DNLI

EX-99.1

2 ex991pressreleaseq12026.htm

EX-99.1

Document

Exhibit 99.1

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

•FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier

•AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting in April

•Broad clinical pipeline progressing for lysosomal storage and neurodegenerative diseases, including first patient dosed with Oligonucleotide TransportVehicle™(OTV)-enabled DNL628 (OTV:MAPT) targeting tau for Alzheimer's disease

•Advancing DNL593 (PTV:PGRN) in Phase 1/2 study for GRN-related frontotemporal dementia after regaining full rights, with data expected by end of 2026

SOUTH SAN FRANCISCO, Calif., – May 7, 2026 – Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2026, and provided business highlights, including the recent U.S. Food and Drug Administration (FDA) approval of AVLAYAH™ (tividenofusp alfa-eknm).

“The FDA approval of AVLAYAH is a major milestone for Denali, for the Hunter syndrome community, and for the field of biotherapeutics enabled to cross the blood-brain barrier. We are thrilled by the strong engagement with the community, seamless execution by our commercial team, and achievement of our first patient dosed in less than one month from approval,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “AVLAYAH provides validation for our TransportVehicle™ (TV) platform enabling our broad clinical portfolio for lysosomal storage and neurodegenerative diseases. We are excited about progress achieved across the portfolio, including dosing of the first patients with our Oligonucleotide TV-enabled investigational therapy DNL628 (OTV:MAPT) targeting tau for Alzheimer’s disease and advancing DNL593 (PTV:PGRN) for FTD-GRN after regaining full rights."

First Quarter 2026 and Recent Program Updates

COMMERCIAL PRODUCT

AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome (mucopolysaccharidosis type II [MPS II])

On March 25, 2026, Denali announced AVLAYAH (tividenofusp alfa-eknm) received accelerated approval for the treatment of neurologic manifestations of Hunter syndrome (MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. The U.S. commercial launch of AVLAYAH is underway and the first patients have received therapy. All key operational launch components are in place, including availability of commercial product through an established distribution channel and fully operational patient support hub. The major health systems and key national and regional payers have been engaged. The ongoing global Phase 2/3 COMPASS study is designed to generate confirmatory evidence and support global regulatory submissions for AVLAYAH.

CLINICAL PROGRAMS

DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA)

DNL126 is an investigational, intravenously administered, Enzyme TransportVehicle™ (ETV)-enabled N-sulfoglucosamine sulfohydrolase (SGSH) replacement therapy designed to deliver SGSH into the brain and body, with the goal of addressing the behavioral, cognitive and physical manifestations of Sanfilippo syndrome type A. The Phase 1/2 trial of DNL126 is ongoing, and start-up activities are underway for a global Phase 3 confirmatory study. Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for DNL126 for Sanfilippo syndrome type A in 2027.

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DNL593 (PTV:PGRN) for GRN-related frontotemporal dementia (FTD-GRN)

Denali is conducting a Phase 1/2 study of DNL593, an investigational, intravenously administered progranulin replacement therapy utilizing Denali’s Protein TransportVehicle™ (PTV) to deliver progranulin across the blood-brain barrier (BBB) and into the brain for individuals with FTD-GRN. Enrollment in the study is complete with a total of 40 participants with FTD-GRN, and results are expected by the end of 2026.

DNL628 (OTV:MAPT) for Alzheimer's disease

In March 2026, the first patient was dosed in the Phase 1b study of DNL628, which is an investigational therapy for Alzheimer’s disease and enabled by Denali’s Oligonucleotide TransportVehicle™ (OTV). DNL628 is designed to cross the BBB and reduce the tau protein by targeting the MAPT gene that encodes for tau. Denali expects data from this study in 1H 2027.

DNL952 (ETV:GAA) for Pompe disease

DNL952 is enabled by Denali’s ETV and designed to enhance delivery of the missing enzyme, GAA, into muscle tissues and across the BBB into the brain. Phase 1 study start-up activities are underway.

BIIB122/DNL151 (small molecule LRRK2 inhibitor) for Parkinso

dnli-202602260001714899FALSE00017148992026-02-262026-02-26

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 26, 2026

Denali Therapeutics Inc. (Exact name of registrant as specified in its charter)

Delaware001-3831146-3872213 (State or other jurisdiction of(Commission(I.R.S. Employer incorporation)File Number)Identification No.)

161 Oyster Point Blvd. South San Francisco, California 94080 (Address of principal executive offices, including zip code)

(650) 866-8547 (Registrant’s telephone number, including area code)

Not Applicable (Former name or former address, if changed since last reports)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol (s) Name of each exchange on which registered Common Stock, par value $0.01 per shareDNLINasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02     Results of Operations and Financial Condition. On February 26, 2026, Denali Therapeutics Inc. (the "Company") issued a press release announcing its financial results for the fourth quarter ended December 31, 2025. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. All of the information furnished in this Item 2.02 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. Item 9.01    Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release dated February 26 2026.

104Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

DENALI THERAPEUTICS INC.

Date:February 26, 2026By:/s/ Alexander O. Schuth Alexander O. Schuth, M.D. Chief Operating and Financial Officer

dnli-202511060001714899FALSE00017148992025-11-062025-11-06

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 6, 2025

Denali Therapeutics Inc. (Exact name of registrant as specified in its charter)

Delaware001-3831146-3872213 (State or other jurisdiction of(Commission(I.R.S. Employer incorporation)File Number)Identification No.)

161 Oyster Point Blvd. South San Francisco, California 94080 (Address of principal executive offices, including zip code)

(650) 866-8547 (Registrant’s telephone number, including area code)

Not Applicable (Former name or former address, if changed since last reports)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol (s) Name of each exchange on which registered Common Stock, par value $0.01 per shareDNLINasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02     Results of Operations and Financial Condition. On November 6, 2025, Denali Therapeutics Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2025. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. All of the information furnished in this Item 2.02 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. Item 9.01    Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release dated November 6 2025.

104Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

DENALI THERAPEUTICS INC.

Date:November 6, 2025By:/s/ Alexander O. Schuth Alexander O. Schuth, M.D. Chief Operating and Financial Officer