Short answer
Denali Therapeutics Inc. (DNLI) filed its Q1 2026 10-Q quarterly report on May 7, 2026 for the quarter ended Mar 31, 2026.
Q1 2026 key financials · XBRL
- Net income
- −$128M
- +3.4% YoY
- EPS (diluted)
- −$0.69
- +11.5% YoY
Source: XBRL data from the Denali Therapeutics Inc. (DNLI) Q1 2026 10-Q on SEC EDGAR. USD.
Denali Therapeutics Inc. Q1 2026 10-Q analysis
AI summary of MD&A and risk factor updates
Management Discussion & Analysis
- Revenue not disclosed; AVLAYAH commercial distribution began April 2026 after FDA approval
- Net loss $128.4M vs $133.0M YoY; loss from operations $137.4M vs $145.6M
- R&D expense $103.8M, down 11% YoY; G&A expense $33.5M, up 14%
- Cash, equivalents and marketable securities $1.05B at March 31; $200.0M gross Royalty Pharma proceeds
- Near-term outlook: continued significant losses; AVLAYAH revenue insufficient to offset expenses initially
Risk Factors
- Newly triggered commercialization risk: first FDA approval for AVLAYAH in March 2026, with no prior product-launch experience
- Most materially updated operating risk: transition from research-focused company to commercial-stage operations, including third-party manufacturing, sales, marketing, and distribution
- Regulatory risk: AVLAYAH remains subject to extensive post-approval scrutiny, including required or committed post-marketing studies
- Near-term market risk: AVLAYAH is the only approved product, with commercialization limited to specified pediatric Hunter syndrome patients
- Financial risk: $1.05 billion in cash, equivalents, and marketable securities supports projected operations through at least the next twelve months, but no committed additional capital source
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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