DNLI Denali Therapeutics Inc.
FY2025 10-K
Denali Therapeutics Inc. (DNLI) filed its fiscal year 2025 10-K annual report with the SEC on Feb 26, 2026. This page provides AI-powered analysis of the filing, including business overview, management discussion, risk factors, and key financial metrics from XBRL data.
AI Filing AnalysisFY2025 10-K
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
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
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
Financial SummaryXBRL
Revenue
$0
Net Income
-$513M
ROE
-50.6%
Total Assets
$1.1B
EPS (Diluted)
$-2.97
Operating Cash Flow
-$413M
Source: XBRL data from Denali Therapeutics Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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