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Sep 30, 2023
Capricor Q3 2023 Earnings Report
Capricor Therapeutics reported financial results for Q3 2023 and provided a corporate update.
Key Takeaways
Capricor Therapeutics reported revenue of $6.2 million and a net loss of $6.4 million, or $0.25 per share, for the third quarter of 2023. The company's cash, cash equivalents, and marketable securities totaled approximately $28.5 million as of September 30, 2023. Targeted enrollment for HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy was completed.
Completed targeted enrollment for HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy.
On track to report interim futility analysis in fourth quarter of 2023; Successful outcome would trigger milestone payment to Capricor under commercialization and distribution deal with Nippon Shinyaku.
Positive FDA feedback on the proposed key clinical and regulatory requirements confirms CAP-1002’s path towards a Biologics License Application Submission.
Company believes that based on the current operating plan and financial resources, its available cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements into 2025.
Forward Guidance
Capricor anticipates several milestones and events related to their pipeline progression.
Positive Outlook
- Plan to report outcome from interim futility analysis of HOPE-3 (Cohort A) in the fourth quarter of 2023.
- Plan to initiate HOPE-3 (Cohort B) enrollment in the fourth quarter of 2023.
- Capricor plans to request a meeting with FDA in the first quarter of 2024 to discuss our CAP-1002 program for DMD.
- 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 commercialization of CAP-1002 in DMD.
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