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Medtronic Agreement

6 Months Ended

Jun. 30, 2025

Medtronic Agreement

Medtronic Agreement

4. Medtronic Agreement

In June 2022, Legacy Orchestra, BackBeat and Medtronic entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of anti-hypertensive medications (the “Primary Field”). Under the terms of the Medtronic Agreement, the Company is sponsoring an ongoing multinational pivotal study, to support regulatory approval of AVIM therapy in the Primary Field and be financially responsible for development, clinical and regulatory costs associated with this pivotal study. AVIM therapy has been integrated into the Medtronic top-of-the-line, commercially available dual-chamber pacemaker system specifically for use in the pivotal trial and will provide development, clinical and regulatory resources in support of the pivotal trial, for which the Company will reimburse Medtronic at cost.

Under the terms of the Medtronic Agreement, Medtronic will have exclusive rights to commercialize AVIM-enabled pacing systems globally following receipt of regulatory approval. Medtronic would be entirely responsible for global commercialization following receipt of regulatory approvals, including manufacturing, sales, marketing and distribution costs.

The Company is expected to receive between $500 and $1,600 per AVIM-enabled device sold based on a formula of the higher of (1) a fixed dollar amount per AVIM-enabled device (amount varies materially on a country-by-country basis) or (2) a percentage of the AVIM therapy-generated sales. Procedures using the AVIM-enabled pacemakers are expected to be billed under existing reimbursement codes.

Medtronic has a right of first negotiation through FDA approval of AVIM therapy in the Primary Field, to expand its global rights to AVIM therapy for the treatment of HTN patients not indicated for a pacemaker.

The Company assessed whether the Medtronic Agreement fell within the scope of ASC 808 and concluded that the Medtronic Agreement is a collaboration within the scope of ASC 808. In addition, the Company determined that Medtronic is a customer for a good or service that is a distinct unit of account, and therefore, the transactions in the Medtronic Agreement should be accounted for under ASC 606.

The Company has concluded that the license granted to Medtronic is not distinct from the development and implementation services that will be provided to Medtronic through the completion of the development of HTN indication, as Medtronic cannot obtain the benefit of the license without the related development and implementation services. ASC 606-10-55-65 includes an exception for the recognition of revenue relating to licenses of intellectual property with sales-based or usage-based royalties. Under this exception, royalty revenue is not recorded until the subsequent sale or usage occurs, or the performance obligation has been satisfied, whichever is later.

The Company concluded that the exemption applies and therefore, the royalty revenue associated with these performance obligations will be recognized as the underlying sales occur. Additionally, pursuant to the Medtronic Agreement, expenses incurred by Medtronic in connection with clinical device development and regulatory activities performed will be reimbursed by the Company. The Company will record such expenses as research and development expenses as incurred. During the three and six months ended June 30, 2025, the Company incurred approximately $4.0 million and $7.4 million, respectively, of research and development costs related to these reimbursements pursuant to the Medtronic Agreement, of which $6.2 million is included within accounts payable and accrued expenses in the Company’s June 30, 2025 condensed consolidated balance sheet. During the three and six months ended June 30, 2024, the Company incurred approximately $1.9 million and $3.1 million, respectively, of research and development costs related to these reimbursements pursuant to the Medtronic Agreement. 

Concurrently with the close of the Medtronic Agreement, Legacy Orchestra also received a $40 million investment from Medtronic in connection with Legacy Orchestra’s Series D-2 Preferred Stock financing. The equity was purchased at a fair value consistent with the price paid by other investors at that time, and accordingly, the proceeds received were recorded as an equity investment.

Through June 30, 2025, there have been no amounts recognized as revenue under the Medtronic Agreement.

On July 31, 2025, the Company, BackBeat and Medtronic entered into an amendment to the Medtronic Agreement, which became effective on August 4, 2025 (see Note 16 – “Subsequent Events”).

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Financial Instruments and Fair Value Measurements

6 Months Ended

Jun. 30, 2025

Financial Instruments and Fair Value Measurements

Financial Instruments and Fair Value Measurements

5. Financial Instruments and Fair Value Measurements

The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy:

	June 30, 2025
(in thousands)	Level 1		Level 2		Level 3		Total
Assets
Money market fund (included in cash and cash equivalents)	$	9,147	$	—	$	—	$	9,147
Corporate and government debt securities (included in Marketable securities)		—		15,175		—		15,175
Total assets	$	9,147	$	15,175	$	—	$	24,322

	December 31, 2024
(in thousands)	Level 1		Level 2		Level 3		Total
Assets
Money market fund (included in cash and cash equivalents)	$	12,248	$	—	$	—	$	12,248
Corporate and government debt securities (included in Marketable securities)		—		44,551		—		44,551
Total assets	$	12,248	$	44,551	$	—	$	56,799

The Level 2 assets consist of government and corporate debt securities which are valued using market observable inputs, including the current interest rate and other characteristics for similar types of investments, whose fair value may not represent actual transactions of identical securities. There were no transfers between Levels 1, 2 or 3 for the periods presented.

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Marketable Securities and Strategic Investments

6 Months Ended

Jun. 30, 2025

Marketable Securities and Strategic Investments

Marketable Securities and Strategic Investments

6. Marketable Securities and Strategic Investments

Marketable Securities

The following is a summary of the Company’s marketable securities as of June 30, 2025 and December 31, 2024:

	June 30, 2025
	Amortized		Unrealized		Unrealized		Fair
(in thousands)	Cost Basis		Gains		Losses		Value
Corporate debt securities	$	14,369	$	17	$	(1)	$	14,385
Government debt securities		790		—		—		790
Total	$	15,159	$	17	$	(1)	$	15,175

	December 31, 2024
	Amortized		Unrealized		Unrealized		Fair
(in thousands)	Cost Basis		Gains		Losses		Value
Corporate debt securities	$	43,724	$	57	$	(5)	$	43,776
Government debt securities		775		—		—		775
Total	$	44,499	$	57	$	(5)	$	44,551

The Company believes it is more likely than not that its marketable securities in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has not recorded any allowance for credit losses on its investment securities. The Company determined that the unrealized losses were not attributed to credit risk but were primarily driven by the broader change in interest rates. As of June 30, 2025, $1.3 million of the Company’s marketable securities had maturities of 12 to 36 months while the remaining marketable securities had maturities of less than 12 months.

For the three and six months ended June 30, 2025 and 2024, the Company did not recognize any realized gains or losses on its marketable securities.

Strategic Investments

The Company’s long-term strategic investments as of June 30, 2025 represent investments made in Vivasure in 2022, 2021 and 2020 that were originally recorded at cost. There were no observable price changes, other than as described below, or impairments identified during the six months ended June 30, 2025 and 2024 related to these investments.

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Balance Sheet Components

6 Months Ended

Jun. 30, 2025

Balance Sheet Components

Balance Sheet Components

7. Balance Sheet Components

Property and Equipment, Net

Property and equipment, net consists of the following:

	June 30,		December 31,
(in thousands)	2025		2024
Equipment	$	2,231	$	2,084
Office furniture		443		444
Leasehold improvements		159		159
Property and equipment, gross		2,833		2,687
Less accumulated depreciation and amortization		(1,467)		(1,303)
Total Property and equipment, net	$	1,366	$	1,384

Depreciation and amortization expense was $81,000 and $74,000 for the three months ended June 30, 2025 and 2024, respectively. Depreciation and amortization expense was $164,000 and $148,000 for the six months ended June 30, 2025 and 2024, respectively.

Accrued Expenses and Other Liabilities

Accrued expenses and other liabilities consist of the following:

	June 30,		December 31,
(in thousands)	2025		2024
Clinical trial accruals	$	3,796	$	2,893
Accrued compensation		1,975		2,612
Other accrued expenses		879		579
Total Accrued expenses and other liabilities	$	6,650	$	6,084

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Common and Preferred Stock

6 Months Ended

Jun. 30, 2025

Common and Preferred Stock

Common and Preferred Stock

8. Common and Preferred Stock

Common Stock

The Company is authorized to issue up to 340,000,000 shares of Company Common Stock.

Preferred Stock

The Company is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.0001 per share. The board of directors of the Company (the “Board”) has the authority to issue preferred stock and to determine the rights, privileges, preferences, restrictions, and voting rights of those shares. As of June 30, 2025, no shares of preferred stock were outstanding.

At-the-Market Offering and Shelf Registration Statement

On May 15, 2024, the Company entered into an Open Market Sale Agreement^SM (the “Prior Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company could offer and sell, from time to time through Jefferies, up

to $100 million of shares of Company Common Stock (the “Prior ATM Shares”) by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the “Securities Act”).

Also on May 15, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC (the “Shelf Registration Statement”), which contains a base prospectus, covering up to a total aggregate offering price of $300 million of Company Common Stock, preferred stock, debt securities, warrants, right and/or units, and a prospectus supplement that covered the offering, issuance and sale of the Prior ATM Shares, which are included in the $300 million of securities that may be offered, issued and sold by the Company pursuant to the Shelf Registration Statement.

On July 11, 2024, the Company sold 2,000,000 shares of Company Common Stock under the Prior Agreement resulting in aggregate gross proceeds to the Company of approximately $15.5 million and net proceeds to the Company of approximately $15.0 million.

On August 12, 2024, the Company entered into a sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC, as agent (“TD Cowen”), pursuant to which the Company may offer and sell, from time to time through TD Cowen, up to $100 million of shares of Company Common Stock (the “Offering”) by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. The Offering is being made pursuant to the Shelf Registration Statement, filed with the SEC on May 15, 2024 and declared effective on May 24, 2024, a base prospectus, dated May 24, 2024, included as part of the Shelf Registration Statement, and a prospectus supplement, dated August 12, 2024 filed with the SEC pursuant to Rule 424(b)(5) on August 12, 2024. As of June 30, 2025, no sales had been made under the Sales Agreement.

Termination of Prior Agreement

In connection with the entry into the Sales Agreement, on August 12, 2024, the Company terminated the Prior Agreement between the Company and Jefferies (the “Termination”), in accordance with its terms and with the mutual agreement of Jefferies. The purpose of the Termination was to eliminate restrictions under certain SEC rules relating to the publication or dissemination of new research reports on the Company’s business by Jefferies in light of its role as sales agent under the Prior Agreement. The Company had $84.5 million remaining available under the Prior Agreement. The Company cannot make any further sales of Company Common Stock pursuant to the Prior Agreement.

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Warrants

6 Months Ended

Jun. 30, 2025

Warrants

Warrants

9. Warrants

The Company evaluates its outstanding warrants to determine if the instruments qualify for equity or liability classification.

Non-employee Warrants

On February 28, 2025, the Company issued equity-classified warrants to purchase 60,000 shares of Company Common Stock at an exercise price of $4.69 per share to non-employee consultants. The warrants were issued as consideration for entering into an agreement for future services. As of February 28, 2025, the Company valued the non-employee warrants using the Black-Scholes option-pricing model and determined the fair value at $187,000. The key inputs to the valuation model included the annualized volatility of 110.1% and a risk-free rate of 3.99%.

Summarized Outstanding Warrants

The following table summarizes outstanding warrants to purchase shares of Company Common Stock as of June 30, 2025 and December 31, 2024:

	Number of Shares
	June 30,	December 31,	Exercise
	2025	2024	Price	Term
Equity-classified Warrants
Legacy Orchestra Warrants	507,841	507,841	$1.08 – $30.11	0.10 – 8.75
Hercules Warrants (Note 13)	52,264	52,264	$5.74	3.50
Avenue Warrants	27,707	27,707	$7.67	2.50
Non-employee Warrants	60,000	—	$4.69	3.12
Private Warrants Held by Sponsor*	750,000	750,000	$11.50	4.32 – 4.57
Private Warrants Held by Employees	660,000	660,000	$11.50	4.32
Total Outstanding	2,057,812	1,997,812

*Sponsor is defined as HSAC2 Holdings, LLC

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Stock-Based Compensation

6 Months Ended

Jun. 30, 2025

Stock-Based Compensation

Stock-Based Compensation

10. Stock-Based Compensation

As of June 30, 2025, the only equity compensation plan from which the Company may issue new awards is the Company’s 2023 Equity Incentive Plan (the “2023 Plan”), as more fully described below.

