Orchestra BioMed Files 8-K on Agreements and Equity Sales

TL;DR

Orchestra BioMed 8-K: Material agreements entered & terminated, plus unregistered equity sales.

AI Summary

Orchestra BioMed Holdings, Inc. filed an 8-K on October 28, 2025, reporting on events as of October 24, 2025. The filing indicates the entry into and termination of material definitive agreements, unregistered sales of equity securities, and other events. The company was formerly known as Health Sciences Acquisitions Corp 2 and changed its name on June 3, 2020.

Why It Matters

This 8-K filing signals significant corporate actions, including potential changes in agreements and equity transactions, which could impact the company's financial structure and future operations.

Risk Assessment

Risk Level: medium — The filing mentions both the entry into and termination of material definitive agreements, as well as unregistered sales of equity, which can introduce uncertainty and potential financial risks.

Key Players & Entities

• Orchestra BioMed Holdings, Inc. (company) — Registrant
• Health Sciences Acquisitions Corp 2 (company) — Former company name
• October 24, 2025 (date) — Earliest event reported date
• October 28, 2025 (date) — Filing date
• June 3, 2020 (date) — Date of name change

FAQ

Key Financial Figures

• $0.0001 — h registered Common stock, par value $0.0001 per share OBIO The Nasdaq Global Mark
• $10 million — sease globally in exchange for a fee of $10 million (the " ROFR Fee "), which is to be paid
• $30 million — eement, Orchestra previously received a $30 million non-refundable payment from Terumo, whi
• $100.00 — d Stock ") at a purchase price equal to $100.00 per Share (the " Purchase Price ") for
• $20.0 million — ") for gross proceeds to the Company of $20.0 million. The closing of the sale of the Shares
• $5 million — ion Agreement, Terumo previously made a $5 million common stock investment in Orchestra. A
• $15.00 — rice of the Common Stock has been above $15.00 per share on any trading day subsequent
• $12.00 — ferred Stock will be the greater of (i) $12.00 per share and (ii) a 20% discount to th
• $10 billion — ty for drug-eluting balloons to be over $10 billion annually. A Head-to-Head Randomized E

Filing Documents

• tm2529597d1_8k.htm (8-K) — 60KB
• tm2529597d1_ex99-1.htm (EX-99.1) — 20KB
• tm2529597d1_ex10-1.htm (EX-10.1) — 98KB
• tm2529597d1_ex10-2.htm (EX-10.2) — 153KB
• tm2529597d1_ex10-3.htm (EX-10.3) — 16KB
• tm2529597d1_ex10-3img01.jpg (GRAPHIC) — 4KB
• 0001104659-25-102862.txt ( ) — 598KB
• obio-20251024.xsd (EX-101.SCH) — 3KB
• obio-20251024_lab.xml (EX-101.LAB) — 33KB
• obio-20251024_pre.xml (EX-101.PRE) — 22KB
• tm2529597d1_8k_htm.xml (XML) — 4KB

01. Entry into Material Definitive Agreement

Item 1.01. Entry into Material Definitive Agreement. Termination and Right of First Refusal Agreement On October 24, 2025 (the " Effective Date "), Orchestra BioMed, Inc. (" Orchestra "), a wholly owned subsidiary of Orchestra BioMed Holdings, Inc. (the " Company "), entered into a termination and right of first refusal agreement (the " Termination and ROFR Agreement ") with Terumo Medical Corporation (" TMC ") and Terumo Corporation (" TC " and, together with TMC " Terumo "), pursuant to which that certain Distribution Agreement by and between Orchestra and Terumo, dated June 13, 2019 (as subsequently amended, the " Distribution Agreement "), was terminated, and Orchestra agreed to grant Terumo a right of first refusal (the " ROFR ") with respect to certain transactions involving the Company's product candidate known as Virtue Sirolimus AngioInfusion Balloon (" Virtue SAB ") for the treatment of coronary artery disease globally in exchange for a fee of $10 million (the " ROFR Fee "), which is to be paid no later than 10 business days after the Effective Date. The ROFR does not apply to other vascular indications, such as below-the-knee peripheral artery disease, which were covered by the Distribution Agreement prior to its termination. Accordingly, all rights to these indications are fully retained by the Company. Pursuant to the Distribution Agreement, Orchestra previously received a $30 million non-refundable payment from Terumo, which is not affected by the Termination and ROFR Agreement. Pursuant to the terms of the Termination and ROFR Agreement, Orchestra has no further performance obligations under the Distribution Agreement. The ROFR has a term that began on the Effective Date and will end on the date that is 90 days after Orchestra discloses primary endpoint data from its U.S. clinical trial for Virtue SAB pursuant to its investigational device exemption (" IDE ") for coronary in-stent restenosis (" ISR ") to Terumo or the public, whichever occurs fi

02. Termination of a Material Definitive Agreement

Item 1.02. Termination of a Material Definitive Agreement. The information required by this item with respect to the Termination and ROFR Agreement and the termination of the Distribution Agreement is included in Item 1.01 hereto and is incorporated herein by reference.

