0001104659-26-093357 | 10-Q | XBRL Viewer | Orchestra Biomed Holdings INC

Common and Preferred Stock (Tables)

6 Months Ended

Jun. 30, 2026

Schedule of roll-forward of the Series A Preferred Stock activity

A roll-forward of the Series A Preferred Stock activity is presented below for the six months ended June 30, 2026 (in thousands):


Beginning balance, January 1, 2026	$	9,808
Adjustment to carrying value of Series A Preferred Stock		289
Ending balance, June 30, 2026	$	10,097

- Definition

Tabular disclosure of temporary equity. Temporary equity is a security with redemption features that are outside the control of the issuer, is not classified as an asset or liability in conformity with GAAP, and is not mandatorily redeemable. Includes any type of security that is redeemable at a fixed or determinable price or on a fixed or determinable date or dates, is redeemable at the option of the holder, or has conditions for redemption which are not solely within the control of the issuer. If convertible, the issuer does not control the actions or events necessary to issue the maximum number of shares that could be required to be delivered under the conversion option if the holder exercises the option to convert the stock to another class of equity. If the security is a warrant or a rights issue, the warrant or rights issue is considered to be temporary equity if the issuer cannot demonstrate that it would be able to deliver upon the exercise of the option by the holder in all cases. Includes stock with put option held by ESOP and stock redeemable by holder only in the event of a change in control of the issuer.

+ References + Details

Warrants

6 Months Ended

Jun. 30, 2026

Warrants

Warrants

9. Warrants

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

Summarized Outstanding Warrants

The following table summarizes outstanding warrants to purchase shares of Common Stock as of June 30, 2026 and December 31, 2025:


		Number of Shares				Remaining
		June 30,		December 31,	Exercise	Term in
		2026		2025	Price	Years
Equity-classified Warrants
Pre-Funded Warrants⁽¹⁾		3,886,331		5,136,363	$0.0001	N/A
Ligand Warrant (Note 13)		2,000,000		2,000,000	$3.67	9.09
Orchestra BioMed, Inc. Warrants⁽²⁾		507,841		507,841	$1.08 – $30.11	0.93 – 2.07
Hercules Warrants (Note 14)		167,598		167,598	$3.58	5.36
Avenue Warrants		27,707		27,707	$7.67	2.27
Non-employee Warrants (Note 10)		60,000		60,000	$4.69	3.67
Private Warrants Held by Sponsor⁽³⁾		750,000		750,000	$11.50	6.58
Officer and Director Warrants⁽⁴⁾		635,000		635,000	$11.50	6.58
Total Outstanding		8,034,477		9,284,509

(1)

In August 2025, the Company received $2.7499 per the Pre-Funded Warrant issued, or $14.1 million in aggregate proceeds. Each Pre-Funded Warrant may be exercised for $0.0001 per Pre-Funded Warrant. During the six months ended June 30, 2026, 1,250,032 Pre-Funded Warrants were exercised in a cashless transaction.

(2)	Represents warrants initially issued by Orchestra BioMed, Inc., which converted into warrants to acquire Common Stock in connection with the Business Combination (the “Orchestra BioMed, Inc. Warrants”).

(3)

The Sponsor purchased 1,500,000 warrants to purchase shares of HSAC2 in a private placement upon consummation of the HSAC2 initial public offering (the “Private Warrants”), 750,000 of which were forfeited by the Sponsor immediately prior to the closing of the Business Combination (the “Sponsor Forfeiture”).

(4)

Pursuant to the terms of the Business Combination, immediately following the Sponsor Forfeiture and prior to the closing of the Business Combination, HSAC2 issued 750,000 warrants to purchase Common Stock to eleven specified employees and directors of Orchestra (the “Officer and Director Warrants”). These Officer and Director Warrants have substantially similar terms to the forfeited Private Warrants, except they were subject to vesting provisions that expired in January 2026. There are fewer than 750,000 Officer and Director Warrants outstanding currently due to forfeitures by persons that resigned from the Company prior to the vesting of the Officer and Director Warrants.

Marketable Securities and Strategic Investments (Tables)

6 Months Ended

Jun. 30, 2026

Marketable Securities and Strategic Investments

Schedule of marketable securities


		June 30, 2026
		Amortized			Unrealized			Unrealized			Fair
(in thousands)		Cost Basis			Gains			Losses			Value
Corporate debt securities		$	78,375		$	4		$	(74)		$	78,305
Government debt securities			11,197			—			(11)			11,186
Total		$	89,572		$	4		$	(85)		$	89,491


		December 31, 2025
		Amortized			Unrealized			Unrealized			Fair
(in thousands)		Cost Basis			Gains			Losses			Value
Corporate debt securities		$	69,308		$	60		$	(2)		$	69,366
Government debt securities			2,454			2			—			2,456
Total		$	71,762		$	62		$	(2)		$	71,822

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Jun. 30, 2026	Dec. 31, 2025
CURRENT ASSETS:
Cash and cash equivalents	$ 20,472	$ 34,690
Marketable securities	89,491	71,822
Accounts receivable, net	51	95
Inventory	250	310
Prepaid expenses and other current assets	977	994
Total current assets	111,241	107,911
Property and equipment, net	2,045	1,715
Right-of-use assets	1,171	1,496
Strategic investments		2,495
Deposits and other assets	1,243	1,240
TOTAL ASSETS	115,700	114,857
CURRENT LIABILITIES:
Accounts payable	6,132	6,095
Accrued expenses and other liabilities	6,531	9,890
Operating lease liability, current portion	808	751
Total current liabilities	13,471	16,736
Royalty purchase agreement	34,593	16,482
Note payable	20,442
Loans payable	14,397	14,268
Derivative liability	2,460	2,749
Operating lease liability, less current portion	520	936
Other long-term liabilities	397	308
TOTAL LIABILITIES	86,280	51,479
Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at June 30, 2026 and December 31, 2025; aggregate liquidation preference of $20,000	10,097	9,808
STOCKHOLDERS' EQUITY
Preferred stock, $0.0001 par value, 10,000,000 shares authorized;
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 60,105,049 and 57,032,963 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively.	6	6
Additional paid-in capital	426,423	416,083
Accumulated other comprehensive (loss) income	(81)	60
Accumulated deficit	(407,025)	(362,579)
TOTAL STOCKHOLDERS' EQUITY	19,323	53,570
TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS' EQUITY	$ 115,700	$ 114,857

Debt Financing (Tables)

6 Months Ended

Jun. 30, 2026

Debt Financing

Schedule of Obligations under the loan

The obligations under the Medtronic Loan as of June 30, 2026 consisted of the following (in thousands):


	June 30,
	2026
Beginning balance, January 1, 2026	$	—
Proceeds from note payable		20,000
Accrued interest expense on liability		442
Ending balance, June 30, 2026	$	20,442

2024 Loan and Security Agreement

Debt Financing

Schedule of amount of principal payments due


		Principal
		Payments
Year ending December 31:		(in thousands)
2026 (remaining six months)		$	—
2027			—
2028			15,000
2029			—
Total		$	15,000

Secured Subordinated Convertible Promissory Note (the "Notes") | Medtronic | Loan Agreement

Debt Financing

Schedule of amount of principal payments due


		Principal
		Payments
Year ending December 31:		(in thousands)
2026 (remaining six months)		$	—
2027			—
2028			—
2029			—
2030			—
Thereafter			20,000
Total		$	20,000

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Balance Sheet Components - Schedule of accrued expenses and other liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2026	Dec. 31, 2025
Balance Sheet Components
Clinical trial accruals	$ 3,087	$ 4,151
Accrued compensation	1,944	4,160
Other accrued expenses	1,500	1,579
Total Accrued expenses and other liabilities	$ 6,531	$ 9,890

Stock-Based Compensation - Schedule of stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands	6 Months Ended		12 Months Ended
	Jun. 30, 2026	Jun. 30, 2025	Dec. 31, 2025
Weighted Average Remaining Term (years) and Aggregate Intrinsic Value
Weighted average grant date fair value	$ 3.27	$ 2.18
2023 Plan
Shares Underlying Options
Shares Underlying Options, Beginning	7,199,571
Shares Underlying Options, Granted	1,602,434
Shares Underlying Options, Exercised	(8,528)
Shares Underlying Options, Forfeited/canceled	(308,656)
Shares Underlying Options, Ending	8,484,821		7,199,571
Shares Underlying Options, Exercisable	4,969,536
Weighted Average Exercise Price
Weighted Average Exercise Price Outstanding, Beginning	$ 6.23
Weighted Average Exercise Price, Granted	3.85
Weighted Average Exercise Price, Exercised	3.72
Weighted Average Exercise Price, Forfeited/canceled	6.03
Weighted Average Exercise Price Outstanding, Ending	5.79		$ 6.23
Weighted Average Exercise Price, Exercisable	$ 7
Weighted Average Remaining Term (years) and Aggregate Intrinsic Value
Weighted Average Remaining Term (years), Outstanding	7 years 2 months 19 days		7 years 29 days
Weighted Average Remaining Term (years), Exercisable	5 years 11 months 15 days
Aggregate Intrinsic Value Outstanding	$ 2,936		$ 1,963
Aggregate Intrinsic Value, Exercised	6
Aggregate Intrinsic Value, Exercisable	$ 708

Debt Financing - Schedule of amount of principal payments (Details) $ in Thousands	Jun. 30, 2026 USD ($)
2024 Loan and Security Agreement
Debt Maturity
2026 (remaining six months)	$ 0
2027	0
2028	15,000
2029	0
Total	15,000
Secured Subordinated Convertible Promissory Note (the "Notes") \| Medtronic \| Loan Agreement
Debt Maturity
2026 (remaining six months)	0
2027	0
2028	0
2029	0
2030	0
Thereafter	20,000
Total	$ 20,000

Related Party Transactions

6 Months Ended

Jun. 30, 2026

Related Party Transactions

Related Party Transactions

12. Related Party Transactions

In addition to transactions and balances related to cash and stock-based compensation to officers and directors, the Company had the following transactions and balances with related parties during the year ended December 31, 2025:

As part of the Public Offering, on August 4, 2025, (i) entities associated with RTW Investments, LP (collectively, “RTW”), which beneficially owned approximately 21% of the Common Stock immediately prior to the Public Offering, purchased Pre-Funded Warrants exercisable for 3,636,363 shares of Common Stock and (ii) Perceptive Life Sciences Master Fund, Ltd, which beneficially owned approximately 12% of the Common Stock immediately prior to the Public Offering, purchased Pre-Funded Warrants exercisable for 1,500,000 shares of Common Stock. During the six months ended June 30, 2026, RTW exercised 1,250,032 Pre-Funded Warrants on a cashless basis and received 1,250,000 shares of Common Stock.

In addition, transactions between the Company and Medtronic are disclosed in both Note 3 – “Medtronic Agreement” and Note 14 – “Debt Financing.”

The Company had no other transactions or balances with current related parties during the six months ended June 30, 2026.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

+ References

+ Details

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, 2026	Dec. 31, 2025
Financial Instruments and Fair Value Measurements
Total assets	$ 105,040	$ 84,611
Derivative liability	2,460	2,749
Total liabilities	2,460	2,749
Assets transfers within levels	0	0
Liabilities transfers within levels	0	0
Money market fund (included in Cash and cash equivalents)
Financial Instruments and Fair Value Measurements
Total assets	15,549	12,789
Corporate and government debt securities (included in Marketable securities)
Financial Instruments and Fair Value Measurements
Total assets	89,491	71,822
Level 1
Financial Instruments and Fair Value Measurements
Total assets	15,549	12,789
Level 1 \| Money market fund (included in Cash and cash equivalents)
Financial Instruments and Fair Value Measurements
Total assets	15,549	12,789
Level 2
Financial Instruments and Fair Value Measurements
Total assets	89,491	71,822
Level 2 \| Corporate and government debt securities (included in Marketable securities)
Financial Instruments and Fair Value Measurements
Total assets	89,491	71,822
Level 3
Financial Instruments and Fair Value Measurements
Derivative liability	2,460	2,749
Total liabilities	$ 2,460	$ 2,749

Medtronic Agreement

6 Months Ended

Jun. 30, 2026

Medtronic Agreement

Medtronic Agreement

3. Medtronic Agreement

In June 2022, Orchestra BioMed, Inc., 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 is 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 Medtronic is providing development, clinical and regulatory resources in support of the pivotal trial, for which the Company is reimbursing Medtronic at cost.