Orchestra BioMed Holdings, Inc. 2023 Equity Incentive Plan

At the Closing, the Company adopted the 2023 Plan which permits the granting of incentive stock options, non-qualified options, stock appreciation rights, restricted stock, restricted stock units, performance awards and other stock-based award to employees, directors, and non-employee consultants and/or advisors. As of June 30, 2025, approximately 1.0 million shares of Company Common Stock are authorized for issuance pursuant to awards under the 2023 Plan. The pool of available shares will be automatically increased on the first day of each calendar year, beginning January 1, 2024 and ending January 1, 2032, by an amount equal to the lesser of (i) 4.8% of the outstanding shares of the Company Common Stock determined on a fully-diluted basis as of the immediately preceding December 31 and (ii) 3,036,722 shares of Company Common Stock, and (iii) such number of shares of Company Common Stock determined by the Board or the Compensation Committee prior to January 1st of a given year. Employees, consultants, and directors are eligible for awards granted under the 2023 Plan, which generally have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Board. Vesting generally occurs over a period of not greater than four years.

Stock-based Compensation Expense

Total stock-based compensation related to option issuances was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	666	$	308	$	1,273	$	817
Selling, general and administrative		692		710		1,331		1,191
Total stock-based compensation	$	1,358	$	1,018	$	2,604	$	2,008

As of June 30, 2025, there was approximately $7.8 million of unrecognized stock-based compensation expense associated with the stock options noted above that is expected to be recognized over a weighted average period of approximately 2.8 years.

Total stock-based compensation related to restricted stock awards and restricted stock units was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	528	$	392	$	993	$	739
Selling, general and administrative		1,036		1,086		1,986		2,073
Total stock-based compensation	$	1,564	$	1,478	$	2,979	$	2,812

As of June 30, 2025, there was approximately $8.3 million of unrecognized restricted stock-based compensation expense associated with the restricted stock noted above that is expected to be recognized over a weighted average period of approximately 2.0 years.

As previously discussed in Note 9, on February 28, 2025, the Company issued equity-classified warrants to purchase 60,000 shares of Company Common Stock at an exercise price of $4.69 per share to non-employee consultants. The warrants were issued as consideration for entering into an agreement for future services. At the grant date, 6,000 became exercisable while the remaining will vest ratably over eight months. Assumptions used were an expected term (in years) of 3.12, expected volatility of 110%, risk-free interest rate of 3.99%, expected dividend yield of 0%, and the fair value of Company Common Stock of $3.12.

Total stock-based compensation related to warrants was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	121	$	121	$	241	$	241
Selling, general and administrative		207		144		391		288
Total stock-based compensation	$	328	$	265	$	632	$	529

As of June 30, 2025, there was approximately $687,000 of unrecognized stock-based compensation expense associated with the warrants noted above that is expected to be recognized over a weighted average period of approximately 0.6 years.

Stock Option Activity

The following table summarizes the stock option activity of the Company under the 2023 Plan:

		Weighted		Weighted
	Shares	Average		Average	Aggregate
	Underlying	Exercise		Remaining	Intrinsic
	Options	Price		Term (years)	Value
Outstanding at January 1, 2025	5,696,845	$	7.17	7.39	$	3,000
Granted	1,438,524		3.06	—		—
Exercised	(28,251)		4.41	—		33,011
Forfeited/canceled	(143,353)		6.69	—		—
Outstanding June 30, 2025	6,963,765	$	6.34	7.56	$	1,770
Exercisable at June 30, 2025	4,072,270	$	7.54	6.36	$	—

The weighted average grant-date fair value of stock options granted during the six months ended June 30, 2025 and 2024 was $2.18 and $3.56 per share, respectively.

Restricted Equity Awards Activity

The following table summarizes the restricted stock awards and restricted stock units activity of the Company under the Plan:

	Restricted Stock	Weighted Average
	Awards/Units	Grant Date Fair
	Outstanding	Value
Outstanding at January 1, 2025	2,094,584	$	6.54
Granted	682,365		2.85
Vested	(625,414)		6.95
Outstanding June 30, 2025	2,151,535	$	5.26

No performance-based restricted stock awards or units were granted during the six months ended June 30, 2025. The fair value of restricted stock units vested during the three and six months ended June 30, 2025 was $1.4 million and $2.2 million, respectively.  

Determination of Stock Option Awards Fair Value

The estimated grant-date fair value of all the Company’s option awards was calculated using the Black-Scholes option pricing model, based on the following weighted average assumptions:

	Six Months Ended June 30,
	2025			2024
Expected term (in years)		6.08			6.15
Expected volatility		80	%		71	%
Risk-free interest rate		3.92	%		4.44	%
Expected dividend yield		0	%		0	%
Fair value of common stock		3.06			5.29

The fair value of each stock option grant was determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management.

Expected Term — The expected term represents the period that stock-based awards are expected to be outstanding. The Company’s historical share option exercise information is limited due to a lack of sufficient data points and did not provide a reasonable basis upon which to estimate an expected term. The expected term for option grants is therefore determined using the “simplified” method, as prescribed in the Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 107. The simplified method deems the expected term to be the midpoint between the vesting date and the contractual life of the stock-based awards.

Expected Volatility — The Company consummated the Business Combination on January 26, 2023 and lacks sufficient company-specific historical and implied volatility information. Therefore, it derives expected stock volatility using a weighted average blend of historical volatility of comparable peer public companies and its own historical volatility, over a period equivalent to the expected term of the stock-based awards.

Risk-Free Interest Rate — The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the date of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the stock-based awards’ expected term.

Expected Dividend Yield — The expected dividend yield is zero as neither the Company nor Legacy Orchestra has paid, and the Company does not anticipate paying, any dividends on the Company Common Stock in the foreseeable future.

Fair Value of Common Stock — Prior to the Business Combination, as the Legacy Orchestra Common Stock has not historically been publicly traded, its board of directors periodically estimated the fair value of its common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013

Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Subsequent to the Business Combination, the Company utilizes the price of its publicly-traded Company Common Stock to determine the grant date fair value of awards.

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Leases

6 Months Ended

Jun. 30, 2025

Leases

Leases

11. Leases

Office Lease

In August 2024, the Company entered into an additional addendum to the lease agreement for office space in New Hope, PA originally entered into by Legacy Orchestra in December 2009 (as amended, the “New Hope Lease”). The New Hope Lease covers 8,052 square feet and will expire in September 2027. Monthly fees under the New Hope Lease will be between $17,000 and $19,000 for the period from the August 2024 addendum through expiration.

In November 2019, Legacy Orchestra entered into a new lease agreement for approximately 5,200 square feet of office space in New York, NY. In November 2022, Legacy Orchestra entered into an amendment for this lease which increased the office space square footage to approximately 7,800 and amended the expiration to April 2028. Monthly fees will be between $28,000 and $40,000 for the period from commencement through expiration.

In September 2024, the Company entered into a new lease for 6,496 square feet of office space in Fort Lauderdale, Florida. The agreement will expire in December 2027. The monthly fees commenced in November 2024, the commencement date of the agreement, and will be between $16,000 and $17,000 for the period from commencement through expiration.  

Operating cash flow supplemental information for the six months ended June 30, 2025:

Cash paid for amounts included in the present value of operating lease liabilities was $503,000 during the six months ended June 30, 2025 compared to $454,000 during the six months ended June 30, 2024.

As of June 30, 2025:
Weighted average remaining lease term – operating leases, in years	2.63
Weighted average discount rate – operating leases	9.92	%

Operating Leases

Rent/lease expense for office and lab space was approximately $274,000 and $224,000 for the three months ended June 30, 2025 and 2024, respectively. Rent/lease expense for office and lab space was approximately $533,000 and $443,000 for the six months ended June 30, 2025 and 2024, respectively. Variable lease costs were $19,000 and $38,000 for the three months ended June 30, 2025 and 2024, respectively. Variable lease costs were $50,000 and $100,000 for the six months ended June 30, 2025 and 2024, respectively. Variable lease costs consist primarily of common area maintenance costs, insurance and taxes which are paid based upon actual costs incurred by the lessor. The table below shows the future minimum rental payments, exclusive of taxes, insurance, and other costs, under the leases as of June 30, 2025:

	Operating
	Leases
Year ending December 31:	(in thousands)
2025 (remaining six months)	$	373
2026		880
2027		829
2028		159
2029		—
Thereafter		—
Total future minimum lease payments	$	2,241
Imputed interest		(271)
Total liability	$	1,970

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Related Party Transactions

6 Months Ended

Jun. 30, 2025

Related Party Transactions

Related Party Transactions

12. Related Party Transactions

Other than transactions and balances related to cash and stock-based compensation to officers and directors, the Company had no transactions or balances with current related parties during the year ended December 31, 2024 and the six months ended June 30, 2025.

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Debt Financing

6 Months Ended

Jun. 30, 2025

Debt Financing

Debt Financing

13. Debt Financing

2024 Loan and Security Agreement

On November 6, 2024 (the “LSA Closing Date”), the Company and certain of its subsidiaries (together with the Company, the “Borrower”) entered into a Loan and Security Agreement, by and among the Borrower, the several banks and other financial institutions or entities party thereto, as lenders (collectively, the “Hercules Lenders”), and Hercules Capital, Inc. (“Hercules”), as administrative agent and collateral agent for itself and the Hercules Lenders, as amended by that certain First Amendment to Loan and Security Agreement dated as of December 30, 2024 (as amended, the “2024 LSA”). The 2024 LSA provided a secured term loan facility of up to $50.0 million available in up to four tranches (collectively, the “Term Loans”), with the first tranche of $15.0 million drawn on the LSA Closing Date, and a second and third tranche of up to an aggregate of $15.0 million were available upon achievement of certain performance and financing milestones. Additionally, the Company had access to a fourth tranche of $20.0 million subject to future approval. On July 31, 2025, the Borrower, the Hercules Lenders and Hercules entered into that certain second amendment (the “LSA Amendment”) to the 2024 LSA, which became effective on August 4, 2025 (see Note 16 – “Subsequent Events”).

The Term Loans accrue interest at a floating per annum rate equal to the greater of (i) (x) the “prime rate” as reported in The Wall Street Journal plus (y) 2.0%, and (ii) 9.50%. The repayment terms of the Term Loans include monthly payments over a 4-year period, consisting of an initial two-year interest-only period, followed by 24 monthly principal payments plus interest, although the interest-only period can be extended for six months under certain circumstances set forth in the 2024 LSA. At the Company’s option, the Company may prepay all or a portion of the outstanding Term Loans, subject to a prepayment premium equal to (a) 3.0% of the Term Loans being prepaid if the prepayment occurs during the twelve months following the LSA Closing Date, (b) 2.0% of the Term Loans being prepaid if the prepayment occurs after 12 months following the LSA Closing Date but on or prior to 24 months following the LSA Closing Date, and (c) 1.0% of the Term Loans being prepaid if the prepayment occurs after 24 months following the LSA Closing Date and prior to the maturity date. In addition, the Company will pay an end of term charge of 6.35% of the principal amount of the Term Loans upon the prepayment or repayment of the Term Loans and a facility charge of 0.75% upon any draws of the Term Loans.

