enGene Holdings Inc. Reports $50.4 Million Net Loss for Six Months Ending April 30, 2025

enGene Holdings Inc. reported significant financial results for the six months ending April 30, 2025, revealing a net loss of $50.4 million, compared to a loss of $25.7 million for the same period in 2024. The company's total operating expenses surged to $53.7 million, up from $28.1 million year-over-year, primarily driven by increased research and development costs associated with its lead product candidate, detalimogene voraplasmid. Research and development expenses alone rose to $40.2 million from $15.5 million, reflecting heightened clinical activities and personnel costs as the company prepares for a Biologics License Application submission in mid-2026.

In terms of liquidity, enGene reported cash, cash equivalents, and marketable securities totaling approximately $251.5 million as of April 30, 2025. This figure represents a decrease from $264.8 million at the end of the previous fiscal year, largely due to cash used in operating activities amounting to $48.6 million during the first half of 2025. 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 in a Phase 1/2 study known as LEGEND. The trial includes pivotal cohorts for patients with non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guérin (BCG) treatment. The company is also exploring the potential of detalimogene for other forms of NMIBC. As of the reporting date, enGene had 51,070,851 common shares outstanding, reflecting a slight increase from the previous period.

The company has made strategic moves to bolster its financial position, including entering into an amended loan agreement with Hercules Capital, which provides a term loan facility of up to $50 million. As of April 30, 2025, enGene had drawn $22.5 million under this facility. However, the company faces challenges, including the need to address material weaknesses in its internal controls over financial reporting, which have been identified as ongoing concerns. Management is actively working on remediation efforts to enhance these controls.

Looking ahead, enGene expects to continue incurring significant expenses as it progresses through clinical trials and prepares for potential commercialization of detalimogene. The company remains focused on securing additional funding through various means, including public or private equity offerings and strategic partnerships, to support its growth strategy and operational needs.