Under the terms of the Medtronic Agreement, as amended pursuant to the Medtronic Agreement Amendment, 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 U.S. Food and Drug Administration (“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 Amended Medtronic Agreement fell within the scope of ASC 808 and concluded that the Amended 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 Amended 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 Amended 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, 2026, the Company incurred approximately $2.8 million and $5.4 million, respectively, of research and development costs related to these reimbursements pursuant to the Amended Medtronic Agreement, of which $4.5 million is included within accounts payable and accrued expenses in the Company’s June 30, 2026 condensed consolidated balance sheet. 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 Amended Medtronic Agreement.

Concurrently with the close of the Medtronic Agreement, Orchestra BioMed, Inc. also received a $40.0 million investment from Medtronic in connection with Orchestra BioMed, Inc.’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.

On July 31, 2025, Orchestra BioMed, Inc., 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.

On July 31, 2025, the Company and its wholly-owned subsidiaries, Orchestra BioMed, Inc. and BackBeat, entered into a 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. For additional details, see Note 14 – “Debt Financing.”

Concurrently with the close of the Medtronic Agreement Amendment on August 4, 2025, Medtronic, through an affiliate, Covidien Group S.à.r.l. (“Covidien”), purchased 4,077,427 shares of Common Stock at a purchase price of $2.75 per share, for an aggregate purchase price of approximately $11.2 million, 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”). Pursuant to the terms of the Medtronic Stock Purchase Agreement, Covidien purchased an additional 132,282 shares of Common Stock on August 28, 2025 at a purchase price of $2.75 per share, for an aggregate purchase price of $363,775, as a result of the exercise by the underwriters in the Public Offering (as defined below) of their option to purchase an additional 2,182,500 shares of Common Stock (See Note 7 – “Common and Preferred Stock”). 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, 2026, there have been no amounts recognized as revenue under the Amended Medtronic Agreement.

Stock-Based Compensation - Schedule of cost related to stock-based compensation (Details) - 2023 Plan - Legacy Orchestra - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025
Stock options
Stock-Based Compensation
Total stock-based compensation	$ 1,048	$ 1,358	$ 1,914	$ 2,604
Unrecognized stock-based compensation expense for options	9,700		$ 9,700
Expected period to be recognized			2 years 10 months 24 days
Stock options \| Location, Statement of Income, Balance [Axis]: us-gaap:ResearchAndDevelopmentExpense
Stock-Based Compensation
Total stock-based compensation	637	666	$ 1,131	1,273
Stock options \| Location, Statement of Income, Balance [Axis]: us-gaap:SellingGeneralAndAdministrativeExpense
Stock-Based Compensation
Total stock-based compensation	411	692	783	1,331
Restricted Stock
Stock-Based Compensation
Total stock-based compensation	1,457	1,564	3,371	2,979
Unrecognized stock-based compensation expense for options	9,900		$ 9,900
Expected period to be recognized			2 years 3 months 18 days
Restricted Stock \| Location, Statement of Income, Balance [Axis]: us-gaap:ResearchAndDevelopmentExpense
Stock-Based Compensation
Total stock-based compensation	490	528	$ 1,126	993
Restricted Stock \| Location, Statement of Income, Balance [Axis]: us-gaap:SellingGeneralAndAdministrativeExpense
Stock-Based Compensation
Total stock-based compensation	$ 967	1,036	2,245	1,986
Warrant
Stock-Based Compensation
Total stock-based compensation		328	71	632
Warrant \| Location, Statement of Income, Balance [Axis]: us-gaap:ResearchAndDevelopmentExpense
Stock-Based Compensation
Total stock-based compensation		121	32	241
Warrant \| Location, Statement of Income, Balance [Axis]: us-gaap:SellingGeneralAndAdministrativeExpense
Stock-Based Compensation
Total stock-based compensation		$ 207	$ 39	$ 391

Balance Sheet Components

6 Months Ended

Jun. 30, 2026

Balance Sheet Components

Balance Sheet Components

6. Balance Sheet Components

Property and Equipment, Net

Property and equipment, net consists of the following:


		June 30,			December 31,
(in thousands)		2026			2025
Equipment		$	3,232		$	2,743
Office furniture			459			444
Leasehold improvements			171			159
Property and equipment, gross			3,862			3,346
Less accumulated depreciation and amortization			(1,817)			(1,631)
Total Property and equipment, net		$	2,045		$	1,715

As of June 30, 2026, $703,000 of equipment is not yet in service and has not yet commenced depreciation.

Accrued Expenses and Other Liabilities

Accrued expenses and other liabilities consist of the following:


		June 30,			December 31,
(in thousands)		2026			2025
Clinical trial accruals		$	3,087		$	4,151
Accrued compensation			1,944			4,160
Other accrued expenses			1,500			1,579
Total Accrued expenses and other liabilities		$	6,531		$	9,890

Derivative Liability - Assumptions for derivative components (Details)	Jun. 30, 2026 Y $ / shares	Dec. 31, 2025 Y $ / shares
Expected term (in years)
Assumptions for derivative components
Embedded derivative liability, measurement input \| Y	1.5	2
Expected volatility
Assumptions for derivative components
Embedded derivative liability, measurement input	0.84	0.80
Risk-free interest rate
Assumptions for derivative components
Embedded derivative liability, measurement input	0.0398	0.0341
Expected dividend yield
Assumptions for derivative components
Embedded derivative liability, measurement input	0	0
Market discount rate
Assumptions for derivative components
Embedded derivative liability, measurement input	0.2235	0.1479
Fair value of common stock
Assumptions for derivative components
Embedded derivative liability, measurement input \| $ / shares	4.32	4.15

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

Medtronic Agreement (Details) - USD ($)			3 Months Ended			6 Months Ended
Medtronic Agreement (Details) - USD ($)	Aug. 28, 2025	Aug. 04, 2025	Jun. 30, 2026	Mar. 31, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025	Jul. 31, 2025
Medtronic Agreement
Aggregate purchase price				$ 5,855,000
Public Offering
Medtronic Agreement
Additional shares to be purchased	2,182,500
Medtronic, Inc.
Medtronic Agreement
Reimbursable research and development expense			$ 2,800,000		$ 4,000,000	$ 5,400,000	$ 7,400,000
Revenue recognized to date			$ 0			0
Medtronic, Inc. \| Series D-2 Preferred Stock
Medtronic Agreement
Proceeds from issuance of Series D-2 Preferred Stock						40,000,000
Medtronic, Inc. \| Private Placement \| Related Party
Medtronic Agreement
Shares issued (in shares)	132,282	4,077,427
Share issue price (in dollars per share)	$ 2.75	$ 2.75
Aggregate purchase price	$ 363,775	$ 11,200,000
Medtronic, Inc. \| Loan Agreement \| Secured Subordinated Convertible Promissory Note (the "Notes")
Medtronic Agreement
Term loan								$ 20,000,000
Minimum \| Medtronic, Inc.
Medtronic Agreement
Expected to receive product price						500
Maximum \| Medtronic, Inc.
Medtronic Agreement
Expected to receive product price						1,600
Location, Statement of Financial Position, Activity, Accrual [Axis]: us-gaap:AccruedLiabilitiesCurrent \| Medtronic, Inc.
Medtronic Agreement
Reimbursable research and development expense						$ 4,500,000

Net Loss Per Share - Schedule of calculation of diluted net loss per share (Details) - shares	6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025
Anti-dilutive Securities
Antidilutive securities	22,317,859	15,673,112
Stock options
Anti-dilutive Securities
Antidilutive securities	8,484,821	6,963,765
Common stock warrants
Anti-dilutive Securities
Antidilutive securities	4,148,146	2,057,812
Unvested restricted stock units
Anti-dilutive Securities
Antidilutive securities	3,518,226	2,151,535
Series A Preferred Stock
Anti-dilutive Securities
Antidilutive securities	1,666,666
Forfeitable Shares
Anti-dilutive Securities
Antidilutive securities	500,000	500,000
Earnout Consideration
Anti-dilutive Securities
Antidilutive securities	4,000,000	4,000,000

Balance Sheet Components (Tables)

6 Months Ended

Jun. 30, 2026

Balance Sheet Components

Schedule of property and equipment balances, net


		June 30,			December 31,
(in thousands)		2026			2025
Equipment		$	3,232		$	2,743
Office furniture			459			444
Leasehold improvements			171			159
Property and equipment, gross			3,862			3,346
Less accumulated depreciation and amortization			(1,817)			(1,631)
Total Property and equipment, net		$	2,045		$	1,715

Schedule of accrued expenses and other liabilities


		June 30,			December 31,
(in thousands)		2026			2025
Clinical trial accruals		$	3,087		$	4,151
Accrued compensation			1,944			4,160
Other accrued expenses			1,500			1,579
Total Accrued expenses and other liabilities		$	6,531		$	9,890

Marketable Securities and Strategic Investments - (Other Information) (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025	Jan. 09, 2026
Marketable Securities
Realized gains	$ 0	$ 0	$ 0	$ 0
Realized losses	0	$ 0	0	0
Proceeds from investments			4,781,000
Debt securities with maturities between 12 and 36 months	7,100,000		7,100,000
Gain on sale of strategic investments	$ 45,000		2,286,000
Strategic investments Motus GI
Marketable Securities
Impairment charge				$ 0
Strategic Investment Vivasure
Marketable Securities
Consideration receivable equity securities					$ 10,700,000
Proceeds from investments			$ 4,800,000

Related Party Transactions (Details) - shares		6 Months Ended
Related Party Transactions (Details) - shares	Aug. 04, 2025	Jun. 30, 2026
Pre-Funded Warrants
Related Party Transactions
Exercise of pre-funded warrants (in shares)		1,250,032
Related Party \| Entities associated with RTW Investments, LP
Related Party Transactions
Percentage of beneficially owned equity ownership	21.00%
Related Party \| Entities associated with RTW Investments, LP \| Public Offering
Related Party Transactions
Shares issued (in shares)	3,636,363	1,250,000
Related Party \| Perceptive Life Sciences Master Fund, Ltd
Related Party Transactions
Percentage of beneficially owned equity ownership	12.00%
Related Party \| Perceptive Life Sciences Master Fund, Ltd \| Public Offering
Related Party Transactions
Shares issued (in shares)	1,500,000
Related Party \| Pre-Funded Warrants \| Entities associated with RTW Investments, LP
Related Party Transactions
Exercise of pre-funded warrants (in shares)		1,250,032

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

- Definition

Number of new stock issued during the period.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 505
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Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 7: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 8: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 9: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 10: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Summary of Significant Accounting Policies - Schedule of property and equipment (Details)	Jun. 30, 2026
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

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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+ Details

