enGene Holdings Inc. Reports Full Year 2025 Financial Results and Provides Business Update

enGene Holdings Inc. announced its financial results for the year ended October 31, 2025. The company reported total operating expenses of $123.2 million, a significant increase from $62.3 million in 2024, primarily due to higher research and development costs related to the LEGEND trial and Biologics License Application (BLA) submission preparations. Net loss attributable to common shareholders was $117.3 million, or $2.29 per share, compared to $55.1 million, or $1.46 per share, in the previous year. As of October 31, 2025, cash, cash equivalents, and marketable securities stood at $202.3 million. The company also announced the completion of enrollment in LEGEND’s pivotal cohort, with preliminary 6-month complete response rates of 62% in high-risk, BCG-unresponsive NMIBC patients. enGene was selected for the FDA’s CDRP Program to support CMC readiness, with a planned BLA submission for detalimogene in the second half of 2026. The company expects its current cash and proceeds from a November financing to provide a runway into the second half of 2028. A key executive hire, Dr. Hussein Sweiti, was appointed as Chief Medical Officer in September.