Announcement • Jun 16
enGene Therapeutics Inc. Provides Clinical Updates enGene Therapeutics Inc. announced that during a plenary presentation at the recent American Urological Association (AUA) meeting, interim data wereshared from LEGEND’s pivotal Cohort 1 studying detalimogene without surfactant in high-risk (HR), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS). Efficacy overview: 54% (95% CI: 45%, 63%) complete response (CR) at any time (67/124); Low rate of progression to muscle invasive or more advanced disease (3.2%). Safety overview: Low percentage of patients experienced treatment-related adverse events (TRAEs) leading to treatment interruption (2.4%) and treatment discontinuation (2.4%). Twenty-one patients were pending disease assessments at either six-, nine-, or 12-months as of the data cutoff date of April 21, 2026. enGene is awaiting 12-month CR data from Cohort 1, as well as the majority of 12-month durability data, and expects to engage with the FDA in 2H 2026 to discuss a BLA filing. Detalimogene plus Surfactant Cohort: In tandem with its pivotal update in May, the Company announced the initiation of an additional LEGEND cohort, which incorporates a short surfactant bladder rinse using diluted polidocanol solution. Polidocanol is an FDA-approved product used for the treatment of spider and reticular veins. Surfactants have been shown to boost efficacy with other gene therapies in preclinical models and were subsequently incorporated into clinical development of those gene therapies. In murine models tested by the Company, pretreatment with polidocanol demonstrated a 10-fold increase in mean IL-12 expression and was able to boost efficacy of a subtherapeutic dose of detalimogene. Findings were validated in a large mammal model tested by the Company where a surfactant rinse increased the distribution of detalimogene nanoparticles throughout the bladder by approximately 50% and IL-12 expression by nine-fold. The first patients have been enrolled in the surfactant cohort, and the Company may enroll up to 80 patients in this global cohort. The Company believes this approach has the potential to further enhance efficacy and durability while preserving the simplicity, tolerability, and office-based administration profile that may make detalimogene a preferred option for community urology practices, where approximately 80% of NMIBC patients receive treatment. LEGEND Cohorts 2a, 2b and 3: As part of cash conservation efforts, the Company has stopped enrollment in these additional cohorts and plans to reevaluate its strategy for them following discussion with the FDA in 2H 2026. Announcement • Jun 15
enGene Therapeutics Inc. Announces CFO Changes enGene Therapeutics Inc. announced that in connection with the strategic restructuring, on June 15, 2026, the company announced that its Chief Financial Officer, Ryan Daws, will depart the Company effective July 15, 2026 (the “Daws Separation Date”). On June 14, 2026, the Board appointed Kathleen Richton and announced that Ms. Richton will succeed Mr. Daws as principal financial officer and principal accounting officer of the Company. Ms. Richton, 48, has served as Vice President, Controller of the Company since March 2026. Ms. Richton also served as Executive Director of Finance of the Company from January 2025 to March 2026. Prior to joining the Company, Ms. Richton served as Vice President, Controller at Sumitomo Pharma America from September 2020 to July 2023. Earlier in her career, Ms. Richton spent over 15 years at Sunovion Pharmaceuticals, where she held positions of increasing responsibility within the finance organization, most recently serving as Executive Director, Corporate Financial Planning & Strategic Analysis from 2017 to 2020. Ms. Richton holds a B.Sc. in Accountancy and a M.S. in Accounting Information Systems from Bentley University and is a Certified Public Accountant in Massachusetts. 
