Form 8-K
8-K — enGene Therapeutics Inc.
Accession: 0001193125-26-270384
Filed: 2026-06-15
Period: 2026-06-13
CIK: 0001980845
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Cost Associated with Exit or Disposal Activities
Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers
Item: Regulation FD Disclosure
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — engn-20260613.htm (Primary)
EX-99.1 (engn-ex99_1.htm)
GRAPHIC (img7790613_0.jpg)
XML — IDEA: XBRL DOCUMENT (R1.htm)
8-K
8-K (Primary)
Filename: engn-20260613.htm · Sequence: 1
8-K
false000198084500-00000000001980845us-gaap:CommonStockMember2026-06-132026-06-130001980845us-gaap:WarrantMember2026-06-132026-06-1300019808452026-06-132026-06-13
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 13, 2026
enGene Therapeutics Inc.
(Exact name of Registrant as Specified in Its Charter)
British Columbia
001-41854
Not applicable
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
4868 Rue Levy, Suite 220
Saint-Laurent, Quebec, Canada
H4R 2P1
(Address of Principal Executive Offices)
(Zip Code)
Registrant’s Telephone Number, Including Area Code: (514) 332-4888
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Shares
ENGN
The Nasdaq Stock Market LLC
Warrants, each exercisable for one Common Share, at an exercise price of $11.50 per Common Share
ENGNW
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02 Results of Operations and Financial Condition.
On June 15, 2026, enGene Therapeutics Inc. (the “Company”) announced its financial results for the three months ended April 30, 2026. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth in this Item 2.02 to this Current Report on Form 8-K is intended to be furnished and 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 (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 2.05 Costs Associated with Exit or Disposal Activities.
On June 15, 2026, the Company announced the implementation of a plan to reduce its workforce by approximately 50% to streamline operations and preserve cash. The Company’s board of directors (the “Board”) approved this strategic restructuring, effective June 14, 2026, in order to preserve shareholder capital as the Company awaits additional durability data and meetings with the Food and Drug Administration (“FDA”) in connection with the Company’s LEGEND pivotal cohort. The Company has retained personnel and resources required to meet its key strategic goals and milestones, including completion of the LEGEND Cohort 1; enrolling the detalimogene plus surfactant cohort; meeting with the FDA and planning for Biologics License Application (“BLA”) initiation in the second half of 2026; and completing necessary pre-commercial activities required to support the commercial launch of detalimogene in 2027, if approved. The Company currently estimates it will incur restructuring costs of approximately $5.7 to $6.4 million, consisting primarily of employee severance, benefits, and other related costs, as well as approximately $4.7 million to $5.0 million in non-cash stock-based compensation expense primarily associated with accelerated vesting of stock options.
Further, in connection with the strategic restructuring, on June 14, 2026, the Company’s board of directors approved performance-based cash retention bonus awards for certain executive employees and the non-executive employees of the Company. Subject to remaining actively employed and in good standing with the Company, aggregate cash retention bonus awards of approximately $1.7 million will be paid upon the achievement of two milestones: (i) the completion of the pre-BLA meeting with the FDA relating to detalimogene on or prior to December 31, 2026 and (ii) confirmation from the FDA that the Company’s filing of the BLA with the FDA with respect to detalimogene has been completed and accepted by the FDA, provided that such confirmation is received by the Company from the FDA no later than September 30, 2027.
The estimated charges that the Company expects to incur as a result of the restructuring are subject to several assumptions, and actual results may differ materially from these estimates. The Company may incur additional costs due to events associated with or resulting from the strategic restructuring and workforce reduction. The Company expects to record the majority of these expenses in the second half of 2026.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Resignation of Chief Medical Officer
On June 13, 2026, Dr. Hussein Sweiti notified the Company of his resignation from his position as Chief Medical Officer and Head of Research and Development of the Company, with his resignation to be effective as of June 14, 2026. The Company expects to enter into an agreement with Dr. Sweiti providing for a general release and waiver of claims against the Company, after which Dr. Sweiti will be entitled to receive the severance benefits under his Amended and Restated Employment Agreement with enGene USA, Inc., effective May 6, 2026, as described in the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on May 7, 2026.
Strategic Restructuring
The information set forth in Item 2.05 of this Current Report on Form 8-K is incorporated herein by reference as if set forth herein.
