enGene Therapeutics Inc. 8-K Filings

enGene Therapeutics Inc. reported that it hosted a virtual key opinion leader event focused on emerging market research for non-muscle invasive bladder cancer (NMIBC) and its lead program, detalimogene voraplasmid. Management’s presentation describes detalimogene as a non-viral gene therapy being studied in multiple Phase 2 LEGEND cohorts for high-risk NMIBC, including BCG-unresponsive and BCG-naïve settings, with a cited 54% complete response rate at any time based on interim data as of April 21, 2026 and a tolerability profile the company characterizes as favorable.

The company states it has $285 million in cash and is targeting pivotal cohort 12‑month data and a potential BLA filing for detalimogene in the second half of 2026. Cited market research estimates an addressable U.S. NMIBC BCG-unresponsive population of about 20,000 patients, with most treated in community practices and many cycling through multiple lines of therapy. The slides also highlight benchmark U.S. NMIBC therapy pricing, with annual wholesale acquisition cost moving from $220,000 to about $690,000 per year, and discuss practice economics such as reliance on buy‑and‑bill reimbursement.

enGene Therapeutics Inc. provides an update on detalimogene voraplasmid, an investigational non‑viral gene therapy for high‑risk non‑muscle invasive bladder cancer (NMIBC). In the Phase 2 LEGEND pivotal Cohort 1 in BCG‑unresponsive NMIBC with carcinoma in situ, 125 patients were enrolled. Interim data as of 21 April 2026 show a 54% complete response at any time, with a 43.0% 6‑month complete response rate based on landmark and Kaplan‑Meier analyses.

The safety profile in this cohort shows 55.2% of participants experienced at least one treatment‑related adverse event, mostly grade 1–2, with 4.8% having grade ≥3 events, low dose interruptions and discontinuations (each 2.4%), and a median 8‑day resolution time. The company highlights plans to evaluate a polidocanol surfactant bladder rinse to potentially increase efficacy and durability while preserving ease of use, and notes $285M in cash is expected to support operations through planned BLA filing and potential approval, alongside an NMIBC market forecast of over $20B and a future total addressable patient population of more than 120,000.

enGene Therapeutics Inc. reported that longtime chairman and director Dr. Richard Glickman resigned from the board, effective July 15, 2026, and that existing director Michael Heffernan has been appointed chairman. The company states that Dr. Glickman’s resignation was not due to any disagreement regarding operations, policies, or practices.

The company highlights upcoming regulatory milestones for its lead program, detalimogene voraplasmid, a non-viral gene therapy in the Phase 2 LEGEND trial for high-risk non-muscle invasive bladder cancer. The pivotal Cohort 1 includes 125 patients with BCG-unresponsive disease and is intended to support a planned Biologics License Application, with a pre-BLA FDA meeting and initiation of BLA submission planned for the second half of 2026 and a potential FDA approval in 2027. Detalimogene has received RMAT and Fast Track designations and is included in the FDA’s CMC Development and Readiness Pilot program.

enGene Therapeutics Inc. filed an amended report updating details of its previously announced strategic restructuring, which includes reducing its workforce by about 50% to streamline operations and preserve cash. The company now expects restructuring cash costs of approximately $5.7–$6.4 million and non-cash stock-based compensation of about $4.7–$5.0 million, mainly from accelerated option vesting.

enGene also estimates up to $1.7 million in cash retention costs and up to $2.8 million in non-cash stock-based compensation tied to new performance-based equity retention awards. These awards, including a 400,000-share option grant to CEO Ronald Cooper at $1.75 per share, vest only if FDA milestones for detalimogene are met by late 2027 and 2028.

enGene Therapeutics reported a Q2 2026 net loss of $30.2 million, or $0.43 per share, as total operating expenses rose to $32.0 million from $27.1 million a year earlier, driven by higher research, clinical and administrative costs.

