enGene Therapeutics (Nasdaq: ENGN) names new chair, plans BLA filing

Rhea-AI Filing Summary

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.

8-K Event Classification

3 items: 5.02, 7.01, 9.01

3 items

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers Governance

Key personnel changes including departures, elections, or appointments of directors and executive officers.

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Pivotal cohort size: 125 patients Planned pre-BLA FDA meeting: 2H 2026 Planned BLA submission initiation: 2H 2026 +3 more

6 metrics

Pivotal cohort size 125 patients High-risk BCG-unresponsive NMIBC patients with CIS in LEGEND Cohort 1

Planned pre-BLA FDA meeting 2H 2026 Pre-Biologics License Application meeting for detalimogene

Planned BLA submission initiation 2H 2026 Initiation of BLA submission for detalimogene

Potential FDA approval timing 2027 Potential approval year for detalimogene, subject to review

Tenure as chairman Over 14 years Dr. Richard Glickman’s service as enGene’s chairman

Industry experience of new chair Over 30 years Michael Heffernan’s biopharmaceutical industry experience

Key Terms

Biologics License Application (BLA), Regenerative Medicine Advanced Therapy (RMAT), Fast Track designations, Chemistry, Manufacturing, and Controls (CMC), +2 more

6 terms

Biologics License Application (BLA) regulatory

"Pre-Biologics License Application (BLA) meeting with the FDA planned"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

Regenerative Medicine Advanced Therapy (RMAT) regulatory

"Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track"

A Regenerative Medicine Advanced Therapy (RMAT) is a U.S. regulatory designation for cell, gene and tissue-based treatments addressing serious or life-threatening conditions that shows early evidence of potential benefit. Think of it as a VIP lane with extra access to the regulator — more interaction, guidance and faster review — which can shorten development time and lower costs, making a program more valuable to investors, though it does not guarantee approval.

Fast Track designations regulatory

"Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations"

A fast track designation is a regulatory status granted to a drug or therapy intended to treat a serious condition with unmet medical need, which gives the developer access to expedited interactions and review procedures with regulators. For investors, it’s like an express lane: it can shorten development and review timelines and reduce regulatory uncertainty, potentially speeding a product to market—but it does not guarantee approval or commercial success.

Chemistry, Manufacturing, and Controls (CMC) regulatory

"selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development"

Chemistry, manufacturing, and controls (CMC) is the collection of information and data that describes a drug’s recipe, how it is made at scale, and the quality checks that ensure each batch is consistent and safe. For investors, CMC matters because regulators use it to decide approvals and manufacturing reliability; weak or incomplete CMC can delay launches, raise production costs, or create supply risks much like a flawed recipe or factory process undermines a product’s reliability.

non-muscle invasive bladder cancer (NMIBC) medical

"safety and efficacy in high-risk non-muscle invasive bladder cancer (NMIBC)"

Non-muscle invasive bladder cancer (NMIBC) is a form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it as a superficial patch on wallpaper rather than a stain that has soaked through the wall. It matters to investors because NMIBC often requires repeated treatments and monitoring, drives demand for outpatient therapies and diagnostics, and creates a sizable, ongoing market for drugs, devices, and procedures due to high recurrence and long-term care costs.

Bacillus Calmette-Guérin (BCG)-unresponsive medical

"high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ"

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Available on EDGAR 07/16/2026 - 08:07 AM Accepted by SEC EDGAR 07/16/2026 - 08:06 AM Learn about SEC filing dates

FAQ

What board changes did enGene Therapeutics (ENGN) disclose in this filing?

enGene reported that Dr. Richard Glickman resigned as director and chairman effective July 15, 2026, and that existing board member Michael Heffernan has been appointed chairman. The company notes the resignation was not due to any disagreement on operations, policies, or practices.

Did Dr. Richard Glickman resign from enGene (ENGN) due to a disagreement with the company?

No. enGene states that Dr. Glickman’s resignation as director and chairman was not due to any disagreement with the company on matters relating to operations, policies, or practices. He is recognized for contributions over more than 14 years as chairman.

Who is Michael Heffernan, the new chairman of enGene Therapeutics (ENGN)?

Michael Heffernan is a biopharmaceutical executive with over 30 years of industry experience, founder and former CEO and chairman of Collegium Pharmaceutical. He currently chairs boards at multiple biotech companies and joined enGene’s board in July 2025 before becoming chairman.

What are the key regulatory milestones for detalimogene noted by enGene (ENGN)?

enGene plans a pre-BLA FDA meeting in 2H 2026, initiation of BLA submission for detalimogene in the second half of 2026, and cites a potential FDA approval in 2027, subject to clinical results and regulatory review outcomes.

What is the LEGEND trial for detalimogene described by enGene (ENGN)?

