MASHINIi

enGene Holdings Inc..

ENGN.US | Manufacture of pharmaceuticals, medicinal chemical and botanical products

enGene Holdings Inc. is a clinical-stage genetic medicines company focused on developing transformative gene therapies for a broad range of diseases. The company's lead product candidate, EG-70, is an investigational gene therapy being developed for the treatment of high-risk, BCG-unresponsive non-m...Show More

Ethical Profile

Mixed.

enGene Holdings Inc. (ENGN.US) develops a gene therapy for non-muscle invasive bladder cancer, with its LEGEND study reporting a 71% complete response rate and FDA RMAT designation, addressing a significant unmet medical need. However, enGene's ethical transparency is mixed. As a clinical-stage biotech, it likely uses animal testing in preclinical research, but specific data on its extent or reduction efforts is unavailable. Reports suggest insufficient public information on fair pay, ethical sourcing, environmental impact, or the effectiveness of data security. While a Code of Business Conduct exists, quantitative data on its enforcement or regulatory compliance is limited.

Value Scores

Better Health for All-10
-100100
Fair Money & Economic Opportunity0
-100100
Fair Pay & Worker Respect0
-100100
Fair Trade & Ethical Sourcing0
-100100
Honest & Fair Business-40
-100100
Kind to Animals0
-100100
No War, No Weapons0
-100100
Planet-Friendly Business0
-100100
Respect for Cultures & Communities0
-100100
Safe & Smart Tech0
-100100
Zero Waste & Sustainable Products0
-100100

Better Health for All

-10

enGene Holdings Inc. is a clinical-stage company entirely focused on developing non-viral gene therapies for urological cancers, specifically high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

1
Its lead product, detalimogene, has shown promising results in Phase 2 trials, with a 71% complete response rate at any time in a pivotal cohort, 67% at 3 months, and 47% at 6 months.
2
The company's Dually Derivatized Oligochitosan (DDX) platform aims to transform gene therapy accessibility and utilization, and the product requires no specialized handling or cold-chain storage, making it suitable for busy urology clinics.
3
The company has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA.
4
The company's entire business is devoted to health improvement through this product, which addresses a severe condition with limited treatment options. However, 42% to 48% of patients experienced treatment-related adverse events (TRAEs), primarily Grade 1/2, with 0.8% experiencing dose discontinuations due to TRAEs.
5
There were no Grade 4 or 5 TRAEs reported among 125 patients assessed as of October 2025.
6
Spark, TipRanks’ AI Analyst, rates ENGN as Neutral, indicating significant financial challenges with no revenue generation and persistent losses.
7
While the company supports non-profit organizations like the Bladder Cancer Advocacy Network (BCAN), there is no specific evidence of the scale of funding or reach of health equity programs.
8
Similarly, while the company offers professional development and competitive benefits to employees, there is no quantitative data on the scale of support for the broader healthcare workforce.
9
The company offers wellness programs, but there is no specific expenditure data on preventative health measures.
10
The company does not provide Expanded Access to investigational medicine outside of its clinical trial program.
11

Fair Money & Economic Opportunity

0

No evidence available to assess enGene Holdings Inc. on Fair Money & Economic Opportunity.

Fair Pay & Worker Respect

0

The company provides employer-funded health insurance coverage to its workforce, effective on their first day of employment.

1
No other quantitative data related to fair pay or worker respect is available in the provided articles.

Fair Trade & Ethical Sourcing

0

No specific, concrete evidence regarding enGene Holdings Inc.'s fair trade certifications, supplier audit frequency, forced or child labor incidents, supply chain traceability, remediation speed, ethical clause coverage in contracts, share of high-risk materials, or supplier diversity spend was found in the provided articles. The articles consist of a Terms of Use agreement, a general Code of Business Conduct and Ethics, and an investor relations page, none of which contain quantitative data or specific details on the company's ethical sourcing practices.

Honest & Fair Business

-40

enGene Holdings Inc. adopted a whistleblower policy on October 31, 2023, which outlines procedures for confidential and anonymous submissions, including a web complaint form and contacting specific officers.

1
The policy covers accounting, auditing, and anti-corruption violations, includes investigation procedures, and prohibits retaliation.
2
The company also has a Code of Business Conduct and Ethics that mentions policies regarding anti-corruption and anti-bribery, including compliance with FCPA and the Canadian Corruption of Foreign Public Officials Act.
3
KPMG serves as the independent registered public accounting firm, and audit committee policies and procedures are in place.
4

Kind to Animals

0

The available information states that enGene Holdings Inc. uses animal testing for product development.

1
However, no specific details are provided regarding the company's animal testing policy, the volume of animals used, the extent of alternative testing methods employed, or any efforts to reduce or replace animal testing.
2
There is also no data on cruelty-free certifications, humane certifications for operations, wildlife conservation impact, ethical input substitution, supplier audits, cage-free sourcing, innovation investment in animal-free technologies, animal agriculture ethics, animal-free R&D collaboration, or public policy engagement related to animal welfare.
3

No War, No Weapons

0

The provided article focuses exclusively on enGene Holdings Inc.'s gene therapy research and development for medical purposes.

1
It explicitly states that no data relevant to the 'No War, No Weapons' value is presented.
2
Consequently, there is no specific, concrete evidence to assess the company against any of the defined KPIs for this ethical value.
3

Planet-Friendly Business

0

No specific, quantitative data or concrete actions related to environmental performance, emissions, renewable energy, water usage, waste management, green building certifications, supply chain climate impact, biodiversity, deforestation, environmental compliance, climate risk, or climate justice initiatives for enGene Holdings Inc. were found in the provided articles. The articles focused on Harvard's lab sustainability (not relevant to enGene), enGene's code of business conduct (without specific environmental metrics), and enGene's financial and clinical trial results.

1

Respect for Cultures & Communities

0

No evidence available to assess enGene Holdings Inc. on Respect for Cultures & Communities.

Safe & Smart Tech

0

The company's privacy policy mentions GDPR and includes a cookie notice, indicating basic compliance with applicable regulations.

1
No specific data or details were provided for any other Safe & Smart Tech KPIs.
2

Zero Waste & Sustainable Products

0

No information was provided in the articles regarding enGene Holdings Inc.'s performance across any of the KPIs related to Zero Waste & Sustainable Products.

1

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AI-generated analysis based on publicly available data. Not financial advice. Ratings are expressions of opinion derived from automated models and may contain inaccuracies. See our Risk Disclosure for full details.