enGene interim 12-month complete response reaches 24%
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
enGene Therapeutics Inc. (ENGN) reported updated Cohort 1 interim results from its ongoing Phase 2 LEGEND trial of investigational detalimogene. Among 120 efficacy-evaluable patients, complete response (CR) at any time was 56% (95% CI: 47%-65%), versus 54% in April 2026; 12-month CR was 24%, versus 13%. The preliminary Kaplan-Meier estimate of duration of response of at least 12 months was 43%, versus 25%, and median duration of response was 10.1 months, versus 8.6 months. Data are as of October 29, 2026; collection and cleaning are ongoing.
Among 125 patients assessed for safety, 59% experienced at least one treatment-related adverse event; 2% had a serious event and 4% had Grade 3 TRAEs, with no Grade 4 or 5 events reported. After a positive pre-BLA meeting, ENGN reported FDA alignment on planned BLA components, including the efficacy-evaluable population. It expects to initiate submission by year-end 2026 and complete it in the first half of 2027, with potential approval in 2027; a detalimogene-plus-surfactant cohort update is expected mid-2027. Preliminary cash, cash equivalents and marketable securities were approximately $245.8 million as of October 31, 2026, subject to closing procedures and final adjustments.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point56% any-time complete response reported among 120 efficacy-evaluable Cohort 1 patients.
- Moderate point. Forward-looking: it has not happened yet and may not happen.FDA aligned on planned BLA components; submission initiation is expected by year-end 2026.
Negative
- None.
Filing Explained
The filing reports that the LEGEND surfactant cohort has enrolled its first patients; it tests a five-minute bladder rinse with
8-K Event Classification
Key Figures
Key Terms
Biologics License Application regulatory
efficacy evaluable population medical
Kaplan-Meier estimate technical
complete response medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were ENGN’s updated LEGEND Cohort 1 results?
When does ENGN expect to submit a BLA for detalimogene?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
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Securities registered pursuant to Section 12(b) of the Act:
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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.
The disclosure set forth under the caption “Financial and Operational Updates – Preliminary Financial Information for the Fiscal Year Ended October 31, 2026” in Item 8.01 below is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On November 11, 2026, enGene Therapeutics Inc. (the “Company”) updated its Corporate Presentation and its Investor Presentation, copies of which are furnished with this Current Report on Form 8-K as Exhibits 99.1 and 99.2 and incorporated into this Item 7.01 by reference.
The information in this Item 7.01 (including Exhibits 99.1 and 99.2) 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 8.01 Other Events.
Update on Phase 2 LEGEND Trial
On November 11, 2026, the Company announced results from the pivotal Cohort 1 of its ongoing, Phase 2 LEGEND trial of detalimogene, and alignment with the FDA on key components of the planned Biologics License Application. A copy of the press release issued in connection with the announcement is attached hereto as Exhibit 99.3 to this Current Report on Form 8-K and incorporated herein by reference.
Financial Updates
The Company wishes to provide certain financial updates, as described further below.
Preliminary Financial Information for the Fiscal Year Ended October 31, 2026
The Company has not yet finalized its financial statements as of and for the fiscal year ended October 31, 2026 (“Fiscal Year 2026”). However, based on its current estimates, the Company expects to report that it had approximately $245.8 million in cash, cash equivalents and marketable securities as of October 31, 2026.
