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Jun 30, 2023
Capricor Q2 2023 Earnings Report
Capricor reported financial results for the second quarter ended June 30, 2023 and provided a corporate update
Key Takeaways
Capricor Therapeutics reported revenue of $3.9 million for the second quarter of 2023, primarily from the recognition of an upfront payment related to a commercialization agreement. The company's net loss for the quarter was $7.4 million, or $0.29 per share. They believe that their current financial resources will be sufficient to cover expenses through the third quarter of 2024.
Presented positive two-year data from the HOPE-2 open label extension (OLE) study, supporting the CAP-1002 program in Duchenne Muscular Dystrophy (DMD).
Continued progress in HOPE-3, the Phase 3 clinical trial of CAP-1002 in DMD, expecting to complete enrollment and report interim analysis in the fourth quarter of 2023.
Held a Type-B clinical meeting with the FDA to discuss CAP-1002’s pathway towards potential Biologics License Application (BLA) submission.
Exploring opportunities for additional partnerships for DMD and potential new indications for CAP-1002.
Forward Guidance
Capricor anticipates several milestones including continued discussions with the FDA, sharing FDA feedback on the HOPE-3 clinical trial, submitting data from the HOPE-2-OLE study, completing enrollment of the HOPE-3 trial, reporting the outcome from the interim analysis of HOPE-3, and exploring additional partnership opportunities.
Positive Outlook
- Continue discussions with FDA regarding pathway towards BLA for CAP-1002 in DMD
- Plan to share FDA feedback on the HOPE-3 clinical trial once final minutes are available
- Plan to submit data from the ongoing HOPE-2-OLE study at a medical meeting in the fourth quarter of 2023
- Plan to complete enrollment of the currently designed HOPE-3 trial in the fourth quarter of 2023
- Plan to report outcome from interim analysis of HOPE-3 in fourth quarter of 2023
Historical Earnings Impact
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Avg. Return Before/After Earnings
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