Quarterly ResultMay 12, 2026, 04:19 PM
Orchestra BioMed Q1 Net Loss $20.7M; AVIM Therapy gets 2nd FDA BDD
AI Summary
Orchestra BioMed reported a net loss of $20.7 million, or ($0.33) per share, on revenue of $0.1 million for Q1 2026. The company announced a second FDA Breakthrough Device Designation for its AVIM Therapy for uncontrolled hypertension, expanding its market potential. Significant progress was made in its pivotal clinical trials, with the BACKBEAT Trial targeting enrollment completion by Q3 2026 and the Virtue Trial accelerating patient enrollment. The company also strengthened its balance sheet by receiving $35 million in strategic capital from Medtronic and Ligand, extending its cash runway into Q4 2027.
Key Highlights
- AVIM Therapy received a second FDA Breakthrough Device Designation.
- BACKBEAT Global Pivotal Trial enrollment completion targeted by Q3 2026.
- Q1 2026 Net Loss attributable to common stockholders was $20.7 million.
- Q1 2026 Revenue was $0.1 million, down from $0.9 million in Q1 2025.
- Received $35 million in strategic capital from Medtronic ($20M) and Ligand ($15M).
- Cash and marketable securities totaled $94.4 million as of March 31, 2026.
- Cash runway projected into Q4 2027.
- R&D expenses rose 17% to $15.8 million in Q1 2026.