Current Report · Items 7.01, 9.01 · 8-K

Orchestra BioMed Holdings, Inc.

OBIONASDAQEQUITYCurrent

Regulation FD Disclosure

Filed Nov 13, 2025Accepted Nov 13, 2025, 3:30 AM ESTCIK 1814114Accession 0001104659-25-110907

Company context

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 by 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, one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations 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 non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of si

Current securities

OBIONASDAQ · EQUITY · Current

Historical securities (1)

HSAQNASDAQ · EQUITY · Historical · closed Jan 27, 2023

Recent company filings

Disclosure sections

Items 7.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On November 12, 2025, Orchestra BioMed Holdings, Inc. (the “Company”) held a conference call via a live audio and video webcast (the “Conference Call”), to discuss certain significant business updates with respect to clinical, strategic and financing developments of the Company. A copy of the transcript of the Conference Call (the “Transcript”) and the investor presentation presented during the Conference Call (the “Investor Presentation”), are attached to this Current Report on Form 8-K (“Current Report”) as Exhibit 99.1 and as Exhibit 99.2, respectively, and are incorporated herein by reference solely for purposes of this Item 7.01 disclosure. The information in Item 7.01 of this Current Report, including Exhibit 99.1 and Exhibit 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1 and Exhibit 99.2, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing.

Filed exhibits (2)

EX-99.1 (by filename) tm2531129d1_ex99-1.htm

EX-99.1 2 tm2531129d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Orchestra BioMed Third Quarter 2025 Corporate Update Conference Call 12 November 2025 C O R P O R A T E P A R T I C I P A N T S Kelsey Kirk-Ellis, Director, Corporate Communications David Hochman, Chairman, Chief Executive Officer and Founder Andrew Taylor, Chief Financial Officer C O N F E R E N C E C A L L P A R T I C I P A N T S Matthew O’Brien, Piper Sandler Matthew Miksic, Barclays Marie Thibault, BTIG Anderson Schock, B. Riley Securities Josh Jennings, TD Cowen Eduardo for Yi Chen, H.C. Wainwright P R E S E N T A T I O N Operator Greetings. Welcome to Orchestra Bio’s Third Quarter 2025 Corporate Update Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star, zero on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to Kelsey Kirk-Ellis, Director of Corporate Communications. Thank you. You may begin. Kelsey Kirk-Ellis Starting on Slide 2, before the call begins we would like to a…

Open exhibit ↗

EX-99.2 (by filename) tm2531129d1_ex99-2.htm

EX-99.2 3 tm2531129d1_ex99-2.htm EXHIBIT 99.2 Exhibit 99.2 Orchestra BioMed Business Update November 2025 Nasdaq: OBIO Forward - Looking Statements dŚŝƐ ƉƌĞƐĞŶƚĂƚŝŽŶ ŚĂƐ ďĞĞŶ ƉƌĞƉĂƌĞĚ ĨŽƌ ŝŶĨŽƌŵĂƚŝŽŶĂů ƉƵƌƉŽƐĞƐ ŽŶůǇ ĨƌŽŵ ŝŶĨŽƌŵĂƚŝŽŶ ƐƵƉƉůŝĞĚ ďǇ KƌĐŚĞƐƚƌĂ ŝŽDĞĚ,ŽůĚŝŶŐƐ͕ /ŶĐ ͘ ͕ ƌĞĨĞƌƌĞĚ ƚŽ ŚĞƌĞŝŶ ĂƐ ͞ ǁĞ͕ ͟ ͞ ŽƵƌ͕ ͟ ͞ KƌĐŚĞƐƚƌĂ ŝŽDĞĚ͕ ͟ ĂŶĚ ͞ ƚŚĞ ŽŵƉĂŶǇ͕ ͟ ĂŶĚ ĨƌŽŵ ƚŚŝƌĚ Ͳ ƉĂƌƚǇ ƐŽƵƌĐĞƐ ŝŶĚŝĐĂƚĞĚ ŚĞƌĞŝŶ ͘ ^ƵĐŚ ƚŚŝƌĚ Ͳ ƉĂƌƚǇ ŝŶĨŽƌŵĂƚŝŽŶ ŚĂƐ ŶŽƚ ďĞĞŶ ŝŶĚĞƉĞŶĚĞŶƚůǇ ǀĞƌŝĨŝĞĚ ͘ KƌĐŚĞƐƚƌĂ ŝŽDĞĚ ŵĂŬĞƐ ŶŽ ƌĞƉƌĞƐĞŶƚĂƚŝŽŶ Žƌ ǁĂƌƌĂŶƚǇ͕ ĞǆƉƌĞƐƐĞĚ Žƌ ŝŵƉůŝĞĚ͕ ĂƐ ƚŽ ƚŚĞ ĂĐĐƵƌĂĐǇ Žƌ ĐŽŵƉůĞƚĞŶĞƐƐ ŽĨ ƐƵĐŚ ŝŶĨŽƌŵĂƚŝŽŶ ͘ ĞƌƚĂŝŶ ƐƚĂƚĞŵĞŶƚƐ ŝŶĐůƵĚĞĚ ŝŶ ƚŚŝƐ ĚŽĐƵŵĞŶƚ ƚŚĂƚ ĂƌĞ ŶŽƚ ŚŝƐƚŽƌŝĐĂů ĨĂĐƚƐ ĂƌĞ ĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ ĨŽƌ ƉƵƌƉŽƐĞƐ ŽĨ ƚŚĞ ƐĂĨĞ ŚĂƌďŽƌ ƉƌŽǀŝƐŝŽŶƐ ƵŶĚĞƌ ƚŚĞ hŶŝƚĞĚ ^ƚĂƚĞƐ WƌŝǀĂƚĞ ^ĞĐƵƌŝƚŝĞƐ >ŝƚŝŐĂƚŝŽŶ ZĞĨŽƌŵ Đƚ ŽĨ ϭϵϵϱ ͘ &ŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ ŐĞŶĞƌĂůůǇ ĂƌĞ ĂĐĐŽŵƉĂŶŝĞĚ ďǇ ǁŽƌĚƐ ƐƵĐŚ ĂƐ ͞ ďĞůŝĞǀĞ͕ ͟ ͞ ŵĂǇ͕ ͟ ͞ ǁŝůů͕ ͟ ͞ ĞƐƚŝŵĂƚĞ͕ ͟ ͞ ĐŽŶƚŝŶƵĞ͕ ͟ ͞ ĂŶƚŝĐŝƉĂƚĞ͕ ͟ ͞ ŝŶƚĞŶĚ͕ ͟ ͞ ĞǆƉĞĐƚ͕ ͟ ͞ ƐŚŽƵůĚ͕ ͟ ͞ ǁŽƵůĚ͕ ͟ ͞ ƉůĂŶ͕ ͟ ͞ ƉƌĞĚŝĐƚ͕ ͟ ͞ ƉŽƚĞŶƚŝĂů͕ ͟ ͞ ƐĞĞŵ͕ ͟ ͞ ƐĞĞŬ͕ ͟ ͞ ĨƵƚƵƌĞ͕ ͟ ͞ ŽƵƚůŽŽŬ ͟ ĂŶĚ ƐŝŵŝůĂƌ ĞǆƉƌĞƐƐŝŽŶƐ ƚŚĂƚ ƉƌĞĚŝĐƚ Žƌ ŝŶĚŝĐĂƚĞ ĨƵƚƵƌĞ ĞǀĞŶƚƐ Žƌ ƚƌĞŶĚƐ Žƌ ƚŚĂƚ ĂƌĞ…