Separation of Chief Financial Officer
In connection with the strategic restructuring, on June 15, 2026, the Company announced that its Chief Financial Officer, Ryan Daws, will depart the Company effective July 15, 2026 (the “Daws Separation Date”). The Company, through its subsidiary, enGene USA, Inc. (“enGene USA”), expects to enter into a separation and general release agreement with Mr. Daws (the “Daws Separation
Agreement”), that will supplement the Amended and Restated Employment Agreement, dated June 10, 2025, between Mr. Daws and enGene USA.
If the parties enter into the Daws Separation Agreement, in exchange for his execution and non-revocation of a customary release, Mr. Daws will be entitled to (i) continuation of his base salary for a period of twelve months, in a total amount of $517,880, to be paid over the length of such term; (ii) subject to Mr. Daws’ continued copayment of health insurance premium amounts, a monthly payment equal to the employer payment toward twelve months of continued health insurance benefits, (iii) payment of a prorated portion of his 2026 target annual bonus and (iv) acceleration and vesting of any then unvested time-based equity awards that would have vested in the twelve-month period following the Separation Date.
If the parties enter into the Daws Separation Agreement, the Company intends to file a copy of such agreement as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended July 31, 2026.
Appointment of Principal Financial Officer and Principal Accounting Officer
On June 14, 2026, the Board appointed Kathleen Richton as Senior Vice President, Finance of the Company, with her appointment to become effective on or about July 16, 2026. Upon her appointment, Ms. Richton will succeed Mr. Daws as principal financial officer and principal accounting officer of the Company.
Ms. Richton, 48, has served as Vice President, Controller of the Company since March 2026. Ms. Richton also served as Executive Director of Finance of the Company from January 2025 to March 2026. Prior to joining the Company, Ms. Richton served as Vice President, Controller at Sumitomo Pharma America from September 2020 to July 2023. Earlier in her career, Ms. Richton spent over 15 years at Sunovion Pharmaceuticals, where she held positions of increasing responsibility within the finance organization, most recently serving as Executive Director, Corporate Financial Planning & Strategic Analysis from 2017 to 2020. Ms. Richton holds a B.Sc. in Accountancy and a M.S. in Accounting Information Systems from Bentley University and is a Certified Public Accountant in Massachusetts.
The Company, through its subsidiary enGene USA, expects to enter into an employment agreement with Ms. Richton, to be effective on or about July 15, 2026 (the “Richton Employment Agreement”). If the parties enter into the Richton Employment Agreement, it is anticipated such agreement will have no fixed term and be terminable at will, and will entitle Ms. Richton to an annual base salary of $370,000, to an annual 35% bonus opportunity, and to participate in employee benefit plans. In addition, (a) upon the termination of Ms. Richton’s employment by enGene USA without Cause (as defined in the Richton Employment Agreement) or by Ms. Richton for Good Reason (as defined in the Richton Employment Agreement), Ms. Richton will be entitled to receive post-termination severance benefits from enGene USA consisting of (i) twelve months’ base salary, (ii) twelve months of continued health insurance benefits, (iii) a prorated portion of her annual bonus, if such termination occurs six months or more into the applicable performance period for such annual bonus, and (iv) acceleration and vesting of any then unvested time-based equity awards that would have vested in the twelve-month period following such termination; and (b) upon the termination of Ms. Richton by enGene USA without Cause or by Ms. Richton for Good Reason during a change in control period, which includes the ninety days prior to and twelve months following a change in control, the Company expects that Ms. Richton will be entitled to receive post-termination severance benefits from enGene USA consisting of (i) twelve months’ base salary, (ii) an amount equal to her annual bonus opportunity at the target level, (iii) twelve months of post-termination health insurance benefits; and (iv) acceleration and vesting of all then unvested time-based equity awards. In addition, the Company expects that the Richton Employment Agreement will provide for standard restrictive covenant obligations for Ms. Richton, including a noncompete and nonsolicit obligation which will run while employed and for twelve months thereafter.
If the parties enter into the Richton Employment Agreement, the Company intends to file a copy of such agreement as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended July 31, 2026.
Item 7.01 Regulation FD Disclosure.
On June 15, 2026, the Company issued a press release announcing its financial results for the second quarter ended April 30, 2026, and provided clinical and corporate updates related to the strategic restructuring. 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.
