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.
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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.
Denali Therapeutics insider sale to cover taxes; holdings after transaction detailed. Director and Chief Operating and Financial Officer Alexander O. Schuth sold 2,937 shares of Denali common stock on 08/12/2025 at a weighted average price between $13.35 and $13.58 per share to satisfy tax obligations from the settlement of previously vested restricted stock units. After the sale, Mr. Schuth beneficially owns 242,346 shares directly (including 128,405 unvested RSUs and 975 shares from an ESPP purchase) and 523,749 shares indirectly via The Schuth Family Trust, for which he is trustee.
Denali Therapeutics (DNLI) insider sale by Chief Medical Officer Carole Ho. The filing reports two open-market sales executed on 08/12/2025 and 08/13/2025 of a combined 3,743 shares, at weighted average prices ranging roughly from $13.34 to $14.64 per share, to satisfy tax obligations related to the settlement of previously vested restricted stock units. After the transactions, the reporting person directly beneficially owned 216,585 shares. The filing also discloses indirect holdings of 183,219 shares held by the Rohatgi-Ho Family 2009 Revocable Trust and 25,000 shares held by The Rohatgi-Ho Irrevocable GST Trust for the benefit of the reporting person’s children. The sales on 08/12/2025 were S-code disposals with a weighted average reported sale price up to $13.58 and were effected pursuant to a Rule 10b5-1 trading plan adopted on December 11, 2024.
Denali Therapeutics (DNLI) reported a Form 144 notice showing an intended sale of 806 shares of common stock, representing restricted stock units acquired on 08/11/2025. The aggregate market value of the proposed sale is $10,655.32, with an approximate sale date of 08/13/2025 on NASDAQ through Morgan Stanley Smith Barney.
The filing also discloses a sale earlier in the three‑month window by Carole Ho of 2,937 shares on 08/12/2025 for gross proceeds of $39,880.52. The notice includes the standard representation that the seller does not possess undisclosed material information about the issuer.
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