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enGene Holdings (ENGN) investor relations material
enGene Holdings Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary11 Sep, 2025
Executive summary
Focused on developing genetic medicines for bladder cancer, with lead candidate detalimogene voraplasmid in pivotal Phase 2 trials for BCG-unresponsive NMIBC with CIS.
No products approved or revenue generated; operations funded by PIPE financings, debt, and warrants.
Net loss of $29.0M for Q3 2025 and $79.4M for nine months ended July 31, 2025, reflecting increased R&D and G&A expenses.
Cash, cash equivalents, and marketable securities totaled $224.9M as of July 31, 2025, expected to fund operations for at least 12 months.
Financial highlights
Research and development expenses rose to $22.6M in Q3 2025 (up $11.0M YoY) and $62.8M for nine months (up $35.7M YoY), driven by clinical and manufacturing activities and personnel expansion.
General and administrative expenses increased to $7.4M in Q3 2025 (up $2.2M YoY) and $20.9M for nine months (up $3.1M YoY), mainly due to hiring and commercialization preparation.
Net loss per share was $0.57 for Q3 2025 and $1.56 for the nine months, compared to $0.32 and $1.12 in the prior year periods.
Net cash used in operating activities was $74.3M for the nine months, primarily due to net loss and working capital changes.
Outlook and guidance
Existing cash and marketable securities expected to cover operating and debt obligations for at least the next 12 months.
Anticipates continued significant expenses and operating losses as clinical trials progress and commercialization infrastructure is built.
Plans to file a Biologics License Application for detalimogene in 2H 2026.
Detail funding strategy beyond 12 months
Risks to 2H 2026 BLA filing for detalimogene?
Timeline for internal control remediation
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Next enGene Holdings earnings date
Q4 202519 Dec, 2025
Next enGene Holdings earnings date
Q4 202519 Dec, 2025
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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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