The actual amounts that the Company reports for Fiscal Year 2026 will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its financial results for Fiscal Year 2026 are finalized and filed with the SEC. The preliminary financial information included in this Current Report on Form 8-K has been prepared by, and is the responsibility of, the Company’s management. KPMG LLP has not audited, reviewed, examined, compiled, or applied agreed-upon procedures with respect to the preliminary financial information and, accordingly, does not express an opinion or any other form of assurance with respect thereto. These estimates should not be viewed as a substitute for financial statements prepared in accordance with accounting principles generally accepted in the United States and they are not necessarily indicative of the results to be achieved in any future period. Accordingly, investors should not place undue reliance on these preliminary estimates. The Company assumes no duty to update these preliminary estimates except as required by law.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K contains certain forward-looking statements within the meaning of the federal securities laws, including the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements may be identified by the use of the words such as “forecast”, “intend”, “develop”, “expect”, “anticipate”, “become”, “believe”, “continue”, “could”, “estimate”, “goal”, “intends”, “may”, “might”, “plan”, “possible”, “project”, “should”, “strategy”, “future”, “potential”, “opportunity”, “target”, “term”, “will”, “would”, “will be” or similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding detalimogene’s potential efficacy, durability, safety, tolerability and ease of use profile, the development of detalimogene, the potential benefits 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, plans regarding regulatory interactions for detalimogene, plans regarding updates on the LEGEND study, including clinical data and engagement with the FDA, our current views and market research on the non-muscle invasive bladder cancer market, the depth, breadth and quality of our market research, our conclusions, implications or take-aways from the results of our market research, estimates, projections or forecasts of payer coverage of therapies, projected revenues for detalimogene at pricing parity with new therapies, the size of the addressable BCG unresponsive population, our expectations regarding the frequency or manner in which healthcare providers may use detalimogene, potential growth of the potential patient population, sequencing of products, the potential benefits of combining a surfactant bladder rinse with detalimogene, including the potential for increased efficacy and durability, estimates and forecasts of financial and performance metrics, projections of market opportunity and market share, the anticipated market acceptance of detalimogene, expectations and timing related to regulatory submissions and commercial product launches and the prospects for regulatory approval of detalimogene. These forward-looking statements are based on various estimates and assumptions, whether or not identified in this presentation, and on the current expectations of the management of enGene Therapeutics Inc. (“enGene”), are not predictions of actual performance, and are subject to risks and uncertainties. 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 report 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 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 carefully consider the risks and uncertainties described in the “Risk Factors” section of such Annual Report, as well as other documents if and when filed by enGene from time to time with the SEC and Canadian securities regulators. If any of these risks materialize or our assumptions prove incorrect, actual events and results could differ materially from those contained in the forward-looking statements. There may be additional risks that enGene does not presently know or that enGene currently believes are immaterial that could also cause actual events and results to differ. In addition, forward-looking statements reflect enGene’s expectations, plans, or forecasts of future events and views as of the date of this report. 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. These forward-looking statements should not be relied upon as representing enGene’s assessments as of any date subsequent to the date of this report. Accordingly, undue reliance should not be placed upon the forward-looking statements contained herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Description of Exhibits |
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Corporate Presentation, dated November 2026 |
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Investor Presentation, dated November 2026 |
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Press Release, dated November 11, 2026 |
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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.
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ENGENE THERAPEUTICS INC. |
