Q1 2024 Capricor Therapeutics Inc Earnings Call Transcript
Key Points
- Completed enrollment for Cohort A in the HOPE three Phase three pivotal trial, with positive interim analysis indicating potential efficacy of CAP 1002 in treating Duchenne muscular dystrophy (DMD).
- Received a $10 million milestone payment from distribution partner Nippon Shinyaku, enhancing financial stability.
- FDA approval to transition to the San Diego manufacturing facility without additional site-specific clinical data, saving time and resources.
- Strong safety profile and quarterly infusion schedule of CAP 1002 expected to encourage rapid adoption within the DMD community.
- Strategic advancements in exosome platform technology, positioning the company for future clinical trials and potential new therapy developments.
- Increased research and development expenses, rising by $2.9 million from the previous year due to clinical and manufacturing costs associated with the HOPE three trial.
- Uncertainty and risks highlighted in forward-looking statements, which could affect future results and company performance.
- The need for further discussions with the FDA to finalize the regulatory pathway for CAP 1002, including a pre-BLA meeting and rolling BLA submission.
- Ongoing need to raise capital, as evidenced by the utilization of an at-the-market offering program to fund operations.
- Dependence on regulatory and market acceptance for the new San Diego manufacturing facility to meet projected market demand for CAP 1002.
Good afternoon, ladies and gentlemen, and welcome to the Capricor Therapeutics First-Quarter 2024 earnings call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. (Operator Instructions)
I would now like to turn the conference over to A.J. Bergman. 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 research and development 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
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