Detalimogene 62% CR at 6 months; primary endpoint changed; BLA on track H2 2026

enGene Therapeutics Inc.

Post-protocol amendment patients achieved 62% CR at 6 months (n=37) and 63% at any time (n=62).
Primary endpoint for pivotal cohort changed to CR at any time following FDA discussions; duration of response is key secondary.
BLA submission for detalimogene planned in H2 2026; potential FDA approval in 2027.
Cash, cash equivalents and short-term investments of $202.4M as of Oct 31, 2025.
Safety: 42% patients had TRAEs, mainly Grade 1/2; no Grade 4/5; dose interruptions 1.6%, discontinuations 0.8%.

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