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Jun 30, 2024
Capricor Q2 2024 Earnings Report
Capricor reported financial results for Q2 2024 and provided a corporate update.
Key Takeaways
Capricor Therapeutics reported revenue of $4.0 million and a net loss of $11.0 million, or $0.35 per share, for the second quarter of 2024. The company is focused on advancing its lead asset, deramiocel, and securing a partnership in Europe.
Completed a positive pre-BLA meeting with the FDA to accelerate the approval pathway of deramiocel for Duchenne Muscular Dystrophy (DMD).
Fully enrolled the Phase 3, HOPE-3 trial of deramiocel in DMD and is on track to report top-line data from Cohort A in Q4 2024.
Reported positive 3-year skeletal and cardiac data from the HOPE-2 open-label extension trial.
StealthX™ vaccine for the prevention of SARS-CoV-2 was selected to be part of Project NextGen.
Capricor
Capricor
Forward Guidance
Capricor anticipates several milestones including announcing the outcome from pre-BLA meeting, presenting additional 3-year data from HOPE-2 OLE study, and reporting topline data from HOPE-3 (Cohort A).
Positive Outlook
- Plan to announce the outcome from our pre-BLA meeting in the third quarter of 2024.
- Plan to present additional 3-year data from our HOPE-2 OLE study at a medical meeting in the fourth quarter of 2024.
- Plan to report topline data from HOPE-3 (Cohort A) in the fourth quarter of 2024.
- Continue to explore opportunities for additional partnerships outside of the U.S. and Japan to support the potential approval and commercialization of deramiocel in DMD.
- Plan to provide updates on our NIAID collaboration for our StealthX™ vaccine as they become available.
Challenges Ahead
- Available cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements into the first quarter of 2025.
- Expectation excludes any additional potential milestone payments under Commercialization and Distribution Agreements with Nippon Shinyaku.
- Expectation excludes any strategic use of capital not currently in the Company’s base-case planning assumptions.