Orchestra BioMed Reports Third Quarter 2025 Financial Results and Highlights Recent Business Updates

Rhea-AI Summary

Orchestra BioMed (Nasdaq: OBIO) reported Q3 2025 results and secured $147.6 million in gross proceeds and committed capital from strategic transactions and equity offerings to fund pivotal programs. Cash and marketable securities were $95.8 million as of Sept 30, 2025, with additional $30.0 million received Nov 7, 2025 and commitments of $35.0 million from Ligand and Medtronic by May 1, 2026. Company extended runway into Q4 2027 to support BACKBEAT and the Virtue SAB pivotal trial.

Clinical progress includes initiated enrollment in the Virtue SAB randomized IDE pivotal trial and BACKBEAT protocol enhancements; Q3 operating cash use was $14.9M and net loss was $20.8M (Q3 2025).

Positive

• Secured $147.6M gross proceeds and committed capital
• Cash and marketable securities of $95.8M at Sept 30, 2025
• Extended cash runway into Q4 2027
• Initiated enrollment in U.S. randomized Virtue SAB pivotal trial
• BACKBEAT protocol broadened eligible pool > 24-fold
• Committed $35.0M additional proceeds from Ligand and Medtronic

Negative

• Net loss of $20.8M for Q3 2025
• Quarterly R&D spending increased to $14.0M (+20.7% vs prior year)
• SG&A rose to $7.1M in Q3 2025
• Operating cash used $14.9M in Q3 2025
• Issued convertible preferred stock (convertible at minimum $12 per share)

Insights

Financial Strategy Analyst

Strong capital raise and extended runway materially de-risk near-term financing for pivotal programs.

Orchestra BioMed secured approximately $147.6 million in combined proceeds and commitments, including strategic investments from Medtronic, Ligand, and Terumo, and an oversubscribed public offering. This infusion raises cash and committed capital and increases operational flexibility while the company advances two registrational clinical programs.

The company reports $95.8 million in cash and marketable securities as of September 30, 2025, plus a $30.0 million receipt on November 7, 2025 and commitments to receive an additional $35.0 million by May 1, 2026. These facts support management's statement that runway extends into Q4 2027, reducing near-term dilution risk and enabling execution of planned enrollment and endpoint milestones.

Watch for cash-burn trends and milestone timing: quarterly R&D and SG&A are rising, with net cash used of $14.9 million in Q3 and net loss of $20.8 million. Monitor quarterly cash balance updates, receipt of the committed $35.0 million by May 1, 2026, and the company’s progress toward the stated enrollment completion timelines through mid-2027.

Clinical Development Analyst

Pivotal trials are enrolling and protocol enhancements widen eligible populations, advancing regulatory timelines.

Enrollment has started in the U.S. pivotal randomized Virtue SAB trial versus a commercially available paclitaxel-coated balloon and the BACKBEAT global pivotal study remains active. The company also implemented FDA-approved BACKBEAT protocol enhancements that expand the eligible patient pool by over 24-fold, which should accelerate screening and enrollment rates.

Key dependencies include sustained enrollment rates and data quality: target completion of BACKBEAT enrollment is mid-2026, and Virtue enrollment target is mid-2027. Concrete near-term items to watch are enrollment milestones for BACKBEAT and interim follow-up for its primary endpoint, plus completion of Virtue enrollment; these events drive regulatory-readiness timelines and are expected within the stated horizons.

• Secured $147.6 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by $71.6 million in committed capital from Medtronic and Ligand, as well as $30 million from Terumo
  
  
• Initiated patient enrollments in the Virtue Trial evaluating Virtue^® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) trial versus commercially available paclitaxel-coated balloon
  
  
• Demonstrated partnership-driven business model execution with expanded strategic collaboration with Medtronic and new right of first refusal agreement with Terumo
  

NEW HOPE, Pa., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the third quarter ended September 30, 2025, and provided a business update highlighting recent financial and regulatory milestones.

