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Sep 30, 2024
Capricor Q3 2024 Earnings Report
Capricor reported financial results for Q3 2024 and provided a corporate update.
Key Takeaways
Capricor Therapeutics reported a net loss of $12.6 million, or $0.38 per share, for the third quarter of 2024. The company's cash, cash equivalents, and marketable securities totaled approximately $85.0 million as of September 30, 2024. They commenced the submission of BLA and significantly strengthened their balance sheet.
Initiated rolling BLA submission for deramiocel to treat all patients with DMD-cardiomyopathy, expected to be complete by year-end 2024.
Signed binding term sheet with Nippon Shinyaku for European expansion and commercialization of deramiocel; potential milestones of approximately $1.5 billion.
Presented positive long-term data from HOPE-2 OLE trial at the 2024 World Muscle Society Congress.
Completed public offering of common stock for gross proceeds of approximately $86 million, with cash runway expected to support operations into 2027.
Capricor
Capricor
Forward Guidance
Capricor believes that its available cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements into 2027.
Positive Outlook
- Potential PDUFA date in the second half of 2025.
- Potential milestones from combined agreements with Nippon Shinyaku would total approximately $1.5 billion.
- Expansion of commercial manufacturing capacity and throughput actively underway.
- Exploring expansion opportunities for GMP production for additional capacity.
- Completed public offering of common stock for gross proceeds of approximately $86.3 million.
Challenges Ahead
- HOPE-3 Cohort A unblinding delayed.
- Revenue decreased from $6.2 million in Q3 2023 to $2.3 million in Q3 2024.
- Total operating expenses increased from $13.1 million in Q3 2023 to $15.3 million in Q3 2024.
- Net loss increased from $6.4 million in Q3 2023 to $12.6 million in Q3 2024.
- Reliance on potential milestone payments under the Commercialization and Distribution Agreements with Nippon Shinyaku.