enGene Holdings Inc. announces financial results for the full year ended October 31, 2025.
Completed enrollment in LEGEND's pivotal cohort with 125 patients in high-risk, BCG-unresponsive NMIBC with carcinoma in situ.
Cash and marketable securities plus proceeds from November financing expected to provide cash runway into 2H 2028.
LEGEND's Pivotal Cohort Enrollment
Enrollment completed with 125 patients, exceeding target by 25%.
FDA's CDRP Program
EnGene selected to participate in FDA's CDRP program for CMC readiness.
BLA Submission for Detalimogene
BLA submission planned for 2H 2026 for detalimogene.
Cash Position
Company's cash position of $342.4 million extends runway into 2H 2028.
- Enrollment completion in LEGEND's pivotal cohort shows a competitive profile for detalimogene.
- EnGene's participation in FDA's CDRP program indicates confidence in drug manufacturing readiness.
EnGene is focused on scaling the organization for BLA filing in 2H 2026 and potential approval in 2027, with a strong financial position and promising clinical data.