Q3 2025 and Recent Business Highlights:

• Completed multiple strategic transactions and concurrent public and private equity offerings totaling $147.6 million in gross proceeds to support continued advancement of the Company’s pivotal trial-stage Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and Virtue SAB clinical programs. Gross proceeds are comprised of:
  • $55 million received or to be received by May 1, 2026, subject to certain conditions, in strategic investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc (NYSE: MDT, “Medtronic”)
  • $62.6 million received from a $46 million oversubscribed, underwritten public offering of common stock and prefunded warrants and $11.6 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectively
  • $30 million received from Terumo Corporation, including a $10 million payment in exchange for granting Terumo a right of first refusal (“ROFR”) and a $20 million purchase of non-voting preferred stock, convertible into common stock at a minimum of $12 per share (the “Preferred Stock”)
• Extended cash runway into Q4 2027, supporting potentially significant value-creating catalysts, including:
  • BACKBEAT study enrollment completion in mid-2026
  • Follow up for the BACKBEAT study primary endpoint data
  • Completion of enrollment of the Virtue Trial (as defined below) in mid-2027
• Initiated patient enrollments in the Virtue SAB U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ DCB paclitaxel-coated balloon for the treatment of coronary in-stent restenosis (the “Virtue Trial”). Target completion of enrollment is expected in mid-2027.
• Entered into new strategic rights agreement with Terumo, superseding prior agreement which is now terminated, and providing Terumo with a ROFR with respect to certain strategic transactions relating to Virtue SAB for the treatment of coronary artery disease.
  • Orchestra BioMed retains all development and distribution rights for Virtue SAB across all indications and has strategic optionality to explore potential transactions
  • Orchestra BioMed is sponsoring and in full operational control of the Virtue Trial
  • Orchestra BioMed received $30 million for granting the ROFR and selling Terumo the Preferred Stock in additional payments on top of the prior $30 million payment and $5 million equity investment
• Expanded strategic collaboration with Medtronic, providing pathway for future development of AVIM Therapy-enabled leadless pacemakers.
• Implemented FDA-approved BACKBEAT global pivotal study protocol enhancements, broadening patient enrollment criteria for a more than 24-fold increase in the potentially eligible patient pool.
  

Chairman and Chief Executive Officer Commentary from David Hochman:

Mr. Hochman stated: “The last several months have been a period of exceptional execution, during which we secured nearly $150 million in capital and committed capital, positioning Orchestra BioMed to advance both of our pivotal-stage, high-impact programs with full momentum. Enrollment is actively underway in our pivotal, registrational trials for both AVIM Therapy and Virtue SAB. We are proud to have achieved a favorable realignment with Terumo, expanded our collaboration with Medtronic, and secured significant additional funding on terms we believe are highly attractive for shareholders, including a new strategic financial partnership with Ligand. As a result, we are well-financed through key clinical and regulatory milestones. We believe 2026 will be a landmark year for Orchestra, with the target completion of enrollment in the BACKBEAT study and active execution of the Virtue Trial toward completion of enrollment in the Virtue Trial in 2027.”

Financial Results for the Third Quarter Ended September 30, 2025

• Cash and cash equivalents and Marketable securities totaled $95.8 million as of September 30, 2025. On November 7, 2025, we received $30.0 million pursuant to new strategic rights and Terumo stock purchase agreements. The Company has commitments from Ligand and Medtronic to receive a combined $35.0 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties.
• Net cash used in operating activities and for the purchase of fixed assets was $14.9 million during the third quarter of 2025, compared with $13.8 million for the third quarter in 2024, with the primary driver being increased research and development costs during the third quarter of 2025.
• Revenue for the third quarter of 2025 was $0.9 million, compared with $1.0 million for the third quarter in 2024.
• Research and development expenses for the third quarter of 2025 were $14.0 million, compared with $11.6 million for the third quarter in 2024. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study.
• Selling, general and administrative expenses for the third quarter of 2025 were $7.1 million, compared with $5.7 million for the third quarter of 2024. The increase was primarily due to an increase in professional fees.
• Net loss for the third quarter of 2025 was $20.8 million, or $0.40 per share, compared with a net loss of $15.4 million, or $0.41 per share, for the third quarter of 2024. Net loss for the third quarter of 2025 included $3.0 million in non-cash stock-based compensation expense as compared to $2.4 million for the same period in 2024.

About Orchestra BioMed

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue^® Sirolimus AngioInfusion™ Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.