The information in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of 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, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Information.
Appointment of Interim Chief Medical Officer
On June 14, 2026, the Board appointed Dr. William Grossman, a current member of the Board and chair of the Board’s Research and Development Committee, to the position of Interim Chief Medical Officer of the Company, effective June 15, 2026. The Company, through its subsidiary enGene USA, expects to enter into a part-time employment agreement with Dr. Grossman that will provide for his employment by the Company for up to 15 hours per week. If the parties enter into the Grossman Employment Agreement, the Company intends to file a copy of such agreement as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended July 31, 2026. Dr. Grossman will continue to serve as a member of the Board following his appointment as Interim Chief Medical Officer. In connection with Dr. Grossman’s appointment, the Board has determined to dissolve the Research & Development Committee of the Board.
As a result of his appointment, Dr. Grossman will no longer be deemed an “independent director” under the applicable rules and regulations of the U.S. Securities and Exchange Commission and the Nasdaq Stock Market listing rules, and will temporarily cease receiving compensation as a director during his tenure as the Interim Chief Medical Officer of the Company.
For more information regarding Dr. Grossman, including his biography, please refer to the Company’s Annual Report on Form 10-K filed with the SEC on December 22, 2025, as amended by Amendment No. 1 of the Company’s Annual Report on Form 10-K/A filed with the SEC on February 19, 2026.
Strategic Restructuring
The information set forth in Item 2.05 of this Current Report on Form 8-K is incorporated herein by reference as if set forth herein.
Separation of Certain Executive Officers
In connection with the strategic restructuring, on June 15, 2026, the Company announced that Lee Giguere, Chief Legal Officer and Secretary and Alex Nichols, Chief Strategy and Operations Officer will each depart the Company effective July 15, 2026. In addition, Anthony Cheung, Chief Scientific Officer will conclude his employment with the Company effective September 30, 2026, but is expected to continue with the Company as a consultant.
The Company, through its subsidiary enGene USA, expects to enter into a separation and general release agreement with each of Mr. Giguere (the “Giguere Separation Agreement”) and Dr. Nichols (the “Nichols Separation Agreement”). In addition, the Company, through its subsidiary enGene, Inc., expects to enter into a transition services agreement and general release with Dr. Cheung, which is expected to include a one-year consulting arrangement commencing October 1, 2026 (the “Cheung Transition Agreement”).
If the respective parties enter into the Giguere Separation Agreement, the Nichols Separation Agreement or the Cheung Transition Agreement, as the case may be, the Company intends to file a copy of each such agreement as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended July 31, 2026.
Cash Retention Agreements
As discussed above in Item 2.05, in connection with the strategic restructuring, the Company, through its subsidiary enGene USA, expects to enter into performance-based cash retention bonus agreements with each of (i) Matthew Boyd, Chief Regulatory Officer, (ii) Jill Buck, Chief Development Officer, (iii) Joan Connolly, Chief Technology Officer and (iv) Amy Pott, Chief Global Commercialization Officer (collectively, the “Executive Cash Retention Agreements”). Additionally, the Company, through its subsidiaries enGene USA and enGene Inc. expects to enter into performance-based cash retention bonus agreements with certain non-executive employees (collectively, the “Employee Cash Retention Agreements”, and together with the Executive Cash Retention Agreements, the “Cash Retention Agreements”).
Additional information regarding the applicable performance conditions and aggregate amount of estimated Cash Retention Agreements is set forth in Item 2.05 hereto.
The foregoing descriptions of the Executive Cash Retention Agreements and the Employee Cash Retention Agreements are qualified in their entirety by the complete text of the respective agreements, forms of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended July 31, 2026.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
Description of Exhibits
99.1
Press Release dated June 15, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ENGENE THERAPEUTICS INC.
Date:
June 15, 2026
By:
/s/ Ronald H. W. Cooper
Name: Ronald H. W. Cooper
Title: Chief Executive Officer
EX-99.1
EX-99.1
Filename: engn-ex99_1.htm · Sequence: 2
EX-99.1
Exhibit 99.1
enGene Reports Second Quarter 2026 Financial Results and Provides Business Update
12-month complete response data from LEGEND pivotal cohort and subsequent FDA engagement planned for 2H 2026
Initiation of Biologics License Application (BLA) filing for detalimogene planned for 2H 2026
First patients enrolled in surfactant plus detalimogene cohort
Approximately 50% reduction in force to streamline operations and preserve cash to focus on BLA and precommercial activities
Well capitalized with cash, cash equivalents and marketable securities of $285 million
BOSTON & MONTREAL, June 15, 2026 – enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company today announced its financial results for the second quarter ended April 30, 2026, and provided clinical and corporate updates.
