Short answer
CAPRICOR THERAPEUTICS, INC. (CAPR) filed its fiscal 2025 10-K annual report with the SEC on Mar 17, 2026. It reported revenue of $0 (−100.0% year over year) and net income of −$105M.
- Top risk flagged: Regulatory risk: FDA Complete Response Letter in July 2025 for Deramiocel BLA, requiring additional Phase 3 HOPE-3 trial data, new PDUFA date August 22, 2026
FY2025 key financial metrics · XBRL
- Revenue
- $0
- −100.0% YoY
- Net income
- −$105M
- −159.6% YoY
- EPS (diluted)
- −$2.26
- −96.5% YoY
- ROE
- -34.4%
- −6.5 pp YoY
- Operating cash flow
- −$70M
- −74.5% YoY
Source: XBRL data from the CAPRICOR THERAPEUTICS, INC. (CAPR) FY2025 10-K on SEC EDGAR. USD.
CAPRICOR THERAPEUTICS, INC. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business model: development and manufacturing of cell-based therapies and exosome technologies, focus on Deramiocel for commercial and clinical use
- New emphasis on potential vaccine candidates using exosome technologies with unique manufacturing and regulatory challenges highlighted
- Strategic focus on scaling manufacturing capacity including addition of 22,000 sq ft expansion to San Diego GMP facility ahead of potential commercial launch
- Quantitative manufacturing milestone: completed San Diego facility with FDA pre-license inspection, received acceptable responses to Form 483 observations, lease at Cedars-Sinai expiring July 2026
- Noteworthy risks this year: detailed impact of May 2025 U.S. MFN drug pricing initiatives and CMS GENEROUS, GLOBE, and GUARD models on future product revenues and federal reimbursement
Management Discussion & Analysis
- No profitability, margin, or segment performance metrics mentioned
- Forward-looking statements referenced but without specific management outlook or guidance
Risk Factors
- Regulatory risk: FDA Complete Response Letter in July 2025 for Deramiocel BLA, requiring additional Phase 3 HOPE-3 trial data, new PDUFA date August 22, 2026
- Geopolitical/macro risk: Exposure to U.S. public health policy through NIH/NIAID collaboration on StealthX™ vaccine under Project NextGen initiative
- Operational risk: Dependence on qualified donated human hearts as source material for CDCs in Deramiocel manufacturing scale-up
- Competitive risk: Potential market disruption from alternative DMD therapies, including gene editing and exon skipping technologies by competitors like Sarepta Therapeutics
- Financial risk: Reliance on equity financings with $318.1M cash (2025 year end) but net loss increased to $105.0M in 2025, risking dilution or funding gaps for further development
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