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enGene (ENGN) investor relations material

enGene Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Oppenheimer 36th Annual Healthcare Life Sciences Conference summary26 Feb, 2026

Strategic focus and market outlook

  • Emphasis on non-viral genetic medicines, with detalimogene voraplasmid as the lead product targeting non-muscle invasive bladder cancer (NMIBC).

  • NMIBC market expected to grow significantly, with projections from $1 billion to over $20 billion as new agents are adopted and sequencing becomes standard.

  • Majority of NMIBC patients are treated in community settings, driving demand for therapies that are easy to administer and integrate into existing practices.

  • Detalimogene is positioned as a convenient, well-tolerated, and efficacious option, fitting the needs of both patients and community urologists.

  • Anticipated data update in the second half of 2024, BLA filing by year-end, and potential product launch in 2027.

Clinical development and efficacy data

  • Pivotal trial for detalimogene is fully enrolled with 125 patients, exceeding the initial target.

  • Six-month complete response (CR) rate of 62% and anytime CR rate of 63% in a high-risk, heavily pretreated population.

  • Early nine-month data show all evaluable patients remained responders, indicating durable efficacy.

  • Post-protocol amendment patients demonstrated improved CR rates compared to pre-amendment cohorts.

  • Competitive efficacy profile compared to other approved and investigational agents in NMIBC.

Safety, tolerability, and administration advantages

  • Most adverse events are mild (Grade 1 or 2), primarily related to catheterization.

  • Dose interruptions and discontinuations are very low, supporting strong tolerability.

  • Detalimogene can be administered quickly, with minimal chair time and no special handling or decontamination required.

  • Product is stable in standard freezers and refrigerators, simplifying logistics for practices.

  • Best-in-class convenience and ease of use for both patients and healthcare providers.

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Frequently asked questions

enGene Holdings Inc. operates through its subsidiary, enGene, Inc., as a clinical-stage biotechnology company focused on developing genetic medicines. The company specializes in the delivery of therapeutics to mucosal tissues and other organs using non-viral methods. Its primary product candidate is EG-70 (detalimogene voraplasmid), a non-viral immunotherapy aimed at treating non-muscle invasive bladder cancer in patients unresponsive to traditional treatments. The company is headquartered in Montreal, Quebec, Canada, and its shares are listed on the NASDAQ.

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