Short answer
Stoke Therapeutics, Inc. (STOK) filed its fiscal 2025 10-K annual report with the SEC on Mar 16, 2026. It reported revenue of $184M (+404.5% year over year) and net income of −$7M.
- Top risk flagged: Regulatory risk from FDA clinical holds: partial hold on zorevunersen doses removed, future holds possible delaying development
FY2025 key financial metrics · XBRL
- Revenue
- $184M
- +404.5% YoY
- Net income
- −$7M
- +92.3% YoY
- Operating margin
- -11.2%
- +266.1 pp YoY
- EPS (diluted)
- −$0.12
- +92.7% YoY
- ROE
- -2.0%
- +36.9 pp YoY
- Operating cash flow
- $46M
- +152.5% YoY
Source: XBRL data from the Stoke Therapeutics, Inc. (STOK) FY2025 10-K on SEC EDGAR. USD.
Stoke Therapeutics, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business model: RNA-based medicines using proprietary TANGO platform to upregulate protein expression for treating severe genetic diseases
- New focus: Phase 3 study of zorevunersen for Dravet syndrome initiated May 2025, plus Phase 1 study of STK-002 for autosomal dominant optic atrophy
- Strategic shift: Emphasis on rapid commercial preparation in US, Canada, Mexico for zorevunersen; global commercial partner Biogen for other territories
- Notable metric: EMPEROR Phase 3 enrollment target ~150 patients; OLE studies sustained seizure reduction through 3 years in 74 patients enrolled
- Unique fact: Zorevunersen granted FDA Breakthrough Therapy Designation Dec 2024; Phase 1/2a and OLE data published in New England Journal of Medicine March 2026
Management Discussion & Analysis
- Revenue $184.4M in 2025 vs $36.6M in 2024, up $147.8M mainly from Biogen collaboration ($168.3M in 2025) offset by Acadia decline
- Net loss $6.9M in 2025 vs $89.0M in 2024; operating loss improved to $20.6M from $101.4M; operating margin approx. -11.2% vs -277.1%
- Best segment: Biogen collaboration revenue $168.3M in 2025, no revenue in 2024; worst: ADOA R&D costs mostly flat ($5.1M vs $5.8M) with limited impact on revenue
- Cash $390.9M at end 2025 vs $246.7M end 2024; capital raised via equity offerings netting $168.8M in 2025; no dividends or buybacks disclosed; expected to fund operations into 2028
- Forward outlook: expect increased R&D and SG&A costs to support clinical development and commercialization; risks from clinical, regulatory, and financing uncertainties remain
Risk Factors
- Regulatory risk from FDA clinical holds: partial hold on zorevunersen doses removed, future holds possible delaying development
- Macroeconomic exposure: potential impacts from inflation, fluctuating interest rates, tariffs, recessions, and government shutdowns on operations
- Supply chain risk: dependency on third-party CMOs for clinical and commercial manufacturing supply and backup sources
- Competitive risk: uncertainty if regulatory labeling excludes secondary endpoints potentially weakening competitive positioning
- Financial risk: history of losses with anticipated continued deficits and need for additional funding before profitability achievable
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