CAPRICOR THERAPEUTICS, INC. (CAPR) FY2025 10-K Annual Report
CAPRICOR THERAPEUTICS, INC. (CAPR) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Mar 17, 2026. This page provides AI-powered analysis including business overview, management discussion & analysis (MD&A), risk factors, and key financial data such as revenue, net income, gross margin, operating margin, and return on equity (ROE) extracted from XBRL.
CAPRICOR THERAPEUTICS, INC. FY2025 10-K Analysis
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 specific revenue figures or YoY changes disclosed in provided text
- • No profitability, margin, or segment performance metrics mentioned
- • No cash flow, buybacks, dividends, or capital expenditure details provided
- • 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
CAPRICOR THERAPEUTICS, INC. FY2025 Key Financial MetricsXBRL
Revenue
$0
▼ -100.0% YoY
Net Income
-$105M
▼ -159.6% YoY
ROE
-34.4%
▼ -653bp YoY
Total Assets
$356M
▲ +108.8% YoY
EPS (Diluted)
$-2.26
▼ -96.5% YoY
Operating Cash Flow
-$70M
▼ -74.5% YoY
Source: XBRL data from CAPRICOR THERAPEUTICS, INC. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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