Denali Therapeutics Files 8-K on Regulation FD Disclosure

TL;DR

**Denali Therapeutics just filed an 8-K for Regulation FD Disclosure, signaling they're keeping the market informed.**

AI Summary

Denali Therapeutics Inc. filed an 8-K on February 16, 2024, under Regulation FD Disclosure. The filing indicates an event reported on February 16, 2024, and was submitted to the SEC on the same date. The company, based in South San Francisco, CA, operates in the biological products industry.

Why It Matters

This filing ensures Denali Therapeutics Inc. is transparent about any material non-public information, maintaining fair disclosure to all investors.

Risk Assessment

Risk Level: low — This 8-K is a routine disclosure under Regulation FD and does not indicate any specific financial or operational risks.

Key Players & Entities

• Denali Therapeutics Inc. (company) — Registrant
• February 16, 2024 (date) — Date of earliest event reported and filing date
• South San Francisco, CA (company) — Business address of Denali Therapeutics Inc.
• 001-38311 (other) — Commission File Number
• 46-3872213 (other) — I.R.S. Employer Identification No.

FAQ

Key Financial Figures

• $0.01 — ich registered Common Stock, par value $0.01 per share DNLI NASDAQ Global Select Mar

Filing Documents

• dnli-20240216.htm (8-K) — 29KB
• 0001714899-24-000065.txt ( ) — 151KB
• dnli-20240216.xsd (EX-101.SCH) — 2KB
• dnli-20240216_lab.xml (EX-101.LAB) — 23KB
• dnli-20240216_pre.xml (EX-101.PRE) — 12KB
• dnli-20240216_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. Denali Therapeutics was informed by its strategic partner Sanofi that the Phase 2 HIMALAYA study evaluating SAR443820/DNL788 in participants with amyotrophic lateral sclerosis (ALS) did not meet the primary endpoint of change in ALS Functional Rating Scale-Revised (ALSFRS-R). Sanofi intends to present the detailed efficacy and safety results of the ALS Phase 2 HIMALAYA study at a future scientific forum. SAR443820/DNL788 is an investigational oral brain-penetrant RIPK1 inhibitor being co-developed by Sanofi and Denali. Sanofi will continue to conduct the K2 Phase 2 study of SAR443820/DNL788 in participants with multiple sclerosis. 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

Forward-Looking Statements Certain of the statements made in this report are forward looking, such as those relating to Denali's and Sanofi's plans regarding SAR443820/DNL788, including the Phase 2 study in ALS and the Phase 2 study in MS. 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 and Quarterly Reports filed on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (the "SEC") on February 27, 2023, and November 7, 2023, respectively, 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. 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 16, 2024 By: /s/ Alexander O. Schuth Alexander O. Schuth, M.D. Chief Operating and Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR