Short answer
Dyne Therapeutics, Inc. (DYN) filed its fiscal 2025 10-K annual report with the SEC on Mar 2, 2026.
- Top risk flagged: FDA clinical hold on z-rostudirsen IND in Jan 2022, delaying trial start until July 2022 clearance
FY2025 key financial metrics · XBRL
- Net income
- −$446M
- −40.6% YoY
- EPS (diluted)
- −$3.47
- −3.0% YoY
- ROE
- -45.9%
- +4.5 pp YoY
- Operating cash flow
- −$403M
- −37.9% YoY
Source: XBRL data from the Dyne Therapeutics, Inc. (DYN) FY2025 10-K on SEC EDGAR. USD.
Dyne Therapeutics, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business model: Development of product candidates for rare muscle diseases, leveraging manufacturing agreements with CMOs
- New master manufacturing services agreements in 2025 securing $169.9M total fees committed through 2027 for product candidate components
- Strategic emphasis on formalizing manufacturing capacity to support clinical and production scalability versus prior informal agreements
- Notable R&D investment: $31.2M paid towards non-current assets under manufacturing agreement as of Dec 31, 2025, with additional $109.5M committed
- Lease agreement for office and lab space with 8.5-year term started Sept 2021, with monthly rent increasing to $0.5M during term
Management Discussion & Analysis
- No profitability or margin figures provided, expenses expected to increase with ongoing activities
- No segment financial data; primary emphasis on research and development of multiple product candidates
- Cash, cash equivalents, marketable securities sufficient to fund operations into Q1 2028
- Capital needs to be met via equity, debt, collaborations, with risk of dilution and restrictive covenants; risk of delayed development if funding unmet
Risk Factors
- FDA clinical hold on z-rostudirsen IND in Jan 2022, delaying trial start until July 2022 clearance
- Geopolitical and market risk from clinical and regulatory approval uncertainty in US and EU (FDA, EMA) regulatory agencies
- Supply chain vulnerability in establishing manufacturing for Fab antibody, linker, therapeutic payload components for clinical and commercial supply
- Competitive risk from delayed commercialization of product candidates until at least 2027, risking losing market share to established biotech peers
- Financial risk from $1.4B accumulated deficit with net losses of $446.2M in 2025 and $317.4M in 2024, reliant on $1.1B cash runway to Q1 2028 and $275M Hercules loan facility with restrictive covenants
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