In connection with the entry into the 2024 LSA, on the LSA Closing Date, the Company issued each of the Hercules Lenders a warrant to purchase Company Common Stock (each a “Hercules Warrant” and, collectively, the “Hercules Warrants”). Pursuant to the terms of the Hercules Warrants, each Hercules Lender could purchase that number of shares of Company Common Stock equal to (i)(x) 0.02, multiplied by (y) the aggregate principal amount of all Term Loan Advances (as defined in the 2024 LSA) made to the Company by the applicable Lender, divided by (ii) $5.74, which was the exercise price of the Hercules Warrants. Each Hercules Warrant is exercisable for seven years from the LSA Closing Date. In connection with the LSA Amendment, on July 31, 2025, the Company entered into amendments to the Hercules Warrants (see Note 16 – “Subsequent Events”).

The 2024 LSA includes customary affirmative and negative covenants and representations and warranties, including a covenant against the occurrence of a “change in control,” financial reporting obligations, and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, transfers, mergers or acquisitions, taxes, corporate changes, and bank accounts. The 2024 LSA also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the 2024 LSA, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, Hercules may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the 2024 LSA.

The Company must maintain Qualified Cash (as defined in the 2024 LSA) in an amount greater than or equal to (x) the outstanding principal amount of the Term Loan Advances, multiplied by (y) (1) prior to December 1, 2025, 35% or (2) on and after December 1, 2025, (A) if the Performance Milestone Date (as defined in the 2024 LSA) has not occurred on or prior to December 1, 2025, 50% until the date on which the Performance Milestone Date has occurred and (B) on and after the Performance Milestone Date, 35% (the “Minimum Cash Covenant”). The Minimum Cash Covenant will be waived if the Company’s Market Capitalization (as defined in the 2024 LSA) exceeds $500.0 million.

 The following table shows the amount of principal payments due pursuant to the Term Loans by year:

	Principal
	Payments
Year ending December 31:	(in thousands)
2025 (remaining six months)	$	—
2026		570
2027		7,187
2028		7,243
Total	$	15,000

Total interest expense recorded on this facility during the three and six months ended June 30, 2025 was approximately $466,000 and $928,000, respectively. There was no interest expense recorded during the six months ended June 30, 2024.

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Segment Disclosures

6 Months Ended

Jun. 30, 2025

Segment Disclosures

Segment Disclosures

14. Segment Disclosures

The Company has one reportable segment, which consists of the development of clinical and preclinical product candidates through risk-reward sharing partnerships with leading medical device companies. The Company’s CODM, its Chief Executive Officer, manages the Company's operations on a consolidated basis for the purpose of assessing performance and allocating resources based on net loss that also is reported on the condensed consolidated statement of operations and comprehensive loss as consolidated net loss. Net loss is used by the CODM to make key strategic and operational decisions. To date, the Company has not generated material revenues. However, the majority of that revenue is attributed to one of its two collaboration agreements to accelerate and commercialize high-impact technologies. The measure of segment assets is reported on the condensed consolidated balance sheets as total consolidated assets. The majority of the Company's long-lived assets are held in the United States.

The following table presents selected financial information, including significant expenses regularly reviewed by the CODM, about the Company’s single operating segment for the three and six months ended June 30, 2025, and 2024:

	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
(in thousands)
Partnership revenue	$	667	$	628	$	1,399	$	1,125
Product revenue		169		150		305		273
Expenses:
Cost of product revenues		46		44		90		78
Non-clinical development costs		4,607		4,648		9,072		7,947
Clinical development costs		2,633		1,504		5,575		2,547
Personnel and consulting costs		7,002		5,913		13,666		11,407
Stock-based compensation		3,250		2,761		6,215		5,349
Depreciation expense		81		74		164		148
Other segment expenses(1)		2,544		2,716		5,170		5,283
Interest income (expense), net		36		(902)		(130)		(1,918)
Net Loss	$	(19,363)	$	(15,980)	$	(38,118)	$	(29,443)

¹Other segment expenses primarily include general and administrative costs not presented in other line items.

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Net Loss Per Share

6 Months Ended

Jun. 30, 2025

Net Loss Per Share

Net Loss Per Share

15. Net Loss Per Share

Basic net loss per share of Company Common Stock is computed by dividing net loss by the weighted-average number of shares of Company Common Stock. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. In connection with the Business Combination, HSAC2 Holdings, LLC (the “Sponsor”) agreed that 25% or 1,000,000 of the shares of Company Common Stock held by the Sponsor will be forfeited to the Company on the first business day following the fifth anniversary of the Closing unless, as to 500,000 shares, the volume-weighted average price of the Company Common Stock is greater than or equal to $15.00 per share over any 20 trading days within any 30-trading day period (the “Initial Milestone Event”), and as to the remaining 500,000 shares, the volume-weighted average price of the Company Common Stock is greater than or equal to $20.00 per share over any 20 trading days within any 30-trading day period (the “Final Milestone Event”).

In connection with the Business Combination, existing Legacy Orchestra stockholders had the opportunity to elect to participate in an earnout (the “Earnout”) pursuant to which such each electing stockholder (each, an “Earnout Participant”) may receive a portion of additional contingent consideration of up to 8,000,000 shares of Company Common Stock (the “Earnout Consideration”). Each Earnout Participant agreed to extend their applicable lock-up period from 6 months to 12 months after the Closing, pursuant to an Earnout Election Agreement and such Earnout Participants will collectively be entitled to receive: (i) 4,000,000 shares of the Earnout Consideration, in the event that, from the time beginning immediately after the Closing until the fifth anniversary of the Closing (the “Earnout Period”), the Initial Milestone Event occurs; and (ii) an additional 4,000,000 shares of the Earnout Consideration, in the event that, during the Earnout Period, the Final Milestone Event occurs. Approximately 91% of Legacy Orchestra stockholders elected to participate in the Earnout. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding). Additionally, 500,000 of the Forfeitable Shares are no longer subject to forfeiture as a result of the Initial Milestone Event.

Diluted net loss per share of Company Common Stock includes the effect, if any, from the potential exercise or conversion of securities, such as stock options, Legacy Orchestra Warrants and Private Warrants, and Forfeitable Shares and Earnout Consideration, which would result in the issuance of incremental shares of Company Common Stock, unless their effect would be anti-dilutive.

The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2025 and June 30, 2024, as their effect is anti-dilutive:

	Three and Six Months Ended June 30,
	2025	2024
Stock options	6,963,765	5,164,962
Company common stock warrants	2,057,812	1,945,548
Unvested restricted stock equity awards	2,151,535	2,475,786
Forfeitable shares	500,000	500,000
Earnout consideration	4,000,000	4,000,000
Total	15,673,112	14,086,296

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Subsequent Events

6 Months Ended

Jun. 30, 2025

Subsequent Events

Subsequent Events

16. Subsequent Events

Ligand Pharmaceuticals Incorporated Revenue Participation Right Purchase and Sale Agreement and Purchase of Shares

On July 31, 2025, the Company entered into a revenue participation right purchase and sale agreement (the “Revenue Purchase and Sale Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”). Under the terms of the Revenue Purchase and Sale Agreement, in exchange for payment of $35.0 million (the “Investment Amount”), less certain reimbursable expenses, Ligand acquired from the Company the right to receive tiered revenue payments (the “Revenue Interest”) with respect to revenue (including certain licensing revenue) received by the Company in a calendar year in connection with worldwide net product sales, or other product revenue received by, by the Company and its licensees

(“Annual Net Sales”) of (a) AVIM therapy (the “Primary Product”) and (b) Virtue SAB (the “Secondary Product” and together with the Primary Product, the “Products”) in the field of coronary artery treatment.

Subject to the Performance Ratchet (as defined below), Revenue Interest rates are based on the Annual Net Sales of the Products. The Applicable Purchaser Revenue Interest Rate is 17.0% for Annual Net Sales less than or equal to $100 million, in any field. The Applicable Purchaser Revenue Interest Rate is 4.0% for Annual Net Sales of greater than or equal to $100 million, only in the fields described above.

Pursuant to the Revenue Purchase and Sale Agreement, the Investment Amount shall be paid in two tranches: (i) $20.0 million was paid on August 4, 2025 (the “Ligand Closing”) and (ii) $15.0 million is payable on May 1, 2026 (the “Second Installment”), provided certain conditions have been met. In accordance with the terms of the Revenue Purchase and Sale Agreement, the Applicable Purchaser Revenue Interest Rates set forth above will incrementally increase from 17.0% and 4.0% up to 20.0% and 7.0%, respectively, if the Company does not achieve certain enrollment milestones relating to the BACKBEAT clinical study through January 1, 2027 (the “Performance Ratchet”).

The Revenue Interest in respect of Annual Net Sales of the Products will end on the date in which no Product is being developed or commercialized by or on behalf of the Company, any of its affiliates, or any of its or their licensees or distributors and Ligand has received the last Revenue Interest payment payable under the terms of the Revenue Purchase and Sale Agreement. The obligations arising under the Revenue Purchase and Sale Agreement are secured by security interests in, and pledges over, the Revenue Interest, the Revenue Participation Right (as defined in the Revenue Purchase and Sale Agreement) and the Company’s interests in the Products and associated intellectual property rights, subject to certain agreed security principles, permitted liens and other customary exceptions and qualifications, and the security interests in the Products and associated intellectual property rights of the Company are subordinate in right of payment to the prior payment in full of the outstanding indebtedness under the 2024 LSA. The Revenue Purchase and Sale Agreement contains customary representations, warranties and indemnities of the Company and Ligand, and customary covenants on the part of the Company. The Ligand Closing occurred on August 4, 2025. 

In connection with the sale of the Revenue Interest, and pursuant to the terms of the Revenue Purchase and Sale Agreement, on August 4, 2025, the Company issued to Ligand a warrant (the “Ligand Warrant”) to purchase up to 2,000,000 shares of the Company Common Stock (and, such shares underlying the Ligand Warrant, the “Ligand Warrant Shares”), at an exercise price equal to $3.67 per share. The exercise price of the Ligand Warrant and the number of Ligand Warrant Shares issuable upon exercise of the Ligand Warrant are subject to adjustments for stock splits, combinations, stock dividends or similar events. Pursuant to the terms of the Ligand Warrant, the Ligand Warrant Shares shall vest and become exercisable as follows: (i) 1,142,857 of the Ligand Warrant Shares (the “First Tranche”) vested upon issuance; however, the Ligand Warrant may not be exercised for six months after the issuance of the Ligand Warrant and (ii) 857,143 of the Ligand Warrant Shares will vest on the date of payment of the Second Installment. In the event that the Second Installment is not paid, the Ligand Warrant shall only be exercisable with respect to the First Tranche. The Ligand Warrant is exercisable for ten years from the date of issuance.

Concurrent with the execution of the Revenue Purchase and Sale Agreement, Ligand also agreed to purchase $5.0 million of shares of Company Common Stock (the “Ligand Private Placement Shares”) pursuant to a stock purchase agreement, dated as of July 31, 2025, between the Company and Ligand (the “Ligand Stock Purchase Agreement”), at a purchase price per share equal to the public offering price per share in the Company’s next public offering of its equity securities. Pursuant to the Ligand Stock Purchase Agreement, Ligand purchased 1,818,181 shares of Company Common Stock at a purchase price of $2.75 per share on August 4, 2025 in connection with the closing of the Public Offering (as defined below).

Purchase of Shares by Medtronic and Loan Agreement with Medtronic

On July 31, 2025, the Company and its wholly-owned subsidiaries, Legacy Orchestra and BackBeat, entered into a Loan Agreement (the “Medtronic Loan Agreement”) with Medtronic, pursuant to which Medtronic agreed to extend a convertible loan to the Company in the aggregate original principal amount of $20.0 million (the “Medtronic Loan”). The Medtronic Loan is evidenced by a secured subordinated convertible promissory note (the “Medtronic Note”) of the

Company. The issuance of the Medtronic Note to Medtronic and the funding of the Medtronic Loan will take place on April 27, 2026 subject to certain closing conditions as described in the Medtronic Loan Agreement.

