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enGene Holdings (ENGN) investor relations material
enGene Holdings Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary18 Dec, 2025
Executive summary
Completed enrollment in LEGEND's pivotal cohort with 125 patients in high-risk, BCG-unresponsive NMIBC with carcinoma in situ, exceeding target by 25%.
Reported preliminary 6-month complete response rate of 62% in pivotal cohort under amended protocol.
Selected for FDA's CDRP Program to support CMC readiness, enhancing regulatory engagement.
Planned Biologic License Application (BLA) submission for detalimogene in 2H 2026, with potential approval in 2027.
Cash and marketable securities, including November financing, expected to fund operations into 2H 2028.
Financial highlights
Cash, cash equivalents, and marketable securities totaled $202.3 million as of October 31, 2025.
Raised $140.1 million in net proceeds from a public offering in November 2025.
Total operating expenses for FY2025 were $123.2 million, up from $62.3 million in FY2024, driven by increased R&D and G&A costs.
Net loss attributable to common shareholders was $117.3 million ($2.29 per share) for FY2025, compared to $55.1 million ($1.46 per share) in FY2024.
Outlook and guidance
Cash runway expected to extend into the second half of 2028.
Data update on LEGEND pivotal cohort anticipated in 2H 2026, following FDA discussions and accumulation of 12-month CR data.
BLA filing for detalimogene planned for 2H 2026.
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Q1 20269 Mar, 2026
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Q1 20269 Mar, 2026
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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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