Core Insights - enGene Holdings Inc. is positioned strongly at the end of 2025, with completed enrollment in the LEGEND pivotal cohort and a cash position of $342.4 million, extending its financial runway into the second half of 2028 [2][9] - The company aims to file a Biologics License Application (BLA) in the second half of 2026, with potential approval anticipated in 2027 [2][14] Financial Performance - For the full year ended October 31, 2025, total operating expenses were $123.2 million, a significant increase from $62.3 million in 2024, primarily due to higher research and development costs [10][24] - The net loss attributable to common shareholders was approximately $117.3 million, or $2.29 per share, compared to a net loss of $55.1 million, or $1.46 per share, for the previous year [11][25] - As of October 31, 2025, cash, cash equivalents, and marketable securities totaled $202.3 million, with an additional $140.1 million raised from a public offering in November [9][26] Clinical Development Updates - The LEGEND pivotal cohort has completed enrollment of 125 patients, exceeding the target by 25%, and has shown a generally favorable tolerability profile [3][4] - Recent data from the LEGEND trial indicated a 63% complete response (CR) rate at any time, with 56% at 3 months and 62% at 6 months for post-baseline assessments [6][17] - The company is also participating in the FDA's Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, which aims to facilitate the development of therapies with compressed clinical timelines [5][16] Corporate Developments - enGene appointed Hussein Sweiti, M.D., MSc, as Chief Medical Officer, bringing over 15 years of experience in oncology clinical research and drug development [8] - The company successfully closed a public offering of common shares and pre-funded warrants, raising $140.1 million in net proceeds [4]
enGene Reports Full Year 2025 Financial Results and Provides Business Update