Q1 2025 Capricor Therapeutics Inc Earnings Call Transcript
Key Points
- Capricor Therapeutics Inc (CAPR) is on track with its BLA seeking full approval for its product candidate, damy cell, for treating Duchenne muscular dystrophy (DMD) cardiomyopathy.
- The company has a strong safety record for damy cell, demonstrated in over 700 infusions treating more than 250 patients.
- Capricor Therapeutics Inc (CAPR) is transitioning from a translational medicine company to a commercial stage entity, actively working with its commercial partner NS Pharma on launch readiness in the United States.
- The company has a robust cash position with approximately $145 million, providing a financial runway into 2027 without additional cash infusions.
- Capricor Therapeutics Inc (CAPR) is actively expanding its manufacturing capabilities, with plans to operationalize additional clean rooms by mid to late 2026 to meet potential demand.
- Revenues for the first quarter of 2025 were zero, compared to approximately $4.9 million in the first quarter of 2024.
- Operating expenses have increased, with research and development expenses rising to approximately $16.2 million in Q1 2025 from $10.1 million in Q1 2024.
- The net loss for the first quarter of 2025 was approximately $24.4 million, compared to a net loss of $9.8 million in the first quarter of 2024.
- There is uncertainty regarding the outcome of the FDA advisory committee meeting, which could impact the approval process for damy cell.
- Negotiations for European distribution with Nippon Shinyaku have been extended, indicating potential delays or challenges in finalizing agreements for the European market.
Good afternoon ladies and gentlemen and welcome to the Capricor Therapeutics first quarter 2025 earnings call. (Operator Instructions). I would now like to turn the conference over to our CFO, AJ Bergmann for the forward-looking statement. Please go ahead.
Thank you and good afternoon everyone. Before we start, I would like to state that we will be making certain forward-looking statements during today's presentation. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our product candidates, our future R&D plans, including our anticipated conduct and timing of pre-clinical and clinical studies, our enrollment of patients in clinical studies, our plans to present or report additional data, our plans regarding regulatory filings, potential regulatory development. Involving our product candidates, potential regulatory inspections, revenue and reimbursement estimates, projected terms of definitive agreements, manufacturing
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