Every 8-K that Orchestra BioMed Holdings, Inc. (OBIO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow OBIO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full OBIO filings page.
Orchestra BioMed Holdings, Inc. (OBIO) announced that 330 patients had been randomized in the BACKBEAT global pivotal trial as of September 30, 2026, exceeding its 316-patient enrollment target. The trial evaluates investigational AVIM Therapy in pacemaker-indicated patients with uncontrolled hypertension despite medication. Its FDA-approved protocol specifies 284 evaluable randomized subjects for primary-endpoint analysis, with the enrollment target accounting for potential loss to follow-up.
Patients are randomized between AVIM Therapy with continued medical therapy and pacing, and continued medical therapy with standard pacing alone. Orchestra BioMed and Medtronic intend to submit primary-endpoint results for consideration as a late-breaking presentation at a major cardiovascular conference in Q2 2027. Assuming positive trial results, Medtronic plans to submit marketing applications to the FDA and other global regulatory agencies.
Orchestra BioMed Holdings, Inc. (OBIO) furnished an investor presentation outlining a capital‑efficient, partnership‑driven model focused on cardiovascular devices. The company highlights two pivotal‑stage programs: AVIM Therapy, a pacemaker‑delivered treatment for hypertension and hypertensive heart disease, and Virtue SAB, a sirolimus AngioInfusion balloon for coronary artery disease.
The presentation describes large target markets (multi‑billion‑dollar annual TAMs), Breakthrough Device Designations for AVIM Therapy indications, and IDE pivotal trials for both AVIM (BACKBEAT Trial) and Virtue SAB that are actively enrolling. OBIO reports receiving more than $185 million in strategic capital from partners including Medtronic, Terumo and Ligand, with current cash described as providing runway through 2027.
Orchestra BioMed Holdings, Inc. reported the results of its 2026 Annual Meeting of Stockholders. Of 59,880,715 common shares entitled to vote as of April 28, 2026, 49,053,298 shares were represented, allowing stockholders to act on five proposals.
Stockholders elected three Class III directors, David P. Hochman, Darren R. Sherman, and Eric S. Fain, to serve until the 2029 annual meeting. They ratified Ernst & Young LLP as independent auditor for 2026, approved the 2026 equity incentive plan, and supported, on an advisory basis, the compensation of named executive officers. In an advisory vote on frequency of future say‑on‑pay votes, stockholders indicated a preference for holding this vote every one year, which the company intends to follow until the next required frequency vote, expected in 2032.
Orchestra BioMed Holdings outlined new 2026 compensation structures for senior leadership. The Board approved a 2026 cash bonus plan for all executive officers, with payouts tied to specific company performance goals and additional, more demanding stretch goals covering pivotal study enrollment, partnership expansion, and financial and operating metrics.
Under these terms, the Chief Executive Officer and President/Chief Operating Officer have 100% of their 2026 cash bonuses based on achieving these goals. The Chief Financial Officer’s bonus is also tied to these targets but can be adjusted upward by up to 45% or down to zero based on individual performance objectives. The Board also adopted a revised restricted stock unit vesting schedule, shifting to four equal vesting installments over three years at 18, 24, 30, and 36 months.
Orchestra BioMed Holdings, Inc. reported that it expects to receive up to $21 million in proceeds in connection with the acquisition of Vivasure by Haemonetics. The company disclosed this development via a press release titled “Orchestra BioMed to Receive Up to $21 Million in Proceeds from Acquisition of Vivasure by Haemonetics,” which is filed as an exhibit to this report.
Orchestra BioMed Holdings, Inc. furnished materials under Item 7.01. The company held a live webcast on November 12, 2025 to discuss clinical, strategic and financing updates, and made the transcript (Exhibit 99.1) and investor presentation (Exhibit 99.2) available. The information is furnished, not filed under the Exchange Act and is not incorporated by reference.
Orchestra BioMed Holdings, Inc. (OBIO) furnished an investor presentation under Item 7.01 of a Form 8-K. The slide deck is attached as Exhibit 99.1 and is also available on the company’s website in the Investor Relations section.
The information was furnished, not filed, meaning it is not subject to Section 18 of the Exchange Act and is not incorporated by reference into other Securities Act or Exchange Act filings. OBIO’s common stock trades on the Nasdaq Global Market under the symbol OBIO, and the company is identified as an emerging growth company.
Orchestra BioMed (OBIO) ended its prior distribution agreement with Terumo and granted Terumo a right of first refusal on Virtue SAB for coronary use in exchange for a $10 million fee due within 10 business days. Concurrently, Terumo agreed to purchase 200,000 shares of Series A Convertible Preferred Stock at $100 per share for $20.0 million in gross proceeds, via a private placement exempt under Section 4(a)(2).
The Series A Preferred carries a $100 per share liquidation value, no voting rights, and participating dividends. Conversion is permitted after primary endpoint data are publicly disclosed and the common stock trades above $15.00 on any trading day thereafter, or upon a Change of Control, at the greater of $12.00 or a 20% discount to the conversion-date closing price; at $12.00, 200,000 shares would convert into up to 1,666,666 common shares. Terumo’s 493,037 common shares are locked up until October 24, 2026.
The company also announced first patient enrollments in its U.S. IDE pivotal Virtue Trial, targeting 740 patients at up to 75 centers, with enrollment completion planned for mid-2027.
Orchestra BioMed (OBIO) filed an 8-K announcing a $40 m underwritten equity offering and a concurrent $16.2 m private placement.
The public deal comprises 9.4 m common shares priced at $2.75 and 5.1 m pre-funded warrants priced at $2.7499; underwriters (Piper Sandler, TD Securities) hold a 30-day option for 2.18 m additional shares. Pre-funded warrants carry a $0.0001 exercise price and a 9.99 % beneficial-ownership cap, adjustable to 19.99 % on 61-days’ notice.
Immediately after the offering closed on 4 Aug 2025, the company sold 5.9 m shares to Ligand and a Medtronic affiliate in a PIPE, and issued Ligand a warrant for up to 2 m shares at $3.67. Aggregate gross proceeds reach roughly $56 m before fees.
OBIO plans to deploy the capital to advance its atrioventricular interval modulation therapy (BACKBEAT study) and Virtue Sirolimus AngioInfusion Balloon programs, and for general corporate purposes. The filing also includes customary indemnities, legal opinions and forward-looking-statement disclaimers.
On 24 June 2025 Orchestra BioMed Holdings, Inc. (NASDAQ: OBIO) filed a Form 8-K (Item 5.07) disclosing the final voting results of its 2025 Annual Meeting of Stockholders. Of the 38,312,512 shares entitled to vote, 28,177,159 shares (73.6%) were present in person or by proxy, establishing a quorum.
Proposal 1 – Election of Class II Directors (terms expiring 2028)
- Chris Cleary: 24,555,860 for / 64,650 withheld / 3,556,649 broker non-votes
- Pamela Connealy: 23,674,360 for / 946,150 withheld / 3,556,649 broker non-votes
- David Pacitti: 24,227,123 for / 393,387 withheld / 3,556,649 broker non-votes
All three nominees were elected by comfortable majorities.
Proposal 2 – Ratification of Independent Auditor
- Ernst & Young LLP re-appointed for the fiscal year ending 31-Dec-2025 with 28,140,709 for, 34,087 against and 2,363 abstentions (no broker non-votes).
No other matters were submitted and the filing provides no financial metrics, guidance or strategic updates. The disclosure is routine, focused solely on corporate governance housekeeping and does not indicate any immediate operational or financial impact.