Royalty Purchase Agreement - Other (Details) $ / shares in Units, $ in Thousands				6 Months Ended
	May 01, 2026 USD ($) shares	Aug. 04, 2025 USD ($) tranche $ / shares shares	Jul. 31, 2025 USD ($) shares	Jun. 30, 2026 USD ($) $ / shares	Dec. 31, 2025
Royalty Purchase Agreement
Proceeds from the royalty purchase agreement				$ 15,000
Ligand Warrant
Royalty Purchase Agreement
Price per share (in dollars per share) \| $ / shares				$ 3.67
Term				9 years 1 month 2 days
Revenue Participation Right Purchase and Sale Agreement \| AVIM Therapy and Virtue Sab Products ("Products") \| Ligand Warrant
Royalty Purchase Agreement
Percentage of revenue repayment			17.00%
Amount of revenue repayment			$ 17,000
Revenue Participation Right Purchase and Sale Agreement \| Avim Therapy Products \| Ligand Warrant
Royalty Purchase Agreement
Threshold amount of revenue repayment			4.00%
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement
Royalty Purchase Agreement
Investment amount			$ 35,000
Interest rate				21.20%	23.10%
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement \| AVIM Therapy and Virtue Sab Products ("Products")
Royalty Purchase Agreement
Number of tranches \| tranche		2
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement \| AVIM Therapy and Virtue Sab Products ("Products") \| Minimum \| Annual Net Sales of the products are less than or equal to $100 million
Royalty Purchase Agreement
Revenue sharing percentage (%)			17.00%
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement \| AVIM Therapy and Virtue Sab Products ("Products") \| Minimum \| Annual Net Sales of the products are greater than or equal to $100 million
Royalty Purchase Agreement
Revenue sharing percentage (%)			4.00%
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement \| AVIM Therapy and Virtue Sab Products ("Products") \| Maximum \| Annual Net Sales of the products are less than or equal to $100 million
Royalty Purchase Agreement
Revenue sharing percentage (%)			20.00%
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement \| AVIM Therapy and Virtue Sab Products ("Products") \| Maximum \| Annual Net Sales of the products are greater than or equal to $100 million
Royalty Purchase Agreement
Revenue sharing percentage (%)			7.00%
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement \| AVIM Therapy and Virtue Sab Products ("Products") \| Tranche One
Royalty Purchase Agreement
Proceeds from the royalty purchase agreement		$ 20,000
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement \| AVIM Therapy and Virtue Sab Products ("Products") \| Tranche Two
Royalty Purchase Agreement
Investment amount	$ 15,000
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Revenue Participation Right Purchase and Sale Agreement \| Virtue Sab Products
Royalty Purchase Agreement
Threshold amount of revenue repayment			4.00%
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Ligand Stock Purchase Agreement \| Ligand Warrant
Royalty Purchase Agreement
Price per share (in dollars per share) \| $ / shares		$ 3.67
Term			10 years
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Ligand Stock Purchase Agreement \| Ligand Warrant \| Maximum
Royalty Purchase Agreement
Number of warrants to be issued \| shares		2,000,000
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Ligand Stock Purchase Agreement \| Tranche One \| Ligand Warrant
Royalty Purchase Agreement
Number of warrants to be issued \| shares			1,142,857
Ligand Pharmaceuticals Incorporated (the "Purchaser") \| Ligand Stock Purchase Agreement \| Tranche Two \| Ligand Warrant
Royalty Purchase Agreement
Number of warrants to be issued \| shares	857,143

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive (Loss) Income	Accumulated Deficit	Total
Balance at Dec. 31, 2024	$ 4	$ 342,780	$ 52	$ (309,878)	$ 32,958
Balance (in shares) at Dec. 31, 2024	38,194,442
Increase (Decrease) in Stockholders' Equity
Unrealized 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 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
Increase (Decrease) in Stockholders' Equity
Unrealized loss on marketable securities					(36)
Net 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
Increase (Decrease) in Stockholders' Equity
Unrealized 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 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
Balance at Dec. 31, 2025	$ 6	416,083	60	(362,579)	53,570
Balance (in shares) at Dec. 31, 2025	57,032,963
Increase (Decrease) in Stockholders' Equity
At-the-Market offering, net of issuance costs		5,855			5,855
At-the-Market offering, net of issuance costs (in shares)	1,451,439
Unrealized loss on marketable securities			(100)		(100)
Stock-based compensation		2,851			2,851
Restricted stock unit vesting		(354)			(354)
Restricted stock unit vesting (in shares)	140,035
Exercise of stock options		26			26
Exercise of stock options (in shares)	6,278
Adjustment to carrying value of Series A Preferred Stock		35			35
Net loss				(20,691)	(20,691)
Balance at Mar. 31, 2026	$ 6	424,496	(40)	(383,270)	41,192
Balance (in Shares) at Mar. 31, 2026	58,630,715
Balance at Dec. 31, 2025	$ 6	416,083	60	(362,579)	53,570
Balance (in shares) at Dec. 31, 2025	57,032,963
Increase (Decrease) in Stockholders' Equity
Unrealized loss on marketable securities					(141)
Net loss					(44,446)
Balance at Jun. 30, 2026	$ 6	426,423	(81)	(407,025)	19,323
Balance (in Shares) at Jun. 30, 2026	60,105,049
Balance at Mar. 31, 2026	$ 6	424,496	(40)	(383,270)	41,192
Balance (in shares) at Mar. 31, 2026	58,630,715
Increase (Decrease) in Stockholders' Equity
Unrealized loss on marketable securities			(41)		(41)
Stock-based compensation		2,505			2,505
Restricted stock unit vesting		(262)			(262)
Restricted stock unit vesting (in shares)	222,084
Exercise of stock options		8			8
Exercise of stock options (in shares)	2,250
Exercise of pre-funded warrants (in shares)	1,250,000
Adjustment to carrying value of Series A Preferred Stock		(324)			(324)
Net loss				(23,755)	(23,755)
Balance at Jun. 30, 2026	$ 6	$ 426,423	$ (81)	$ (407,025)	$ 19,323
Balance (in Shares) at Jun. 30, 2026	60,105,049

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025
Revenue:
Total revenue	$ 88	$ 836	$ 198	$ 1,704
Expenses:
Cost of product revenues	25	46	57	90
Research and development	16,590	13,853	32,371	27,335
Selling, general and administrative	5,829	6,264	12,202	12,527
Total expenses	22,444	20,163	44,630	39,952
Loss from operations	(22,356)	(19,327)	(44,432)	(38,248)
Other (expense) income:
Interest (expense) income, net	(1,768)	(36)	(2,589)	130
Change in the fair value of derivative liability	324		289
Gain on sale of strategic investments	45		2,286
Total other (expense) income	(1,399)	(36)	(14)	130
Net loss	(23,755)	(19,363)	(44,446)	(38,118)
Adjustment to carrying value of Series A Preferred Stock	(324)		(289)
Net loss attributable to common stockholders	$ (24,079)	$ (19,363)	$ (44,735)	$ (38,118)
Net loss attributable to common stockholders per share
Basic (in dollars per share)	$ (0.38)	$ (0.5)	$ (0.72)	$ (0.99)
Diluted (in dollars per share)	$ (0.38)	$ (0.5)	$ (0.72)	$ (0.99)
Weighted-average shares used in computing net loss attributable to common stockholders per share, basic (in shares)	63,812,098	38,392,716	62,019,963	38,314,936
Weighted-average shares used in computing net loss attributable to common stockholders per share, diluted (in shares)	63,812,098	38,392,716	62,019,963	38,314,936
Comprehensive loss
Net loss	$ (23,755)	$ (19,363)	$ (44,446)	$ (38,118)
Unrealized loss on marketable securities	(41)	(21)	(141)	(36)
Comprehensive loss	(23,796)	(19,384)	(44,587)	(38,154)
Partnership revenue
Revenue:
Total revenue		667		1,399
Product revenue
Revenue:
Total revenue	$ 88	$ 169	$ 198	$ 305

Segment Disclosures (Details) $ in Thousands	3 Months Ended				6 Months Ended
Segment Disclosures (Details) $ in Thousands	Jun. 30, 2026 USD ($)	Mar. 31, 2026 USD ($)	Jun. 30, 2025 USD ($)	Mar. 31, 2025 USD ($)	Jun. 30, 2026 USD ($) segment	Jun. 30, 2025 USD ($)
Segment Disclosures
Number of reportable segments \| segment					1
Total revenue	$ 88		$ 836		$ 198	$ 1,704
Cost of product revenues	25		46		57	90
Depreciation and amortization expense					186	164
Interest expense (income), net	1,768		36		2,589	(130)
Net loss	(23,755)	$ (20,691)	(19,363)	$ (18,755)	(44,446)	(38,118)
Partnership revenue
Segment Disclosures
Total revenue			667			1,399
Product revenue
Segment Disclosures
Total revenue	88		169		198	305
Single Reportable Segment
Segment Disclosures
Cost of product revenues	25		46		57	90
Personnel and consulting costs	8,823		7,002		17,611	13,666
Stock-based compensation	2,505		3,250		5,356	6,215
Depreciation and amortization expense	96		81		186	164
Other segment expenses	$ 2,287		$ 2,544		$ 2,882	$ 5,170
Segment Reporting, Other Segment Item, Composition, Description	Other segment expenses primarily include the gain on the sale of strategic investments as well as general and administrative costs not presented in other line items		Other segment expenses primarily include the gain on the sale of strategic investments as well as general and administrative costs not presented in other line items		Other segment expenses primarily include the gain on the sale of strategic investments as well as general and administrative costs not presented in other line items	Other segment expenses primarily include the gain on the sale of strategic investments as well as general and administrative costs not presented in other line items
Interest expense (income), net	$ 1,768		$ 36		$ 2,589	$ (130)
Net loss	(23,755)		(19,363)		(44,446)	(38,118)
Single Reportable Segment \| Partnership revenue
Segment Disclosures
Total revenue			667			1,399
Single Reportable Segment \| Product revenue
Segment Disclosures
Total revenue	88		169		198	305
Single Reportable Segment \| Non-clinical development costs
Segment Disclosures
Development costs	3,379		4,607		7,429	9,072
Single Reportable Segment \| Clinical development costs
Segment Disclosures
Development costs	$ 4,960		$ 2,633		$ 8,534	$ 5,575

Leases - Schedule of future minimum rental payments, exclusive of taxes, insurance and other costs, under the leases (Details) $ in Thousands	Jun. 30, 2026 USD ($)
Operating Lease Maturity
2026 (remaining six months)	$ 447
2027	829
2028	159
2029	0
2030	0
Thereafter	0
Total future minimum lease payments	1,435
Imputed interest	(107)
Total liability	$ 1,328

Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2026

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, research and development costs incurred, effective interest expense related to the Royalty Purchase Agreement (as defined below) (see Note 13 – “Royalty Purchase Agreement” for additional information), effective interest expense related to the Medtronic Loan Agreement (as defined below) (see Note 14 – “Debt Financing” for additional information), and the fair value of the derivative liability related to the Company’s Series A Preferred Stock, $0.0001 par value per share (the “Series A Preferred Stock”) (see Note 8 – “Derivative Liability” 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 (loss) income. 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 had made investments in certain companies and assessed whether the Company exerted significant influence over its strategic investments. The Company considered the nature and magnitude of its investment, any voting and protective rights it held, 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 did not have the ability to exercise significant influence over its strategic investments.

As of December 31, 2025, the Company’s strategic investments consisted of preferred shares of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party. The investments in Vivasure did not have readily determinable fair values and were 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 were not readily marketable, the Company categorized the investments as non-current assets. As of December 31, 2025, the carrying value of the investments in Vivasure was $2.5 million. On January 9, 2026, Haemonetics Corporation, a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, announced its acquisition of Vivasure. As a result, the Company recognized a gain of $2.3 million on the sale of strategic investments during the six months ended June 30, 2026 (see Note 5 – “Marketable Securities and Strategic Investments” for additional information).

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 4 – “Financial Instruments and Fair Value Measurements” for additional information regarding fair value measurements. For additional information on the fair value measurements performed related to the derivative liability, see Note 8 – “Derivative Liability.”

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, 2026 and December 31, 2025, 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, 2026 and December 31, 2025, 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 to which the Company expects to be entitled. 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 were previously comprised of partnership revenues from the Terumo Agreement relating to the development and commercialization of Virtue SAB, and continue to include product revenue from the sale of FreeHold’s intracorporeal organ retractors.

Partnership Revenues

Previously, the Company’s partnership revenues have related to the Terumo Agreement (as defined below), which was terminated pursuant to a termination and right of first refusal agreement on October 24, 2025 (the “Termination and ROFR Agreement”). In future periods, partnership revenues may also include revenues related to the Amended Medtronic Agreement as discussed in Note 3 – “Medtronic Agreement”.

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.

Series A Preferred Stock

The Company applies ASC 480-10, Distinguishing Liabilities from Equity (“ASC 480”), which requires an evaluation to determine if liability classification is required for redeemable convertible stock. Liability classification is required for freestanding financial instruments that are (1) subject to an unconditional obligation requiring the issuer to redeem the instrument by transferring assets, such as those that are mandatorily redeemable, (2) instruments other than equity shares that embody an obligation of the issuer to repurchase its equity shares, or (3) certain types of instruments that obligate the issuer to issue a variable number of equity shares.

