enGene Therapeutics (ENGN) investor relations material

Executive summary

• Focused on developing genetic medicines for non-muscle invasive bladder cancer (NMIBC), with lead candidate detalimogene in pivotal Phase 2 trial and 12-month complete response data expected in 2H 2026, alongside FDA engagement and BLA filing plans.

• Interim results for pivotal LEGEND cohort: 54% any-time complete response, with 43%, 32.7%, and 13.3% CR at 6, 9, and 12 months, respectively; first patients enrolled in surfactant plus detalimogene cohort.

• Workforce reduced by approximately 50% to preserve cash and streamline operations for BLA and precommercial activities.

• Multiple executive departures and interim appointments, including Chief Medical Officer and Chief Business Officer.

Financial highlights

• Net loss of $30.2 million for the quarter and $60.0 million for the six months ended April 30, 2026, with operating expenses rising to $32.0 million for the quarter, driven by higher R&D and G&A costs.

• Cash, cash equivalents, and marketable securities totaled $285.2 million as of April 30, 2026.

• Accumulated deficit reached $432.0 million as of April 30, 2026.

• Shareholders’ equity stood at $255.2 million as of April 30, 2026.

Outlook and guidance

• Existing cash and equivalents expected to fund operations and debt obligations for at least the next 12 months.

• 12-month pivotal data and pre-BLA meeting with FDA anticipated in 2H 2026, with BLA filing and potential commercial launch in 2027 if approved.

• Additional funding will be needed to support ongoing operations and growth strategy.