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Jul 31
Engene Q3 2025 Earnings Report
enGene reported a wider net loss in Q3 2025 due to higher R&D and G&A expenses, while advancing its pivotal LEGEND trial.
Key Takeaways
enGene posted a net loss of $28.9M in Q3 2025 as operating expenses nearly doubled year-over-year. Despite no revenue, the company achieved major milestones including full enrollment of its LEGEND pivotal cohort and RMAT designation for detalimogene.
Net loss expanded to $28.9M due to increased clinical and operational costs
Reached 100-patient target enrollment for pivotal LEGEND trial cohort
Received RMAT designation from FDA for detalimogene
Cash runway of $224.9M expected to fund operations into 2027
Engene
Engene
Forward Guidance
enGene expects continued clinical progress and remains on track to submit a BLA in 2H 2026, with funding secured into 2027.
Positive Outlook
- LEGEND pivotal cohort fully enrolled
- RMAT and Fast Track designations strengthen regulatory path
- Preliminary data update expected in Q4 2025
- Cash reserves support multi-year runway
- Management team expanded with key hires
Challenges Ahead
- No revenue reported as company remains in clinical stage
- R&D expenses doubled due to scaling of pivotal trial
- G&A expenses rose from public company transition
- Net loss widened significantly year-over-year
- No near-term commercialization expected before BLA in 2026