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November 12, 2026 |
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/s/ Ronald H. W. Cooper |
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Name: Ronald H. W. Cooper |
Corporate Presentation Non-Viral Genetic Medicine
Disclaimers Cautionary Statement Regarding Forward-Looking Statements This Presentation contains certain forward-looking statements within the meaning of the federal securities laws and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements may be identified by the use of the words such as “forecast”, “intend”, “develop”, “expect”, “anticipate”, “become”, “believe”, “continue”, “could”, “estimate”, “goal”, “intends”, “may”, “might”, “plan”, “possible”, “project”, “should”, “strategy”, “future”, “potential”, “opportunity”, “target”, “term”, “will”, “would”, “will be” or similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding detalimogene’s potential efficacy, durability, safety, tolerability and ease of use profile, our current views and market research on the non-muscle invasive bladder cancer market, the depth, breadth and quality of our market research, our conclusions, implications or take-aways from the results of our market research, estimates, projections or forecasts of payer coverage of therapies, projected revenues for detalimogene at pricing parity with new therapies, the size of the addressable BCG unresponsive population, our expectations regarding the frequency or manner in which healthcare providers may use detalimogene, potential growth of the potential patient population, sequencing of products the development of detalimogene, the potential benefits of detalimogene, plans regarding regulatory interactions and potential biologics license application (“BLA”) submission for detalimogene, plans regarding updates on the LEGEND study, including clinical data and engagement with the FDA, the development of detalimogene, projections of market opportunity and market share, and the anticipated market acceptance of detalimogene, if approved, the potential benefits of combining a surfactant bladder wash with detalimogene, including the potential for increased efficacy and durability, estimates and forecasts of financial and performance metrics, projections of market opportunity and market share, the anticipated market acceptance of detalimogene, expectations and timing related to regulatory submissions and commercial product launches and the prospects for regulatory approval of detalimogene. These forward-looking statements are based on various estimates and assumptions, whether or not identified in this presentation, and on the current expectations of the management of enGene Therapeutics Inc. ("enGene"), are not predictions of actual performance, and are subject to risks and uncertainties. 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 presentation 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 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 carefully consider the risks and uncertainties described in the “Risk Factors” section of such Annual Report, as well as other documents if and when filed by enGene from time to time with the SEC and Canadian securities regulators. If any of these risks materialize or our assumptions prove incorrect, actual events and results could differ materially from those contained in the forward-looking statements. There may be additional risks that enGene does not presently know or that enGene currently believes are immaterial that could also cause actual events and results to differ. In addition, forward-looking statements reflect enGene’s expectations, plans, or forecasts of future events and views as of the date of this presentation. 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. These forward-looking statements should not be relied upon as representing enGene’s assessments as of any date subsequent to the date of this presentation. Accordingly, undue reliance should not be placed upon the forward-looking statements contained herein. Intellectual Property This Presentation contains trademarks, service marks, trade names, copyrights, and products of enGene and other companies, which are the property of their respective owners. The use or display of third parties’ trademarks, service marks, trade names, copyrights, or products in this Presentation is not intended to, and does not, imply a relationship with enGene, or an endorsement of or sponsorship by enGene. Solely for convenience, the trademarks, service marks, and trade names referred to in this Presentation may appear without the ®, TM or SM symbols, but such references are not intended to indicate, in any way, that enGene will not assert, to the fullest extent permitted under applicable law, its rights or the rights of the applicable licensor in such trademarks, service marks and trade names. Industry and Market Data This Presentation relies on and refers to certain information and statistics based on estimates by enGene’s management and/or obtained from third party sources which enGene believes to be reliable. enGene