and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Completion of Acquisition or Disposition of Assets. On July 27, 2026, Denali Therapeutics Inc. (the “Company”) completed the previously disclosed sale (the “Sale”) of its Rare Pediatric Disease Priority Review Voucher (the “PRV”) to a large pharmaceutical company. The Company received the PRV when AVLAYAHTM (tividenofusp alfa) was approved by the U.S. Food and Drug Administration for the treatment of Hunter syndrome (mucopolysaccharidosis type II; MPS II) in March 2026. The Sale was completed…

Entry into a Material Definitive Agreement On June 12, 2026, Denali Therapeutics Inc. (the “Company”) entered into an asset purchase agreement (the “PRV Transfer Agreement”), pursuant to which the Company agreed to sell its Rare Pediatric Disease Priority Review Voucher (“PRV”). The Company was awarded the voucher under a U.S. Food and Drug Administration (“FDA”) program intended to encourage the development of certain rare pediatric disease product applications. The Company received the PRV…

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Termination of a Material Definitive Agreement. On April 3, 2026, Denali Therapeutics Inc. (“Denali”) received written notice from Takeda Pharmaceutical Company Limited (“Takeda”) of its decision to terminate the Collaboration Agreement (the “Agreement”), dated January 3, 2018, between the two companies to co-develop and co-commercialize DNL593 (PTV:PGRN). The decision was driven by strategic considerations and is not related to efficacy or safety data. The termination will become effective 6…

of the Form 8-K filed by Denali Therapeutics Inc. (the “Company”) on December 4, 2025 related to the synthetic royalty funding agreement between the Company and Royalty Pharma (the “Royalty Agreement”), and the information contained in

Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. The information contained in

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Entry into a Material Definitive Agreement. On December 9, 2025, Denali Therapeutics Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the public offering of 9,142,857 shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”), at a pr…

Entry into a Material Definitive Agreement On December 4, 2025, Denali Therapeutics Inc. (“Denali” or the “Company”) entered into a synthetic royalty funding agreement (the “Royalty Agreement”) with Royalty Pharma plc (“Royalty Pharma”). Pursuant to the Royalty Agreement, Royalty Pharma has agreed to provide up to $275 million in funding to the Company in exchange for a 9.25% royalty on future net sales of tividenofusp alfa, Denali’s investigational TransportVehicle™-enabled enzyme replacemen…

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Entry into a Material Definitive Agreement. On June 3, 2025, Denali Therapeutics Inc. (the “Company”) entered into a registration rights agreement (the “Affiliate Registration Rights Agreement”) with Baker Brothers Life Sciences, L.P. and 667, L.P. (collectively, the “BBA Funds”), in connection with the election of Julian C. Baker as a director of the Company. Pursuant to the Affiliate Registration Rights Agreement, the BBA Funds are entitled to certain resale registration rights with respect…

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Termination of a Material Definitive Agreement On February 27, 2025, the Company terminated its equity distribution agreement, dated February 28, 2022, by and between the Company, Goldman Sachs & Co. LLC (“Goldman”), Leerink Partners LLC (“Leerink Partners”), and Cantor Fitzgerald & Co. ("Cantor") (the “Prior Sales Agreement”), pursuant to which the Company was permitted to sell shares of common stock in “at-the-market offerings” as defined by Rule 415 of the Securities Act. The Company previ…

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Entry into a Material Definitive Agreement. On February 27, 2025, Denali Therapeutics Inc. (the “Company”) entered into an equity distribution agreement (the “Agreement”) with Goldman Sachs & Co. LLC (“Goldman”) and Leerink Partners LLC (“Leerink Partners”), pursuant to which the Company may offer and sell shares of the Company’s common stock, par value $0.01 per share, having aggregate gross proceeds of up to $400 million from time to time, through an “at the market offering” program under w…

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Unregistered Sales of Equity Securities. The disclosures set forth in

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Entry into a Material Definitive Agreement Securities Purchase Agreement On February 27, 2024, Denali Therapeutics Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with the purchasers named therein (the “Purchasers”), for the private placement (the “Private Placement”) of (i) 3,244,689 shares (the “Shares”) of the Company’s common stock, par value $0.01 per share (the “Common Stock”), at $17.07 per Share, and (ii) pre-funded warrants (the “Pre-Funde…

and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Entry into a Material Definitive Agreement. Consistent with Denali’s previous announcement on June 5, 2023, on August 17, 2023, Denali Therapeutics Inc., (“Denali” or “we”) and Biogen MA, Inc. and Biogen International GmbH, (collectively, “Biogen”) executed an Amendment to the Definitive LRRK2 Agreement and Waiver of and Amendment to Right of First Negotiation, Option, and License Agreement (the “Amendment”). The Amendment amends two agreements entered into between Denali and Biogen, namely t…