Capricor Therapeutics announced an upcoming Type-B clinical meeting with the U.S. Food and Drug Administration (FDA), planned in early Third Quarter 2023. During the planned meeting with the FDA, Capricor will outline its proposed path towards submission of a potential Biologics License Application (BLA) and further discuss its ongoing HOPE-3 clinical trial with the agency. The regulatory pathway for CAP-1002 is supported by RMAT (Regenerative Medicine Advanced Therapy Designation) as well as Orphan Drug Designation.

If Capricor were to receive market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher based on its designation as a rare pediatric disease. HOPE-3, the Company's Phase 3 clinical trial of CAP-1002 is a multi-center, randomized, double-blind, placebo-controlled study (NCT05126758) which is designed to treat up to 68 subjects in the United States. Duchenne muscular dystrophy is a devastating genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.

CAP-1002 consists of allogeneic cardiosphere-derived cells (CDCs), a type of progenitor cell that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity and is being investigated for its potential to modify the immune system's activity to encourage cellular regeneration. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to over 200 human subjects across several clinical trials.