02. Unregistered Sales of Equity Securities

Item 3.02. Unregistered Sales of Equity Securities. The information required by this item with respect to the Series A Preferred Stock is included in Item 1.01 hereto and is incorporated herein by reference. The Series A Preferred Stock was sold in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the " Securities Act "). TMC provided written representations to the Company regarding its suitability to invest in the Series A Preferred Stock. The Company did not engage in general solicitation in connection with the sale of the Series A Preferred Stock.

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On October 28, 2025, the Company issued a press release announcing, among other things, the Termination and ROFR Agreement and the Stock Purchase Agreement. A copy of the press release is attached to this Current Report as Exhibit 99.1 and is incorporated herein solely for purposes of this

01 disclosure

Item 7.01 disclosure. The information in Item 7.01 of this Current Report, including Exhibit 99.1 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 incorporated by reference into any filing under the Securities Act or the Exchange Act, regardless of any incorporation by reference language in any such filing.

01. Other Events

Item 8.01. Other Events. On October 27, 2025, the Company announced the first patient enrollments in the Virtue SAB in the Treatment of Coronary ISR Trial (" Virtue Trial "), the Company's U.S. IDE pivotal trial comparing its highly differentiated Virtue Sirolimus AngioInfusionTM Balloon (" Virtue SAB ") to the AGENT paclitaxel-coated balloon, currently the only drug-coated balloon (" DCB ") FDA-approved for a coronary indication. The initial cases were successfully completed by the teams at The Christ Hospital Heart & Vascular Institute in Cincinnati, OH, and St. Francis Hospital & Heart Center in Roslyn, NY, marking the initiation of the Virtue Trial. Designed to support regulatory approval of Virtue SAB, the Virtue Trial is expected to enroll 740 patients at up to 75 centers in the United States with enrollment completion currently planned for mid-2027. Virtue SAB: Redefining Delivery of Sirolimus Virtue SAB is designed to deliver a large liquid dose of a proprietary extended-release formulation of sirolimus, SirolimusEFR, through a non-coated microporous AngioInfusion Balloon that protects the drug in transit and helps overcome certain limitations of DCBs. SirolimusEFR is designed to enable enhanced tissue uptake and extended release of therapeutic levels of sirolimus through the critical healing period, exceeding previously published target tissue concentrations of proven drug-eluting stents. In the multi-center SABRE pilot study, Virtue SAB demonstrated promising clinical results for the treatment of single-layer coronary ISR: 12-month target lesion failure of 2.8% Zero target lesion revascularizations from 12-month follow-up through 36-month follow-up; and 6-month late lumen loss of 0.12mm. Virtue SAB has FDA Breakthrough Device Designation for the treatment of coronary in-stent restenosis (" ISR "), as well as for coronary small vessel disease and below-the-knee peripheral artery disease. The Company estimates the total global market opportunity

Forward-Looking Statements

Forward-Looking Statements Certain statements included in this Current Report on Form 8-K (this "Current Report") 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 enrollment, timing, implementation and design of the Virtue Trial, the ability of data from the Virtue Trial to support regulatory approval in the U.S., and the potential efficacy and safety of the Company's commercial product candidates. These statements are based on various assumptions, whether or not identified in this Current Report, 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; failure to realize the anticipated benefits of the business combination; risks related to regulatory approval of the Company's product candidates; the timing of, and the Company's ability to achieve, exp

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 10.1 Termination and ROFR Agreement, by and between the Orchestra BioMed, Inc., Terumo Corporation and Terumo Medical Corporation, dated October 24, 2025 10.2 Stock Purchase Agreement, by and between the Company and Terumo Medical Corporation, dated October 24, 2025 10.3 Lockup Agreement, by and among the Company, Terumo Corporation and Terumo Medical Corporation, dated October 24, 2025 99.1 Press Release, dated October 28, 2025 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ORCHESTRA BIOMED HOLDINGS, INC. By: /s/ Andrew Taylor Name: Andrew Taylor Title: Chief Financial Officer Date: October 28, 2025

View Full Filing

View this 8-K filing on SEC EDGAR