Stoke Therapeutics, Inc. (STOK) FY2025 10-K Annual Report
Stoke Therapeutics, Inc. (STOK) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Mar 16, 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.
Stoke Therapeutics, Inc. FY2025 10-K Analysis
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
Stoke Therapeutics, Inc. FY2025 Key Financial MetricsXBRL
Revenue
$184M
▲ +404.5% YoY
Net Income
-$7M
▲ +92.3% YoY
Operating Margin
-11.2%
▲ +26615bp YoY
Net Margin
-3.7%
▲ +23968bp YoY
ROE
-2.0%
▲ +3690bp YoY
Total Assets
$418M
▲ +54.1% YoY
EPS (Diluted)
$-0.12
▲ +92.7% YoY
Operating Cash Flow
$46M
▲ +152.5% YoY
Source: XBRL data from Stoke Therapeutics, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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