Securities that do not meet the scoping criteria to be classified as a liability under ASC 480 are subject to redeemable equity guidance, which prescribes that securities that may be subject to redemption upon an event not solely within the Company’s control should be classified as mezzanine equity. Securities classified in mezzanine equity are initially measured at the fair value, net of issuance costs and excluding the fair value of bifurcated embedded derivatives, if any. Subsequent measurement is required when the combined initial amount recorded in mezzanine equity and its related derivative liability is greater than the period end carrying amount. Adjustments to the carrying amount are charged to retained earnings (or additional paid in capital if there are no retained earnings) and do not affect net loss or comprehensive loss in the condensed consolidated financial statements. Subsequent measurement of the carrying value of the redeemable convertible preferred stock is also required when the instrument is probable of becoming redeemable. The Company will accrete the redeemable convertible preferred stock to its redemption value once the instrument is probable of becoming redeemable. In certain circumstances, the redemption price may vary based on changes in stock price, in which case the Company recognizes changes in the redemption value immediately as they occur and adjusts the carrying value of the security to equal the then current maximum redemption value at the end of each reporting period.

Derivative Liability

The Company evaluates all its financial instruments, including convertible debt and redeemable convertible preferred stock, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. The Company applies significant judgment to identify and evaluate complex terms and conditions in these contracts and agreements to determine whether embedded derivatives exist. Embedded derivatives must be separately measured from the host contracts if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the condensed consolidated statements of operations and comprehensive loss at each reporting period end. Bifurcated embedded derivatives are classified as a separate liability in the condensed consolidated balance sheets.

The Company’s derivative liability is related to the conversion features embedded in the Series A Preferred Stock. See Note 7 – “Common and Preferred Stock” for additional information.

Net Loss Per Share

Basic net loss per share is calculated by dividing net loss less the adjustment to carrying value of Series A Preferred Stock by the weighted-average number of shares of common stock of the Company (“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 16 – “Net Loss Per Share”), unvested restricted stock awards, convertible preferred shares (see Note 7 – “Common and Preferred Stock”) and restricted stock units. Shares of Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares (as defined in Note 16)) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. Pre-funded warrants (see Note 9 – “Warrants”) are considered outstanding for the purposes of computing basic and diluted net loss per share because shares may be issued for little or no additional consideration and are fully vested and exercisable after the original issuance date of the pre-funded warrant. 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, 2026 and December 31, 2025, 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, 2026, the Company made $127,000 and $291,000, respectively, in contributions under this safe harbor 401(k) Plan. During 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.

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 15 - “Segment Disclosures.”

New Accounting Standards

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.

Leases - Schedule of recognized as an asset and operating lease liabilities (Details)	Jun. 30, 2026
Leases
Weighted average remaining lease term - operating leases, in years	1 year 7 months 24 days
Weighted average discount rate - operating leases	9.92%

Net Loss Per Share

6 Months Ended

Jun. 30, 2026

Net Loss Per Share

Net Loss Per Share

16. Net Loss Per Share

Basic net loss per share of Common Stock is computed by dividing net loss less any adjustment to the carrying value of Series A Preferred Stock by the weighted-average number of shares of Common Stock which includes the weighted average effect of the Pre-Funded

Warrants, for the purchase of shares of Common Stock, for which the remaining unfunded exercise price is $0.0001 per share. Shares of 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, the Sponsor agreed that 25% or 1,000,000 of the shares of Common Stock held by the Sponsor (the “Forfeitable Shares”) will be forfeited to the Company on the first business day following the fifth anniversary of the closing of the Business Combination (the “Closing”), unless, as to 500,000 shares, the volume-weighted average price of the 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 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”). On April 12, 2023, the Initial Milestone Event was achieved and 500,000 of the Forfeitable Shares are no longer subject to forfeiture. However, the Final Milestone event has not occurred, and 500,000 Forfeitable Shares remain subject to forfeiture.

In connection with the Business Combination, existing Orchestra BioMed, Inc. 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 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 are 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 Orchestra BioMed, Inc. 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 for the Business Combination) of 4,000,000 shares of Common Stock, resulting in a total of 3,999,987 shares of Common Stock being issued (less than 4,000,000 due to rounding).

Diluted net loss per share of Common Stock includes the effect, if any, from the potential exercise or conversion of securities, such as stock options, Orchestra BioMed, Inc. Warrants, Private Warrants, Officer and Director Warrants, Forfeitable Shares, Earnout Consideration, and Series A Preferred Stock, using the if-converted method, which would result in the issuance of incremental shares of 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, 2026 and June 30, 2025, as their effect is anti-dilutive:



		Six Months Ended June 30,
		2026		2025
Stock options		8,484,821		6,963,765
Common stock warrants		4,148,146		2,057,812
Unvested restricted stock units		3,518,226		2,151,535
Series A Preferred Stock		1,666,666		—
Forfeitable Shares		500,000		500,000
Earnout Consideration		4,000,000		4,000,000
Total		22,317,859		15,673,112

Stock-Based Compensation - Other (Details)		6 Months Ended
Stock-Based Compensation - Other (Details)	Feb. 28, 2025 Y $ / shares shares	Jun. 30, 2026 employee $ / shares shares	Nov. 30, 2025 shares
2023 Plan
Stock-Based Compensation
Shares Underlying Options, Granted		1,602,434
2023 Plan \| Legacy Orchestra
Stock-Based Compensation
Number of shares authorized		424,000
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
New Hire Inducement Plan
Stock-Based Compensation
Number of shares authorized			950,000
Number of new employees to whom inducement equity awards granted \| employee		14
Shares Underlying Options, Granted		205,500
Shares available for future issuance		616,000
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	2.84
Non-employee Warrants \| Expected volatility
Stock-Based Compensation
Warrants, measurement input	110.1
Non-employee Warrants \| Risk-free interest rate
Stock-Based Compensation
Warrants, measurement input	3.99
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

Organization and Basis of Presentation (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2026 USD ($) item	Dec. 31, 2025 USD ($)
Organization and Basis of Presentation
Number of product candidates \| item	2
Accumulated deficit \| $	$ (407,025)	$ (362,579)

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S45
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480100/505-10-S45-4

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
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-Name Accounting Standards Codification
-Section S45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477657/942-210-S45-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-03(21))
-Publisher FASB
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
-Subparagraph (SX 210.5-02(30)(a)(3))
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
-Subparagraph (SX 210.5-02(30)(b))
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Reference 7: http://www.xbrl.org/2003/role/exampleRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 65
-Paragraph 2
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (h)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480016/944-40-65-2

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-Section 50
-Paragraph 11
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-11

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (SX 210.6-04(17))
-Publisher FASB
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+ Details

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (44,446)	$ (38,118)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	186	164
Stock-based compensation	5,356	6,215
Non-cash interest expense on liability related to the royalty purchase agreement	3,111
Accrued interest expense on liability related to the note payable	442
Gain on sale of strategic investments	(2,286)
Accretion and interest related to marketable securities	(476)	(161)
Non-cash lease expense	325	297
Change in the fair value of derivative liability	(289)
Amortization of deferred financing fees	129	92
Changes in operating assets and liabilities:
Accounts receivable	44	9
Inventory	60	(11)
Prepaid expenses and other assets	14	148
Accounts payable, accrued expenses and other liabilities	(3,311)	888
Operating lease liabilities - current and non-current	(359)	(267)
Deferred revenue		(1,399)
Net cash used in operating activities	(41,500)	(32,143)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(438)	(146)
Sales of marketable securities	38,791	32,403
Purchases of marketable securities	(56,125)	(2,902)
Sale of strategic investments	4,781
Net cash (used in) provided by investing activities	(12,991)	29,355
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from the royalty purchase agreement	15,000
Proceeds from Medtronic term loan	20,000
Proceeds from At-The-Market offering, net of issuance costs	5,855
Proceeds from exercise of stock options	34	91
Restricted stock units withheld for tax	(616)	(815)
Net cash provided by (used in) financing activities	40,273	(724)
Net decrease in cash and cash equivalents	(14,218)	(3,512)
Cash and cash equivalents, beginning of the period	34,690	22,261
Cash and cash equivalents, end of the period	20,472	18,749
Cash paid during the six months ended June 30:
Interest	720	722
Supplemental disclosure of noncash activities
Purchases of Property & equipment within accounts payable, accrued expenses and other liabilities	$ 78	$ 23

Financial Instruments and Fair Value Measurements (Tables)

6 Months Ended

Jun. 30, 2026

Financial Instruments and Fair Value Measurements

Schedule of financial assets and liabilities measured at fair value


		June 30, 2026
(in thousands)		Level 1			Level 2			Level 3			Total
Assets
Money market fund (included in Cash and cash equivalents)		$	15,549		$	—		$	—		$	15,549
Corporate and government debt securities (included in Marketable securities)			—			89,491			—			89,491
Total assets		$	15,549		$	89,491		$	—		$	105,040

Liabilities
Derivative liability (Note 8)			—			—			2,460			2,460
Total liabilities		$	—		$	—		$	2,460		$	2,460


		December 31, 2025
(in thousands)		Level 1			Level 2			Level 3			Total
Assets
Money market fund (included in Cash and cash equivalents)		$	12,789		$	—		$	—		$	12,789
Corporate and government debt securities (included in Marketable securities)			—			71,822			—			71,822
Total assets		$	12,789		$	71,822		$	—		$	84,611

Liabilities
Derivative liability (Note 8)			—			—			2,749			2,749
Total liabilities		$	—		$	—		$	2,749		$	2,749

Derivative Liability

6 Months Ended

Jun. 30, 2026

Derivative Liability

Derivative Liability

8. Derivative Liability

The Company assessed the Series A Preferred Stock features to determine whether any features are required to be bifurcated and separately accounted for as an embedded derivative. The Company concluded that certain conversion and redemption features meet the requirements to be separately accounted for as a bifurcated derivative. The Series A Preferred Stock was accounted for as mezzanine equity in accordance with ASC 480 and the embedded conversion and redemption features were separated from the host instrument and recognized as derivative liabilities with change in fair value at each reporting period end recognized in the condensed consolidated statements of operations and comprehensive loss.

The Company performed a “with-and-without” scenario analysis to determine the fair value of the derivative liability by comparing the value of the Series A Preferred Stock including the bifurcated embedded derivatives to the value of the Series A Preferred Stock excluding them. The Company utilized an option pricing valuation with the expected life of Series A Preferred Stock, expected volatility, and discount rate as significant inputs as well as probability-weighted outcomes. Assumptions used in the valuation also take into account the contractual terms as well as the quoted price of the Common Stock in an active market. Significant changes in any of those inputs in isolation would result in significant changes to the fair value measurement.

The following table presents changes in Level 3 liabilities measured at fair value for the six months ended June 30, 2026 (in thousands):


		June 30, 2026
Beginning balance, January 1, 2026	$	2,749
Change in the fair value of derivative liability		(289)
Ending balance, June 30, 2026	$	2,460

The option pricing valuation used to determine the fair value, used the following assumptions:


	June 30, 2026		December 31, 2025
Expected term (in years)	1.50		2.00
Expected volatility	84	%	80	%
Risk-free interest rate	3.98	%	3.41	%
Expected dividend yield	0	%	0	%
Market discount rate	22.35	%	14.79	%
Fair value of common stock	4.32		4.15

Each of these inputs is subjective and generally requires significant judgment and estimation by management:

Expected Term — The expected term represents the estimated time until the conversion or redemption events are achieved.

Expected Volatility — The Company derives volatility over the expected term using its own historical stock price volatility.

Risk-Free Interest Rate — The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the date of the remeasurement and all thereafter for zero-coupon U.S. Treasury notes with maturities commensurate with the remaining term.

Expected Dividend Yield — The expected dividend yield is zero as the Company has not paid, and the Company does not anticipate paying, any dividends on the Common Stock in the foreseeable future.

Market Discount Rate – The Company utilizes the S&P corporate yield curve with a tenor commensurate with the expected term to estimate a discount rate applicable to the Company’s credit risk.

Fair Value of Common Stock — The Company utilizes the price of its publicly-traded Common Stock as an input in determining the fair value of the derivative.