Cash, cash equivalents and marketable securities were $285.2 million as of April 30, 2026, supporting ongoing development of detalimogene. Interim data from the LEGEND pivotal Cohort 1 showed a 54% complete response rate (67/124 patients) with a 3.2% progression rate in high-risk BCG‑unresponsive NMIBC.

The company is implementing a strategic restructuring, including an approximately 50% workforce reduction, with estimated restructuring costs of $5.7–$6.4 million plus $4.7–$5.0 million in non‑cash stock‑based compensation. Several senior executives, including the CFO, CMO, CLO and CSO, are departing, while new finance leadership and an interim CMO have been appointed.

enGene Therapeutics Inc. reported the results of its 2026 Annual General Meeting of shareholders. The meeting was held on June 9, 2026, with 56,196,302 common shares represented, about 83.89% of the 66,989,466 shares outstanding and entitled to vote as of April 28, 2026.

Shareholders voted on the election of directors and on the appointment and remuneration of the auditor. Director nominees, including Philip Astley-Sparke and Ronald H.W. Cooper, each received more than 47.1 million votes “for,” with relatively few “withhold” votes and substantial broker non-votes. The auditor proposal received 56,180,287 votes “for” and 16,015 “withhold.”

enGene Therapeutics Inc. reported updated interim results from the pivotal Cohort 1 of its Phase 2 LEGEND trial of detalimogene voraplasmid in high-risk, BCG-unresponsive NMIBC, and amended the employment agreement of Dr. Hussein Sweiti. Among 125 patients, detalimogene achieved a 54% complete response rate at any time and 43% at six months, with a low 3.2% progression rate to muscle-invasive or more advanced disease. Treatment-related adverse events occurred in 55% of patients, were mainly Grade 1–2, and led to dose interruptions or discontinuations in 2.4% of patients each. A Kaplan-Meier estimate showed a 12‑month complete response rate of 25%, and later-enrolling patients had lower response rates than earlier subgroups, which the company is further analyzing.

enGene Therapeutics Inc., formerly enGene Holdings Inc., has changed its corporate name to enGene Therapeutics Inc., effective April 8, 2026. The amendment affects only the name; no other changes were made to the company’s articles. The company’s common shares and warrants will continue trading on Nasdaq under the symbols ENGN and ENGNW, respectively.

In a related press release, enGene explained that the new name reflects its transition toward potential commercialization of its lead gene therapy detalimogene voraplasmid. The company plans a Biologics License Application submission for detalimogene in the second half of 2026, targeting potential approval and a commercial organization in 2027.

enGene Holdings Inc. entered a new sales agreement with Leerink Partners that allows it to sell common shares from time to time in an at-the-market offering for an aggregate offering price of up to $100,000,000 under its existing shelf registration.

Leerink Partners will act as sales agent and receive a commission of up to 3.0% of the gross proceeds, with no obligation for enGene to sell or for Leerink to place any shares. In connection with this new arrangement, enGene terminated its prior open market sale agreement with Jefferies LLC, under which no common shares had been sold.

enGene Holdings Inc. reported a first quarter 2026 net loss attributable to common shareholders of approximately $29.8 million, or $0.44 per share, compared with about $24.6 million, or $0.48 per share, a year earlier. Operating expenses rose to $31.2 million from $26.6 million, driven by higher research and development spending on the LEGEND trial and preparation for a planned Biologics License Application, as well as increased general and administrative costs to support public company operations. Cash, cash equivalents and marketable securities were $312.5 million as of January 31, 2026, supported by a $140.1 million underwritten offering completed in November 2025 and an expanded $125 million debt facility with Hercules Capital, giving an expected cash runway into the second half of 2028. Preliminary data from the LEGEND pivotal cohort in high-risk, BCG-unresponsive non-muscle invasive bladder cancer showed complete response rates of 63% at any time (n=62), 56% at 3 months (n=62), and 62% at 6 months (n=37), with a generally favorable tolerability profile and low rates of treatment-related dose interruptions and discontinuations.

enGene Holdings Inc. entered into a Second Amendment to its loan and security agreement with Hercules Capital and other lenders, expanding its term loan facility from $50 million to up to $125 million, available in multiple milestone-based tranches. An initial $25 million Tranche 1 advance was funded on January 20, 2026 to refinance the prior term loans, and additional tranches of up to $35 million, $20 million, and $20 million are tied to defined clinical, approval and commercial milestones, plus an uncommitted $25 million tranche subject to lender approval.