“Feedback from the urology community on the emerging detalimogene without surfactant profile, presented at the AUA meeting in May, supports our plan to await mature durability data in the second half of 2026 and meet with the FDA about initiating a BLA submission for detalimogene before year end,” said Ron Cooper, President and Chief Executive Officer, enGene.
Mr. Cooper continued, “We are also encouraged by the interest in the detalimogene surfactant bladder rinse study from the medical community. With patients already enrolled, we are optimistic about the potential to further enhance efficacy while maintaining the ease of use and tolerability profile that has resonated with urologists.”
"To preserve shareholder capital as we await additional durability data and meetings with the FDA, we made the very difficult decision to downsize the organization to streamline operations. We are sincerely grateful to the enGeneers who have created a high-performance culture and helped advance detalimogene and our mission to provide people living with NMIBC a new treatment option,” added Mr. Cooper.
Recent Clinical Updates
LEGEND Pivotal Cohort 1: During a plenary presentation at the recent American Urological Association (AUA) meeting, interim data were shared from LEGEND’s pivotal Cohort 1 studying detalimogene without surfactant in high-risk (HR), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS).
Efficacy overview:
•
54% (95% CI: 45%, 63%) complete response (CR) at any time (67/124)
•
Low rate of progression to muscle invasive or more advanced disease (3.2%)
Safety overview:
•
Low percentage of patients experienced treatment-related adverse events (TRAEs) leading to treatment interruption (2.4%) and treatment discontinuation (2.4%)
Twenty-one patients were pending disease assessments at either six-, nine-, or 12-months as of the data
Exhibit 99.1
cutoff date of April 21, 2026. enGene is awaiting 12-month CR data from Cohort 1, as well as the majority of 12-month durability data, and expects to engage with the FDA in 2H 2026 to discuss a BLA filing.
Detalimogene plus Surfactant Cohort: In tandem with its pivotal update in May, the Company announced the initiation of an additional LEGEND cohort, which incorporates a short surfactant bladder rinse using diluted polidocanol solution. Polidocanol is an FDA-approved product used for the treatment of spider and reticular veins. Surfactants have been shown to boost efficacy with other gene therapies in preclinical models and were subsequently incorporated into clinical development of those gene therapies. In murine models tested by the Company, pretreatment with polidocanol demonstrated a 10-fold increase in mean IL-12 expression and was able to boost efficacy of a subtherapeutic dose of detalimogene. Findings were validated in a large mammal model tested by the Company where a surfactant rinse increased the distribution of detalimogene nanoparticles throughout the bladder by approximately 50% and IL-12 expression by nine-fold. The first patients have been enrolled in the surfactant cohort, and the Company may enroll up to 80 patients in this global cohort. The Company believes this approach has the potential to further enhance efficacy and durability while preserving the simplicity, tolerability, and office-based administration profile that may make detalimogene a preferred option for community urology practices, where approximately 80% of NMIBC patients receive treatment.
LEGEND Cohorts 2a, 2b and 3: As part of cash conservation efforts, the Company has stopped enrollment in these additional cohorts and plans to reevaluate its strategy for them following discussion with the FDA in 2H 2026.
Recent Corporate Updates
Reduction in Force and Executive Departures: In June 2026, enGene implemented a plan to reduce its workforce by approximately 50% to streamline operations and preserve cash. The Company has retained personnel and resources required to meet its key strategic goals and milestones, including completion of LEGEND Cohort 1; enrolling the detalimogene plus surfactant cohort; meeting with the FDA and planning for BLA initiation in 2H 2026; and completing necessary pre-commercial activities required to support the planned commercial launch of detalimogene in 2027.
In conjunction with its reduction in force, the following executive officers will depart from the Company, effective July 15, 2026: Ryan Daws, Chief Financial Officer, Lee Giguere, Chief Legal Officer and Alex Nichols, Chief Strategy and Operations Officer.
