Neurogene Inc 2025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 endedMarch 31, 2025OR 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.) (855)508-3568 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 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 for complyingwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.o 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 May5, 2025, there were14,262,066shares 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 Operations20Item 3.Quantitative and Qualitative Disclosures About Market Risk34Item 4.Controls and Procedures34 Part IIOther Information35Item 1.Legal Proceedings35Item 1A.Risk Factors35Item 2.Unregistered Sales of Equity Securities and Use of Proceeds84Item 3.Defaults Upon Senior Securities84Item 4.Mine Safety Disclosures84Item 5.Other Information85Item 6.Exhibits86Signatures87 Neurogene Inc.Condensed Consolidated Balance Sheets(In Thousands, Except Share Information)(Unaudited) Neurogene Inc.Condensed Consolidated Statements of Operations(In Thousands, Except Share Information)(Unaudited) Neurogene Inc.Condensed Consolidated Statement of Stockholders’ Equity(In Thousands, Except Share Information)(Unaudited) The accompanying notes are an integral part of these condensed consolidated financial statements. 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.) (the “Company” or “Neurogene”) is a clinical-stage biotechnologycompany that is a result of the reverse merger discussed below. 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 is in anongoing Phase 1/2 clinical trial for the treatment of Rett syndrome. Since beginning operations, the Company has devoted substantially all itsefforts to research and development, recruiting management and technical staff, administration, and raising capital.TM 2.Risks and Uncertainties The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, successful developmentof technology, obtaining additio