enGene Holdings Inc. reported a significant increase in its financial losses for the first quarter of 2025, with a net loss of $24.6 million compared to $10.7 million in the same period last year. The company's total operating expenses surged to $26.6 million, up from $10.8 million, primarily driven by a substantial rise in research and development costs, which escalated from $5.6 million to $20 million. This increase reflects the company's intensified clinical and manufacturing activities related to its lead product candidate, detalimogene voraplasmid, as it prepares for a planned Biologics License Application submission in mid-2026.
In terms of liquidity, enGene reported cash, cash equivalents, and marketable securities totaling approximately $272.8 million as of January 31, 2025. This figure represents a decrease from $311.2 million at the end of the previous fiscal year, largely due to cash outflows from operating activities, which amounted to $25.7 million for the quarter. The company has not yet generated any revenue from product sales and anticipates needing substantial additional funding to support ongoing operations and development efforts.
Operationally, enGene is focused on advancing its clinical trials for detalimogene, which is currently being evaluated in a Phase 1/2 study known as LEGEND. The trial includes multiple cohorts, targeting patients with non-muscle invasive bladder cancer who are unresponsive to Bacillus Calmette-Guérin treatment. The company is also exploring the potential of its DDX gene delivery platform for other cancer indications, indicating a strategic focus on expanding its product pipeline.
As of January 31, 2025, enGene had 50,977,560 common shares outstanding, reflecting a slight increase from the previous quarter. The company remains classified as a smaller reporting company and an emerging growth company, which allows it to take advantage of certain regulatory exemptions. Looking ahead, enGene's management has expressed confidence that its existing cash reserves will be sufficient to fund operations for at least the next 12 months, although the company acknowledges the inherent uncertainties in securing future financing and the potential impact of market conditions on its capital-raising efforts.
About enGene Holdings Inc.
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