- Definition

The entire disclosure for derivative instruments and hedging activities including, but not limited to, risk management strategies, non-hedging derivative instruments, assets, liabilities, revenue and expenses, and methodologies and assumptions used in determining the amounts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Condensed Consolidated Balance Sheets (Parentheticals) - USD ($) $ in Thousands	Jun. 30, 2026	Dec. 31, 2025
Condensed Consolidated Balance Sheets
Series A redeemable preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Series A redeemable preferred stock, shares issued	200,000	200,000
Series A redeemable preferred stock, shares outstanding	200,000	200,000
Series A redeemable preferred stock, liquidation preference	$ 20,000	$ 20,000
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	10,000,000	10,000,000
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	60,105,049	57,032,963
Common stock, shares outstanding	60,105,049	57,032,963

Segment Disclosures

6 Months Ended

Jun. 30, 2026

Segment Disclosures

Segment Disclosures

15. 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. 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, 2026 and 2025:


		Three Months Ended June 30,					Six Months Ended June 30,
		2026		2025			2026		2025
(in thousands)
Partnership revenue		$	—	$	667		$	—	$	1,399
Product revenue			88		169			198		305
Expenses:
Cost of product revenues			25		46			57		90
Non-clinical development costs			3,379		4,607			7,429		9,072
Clinical development costs			4,960		2,633			8,534		5,575
Personnel and consulting costs			8,823		7,002			17,611		13,666
Stock-based compensation			2,505		3,250			5,356		6,215
Depreciation and amortization expense			96		81			186		164
Other segment expenses⁽¹⁾			2,287		2,544			2,882		5,170
Interest expense (income), net			1,768		36			2,589		(130)
Net loss		$	(23,755)	$	(19,363)		$	(44,446)	$	(38,118)

(1)	Other segment expenses primarily include the gain on the sale of strategic investments as well as general and administrative costs not presented in other line items.

- Definition

The entire disclosure for segment reporting.

+ References

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+ Details

Marketable Securities and Strategic Investments - Schedule of marketable securities (Details) - USD ($) $ in Thousands	Jun. 30, 2026	Dec. 31, 2025
Marketable Securities
Amortized Cost Basis	$ 89,572	$ 71,762
Unrealized Gains	4	62
Unrealized Losses	(85)	(2)
Fair Value	89,491	71,822
Corporate debt Securities
Marketable Securities
Amortized Cost Basis	78,375	69,308
Unrealized Gains	4	60
Unrealized Losses	(74)	(2)
Fair Value	78,305	69,366
Government debt securities
Marketable Securities
Amortized Cost Basis	11,197	2,454
Unrealized Gains		2
Unrealized Losses	(11)
Fair Value	$ 11,186	$ 2,456

- Definition

Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

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+ Details

Leases (Tables)

6 Months Ended

Jun. 30, 2026

Leases

Schedule of recognized as an asset and operating lease liabilities


As of June 30, 2026:
Weighted average remaining lease term – operating leases, in years	1.65
Weighted average discount rate – operating leases	9.92	%

Schedule of lease expense


		Three Months Ended June 30,						Six Months Ended June 30,
(in thousands)		2026			2025			2026			2025
Fixed operating expense		$	157		$	274		$	401		$	533
Short-term lease expense			45			73			88			132
Variable lease expense			38			19			59			50
		$	240		$	366		$	548		$	715

Schedule of future minimum rental payments, exclusive of taxes, insurance and other costs, under the leases

The table below shows the future minimum rental payments, exclusive of taxes, insurance, and other costs, under the leases as of June 30, 2026:


		Operating
		Leases
Year ending December 31:		(in thousands)
2026 (remaining six months)		$	447
2027			829
2028			159
2029			—
2030			—
Thereafter			—
Total future minimum lease payments		$	1,435
Imputed interest			(107)
Total liability		$	1,328

Leases - Components of lease expense (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025
Leases
Fixed operating expense	$ 157	$ 274	$ 401	$ 533
Short-term lease expense	45	73	88	132
Variable lease expense	38	19	59	50
Total lease expense	$ 240	$ 366	$ 548	$ 715

Net Loss Per Share (Tables)

6 Months Ended

Jun. 30, 2026

Net Loss Per Share

Schedule of calculation of diluted net loss per share



		Six Months Ended June 30,
		2026		2025
Stock options		8,484,821		6,963,765
Common stock warrants		4,148,146		2,057,812
Unvested restricted stock units		3,518,226		2,151,535
Series A Preferred Stock		1,666,666		—
Forfeitable Shares		500,000		500,000
Earnout Consideration		4,000,000		4,000,000
Total		22,317,859		15,673,112

Segment Disclosures (Tables)

6 Months Ended

Jun. 30, 2026

Segment Disclosures

Schedule of significant expense categories regularly reviewed by the CODM


		Three Months Ended June 30,					Six Months Ended June 30,
		2026		2025			2026		2025
(in thousands)
Partnership revenue		$	—	$	667		$	—	$	1,399
Product revenue			88		169			198		305
Expenses:
Cost of product revenues			25		46			57		90
Non-clinical development costs			3,379		4,607			7,429		9,072
Clinical development costs			4,960		2,633			8,534		5,575
Personnel and consulting costs			8,823		7,002			17,611		13,666
Stock-based compensation			2,505		3,250			5,356		6,215
Depreciation and amortization expense			96		81			186		164
Other segment expenses⁽¹⁾			2,287		2,544			2,882		5,170
Interest expense (income), net			1,768		36			2,589		(130)
Net loss		$	(23,755)	$	(19,363)		$	(44,446)	$	(38,118)

(1)	Other segment expenses primarily include the gain on the sale of strategic investments as well as general and administrative costs not presented in other line items.

- Definition

Tabular disclosure of segment reporting. Includes, but is not limited to, reconciliation of reportable segment amount to corresponding consolidated total.

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+ Details

Debt Financing - Schedule of obligations under the loan (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2026 USD ($)
Obligations under the loan
Proceeds from note payable	$ 20,000
Ending balance	20,442
Secured Subordinated Convertible Promissory Note (the "Notes") \| Medtronic \| Loan Agreement
Obligations under the loan
Proceeds from note payable	20,000
Accrued interest expense on liability	442
Ending balance	$ 20,442

Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2026

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Use of Estimates

Cash and Cash Equivalents

Marketable Securities

Strategic Investments

Fair Value of Financial Instruments

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

Inventory

Research and Development Prepayments, Accruals and Related Expenses

Property and Equipment


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

Leases

Debt Discount and Debt Issuance Costs

Impairment of Long-Lived Assets

Revenue Recognition

Partnership Revenues

Product Revenues

Stock-Based Compensation

Series A Preferred Stock

Derivative Liability

The Company’s derivative liability is related to the conversion features embedded in the Series A Preferred Stock. See Note 7 – “Common and Preferred Stock” for additional information.

Net Loss Per Share

Income Taxes

Defined Contribution 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

New Accounting Standards

Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2026

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

Stock-Based Compensation (Tables)

6 Months Ended

Jun. 30, 2026

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)		2026			2025			2026			2025
Research and development		$	637		$	666		$	1,131		$	1,273
Selling, general and administrative			411			692			783			1,331
Total stock-based compensation		$	1,048		$	1,358		$	1,914		$	2,604

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)		2026			2025			2026			2025
Research and development		$	490		$	528		$	1,126		$	993
Selling, general and administrative			967			1,036			2,245			1,986
Total stock-based compensation		$	1,457		$	1,564		$	3,371		$	2,979

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


		Three Months Ended June 30,						Six Months Ended June 30,
(in thousands)		2026			2025			2026			2025
Research and development		$	—		$	121		$	32		$	241
Selling, general and administrative			—			207			39			391
Total stock-based compensation		$	—		$	328		$	71		$	632

Schedule of stock option activity


				Weighted			Weighted
		Shares		Average			Average		Aggregate
		Underlying		Exercise			Remaining		Intrinsic
		Options		Price			Term (years)		Value (000s)
Outstanding at January 1, 2026		7,199,571		$	6.23		7.08		$	1,963
Granted		1,602,434			3.85		—			—
Exercised		(8,528)			3.72		—			6
Forfeited/canceled		(308,656)			6.03		—			—
Outstanding June 30, 2026		8,484,821		$	5.79		7.22		$	2,936
Exercisable at June 30, 2026		4,969,536		$	7.00		5.96		$	708

Schedule of restricted stock activity


	Restricted Stock	Weighted Average
	Awards/Units	Grant Date Fair
	Outstanding	Value
Outstanding at January 1, 2026	2,300,651	$	3.95
Granted	1,721,631		3.83
Vested	(504,056)		6.45
Forfeited/canceled	—		—
Outstanding June 30, 2026	3,518,226	$	3.55

Schedule of estimated grant-date fair value calculated using Black-Scholes option pricing model


		Six Months Ended June 30,
		2026			2025
Expected term (in years)			6.17			6.08
Expected volatility			111	%		80	%
Risk-free interest rate			3.88	%		3.92	%
Expected dividend yield			0	%		0	%
Fair value of common stock			3.27			3.06

Balance Sheet Components - Schedule of property and equipment, net (Details) - USD ($) $ in Thousands	Jun. 30, 2026	Dec. 31, 2025
Schedule of Property and Equipment, Net
Property and equipment, gross	$ 3,862	$ 3,346
Less accumulated depreciation and amortization	(1,817)	(1,631)
Total Property and equipment, net	2,045	1,715
Equipment
Schedule of Property and Equipment, Net
Property and equipment, gross	3,232	2,743
Office furniture
Schedule of Property and Equipment, Net
Property and equipment, gross	459	444
Leasehold improvements
Schedule of Property and Equipment, Net
Property and equipment, gross	$ 171	$ 159

- Definition

Amount of accumulated depreciation, depletion, and amortization of property, plant, and equipment. Includes, but is not limited to, land and land improvement; building; machinery and equipment; furniture and fixture; and work of art, historical treasure, or similar asset classified as collection.

+ References + Details

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

- Definition

Amount, after accumulated depreciation, depletion, and amortization, of property, plant, and equipment. Includes, but is not limited to, land and land improvement; building; machinery and equipment; furniture and fixture; and work of art, historical treasure, or similar asset classified as collection.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 360
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482099/360-10-50-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 360
-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478443/942-360-45-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 360
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
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-URI https://asc.fasb.org/1943274/2147478451/942-360-50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section S45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477657/942-210-S45-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478478/942-210-S50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-03(8))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478546/942-210-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 842
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 7A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478964/842-20-50-7A

Reference 8: http://www.xbrl.org/2003/role/exampleRef
-Topic 852
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481372/852-10-55-10

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-03(a)(8))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478777/944-210-S99-1

+ Details

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, 2026	Jun. 30, 2025
Stock-Based Compensation
Expected term	6 years 2 months 1 day	6 years 29 days
Expected volatility	111.00%	80.00%
Risk-free interest rate	3.88%	3.92%
Expected dividend yield	0.00%	0.00%
Fair value of common stock	$ 3.27	$ 3.06

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (f)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (f)(2)(v)
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Section 50
-Paragraph 2
-Subparagraph (f)(2)(i)
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

+ Details

Common and Preferred Stock - Other Information (Details) - USD ($) $ / shares in Units, $ in Millions	Oct. 24, 2025	Jun. 30, 2026	Dec. 31, 2025
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		200,000	200,000
Terumo securities purchase agreement
Preferred Stock
Issuance of Series A Preferred Stock (in shares)	200,000
Series A redeemable preferred stock, issue price	$ 100
Series A preferred stock, gross proceeds	$ 20.0

