enGene Holdings Inc.

enGene Holdings Inc. announced updated results from its Phase 2 LEGEND trial of detalimogene for BCG-unresponsive NMIBC, showing improved efficacy across key endpoints. The company plans to initiate a Biologics License Application (BLA) submission by year-end 2026, following alignment with the FDA. Detalimogene demonstrated a 56% CR rate at any time and a 43% estimated DoR of >= 12 months, with a favorable safety profile. Additionally, the company provided preliminary financial information for the fiscal year ended October 31, 2026, expecting to report approximately $245.8 million in cash, cash equivalents, and marketable securities.

enGene Therapeutics announced a change in its Board leadership, with Dr. Richard Glickman resigning as director and chairman, effective July 15, 2026. His departure was amicable and not due to any disagreements. Michael Heffernan, who joined the Board in July 2025 and has over 30 years of biopharmaceutical experience, has been appointed as the new Chairman. These changes are intended to strategically position the company for upcoming regulatory and commercial milestones, including a planned pre-BLA meeting and BLA submission for detalimogene in the second half of 2026, with potential FDA approval in 2027.

enGene Holdings Inc. updated its estimated costs for the previously announced 50% workforce reduction, now expecting $5.7 to $6.4 million in cash restructuring costs and $4.7 to $5.0 million in non-cash stock-based compensation from accelerated vesting. The company also approved new performance-based equity retention awards, totaling up to $2.8 million in non-cash expense, which will vest upon FDA Biologics License Application (BLA) acceptance and regulatory approval for detalimogene by September 2027 and December 2028, respectively. CEO Ronald Cooper received a performance-based option award for 400,000 shares linked to these same milestones.

enGene Holdings Inc. reported a net loss of $30.2 million for the three months ended April 30, 2026, and $59.9 million for the six months ended April 30, 2026. The company also announced a plan to reduce its workforce by approximately 50% to streamline operations and preserve cash. Despite ongoing losses and negative cash flows, recent financing activities, including a public offering and a new term loan, have significantly increased total assets and shareholders' equity, with management expecting sufficient liquidity for at least the next 12 months.

enGene Holdings Inc. announced a strategic restructuring plan, including a 50% workforce reduction, to streamline operations and preserve cash while awaiting additional durability data and FDA meetings for its LEGEND pivotal cohort. The company expects to incur $5.7M to $6.4M in restructuring costs and $4.7M to $5.0M in non-cash stock-based compensation. Additionally, Chief Medical Officer Dr. Hussein Sweiti resigned, and Chief Financial Officer Ryan Daws, Chief Legal Officer Lee Giguere, and Chief Strategy and Operations Officer Alex Nichols will depart. For the second quarter ended April 30, 2026, enGene reported a net loss of $30.2M, or $0.43 per share, and held $285.2M in cash, cash equivalents, and marketable securities.

enGene Holdings Inc. held its 2026 Annual General Meeting on June 9, 2026. A total of 56,196,302 common shares, representing approximately 83.89% of outstanding shares, were present or represented by proxy. Shareholders voted to elect all four director nominees and approved the appointment and remuneration of the auditor.

enGene Therapeutics Inc. announced its Annual General Meeting of Shareholders will be held virtually on June 9, 2026, at 8:30 a.m. Eastern time. Shareholders will vote on receiving the audited financial statements for the year ended October 31, 2025, electing four director nominees, and appointing KPMG LLP as the company's auditor. The record date for shareholders entitled to vote is April 28, 2026, and voting instructions are provided for both registered and beneficial owners.

enGene Therapeutics announced updated interim results from the pivotal cohort of its Phase 2 LEGEND trial for detalimogene voraplasmid in high-risk, BCG-unresponsive NMIBC patients. The trial showed a 54% complete response (CR) rate at any time and a 43% CR rate at six months, with a low progression rate to muscle-invasive disease (3.2%). However, the Kaplan-Meier estimate for the 12-month CR rate was 25%, which the CEO noted was "not what we hoped." The company also amended the employment agreement for Dr. Hussein Sweiti, increasing his base salary to $561,750 and annual bonus opportunity to 40%.