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Mar 31, 2024
Capricor Q1 2024 Earnings Report
Capricor reported financial results for the first quarter of 2024 and provided a corporate update.
Key Takeaways
Capricor Therapeutics reported revenue of $4.9 million and a net loss of $9.8 million for the first quarter of 2024. The company received a $10 million milestone payment under its U.S. Distribution and Commercialization Agreement with Nippon Shinyaku.
Phase 3, HOPE-3 Trial (Cohort A) of CAP-1002 in Duchenne Muscular Dystrophy fully enrolled and on track to report top-line data in Q4 2024.
Positive Type-B CMC FDA Meeting held in Q1; Company aligned with FDA on demonstration of non-clinical comparability.
Received First Milestone Payment of $10 Million under U.S. Distribution and Commercialization Agreement with Nippon Shinyaku in Q1.
Recent FDA Feedback Supports Requests for a Pre-BLA Meeting and Subsequent Rolling BLA Submission at Upcoming Type-B Clinical FDA Meeting in May 2024.
Capricor
Capricor
Forward Guidance
Capricor anticipates several milestones, including a Type-B clinical FDA meeting in May 2024, reporting 3-year HOPE-2 OLE data in Q2 2024, and topline data from HOPE-3 (Cohort A) in Q4 2024. They expect cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements into the first quarter of 2025.
Positive Outlook
- Type-B clinical FDA meeting in May 2024 to discuss requests for a pre-BLA meeting and rolling BLA schedule.
- Plan to report 3-year HOPE-2 OLE data in the second quarter of 2024.
- Plan to announce further updates with respect to next steps for HOPE-3 (Cohort B), when available.
- Plan to report topline data from HOPE-3 (Cohort A) in the fourth quarter of 2024.
- Updates on NIAID collaboration for StealthX™ vaccine as they become available; NIAID plans to initiate Phase 1 clinical trial in late 2024, subject to regulatory approval.
Challenges Ahead
- Expectation excludes potential milestone payments under Commercialization and Distribution Agreements with Nippon Shinyaku.
- Excludes strategic use of capital not currently in the Company’s base-case planning assumptions.
- R&D expenses increased from $7.66 million to $11.10 million compared to last year
- General and administrative expenses increased from $3.50 million to $4.07 million compared to last year
- Net loss increased from $7.76 million to $9.79 million compared to last year