Debt Financing - Other (Details)			3 Months Ended		6 Months Ended
Debt Financing - Other (Details)	Jul. 31, 2025 USD ($)	Nov. 06, 2024 USD ($) item	Jun. 30, 2026 USD ($) $ / shares	Jun. 30, 2025 USD ($)	Jun. 30, 2026 USD ($) $ / shares	Jun. 30, 2025 USD ($)	Aug. 04, 2025 $ / shares
2024 Loan and Security Agreement
Debt Financing
Term loan		$ 50,000,000
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
Number of principal plus interest payments \| item		6
End of term charge (in percent)		6.35%
Facility charge (in percent)		0.75%
Interest expense			$ 485,000	$ 466,000	$ 965,000	$ 928,000
Tranche one loan and security agreement
Debt Financing
Term loan		$ 15,000,000
Tranche two loan and security agreement
Debt Financing
Term loan		$ 35,000,000
Minimum \| 2024 Loan and Security Agreement
Debt Financing
Cash coverage percentage							45.00%
Maximum \| 2024 Loan and Security Agreement
Debt Financing
Interest rate stated (as a percent)		9.50%
Cash coverage percentage							75.00%
Prepayment within 12 months of agreement closing date \| 2024 Loan and Security Agreement
Debt Financing
Prepayment premium		3.00%
Prepayment after 12 months but within 24 months of agreement closing date \| 2024 Loan and Security Agreement
Debt Financing
Prepayment premium		2.00%
Prepayment after 24 months of agreement closing date \| 2024 Loan and Security Agreement
Debt Financing
Prepayment premium		1.00%
Hercules Warrants
Debt Financing
Exercise Price \| $ / shares			$ 3.58		$ 3.58
Warrants expiry term			5 years 4 months 9 days		5 years 4 months 9 days
Hercules Warrants \| 2024 Loan and Security Agreement
Debt Financing
Multiplier factor used to calculate common stock							0.04
Exercise Price \| $ / shares							$ 3.58
Warrants expiry term							7 years
Secured Subordinated Convertible Promissory Note (the "Notes") \| Medtronic \| Loan Agreement
Debt Financing
Term loan	$ 20,000,000
Interest rate stated (as a percent)			11.00%		11.00%
Maturing or Repayment date of the Note	Apr. 27, 2031
Additional debt default interest rate (%)	2.00%
Interest rate			13.20%		13.20%
Interest expense			$ 442,000		$ 442,000	$ 0
Secured Subordinated Convertible Promissory Note (the "Notes") \| Medtronic \| FDA approval of a Medtronic device incorporating AVIM is achieved prior to the Repayment Date \| Loan Agreement
Debt Financing
Debt extinguishment, percentage of revenue share amount (%)	15.00%
Debt extinguishment, Revenue Share Credit payments	$ 40,000,000

Common and Preferred Stock - At-the-Market Offering and Shelf Registration Statement (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2026	Aug. 12, 2024
Common and Preferred Stock
Net proceeds from common stock	$ 5,855
Sales agreement
Common and Preferred Stock
Aggregate offering price of common stock		$ 100,000
Shares issued (in shares)	1,451,439
Aggregate gross proceeds from common stock	$ 6,000
Net proceeds from common stock	5,900
Common stock reserved for future issuance	$ 92,400

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-5

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480008/505-10-S99-1

Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
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-URI https://asc.fasb.org/1943274/2147480070/505-10-S50-2

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-11

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-5

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-3

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S45
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480100/505-10-S45-3

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480100/505-10-S45-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-2

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(29))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
-Section S45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477657/942-210-S45-1

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478478/942-210-S50-1

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
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-URI https://asc.fasb.org/1943274/2147478546/942-210-S99-1

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (SX 210.9-03(19))
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-URI https://asc.fasb.org/1943274/2147478546/942-210-S99-1

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480657/210-10-S50-13

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
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-Section S50
-Paragraph 11
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480657/210-10-S50-11

Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
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-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(27)(b))
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-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8A
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-8A

Reference 25: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480738/235-10-S50-1

Reference 26: http://www.xbrl.org/2003/role/disclosureRef
-Topic 480
-SubTopic 10
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479857/480-10-S50-1

Reference 27: http://www.xbrl.org/2003/role/recommendedDisclosureRef
-Topic 272
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483014/272-10-45-3

Reference 28: http://www.xbrl.org/2003/role/disclosureRef
-Topic 272
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482987/272-10-50-1

Reference 29: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(d))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 30: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 31: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 32: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 33: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 34: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 3
-Subparagraph (SX 210.6-03(i)(2))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479886/946-10-S99-3

Reference 35: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 3
-Subparagraph (SX 210.6-03(i)(1))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479886/946-10-S99-3

Reference 36: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 3
-Subparagraph (SX 210.6-03(i)(2)(i))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479886/946-10-S99-3

Reference 37: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 3
-Subparagraph (SX 210.6-03(i)(2)(ii))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479886/946-10-S99-3

+ Details

- Definition

Number of new stock issued during the period.

+ References

+ Details

Marketable Securities and Strategic Investments

6 Months Ended

Jun. 30, 2026

Marketable Securities and Strategic Investments

Marketable Securities and Strategic Investments

5. Marketable Securities and Strategic Investments

Marketable Securities

The following is a summary of the Company’s marketable securities as of June 30, 2026 and December 31, 2025:


		June 30, 2026
		Amortized			Unrealized			Unrealized			Fair
(in thousands)		Cost Basis			Gains			Losses			Value
Corporate debt securities		$	78,375		$	4		$	(74)		$	78,305
Government debt securities			11,197			—			(11)			11,186
Total		$	89,572		$	4		$	(85)		$	89,491


		December 31, 2025
		Amortized			Unrealized			Unrealized			Fair
(in thousands)		Cost Basis			Gains			Losses			Value
Corporate debt securities		$	69,308		$	60		$	(2)		$	69,366
Government debt securities			2,454			2			—			2,456
Total		$	71,762		$	62		$	(2)		$	71,822

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, 2026, $7.1 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, 2026 and 2025, 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 December 31, 2025 represented 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 related to these investments.

On January 9, 2026, Haemonetics Corporation, a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, announced its acquisition of Vivasure. Vivasure was a strategic investment of the Company prior to its acquisition. In connection with the closing of the transaction, the Company is eligible to receive up to approximately $10.7 million of proceeds in 2026 associated with the transaction. During the six months ended June 30, 2026, the Company received proceeds of $4.8 million and the remainder may be received in 2026 based on the achievement of a milestone. For the six months ended June 30, 2026, the Company recognized a gain on the sale of strategic investments of $2.3 million. The Company may receive additional proceeds in the future associated with revenue earnouts based on the achievement of certain milestones.

Stock-Based Compensation - Schedule of restricted stock activity (Details) - USD ($) $ / shares in Units, $ in Millions	3 Months Ended	6 Months Ended
	Jun. 30, 2026	Jun. 30, 2026
Restricted Stock
Restricted Stock Outstanding
Restricted stock, Beginning		2,300,651
Restricted stock, Granted		1,721,631
Restricted stock, Vested		(504,056)
Restricted stock, Ending	3,518,226	3,518,226
Weighted Average Grant Date Fair Value
Weighted Average Grant Date Fair Value, Beginning		$ 3.95
Weighted Average Grant Date Fair Value, Granted		3.83
Weighted Average Grant Date Fair Value, Vested		6.45
Weighted Average Grant Date Fair Value, Ending	$ 3.55	$ 3.55
Aggregate Intrinsic Value, Vested	$ 1.7	$ 3.2
Performance-Based Restricted Stock Awards
Restricted Stock Outstanding
Restricted stock, Granted		0

Derivative Liability (Tables)

6 Months Ended

Jun. 30, 2026

Derivative Liability

Schedule of reconciliation of the derivative liability associated with the Series A Preferred Stock

The following table presents changes in Level 3 liabilities measured at fair value for the six months ended June 30, 2026 (in thousands):


		June 30, 2026
Beginning balance, January 1, 2026	$	2,749
Change in the fair value of derivative liability		(289)
Ending balance, June 30, 2026	$	2,460

Schedule of assumptions to value the derivative components


	June 30, 2026		December 31, 2025
Expected term (in years)	1.50		2.00
Expected volatility	84	%	80	%
Risk-free interest rate	3.98	%	3.41	%
Expected dividend yield	0	%	0	%
Market discount rate	22.35	%	14.79	%
Fair value of common stock	4.32		4.15

Derivative Liability - Reconciliation of the derivative liability associated with the series A preferred stock (Details) - USD ($) $ in Thousands	3 Months Ended	6 Months Ended
	Jun. 30, 2026	Jun. 30, 2026
Derivative Liability
Derivative liability, beginning balance		$ 2,749
Change in the fair value of derivative liability	$ (324)	(289)
Derivative liability, ending balance	$ 2,460	$ 2,460

Leases - Other (Details)	1 Months Ended			6 Months Ended
Leases - Other (Details)	Nov. 30, 2024 USD ($)	Aug. 31, 2024 USD ($) ft²	Nov. 30, 2022 USD ($) ft²	Jun. 30, 2026 USD ($)	Jun. 30, 2025 USD ($)	Sep. 30, 2024 ft²	Nov. 30, 2019 ft²
Leases
Lease space \| ft²		8,052	7,800			6,496	5,200
Cash paid for operating lease liabilities				$ 524,000	$ 503,000
Minimum
Leases
Monthly rent expense	$ 16,000	$ 17,000	$ 28,000
Maximum
Leases
Monthly rent expense	$ 17,000	$ 19,000	$ 40,000

Royalty Purchase Agreement - Activity of the Revenue purchase agreement (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2026 USD ($)
Royalty Purchase Agreement
Beginning balance	$ 16,482
Proceeds from the royalty purchase agreement	15,000
Non-cash interest expense on liability	3,111
Ending balance	$ 34,593

Royalty Purchase Agreement

6 Months Ended

Jun. 30, 2026

Royalty Purchase Agreement

Royalty Purchase Agreement

13. Royalty Purchase Agreement

On July 31, 2025, the Company entered into a revenue participation right purchase and sale agreement (the “Royalty Purchase Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”). Under the terms of the Royalty Purchase Agreement, in exchange for payment of $35.0 million (the “Investment Amount”), less certain reimbursable expenses, Ligand acquired the right to receive tiered royalty payments from the Company (the “Royalty 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 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.

Pursuant to the Royalty Purchase Agreement, the Investment Amount was received in two tranches: (i) $20.0 million was received on August 4, 2025 and (ii) $15.0 million was received on May 1, 2026 (the “Second Installment”). In repayment of the Investment Amount, the Company will remit 17.0% of revenues related to the Products until an annual total of $17.0 million has been remitted to Ligand, thereafter the Company will remit (a) 4.0% of revenues related to the Primary Product in the field of HTN treatment and (b) 4.0% of revenues related to the Secondary Product in the field of coronary artery treatment. Under the terms of the Royalty Purchase Agreement, the percentages 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 Royalty 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 Royalty Interest payment payable under the terms of the Royalty Purchase Agreement. The obligations arising under the Royalty

Purchase Agreement are secured by security interests in, and pledges over, the Royalty Interest, the Revenue Participation Right (as defined in the Royalty Purchase 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 (as defined below). The Royalty Purchase Agreement contains customary representations, warranties and indemnities of the Company and Ligand, and customary covenants on the part of the Company.

In connection with the sale of the Royalty Interest, and pursuant to the terms of the Royalty Purchase 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 Common Stock (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 vested and became exercisable as follows: (i) 1,142,857 of the Ligand Warrant Shares (the “First Tranche”) vested upon issuance; and (ii) 857,143 of the Ligand Warrant Shares vested on the date of payment of the Second Installment. The Ligand Warrant is exercisable for ten years from the date of issuance.

The Company accounted for its sale of royalty revenues to Ligand, pursuant to the Royalty Purchase Agreement, in accordance with ASC 470, Debt, which addresses situations in which an entity receives cash from an investor in return for an agreement to pay the investor a specified percentage of the revenue from a contractual right. The Company classified the proceeds received from the sale to Ligand as debt as the Company determined that it had significant continuing involvement in the generation of the cash flows to Ligand. Interest related to the Royalty Purchase Agreement will be recognized utilizing the effective interest method over the estimated term.

The Company’s estimate of interest expense associated with the Royalty Interest resulted in an effective annual interest rate of approximately 21.2% as of June 30, 2026 and 23.1% as of December 31, 2025. This estimate contains significant assumptions that impact the interest expense that will be recognized over the royalty period. The Company will periodically assess the estimated amounts due and payable to Ligand and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to the condensed consolidated statements of operations and comprehensive loss. There are a number of factors that could materially affect the amount and timing of the royalty payments to be paid by the Company to Ligand and, correspondingly, the amount of interest expense recorded by the Company.

The following table shows the activity of the Royalty Purchase Agreement for the six months ended June 30, 2026 (in thousands):


	June 30,
	2026
Beginning balance, January 1, 2026	$	16,482
Proceeds from the royalty purchase agreement		15,000
Non-cash interest expense on liability		3,111
Ending balance, June 30, 2026	$	34,593

Debt Financing

6 Months Ended

Jun. 30, 2026

Debt Financing

Debt Financing

14. Debt Financing

2025 Medtronic Loan Agreement

On July 31, 2025, the Company and its wholly-owned subsidiaries, Orchestra BioMed, Inc. and BackBeat, entered into a Loan Agreement with Medtronic (the “Medtronic Loan Agreement”), 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”) issued by the Company. The issuance of the Medtronic Note to Medtronic and the funding of the Medtronic Loan occurred on May 1, 2026 pursuant to the conditions described in the Medtronic Loan Agreement.

