Engene Therapeutics Inc. · NASDAQ:ENGN
Engene Therapeutics — Corporate Update (November 2025)
15 slides from Engene Therapeutics's corporate update, Nov 12, 2025
Slide 1: LEGEND Data Update
LEGEND Data Update November 11, 2025 Exhibit 99.3
Slide 2: Disclaimers: Cautionary Statement Regarding Forward-Looking Statements
Disclaimers Cautionary Statement Regarding Forward-Looking Statements This Presentation contains certain forward-looking statements within the meaning of the federal securities laws and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking state
Slide 3: Protocol Changes
Protocol Changes Prior LEGEND Protocol Current LEGEND Protocol T1 disease at pre-enrollment screen Surgically resect lesion via TURBT Enroll patient Perform 2nd resection at lesion site and restage If residual T1 disease present, patient ineligible Ta disease detected at 3 months Response deemed “Pr
Slide 4: Enrollment Complete: Patients Enrolled in Pivotal Cohort
Enrollment Complete: 125 Patients Enrolled in Pivotal Cohort 125 Total Intention to Treat Population (ITT) Pts. 94 Post-Amendment Pts. (75%) 31 Pre-Amendment Pts. (25%) November update based on October 24, 2025 data cut FDA review and agreement on Statistical Analysis Plan (SAP) will impact final pa
Slide 5: LEGEND Pivotal Cohort Pre- and Post-Protocol Amendment Characteristics
LEGEND Pivotal Cohort Pre- and Post-Protocol Amendment Characteristics Baseline characteristic POST N=94 PRE N=31 Gender, n (%) Male 76 (80.9) 25 (80.6) Female 18 (19.1) 6 (19.4) Age, years Mean (SD) 69.6 (10.1) 71.8 (10.4) Median (range) 70.5 (35, 85) 74 (46, 90) BCG Doses Median 12.5 12.0 Range 7,
Slide 6: Post-Protocol Amendment - Preliminary Data
Post-Protocol Amendment - Preliminary Data Post Protocol Amendment Any Time (N=62) 3 Month (N=62) 6 Month (N=37)** ITT N=62* CR Rate 63% (CI:51-74) 56% (CI: 44-68) 62% (CI: 46-76) KM Estimate 63% *ITT: Post-protocol amendment patients in Cohort 1 who received at least 1 dose of treatment and had at
Slide 7: Pre-Protocol Amendment Data - Preliminary Data
Pre-Protocol Amendment Data - Preliminary Data Sept. 2024 Data Cut Updated With Additional Patients N=31 Data Cut Oct. 2025 Any Time (N=31) 3 Month (N=31) 6 Month (N=27)** ITT Population* CR Rate 55% (CI: 38-71) 55% (CI: 38-71) 41% (CI: 25-59) KM Estimate 42% N=21 Data Cut Sept. 2024 Any Time (N=21)
Slide 8: Evolution of CR Rate With Protocol Amendment
Post-Protocol Amendment N=31 as of Oct. 2025 Any Time (N=31) 3 Month (N=31) 6 Month (N=27)** ITT Population* CR Rate 55% (CI: 38-71) 55% (CI: 38-71) 41% (CI: 25-59) KM Estimate 42% Evolution of CR Rate With Protocol Amendment Pre-Protocol Amendment N=62 as of Oct. 2025 Any Time (N=62) 3 Month (N=62)
Slide 9: Any Time CR Rate: Efficacy in Range With Novel Products
Any Time CR Rate: Efficacy in Range With Novel Products 6-Month CR Rate Trending Competitively These data are presented for informational purposes and are not based on any head-to-head or comparator clinical studies. Cross-trial comparisons are inherently limited and may suggest misleading similarit
Slide 10: Enrollment Rate Heavily Skewed to Last Months
Enrollment Rate Heavily Skewed to Last 10 Months Bolus of 12-month Patient Evaluations in 2H 2026
Slide 11: Cohort Tolerability Update: All Patients (n = 125)
Cohort 1 Tolerability Update: All Patients (n = 125) * 2 patients experienced urinary tract infection, 1 experienced pyelonephritis. Data as of October 24, 2025; Data collection and cleaning is ongoing, TRAE = Treatment-Related Adverse Event. Any Grade Grade 1 Grade 2 Grade 3 Grade 4/5 Patients with
Slide 12: Trending to Best-in-Class Tolerability for Detalimogene
Trending to Best-in-Class Tolerability for Detalimogene Investigational Agents based on TRAEs*** Deta n=125 Creto n = 112 Any Grade 42% 63% Serious 1.6% 1.8% Fatal 0 0 Dose Interruptions 1.6% Not reported Dose Discontinuations 0.8% 0 Source Internal Data* CG Investor Deck** Approved Products based o
Slide 13: Additional Cohorts - Trial in Progress Update
Additional Cohorts - Trial in Progress Update All NMIBC cohorts refer to high-risk NMIBC unless otherwise specified. Expected data update, timelines, enrollment targets, and anticipated milestones reflect enGene management's current estimate and are subject to change. Enrollment Status Detalimogene
Slide 14: LEGEND Cohort Update Summary
LEGEND Cohort 1 Update Summary Preliminary data suggest positive impact on efficacy post-protocol amendment Trending to best-in-class tolerability profile FDA review and agreement on Statistical Analysis Plan (SAP) will impact final patient (n) Heavily skewed enrollment curve delays insights into lo
Slide 15: Detalimogene: Designed to Meet the Needs of Urologists and Patients
Detalimogene: Designed to Meet the Needs of Urologists and Patients Preliminary evidence of efficacy* Non-viral gene therapy designed for streamlined clinical experience *LEGEND phase 1 reported data and September 2024 and November 2025 preliminary pivotal phase 2 reported data Efficacy Ease-of-Use