Short answer
Denali Therapeutics Inc. (DNLI) filed its fiscal 2025 10-K annual report with the SEC on Feb 26, 2026. It reported revenue of $0 and net income of −$513M.
- Top risk flagged: FDA regulatory risk: Phase 2/3 HEALEY ALS trial of DNL343 missed primary endpoints in Jan 2025, risking program discontinuation or delays
FY2025 key financial metrics · XBRL
- Revenue
- $0
- Net income
- −$513M
- −21.2% YoY
- EPS (diluted)
- −$2.97
- −15.6% YoY
- ROE
- -50.6%
- −16.2 pp YoY
- Operating cash flow
- −$413M
- −18.7% YoY
Source: XBRL data from the Denali Therapeutics Inc. (DNLI) FY2025 10-K on SEC EDGAR. USD.
Denali Therapeutics Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Developing biotherapeutics using proprietary TransportVehicle™ (TV) technology to cross blood-brain barrier and treat neurodegenerative and lysosomal storage diseases
- New emphasis: Advancing two near-launch products (tividenofusp alfa for MPS II (Hunter syndrome) and DNL126 for MPS IIIA) with $1B+ initial market opportunity
- Strategic shift: Transitioning from platform validation to commercial delivery with D3X3 strategy targeting two commercial brands, five clinical proof-of-concept readouts, and 4-6 new clinical programs (2026-2028)
- Quantitative highlight: Over 200 clinical trial participants dosed with 11,000+ TV-enabled therapeutic doses; commercial readiness established including dedicated commercial team
- Noteworthy fact: April 5, 2026 PDUFA date for tividenofusp alfa’s FDA accelerated approval BLA with expected first product launch, despite regulatory review extension due to major amendment
Management Discussion & Analysis
- Revenue recognition requires significant judgment on collaboration arrangements; no material revenue true ups reported to date
- Research & development (R&D) expenses mainly external, based on estimates from progress reports; no material true ups in R&D expenses or reimbursements to date
- Increasing judgment required for R&D expense estimates due to more extensive late-stage clinical trials
- R&D funding payments recorded as liability and offset to R&D expenses; no material true ups in funding recognition
- No specific revenue, profitability, segment performance, cash flow, or forward-looking guidance disclosed in this section
Risk Factors
- FDA regulatory risk: Phase 2/3 HEALEY ALS trial of DNL343 missed primary endpoints in Jan 2025, risking program discontinuation or delays
- Geopolitical/macro exposure: $966.2M cash runway through 12+ months threatened by inflation, tariffs, foreign currency risks, and economic downturns
- Supply chain: Reliance on third parties for clinical trial manufacturing and raw materials may cause shortages or delays in product supply
- Competition: Risk from other neurodegenerative disease biotech firms as limited approved therapies increase pressure to demonstrate efficacy first
- Financial risk: Accumulated deficit $2.05B with $512.5M net loss in 2025; no product revenue, ongoing need for additional financing to continue development
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