has not independently verified the accuracy or completeness of any such third party information, which involves elements of subjective judgment and analysis that may or may not prove to be accurate. None enGene, or its affiliates or any third parties that provide information to enGene or its affiliates, such as market research firms, guarantees the accuracy, completeness, timeliness, or availability of any information. Neither enGene nor its affiliates nor any third parties that provide information to enGene and its affiliates, such as market research firms, is responsible for any errors or omissions (negligent or otherwise), regardless of the cause, or the results obtained from the use of such content. enGene may have supplemented such information where necessary, taking into account publicly available information about other industry participants and enGene management’s best view as to information that is not publicly available. Neither enGene nor its affiliates give any express or implied warranties with respect to the information included herein, including, but not limited to, any warranties regarding its accuracy or of merchantability or fitness for a particular purpose or use, and they expressly disclaim any responsibility or liability for direct, indirect, incidental, exemplary, compensatory, punitive, special, or consequential damages, costs, expenses, legal fees, or losses (including lost income or profits and opportunity costs) in connection with the use of the information herein. Lead Program (detalimogene voraplasmid) The lead program described herein is an investigational drug therapy that has not been subject to testing designed to demonstrate that the therapy is effective in humans or to provide a basis to predict in advance whether an adequate level of efficacy in humans will be demonstrated in further testing. Although the FDA has indicated that the Phase 2 portion of the current LEGEND study may potentially support BLA approval, that outcome will depend entirely on the final results of Phase 2 clinical testing. Corporate Presentation November 2026
Unlocking Community Practices Unique Non-Viral Offering Simple storage and handling designed to support broad community adoption Provides opportunity to redefine community care 75% of the patients are in community practices 4Q 2026 Initiate BLA Filing; 2027 Potential BLA Approval; Detalimogene + Surfactant Data Mid 2027 Compelling Clinical Profile* Enhancement with Surfactant Potential future opportunity to improve CR any time and durability with surfactant bladder rinse Potential to decrease dwell of detalimogene from 60-minutes to 30-minutes with surfactant *Reflective of data as available in the database as of 29 October 2026. Data Collection and Cleaning is ongoing and is subject to change. **Compared to approved products USPI which references dose discontinuations and interruptions due to adverse reactions. Differences in compounds and trial designs require data comparisons to be interpreted with caution TRAEs = treatment-related adverse events, CR = complete response, NMIBC = non-muscle-invasive bladder cancer, BLA = biologics license applications, PI = product information, CDRP = Chemistry, Manufacturing, and Controls Development and Readiness Pilot, DOR = duration of response. 56% CR at any time (primary endpoint) within the range observed from approved products Durability trending toward range of approved products Lowest rates of discontinuations or dose interruptions due to treatment related adverse events** More treatment options are expected to increase sequencing which will expand treatable population Detalimogene non-viral approach provides a unique MOA for when doctors sequence therapies Low treatment burden for patients Detalimogene: First & Only NMIBC Non-Viral Investigational Gene Therapy Corporate Presentation November 2026
DDX Platform: Unique Non-Viral Gene Therapy Without the Headaches First Plasmid Gene Therapy in Development Large Genetic Cargo Redosable Low Cost of Goods/ No Specialized Handling Corporate Presentation November 2026 Detalimogene
Non-Muscle Invasive Bladder Cancer
Non-Muscle Invasive Represents 75%-80% of Bladder Cancer Diagnoses High-Risk NMIBC Patient Segmentation CIS +/- papillary tumors Papillary tumors only NMIBC = non-muscle invasive bladder cancer, HR = High-risk. Sources: SEER database; Knowles et al., Nat Rev Cancer 15, 25–41 (2015); Isharwal and Konety, Indian Journal of Urology, 2015; TNM Classification, 8th Edition; Tan et al., Eur Urol Oncol (2022): https://doi.org/10.1016/j.euo.2022.05.005, Nielson et al. Cancer. 2013 Oct 10;120(1):86–95. doi: 10.1002/cncr.28397, and Company estimates. US Incident Bladder Cancer ~90,000/year Incident NMIBC ~72,000/year Incident HR NMIBC ~22,000/year US Prevalent Bladder Cancer ~740,000 Corporate Presentation November 2026
