Q4 2024 Capricor Therapeutics Inc Earnings Call Transcript
Key Points
- Capricor Therapeutics Inc (CAPR) has received FDA acceptance for priority review of its Biologic License Application (BLA) for deramiocel to treat DMD cardiomyopathy.
- The company has a strong safety profile for deramiocel, with over 700 infusions showing safety and efficacy in attenuating disease progression.
- Capricor Therapeutics Inc (CAPR) has a robust cash position of approximately $150 million, with a runway into 2027 without additional cash infusions.
- The company is actively preparing for the commercial launch of deramiocel in collaboration with NS Pharma, with a focus on market access and reimbursement.
- Capricor Therapeutics Inc (CAPR) is expanding its manufacturing capacity to support anticipated demand, with plans to increase capacity to 2,000 to 3,000 patients per year by mid-2026.
- The company reported a net loss of approximately $40.5 million for the year ended December 31, 2024, compared to a net loss of approximately $22.3 million for the previous year.
- Revenues for the fourth quarter of 2024 decreased to approximately $11.1 million from $12.1 million in the fourth quarter of 2023.
- There is uncertainty regarding whether an FDA Advisory Committee (ADCOM) meeting will be required for the approval process of deramiocel.
- The company is still negotiating final terms for a definitive agreement with Nippon Shinyaku for the European market.
- Capricor Therapeutics Inc (CAPR) faces potential challenges in expanding its exosome platform technology, which is still in the early stages of development.
Good afternoon, ladies and gentlemen, and welcome to the Capricor Therapeutics' second-quarter (sic - "fourth-quarter") 2024 earnings call. (Operator Instructions) This call is being recorded on Wednesday, March 19, 2025.
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 preclinical and clinical studies, our enrollment of patients in our clinical studies, our plans to present or report additional data, our plans regarding regulatory filings, potential regulatory developments involving our product candidates, revenue and reimbursement
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