enGene Therapeutics Inc. (Nasdaq: ENGN) announced its financial results for the three and nine months ended July 31, 2026, alongside updates regarding its clinical development pipeline. As of July 31, 2026, the company held $266.3 million in cash, cash equivalents, and marketable securities.
For the three months ended July 31, 2026, total operating expenses were $34.0 million, compared to $29.9 million for the same period in the prior year. Research and development expenses decreased by $2.5 million, primarily due to timing in process validation manufacturing activities, while general and administrative expenses increased by $6.6 million driven by workforce reduction-related costs and annualization of personnel expenses. Net loss attributable to common shareholders was approximately $32.5 million, or $0.47 per share, compared to a loss of approximately $29.0 million, or $0.57 per share, in the prior year.
Clinically, the company is advancing its lead program, detalimogene voraplasmid, for high-risk, non-muscle invasive bladder cancer (NMIBC). The LEGEND trial includes a pivotal cohort of 125 patients. Previously reported interim data from this cohort showed a 54% complete response (CR) rate at any time and a 3.2% progression rate to muscle-invasive disease. enGene expects to report updated data on key regulatory endpoints, including CR at any time and Duration of Response (DOR) ≥ 12 months, in the fourth quarter of 2026.
The company is also advancing a cohort evaluating detalimogene combined with a surfactant bladder rinse. Preclinical data indicated that pretreatment with polidocanol increased mean IL-12 expression by 10-fold in murine models and over nine-fold in large mammal models. The safety run-in for this cohort has been successfully cleared. enGene plans to host a webinar on October 15, 2026, to present preclinical data and clinical enrollment guidance.
Regulatory milestones for the remainder of 2026 include a pre-Biologics License Application (BLA) meeting with the FDA and the initiation of the BLA submission for detalimogene. The company anticipates a potential FDA approval decision in 2027. Additionally, Michael Heffernan assumed the role of Chairman of the Board in July 2026, succeeding Dr. Richard Glickman.
