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Mar 31
Orchestra Biomed Q1 2025 Earnings Report
Orchestra BioMed reported a net loss of $18.755 million for Q1 2025, with total revenue of $0.868 million.
Key Takeaways
Orchestra BioMed Holdings, Inc. reported a net loss of $18.755 million for the three months ended March 31, 2025, an increase from the $13.463 million net loss in the same period last year. Total revenue for the quarter was $0.868 million, primarily driven by partnership and product revenues. The company continues to incur substantial operating losses and anticipates needing additional capital to fund its operations.
Net loss increased by 39% to $18.755 million in Q1 2025 compared to $13.463 million in Q1 2024.
Total revenue grew by 40% to $0.868 million in Q1 2025, up from $0.620 million in Q1 2024.
Research and development expenses significantly increased by 48% to $13.482 million, reflecting ongoing work on the BACKBEAT study and Virtue SAB program.
The company had $18.348 million in cash and cash equivalents and $31.536 million in marketable securities as of March 31, 2025, but management concluded that sufficient capital may not be available to fund operations for the next twelve months.
Orchestra Biomed
Orchestra Biomed
Orchestra Biomed Revenue by Segment
Orchestra Biomed Revenue by Geographic Location
Revenue by Segment
Partnership Revenue
CapyFin.comProduct Revenue
CapyFin.comRevenue by Geographic Location
United States Revenue
CapyFin.com Forward Guidance
Orchestra BioMed expects operating expenses to increase due to ongoing clinical studies and research and development activities, particularly for the AVIM therapy program and the Virtue SAB program. The company anticipates needing additional capital and is exploring various financing options.
Positive Outlook
- Received FDA Breakthrough Device Designation for AVIM therapy, potentially expediting development and review.
- Received FDA approval for an IDE amendment to initiate an updated design of the Virtue Trial, targeting initiation in H2 2025.
- Continued focus on advancing the BACKBEAT global pivotal study.
- Exploring additional sources of liquidity, including new equity issuance and debt drawdowns.
- Potential for future collaborations and realization of cash from the acquisition of Vivasure by Haemonetics.
Challenges Ahead
- Substantial doubt about the company's ability to continue as a going concern due to insufficient capital.
- Unlikely to complete remaining time-based milestones for the Terumo Agreement due to delays and changes in regulatory requirements.
- Potential for adverse impact on clinical study, product development, and commercialization plans if Terumo Agreement is terminated.
- Exercise price of outstanding warrants may be higher than prevailing market price, limiting cash proceeds from warrant exercises.
- Increased operating expenses expected due to clinical study costs and research and development activities.