Anthony Cheung, Chief Scientific Officer, will continue in his role through September 30, 2026, after which, he will transition into a consulting arrangement.
Hussein Sweiti, M.D., Chief Medical Officer, stepped down from his position to pursue a new professional opportunity, effective June 14, 2026. Effective immediately, William Grossman, M.D., Ph.D., a member of enGene’s Board of Directors, will act as interim Chief Medical Officer. He is the former Senior Vice President and Therapeutic Area Head of Oncology Clinical Development at Gilead Sciences Inc. where he oversaw the oncology portfolio (early and late-stage clinical development) and collaboration programs. Prior to that, he held several Chief Medical Officer roles including at Arcus Biosciences and Bellicum Pharmaceuticals. He has held additional leadership roles at Genentech/Roche, Merck, AbbVie, and Biothera. Dr. Grossman received his M.D. and Ph.D. in Immunology from Washington University School of Medicine’s Medical Scientist Training Program and completed his medical and post-doctoral training in both the Divisions of Pediatrics and Medicine at Washington University School of Medicine. He also currently serves on several advisory boards and will continue to serve on enGene’s Board of Directors as a non-independent Director during his interim CMO role.
Constantine Chinoporos, who joined the Company in May as a business development consultant, is expected to act as enGene’s interim Chief Business Officer. Mr. Chinoporos brings deep experience
Exhibit 99.1
across business development, licensing, and M&A in the biopharma sector. He is a member of the Board of Directors at Geron Corporation, and most recently served as Chief Operating Officer and Chief Business Officer of Applied Therapeutics. Prior to his role at Applied Therapeutics, Mr. Chinoporos served as Chief Business Officer at Albireo Pharmaceuticals, Inc. from 2021 until its acquisition by Ipsen S.A. in 2023. From 2015 to 2021, he served as Chief Business Officer at Boston Pharmaceuticals, Inc. Previously, he held senior positions in worldwide licensing, business development, corporate development, corporate finance and alliance management at Sanofi S.A., Genzyme Corporation, and Eli Lilly and Company. Mr. Chinoporos holds an M.B.A. from the Johnson Graduate School of Management at Cornell University and a B.A. in History from Cornell University.
Anticipated Milestones
•
12-month complete response data for all of Cohort 1 and pre-BLA meeting in 2H 2026
•
Initiation of BLA filing for detalimogene in 2H 2026
•
Potential detalimogene FDA approval decision and platform designation in 2027
Second Quarter 2026 Financial Results
As of April 30, 2026, cash, cash equivalents and marketable securities were $285.2 million providing significant operational flexibility.
Total operating expenses were $32.0 million for the three months ended April 30, 2026, compared to $27.1 million for the three months ended April 30, 2025. Research and development expenses increased by $2.0 million, primarily driven by increased personnel and clinical costs related to our LEGEND trial, completion of PPQ batch manufacturing and preparation to initiate the submission of a planned Biologics License Application with the FDA in the second half of 2026. General and administrative expenses increased by $2.9 million, primarily driven by annualization of personnel-related costs and increased facility costs.
For the three months ended April 30, 2026, net loss attributable to common shareholders was approximately $30.2 million, or $0.43 per share, compared to approximately $25.8 million, or $0.51 per share, for the three months ended April 30, 2025. The increase in net loss is mainly attributed to the increase in operating expenses, partially offset by net interest income earned during the period.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.
About Detalimogene Voraplasmid
Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.
Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan® (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene
Exhibit 99.1
therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.
Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations
Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. These designations are intended to expedite the development and review of drugs intended to treat serious or life-threatening conditions and fill an unmet medical need. Detalimogene has also been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, designed to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.
About the LEGEND Trial
Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes four additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3); and BCG-unresponsive high-risk NMIBC patients with CIS who receive polidocanol plus detalimogene.
About enGene
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.
Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.
To learn more, please visit enGene.com and follow us on LinkedIn, X and BlueSky.
