**enGene Holdings Inc. Reports Fiscal Year 2025 Financial Results and Operational Progress**

enGene Holdings Inc., a clinical-stage biotechnology company, reported a net loss of $117.3 million for the fiscal year ended October 31, 2025, compared to a net loss of $55.1 million for the previous fiscal year. The increased loss was primarily driven by a significant rise in research and development expenses, which totaled $94.5 million in fiscal year 2025, up from $38.3 million in fiscal year 2024. General and administrative expenses also increased, reaching $28.7 million compared to $24.0 million in the prior year. The company has not generated any revenue from product sales to date.

The surge in research and development expenses was mainly attributed to increased manufacturing activities related to detalimogene, the company's lead product candidate, as enGene prepares for a planned Biologics License Application (BLA) submission in the second half of 2026. Clinical operations expenses also rose due to ongoing clinical trial activities, including the completed enrollment of the pivotal cohort in the Phase 2 LEGEND study of detalimogene in BCG-unresponsive NMIBC. Personnel-related costs increased as the company expanded its team to support clinical operations, quality control, medical affairs, and manufacturing functions.

Operationally, enGene continued to advance its lead product candidate, detalimogene, through the LEGEND clinical trial. As of November 11, 2025, enrollment in Cohort 1, the pivotal cohort, was completed with 125 patients. Cohort 2a, evaluating detalimogene in BCG-naïve NMIBC with CIS, had enrolled 30 patients, while Cohort 2b, evaluating detalimogene in BCG-exposed NMIBC with CIS, had enrolled 45 patients. Cohort 3, evaluating detalimogene in BCG-unresponsive NMIBC with papillary-only disease, had enrolled 36 patients. The company plans to file a BLA with the FDA in the second half of 2026 for approval to market detalimogene in the United States as a monotherapy for BCG-unresponsive NMIBC with CIS.

Looking ahead, enGene anticipates that its operating expenses will continue to increase as it progresses the LEGEND study, pursues pipeline expansion, and prepares for the potential commercial launch of detalimogene. As of October 31, 2025, enGene had cash, cash equivalents, and marketable securities totaling $202.3 million. The company believes these funds, along with the $140.1 million in net proceeds from a November 2025 public offering, will be sufficient to fund operations for at least the next 12 months. enGene is also subject to certain covenants under its Amended Loan Agreement with Hercules Capital, Inc., which could restrict its ability to take specific actions. The company is focused on advancing detalimogene through late-stage clinical development and seeking regulatory marketing approval in the United States.

About enGene Holdings Inc.

enGene Holdings Inc. is a biotech company developing genetic medicines using its proprietary DDX platform. Its lead candidate, detalimogene, aims to treat bladder cancer, particularly BCG-unresponsive NMIBC with CIS. The company focuses on localized gene delivery, immune activation, and scalable manufacturing. It targets unmet medical needs in oncology, with plans for regulatory approval and independent commercialization in the U.S. market.

This description was generated via AI from an annual report. Updated 9 months ago.

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