Detalimogene Demonstrates Improved Complete Response Rate of 62% at 6 Months

Low rates of treatment-related adverse events (42%) and dose interruptions (1.6%) Emerging detalimogene profile supports potential first line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CIS LEGEND trial pivotal cohort completed enrollment with 125 patients, exceeding target enGene to host conference call and webcast at 8:00 a.m. ET BOSTON & MONTREAL – enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today reported additional preliminary data from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene and previously EG-70) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease. Detalimogene’s preliminary data to date and differentiated profile continue to support the Company’s planned Biologics License Application (BLA) submission in the second half of 2026. The preliminary analysis included 62 patients at 3 months and 37 patients at 6 months. All patients included in this analysis were evaluated under LEGEND’s amended protocol, which went into effect in the fourth quarter of 2024, and was designed to more closely align the LEGEND trial with the American Urological Association’s Guidelines and standard of care. Data from 62 patients enrolled under the amended protocol with at least one post-baseline disease assessment demonstrated: 63% complete response (CR) rate at any time (n=62); 56% CR rate at 3 months (n=62); 62% CR rate at 6 months (n=37), with 4 patients having successfully converted to CR post reinduction; and

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