Capricor Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Capricor Therapeutics is making significant progress towards delivering the first approved therapy for Duchenne cardiomyopathy, with an FDA target action date of August 31, 2025 for their Biologics License Application (BLA) [2][4][5] Financial Results - As of March 31, 2025, Capricor reported a cash position of approximately $145 million, down from $151.5 million at the end of 2024 [6][9] - Revenues for the first quarter of 2025 were $0, a decrease from $4.9 million in the same quarter of 2024, primarily due to the recognition of previous milestone payments [7] - Total operating expenses for Q1 2025 were approximately $25 million, compared to $15.2 million in Q1 2024, leading to a net loss of approximately $24.4 million, or $0.53 per share, compared to a net loss of $9.8 million, or $0.31 per share, in Q1 2024 [8][20] Corporate Developments - The FDA has accepted Capricor's BLA for deramiocel, which is under priority review, with no significant deficiencies identified in the recent mid-cycle review [4][5] - Capricor appointed Dr. Michael Binks as Chief Medical Officer, who brings over 25 years of experience in clinical development [5] - The National Institute of Allergy and Infectious Diseases (NIAID) plans to initiate a Phase 1 clinical trial of Capricor's StealthX™ exosome vaccine in Q3 2025, pending regulatory approval [5][12] Upcoming Milestones - Capricor is preparing for an FDA advisory committee meeting and a pre-approval inspection as part of the BLA process [2][4] - The company expects its cash reserves to support operations into 2027, excluding additional potential milestone payments [9]