The Medtronic Note accrues simple interest at a rate of 11% per annum provided that no interest payments will be paid or due until the April 27, 2031 (the “Maturity Date”). 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 the Maturity 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 Therapy is achieved prior to the Maturity 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 Amended 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.

The Company recognizes interest expense using the effective interest method over the estimated term of the arrangement. The effective interest rate is based on the Company’s estimate of the timing and amount of future payments expected to be made under the arrangement. The total interest expense associated with the Medtronic Note resulted in an effective interest rate of 13.2% as of June 30, 2026. The Company will periodically assess the estimated amounts due and payable to Medtronic and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to the condensed consolidated statements of operations and comprehensive loss.

The obligations under the Medtronic Loan as of June 30, 2026 consisted of the following (in thousands):


	June 30,
	2026
Beginning balance, January 1, 2026	$	—
Proceeds from note payable		20,000
Accrued interest expense on liability		442
Ending balance, June 30, 2026	$	20,442

The following table shows the amount of principal payments due pursuant to the Medtronic Loan by year:


		Principal
		Payments
Year ending December 31:		(in thousands)
2026 (remaining six months)		$	—
2027			—
2028			—
2029			—
2030			—
Thereafter			20,000
Total		$	20,000

Total interest expense recorded on this facility during the three and six months ended June 30, 2026 was approximately $442,000. No interest expense was recorded on this facility during the three and six months ended June 30, 2025.

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, Second Amendment to Loan and Security Agreement dated as of July 31, 2025 and Third Amendment to the Loan and Security Agreement, dated as of April 6, 2026 (as amended, the “2024 LSA”).

The 2024 LSA provides a secured term loan facility of up to $50.0 million in up to two tranches (collectively, the “Term Loans”), with the first tranche of $15.0 million drawn on the LSA Closing Date, and a second tranche of up to $35.0 million that may be borrowed by the Company in the discretion of the lender’s investment committee.

Under the terms of the 2024 LSA, the initial date upon which the Company has to begin amortizing the Term Loans is June 1, 2028. 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 interest-only period expiring June 1, 2028, followed by six monthly principal payments plus interest. 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 Common Stock, which warrants were amended effective August 4, 2025 in connection with the Second Amendment to Loan and Security Agreement (as amended, each a “Hercules Warrant” and, collectively, the “Hercules Warrants”). Pursuant to the terms of the Hercules Warrants, each Hercules Lender can purchase that number of shares of Common Stock equal to (i)(x) 0.04, 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) $3.58, which is the exercise price of the Hercules Warrants. Each Hercules Warrant is exercisable for seven years from the LSA Closing Date.

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), beginning on January 1, 2027 (subject to being extended to as late as January 1, 2028 depending on the Company’s receipt of specified net cash proceeds from specified sources), 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 2024 LSA), which percentage ranges from a minimum of 45% to a maximum of 75% of Term Loan Advances, depending upon the amount of Qualified Cash.

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)
2026 (remaining six months)		$	—
2027			—
2028			15,000
2029			—
Total		$	15,000

Total interest expense recorded on these facilities during the three and six months ended June 30, 2026 was approximately $485,000 and $965,000, respectively. Total interest expense recorded on these facilities during the three and six months ended June 30, 2025 was approximately $466,000 and $928,000, respectively.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

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+ Details

Common and Preferred Stock - Schedule of roll-forward of the Series A Preferred Stock activity (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2026 USD ($)
Increase (Decrease) in Mezzanine Equity
Beginning balance	$ 9,808
Adjustment to carrying value of Series A Preferred Stock	289
Ending balance	$ 10,097

- Definition

Carrying amount, attributable to parent and noncontrolling interests, of an entity's issued and outstanding stock which is not included within permanent equity. Temporary equity is a security with redemption features that are outside the control of the issuer, is not classified as an asset or liability in conformity with GAAP, and is not mandatorily redeemable. Includes any type of security that is redeemable at a fixed or determinable price or on a fixed or determinable date or dates, is redeemable at the option of the holder, or has conditions for redemption which are not solely within the control of the issuer. Includes stock with a put option held by an ESOP and stock redeemable by a holder only in the event of a change in control of the issuer.

+ References

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+ Details

Balance Sheet Components - Other (Details)	Jun. 30, 2026 USD ($)
Balance Sheet Components
Property plant and equipment not placed in service yet and has not commenced	$ 703,000

Summary of Significant Accounting Policies - Other (Details)		3 Months Ended		6 Months Ended
	Jan. 01, 2023	Jun. 30, 2026 USD ($) $ / shares	Jun. 30, 2025 USD ($)	Jun. 30, 2026 USD ($) segment $ / shares	Jun. 30, 2025 USD ($)	Dec. 31, 2025 USD ($) $ / shares
Summary of Significant Accounting Policies
Series A redeemable preferred stock, par value (in dollars per share) \| $ / shares		$ 0.0001		$ 0.0001		$ 0.0001
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		127,000	$ 119,000	$ 291,000	$ 239,000
Number of reportable segments \| segment				1
Strategic investments						$ 2,495,000
Gain on sale of strategic investments		$ 45,000		$ 2,286,000

Royalty Purchase Agreement (Tables)

6 Months Ended

Jun. 30, 2026

Royalty Purchase Agreement

Schedule of royalty purchase agreement

The following table shows the activity of the Royalty Purchase Agreement for the six months ended June 30, 2026 (in thousands):


	June 30,
	2026
Beginning balance, January 1, 2026	$	16,482
Proceeds from the royalty purchase agreement		15,000
Non-cash interest expense on liability		3,111
Ending balance, June 30, 2026	$	34,593

Warrants (Tables)

6 Months Ended

Jun. 30, 2026

Warrants

Schedule of purchase shares of Company Common Stock


		Number of Shares				Remaining
		June 30,		December 31,	Exercise	Term in
		2026		2025	Price	Years
Equity-classified Warrants
Pre-Funded Warrants⁽¹⁾		3,886,331		5,136,363	$0.0001	N/A
Ligand Warrant (Note 13)		2,000,000		2,000,000	$3.67	9.09
Orchestra BioMed, Inc. Warrants⁽²⁾		507,841		507,841	$1.08 – $30.11	0.93 – 2.07
Hercules Warrants (Note 14)		167,598		167,598	$3.58	5.36
Avenue Warrants		27,707		27,707	$7.67	2.27
Non-employee Warrants (Note 10)		60,000		60,000	$4.69	3.67
Private Warrants Held by Sponsor⁽³⁾		750,000		750,000	$11.50	6.58
Officer and Director Warrants⁽⁴⁾		635,000		635,000	$11.50	6.58
Total Outstanding		8,034,477		9,284,509

(1)

(2)	Represents warrants initially issued by Orchestra BioMed, Inc., which converted into warrants to acquire Common Stock in connection with the Business Combination (the “Orchestra BioMed, Inc. Warrants”).

(3)

(4)

Document And Entity Information - shares	6 Months Ended
Document And Entity Information - shares	Jun. 30, 2026	Aug. 06, 2026
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2026
Document Fiscal Year Focus	2026
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	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		60,105,049
Entity Central Index Key	0001814114
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q2
Amendment Flag	false

Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) $ in Thousands	3 Months Ended
	Mar. 31, 2026 USD ($)
Condensed Consolidated Statements of Stockholders' Equity
Offering costs	$ 150

Stock-Based Compensation

6 Months Ended

Jun. 30, 2026

Stock-Based Compensation

Stock-Based Compensation

10. Stock-Based Compensation

Orchestra BioMed Holdings, Inc. 2023 Equity Incentive Plan

On January 26, 2023, the Company adopted the Orchestra BioMed Holdings, Inc. 2023 Equity Incentive Plan (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, 2026, approximately 424,000 shares of Common Stock were authorized for issuance pursuant to awards under the 2023 Plan. The pool of available shares is 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 Common Stock determined on a fully-diluted basis as of the immediately preceding December 31 and (ii) 3,036,722 shares of Common Stock, and (iii) such number of shares of 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.

Orchestra BioMed Holdings, Inc. 2025 New Hire Inducement Plan

In November 2025, the Company's Board of Directors adopted the 2025 New Hire Inducement Plan (the "Inducement Plan"). The Inducement Plan provides for the grant of nonstatutory stock options, stock appreciation rights, restricted stock, RSUs and other stock-based awards with respect to an aggregate of 950,000 shares of Common Stock (subject to adjustment as provided in the Inducement Plan). Awards under the Inducement Plan may only be granted to new employees who were not previously an employee or director of the Company or are commencing employment with the Company following a bona fide period of non-employment, in either case, as an inducement material to the individual’s entering into employment with the Company and in accordance with the requirements of Nasdaq Stock Market Rule 5635(c)(4). During the six months ended June 30, 2026, the Company granted inducement equity awards to 14 new employees as a material inducement to acceptance of their respective employment consisting of stock options to purchase up to an aggregate of 205,500 shares of the Common Stock. As of June 30, 2026, there were approximately 616,000 shares remaining available for future issuance under the Inducement Plan.

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)		2026			2025			2026			2025
Research and development		$	637		$	666		$	1,131		$	1,273
Selling, general and administrative			411			692			783			1,331
Total stock-based compensation		$	1,048		$	1,358		$	1,914		$	2,604

As of June 30, 2026, there was approximately $9.7 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 2.9 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)		2026			2025			2026			2025
Research and development		$	490		$	528		$	1,126		$	993
Selling, general and administrative			967			1,036			2,245			1,986
Total stock-based compensation		$	1,457		$	1,564		$	3,371		$	2,979

As of June 30, 2026, there was approximately $9.9 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 2.3 years.

On February 28, 2025, the Company issued equity-classified warrants to purchase 60,000 shares of 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 vested ratably over eight months. Assumptions used were an expected term (in years) of 2.84, expected volatility of 110.1%, risk-free interest rate of 3.99%, expected dividend yield of 0%, and the fair value of 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)		2026			2025			2026			2025
Research and development		$	—		$	121		$	32		$	241
Selling, general and administrative			—			207			39			391
Total stock-based compensation		$	—		$	328		$	71		$	632

As of June 30, 2026, the stock-based compensation expense associated with the warrants noted above is fully recognized.

Stock Option Activity

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


				Weighted			Weighted
		Shares		Average			Average		Aggregate
		Underlying		Exercise			Remaining		Intrinsic
		Options		Price			Term (years)		Value (000s)
Outstanding at January 1, 2026		7,199,571		$	6.23		7.08		$	1,963
Granted		1,602,434			3.85		—			—
Exercised		(8,528)			3.72		—			6
Forfeited/canceled		(308,656)			6.03		—			—
Outstanding June 30, 2026		8,484,821		$	5.79		7.22		$	2,936
Exercisable at June 30, 2026		4,969,536		$	7.00		5.96		$	708

The weighted average grant-date fair value of stock options granted during the six months ended June 30, 2026 and 2025 was $3.27 and $2.18 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 2023 Plan:


	Restricted Stock	Weighted Average
	Awards/Units	Grant Date Fair
	Outstanding	Value
Outstanding at January 1, 2026	2,300,651	$	3.95
Granted	1,721,631		3.83
Vested	(504,056)		6.45
Forfeited/canceled	—		—
Outstanding June 30, 2026	3,518,226	$	3.55

No performance-based restricted stock awards or units were granted during the six months ended June 30, 2026. The fair value of restricted stock units vested during the three and six months ended June 30, 2026 was $1.7 million and $3.2 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,
		2026			2025
Expected term (in years)			6.17			6.08
Expected volatility			111	%		80	%
Risk-free interest rate			3.88	%		3.92	%
Expected dividend yield			0	%		0	%
Fair value of common stock			3.27			3.06

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 derives volatility over the expected term using its own historical stock price volatility.

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 the Company has not paid, and the Company does not anticipate paying, any dividends on the Common Stock in the foreseeable future.

Fair Value of Common Stock — The Company utilizes the price of its publicly-traded Common Stock to determine the grant date fair value of awards.

