0001714899FALSE00017148992025-03-052025-03-05

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):
March 5, 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 7.01     Regulation FD Disclosure.
On March 5, 2025, Denali Therapeutics Inc. provided an update that further analyses from Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis (ALS) did not demonstrate a treatment effect on neurofilament light (NfL), a biomarker of neuronal damage, over the 24-week, double-blind period and in a subset of participants that completed an additional 28 weeks in the open-label active treatment extension.

On January 6, 2025, Denali announced that the study did not meet the primary endpoint of efficacy in slowing disease progression as compared with placebo. Key secondary endpoints were also not statistically different between the active and placebo groups at week 24.

Based on these outcomes, the active treatment extension in Regimen G will be discontinued. Overall, DNL343 was found to be safe and well tolerated. Data from Regimen G will be presented at a future medical meeting. Denali intends to assess potential future development opportunities for DNL343.

The information furnished in this Item 7.01 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Forward-Looking Statements

Certain statements in this report are forward looking, such as those regarding the timing and presentation of Regimen G data and plans for the future development of DNL343. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Denali may be found in Denali’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 27, 2025, and Denali’s future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali’s expectations, except as required by law.
Exhibit No.Description
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:March 5, 2025By:/s/ Alexander O. Schuth
Alexander O. Schuth, M.D.
Chief Operating and Financial Officer


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Cover
Mar. 05, 2025
Cover [Abstract]  
Document Type 8-K
Document Period End Date Mar. 05, 2025
Entity Registrant Name Denali Therapeutics Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 001-38311
Entity Tax Identification Number 46-3872213
Entity Address, Address Line One 161 Oyster Point Blvd.
Entity Address, City or Town South San Francisco
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94080
City Area Code 650
Local Phone Number 866-8547
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Trading Symbol DNLI
Security Exchange Name NASDAQ
Entity Central Index Key 0001714899
Amendment Flag false
Title of 12(b) Security Common Stock, par value $0.01 per share
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