The 2026 Term Loans mature on January 1, 2030 and bear interest at the greater of the prime rate plus 2.25% (capped at 10.25%) or 9.25%, with facility charges and a 5.95% end-of-term fee. The loans are secured by a senior lien on substantially all of the borrowers’ assets, including intellectual property. In connection with each loan advance, the lenders receive 2026 Warrants exercisable at $9.18 per share for seven years; on the Closing Date, they received 40,850 warrants, and the total potential issuance is capped at 204,248 warrants and underlying common shares if the full commitment is drawn.

enGene Holdings Inc. filed a current report describing a communication about its debt arrangements. The company announced that it entered into a Second Amendment to its Amended and Restated Loan and Security Agreement with Hercules Capital, Inc. and other lenders. This amendment builds on the original agreement dated December 22, 2023 and a prior amendment dated December 18, 2024, together referred to as the Amended Loan Agreement.

The company issued a press release on January 20, 2026 explaining the updated loan terms, which is furnished as an exhibit to the report rather than filed. As an emerging growth company with common shares and warrants listed on Nasdaq, enGene is using this report primarily to provide investors with notice of the press release and the existence of the amended loan agreement.

enGene Holdings Inc. reported updates from its ongoing Phase 2 LEGEND trial of detalimogene voraplasmid in high-risk, BCG‑unresponsive NMIBC. After discussions with the FDA, the pivotal cohort’s primary endpoint changed to complete response (CR) at any time, with duration of response as a key secondary endpoint. Cohort 1 completed enrollment of 125 patients.

Preliminary efficacy in the ITT subpopulations showed for Post‑Protocol Amendment Patients: CR rates of 63% (95% CI: 51–74) at any time, 56% at 3 months, and 62% at 6 months. For Pre‑Protocol Amendment Patients: 55% at any time, 55% at 3 months, and 41% at 6 months. Four Post‑Protocol patients without CR at 3 months converted to CR at 6 months.

Safety was favorable: among 125 patients, 42% experienced treatment‑related adverse events, mainly Grade 1/2; Grade 3 TRAEs occurred in 2.4%, with no Grade 4/5 reported. As of October 31, 2025, cash, cash equivalents and short‑term investments were $202.4 million.

enGene Holdings Inc. updated the employment agreement of executive Ronald H. W. Cooper. The Board of Directors, following a recommendation from its Compensation Committee, approved an amendment that increases his potential cash payout if his employment ends in connection with a change in control of the company.

Under the revised terms, if Mr. Cooper experiences a CIC Termination as defined in his agreement and complies with its conditions, he will receive a lump sum payment equal to 1.5x his annual target bonus, instead of the prior 1.0x multiple. This payment would be made within 45 days of the qualifying termination. The full amendment will be included as an exhibit to enGene’s Form 10-K for the fiscal year ending October 31, 2025.

enGene Holdings Inc. updated a prior report to clarify board committee assignments for two recently appointed directors. Effective October 2, 2025, the board named Philip Astley-Sparke to the Audit Committee and the Nominating and Corporate Governance Committee. Michael Heffernan was appointed to the Audit Committee and the Compensation Committee.

enGene Holdings Inc. filed a current report noting that it issued a press release on September 30, 2025 announcing the appointment of Dr. Hussein Sweiti as Chief Medical Officer. The press release is furnished, not filed, as Exhibit 99.1 and is not automatically incorporated into other securities filings.