The following is a summary of the Capricor Therapeutics, Inc. (CAPR) Q3 2024 Earnings Call Transcript:

Financial Performance:

• Capricor reported Q3 2024 revenues of approximately $2.3 million, a decrease from $6.2 million in Q3 2023.

• The net loss for Q3 2024 increased to approximately $12.6 million from $6.4 million in Q3 2023.

Business Progress:

• Capricor is on track to complete the submission of its BLA for deramiocel, a therapy for DMD cardiomyopathy, by the end of 2024, with FDA feedback expected by Q1 2025.

• The company has expanded manufacturing capabilities, establishing a commercial manufacturing facility in San Diego to meet anticipated market demand.

Opportunities:

• Capricor is preparing for potential commercial launch of deramiocel, targeting approximately 8,000 DMD patients in the U.S., and anticipates rapid adoption upon approval.

• New market opportunities in Europe and Japan through partnerships with Nippon Shinyaku, including milestone payments totaling $1.5 billion, and revenue sharing.

Risks:

• The uncertainty of receiving FDA approval for deramiocel, with a planned advisory committee potentially affecting the approval process.

• Manufacturing scale-up must align with market demands and regulatory expectations, posing risks to meeting projected timelines and market launch.

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