Dyne Therapeutics, Inc. (DYN) FY2025 10-K Annual Report
Dyne Therapeutics, Inc. (DYN) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Mar 2, 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.
Dyne Therapeutics, Inc. FY2025 10-K Analysis
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 revenue disclosed, focus on clinical development expenses for z-rostudirsen, z-basivarsen, FSHD and Pompe programs
- • 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
Dyne Therapeutics, Inc. FY2025 Key Financial MetricsXBRL
Net Income
-$446M
▼ -40.6% YoY
ROE
-45.9%
▲ +450bp YoY
Total Assets
$1.2B
▲ +71.7% YoY
EPS (Diluted)
$-3.47
▼ -3.0% YoY
Operating Cash Flow
-$403M
▼ -37.9% YoY
Source: XBRL data from Dyne Therapeutics, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
Get deeper insights on Dyne Therapeutics, Inc.
Access full AI analysis, insider trading data, fund holdings, and cross-signal detection on SignalX.