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Dec 31, 2023
Capricor Q4 2023 Earnings Report
Capricor reported financial results for Q4 2023 and provided a corporate update.
Key Takeaways
Capricor Therapeutics reported Q4 2023 revenue of $12.1 million, a net loss of $0.8 million, or $0.02 per share. The company's cash, cash equivalents, and marketable securities totaled approximately $39.5 million as of December 31, 2023.
Enrollment completed in Cohort A of Phase 3 HOPE-3 trial of CAP-1002 in Duchenne Muscular Dystrophy.
Successful interim futility analysis announced.
Type-B meeting with FDA planned in Q1 2024 to discuss commercial manufacturing.
CAP-1002 scale-up expansion underway at new San Diego manufacturing facility.
Capricor
Capricor
Forward Guidance
Capricor anticipates several milestones for its CAP-1002 program and exosome platform, including FDA meetings, data reports, and partnership explorations. They expect current resources to cover expenses into Q1 2025, excluding potential milestone payments.
Positive Outlook
- Type-B meeting with FDA in Q1 2024 to discuss commercial manufacturing planning.
- Report 3-year HOPE-2 OLE data in Q2 2024.
- Complete HOPE-3 (Cohort B) enrollment in Q2 2024.
- Report topline data from HOPE-3 (Cohort A) in Q4 2024.
- Explore opportunities for additional partnerships outside of the U.S. and Japan.
Challenges Ahead
- Reliance on successful clinical trials and regulatory approvals.
- Dependence on continued collaboration with Nippon Shinyaku.
- Uncertainties in exosome platform development and partnerships.
- Potential delays in IND clearance for StealthX™ vaccine.
- Exclusion of additional potential milestone payments and strategic use of capital in financial outlook.