enGene Holdings Inc-2026年季度报告

Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS PART I.FINANCIAL INFORMATION Item 1.Financial Statements (Unaudited)Condensed Consolidated Balance Sheets as of January 31, 2026 and October 31, 2025Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended January 31, 2026 and 2025Condensed Consolidated Statements of Shareholders’ Equity for the Three Months Ended January 31, 2026 and 20256Condensed Consolidated Statements of Cash Flows for the Three Months Ended January 31, 2026 and 20257Notes to the Condensed Consolidated Financial Statements8Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations24Item 3.Quantitative and Qualitative Disclosures About Market Risk33Item 4.Controls and Procedures33 PART II.OTHER INFORMATION Item 1.Legal ProceedingsItem 1A.Risk FactorsItem 2.Unregistered Sales of Equity Securities and Use of ProceedsItem 3.Defaults Upon Senior Securities.Item 4.Mine Safety Disclosures.Item 5.Other InformationItem 6.ExhibitsSignatures SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain statements in this Quarterly Report on Form 10-Q (this “Quarterly Report”) may constitute “forward-lookingstatements” within the meaning of U.S. securities laws and “forward-looking information” within the meaning of Canadiansecurities laws (collectively, “forward-looking statements”). Our forward-looking statements include, but are not limited to,statements regarding management teams’ expectations, hopes, beliefs, intentions, goals or strategies regarding the future. Inaddition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, includinganyunderlying assumptions,are forward-looking statements.The words“anticipate,”“appear,”“approximate,”“believe,” •our financial performance, including financial projections and business metrics and any underlying assumptionsthereunder;•our ability to maintain the listing of the Company’s common shares (“Common Shares”) and warrants to purchaseCommon Shares (“Warrants”) on The Nasdaq Capital Market (“Nasdaq”) or another national securities exchange;•our success in recruiting and retaining, or changes required in, officers, key personnel or directors;•our plans and ability to execute product development, manufacturing process development, preclinical and clinicaldevelopment efforts successfully and on anticipated timelines;•our ability to design, initiate and successfully complete clinical trials and other studies for detalimogene voraplasmid, ordetalimogene, formerly referred to as EG-70, and any other product candidates we develop and our plans andexpectations regarding our ongoing or planned clinical trials; All forward-looking statements, including, without limitation, our examination of historical operating trends, are basedupon our current expectations and various assumptions. Certain assumptions made in preparing the forward-looking statements •we are able to recruit and retain qualified scientific and management personnel, establish clinical trial sites and patientregistration for clinical trials and acquire technologies complementary to, or necessary for, detalimogene or any otherprograms; •we are able to submit our planned Biologics License Application in second half of 2026 with the FDA for approval tomarket detalimogene in the United States as a monotherapy to treat BCG-unresponsive NMIBC with CIS;•detalimogene’s product profile can be integrated seamlessly into community urology clinics where the vast majority ofNMIBC patients are treated; You should not place undue reliance on these forward-looking statements which speak only as of the date hereof. Theforward-looking statements contained in this Quarterly Report are based primarily on current expectations and projections aboutfuture events and trends that may affect our business, financial condition and operating results. The following uncertainties andfactors, among other things (including those described in “Risk Factors” in our Annual Report on Form 10-K for the fiscal yearended October 31, 2025, as amended by Amendment No. 1 to Form 10-K filed with Securities and Exchange Commission (the •risks applicable to our business, including the heavy dependence on the success of detalimogene and the extensiveregulation of all aspects of our business, competition from other existing or newly developed products and treatments;•risks associated with the protection of intellectual property, our ability to raise additional capital to fund our productdevelopment activity, and our ability to maintain key relationships and to attract and retain talented personnel;•the possibility that we may be adversely affected by changes in domestic and foreign laws and regulations, including In addition, statements that “we believe” and similar statements reflect beliefs and opinions on the relevant subject. Thesestatements are based on information available to us