Short answer
Denali Therapeutics Inc. (DNLI) filed its Q3 2025 10-Q quarterly report on Nov 6, 2025 for the quarter ended Sep 30, 2025.
Q3 2025 key financials · XBRL
- Net income
- −$127M
- −18.4% YoY · −2.2% QoQ
- EPS (diluted)
- −$0.74
- −17.5% YoY · −2.8% QoQ
Source: XBRL data from the Denali Therapeutics Inc. (DNLI) Q3 2025 10-Q on SEC EDGAR. USD.
Denali Therapeutics Inc. Q3 2025 10-Q analysis
AI summary of MD&A and risk factor updates
Risk Factors
- New clinical trial failure risk: Phase 2/3 HEALEY ALS Platform Trial of DNL343 missed primary/secondary endpoints in Jan 2025, raising pipeline uncertainty
- Updated financial risk: Net loss increased to $126.9M Q3 2025 vs $107.2M Q3 2024, accumulated deficit $1.92B as of Sept 30, 2025
- Regulatory risk: Difficulty obtaining orphan drug designation and reliance on FDA/EMA acceptance of foreign clinical data emphasized
- Operational risk: Dependence on third parties for clinical trials, manufacturing, and supply of key raw materials may delay development or commercialization
- Financial liquidity risk: $872.9M cash and equivalents as of Sept 30, 2025, sufficient for next 12 months but no committed additional capital sources
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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