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Oct 31, 2025
Engene Q4 2025 Earnings Report
enGene reported its Q4 2025 results with a significant increase in R&D spending as it advanced its LEGEND clinical program.
Key Takeaways
The company posted a Q4 net loss of $37.9 million as it continued investing heavily in clinical development and regulatory preparation. enGene ended the quarter with over $200 million in cash, bolstered by a recent financing round.
Q4 net loss was $37.9 million, reflecting intensified R&D and G&A activity.
Q4 EPS (GAAP) was -$0.74, based on 51.1 million weighted average shares.
Total operating expenses for Q4 reached $39.5 million.
Cash and marketable securities totaled $202.3 million at quarter-end.
Forward Guidance
enGene expects to file a Biologics License Application for detalimogene in the second half of 2026, following positive clinical progress and regulatory engagement.
Positive Outlook
- Fully enrolled pivotal cohort of the LEGEND trial with 125 patients.
- Reported 62% complete response rate at 6 months in post-amendment cohort.
- Accepted into FDA’s CDRP program to accelerate regulatory readiness.
- Raised $140.1 million in net proceeds through a public offering.
- Cash runway projected to extend into the second half of 2028.
Challenges Ahead
- Q4 continued to show no revenue generation.
- Ongoing operating losses driven by R&D investment.
- Heavy reliance on equity and debt financing.
- Year-over-year increase in net loss and operating expenses.
Historical Earnings Impact
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