Capricor Therapeutics(US:CAPR) Globenewswire·2026-03-12 20:01Core Insights - Capricor Therapeutics is advancing its lead product candidate, Deramiocel, for Duchenne muscular dystrophy (DMD) with a Biologics License Application (BLA) currently under FDA review, targeting a decision date of August 22, 2026 [2][5] - The company reported significant financial results for the fourth quarter and full year of 2025, including a cash balance of approximately $318 million, which is expected to support operations through 2027 [7][11] Regulatory and Clinical Updates - The FDA is reviewing Capricor's BLA for Deramiocel, classified as a Class 2 resubmission, with the company focusing on execution and preparation for a potential launch [5][6] - The pivotal HOPE-3 Phase 3 trial met its primary endpoint and key secondary cardiac endpoint, demonstrating statistical significance [4][5] - Late-breaking data from the HOPE-3 trial presented at the 2026 MDA Conference highlighted Deramiocel's benefits on cardiac function and disease progression [4][5] Financial Performance - Capricor reported no revenues for the fourth quarter and full year of 2025, a decrease from $11.1 million and $22.3 million in the respective periods of 2024 [8] - Total operating expenses for Q4 2025 were approximately $29.2 million, up from $18.8 million in Q4 2024, with total operating expenses for the year reaching approximately $108.1 million [9] - The net loss for Q4 2025 was approximately $30.2 million, or $0.62 per share, compared to a net loss of $7.1 million, or $0.16 per share, in Q4 2024 [10] Corporate Developments - Capricor's GMP manufacturing facility in San Diego is operational and has completed an FDA Pre-License Inspection, positioning the company for a potential commercial launch [6][4] - The company successfully uplisted to the Nasdaq Global Select Market, enhancing its visibility and access to capital [4][14] - Capricor's balance sheet was strengthened by a public offering that generated approximately $161.9 million in net proceeds [14][7]