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enGene Holdings (ENGN) investor relations material
enGene Holdings Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Piper Sandler 37th Annual Healthcare Conference summary2 Dec, 2025
Company overview and technology platform
Focused on a novel non-viral genetic therapy platform developed in-house, enabling delivery of larger genetic cargoes and favorable manufacturing costs.
Lead product, detalimogene voraplasmid, targets non-muscle invasive bladder cancer (NMIBC) and is positioned for significant market growth.
Platform addresses key gene therapy limitations: immunogenicity, cargo size, and manufacturing complexity.
Disease landscape and unmet needs
NMIBC is highly prevalent and costly, with 25,000 high-risk cases diagnosed annually in the US and over $6.5 billion in annual management costs.
Standard therapies like BCG face chronic shortages and limited long-term efficacy, often leading to radical cystectomy with significant quality-of-life impacts.
FDA guidance since 2018 has streamlined development for new CIS therapies, reaffirmed in 2024, highlighting the urgent need for new options.
Product profile and clinical development
Detalimogene voraplasmid is a lyophilized, non-viral gene therapy nanoparticle designed for intravesical delivery, stimulating both innate and adaptive immunity.
Manufacturing is straightforward, leveraging proprietary DDX polymer and PEGylation, recently enhanced by CDRP and RMAT designations from the FDA.
The LEGEND study, a global single-arm trial, is fully enrolled with 125 patients, focusing on BCG-unresponsive and other NMIBC subgroups.
Assess durability post-protocol amendment
How ease-of-use drives NMIBC market share
DDX platform's broader therapeutic applications?
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Next enGene Holdings earnings date
Q4 202519 Dec, 2025
Next enGene Holdings earnings date
Q4 202519 Dec, 2025
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Frequently asked questions
enGene Holdings Inc. operates through its subsidiary, enGene, Inc., as a clinical-stage biotechnology company focused on developing genetic medicines. The company specializes in the delivery of therapeutics to mucosal tissues and other organs using non-viral methods. Its primary product candidate is EG-70 (detalimogene voraplasmid), a non-viral immunotherapy aimed at treating non-muscle invasive bladder cancer in patients unresponsive to traditional treatments. The company is headquartered in Montreal, Quebec, Canada, and its shares are listed on the NASDAQ.
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