High-Risk NMIBC is a Slowly Progressing Disease but Highly Recurrent 20% of NMIBC Patients Progress to Muscle Invasive Bladder Cancer (MIBC) Over 10 Years Treatment paradigm diagram is not comprehensive and acts only as an illustration. Additional Sources: Schneider, Bryan J., et al. J Clin Onc 39.36 (2021): 4073-4126; Merck Press Release (https://www.merck.com/stories/facing-a-global-shortage-merck-commits-to-meeting-patient-demand/); https://www.auanet.org/about-us/bcg-shortage-info; product USPI, Korkes et al. Urol Int (2023) 107 (1): 96–104; Stitzenberg et al. J Clin Onc, 33.5 (2015): 455-464.2015; Djaladat et al. World J Uro, 35 (2017): 907-911, Gore et al., J Urol (2025); 213(5S2):e3. Corporate Presentation November 2026 Radical Cystectomy 6-15% mortality rate High morbidity Decreased QoL (e.g., stoma bag, sexual dysfunction) HR NMIBC Diagnosis BCG New Therapies IVI Chemo Standard of care, chronic supply shortage Poor long-term tolerability Used as BCG backstop Poor efficacy 50%: 2-year recurrence
~75% of BCG-Unresponsive NMIBC Treated in Community Urology Practices Corporate Presentation November 2026 Sources: Quantitative Market Research (2,390 patient claims). “The State of the Urology Workforce and Practice in the United States, 2024” American Urological Association Education and Research, Inc, McKinsey & Company “Assessing the Lingering Impact of COVID-19 on the Nursing Workforce” 2024, Hyman et al., J of Urol 2025 April 213(5S) Supplement e288, Kopechek et al. Urol Pract 2025 Jul;12(4):380-390, enGene internal estimate. Community Practices Operations may be strained due to high patient volume, staff shortages, and equipment limitations Community urologists manage higher patient volumes on average compared to academic Increasingly owned by private equity Community Practices Share of High Risk BCG-Unresponsive NMIBC Patients by Practice Setting Academic Medical Center-Owned Practice Health System / Hospital-Owned Practice Private Practice
Community Urologists Balance a Range of Needs in Selecting Treatments Sources: Quantitative Market Research (2,390 patient claims), “The State of the Urology Workforce and Practice in the United States, 2024” American Urological Association Education and Research, Inc. Raymond James & Associates “Community Urologist Survey (n=25) Supportive of enGene’s Strategy” October 2025, Company estimates. 75% of BCG-UR NMIBC Patients in the Community Tolerability 12-month CR Rate 12-month DOR Rate Lack of Freezer Storage & Thaw Time Requirements Cost of Treatment/Coverage Ease of Administration Any time CR Rate Community Urologist Treatment Considerations: Tolerability, Efficacy & Ease of Use % of Respondents that Listed in Top 5 (of 10 options) Corporate Presentation November 2026 Academic Medical Center-Owned Practice Health System / Hospital-Owned Practice Private Practice
Urology Segment NMIBC Patients 19% (~3,800) 11% (~2,200) 11% (~2,200) 6% (~1,200) 29% (~5,800) Academic Medical Center 24% (~4,800) Note: Assumes ~20,000 addressable NMIBC BCG-unresponsive patients. Resource-Limited, Workflow-Constrained, Economics-Focused, and Clinical-Excellence all represent urology private practice. Source: enGene market research (third party claims analysis of real-world data of >2,000 patient claims). Academic Medical Center Prioritize efficacy and safety Health System / Hospital Prioritize efficacy and safety Clinical Excellence Practices Prioritize efficacy and safety Economics-Focused Practices Net cost recovery drives treatment selection Workflow-Constrained Practices Logistical burden is gating Resource-Limited Practices Acquisition cost and logistical burden are gating Private Practices ~40% of Patients Are in Practices that Consider the Balance Between Efficacy, Safety, Available Resources and Practice Economics Corporate Presentation November 2026 75% of High-Risk BCG-Unresponsive NMIBC Patients are Treated in Community Urology Practices
Detalimogene Voraplasmid
Detalimogene: Designed for Bladder-Localized Immune Activation Synergistic Stimulation of Specific Innate and Adaptive Immune Responses 1. Gao J, et al, inventors; enGene, Inc., assignee. US patent WO 2013/138930 A1. September 26, 2013. 2. Joshi S, et al. Presented at: 2025 ASCO GU Cancers Symposium; February 13-15, 2025; San Francisco, CA. Abstract TPS886. 3. Narayan VM, et al. Poster presented at: 2025 ASCO GU Cancers Symposium; February 13-15, 2025; San Francisco, CA. Abstract 826. 4. Taylor J, et al. Presented at: 2025 ASCO GU Cancers Symposium; February 13-15, 2025; San Francisco, CA. Abstract 802. 5. Steinberg JD, et al. Presented at: 2023 SUO; November 28-December 1, 2023; Washington, DC. Abstract 112 Detalimogene delivers plasmid DNA encoding 3 genes that activate the RIG-I pathway and drive expression of IL-12 RIG-I activation triggers innate immune signaling and recruitment of antitumor NK and T cells Localized IL-12 expression drives Th1 polarization of tumor-infiltrating –cells, antitumor cytokine production, and immune memory formation VA1 (RIG-I agonist dsRNA) IL-12 eRNA11a (RIG-I agonist dsRNA) Detalimogene Voraplasmid Detalimogene Plasmid nanoparticle Corporate Presentation November 2026
