GlobeNewswire·Nov 10, 2026, 4:10 PM ET

Orchestra BioMed Reports Third Quarter 2026 Financial Results and Highlights Recent Business Updates

OBIO HAE MDT

BACKBEAT Global Pivotal Trial evaluating AVIM Therapy completed enrollment with 349 randomized patients, exceeding targets.
Primary endpoint data for the BACKBEAT Trial is planned for late-breaking presentation at Heart Rhythm Society 2027.
Medtronic plans to submit a Premarket Approval supplement to the FDA for AVIM Therapy following data presentation if results are positive.
Patient enrollment is accelerating in the Virtue Trial, a U.S. IDE pivotal study comparing Virtue SAB with the AGENT™ paclitaxel-coated balloon.
Orchestra BioMed raised $80.5 million in net proceeds from a public offering of common stock that closed on November 9, 2026.
The company holds $101.9 million in cash, cash equivalents, and marketable securities as of September 30, 2026, providing a cash runway through 2028.
An R&D Day is scheduled for November 12, 2026, in New York City to review AVIM Therapy and Virtue SAB with physician investigators.
A $6.1 million milestone payment was received in September 2026 from Haemonetics Corporation following its acquisition of Vivasure Medical Limited.
Research and development expenses increased 26% to $17.7 million in the third quarter of 2026 due to ongoing clinical trial costs.
Net loss for the third quarter of 2026 was $19.6 million, or $0.30 per share, compared to $20.8 million in the same period in 2025.
AVIM Therapy has received two FDA Breakthrough Device Designations for treating uncontrolled hypertension in pacemaker-indicated patients.
Virtue SAB has received FDA Breakthrough Device Designation for coronary in-stent restenosis, coronary small vessel disease, and below-the-knee peripheral artery disease.

Company: Orchestra BioMed Holdings, Inc.
Keywords: Nasdaq:OBIO, Orchestra BioMed Holdings, Inc.