enGene Therapeutics Inc. (Nasdaq: ENGN) (“enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced the appointments of Erik T. Goluboff, MD, MBA as Chief Medical Officer and Jason Duncan as Chief Legal and Administrative Officer, effective November 9, 2026. enGene’s lead investigational candidate, detalimogene voraplasmid (detalimogene) is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease.

“As a former urologic oncologist and global clinical development leader, Dr. Goluboff’s industry experience and clinical perspective are uniquely suited to support our detalimogene BLA filing and commercialization plans,” said Ron Cooper, Chief Executive Officer, enGene. “At the same time, Jason Duncan brings to us a rare combination of legal, governance and operational experience helping scale biotechnology companies through late-stage development, regulatory approvals, and commercialization.”

Mr. Cooper continued, “We would like to thank Dr. Bill Grossman, a member of our Board of Directors, for his contributions and support while serving as interim Chief Medical Officer since June of this year.”

“The emerging detalimogene profile may provide busy urology practices with a unique balance of efficacy and tolerability without disruption to standard clinical workflows,” said Dr. Goluboff. “I am excited about being part of an important BLA submission and the potential to bring a new bladder-sparing treatment option to patients.”

“With a planned BLA filing later this quarter and preparations for a potential approval of detalimogene next year, I am thrilled to join enGene at this transitional time,” said Mr. Duncan.

Erik T. Goluboff, MD, MBA is a physician-executive with over 30 years of experience spanning biotechnology, global biopharmaceutical development, academic medicine, and frontline patient care. After almost three decades in academic urologic oncology, Dr. Goluboff joined AstraZeneca, where he held the title of Global Clinical Head while assisting in their late-stage research and development efforts in bladder cancer. Following AstraZeneca, he held the role of Principal Medical Lead for urologic cancers at Genentech / Roche. Before joining enGene, Dr. Goluboff was Senior Vice President of Clinical Development, Oncology at Tyra Biosciences.

Dr. Goluboff earned his B.A. in Biology from Columbia University, followed by medical school at Johns Hopkins University. He did his residency training at Johns Hopkins and Columbia, including a fellowship in urologic oncology. He previously held the roles of Director of Urology at New York-Presbyterian Hospital/The Allen Pavilion, Professor of Clinical Urology at Columbia University College of Physicians and Surgeons and also served as a Professor of Urology at the Icahn School of Medicine at Mount Sinai.

Jason Duncan brings more than two decades of legal, compliance, development, and operational experience in the life sciences industry. Most recently, he served as Chief Legal and Administrative Officer at Neumora Therapeutics. Prior to joining Neumora Therapeutics in 2023, he served as Chief Legal Officer, General Counsel, Secretary to the Board of Directors and Head of Program Management at Albireo Pharma, where he helped support the company’s evolution from an early clinical-stage biotechnology company into a fully integrated commercial organization with two drug approvals and a global launch. Albireo Pharma was subsequently acquired by Ipsen.

Before Albireo Pharma, Mr. Duncan served as General Counsel, Americas at Stallergenes Greer Holdings and as Vice President, Head of Compliance and Legal, North America at Sobi, Inc. Earlier in his career, he held positions at EMD Serono, Inc., Acushnet Company, Nixon Peabody LLP and Peabody & Arnold LLP. He earned his J.D., magna cum laude, from Suffolk University Law School and his B.A. in Political Science from Dickinson College.

Inducement Grants

In connection with the appointments of Dr. Goluboff as enGene’s Chief Medical Officer and Mr. Duncan as enGene’s Chief Legal and Administrative Officer, enGene’s Board of Directors approved new employment inducement grants to Dr. Goluboff and Mr. Duncan of 450,000 and 500,000 stock options, respectively.

The stock options will vest over four years, with 25% vesting and becoming exercisable on November 13, 2027, and the remainder vesting and becoming exercisable in substantially equal amounts monthly for three years thereafter, subject to Dr. Goluboff’s and Mr. Duncan’s continued employment with enGene on each such date. The stock options are subject to the terms and conditions of the stock option agreements covering the grants.

enGene will grant the stock options as inducements material to Dr. Goluboff’s and Mr. Duncan’s employment with enGene in accordance with Nasdaq Listing Rule 5635(c)(4).

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot generally be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan® (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. These designations are intended to expedite the development and review of drugs intended to treat serious or life-threatening conditions and fill an unmet medical need. Detalimogene has also been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, designed to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes four additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3); and BCG-unresponsive high-risk NMIBC patients with CIS who receive polidocanol plus detalimogene.

About enGene

enGene Therapeutics Inc. is a clinical-stage biotechnology company mainstreaming non-viral genetic medicine through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid (also known as detalimogene) for patients with non-muscle invasive bladder cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease.

Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.

To learn more, please visit enGene.com and follow us on LinkedIn, X and BlueSky.

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements relating to the Company’s future plans, expectations, hopes, beliefs, intentions, goals or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “forecast”, “intend”, “develop”, “expect”, “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “goal”, “intends”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “strategy”, “future”, “potential”, “opportunity”, “target”, “term”, “will”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: detalimogene’s potential efficacy, durability, safety, tolerability and ease of use profile, the development of detalimogene, the potential benefits of detalimogene, enGene’s estimates regarding expenses, debt obligations and capital requirements necessary to fund its current operating plan, the expected period over which enGene estimates its cash and marketable securities will be sufficient to fund its current operating plan, plans regarding regulatory interactions and the BLA submission for detalimogene, plans regarding updates on the LEGEND study, including clinical data and engagement with the FDA, our current views and market research on the non-muscle invasive bladder cancer market, the depth, breadth and quality of our market research, our conclusions, implications or take-aways from the results of our market research, estimates, projections or forecasts of payer coverage of therapies, projected revenues for detalimogene at pricing parity with new therapies, the size of the addressable BCG unresponsive population, our expectations regarding the frequency or manner in which healthcare providers may use detalimogene, potential growth of the potential patient population, sequencing of products, the potential benefits of combining a surfactant bladder rinse with detalimogene, including the potential for increased efficacy and durability, estimates and forecasts of financial and performance metrics, projections of market opportunity and market share, the anticipated market acceptance of detalimogene, expectations and timing related to regulatory submissions and commercial product launches and the prospects for regulatory approval of detalimogene, plans for the additional cohorts of the LEGEND study, and the potential benefits of medicines developed with the DDX platform. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond enGene’s control, that may cause actual events or results to differ materially from enGene’s current expectations.

Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks, uncertainties and assumptions relating to a number of other factors, which could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the inability of preliminary clinical data to predict the final results of the trial, changes in the results from enGene’s clinical trials, including due to new data collected from the ongoing LEGEND study or future studies, subsequent analysis of existing data, and audit and verification procedures; the content and timing of decisions made by the FDA and other regulatory authorities; the Company’s ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and enroll patients in its clinical trials, execute on the Company’s clinical development plans; and its ability to secure regulatory approval on anticipated timelines, and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2025 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

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