Orchestra Biomed Collects New Proceeds for Hypertension Study Enrollment

Orchestra BioMed Holdings Inc. has secured $111.2 million in strategic transactions and concurrent public and private equity offerings to help advance its late-stage atrioventricular interval modulation (AVIM) therapy and Virtue Sirolimus AngioInfusion Balloon (SAB) clinical programs.

The aggregate $111.2 million in expected gross proceeds is comprised of:

• $55 million received or to be received by May 1, 2026, subject to certain conditions, from royalty-based, non-dilutive investments from Ligand Pharmaceuticals Incorporated and Medtronic plc.
  • Ligand committed $35 million in exchange for a tiered revenue interest in Orchestra BioMed’s future royalties from AVIM therapy and Virtue SAB.
  • Medtronic committed $20 million in exchange for a secured subordinated promissory note convertible to capped prepaid revenue share.
• $56.2 million received from a $40 million underwritten public offering of common stock and prefunded warrants and $11.2 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectively.  

“We are very proud to have secured significant long-term capital from strategic transactions with Medtronic and Ligand and the completion of our first underwritten public equity offering. We believe the success of these financing transactions reflects confidence from strategic partners and shareholders in the transformative potential of our two high impact, late-stage therapeutic programs,” Orchestra Biomed Chairman/CEO David Hochman said. “With Ligand, an established royalty investor, joining us as a strategic capital partner and Medtronic, the global market leader in cardiac rhythm management, expanding their commitment to our existing collaboration, this new capital strongly positions us to advance our core technologies, AVIM therapy and Virtue SAB, toward fundamental clinical and regulatory milestones that have the potential to create significant value for all stakeholders.”

Orchestra BioMed currently intends to use the net proceeds from these transactions to fund potential significant value-creating catalysts, including:

• Full enrollment of the BACKBEAT global pivotal study evaluating AVIM therapy for treating uncontrolled hypertension in patients with a pacemaker.
• Completion of follow-up for the BACKBEAT study primary endpoints
• Completion or near-completion of enrollment of the Virtue Trial evaluating Virtue SAB in the treatment of Coronary in-stent restenosis (ISR).

In the public offering, which closed on Aug. 4, Orchestra BioMed sold 9,413,637 shares of its common stock at $2.75 per share, and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 5,136,363 shares of common stock at $2.7499 per pre-funded warrant. Medtronic purchased 4,077,427 shares, and Ligand purchased 1,818,181 shares also at $2.75 per share in the private placement. The gross proceeds from the public offering and private placement combined were approximately $56.2 million, with net proceeds of approximately $51.8 million after deducting underwriting discounts, commissions, placement fees and offering expenses.

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 further 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 U.S. Food and Drug Administration (FDA) for treating uncontrolled hypertension in patients with an increased cardiovascular risk.

Orchestra BioMed is a biomedical firm accelerating high-impact technologies to patients through risk-reward sharing partnerships with medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for treating uncontrolled hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB to treat atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic to develop and commercialize AVIM therapy for uncontrolled hypertension treatment in pacemaker-indicated patients, and a strategic partnership with Terumo to develop and commercialize Virtue SAB for artery disease treatment. The company has received four Breakthrough Device Designations from the FDA across these two core programs.

Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR through a non-coated microporous AngioInfusion Balloon that protects the drug in transit to 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 approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease, and peripheral artery disease below-the-knee.