The LEGEND trial is an ongoing, open-label, multi-cohort Phase 2 study evaluating detalimogene in high-risk non-muscle invasive bladder cancer. Its pivotal Cohort 1 enrolls 125 BCG-unresponsive NMIBC patients with CIS and is intended to support a planned Biologics License Application.

What special FDA designations has detalimogene received according to enGene (ENGN)?

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for BCG-unresponsive NMIBC with CIS, and has been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program to facilitate CMC development.

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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): July 15, 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On July 15, 2026, Dr. Richard Glickman resigned as a director and chairman of the Board of Directors (the “Board”) of enGene Therapeutics Inc. (the “Company”), including as a member of any committee of the Board. Dr. Glickman first notified the Company of his resignation July 15, 2026, and his resignation became effective immediately. Dr. Glickman’s resignation was not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. The Board thanks Dr. Glickman for his contributions and many years of dedicated service to the Company.

Item 7.01 Regulation FD Disclosure.

On July 16, 2026, the Company issued a press release announcing Dr. Glickman’s resignation and the appointment of current Board member Michael Heffernan as chairman of the Board. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01, including the press release furnished under Exhibit 99.1, 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 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description of Exhibits
99.1		Press Release of the Company, dated as of July 16, 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:	July 16, 2026	By:	/s/ Ronald H. W. Cooper
			Name: Ronald H. W. Cooper Title: Chief Executive Officer and President

Exhibit 99.1

enGene Focuses Board to Support Planned Upcoming Regulatory and Commercial Milestones

Michael Heffernan assumes the role of Chairman of the Board

Dr. Richard Glickman to step down

Pre-Biologics License Application (BLA) meeting with the FDA planned for 2H 2026

Initiation of BLA submission for detalimogene planned for 2H 2026

Potential FDA approval of detalimogene in 2027

BOSTON & MONTREAL, July 16, 2026 – enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced changes to its Board of Directors as it plans for potential regulatory milestones and to support commercial readiness for detalimogene voraplasmid (“detalimogene”) if approved. Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk non-muscle invasive bladder cancer (NMIBC). LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS).

“We are pleased that Michael Heffernan, who has served on our Board since July 2025, will assume the role of Chairman. With a strong track record of guiding companies through development and commercialization, Mike is well positioned to lead our Board as we plan for the potential approval and launch of detalimogene,” said Ron Cooper, President and Chief Executive Officer, enGene. “It has been a pleasure to work alongside Dr. Glickman. As a longtime member of the Board, he has played an essential role in guiding enGene’s evolution from a research organization to a late clinical-stage company.”

Dr. Richard Glickman has served as enGene’s Chairman for over 14 years. His expertise was instrumental in supporting the Company’s scientific and medical leadership in the development of its unique Dually Derivatized Oligochitosan® (DDX) platform, enabling non-viral gene transfection. His experience in company formation, capital raising and capital markets was also critical in guiding enGene’s transition from a seed-stage venture to a publicly listed company. Dr. Glickman continues to serve on the boards of several biotechnology companies.

“With a clinical-stage asset approaching both a key pivotal readout and planned BLA filing in the second half of this year, a potential approval in 2027 and in a strong capital position, enGene is well positioned for a period of meaningful growth,” said Michael Heffernan, Chairman of enGene. “I’m excited to step into the role of Chairman and work closely with the Board and management team to advance detalimogene in NMIBC.”

Michael Heffernan is a seasoned biopharmaceutical executive and entrepreneur with over 30 years of experience in the industry. He was the Founder of Collegium Pharmaceutical and has previously served as its President and Chief Executive Officer, as well as Chairman of the Board. Mr. Heffernan has built and led multiple companies through numerous financings and successful exits. He has also held leadership positions at Onset Dermatologics, Clinical Studies Ltd., and Eli Lilly and Company. Currently, Mr. Heffernan serves as Chairman of the Board at NMD Pharma, Avalo Therapeutics and AAVantgarde Bio, and is a board member at Biohaven, Trevi Therapeutics, and K36 Therapeutics. He holds a Bachelor of Science in Pharmacy from the University of Connecticut and is a registered pharmacist.

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.

Exhibit 99.1

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 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 NMIBC with carcinoma in situ (CIS) (with or without resected papillary tumors) who are unable to undergo cystectomy. These designations are intended to expedite the development and review of drugs to 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 (Cohort 4).

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 NMIBC 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,

Exhibit 99.1

“forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements relating to the Company’s future plans, expectations, intentions, strategies and objectives. 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 “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “goal”, “intend”, “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 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.

Media & Investor Contact:

Lauren Stival Hopfer

lhopfer@engene.com

Exhibit 99.1

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 30.4 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 46.2 KB