References to Websites and Social Media Platforms

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About AVIM Therapy

AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk.

About Virtue SAB

Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™. It uses a non-coated microporous AngioInfusion™ Balloon to protect the drug in transit and consistently deliver a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center, prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials, including the timing of completion of enrollment in the BACKBEAT study and the Virtue Trial, the receipt of committed capital, the Company’s expected cash runway, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025.

The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.

Investor Contact
Silas Newcomb
Orchestra BioMed
Snewcomb@orchestrabiomed.com

Media Contact
Kelsey Kirk-Ellis
Orchestra BioMed
Kkirkellis@orchestrabiomed.com

Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited)
		September 30,				December 31,
		2025				2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	42,012			$	22,261
Marketable securities			53,808				44,551
Accounts receivable, net			52				92
Inventory			365				173
Prepaid expenses and other current assets			1,531				2,094
Total current assets			97,768				69,171
Property and equipment, net			1,595				1,384
Right-of-use assets			1,653				2,103
Strategic investments, less current portion			2,495				2,495
Deposits and other assets			1,296				1,020
TOTAL ASSETS		$	104,807			$	76,173
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	8,473			$	5,134
Accrued expenses and other liabilities			6,837				6,084
Operating lease liability, current portion			696				550
Deferred revenue, current portion			4,649				4,439
Total current liabilities			20,655				16,207
Deferred revenue, less current portion			8,659				10,989
Royalty purchase agreement			16,167				-
Loan payable			14,204				14,292
Operating lease liability, less current portion			1,135				1,687
Other long-term liabilities			248				40
TOTAL LIABILITIES			61,068				43,215
STOCKHOLDERS’ EQUITY
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at September 30, 2025 and December 31, 2024.			-				-
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 56,464,731 and 38,194,442 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively.			6				4
Additional paid-in capital			412,512				342,780
Accumulated other comprehensive income			45				52
Accumulated deficit			(368,824	)			(309,878	)
TOTAL STOCKHOLDERS’ EQUITY			43,739				32,958
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	104,807			$	76,173

ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited)
		Three Months Ended September 30,
		2025				2024
Revenue:
Partnership revenue		$	721			$	803
Product revenue			140				184
Total revenue			861				987
Expenses:
Cost of product revenues			49				68
Research and development			14,027				11,595
Selling, general and administrative			7,098				5,666
Total expenses			21,174				17,329
Loss from operations			(20,313	)			(16,342	)
Other (expense) income:
Interest (expense) income, net			(515	)			916
Total other (expense) income			(515	)			916
Net loss		$	(20,828	)		$	(15,426	)
Net loss per share
Basic and diluted		$	(0.40	)		$	(0.41	)
Weighted-average shares used in computing net loss per share, basic and diluted			52,186,503				37,621,495
Comprehensive loss
Net loss		$	(20,828	)		$	(15,426	)
Unrealized gain on marketable securities			29				121
Comprehensive loss		$	(20,799	)		$	(15,305	)

FAQ

How much capital did Orchestra BioMed raise in November 2025 (OBIO)?

Orchestra reported $147.6 million in gross proceeds and committed capital from strategic and equity transactions.

What cash runway does OBIO have after the Q3 2025 financing?

The company states the financing extends cash runway into Q4 2027 to support pivotal trials.

When will OBIO complete BACKBEAT enrollment and primary endpoint follow-up?

Target completion of BACKBEAT enrollment is mid-2026, with subsequent follow-up for the primary endpoint thereafter.

What is the timeline for the Virtue SAB pivotal trial (OBIO)?

Virtue SAB enrollment has started; target enrollment completion is expected in mid-2027.

How much cash did OBIO report on its balance sheet at Sept 30, 2025?

Cash and marketable securities totaled $95.8 million as of Sept 30, 2025.

What are the near-term financing commitments from partners for OBIO?

Ligand and Medtronic committed a combined $35.0 million payable on or before May 1, 2026 under agreements.

Did OBIO complete any strategic agreements with device partners in Nov 2025?

Yes; OBIO entered a ROFR agreement with Terumo and expanded collaboration with Medtronic, including pathway for leadless pacemaker development.