enGene Holdings Inc (NASDAQ:ENGN) Posts Wider-Than-Expected Q3 Loss as R&D Spending Doubles

enGene Holdings Inc (NASDAQ:ENGN) reported its third quarter 2025 financial results, posting a net loss per share that came in wider than analyst expectations. The clinical-stage biotechnology company, focused on non-viral gene therapies, continues to burn cash as it advances its lead candidate through pivotal trials.

Earnings and Revenue Performance

The company reported a net loss of $0.57 per share for the quarter ended July 31, 2025, compared to analyst estimates of a $0.51 loss. This represents a significant widening from the $0.32 loss per share reported in the same quarter last year. Revenue remained at $0.0, consistent with expectations for a pre-commercial stage biotech company.

Key financial metrics from the quarter include:

• Total operating expenses: $29.9 million, up from $16.8 million year-over-year
• Research and development expenses: $22.6 million, nearly double the $11.5 million from Q3 2024
• Cash, cash equivalents and marketable securities: $224.9 million as of July 31, 2025

The substantial increase in operating expenses reflects the company's accelerated investment in its LEGEND clinical trial and preparation for potential commercialization. Management indicated that current cash reserves are expected to fund operations into 2027.

Market Reaction and Trading Activity

Following the earnings release, enGene shares declined approximately 8.6% in after-market trading. This negative reaction suggests investor disappointment with the wider-than-expected loss despite the company's progress on clinical milestones. The decline contrasts with the stock's recent positive performance, which had seen gains of 29.2% over the past week and 72.8% over the past month leading up to the earnings announcement.

Clinical Development Progress

Beyond the financial results, enGene announced several significant clinical and regulatory milestones. The company achieved target enrollment of 100 patients in the pivotal Cohort 1 of its LEGEND study evaluating detalimogene for high-risk, BCG-unresponsive non-muscle invasive bladder cancer. Additionally, the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene, providing regulatory advantages including early and frequent engagement with the agency and potential for rolling submission and priority review.

The company also strengthened its leadership team with several key appointments to the board of directors and promotions within its regulatory and clinical development departments, positioning the organization for its planned transition toward commercialization.

Forward Outlook and Analyst Expectations

Looking ahead, analysts project continued losses for enGene with estimated EPS of -$0.52 for Q4 2025 and -$2.03 for the full year 2025. Revenue expectations remain at $0.0 for both periods as the company has not yet commercialized any products.

enGene provided guidance on several anticipated milestones:

• Updated preliminary data from the LEGEND trial's pivotal cohort in Q4 2025
• Trial progress updates from additional LEGEND cohorts in Q4 2025
• Planned Biologics License Application filing in the second half of 2026

For more detailed earnings information and analyst estimates, readers can review additional data here.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. The content should not be interpreted as a recommendation to buy, sell, or hold any security. Readers should conduct their own research and consult with a qualified financial advisor before making investment decisions.