The Medtronic Note will accrue simple interest at a rate of 11% per annum. The Medtronic Note does not allow for prepayment without the prior consent of Medtronic. Unless earlier converted, or redeemed, the Medtronic Note will mature on April 27, 2031 (the “Repayment Date”). In addition, the payment or other satisfaction of the obligations set forth in the Medtronic Loan Agreement are subordinate in right of payment to the prior payment in full of the senior obligations. The obligations arising under the Medtronic Loan Agreement and the Medtronic Note are secured by security interests in, and pledges over, the Company’s assets, subject to certain agreed security principles, permitted liens and other customary exceptions and qualifications.

The principal balance of the Medtronic Note, together with all accrued and unpaid interest thereon (collectively, the “Balance”) will automatically convert into a revenue share (the “Revenue Share Credit”), if FDA approval of a Medtronic device incorporating AVIM is achieved prior to the Repayment Date. Upon conversion of the then outstanding Balance the Company shall pay to Medtronic the Revenue Share Credit, which shall equal 15% of the revenue share amounts that the Company receives under the Medtronic Agreement, until such time as the total Revenue Share Credit payments equal $40.0 million.

The Medtronic Loan Agreement contains customary representations, warranties and affirmative and negative covenants. In addition, the Medtronic Loan Agreement contains customary events of default that entitle Medtronic to cause the Company’s indebtedness under the Note to become immediately due and payable, and to exercise remedies against the Company and the collateral securing the Loan. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 2.0% per annum may apply to all obligations owed under the Loan Agreement.

In addition, in connection with the closing of the Public Offering on August 4, 2025, Medtronic, through its affiliate Covidien Group S.à.r.l. (“Covidien”), purchased 4,077,427 shares of Company Common Stock (together with the Ligand Private Placement Shares, the “Private Placement Shares”) pursuant to a stock purchase agreement, dated as of July 31, 2025 and amended on August 1, 2025, between the Company and Covidien (as amended, the “Medtronic Stock Purchase Agreement” and, together with the Ligand Stock Purchase Agreement, the “Stock Purchase Agreements”), at a purchase price of $2.75 per share. In addition, pursuant to the terms and subject to the conditions of the Medtronic Stock Purchase Agreement, if the underwriters in the Public Offering (as defined below) exercise their option to purchase an additional 2,182,500 shares of Company Common Stock, Medtronic will be obligated to purchase an additional 132,282 shares of Company Common Stock at a purchase price of $2.75 per share.

Amendment of Exclusive License and Collaboration Agreement

On July 31, 2025, the Company, BackBeat and Medtronic entered into an amendment to the Medtronic Agreement, which became effective on August 4, 2025 (the “Medtronic Agreement Amendment”), to provide, among other things, a development and commercialization framework for future AVIM-therapy integration into a dual-chamber leadless pacemaker. Pursuant to the Medtronic Agreement Amendment, the Company will, among other things, be required to reimburse Medtronic for certain expenses incurred in connection with the integration of AVIM-therapy into Medtronic’s dual-chamber leadless pacemaker, up to a specified cap.  

Amendments to Hercules Loan and Security Agreement and Warrant Agreements

On July 31, 2025, the Borrower, the Hercules Lenders and Hercules entered into the LSA Amendment to the 2024 LSA, which, among other things, amended the existing 2024 LSA to (i) delay the initial date upon which the Company has to begin amortizing term loans under the 2024 LSA from (a) December 1, 2026 (with amortization payments delayed to as late December 1, 2027 if certain conditions were met) to (b) July 1, 2027 (with amortization payments delayed to as late as January 1, 2028 if certain conditions are met); and (ii) increase by $15.0 million (from $20.0 million to $35.0 million) the amount that that may be borrowed by the Company in the discretion of the lender’s investment committee’s and (iii) eliminate the Company’s ability to draw up to $15.0 million if certain milestones are achieved. The LSA Amendment became effective on August 4, 2025.

Under the 2024 LSA as amended by the LSA Amendment (the “Amended 2024 LSA”), beginning on December 1, 2025, the Borrower must maintain Qualified Cash (as defined in the Amended 2024 LSA) in an amount greater than or equal to (x) the outstanding principal amount of the Term Loan Advances, multiplied by (y) the applicable Cash Coverage Percentage (as defined in the Amended 2024 LSA), which percentage ranges from a minimum of 60% to a maximum of 100% of Term Loan Advances, depending upon the amount of Qualified Cash.

 In addition, on July 31, 2025, the Company entered into amendments to the Hercules Warrants with the Hercules Lenders (the “Warrant Agreement Amendments”). As a result of the Warrant Agreement Amendments, among other things:

● the exercise price under the Hercules Warrants is now $3.58 (“Exercise Price”); and

● the number of shares issuable upon exercise of the Hercules Warrants is equal to 4% of aggregate principal amount of Term Loan Advances divided by the Exercise Price.

Registration Rights Agreement

In connection with the Stock Purchase Agreements and the Ligand Warrant, on August 4, 2025, the Company, Ligand and Medtronic entered into a Registration Rights Agreement (the “Registration Rights Agreement”), pursuant to which the Company has agreed to file a shelf registration statement providing for the resale of the Private Placement Shares and the Ligand Warrant Shares within 90 calendar days of the closing of the Stock Purchase Agreements, to use its commercially reasonable efforts to cause such registration statement to be declared effective after its filing at the earliest possible date, but no later than the earlier of (i) the 180^th calendar day following the issuance of the Private Placement Shares, if the SEC notifies the Company that it will “review” such registration statement and (ii) the 5^th business day after the date the Company is notified by the SEC that such registration statement will not be “reviewed” or will be subject to no further review, and to maintain the effectiveness of such registration statement until the date as of which there are no longer any Registrable Securities (as such term is defined in the Registration Rights Agreement).

Public Offering

On August 4, 2025, the Company closed an underwritten public offering of 9,413,637 shares of Company Common Stock at a price to the public of $2.75 per share and pre-funded warrants to purchase 5,136,363 shares of Company Common Stock at a price to the public of $2.7499 per pre-funded warrant, which represents the per share public offering price for the shares of Company Common Stock less the $0.0001 per share exercise price for each pre-funded warrant, for total gross proceeds of approximately $40.0 million, before deducting underwriting discounts and commissions and estimated offering expenses (the “Public Offering”). In addition, as part of the Public Offering, the Company granted the underwriters a 30-day option to purchase up to an additional 2,182,500 shares of Company Common Stock at the public offering price per share, less underwriting discounts and commissions.

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Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended				6 Months Ended
	Jun. 30, 2025	Mar. 31, 2025	Jun. 30, 2024	Mar. 31, 2024	Jun. 30, 2025	Jun. 30, 2024
Pay vs Performance Disclosure
Net Income (Loss)	$ (19,363)	$ (18,755)	$ (15,980)	$ (13,463)	$ (38,118)	$ (29,443)

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Insider Trading Arrangements	3 Months Ended
	Jun. 30, 2025
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

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Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2025

Summary of Significant Accounting Policies

Use of Estimates

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Areas where significant estimates exist include, but are not limited to, the fair value of stock-based compensation, research and development costs incurred, and the estimated costs to complete the combined performance obligation pursuant to the Terumo Agreement (See Note 3 – “Terumo Agreement” for additional information).

Cash and Cash Equivalents

Cash and Cash Equivalents

Cash and cash equivalents are held in banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.

Marketable Securities

Marketable Securities

The Company accounts for its marketable securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. These investments represent debt investments in corporate or government securities that are designated as available-for-sale and are carried at fair value, with unrealized gains and losses reported in stockholders’ equity as accumulated other comprehensive income (loss). The disclosed fair value related to the Company’s investments is based on market prices from a variety of industry standard data providers and generally represent quoted prices for similar assets in active markets or have been derived from observable market data.

Strategic Investments

Strategic Investments

Management has made investments in affiliated companies and assesses whether the Company exerts significant influence over its strategic investments. The Company considers the nature and magnitude of its investment, any voting and protective rights it holds, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationships. To date, the Company has concluded that it does not have the ability to exercise significant influence over its strategic investments.

The Company’s strategic investments consist of preferred shares of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party. The investments in Vivasure do not have readily determinable fair values and are recorded at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer. Additionally, as the investments in Vivasure are not readily marketable, the Company categorized the investments as non-current assets. As of June 30, 2025 and December 31, 2024, the carrying value of the investments in Vivasure was $2.5 million.

Fair Value of Financial Instruments

Fair Value of Financial Instruments

The Company applies ASC 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s

judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances.

The carrying value of the Company’s cash and cash equivalents, accounts receivable, prepaid expense, accounts payable, and accrued expenses approximate fair value because of the short-term maturity of these financial instruments. In addition, the Company records its investment in marketable securities at fair value. See Note 5 – “Financial Instruments and Fair Value Measurements” for additional information regarding fair value measurements.

The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:

Level 1  —  Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities.

Level 2  —  Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.

Level 3  —  Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities.

Accounts Receivable and Allowance for Doubtful Accounts

Accounts Receivable and Allowance for Doubtful Accounts

Accounts receivable represent amounts due from customers. The allowance for doubtful accounts is recorded for estimated losses by evaluating various factors, including relative creditworthiness of each customer, historical collections experience and aging of the receivable. As of June 30, 2025 and December 31, 2024, an allowance for doubtful accounts was not deemed necessary.

Inventory

Inventory

Inventory is stated at the lower of standard cost (which approximates actual cost on a first-in, first-out basis) and net realizable value. Net realizable value represents the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The Company analyzes its inventory levels and writes down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value or inventory quantities in excess of expected requirements. Excess requirements are determined based on comparison of existing inventories to forecasted sales, with consideration given to inventory shelf life. Expired inventory is disposed of, and the related costs are recognized in cost of goods sold. As of June 30, 2025 and December 31, 2024, an impairment charge as a result of obsolete inventory was not deemed necessary.

Research and Development Prepayments, Accruals and Related Expenses

Research and Development Prepayments, Accruals and Related Expenses

The Company incurs costs of research and development activities conducted by its third-party service providers, which include the conduct of preclinical and clinical studies. The Company is required to estimate its prepaid and accrued research and development costs at each reporting date. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with the Company’s service providers. The Company determines the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel and outside service providers, as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with the third parties and the agreed upon fee to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by the Company or the services are performed. Accruals are recorded for the amounts of services provided that have not yet been invoiced.

Property and Equipment

Property and Equipment

Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are amortized over the lesser of their useful life or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Maintenance and repairs are charged to operations as incurred.

Asset category	Depreciable life
Manufacturing equipment	10 years
Office equipment	3 – 7 years
Research and development equipment	7 years

Leases

Leases

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the terms of the arrangement. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets.

The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the condensed consolidated statements of operations and comprehensive loss.

Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset.

The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

Debt Discount and Debt Issuance Costs

Debt Discount and Debt Issuance Costs

Debt discounts and debt issuance costs incurred in connection with the issuance of debt are capitalized and reflected as a reduction to the related debt liability. The costs are amortized to interest expense over the term of the debt using the effective-interest method.

Impairment of Long-Lived Assets

Impairment of Long-Lived Assets

The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparing the carrying amount to the future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. The Company has not identified any such impairment losses to date.

Revenue Recognition

Revenue Recognition

The Company recognizes revenue under the core principle according to ASC 606, Revenue from Contracts with Customers (“ASC 606”), to depict the transfer of control to the Company’s customers in an amount reflecting the consideration the Company expects to be entitled to. In order to achieve that core principle, the Company applies the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when a performance obligation is satisfied.

The Company’s revenues are currently comprised of partnership revenues from the Terumo Agreement related to the development and commercialization of Virtue SAB, and product revenue from the sale of FreeHold’s intracorporeal organ retractors.

Partnership Revenues

Partnership Revenues

To date, the Company’s partnership revenues have related to the Terumo Agreement as further described in Note 3. In future periods, partnership revenues may also include revenues related to the Medtronic Agreement as discussed in Note 4.

