Current Report · Items 5.02, 7.01, 8.01, 9.01 · 8-K
enGene Therapeutics Inc.
ENGNNASDAQEQUITYCurrent
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Regulation FD Disclosure · Other Events
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On May 5, 2026, enGene USA, Inc. (“enGene USA”), an indirect, wholly-owned subsidiary of enGene Therapeutics Inc. (the “Company”) and Dr.…
Filed May 7, 2026Accepted May 7, 2026, 7:11 AM EDTCIK 1980845Accession 0001193125-26-210316
Company context
enGene Therapeutics Inc. is a clinical-stage biotechnology company mainstreaming non-viral genetic medicine through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid (also known as detalimogene) for patients with non-muscle invasive bladder cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease.
Current securities
Disclosure sections
Items 5.02, 7.01, 8.01, 9.01Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 5.02Item 5.02 - Departure/Election of Directors
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On May 5, 2026, enGene USA, Inc. (“enGene USA”), an indirect, wholly-owned subsidiary of enGene Therapeutics Inc. (the “Company”) and Dr. Hussein Sweiti entered into an Amended and Restated Employment Agreement, effective as of May 6, 2026 (the “Sweiti Employment Agreement”), which amended and restated in its entirety the Employment Agreement, dated September 29, 2025, between enGene USA and Dr. Sweiti (the “Prior Employment Agreement”).
As amended and restated, the Sweiti Employment Agreement (i) reflects Dr. Sweiti’s current compensation arrangements with enGene USA, which includes an annual base salary of $561,750, an annual 40% bonus opportunity, and the ability to participate in employee benefit plans, (ii) revises Section 6(a) of the Prior Employment Agreement to include an additional proviso that, on or after June 1, 2026, Dr. Sweiti may resign for any reason or for no reason upon five business days’ prior written notice and shall remain entitled to receive his post-termination severance benefits from enGene USA, (iii) waives any obligation of Dr. Sweiti to repay the value of his sign-on bonus received under the Prior Employment Agreement, and (iv) provides for certain other administrative changes. Other substantive terms of the Sweiti Employment Agreement remain unchanged from the Prior Employment Agreement.
The foregoing description of the Sweiti Employment Agreement is qualified in its entirety by the complete text of the Sweiti Employment Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended April 30, 2026.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On May 7, 2026, the Company issued a press release announcing updates regarding the pivotal cohort of its ongoing Phase 2 LEGEND trial of detalimogene voraplasmid (also known as “detalimogene” and previously EG-70) in high-risk, Bacillus Calmette-Guérin (“BCG”)-unresponsive patients with carcinoma in situ (“CIS”) with or without concomitant papillary disease, including new interim clinical data. In addition, as announced in the press release, the Company will host a conference call on May 7, 2026 to discuss the interim clinical data and has made available a slide presentation for the conference call. The full text of the press release is set forth in Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the slide presentation for the conference call is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in this Item 7.01, including the slide presentation furnished under Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Information.
As discussed above, on May 7, 2026, the Company issued a press release announcing updates regarding the pivotal cohort of its ongoing Phase 2 LEGEND trial of detalimogene, including new interim clinical data. A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and the full text of the press release is incorporated into this Item 8.01 by reference.
The table below presents a summary of the newly announced interim clinical data supporting the press release; all terms used are as defined in the press release:
Any Time 6 Month 9 Month 12 Month
(N=124) (N=121) (N=113) (N=98)
Total Population CR Rate* 54.0% 43.0% 32.7% 13.3%
N=125 (CI: 44.9%, 63.0%) (CI: 34.0%, 52.3%) (CI: 24.2%, 42.2%) (CI: 7.3%, 21.6%)
───────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────
KM Estimate 39.4% 31.6% 24.5%
Patients who discontinued without any disease evaluation or who discontinued after a CR are excluded from subsequent landmark response analysis.
CR=complete response; defined as negative cystoscopy and negative urine cytology, or positive cystoscopy/cytology with negative bladder biopsy.
CI: 95% Confidence Interval.
Data as of 21 April 2026; Data collection and cleaning is ongoing.
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Filed exhibits (2)
EX-99.1 (by filename) d335486dex991.htmEX-99.1
2
d335486dex991.htm
EX-99.1
EX-99.1
Exhibit 99.1
enGene Announces Updated Interim Results From LEGEND Pivotal Cohort
54% complete response (CR) rate at any time; 43% six-month CR rate
Low rate of progression to muscle-invasive or higher disease (3.2%)
Low percentage of patients experienced treatment-related adverse events (TRAEs) (55%), nearly all of which were mild
Low percentage of patients experienced TRAEs leading to treatment interruption (2.4%) or discontinuation (2.4%)
Kaplan-Meier estimate of 12-month CR rate is 25%
enGene to host webcast to discuss results today, May 7, 2026, at 8:00 a.m. ET
BOSTON & MONTREAL, May 7, 2026 - enGene Therapeutics Inc. (Nasdaq: ENGN or “enGene” or the
“Company”), a clinical-stage, non-viral genetic medicines company, today reported additional interim results from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid
(also known as detalimogene) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ
(CIS) with or without concomitant papillary disease, which enrolled 125 patients. These data, as of April 21, 2026, demo…
Open exhibit ↗EX-99.2 (by filename) d335486dex992.htmEX-99.2
3
d335486dex992.htm
EX-99.2
EX-99.2
LEGEND Interim Data Update May 7, 2026
Exhibit 99.2
Disclaimers Cautionary Statement
Regarding Forward-Looking Statements This Presentation contains certain forward-looking statements within the meaning of the federal securities laws and "forward-looking information" within the meaning of Canadian securities laws (collectively,
"forward-looking statements"). Forward-looking statements may be identified by the use of the words such as “forecast”, “intend”, “develop”, “expect”, “anticipate”,
“become”, “believe”, “continue”, “could”, “estimate”, “goal”, “intends”, “may”, “might”, “plan”, “possible”,
“project”, “should”, “strategy”, “future”, “potential”, “opportunity”, “target”, “term”, “will”, “would”, “will be”
or similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding
detalimogene’s potential efficacy, durability, safety, tolerability and ease of use profile, the development of detalimogene, the potential benefits of detalimogene, plans regarding regulatory interactions
and potential b…
Open exhibit ↗