Full Press Release Details
enGene Announces Board and Leadership Appointments to Support Commercial Readiness
Philip Astley-Sparke, William Grossman and Michael Heffernan join the Board
Management promotions strengthen clinical and regulatory operations
Matthew Boyd named Chief Regulatory Officer, Jill Buck Chief Development Officer, and Katherine Chan Executive
Director, Urology Clinical Lead
BOSTON & MONTREAL - July 8, 2025 - enGene Holdings Inc.
(Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral gene-based immunotherapy company, today announced the appointment of three new members to its Board of Directors: Philip Astley-Sparke, William Grossman, M.D., Ph.D., and Michael
Heffernan, R.Ph. Their combined experience across gene therapy, oncology, clinical development, and global product launches will support enGene's strategic transition toward planned commercialization of its lead investigational therapy, detalimogene.
In connection with the appointment of the new directors, Jasper Bos, Ph.D., stepped down from the Board.
As the Company begins to focus on preparing for planned regulatory filings and commercialization, the organization has promoted the following individuals:
Matthew Boyd has been named Chief Regulatory Officer, Jill Buck has been named Chief Development Officer, and Katherine Chan, M.D., M.P.H., has been appointed Executive Director, Urology Clinical Lead.
"enGene is reaching a new stage, and we are thrilled to welcome such accomplished leaders to our Board and adjust our management team to help drive
long-term growth," said Ron Cooper, Chief Executive Officer of enGene. "Their collective experiences and insights will be invaluable as we continue to advance detalimogene toward planned commercialization. I am also deeply grateful to Jasper for his
dedication and guidance throughout his tenure as a board member - his impact on enGene's progress has been truly meaningful."
Board Appointee Highlights:
2016 until 2021. He has served on numerous public and private boards and is currently Chairman of Synox Therapeutics Ltd.
Management Promotions:
through Marketing Authorization Application (MAA) acceptance. She has led the successful completion of dozens of clinical trials and
has been involved in multiple regulatory filings in the U.S. and internationally. Prior to joining enGene, she was Head, Clinical Development Operations, Rare Diseases at Ipsen from March 2023 to September 2024. Before her time with Ipsen, Ms. Buck
held several senior roles in Clinical Development and Operations at Albireo Pharma, Ziopharm Oncology, and Synageva BioPharma.
These appointments reflect enGene's continued evolution and readiness to execute its long-term vision of delivering innovative, non-viral medicines to
improve the quality of life for people with urological cancers.
Detalimogene is a novel, investigational, non-viral gene-based immunotherapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC),
including Bacillus Calmette-Gu rin (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 therapies, reduce complexities related to safe handling and cold storage, and streamline both
manufacturing processes and administration paradigms.
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. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to
address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to
treat serious conditions and fill an unmet medical need.
enGene is a clinical-stage biotechnology company mainstreaming genetic medicines 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, and previously EG-70) 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 study, which includes a pivotal cohort studying detalimogene in Bacillus Calmette-Gu rin (BCG)-unresponsive patients with carcinoma in situ
(CIS). 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.
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 regarding enGene's management teams' 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 "anticipate", "appear", "approximate", "believe", "continue", "could", "estimate", "expect", "foresee", "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: the growth and business strategy of enGene, the Company's future outlook, the expected contributions of the new directors and promoted executive officers, the
potential regulatory approval and commercial launch of detalimogene, the future growth of enGene, the potential benefits of detalimogene, and the potential benefits of medicines developed with the DDX platform.
Many factors, risks, uncertainties and assumptions 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 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 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, 2024 (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
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