Capricor Therapeutics Inc
NASDAQ:CAPR
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Capricor Therapeutics Inc
Capricor Therapeutics, Inc. engages in the discovery, development and commercialization of first-in-class biological therapies for the treatment of cardiac and other serious medical conditions. The company is headquartered in Beverly Hills, California and currently employs 48 full-time employees. The company went IPO on 2002-06-04. The firm consists of cell therapy program, including CAP-1002 for Duchenne Muscular Dystrophy program and CAP-1002 with CAP-1002 for coronavirus (COVID-19). The Company’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy. CAP-1002 is in clinical development for treating Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also developing its exosome technology therapeutic platform. The firm is focused on developing exosomes capable of delivering nucleic acids, including messenger RNA (mRNA) as well as proteins, to treat or prevent a range of diseases. CAP-1002 cell therapy programs initiated Pivotal Phase III, HOPE-3.
Capricor Therapeutics, Inc. engages in the discovery, development and commercialization of first-in-class biological therapies for the treatment of cardiac and other serious medical conditions. The company is headquartered in Beverly Hills, California and currently employs 48 full-time employees. The company went IPO on 2002-06-04. The firm consists of cell therapy program, including CAP-1002 for Duchenne Muscular Dystrophy program and CAP-1002 with CAP-1002 for coronavirus (COVID-19). The Company’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy. CAP-1002 is in clinical development for treating Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also developing its exosome technology therapeutic platform. The firm is focused on developing exosomes capable of delivering nucleic acids, including messenger RNA (mRNA) as well as proteins, to treat or prevent a range of diseases. CAP-1002 cell therapy programs initiated Pivotal Phase III, HOPE-3.
HOPE-3 Data Imminent: Capricor expects to release top line data from its pivotal HOPE-3 Phase III trial for deramiocel in Duchenne muscular dystrophy within weeks.
Regulatory Focus: The company plans to submit HOPE-3 results as a response to the FDA's Complete Response Letter, aiming for potential approval in early 2026 and eligibility for a priority review voucher.
Financials: Capricor ended Q3 2025 with approximately $98.6 million in cash and equivalents, with no revenue recognized in the quarter and an increased net loss compared to last year.
Manufacturing Readiness: The San Diego commercial facility has passed FDA inspection, and all manufacturing-related regulatory issues have been addressed.
Exosome Platform Progress: The StealthX exosome vaccine program, led by NIAID, is advancing with initial data expected in Q1 2026 and potential for future partnerships.
Burn Rate and Runway: Current cash is expected to fund operations into Q4 2026, with major clinical trial expenses winding down.