The Company assessed whether the Terumo Agreement fell within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) based on whether the arrangement involved joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. The Company determined that the Terumo Agreement did not fall within the scope of ASC 808. The Company then analyzed the arrangement pursuant to the provisions of ASC 606 and determined that the arrangement represents a contract with a customer and is therefore within the scope of ASC 606.

The promised goods or services in the Terumo Agreement include (i) license rights to the Company’s intellectual property, and (ii) research and development services. The Company also has optional additional items in the Terumo Agreement which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct in the Terumo Agreement, the Company considered factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available.

The Company estimates the transaction price for the Terumo Agreement performance obligations based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration includes both fixed consideration and variable consideration. At the inception of the Terumo Agreement, as well as at each reporting period, the Company evaluates the amount of potential payments and the likelihood that the payments will be received. The Company utilizes either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method better predicts the amount expected to be received. If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price.

The Terumo Agreement contains development and regulatory milestone payments. At contract inception and at each reporting period, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect partnership revenues and earnings in the period of adjustment.

The Terumo Agreement also includes sales-based royalties and the license is deemed to be the predominant item to which the royalties relate. Accordingly, the Company will recognize royalty revenue when the related sales occur. To date, the Company has not recognized any royalty revenue under the arrangement.

The Company has determined that intellectual property licensed to Terumo and the research and development services to be provided to support the premarket approval by the U.S. Food and Drug Administration (the “FDA”) for the in-stent restenosis (“ISR”) indication represent a combined performance obligation that is satisfied over time, and that the appropriate method of measuring progress for purposes of recognizing revenues relates to a proportional performance model that measures the proportional performance based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the performance obligation. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

The Company receives payments from Terumo based on billing schedules established in the contract. Such billings for milestone related events have 10-day terms from the date the milestone is achieved, royalty payments are 20-day terms after the close of each quarter, any optional services are 20 days after receipt of an invoice and any sales of the SirolimusEFR are within 30 days after receipt of the shipping invoices. Upfront payments are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the right to consideration is unconditional.

Product Revenues

Product Revenues

Product revenues related primarily to sales of FreeHold’s intracorporeal organ retractors are recognized at a point-in-time upon the shipment of the product to the customer, and there are no significant estimates or judgments related to estimating the transaction price. The product revenues consist of a single performance obligation, and the payment terms are typically 30 days. Product revenues are recognized solely in the United States.

Stock-Based Compensation

Stock-Based Compensation

The Company applies ASC 718-10, Compensation — Stock Compensation, which requires the measurement and recognition of compensation expenses for all stock-based payment awards made to employees and directors including employee stock options under the Company’s stock plans based on estimated fair values (see Note 10 – “Stock-Based Compensation”). Each award vests over the subsequent period during which the recipient is required to provide service in exchange for the award (the vesting period). The cost of each award is recognized as an expense in the financial statements over the respective vesting period on a straight-line basis.

Under the requirements of ASU 2018-07, the Company accounts for stock-based compensation to nonemployees under the fair value method, which requires all such compensation to be calculated based on the fair value at the measurement date (generally the grant date) and recognized in the Company’s condensed consolidated statements of operations and comprehensive loss over the requisite service period. The Company accounts for forfeitures of stock-based awards as they occur.

Net Loss Per Share

Net Loss Per Share

Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Since the Company was in a loss position for the periods presented, basic net loss is the same as diluted net loss since the effects of potentially dilutive securities are antidilutive. Potentially dilutive securities include all outstanding warrants, stock options, Earnout Consideration (see Note 15 – “Net Loss Per Share”), unvested restricted stock awards and restricted stock units. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares (as defined in Note 15)) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. In periods in which there is net income, the Company would apply the two-class method to compute net income per share. Under this method, earnings are allocated to common stock and participating securities based on their respective rights to receive dividends, as if all undistributed earnings for the period were distributed. The two-class method does not apply in periods in which a net loss is reported.

Income Taxes

Income Taxes

The Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740, Income Taxes (“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and liabilities of a change in tax rate is recognized in the period that includes the enactment date. A valuation allowance is recorded if it is more-likely-than-not that some portion or all the deferred tax assets will not be realized in future periods. At June 30, 2025 and December 31, 2024, the Company recorded a full valuation allowance on its deferred tax assets.

The Company follows the guidance in ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties related to tax positions in income tax expense as applicable.

Defined Contribution Plan

Defined Contribution Plan

The Company has a defined retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Effective January 1, 2023, the Company participates in a matching safe harbor 401(k) Plan with a Company contribution of up to 3.5% of each eligible participating employee’s compensation. Safe harbor contributions vest immediately for each participant. During the three and six months ended June 30, 2025, the Company made $119,000 and $239,000, respectively, in contributions under this safe harbor 401(k) Plan. During the three and six months ended June 30, 2024, the Company made $135,000 and $222,000, respectively, in contributions under this safe harbor 401(k) Plan.

Comprehensive Loss

Comprehensive Loss

Comprehensive loss is comprised of net loss and changes in unrealized gains and losses on the Company’s available-for-sale investments.

Segment Reporting

Segment Reporting

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in one segment. For further discussion on Segment Reporting, see Note 14 - “Segment Disclosures.”

New Accounting Standards

New Accounting Standards

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires additional income tax disclosures in the annual consolidated financial statements. The amendments in ASU 2023-09 are intended to enhance the transparency and decision usefulness of income tax disclosures. For public entities, ASU 2023-09 is effective for annual periods beginning after December 15, 2024, with early adoption permitted. As an emerging growth company that has not opted out of the extended transition period for complying with new or revised financial accounting standards, the amendments in ASU 2023-09 are effective for the Company for fiscal years beginning after December 15, 2025, with early adoption permitted.

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“ASU 2024-03”) to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026. Early adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2024-03 on its condensed consolidated financial statements.

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Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2025

Summary of Significant Accounting Policies

Schedule of property and equipment useful lives

Asset category	Depreciable life
Manufacturing equipment	10 years
Office equipment	3 – 7 years
Research and development equipment	7 years

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Terumo Agreement (Tables)

6 Months Ended

Jun. 30, 2025

Terumo Agreement.

Schedule of deferred revenue

Deferred Revenue – December 31, 2024	$	15,428
Revenue recognized		(1,399)
Deferred Revenue – June 30, 2025	$	14,029

Deferred Revenue – December 31, 2023	$	17,433
Revenue recognized		(1,125)
Deferred Revenue – June 30, 2024	$	16,308

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Financial Instruments and Fair Value Measurements (Tables)

6 Months Ended

Jun. 30, 2025

Financial Instruments and Fair Value Measurements

Schedule of financial assets and liabilities measured at fair value

	June 30, 2025
(in thousands)	Level 1		Level 2		Level 3		Total
Assets
Money market fund (included in cash and cash equivalents)	$	9,147	$	—	$	—	$	9,147
Corporate and government debt securities (included in Marketable securities)		—		15,175		—		15,175
Total assets	$	9,147	$	15,175	$	—	$	24,322

	December 31, 2024
(in thousands)	Level 1		Level 2		Level 3		Total
Assets
Money market fund (included in cash and cash equivalents)	$	12,248	$	—	$	—	$	12,248
Corporate and government debt securities (included in Marketable securities)		—		44,551		—		44,551
Total assets	$	12,248	$	44,551	$	—	$	56,799

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Marketable Securities and Strategic Investments (Tables)

6 Months Ended

Jun. 30, 2025

Marketable Securities and Strategic Investments

Schedule of marketable securities

	June 30, 2025
	Amortized		Unrealized		Unrealized		Fair
(in thousands)	Cost Basis		Gains		Losses		Value
Corporate debt securities	$	14,369	$	17	$	(1)	$	14,385
Government debt securities		790		—		—		790
Total	$	15,159	$	17	$	(1)	$	15,175

	December 31, 2024
	Amortized		Unrealized		Unrealized		Fair
(in thousands)	Cost Basis		Gains		Losses		Value
Corporate debt securities	$	43,724	$	57	$	(5)	$	43,776
Government debt securities		775		—		—		775
Total	$	44,499	$	57	$	(5)	$	44,551

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Balance Sheet Components (Tables)

6 Months Ended

Jun. 30, 2025

Balance Sheet Components

Schedule of property and equipment balances, net

	June 30,		December 31,
(in thousands)	2025		2024
Equipment	$	2,231	$	2,084
Office furniture		443		444
Leasehold improvements		159		159
Property and equipment, gross		2,833		2,687
Less accumulated depreciation and amortization		(1,467)		(1,303)
Total Property and equipment, net	$	1,366	$	1,384

Schedule of accrued expenses and other liabilities

	June 30,		December 31,
(in thousands)	2025		2024
Clinical trial accruals	$	3,796	$	2,893
Accrued compensation		1,975		2,612
Other accrued expenses		879		579
Total Accrued expenses and other liabilities	$	6,650	$	6,084

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Warrants (Tables)

6 Months Ended

Jun. 30, 2025

Warrants

Schedule of purchase shares of Company Common Stock

The following table summarizes outstanding warrants to purchase shares of Company Common Stock as of June 30, 2025 and December 31, 2024:

	Number of Shares
	June 30,	December 31,	Exercise
	2025	2024	Price	Term
Equity-classified Warrants
Legacy Orchestra Warrants	507,841	507,841	$1.08 – $30.11	0.10 – 8.75
Hercules Warrants (Note 13)	52,264	52,264	$5.74	3.50
Avenue Warrants	27,707	27,707	$7.67	2.50
Non-employee Warrants	60,000	—	$4.69	3.12
Private Warrants Held by Sponsor*	750,000	750,000	$11.50	4.32 – 4.57
Private Warrants Held by Employees	660,000	660,000	$11.50	4.32
Total Outstanding	2,057,812	1,997,812

*Sponsor is defined as HSAC2 Holdings, LLC

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Stock-Based Compensation (Tables)

6 Months Ended

Jun. 30, 2025

Stock-Based Compensation

Schedule of cost related to stock-based compensation

Total stock-based compensation related to option issuances was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	666	$	308	$	1,273	$	817
Selling, general and administrative		692		710		1,331		1,191
Total stock-based compensation	$	1,358	$	1,018	$	2,604	$	2,008

Total stock-based compensation related to restricted stock awards and restricted stock units was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	528	$	392	$	993	$	739
Selling, general and administrative		1,036		1,086		1,986		2,073
Total stock-based compensation	$	1,564	$	1,478	$	2,979	$	2,812

Total stock-based compensation related to warrants was as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	121	$	121	$	241	$	241
Selling, general and administrative		207		144		391		288
Total stock-based compensation	$	328	$	265	$	632	$	529

Schedule of stock option activity

		Weighted		Weighted
	Shares	Average		Average	Aggregate
	Underlying	Exercise		Remaining	Intrinsic
	Options	Price		Term (years)	Value
Outstanding at January 1, 2025	5,696,845	$	7.17	7.39	$	3,000
Granted	1,438,524		3.06	—		—
Exercised	(28,251)		4.41	—		33,011
Forfeited/canceled	(143,353)		6.69	—		—
Outstanding June 30, 2025	6,963,765	$	6.34	7.56	$	1,770
Exercisable at June 30, 2025	4,072,270	$	7.54	6.36	$	—

Schedule of restricted stock activity

	Restricted Stock	Weighted Average
	Awards/Units	Grant Date Fair
	Outstanding	Value
Outstanding at January 1, 2025	2,094,584	$	6.54
Granted	682,365		2.85
Vested	(625,414)		6.95
Outstanding June 30, 2025	2,151,535	$	5.26

Schedule of estimated grant-date fair value calculated using Black-Scholes option pricing model

	Six Months Ended June 30,
	2025			2024
Expected term (in years)		6.08			6.15
Expected volatility		80	%		71	%
Risk-free interest rate		3.92	%		4.44	%
Expected dividend yield		0	%		0	%
Fair value of common stock		3.06			5.29