Forward-Looking Statements
Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements relating to the Company’s future plans, expectations, hopes, beliefs, intentions, goals or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words
Exhibit 99.1
“anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “goal”, “intends”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: detalimogene’s potential efficacy, durability, safety, tolerability and ease of use profile, the development of detalimogene, enGene’s estimates regarding expenses, debt obligations and capital requirements necessary to fund its current operating plan, the expected period over which enGene estimates its cash and marketable securities will be sufficient to fund its current operating plan, the intended objectives and benefits of the reduction in force, including any estimated cost savings, the potential benefits of detalimogene, plans regarding regulatory interactions and a potential BLA submission for detalimogene, plans regarding updates on the LEGEND study, including clinical data and engagement with the FDA, the potential benefits of combining a surfactant bladder rinse with detalimogene, plans for the additional cohorts of the LEGEND study, and the potential benefits of medicines developed with the DDX platform. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond enGene’s control, that may cause actual events or results to differ materially from enGene’s current expectations. For example, there can be no guarantee that detalimogene will successfully complete necessary clinical development phases, including achieving positive results in the pivotal cohort of the LEGEND study, or that those results or any feedback from regulatory authorities will ultimately lead to a BLA submission for, and the approval of, detalimogene.
Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks, uncertainties and assumptions relating to a number of other factors, which could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the inability of preliminary clinical data to predict the final results of the trial, changes in the results from enGene’s clinical trials, including due to new data collected from the ongoing LEGEND study or future studies, subsequent analysis of existing data, and audit and verification procedures; the content and timing of decisions made by the FDA and other regulatory authorities; the Company’s ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and enroll patients in its clinical trials, execute on the Company’s clinical development plans; and its ability to secure regulatory approval on anticipated timelines, and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2025 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).
You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.
Exhibit 99.1
enGene Therapeutics Inc.
Condensed Consolidated Statements of Operations Information
(unaudited)
(Amounts in thousands of USD, except share and per share data)
Three Months Ended April 30,
Six Months Ended April 30,
2026
2025
2026
2025
Operating expenses:
Research and development
$
22,195
$
20,209
$
44,450
$
40,183
General and administrative
9,773
6,915
18,703
13,554
Total operating expenses
31,968
27,124
63,153
53,737
Loss from operations
31,968
27,124
63,153
53,737
Total other income, net
(1,741
)
(1,549
)
(3,174
)
(3,564
)
Net loss before income tax
30,227
25,575
59,979
50,173
Provision for income tax
-
240
-
258
Net loss
$
30,227
$
25,815
$
59,979
$
50,431
Other comprehensive loss:
Unrealized loss (gain) on available-for-sale investments
$
299
$
(306
)
$
253
$
(450
)
Total comprehensive loss
$
30,526
$
25,509
$
60,232
$
49,981
Net loss attributable to common shareholders, basic and diluted
30,227
25,815
59,979
50,431
Weighted-average common shares outstanding, basic and diluted
69,724,761
51,019,363
68,473,598
50,997,987
Net loss per share of common shares, basic and diluted
$
0.43
$
0.51
$
0.88
$
0.99
enGene Therapeutics Inc.
Condensed Consolidated Balance Sheet Information
(unaudited)
(Amounts in thousands of USD)
April 30,
2026
October 31, 2025
Cash, cash equivalents and marketable securities
$
285,174
$
202,258
Total assets
$
307,524
221,468
Total liabilities
$
52,356
53,758
Total shareholders’ equity
$
255,168
167,710
Media Contact:
Media@engene.com
Investor Contact:
Investors@engene.com
GRAPHIC
GRAPHIC
Filename: img7790613_0.jpg · Sequence: 3
Binary file (13126 bytes)
Download img7790613_0.jpg
XML — IDEA: XBRL DOCUMENT
XML
Filename: R1.htm · Sequence: 6
v3.26.1
Document and Entity Information
Jun. 13, 2026
Document And Entity Information [Line Items]
Document Type
8-K
Amendment Flag
false
Document Period End Date
Jun. 13, 2026
Entity Registrant Name
enGene Therapeutics Inc.
