Every 10-Q that Denali Therapeutics Inc. (DNLI) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-Q covers the quarterly report filed between annual reports, so if you follow DNLI and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full DNLI filings page.
Denali Therapeutics reported Q2 2026 results as it transitioned to commercialization. Net product revenue from AVLAYAH, its first approved therapy for Hunter syndrome, was $3.6 million for both the quarter and first half, following FDA accelerated approval in March and U.S. launch in April.
Net loss was $127.6 million for the quarter and $256.0 million for the first six months of 2026. Research and development expense fell to $97.0 million in the quarter and $200.9 million year to date, down 6% and 8% versus 2025, while selling, general and administrative expense rose with commercialization efforts. Cash and cash equivalents were $201.5 million at June 30, 2026, with short- and long-term marketable securities of $508.9 million and $229.5 million, respectively.
Denali strengthened its balance sheet through a $200.0 million synthetic royalty funding with Royalty Pharma tied to a 9.25% revenue participation right on AVLAYAH and, subsequent to quarter end, a $195.0 million sale of a Rare Pediatric Disease Priority Review Voucher. Pipeline updates included Takeda’s termination of the DNL593 collaboration, with full rights reverting to Denali, and discontinuation of Biogen-partnered BIIB122/DNL151 development in idiopathic Parkinson’s disease after the Phase 2b LUMA study did not meet its endpoints.
Denali Therapeutics reported a Q1 2026 net loss of $128.4 million, slightly improved from $133.0 million a year earlier, as total operating expenses fell 6% to $137.4 million. Research and development was $103.8 million, reflecting lower small-molecule and manufacturing spend, while general and administrative rose to $33.5 million as the company prepared for commercialization.
Cash, cash equivalents and marketable securities totaled $1.05 billion as of March 31, 2026, supported by $200 million of non‑dilutive funding from a synthetic royalty agreement with Royalty Pharma tied to AVLAYAH sales. AVLAYAH, approved in March 2026 for neurologic manifestations of Hunter syndrome, began U.S. commercial distribution in April. The quarter also added a $36.0 million AVLAYAH‑related milestone as an intangible asset and recorded a $199.6 million liability for the revenue participation right.
Denali Therapeutics (DNLI) reported Q3 2025 results with a net loss of $126.9 million as operating expenses rose. Research and development was $101.95 million and general and administrative reached $35.48 million. Interest and other income was $10.53 million.
Liquidity remained anchored by cash and investments: cash and cash equivalents were $90.963 million, short‑term marketable securities $757.241 million, and long‑term marketable securities $24.703 million. Shares outstanding were 146,661,833 as of October 31, 2025; an additional 26,046,065 shares are issuable upon exercise of pre‑funded warrants at $0.01 per share, subject to beneficial ownership limits.
Pipeline updates: the BLA for tividenofusp alfa (DNL310) was accepted for priority review, and the PDUFA target date was extended to April 5, 2026. Denali completed enrollment in the Phase 1/2 DNL126 study supporting a potential accelerated path in MPS IIIA, with a Phase 3 confirmatory study being planned. Biogen completed enrollment in the Phase 2b LUMA study for BIIB122/DNL151.
Denali reported a net loss of $124.1 million for the three months and $257.1 million for the six months ended June 30, 2025, driven by higher research and development and G&A expenses. Research and development spending was $102.7 million for the quarter and $218.9 million year-to-date, including increased TV-platform and manufacturing-related costs tied to the new Salt Lake City facility.
Liquidity remains substantial with $977.4 million in cash, cash equivalents and marketable securities as of June 30, 2025, and short-term marketable securities concentrated in U.S. treasuries. Key operational milestones include Breakthrough Therapy designation and a Priority Review acceptance for tividenofusp alfa (DNL310) with a PDUFA target action date of January 5, 2026, regulatory alignment that cerebrospinal fluid heparan sulfate may support accelerated approval for DNL126, and the March 2025 opening of a clinical biomanufacturing facility.
The company disclosed several collaboration changes: Sanofi’s license to CNS products and Takeda’s ATV:TREM2 collaboration were terminated (no future milestones expected for those programs), and the 2024 divestiture of certain small molecule programs produced a non-cash gain and a retained equity investment in Tenvie. Total assets declined to $1.166 billion and stockholders’ equity to $1.027 billion as of June 30, 2025.