Denali Therapeutics Inc 2025年季度报告

FORM10-Q (Mark One)☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THESECURITIESEXCHANGE ACT OF 1934 For the quarterly period endedJune 30, 2025OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIESEXCHANGE ACT OF 1934 For the transition period fromtoCommission File Number:001-38311 Denali Therapeutics Inc. (Exact name of registrant as specified in its charter) 46-3872213(I.R.S. EmployerIdentification No.) Delaware(State or other jurisdiction ofincorporation or organization) 161 Oyster Point Blvd.South San Francisco,CA,94080(Address of principal executive offices and zip code) (650)866-8547(Registrant’s telephone number, including area code)_______________________________________ Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d) of the Securities Exchange Act of1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject to suchfiling requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405of Regulation S-T(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit suchfiles).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting companyor an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and "emerging growthcompany" in Rule 12b-2 of the Exchange Act. Large accelerated filer☒Accelerated filer☐Non-accelerated filer☐Smallerreportingcompany☐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 anynew or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒ The number of outstanding shares of the registrant’s common stock as of August5, 2025was146,212,278. This number does not include26,046,065 shares of common stock issuable upon the exercise of pre-funded warrants outstanding as ofAugust5, 2025(which are immediatelyexercisable at an exercise price of $0.01 per share of common stock, subject to beneficial ownership limitations) sold in the registrant’s private placementin February 2024. See Note 7 — Common Stock to the registrant’s condensed consolidated financial statements. TABLE OF CONTENTS PART I. FINANCIAL INFORMATION Item1.Financial Statements (Unaudited)Condensed Consolidated Balance SheetsCondensed Consolidated Statements of Operations and Comprehensive LossCondensed Consolidated Statements of Stockholders’ EquityCondensed Consolidated Statements of Cash FlowsNotes to Condensed Consolidated Financial StatementsItem2.Management's Discussion and Analysis of Financial Condition and Results of OperationsItem3.Quantitative and Qualitative Disclosures About Market RiskItem4.Controls and Procedures PART II. OTHER INFORMATION Item1.Legal ProceedingsItem1A.Risk FactorsItem2.Unregistered Sales of Equity Securities and Use of ProceedsItem3.Defaults Upon Senior SecuritiesItem4.Mine Safety DisclosuresItem5.Other InformationItem6.ExhibitsSignatures PART I. FINANCIAL INFORMATION Denali Therapeutics Inc.Condensed Consolidated Balance Sheets(Unaudited)(In thousands, except share amounts) June 30, 2025December 31, 2024 Denali Therapeutics Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited)(In thousands, except share and per share amounts) See accompanying notes to unaudited condensed consolidated financial statements. Denali Therapeutics Inc. Denali Therapeutics Inc. Condensed Consolidated Statements of Cash Flows(Unaudited)(In thousands) Denali Therapeutics Inc.Notes to Condensed Consolidated Financial Statements(Unaudited) 1.Significant Accounting Policies Organization and Description of Business Denali Therapeutics Inc. ("Denali" or the “Company”) is a biopharmaceutical company, incorporated in Delaware,that discovers and develops therapeutics to defeat neurodegenerative diseases and lysosomal storage diseases. TheCompany is headquartered in South San Francisco, California. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance withaccounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial informationand the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission ("SEC") Regulation S-X forinterim financial information. These unaudite