Entity Central Index Key
0001980845
Entity Emerging Growth Company
true
Entity File Number
001-41854
Entity Incorporation, State or Country Code
A1
Entity Tax Identification Number
00-0000000
Entity Address, Address Line One
4868 Rue Levy, Suite 220
Entity Address, City or Town
Saint-Laurent
Entity Address, State or Province
QC
Entity Address, Country
CA
Entity Address, Postal Zip Code
H4R 2P1
City Area Code
514
Local Phone Number
332-4888
Entity Information, Former Legal or Registered Name
Not Applicable
Written Communications
false
Soliciting Material
false
Pre-commencement Tender Offer
false
Pre-commencement Issuer Tender Offer
false
Entity Ex Transition Period
true
Common Stock [Member]
Document And Entity Information [Line Items]
Title of 12(b) Security
Common Shares
Trading Symbol
ENGN
Security Exchange Name
NASDAQ
Warrant [Member]
Document And Entity Information [Line Items]
Title of 12(b) Security
Warrants, each exercisable for one Common Share, at an exercise price of $11.50 per Common Share
Trading Symbol
ENGNW
Security Exchange Name
NASDAQ
X
- Definition
Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
No definition available.
+ Details
Name:
dei_AmendmentFlag
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Area code of city
+ References
No definition available.
+ Details
Name:
dei_CityAreaCode
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
No definition available.
+ Details
Name:
dei_DocumentPeriodEndDate
Namespace Prefix:
dei_
Data Type:
xbrli:dateItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
No definition available.
+ Details
Name:
dei_DocumentType
Namespace Prefix:
dei_
Data Type:
dei:submissionTypeItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Address Line 1 such as Attn, Building Name, Street Name
+ References
No definition available.
+ Details
Name:
dei_EntityAddressAddressLine1
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the City or Town
+ References
No definition available.
+ Details
Name:
dei_EntityAddressCityOrTown
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
ISO 3166-1 alpha-2 country code.
+ References
No definition available.
+ Details
Name:
dei_EntityAddressCountry
Namespace Prefix:
dei_
Data Type:
dei:countryCodeItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Code for the postal or zip code
+ References
No definition available.
+ Details
Name:
dei_EntityAddressPostalZipCode
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the state or province.
+ References
No definition available.
+ Details
Name:
dei_EntityAddressStateOrProvince
Namespace Prefix:
dei_
Data Type:
dei:stateOrProvinceItemType
Balance Type:
na
Period Type:
duration
X
- Definition
A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityCentralIndexKey
Namespace Prefix:
dei_
Data Type:
dei:centralIndexKeyItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Indicate if registrant meets the emerging growth company criteria.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityEmergingGrowthCompany
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 7A
-Section B
-Subsection 2
+ Details
Name:
dei_EntityExTransitionPeriod
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
No definition available.
+ Details
Name:
dei_EntityFileNumber
Namespace Prefix:
dei_
Data Type:
dei:fileNumberItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Two-character EDGAR code representing the state or country of incorporation.
+ References
No definition available.
+ Details
Name:
dei_EntityIncorporationStateCountryCode
Namespace Prefix:
dei_
Data Type:
dei:edgarStateCountryItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Former Legal or Registered Name of an entity
+ References
No definition available.
+ Details
Name:
dei_EntityInformationFormerLegalOrRegisteredName
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityRegistrantName
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityTaxIdentificationNumber
Namespace Prefix:
dei_
Data Type:
dei:employerIdItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Local phone number for entity.
+ References
No definition available.
+ Details
Name:
dei_LocalPhoneNumber
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
+ Details
Name:
dei_PreCommencementIssuerTenderOffer
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
+ Details
Name:
dei_PreCommencementTenderOffer
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Title of a 12(b) registered security.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
+ Details
Name:
dei_Security12bTitle
Namespace Prefix:
dei_
Data Type:
dei:securityTitleItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
+ Details
Name:
dei_SecurityExchangeName
Namespace Prefix:
dei_
Data Type:
dei:edgarExchangeCodeItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
+ Details
Name:
dei_SolicitingMaterial
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
Name:
dei_TradingSymbol
Namespace Prefix:
dei_
Data Type:
dei:tradingSymbolItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
Name:
dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Document And Entity Information Line Items
+ References
No definition available.
+ Details
Name:
engn_DocumentAndEntityInformationLineItems
Namespace Prefix:
engn_
Data Type:
xbrli:stringItemType
Balance Type:
na
Period Type:
duration
X
- Details
Name:
us-gaap_StatementClassOfStockAxis=us-gaap_CommonStockMember
Namespace Prefix:
Data Type:
na
Balance Type:
Period Type:
X
- Details
Name:
us-gaap_StatementClassOfStockAxis=us-gaap_WarrantMember
Namespace Prefix:
Data Type:
na
Balance Type:
Period Type: