Welcome to our dedicated page for Denali Therapeut SEC filings (Ticker: DNLI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Denali Therapeutics Inc. (DNLI) SEC filings page on Stock Titan provides access to the company’s publicly filed documents, including current reports on Form 8‑K and other disclosures incorporated by reference. Denali is a biotechnology and biopharmaceutical company based in South San Francisco, California, focused on product candidates engineered to cross the blood-brain barrier for neurodegenerative and lysosomal storage diseases.
Recent Form 8‑K filings referenced by the company include reports of quarterly financial results, such as second and third quarter 2025 results, and Regulation FD disclosures related to key regulatory milestones. For example, Denali filed 8‑K reports describing FDA acceptance and Priority Review of the Biologics License Application for tividenofusp alfa (DNL310) for Hunter syndrome (MPS II), and a subsequent extension of the Prescription Drug User Fee Act (PDUFA) target action date after submission of updated clinical pharmacology information classified as a Major Amendment.
Through this page, users can track how Denali reports material events such as clinical and regulatory updates, financial results and capital markets transactions, including public offerings of common stock and pre-funded warrants registered on Form S‑3. The filings complement the company’s press releases by providing formal regulatory context and references to exhibits such as earnings releases and detailed financial statements.
Stock Titan enhances access to these filings with tools designed to help readers quickly locate relevant 8‑K disclosures, review historical reporting patterns and connect SEC documents with related news about Denali’s TransportVehicle™ platform, pipeline programs and collaborations.
Denali Therapeutics Inc. officer Alexander O. Schuth, the company’s COFO and Secretary, reported a sale of common stock. On 01/06/2026, he sold 17,218 shares of Denali common stock at $16.5 per share, with the filing stating that the sale was made to satisfy his tax obligations related to the settlement of previously vested restricted stock units (RSUs). After this transaction, he beneficially owned 282,828 shares directly, which the filing notes includes 141,100 unvested RSUs. The filing also reports 523,749 shares held indirectly through The Schuth Family Trust U/A DTD 06/05/2017, for which he serves as trustee.
A shareholder of Denali Therapeutics Inc. has filed a notice of proposed sale under Rule 144 covering 35,198 shares of common stock. The shares are to be sold through Morgan Stanley Smith Barney LLC Executive Financial Services on or about 01/06/2026 on the NASDAQ, with an aggregate market value listed as $580,767. The filing notes that these shares were acquired on 01/03/2026 through a restricted stock lapse described as equity compensation.
Denali Therapeutics Inc. filed a current report to share that it has issued a press release outlining an update on its programs and expected milestones for 2026, and its planned participation in the 44th Annual J.P. Morgan Healthcare Conference. The press release is provided as Exhibit 99.1 and is incorporated by reference. The company notes that the information under Regulation FD in this report, including Exhibit 99.1, is being furnished rather than filed, which limits how it is treated under securities law.
Denali Therapeutics Inc. insiders affiliated with Baker Brothers reported large purchases of $0.01 prefunded warrants to buy the company’s common stock. On December 11, 2025, 667, L.P. acquired 190,523 prefunded warrants and Baker Brothers Life Sciences, L.P. acquired 2,095,191 prefunded warrants in a public offering at $17.49 per warrant. Each warrant is exercisable at any time on a 1-for-1 basis into common stock at an exercise price of $0.01 per share, with no expiration date.
These warrants can only be exercised to the extent the holders and their affiliates would beneficially own no more than 4.99% of Denali’s outstanding common stock, a cap that can be adjusted up to 19.99% with 61 days’ notice. After these transactions, 667, L.P. beneficially owned 2,335,469 prefunded warrants and Baker Brothers Life Sciences, L.P. beneficially owned 25,996,310 prefunded warrants. Julian C. Baker is a director of Denali, and other reporting persons are deemed directors by deputization through their board representation and advisory roles.
Denali Therapeutics (DNLI) filed a Form 4 for a director equity grant. On 11/04/2025, the director received 10,632 restricted stock units at $0 and was shown beneficially owning 10,632 common shares after the transaction, held directly.
The director was also granted a stock option for 31,897 shares at an exercise price of $14.92, expiring 11/04/2034. RSUs vest in four equal annual installments from the grant date, subject to service. Options vest 25% on November 4, 2026, with the remainder vesting monthly in equal 1/48 increments thereafter.
Denali Therapeutics (DNLI) reported an insider Form 3 for a board member. The filing identifies the reporting person as a Director and indicates it is filed by one reporting person. The event date is 11/04/2025. In the remarks, the filer states no securities are beneficially owned. The signature block shows execution on 11/06/2025 by attorney-in-fact.
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 Therapeutics (DNLI) reported that it issued a press release announcing financial results for the third quarter ended September 30, 2025. The company disclosed this under Item 2.02 and furnished the full press release as Exhibit 99.1.
The materials in Item 2.02 and Item 9.01 (including Exhibit 99.1) are designated as furnished, not filed, under the Exchange Act. The filing also lists the Inline XBRL cover page as Exhibit 104.
Denali Therapeutics (DNLI) reported that the FDA has extended the PDUFA action date for its Biologics License Application seeking accelerated approval of tividenofusp alfa to treat MPS II (Hunter syndrome). The decision date moved from January 5, 2026 to April 5, 2026.
According to the company, the FDA granted the extension to allow review of updated clinical pharmacological information, which was classified as a Major Amendment to the BLA. The update was furnished under Regulation FD, and a related press release was included as an exhibit.
Denali Therapeutics insider report: Ryan J. Watts, President and CEO and a director, reported transactions dated 09/03/2025. He made an in-kind charitable contribution of 50,000 shares of DNLI to a donor-advised fund, and the filing also shows a disposal of 253,071 shares. Following the reported transactions, the filing shows 2,152,604 shares beneficially owned indirectly through the Watts Family 2015 Trust (Watts serves as trustee). The filing notes that 177,940 of the holdings are unvested RSUs. The form was signed by a POA on 09/05/2025.