Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

Core Insights - Orchestra BioMed Holdings, Inc. reported financial results for Q1 2025, highlighting regulatory progress and a strengthening clinical pipeline [1][4] - The company received FDA Breakthrough Device Designation for its AVIM therapy, indicating significant recognition of its potential in treating hypertensive heart disease [3][6] - The company is advancing its clinical trials, including the BACKBEAT global pivotal study in collaboration with Medtronic and the initiation of the Virtue Trial for its Virtue SAB product [3][6] Financial Performance - Revenue for Q1 2025 was $0.9 million, an increase from $0.6 million in Q1 2024, primarily due to partnership revenues from Terumo [12] - Research and development expenses rose to $13.5 million in Q1 2025 from $9.1 million in Q1 2024, driven by costs associated with the BACKBEAT study [12] - The net loss for Q1 2025 was $18.8 million, or $0.49 per share, compared to a net loss of $13.5 million, or $0.38 per share, in Q1 2024 [12][19] Regulatory Developments - The FDA granted Breakthrough Device Designation for AVIM therapy, which aims to improve outcomes for patients with uncontrolled hypertension [6][10] - The company received FDA IDE approval for the Virtue SAB U.S. pivotal trial, which will compare its investigational product against a commercially available drug-coated balloon [6][13] Clinical Advancements - AVIM therapy has shown promising results in pilot studies, with reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure [10] - The Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, demonstrating positive clinical data in coronary in-stent restenosis [11][13] Strategic Partnerships - Orchestra BioMed has strategic collaborations with Medtronic for AVIM therapy and Terumo for Virtue SAB, enhancing its commercialization efforts [8][10] - The company continues to expand its intellectual property portfolio, with 137 issued patents worldwide related to AVIM therapy [6]