Neurogene Inc 2026年季度报告

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACTOF1934For the quarterly period ended June 30, 2026OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACTOF1934 For the transition period from ________ to ________Commission file number:001-36327 Neurogene Inc. (Exact name of registrant as specified in its charter) 98-0542593 Delaware(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.) 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 ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)has beensubject to such filing 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 toRule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and“emerging growth company” in Rule 12b-2 of the Exchange Act: If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new 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☒As of August7, 2026, there were 20,011,382 shares of the registrant’s common stock outstanding. Table of Contents Part IFinancial Information1Item 1.Financial Statements1Item 2.Management's Discussion and Analysis of Financial Condition and Results of Operations23Item 3.Quantitative and Qualitative Disclosures About Market Risk37Item 4.Controls and Procedures37 Part IIOther Information39Item 1.Legal Proceedings39Item 1A.Risk Factors39Item 2.Unregistered Sales of Equity Securities and Use of Proceeds91Item 3.Defaults Upon Senior Securities91Item 4.Mine Safety Disclosures91Item 5.Other Information91Item 6.Exhibits92Signatures93 Neurogene Inc.Condensed Consolidated Balance Sheets(In Thousands, Except Share Information)(Unaudited) Neurogene Inc.Condensed Consolidated Statements of Operations(In Thousands, Except Share and Per Share Amounts)(Unaudited) Neurogene Inc.Condensed Consolidated Statement of Stockholders’ Equity(In Thousands, Except Share Information)(Unaudited) Neurogene Inc.Condensed Consolidated Statements of Cash Flows(In Thousands)(Unaudited) NEUROGENE INC.NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1.Organization and Description of Business NeurogeneInc. (formerly known as Neoleukin Therapeutics, Inc. (“Neoleukin”)) (the “Company” or “Neurogene”) is a clinical-stagebiotechnology company that is a result of the reverse merger. The operating entity of Neurogene Inc. is the wholly owned subsidiaryincorporated in the state of Nevada and also named Neurogene Inc. (“Neurogene OpCo”). Neurogene OpCo was incorporated as a limitedliability company in Delaware on January 26, 2018 and converted into a Delaware corporation on July 3, 2018, and then merged with a whollyowned subsidiary of the parent company and re-domiciled to Nevada on December 18, 2023 after completing a reverse merger with NeoleukinTherapeutics, Inc. (the “Closing”), in accordance with the terms of the Agreement and Plan of Merger, dated as of July 17, 2023 (the “MergerAgreement”). Both Neurogene and Neurogene OpCo have a principal place of business in New York, NY. Neurogene was formed to harnessthe power of gene therapy, combined with its EXACTtransgene regulation technology, to turn today’s complex, devastating neurologicaldiseases into treatable conditions. The Company’s first clinical-stage program to utilize the EXACT technology is NGN-401, which hascompleted dosing in a Phase 1/2 clinical trial for the treatment of Rett syndrome. The Company has also completed dosing in its registrationaltrial of NGN-401 to treat Rett syndrome. The trial, known as the Emboldenstudy, is a single‑arm, baseline‑controlled, open‑label studyevaluating NGN‑401 in females with Rett syndrome and has been designed to support a potential Biologics License Application ("BLA")submission. Since beginning operations, the Company has devoted substantially all its resources to conducting research and developmentactivitiesand undertaking preclinical studies,establishing the Company’s