Warrants - Summarized Outstanding Warrants (Details) $ / shares in Units, $ in Millions			1 Months Ended	6 Months Ended
	Feb. 28, 2025 $ / shares shares	Jan. 06, 2023 $ / shares	Aug. 31, 2025 USD ($) $ / shares	Jun. 30, 2026 director $ / shares shares	Dec. 31, 2025 shares
Warrants
Warrants				8,034,477	9,284,509
Pre-Funded Warrants
Warrants
Warrants				3,886,331	5,136,363
Exercise Price \| $ / shares				$ 0.0001
Exercise price of warrants or rights \| $ / shares		$ 0.0001
Pre-funded warrants, exercised				1,250,032
Pre-Funded Warrants \| Public Offering
Warrants
Price of warrants or rights outstanding \| $ / shares			$ 2.7499
Issuances of warrants \| $			$ 14.1
Exercise price of warrants or rights \| $ / shares			$ 0.0001
Ligand Warrant
Warrants
Warrants				2,000,000	2,000,000
Exercise Price \| $ / shares				$ 3.67
Term				9 years 1 month 2 days
Orchestra BioMed, Inc. Warrants
Warrants
Warrants				507,841	507,841
Orchestra BioMed, Inc. Warrants \| Minimum
Warrants
Exercise Price \| $ / shares				$ 1.08
Term				11 months 4 days
Orchestra BioMed, Inc. Warrants \| Maximum
Warrants
Exercise Price \| $ / shares				$ 30.11
Term				2 years 25 days
Hercules Warrants
Warrants
Warrants				167,598	167,598
Exercise Price \| $ / shares				$ 3.58
Term				5 years 4 months 9 days
Avenue Warrants
Warrants
Warrants				27,707	27,707
Exercise Price \| $ / shares				$ 7.67
Term				2 years 3 months 7 days
Non-employee Warrants
Warrants
Warrants				60,000	60,000
Exercise Price \| $ / shares	$ 4.69			$ 4.69
Term				3 years 8 months 1 day
Number of warrants issued	60,000
Private Warrants Held by Sponsor
Warrants
Warrants				750,000	750,000
Exercise Price \| $ / shares				$ 11.5
Term				6 years 6 months 29 days
Number of warrants issued				1,500,000
Number of warrants forfeited				750,000
Officer And Director Warrants
Warrants
Warrants				635,000	635,000
Exercise Price \| $ / shares				$ 11.5
Term				6 years 6 months 29 days
Number of warrants issued				750,000
Number of specified employees and directors warrants issued \| director				11
Officer And Director Warrants \| Maximum
Warrants
Warrants				750,000

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Jun. 30, 2026 shares
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Terminated	false
Andrew Taylor [Member]
Trading Arrangements, by Individual
Material Terms of Trading Arrangement	On May 27, 2026, Andrew Taylor, our Chief Financial Officer, terminated his “Rule 10b5-1 trading arrangement,” as such term is defined in Item 408(c) of Regulation S-K, for the sale of up to 84,000 shares of our common stock, subject to certain conditions. The Rule 10b5-1 trading arrangement was adopted on December 18, 2025, with sales to commence on July 1, 2026 (subject to the satisfaction of certain conditions) and the arrangement to expire on June 30, 2027. At the time of termination, no shares of our common stock had been sold under Mr. Taylor’s Rule 10b5-1 trading arrangement.
Name	Andrew Taylor
Title	Chief Financial Officer
Adoption Date	Dec. 18, 2025
Rule 10b5-1 Arrangement Terminated	true
Termination Date	May 27, 2026
Aggregate Available	84,000

Financial Instruments and Fair Value Measurements

6 Months Ended

Jun. 30, 2026

Financial Instruments and Fair Value Measurements

Financial Instruments and Fair Value Measurements

4. 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, 2026
(in thousands)		Level 1			Level 2			Level 3			Total
Assets
Money market fund (included in Cash and cash equivalents)		$	15,549		$	—		$	—		$	15,549
Corporate and government debt securities (included in Marketable securities)			—			89,491			—			89,491
Total assets		$	15,549		$	89,491		$	—		$	105,040

Liabilities
Derivative liability (Note 8)			—			—			2,460			2,460
Total liabilities		$	—		$	—		$	2,460		$	2,460


		December 31, 2025
(in thousands)		Level 1			Level 2			Level 3			Total
Assets
Money market fund (included in Cash and cash equivalents)		$	12,789		$	—		$	—		$	12,789
Corporate and government debt securities (included in Marketable securities)			—			71,822			—			71,822
Total assets		$	12,789		$	71,822		$	—		$	84,611

Liabilities
Derivative liability (Note 8)			—			—			2,749			2,749
Total liabilities		$	—		$	—		$	2,749		$	2,749

The Level 2 assets consist of corporate and government 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.

The Level 3 liabilities consist of the derivative liability associated with the Series A Preferred Stock, of which the fair values were measured upon issuance of the Series A Preferred Stock and are remeasured to fair value at each reporting period. The valuation methodology and underlying assumptions are discussed further in Note 8 – “Derivative Liability.” Significant change to the inputs used in determining the fair value would result in significant changes to the fair value measurement.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Common and Preferred Stock

6 Months Ended

Jun. 30, 2026

Common and Preferred Stock

Common and Preferred Stock

7. Common and Preferred Stock

Common Stock

The Company is authorized to issue up to 340,000,000 shares of 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, 2026 and December 31, 2025, 200,000 shares of preferred stock were outstanding.

Series A Preferred Stock

On October 24, 2025, concurrent with the execution of the Termination and ROFR Agreement, the Company and Terumo Medical Corporation (“TMC”) entered into a securities purchase agreement (the “Terumo Securities Purchase Agreement”), pursuant to which TMC purchased 200,000 shares of Series A Preferred Stock (“Preferred Shares”) at a purchase price equal to $100.00 per share for gross proceeds to the Company of $20.0 million. The closing of the sale of the Preferred Shares pursuant to the Terumo Securities Purchase Agreement occurred on November 7, 2025.

The Series A Preferred Stock was accounted for as mezzanine equity in accordance with ASC 480 and the embedded conversion and redemption features were separated from the host instrument and recognized as derivative liability with change in fair value at each reporting period end recognized in the condensed consolidated statements of operations and comprehensive loss. (see Note 8 – “Derivative Liability”).

The Company utilized an option pricing valuation to determine the fair value of the Series A Preferred Stock at issuance. The valuation incorporated Level 3 inputs in the fair value hierarchy including the expected life of Series A Preferred Stock, expected volatility, and discount rate as well as probability-weighted outcomes. Assumptions used in the valuation also take into account the contractual terms as well as the quoted price of the Company’s common stock in an active market. Significant changes in any of these inputs in isolation would result in significant changes to the fair value measurement.

A roll-forward of the Series A Preferred Stock activity is presented below for the six months ended June 30, 2026 (in thousands):


Beginning balance, January 1, 2026	$	9,808
Adjustment to carrying value of Series A Preferred Stock		289
Ending balance, June 30, 2026	$	10,097

At-the-Market Offering and Shelf Registration Statement

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 $100.0 million of shares of 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 a shelf registration statement, filed with the SEC on May 15, 2024 and declared effective on May 24, 2024 (the “Shelf Registration Statement”), 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.

During the six months ended June 30, 2026, the Company sold 1,451,439 shares of Common Stock under the Sales Agreement resulting in aggregate gross proceeds to the Company of approximately $6.0 million and net proceeds to the Company of approximately $5.9 million. As of June 30, 2026, the Company had up to $92.4 million of Common Stock available to sell under the Sales Agreement.

- Definition

The entire disclosure for equity.

+ References

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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
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Reference 26: http://www.xbrl.org/2003/role/disclosureRef
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Reference 27: http://www.xbrl.org/2003/role/disclosureRef
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Reference 28: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Leases

6 Months Ended

Jun. 30, 2026

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 Orchestra BioMed, Inc. 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 range between $17,000 and $19,000 for the period from the August 2024 addendum through expiration.

In November 2019, Orchestra BioMed, Inc. entered into a new lease agreement for approximately 5,200 square feet of office space in New York, NY. In November 2022, Orchestra BioMed, Inc. 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 range 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 range 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, 2026:

Cash paid for amounts included in the present value of operating lease liabilities was $524,000 during the six months ended June 30, 2026 compared to $503,000 during the six months ended June 30, 2025.


As of June 30, 2026:
Weighted average remaining lease term – operating leases, in years	1.65
Weighted average discount rate – operating leases	9.92	%

Operating Leases

The components of lease expense were as follows:


		Three Months Ended June 30,						Six Months Ended June 30,
(in thousands)		2026			2025			2026			2025
Fixed operating expense		$	157		$	274		$	401		$	533
Short-term lease expense			45			73			88			132
Variable lease expense			38			19			59			50
		$	240		$	366		$	548		$	715

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, 2026:


		Operating
		Leases
Year ending December 31:		(in thousands)
2026 (remaining six months)		$	447
2027			829
2028			159
2029			—
2030			—
Thereafter			—
Total future minimum lease payments		$	1,435
Imputed interest			(107)
Total liability		$	1,328

Net Loss Per Share - Other (Details)	Apr. 12, 2023 shares	Jan. 26, 2023 D $ / shares shares	Jan. 06, 2023 $ / shares
Pre-Funded Warrants
Net Loss Per Share
Exercise price of warrants or rights \| $ / shares			$ 0.0001
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
Forfeitable shares	500,000
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
Forfeitable shares	500,000
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
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
Number of shares issuable as earnout consideration		8,000,000
Share lock up period		12 months
HSAC2 \| Maximum \| Initial Milestone Event
Net Loss Per Share
Number of shares issuable as earnout consideration	4,000,000

Organization and Basis of Presentation

6 Months Ended

Jun. 30, 2026

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”) 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 two flagship product candidates are Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of hypertension (“HTN”), the leading 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.

The Company was incorporated in the Cayman Islands in 2020, as a special purpose acquisition company under the name Health Sciences Acquisitions Corporation 2 (“HSAC2”). On January 26, 2023, Orchestra BioMed, Inc., the Company’s wholly owned subsidiary, and HSAC2 consummated a business combination pursuant to which, among other things, Orchestra BioMed, Inc. became a wholly owned subsidiary of HSAC2 and HSAC2 changed its name to Orchestra BioMed Holdings, Inc. (the “Business Combination”). HSAC2 Holdings, LLC (the “Sponsor”) was the sponsor of HSAC2 prior to the Business Combination.

Orchestra BioMed, Inc. 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, Orchestra BioMed, Inc. concurrently completed its formation mergers with Caliber Therapeutics, Inc., a Delaware corporation, BackBeat Medical, Inc., a Delaware Corporation, and FreeHold Surgical, Inc., a Delaware corporation. Orchestra BioMed, Inc. completed the conversions of BackBeat Medical, Inc. to BackBeat Medical, LLC, a Delaware limited liability company (“BackBeat”), of FreeHold Surgical, Inc. to FreeHold Surgical, LLC, a Delaware limited liability company (“FreeHold”), and of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC, a Delaware limited liability company (“Caliber”) in 2019.

Caliber

Caliber Therapeutics, Inc. was incorporated in Delaware in October 2005 and began development of its lead product candidate 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 to leave a permanent implant such as a stent in the artery.

BackBeat

BackBeat Medical, Inc. was incorporated in Delaware in January 2010 and began development of its lead product candidate AVIM Therapy that same year. AVIM Therapy is a patented, cardiac pacing therapy for HTN that can be delivered as firmware on a standard dual-chamber pacemaker and is designed to immediately, substantially and sustainably lower blood pressure while simultaneously modulating the autonomic nervous system. Refer to Note 3 – “Medtronic Agreement” for details regarding the Exclusive License and Collaboration Agreement, dated as of June 30, 2022, by and among, Orchestra BioMed, Inc., BackBeat and Medtronic, Inc. (an affiliate of Medtronic plc) (the “Medtronic Agreement”) and as amended pursuant to the Medtronic Agreement Amendment (as defined below), the “Amended 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 visualization 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 regulations 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, 2025 has been derived from the audited financial statements at that date. Operating results and cash flows for the six months ended June 30, 2026 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2026 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, 2025 filed with the SEC on March 12, 2026 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, 2026, the Company had an accumulated deficit of $407.0 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, 2026, 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.