Globenewswire·2025-11-10 21:10Core Insights - Orchestra BioMed Holdings, Inc. reported strong financial results for Q3 2025, securing nearly $150 million in capital to advance its pivotal-stage programs [3][4][5] - The company is actively enrolling patients in the Virtue Trial, which compares its Virtue® Sirolimus AngioInfusion™ Balloon to commercially available options [3][4] - The company has expanded its strategic collaborations with Medtronic and Terumo, enhancing its business model and financial position [3][4][5] Financial Highlights - Cash and cash equivalents and marketable securities totaled $95.8 million as of September 30, 2025, with a cash runway extended into Q4 2027 [10] - Revenue for Q3 2025 was $0.9 million, a slight decrease from $1.0 million in Q3 2024 [10] - The net loss for Q3 2025 was $20.8 million, or $0.40 per share, compared to a net loss of $15.4 million, or $0.41 per share, in Q3 2024 [10][19] Strategic Partnerships - The company secured $71.6 million in committed capital from Medtronic and Ligand, along with $30 million from Terumo, which includes a right of first refusal agreement [3][4] - The collaboration with Medtronic aims to develop AVIM Therapy-enabled leadless pacemakers, while the agreement with Terumo provides strategic options for the Virtue SAB [4][5] Clinical Development - The BACKBEAT study is expected to complete enrollment by mid-2026, while the Virtue Trial aims for completion by mid-2027 [4][5] - AVIM Therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension, targeting a significant patient population in the U.S. [7][11] - Virtue SAB is designed to deliver a proprietary sirolimus formulation and has also received FDA Breakthrough Device Designation for multiple indications [12]