Denali Therapeutics Inc.

Item 1.01 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 when AVLAYAHTM (tividenofusp alfa) was approved by the FDA for the treatment of Hunter syndrome (mucopolysaccharidosis type II; MPS II) in March 2026. Pursuant to the PRV Transfer Agreement, the buyer agreed to pay the Company $195 million, payable in cash, upon the closing of the sale. The PRV Transfer Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The foregoing description of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement, which will be filed as an exhibit to a subsequent filing with the Securities and Exchange Commission (SEC).

Item 7.01 Regulation FD Disclosure On June 18, 2026, the Company issued a press release announcing the matters disclosed in this report. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.