XML

Leases (Tables)

6 Months Ended

Jun. 30, 2025

Leases

Schedule of recognized as an asset and operating lease liabilities

As of June 30, 2025:
Weighted average remaining lease term – operating leases, in years	2.63
Weighted average discount rate – operating leases	9.92	%

Schedule of future minimum rental payments, exclusive of taxes, insurance and other costs, under the leases

	Operating
	Leases
Year ending December 31:	(in thousands)
2025 (remaining six months)	$	373
2026		880
2027		829
2028		159
2029		—
Thereafter		—
Total future minimum lease payments	$	2,241
Imputed interest		(271)
Total liability	$	1,970

XML

Debt Financing (Tables)

6 Months Ended

Jun. 30, 2025

Debt Financing

Schedule of amount of principal payments due

	Principal
	Payments
Year ending December 31:	(in thousands)
2025 (remaining six months)	$	—
2026		570
2027		7,187
2028		7,243
Total	$	15,000

XML

Segment Disclosures (Tables)

6 Months Ended

Jun. 30, 2025

Segment Disclosures

Schedule of significant expense categories regularly reviewed by the CODM

	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
(in thousands)
Partnership revenue	$	667	$	628	$	1,399	$	1,125
Product revenue		169		150		305		273
Expenses:
Cost of product revenues		46		44		90		78
Non-clinical development costs		4,607		4,648		9,072		7,947
Clinical development costs		2,633		1,504		5,575		2,547
Personnel and consulting costs		7,002		5,913		13,666		11,407
Stock-based compensation		3,250		2,761		6,215		5,349
Depreciation expense		81		74		164		148
Other segment expenses(1)		2,544		2,716		5,170		5,283
Interest income (expense), net		36		(902)		(130)		(1,918)
Net Loss	$	(19,363)	$	(15,980)	$	(38,118)	$	(29,443)

¹Other segment expenses primarily include general and administrative costs not presented in other line items.

XML

Net Loss Per Share (Tables)

6 Months Ended

Jun. 30, 2025

Net Loss Per Share

Schedule of calculation of diluted net loss per share

	Three and Six Months Ended June 30,
	2025	2024
Stock options	6,963,765	5,164,962
Company common stock warrants	2,057,812	1,945,548
Unvested restricted stock equity awards	2,151,535	2,475,786
Forfeitable shares	500,000	500,000
Earnout consideration	4,000,000	4,000,000
Total	15,673,112	14,086,296

XML

Organization and Basis of Presentation (Details) - USD ($) $ in Thousands	Jun. 30, 2025	Dec. 31, 2024
Organization and Basis of Presentation
Accumulated deficit	$ (347,996)	$ (309,878)

XML

Summary of Significant Accounting Policies - Other (Details)		3 Months Ended		6 Months Ended
	Jan. 01, 2023	Jun. 30, 2025 USD ($)	Jun. 30, 2024 USD ($)	Jun. 30, 2025 USD ($) segment	Jun. 30, 2024 USD ($)	Dec. 31, 2024 USD ($)
Defined Benefit Plan, Plan Assets, Allocation [Line Items]
Allowance for doubtful accounts receivable		$ 0		$ 0		$ 0
Inventory impairment charge		0		0		0
Impairment of long-lived assets				0
Defined contribution plan, percentage	3.50%
Contribution		119,000	$ 135,000	$ 239,000	$ 222,000
Number of Reportable Segments | segment				1
Strategic investments		$ 2,495,000		$ 2,495,000		$ 2,495,000
Terumo Agreement
Partnership revenues
Term of billing from date of milestone achievement				10 days
Term of royalty payments from close of each quarter				20 days
Term of optional services from receipt of invoice				20 days
Term of SirolimusERF from receipt of shipping invoice				30 days

XML

Summary of Significant Accounting Policies - Schedule of property and equipment (Details)	Jun. 30, 2025
Manufacturing equipment
Schedule of Property and Equipment, Net
Total asset category	10 years
Office equipment | Minimum
Schedule of Property and Equipment, Net
Total asset category	3 years
Office equipment | Maximum
Schedule of Property and Equipment, Net
Total asset category	7 years
Research and development equipment
Schedule of Property and Equipment, Net
Total asset category	7 years

XML

Terumo Agreement - Other (Details) - Collaborative Arrangement - Terumo $ in Millions	1 Months Ended		6 Months Ended	12 Months Ended
	Jun. 30, 2022 USD ($)	Jun. 30, 2019 USD ($)	Jun. 30, 2025 USD ($) item	Dec. 31, 2019 USD ($)
Terumo Agreement
Upfront payment received		$ 30.0		$ 30.0
Amount invested for financing	$ 2.5	2.5
Amount receivable on Milestones		35.0
Number of target milestone payment date already passed | item			3
Target milestone payment date already passed			$ 5.0
Remaining time-based milestones by the specified target achievement		$ 20.0
Stock purchase and the revenue generating elements				32.5
Estimated fair value of the shares				2.5
Transaction price				$ 30.0
Minimum
Terumo Agreement
Royalty receivable percentage		10.00%
Sales-based royalties percentage				10.00%
Maximum
Terumo Agreement
Equity commitment		$ 5.0
Upfront payment and additional payments on the achievement milestone		$ 65.0
Royalty receivable percentage		15.00%
Sales-based royalties percentage				15.00%

XML

Terumo Agreement - Deferred revenue (Details) - Collaborative Arrangement - Terumo - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024
Changes in the Company's deferred revenue balance
Deferred Revenue - Beginning balance	$ 15,428	$ 17,433
Revenue recognized	(1,399)	(1,125)
Deferred Revenue - Ending balance	$ 14,029	$ 16,308

XML

Terumo Agreement - Remaining performance obligation (Details) $ in Millions	Jun. 30, 2025 USD ($)
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-07-01
Terumo Agreement
Revenue remaining performance obligation amount	$ 4.5
Remaining performance obligation recognition period	12 months
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-07-01
Terumo Agreement
Revenue remaining performance obligation amount	$ 9.5
Remaining performance obligation recognition period	24 months

XML

Terumo Agreement - Other narratives (Details) - Collaborative Arrangement - Terumo - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024	Jun. 30, 2025	Jun. 30, 2024
Terumo Agreement
Cost incurred	$ 3,300,000	$ 4,000,000	$ 6,800,000	$ 6,900,000
Estimated total costs increase (decrease) percentage				2.80%
Increase (decrease) in revenue from change in estimate	$ (21,000)	$ (220,000)	$ (27,000)	$ (382,000)
Arrangement, Change in Estimate, Increase (Decrease) in Earnings Per Share, Basic		$ (0.01)		$ (0.01)
Arrangement, Change in Estimate, Increase (Decrease) in Earnings Per Share, Diluted		$ (0.01)		$ (0.01)

XML

Medtronic Agreement (Details) - Medtronic Agreement - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024	Jun. 30, 2025	Jun. 30, 2024
Medtronic agreement
Reimbursable research and development expense	$ 4,000,000	$ 1,900,000	$ 7,400,000	$ 3,100,000
Proceeds from issuance of Series D-2 Preferred Stock			40,000,000
Revenue recognized to date	$ 0		0
Minimum
Medtronic agreement
Expected to receive product price			500
Maximum
Medtronic agreement
Expected to receive product price			1,600
Accounts Payable and Accrued Expenses
Medtronic agreement
Reimbursable research and development expense			$ 6,200,000

XML

Financial Instruments and Fair Value Measurements - Schedule of financial assets and liabilities measured at fair value (Details) - USD ($) $ in Thousands	6 Months Ended	12 Months Ended
	Jun. 30, 2025	Dec. 31, 2024
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Total assets	$ 24,322	$ 56,799
Assets transfers within levels	0	0
Liabilities transfers within levels	0	0
Money market fund (included in cash and cash equivalents)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Total assets	9,147	12,248
Corporate and government debt securities (included in Marketable securities)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Total assets	15,175	44,551
Level 1
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Total assets	9,147	12,248
Level 1 | Money market fund (included in cash and cash equivalents)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Total assets	9,147	12,248
Level 2
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Total assets	15,175	44,551
Level 2 | Corporate and government debt securities (included in Marketable securities)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Total assets	$ 15,175	$ 44,551

XML

Marketable Securities and Strategic Investments - (Other Information) (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024	Jun. 30, 2025	Jun. 30, 2024
Marketable Securities
Realized gains	$ 0	$ 0	$ 0	$ 0
Realized losses	0	$ 0	0	0
Debt securities with maturities between 12 and 36 months	$ 1,300,000		1,300,000
Strategic investments Motus GI
Marketable Securities
Impairment charge			$ 0	$ 0

XML

Marketable Securities and Strategic Investments - Schedule of marketable securities (Details) - USD ($) $ in Thousands	Jun. 30, 2025	Dec. 31, 2024
Marketable Securities
Amortized Cost Basis	$ 15,159	$ 44,499
Unrealized Gains	17	57
Unrealized Losses	(1)	(5)
Fair Value	15,175	44,551
Corporate debt Securities
Marketable Securities
Amortized Cost Basis	14,369	43,724
Unrealized Gains	17	57
Unrealized Losses	(1)	(5)
Fair Value	14,385	43,776
Government debt securities
Marketable Securities
Amortized Cost Basis	790	775
Fair Value	$ 790	$ 775

XML

Balance Sheet Components - Other (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024	Jun. 30, 2025	Jun. 30, 2024
Balance Sheet Components
Depreciation and amortization expense	$ 81,000	$ 74,000	$ 164,000	$ 148,000

XML

Balance Sheet Components - Schedule of property and equipment, net (Details) - USD ($) $ in Thousands	Jun. 30, 2025	Dec. 31, 2024
Schedule of Property and Equipment, Net
Property and equipment, gross	$ 2,833	$ 2,687
Less accumulated depreciation and amortization	(1,467)	(1,303)
Total Property and equipment, net	1,366	1,384
Equipment
Schedule of Property and Equipment, Net
Property and equipment, gross	2,231	2,084
Office furniture
Schedule of Property and Equipment, Net
Property and equipment, gross	443	444
Leasehold improvements
Schedule of Property and Equipment, Net
Property and equipment, gross	$ 159	$ 159

XML

Balance Sheet Components - Schedule of accrued expenses and other liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2025	Dec. 31, 2024
Balance Sheet Components
Clinical trial accruals	$ 3,796	$ 2,893
Accrued compensation	1,975	2,612
Other accrued expenses	879	579
Total Accrued expenses and other liabilities	$ 6,650	$ 6,084

XML

Common and Preferred Stock - Other Information (Details) - $ / shares	Jun. 30, 2025	Dec. 31, 2024
Common Stock
Common stock, shares authorized	340,000,000	340,000,000
Preferred Stock
Preference shares, shares authorized	10,000,000	10,000,000
Preference shares, par value (in Dollars per share)	$ 0.0001	$ 0.0001
Preference shares, shares outstanding	0	0

XML

Common and Preferred Stock - At-the-Market Offering and Shelf Registration Statement (Details) - USD ($) $ in Millions		6 Months Ended
	Jul. 11, 2024	Jun. 30, 2025	Aug. 12, 2024	May 15, 2024
Prior Agreement
Common and Preferred Stock
Aggregate offering price of common stock			$ 84.5	$ 100.0
Shares issued (in shares)	2,000,000
Aggregate gross proceeds from common stock	$ 15.5
Net proceeds from common stock	$ 15.0
Shelf registration statement
Common and Preferred Stock
Total aggregate offering price of common stock				$ 300.0
Shares issued (in shares)		0
Sales agreement
Common and Preferred Stock
Aggregate offering price of common stock			$ 100.0
Shares issued (in shares)		0

