Q2 2024 Capricor Therapeutics Inc Earnings Call Transcript
Key Points
- Capricor Therapeutics Inc (CAPR) is making significant progress towards submitting a Biologics License Application (BLA) for Deramiocel, targeting Duchenne muscular dystrophy (DMD).
- The company has a distribution agreement with Nippon Shinyaku, potentially worth $700 million in developmental and sales milestones.
- Recent clinical trial data shows Deramiocel significantly slows disease progression in DMD patients, with improvements in both skeletal and cardiac functions.
- Capricor's exosome platform, StealthX, is advancing, with promising preclinical data for targeted delivery applications.
- The company is in late-stage discussions for potential partnerships in Europe, which could strengthen its financial position and expand market reach.
- Capricor Therapeutics Inc (CAPR) reported a net loss of approximately $11 million for Q2 2024, an increase from $7.4 million in Q2 2023.
- The company's cash position decreased from $39.5 million at the end of 2023 to $29.5 million as of June 30, 2024, with a cash runway expected to support operations only into Q1 2025.
- Increased R&D expenses, primarily due to clinical and manufacturing costs for the DMD program, contributed to the financial losses.
- There is uncertainty regarding the timing and outcome of the BLA submission, as the company is exploring different pathways with the FDA.
- The exosome program, while promising, is still in preclinical development, and its commercial viability remains uncertain.
Good afternoon, ladies and gentlemen, and welcome to the Capricor Therapeutics Second Quarter 2024 earnings call.
(Operator Instruction) Also know that this call is being recorded on Wednesday, August 7, 2024. And I would like to turn the call over to our CFO, AJ Bergmann, for the forward-looking statements.
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, 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 estimates, manufacturing
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