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Jan 31
Engene Q1 2025 Earnings Report
enGene reported its financial results for the first quarter ended January 31, 2025, and provided a business update.
Key Takeaways
enGene Holdings Inc. reported a net loss of $24.6 million for the first quarter of 2025, an increase from $10.7 million in the same period last year, primarily due to increased operating expenses. The company expanded its LEGEND study sites into Europe and Asia, with enrollment in the pivotal cohort on track for a mid-2026 BLA filing. Cash and marketable securities of $272.8 million are expected to provide a runway into 2027.
Net loss for Q1 2025 was $24.6 million, up from $10.7 million in Q1 2024.
Total operating expenses increased to $26.6 million, mainly due to higher R&D and headcount costs.
Cash and marketable securities stood at $272.8 million, providing a runway into 2027.
LEGEND study enrollment is on track for a mid-2026 BLA filing, with expanded trial sites in Europe and Asia.
Engene
Engene
Forward Guidance
enGene anticipates completing enrollment in the LEGEND pivotal cohort and providing additional updates on other LEGEND study cohorts in 2025. The company plans to file a Biologics License Application (BLA) for detalimogene in mid-2026 and expects its current cash and marketable securities to fund operations into 2027.
Positive Outlook
- Enrollment in the LEGEND study's pivotal cohort continues to track in-line with the plan for a mid-2026 BLA filing.
- Additional preliminary data from the LEGEND study, including the pivotal cohort, is anticipated in 2H 2025.
- Cash and marketable securities of $272.8 million are expected to provide a financial runway into 2027.
- The LEGEND study protocol has been amended to include maintenance dosing, potentially improving durability of response.
- Expansion of LEGEND study sites into Europe and Asia is expected to support global enrollment.
Challenges Ahead
- The company's ability to recruit and retain qualified personnel and enroll patients in clinical trials could impact timelines.
- Securing regulatory approval on anticipated timelines is subject to various risks and uncertainties.
- Actual results may differ materially from forward-looking statements due to various factors, risks, and assumptions.
- The company disclaims any obligation to update forward-looking statements unless required by applicable law.
- No specific negative financial guidance was provided, but general risks associated with clinical-stage biotechnology companies apply.