XML

Warrants - Other (Details) - Non-employee Warrants	Feb. 28, 2025 USD ($) $ / shares shares	Jun. 30, 2025 $ / shares
Warrants
Number of warrants issued | shares	60,000
Exercise Price | $ / shares	$ 4.69	$ 4.69
Warrant liability, Fair value | $	$ 187,000
Expected volatility
Warrants
Warrants, measurement input	1.101
Risk-free interest rate
Warrants
Warrants, measurement input	0.0399

XML

Warrants - Private Warrants and Assumed Legacy Orchestra Warrants (Details) - $ / shares	Jun. 30, 2025	Feb. 28, 2025	Dec. 31, 2024
Equity-classified Warrants
Warrants
Warrants	2,057,812		1,997,812
Legacy Orchestra Warrants
Warrants
Warrants	507,841		507,841
Legacy Orchestra Warrants | Minimum
Warrants
Exercise Price	$ 1.08
Term	1 month 6 days
Legacy Orchestra Warrants | Maximum
Warrants
Exercise Price	$ 30.11
Term	8 years 9 months
Hercules Warrants
Warrants
Warrants	52,264		52,264
Exercise Price	$ 5.74
Term	3 years 6 months
Avenue Warrants
Warrants
Warrants	27,707		27,707
Exercise Price	$ 7.67
Term	2 years 6 months
Non-employee Warrants
Warrants
Warrants	60,000
Exercise Price	$ 4.69	$ 4.69
Term	3 years 1 month 13 days
Private Warrants Held by Sponsor
Warrants
Warrants	750,000		750,000
Exercise Price	$ 11.5
Private Warrants Held by Sponsor | Minimum
Warrants
Term	4 years 3 months 25 days
Private Warrants Held by Sponsor | Maximum
Warrants
Term	4 years 6 months 25 days
Private Warrants Held by Employees
Warrants
Warrants	660,000		660,000
Exercise Price	$ 11.5
Term	4 years 3 months 25 days

XML

Stock-Based Compensation - Other (Details)		6 Months Ended
	Feb. 28, 2025 Y $ / shares shares	Jun. 30, 2025 $ / shares shares
2023 Plan | Legacy Orchestra
Stock-Based Compensation
Number of shares authorized		1,000,000
Percentage of shares outstanding		4.80%
Shares available for future issuance		3,036,722
2023 Plan | Legacy Orchestra | Maximum
Stock-Based Compensation
Expiration period (in years)		10 years
Vesting period (in years)		4 years
Non-employee Warrants
Stock-Based Compensation
Number of warrants issued	60,000
Exercise Price | $ / shares	$ 4.69	$ 4.69
Warrants exercisable	6,000
Warrants vesting period	8 months
Non-employee Warrants | Expected term (in years)
Stock-Based Compensation
Warrants, measurement input | Y	3.12
Non-employee Warrants | Expected volatility
Stock-Based Compensation
Warrants, measurement input	1.101
Non-employee Warrants | Risk-free interest rate
Stock-Based Compensation
Warrants, measurement input	0.0399
Non-employee Warrants | Expected dividend yield
Stock-Based Compensation
Warrants, measurement input	0
Non-employee Warrants | Fair value of common stock
Stock-Based Compensation
Warrants, measurement input | $ / shares	3.12

XML

Stock-Based Compensation - Schedule of cost related to stock-based compensation (Details) - 2023 Plan - Legacy Orchestra - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024	Jun. 30, 2025	Jun. 30, 2024
Stock options
Stock-Based Compensation
Total stock-based compensation	$ 1,358,000	$ 1,018,000	$ 2,604,000	$ 2,008,000
Unrecognized stock-based compensation expense for options	7,800,000		$ 7,800,000
Expected period to be recognized			2 years 9 months 18 days
Stock options | Research and development
Stock-Based Compensation
Total stock-based compensation	666,000	308,000	$ 1,273,000	817,000
Stock options | Selling, general and administrative
Stock-Based Compensation
Total stock-based compensation	692,000	710,000	1,331,000	1,191,000
Restricted Stock
Stock-Based Compensation
Total stock-based compensation	1,564,000	1,478,000	2,979,000	2,812,000
Unrecognized stock-based compensation expense for options	8,300,000		$ 8,300,000
Expected period to be recognized			2 years
Restricted Stock | Research and development
Stock-Based Compensation
Total stock-based compensation	528,000	392,000	$ 993,000	739,000
Restricted Stock | Selling, general and administrative
Stock-Based Compensation
Total stock-based compensation	1,036,000	1,086,000	1,986,000	2,073,000
Warrant
Stock-Based Compensation
Total stock-based compensation	328,000	265,000	632,000	529,000
Unrecognized stock-based compensation expense for options	687,000		$ 687,000
Expected period to be recognized			7 months 6 days
Warrant | Research and development
Stock-Based Compensation
Total stock-based compensation	121,000	121,000	$ 241,000	241,000
Warrant | Selling, general and administrative
Stock-Based Compensation
Total stock-based compensation	$ 207,000	$ 144,000	$ 391,000	$ 288,000

XML

Stock-Based Compensation - Schedule of stock option activity (Details) - 2023 Plan - USD ($) $ / shares in Units, $ in Thousands	6 Months Ended		12 Months Ended
	Jun. 30, 2025	Jun. 30, 2024	Dec. 31, 2024
Shares Underlying Options
Shares Underlying Options, Beginning	5,696,845
Shares Underlying Options, Granted	1,438,524
Shares Underlying Options, Exercised	(28,251)
Shares Underlying Options, Forfeited/canceled	(143,353)
Shares Underlying Options, Ending	6,963,765		5,696,845
Shares Underlying Options, Exercisable	4,072,270
Weighted Average Exercise Price
Weighted Average Exercise Price Outstanding, Beginning	$ 7.17
Weighted Average Exercise Price, Granted	3.06
Weighted Average Exercise Price, Exercised	4.41
Weighted Average Exercise Price, Forfeited/canceled	6.69
Weighted Average Exercise Price Outstanding, Ending	6.34		$ 7.17
Weighted Average Exercise Price, Exercisable	$ 7.54
Weighted Average Remaining Term (years) and Aggregate Intrinsic Value
Weighted Average Remaining Term (years), Outstanding	7 years 6 months 21 days		7 years 4 months 20 days
Weighted Average Remaining Term (years), Exercisable	6 years 4 months 9 days
Aggregate Intrinsic Value Outstanding	$ 1,770		$ 3,000
Aggregate Intrinsic Value, Exercised	$ 33,011
Weighted average grant date fair value	$ 2.18	$ 3.56

XML

Stock-Based Compensation - Schedule of restricted stock activity (Details) - USD ($) $ / shares in Units, $ in Millions	3 Months Ended	6 Months Ended
	Jun. 30, 2025	Jun. 30, 2025
Restricted Stock
Restricted Stock Outstanding
Restricted stock, Beginning		2,094,584
Restricted stock, Granted		682,365
Restricted stock, Vested		(625,414)
Restricted stock, Ending	2,151,535	2,151,535
Weighted Average Grant Date Fair Value
Weighted Average Grant Date Fair Value, Beginning		$ 6.54
Weighted Average Grant Date Fair Value, Granted		2.85
Weighted Average Grant Date Fair Value, Vested		6.95
Weighted Average Grant Date Fair Value, Ending	$ 5.26	$ 5.26
Aggregate Intrinsic Value, Vested	$ 1.4	$ 2.2
Performance-Based Restricted Stock Awards
Restricted Stock Outstanding
Restricted stock, Granted		0

XML

Stock-Based Compensation - Schedule of estimated grant-date fair value calculated using Black-Scholes option pricing model (Details) - Stock options - $ / shares	6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024
Stock-Based Compensation
Expected term	6 years 29 days	6 years 1 month 24 days
Expected volatility	80.00%	71.00%
Risk-free interest rate	3.92%	4.44%
Expected dividend yield	0.00%	0.00%
Fair value of common stock	$ 3.06	$ 5.29

XML

Leases - Other (Details)	1 Months Ended			3 Months Ended		6 Months Ended
	Nov. 30, 2024 USD ($)	Aug. 31, 2024 USD ($) ft²	Nov. 30, 2022 USD ($) ft²	Jun. 30, 2025 USD ($)	Jun. 30, 2024 USD ($)	Jun. 30, 2025 USD ($)	Jun. 30, 2024 USD ($)	Sep. 30, 2024 ft²	Nov. 30, 2019 ft²
Leases
Lease space | ft²		8,052	7,800					6,496	5,200
Rent lease expense				$ 274,000	$ 224,000	$ 533,000	$ 443,000
Variable lease costs				$ 19,000	$ 38,000	50,000	100,000
Cash paid for operating lease liabilities						$ 503,000	$ 454,000
Minimum
Leases
Monthly rent expense	$ 16,000	$ 17,000	$ 28,000
Maximum
Leases
Monthly rent expense	$ 17,000	$ 19,000	$ 40,000

XML

Leases - Schedule of recognized as an asset and operating lease liabilities (Details)	Jun. 30, 2025
Leases
Weighted average remaining lease term - operating leases, in years	2 years 7 months 17 days
Weighted average discount rate - operating leases	9.92%

XML

Leases - Schedule of future minimum rental payments, exclusive of taxes, insurance and other costs, under the leases (Details) $ in Thousands	Jun. 30, 2025 USD ($)
Operating Lease Maturity
2025 (remaining six months)	$ 373
2026	880
2027	829
2028	159
2029
Thereafter
Total future minimum lease payments	2,241
Imputed interest	(271)
Total liability	$ 1,970

XML

Debt Financing (Details)		3 Months Ended	6 Months Ended
	Nov. 06, 2024 USD ($) tranche item $ / shares	Jun. 30, 2025 USD ($) $ / shares shares	Jun. 30, 2025 USD ($) $ / shares shares	Jun. 30, 2024 USD ($)	Dec. 31, 2024 shares
Hercules Warrants
Debt Financing
Exercise Price | $ / shares		$ 5.74	$ 5.74
Warrants expiry term		3 years 6 months	3 years 6 months
Warrants outstanding (in shares) | shares		52,264	52,264		52,264
2024 Loan and Security Agreement
Debt Financing
Term loan	$ 50,000,000
Number of tranches | tranche	4
Interest rate variable (as a percent)	2.00%
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]	us-gaap:PrimeRateMember
Repayment terms of the loan	4 years
Repayment of interest only term	2 years
Number of principal plus interest payments | item	24
Extension term of interest-only period	6 months
End of term charge (in percent)	6.35%
Facility charge (in percent)	0.75%
Interest expense		$ 466,000	$ 928,000	$ 0
Maximum market capitalization, upon which minimum cash covenant waived off	$ 500,000,000
2024 Loan and Security Agreement | Prepayment within 12 months of agreement closing date
Debt Financing
Prepayment premium	3.00%
2024 Loan and Security Agreement | Prepayment after 12 months but within 24 months of agreement closing date
Debt Financing
Prepayment premium	2.00%
2024 Loan and Security Agreement | Prepayment after 24 months of agreement closing date
Debt Financing
Prepayment premium	1.00%
2024 Loan and Security Agreement | Period Prior To December 1, 2025
Debt Financing
Qualified cash, multiplier to outstanding principle amount	35.00%
2024 Loan and Security Agreement | Before Occurrence Of Performance Milestone Date
Debt Financing
Qualified cash, multiplier to outstanding principle amount	50.00%
2024 Loan and Security Agreement | On Or After Occurrence Of Performance Milestone Date [Member]
Debt Financing
Qualified cash, multiplier to outstanding principle amount	35.00%
2024 Loan and Security Agreement | Hercules Warrants
Debt Financing
Multiplier factor used to calculate common stock	0.02
Exercise Price | $ / shares	$ 5.74
Warrants expiry term	7 years
2024 Loan and Security Agreement | Maximum
Debt Financing
Interest rate stated (as a percent)	9.50%
Tranche one loan and security agreement
Debt Financing
Term loan	$ 15,000,000
Tranche two and three loan and security agreement
Debt Financing
Term loan	15,000,000
Tranche four loan and security agreement
Debt Financing
Term loan	$ 20,000,000

