Loading...
Capricor Q1 2025 Earnings Report
Capricor Therapeutics reported a net loss in the first quarter of 2025, with no revenue generated, and provided updates on its BLA for deramiocel and StealthX™ vaccine platform.
Key Takeaways
Capricor Therapeutics reported a net loss of $24.4 million for the first quarter of 2025, compared to a net loss of $9.8 million in the same period last year, with no revenue generated. The company's cash balance was approximately $144.8 million, expected to support operations into 2027. Key updates include the ongoing priority review of its BLA for deramiocel by the FDA, with a PDUFA date of August 31, 2025, and the planned initiation of a Phase 1 clinical trial for its StealthX™ exosome vaccine in Q3 2025.
Capricor Therapeutics reported no revenue for Q1 2025, a decrease from $4.9 million in Q1 2024.
The net loss for Q1 2025 was $24.4 million, significantly higher than the $9.8 million net loss in Q1 2024.
Cash, cash equivalents, and marketable securities totaled approximately $144.8 million as of March 31, 2025, providing expected support for operations into 2027.
The BLA for deramiocel in DMD remains under priority review by the FDA with a PDUFA date of August 31, 2025, and a Phase 1 clinical trial for the StealthX™ vaccine is planned for Q3 2025.
Capricor
Capricor
Forward Guidance
Capricor Therapeutics anticipates its current cash balance will be sufficient to fund operations into 2027, excluding potential future milestone payments or strategic capital uses. The company is focused on advancing its deramiocel BLA and initiating the StealthX™ vaccine clinical trial.
Positive Outlook
- Cash balance of approximately $145 million expected to support planned operations into 2027.
- BLA for deramiocel remains under priority review with a PDUFA date of August 31, 2025.
- Mid-cycle review meeting with FDA identified no significant deficiencies.
- FDA has indicated intent to convene an advisory committee meeting for deramiocel.
- NIAID plans to initiate Phase 1 clinical trial of StealthX™ exosome vaccine in Q3 2025.
Challenges Ahead
- Expectation of cash sufficiency excludes any additional potential milestone payments under existing agreements.
- Expectation of cash sufficiency excludes any strategic use of capital not currently in the Company's base-case planning assumptions.
- Potential for required regulatory inspections to be delayed or not successful, which could delay or prevent product approval.
- The ability to achieve product milestones and receive milestone payments from commercial partners is not guaranteed.
- Future revenue streams and projections are subject to various risks and uncertainties.