XML

Debt Financing - Schedule of amount of principal payments (Details) $ in Thousands	Jun. 30, 2025 USD ($)
Debt Maturity
2025 (remaining six months)
2026	570
2027	7,187
2028	7,243
Total	$ 15,000

XML

Segment Disclosures (Details)	3 Months Ended				6 Months Ended
	Jun. 30, 2025 USD ($)	Mar. 31, 2025 USD ($)	Jun. 30, 2024 USD ($)	Mar. 31, 2024 USD ($)	Jun. 30, 2025 USD ($) segment	Jun. 30, 2024 USD ($)
Segment Disclosures
Number of Reportable Segments | segment					1
Total revenue	$ 836,000		$ 778,000		$ 1,704,000	$ 1,398,000
Cost of product revenues	46,000		44,000		90,000	78,000
Depreciation expense	81,000		74,000		164,000	148,000
Interest income (expense), net	36,000		(902,000)		(130,000)	(1,918,000)
Net loss	(19,363,000)	$ (18,755,000)	(15,980,000)	$ (13,463,000)	(38,118,000)	(29,443,000)
Partnership revenue
Segment Disclosures
Total revenue	667,000		628,000		1,399,000	1,125,000
Product revenue
Segment Disclosures
Total revenue	169,000		150,000		305,000	273,000
Single Reportable Segment
Segment Disclosures
Cost of product revenues	46,000		44,000		90,000	78,000
Personnel and consulting costs	7,002,000		5,913,000		13,666,000	11,407,000
Stock-based compensation	3,250,000		2,761,000		6,215,000	5,349,000
Depreciation expense	81,000		74,000		164,000	148,000
Other segment expenses	2,544,000		2,716,000		5,170,000	5,283,000
Interest income (expense), net	36,000		(902,000)		(130,000)	(1,918,000)
Net loss	(19,363,000)		(15,980,000)		(38,118,000)	(29,443,000)
Single Reportable Segment | Partnership revenue
Segment Disclosures
Total revenue	667,000		628,000		1,399,000	1,125,000
Single Reportable Segment | Product revenue
Segment Disclosures
Total revenue	169,000		150,000		305,000	273,000
Single Reportable Segment | Non-clinical development costs
Segment Disclosures
Development costs	4,607,000		4,648,000		9,072,000	7,947,000
Single Reportable Segment | Clinical development costs
Segment Disclosures
Development costs	$ 2,633,000		$ 1,504,000		$ 5,575,000	$ 2,547,000

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Net Loss Per Share (Details)	Apr. 12, 2023 shares	Jan. 26, 2023 D $ / shares shares
HSAC 2 Holdings, LLC
Net Loss Per Share
Sponsor share forfeiture (as percent)		25.00%
Number of shares forfeiture by sponsor		1,000,000
HSAC 2 Holdings, LLC | Initial Milestone Event
Net Loss Per Share
Number of shares forfeiture by sponsor		500,000
Sponsor share forfeiture, stock price trigger | $ / shares		$ 15
Sponsor share forfeiture, threshold trading days | D		20
Sponsor share forfeiture, threshold consecutive trading days | D		30
HSAC 2 Holdings, LLC | Final Milestone Event
Net Loss Per Share
Number of shares forfeiture by sponsor		500,000
Sponsor share forfeiture, stock price trigger | $ / shares		$ 20
Sponsor share forfeiture, threshold trading days | D		20
Sponsor share forfeiture, threshold consecutive trading days | D		30
HSAC2
Net Loss Per Share
Percent of shareholders elected to participate in earnout		91.00%
HSAC2 | Initial Milestone Event
Net Loss Per Share
Number of shares issuable as earnout consideration	4,000,000	4,000,000
Number of shares issuable as earnout consideration due to rounding	3,999,987
Forfeitable shares	500,000
HSAC2 | Final Milestone Event
Net Loss Per Share
Number of shares issuable as earnout consideration		4,000,000
HSAC2 | Minimum
Net Loss Per Share
Share lock up period		6 months
HSAC2 | Maximum
Net Loss Per Share
Share lock up period		12 months
Number of shares issuable as earnout consideration		8,000,000
HSAC2 | Maximum | Initial Milestone Event
Net Loss Per Share
Number of shares issuable as earnout consideration	4,000,000

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Net Loss Per Share - Schedule of calculation of diluted net loss per share (Details) - shares	6 Months Ended
	Jun. 30, 2025	Jun. 30, 2024
Anti-dilutive Securities
Antidilutive securities	15,673,112	14,086,296
Stock options
Anti-dilutive Securities
Antidilutive securities	6,963,765	5,164,962
Company common stock warrants
Anti-dilutive Securities
Antidilutive securities	2,057,812	1,945,548
Unvested restricted stock equity awards
Anti-dilutive Securities
Antidilutive securities	2,151,535	2,475,786
Forfeitable shares
Anti-dilutive Securities
Antidilutive securities	500,000	500,000
Earnout consideration
Anti-dilutive Securities
Antidilutive securities	4,000,000	4,000,000

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Subsequent Events - Ligand Pharmaceuticals Incorporated Revenue Participation Right Purchase (Details) - Subsequent Events $ / shares in Units, $ in Millions	May 01, 2026 USD ($) shares	Aug. 04, 2025 USD ($) tranche $ / shares shares	Jul. 31, 2025 USD ($) shares
Underwritten public offering
Subsequent Events
Share Price | $ / shares		$ 2.75
Revenue Participation Right Purchase and Sale Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser")
Subsequent Events
Investment amount			$ 35.0
Revenue Participation Right Purchase and Sale Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Avim Therapy And Virtue Sab Products ("Products")
Subsequent Events
Annual net sales threshold			$ 100.0
Number of tranches | tranche		2
Revenue Participation Right Purchase and Sale Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Avim Therapy And Virtue Sab Products ("Products") | Tranche One
Subsequent Events
Investment amount		$ 20.0
Revenue Participation Right Purchase and Sale Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Avim Therapy And Virtue Sab Products ("Products") | Tranche Two
Subsequent Events
Investment amount	$ 15.0
Revenue Participation Right Purchase and Sale Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Avim Therapy And Virtue Sab Products ("Products") | Annual Net Sales of the Products less than or equal to $100 million | Minimum
Subsequent Events
Revenue sharing percentage (%)			17.00%
Revenue Participation Right Purchase and Sale Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Avim Therapy And Virtue Sab Products ("Products") | Annual Net Sales of the Products less than or equal to $100 million | Maximum
Subsequent Events
Revenue sharing percentage (%)			20.00%
Revenue Participation Right Purchase and Sale Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Avim Therapy And Virtue Sab Products ("Products") | Annual Net Sales of the Products greater than or equal to $100 million | Minimum
Subsequent Events
Revenue sharing percentage (%)			4.00%
Revenue Participation Right Purchase and Sale Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Avim Therapy And Virtue Sab Products ("Products") | Annual Net Sales of the Products greater than or equal to $100 million | Maximum
Subsequent Events
Revenue sharing percentage (%)			7.00%
Ligand Stock Purchase Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Underwritten public offering
Subsequent Events
Shares issued (in shares) | shares		1,818,181
Share Price | $ / shares		$ 2.75
Value of shares issued			$ 5.0
Ligand Stock Purchase Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Ligand Warrants
Subsequent Events
Exercise Price | $ / shares		$ 3.67
Warrants expiry term			10 years
Ligand Stock Purchase Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Ligand Warrants | Maximum
Subsequent Events
Number of warrants to be issued | shares		2,000,000
Ligand Stock Purchase Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Tranche One | Ligand Warrants
Subsequent Events
Number of warrants to be issued | shares			1,142,857
Ligand Stock Purchase Agreement | Ligand Pharmaceuticals Incorporated (the "Purchaser") | Tranche Two | Ligand Warrants
Subsequent Events
Number of warrants to be issued | shares	857,143

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Subsequent Events - Purchase of Shares by Medtronic and Loan Agreement with Medtronic and Amendment of Exclusive License and Collaboration Agreement (Details) - Subsequent Events - USD ($) $ / shares in Units, $ in Millions	Aug. 04, 2025	Jul. 31, 2025	Apr. 27, 2026
Underwritten public offering
Subsequent Events
Aggregate gross proceeds from common stock	$ 40.0
Share Price	$ 2.75
Maximum additional shares to be purchased	2,182,500
Medtronic
Subsequent Events
Shares issued (in shares)	4,077,427
Share Price	$ 2.75
Medtronic | Stock Purchase Agreements
Subsequent Events
Maximum additional shares to be purchased	132,282
Medtronic | Underwritten public offering
Subsequent Events
Maximum additional shares to be purchased	2,182,500
Loan Agreement | Medtronic | Secured Subordinated Convertible Promissory Note (the "Notes")
Subsequent Events
Debt original principal amount			$ 20.0
Interest rate stated (as a percent)		11.00%
Maturing or Repayment date of the Note		Apr. 27, 2031
Additional debt default interest rate (%)		2.00%
Loan Agreement | Medtronic | Secured Subordinated Convertible Promissory Note (the "Notes") | FDA approval of a Medtronic device incorporating AVIM is achieved prior to the Repayment Date
Subsequent Events
Debt extinguishment, percentage of revenue share amount (%)		15.00%
Debt extinguishment, Revenue Share Credit payments		$ 40.0

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Subsequent Events - Amendments to Hercules Loan and Security Agreement and Warrant Agreements (Details) $ / shares in Units, $ in Millions	Jul. 31, 2025 USD ($) $ / shares	Jul. 30, 2025 USD ($)	Jun. 30, 2025 $ / shares	Nov. 06, 2024 USD ($) $ / shares
Hercules Warrants
Subsequent Events
Price per share (in dollars per share) | $ / shares			$ 5.74
2024 Loan and Security Agreement
Subsequent Events
Term loan				$ 50.0
2024 Loan and Security Agreement | Hercules Warrants
Subsequent Events
Price per share (in dollars per share) | $ / shares				$ 5.74
Multiplier factor used to calculate common stock				0.02
Tranche four loan and security agreement
Subsequent Events
Term loan				$ 20.0
Tranche two and three loan and security agreement
Subsequent Events
Term loan				$ 15.0
Subsequent Events | 2024 Loan and Security Agreement | Minimum
Subsequent Events
Cash coverage percentage	60.00%
Subsequent Events | 2024 Loan and Security Agreement | Maximum
Subsequent Events
Cash coverage percentage	100.00%
Subsequent Events | 2024 Loan and Security Agreement | Hercules Warrants
Subsequent Events
Price per share (in dollars per share) | $ / shares	$ 3.58
Multiplier factor used to calculate common stock	0.04
Subsequent Events | Tranche four loan and security agreement
Subsequent Events
Increase in term loan	$ 15.0
Term loan	35.0	$ 20.0
Subsequent Events | Tranche two and three loan and security agreement
Subsequent Events
Amount of withdrawal of debt eliminated	$ 15.0

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Subsequent Events - Registration Rights Agreement (Details)	Aug. 04, 2025
Subsequent Events
Subsequent Events
Period to file shelf registration statement	90 days

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Subsequent Events - Public Offering (Details) - Subsequent Events - Underwritten public offering $ / shares in Units, $ in Millions	Aug. 04, 2025 USD ($) $ / shares shares
Subsequent Events
Number of shares issuable | shares	9,413,637
Share price | $ / shares	$ 2.75
Period to exercise option	30 days
Maximum additional shares to be purchased | shares	2,182,500
Aggregate gross proceeds from common stock | $	$ 40.0
Prefunded warrants
Subsequent Events
Share price | $ / shares	$ 2.7499
Number of warrants to be issued | shares	5,136,363
Price per share (in dollars per share) | $ / shares	$ 0.0001