Industrial-Scale Manufacturing With Ease of Handling and Low COGS Note: CDRP = Chemistry, Manufacturing and Controls Development and Readiness Pilot. enGene is one of nine companies awarded CDRP per year. Plasmid DNA Proprietary DDX sugar polymer PEG-PLE Easy to Store and Transport Long storage time: Freezer for years Fridge for months No special delivery, biosafety or PPE requirements Low Supply Shortage Risk FDA validation batches completed Established at-scale manufacturing Selected for FDA CDRP Program Readily Available Low-Cost Components Corporate Presentation November 2026
Designed to Streamline Experience for Patients and Urology Practices Designed to be Simpler to Use than BCG for Both Patients and Practices Patients Practice Fewer doses per 12-week cycle than BCG induction No urine bleaching or close contact precautions with loved ones Storage at 2-8°C* Administered by nurses or medical assistants in exam rooms No decontamination or HCP exposure precautions Detalimogene *Subject to confirmation from the FDA. Minimal office time with no thaw or pre-wash steps and shorter dwell than BCG Corporate Presentation November 2026
Treatment Time Dosing Schedule (First 3 Months) Keytruda Adstiladrin Anktiva + BCG Inlexzo Cretostimogene 60 minutes IVI treatment dwell 30min IV infusion 48hr urine bleaching 60min IVI treatment dwell 25min to 5hr vial thaw 6hr urine bleaching 120min IVI treatment dwell Cystoscope device removal 7 days urine bleaching 60min IVI treatment dwell 1 or 4 steps of bladder washes Source: Derived from product SOPIs and clinical trial publications. Not based on head-to-head or comparator studies, Cretostimogene Grenadenorepvec in Urology Practice Workflows (SUNA Urology Alliance, accessed Oct 27, 2026) IVI = Intravesical. Urine contact precautions Approved Therapies Device insertion Detalimogene Anticholineric treatment Detalimogene is a Potential Low Burden & Convenient Option for Patients Corporate Presentation November 2026
Developed for Logistical and Post-Treatment Protocol Simplicity Non-Viral Gene Therapy Viral Gene Therapy Chemo-Device Combination BCG-Cytokine Combo Therapy Checkpoint Inhibitor No Complex Shipping & Storage Short Administration/Procedure No Viral/Bacterium Decontamination or HCP Exposure Precautions No Post-Treatment Patient Precautions No Requirement for Specially Qualified Staff and/or Facility Sources: Adstiladrin USPI, Inlexzo USPI, BCG USPI, Keytruda USPI, CG Oncology Corporate Presentation accessed November 5 2025, Raymond James & Associates “Community Urologist Survey Supportive of enGene’s Strategy” October 2025 Corporate Presentation November 2026
Multiple LEGEND Cohorts Maximize Detalimogene’s Potential Comprehensive IP Portfolio Through at Least 2040 *These additional non-pivotal cohorts of the LEGEND study provide further opportunity to demonstrate the potential use of detalimogene in clinical settings with unmet need. Progress as of October 24, 2025. All cohorts are currently in Phase 2 clinical trials. All NMIBC cohorts refer to high-risk NMIBC unless otherwise specified Expected data update, timelines, enrollment targets, and anticipated milestones reflect enGene management's current estimate and are subject to change Completed Active Cohort / NMIBC Indication Pre-Clinical Phase 1 Pivotal Status Enrollment Complete First Patients Enrolled 6-month Data: Mid-2027 Enrollment Complete N=30 N=46 N=47 Pivotal Cohort 1: BCG-Unresponsive /w CIS Surfactant Bladder Rinse Cohort: BCG-Unresponsive NMIBC CIS Cohort 2a: BCG-Naïve /w CIS* Cohort 2b: BCG-Exposed /w CIS* Cohort 3: BCG-Unresponsive /w Papillary Only* Corporate Presentation November 2026
Detalimogene Without Surfactant Pivotal Cohort 1
Pivotal Cohort Study Target Enrollment Achieved Patients: BCG-Unresponsive High-risk NMIBC with CIS Design: Global, single-arm, open label N = 125 (fully enrolled) Dosing1: Year 1: 0.8mg/mL in 50mL IVI at weeks 1,2,5,6 Q3M Year 2-3 (Maintenance): 0.8mg/mL IVI at weeks 1,2 Q3M Primary Endpoint: Any time CR rate Statistical Analysis Plan (SAP): Ongoing discussion with FDA on potential label population 1: IVI = Intravesical. LEGEND allows patients from any cohort who are in complete response at 12 months to continue receiving detalimogene on a dose-reduced maintenance schedule throughout their second year of treatment. At the end of year two, patients may optionally elect to remain on maintenance therapy for another year, for a total of three years of therapy. Corporate Presentation November 2026 Key Secondary Endpoint: Duration of Response
LEGEND Pivotal Cohort 1: Baseline Demographics and Disease Characteristics Corporate Presentation November 2026 Characteristics Pivotal Cohort 1 (N=125) Age, years Median (Range) 71.0 (35.0-90.0) Sex, n (%) Female 24 (19%) Male 101 (81%) Race n (%) White 114 (91%) Asian 4 (3%) Black or African American 2 (2%) Not Reported 5 (4%) ECOG PS, n (%) 0 119 (95%) 1 6 (5%) Characteristics Pivotal Cohort 1 (N=125) Tumor stage, n, % CIS with Ta/T1 disease 50 (40%) CIS only 75 (60%) Reason for no cystectomy, % Ineligible 9 (7%) Declined 116 (93%) Prior BCG doses, n Median (Range) 12 (6-50) Patients with prior therapy other than BCG: Total 32 (26%) Intravesical chemotherapy* 22 (18%) Systemic immunotherapy 8 (6%) Viral gene therapy 5 (4%) Other 4 (3%) Prior NMIBC recurrence(s) Median (Range) 2 (1-11) Note: BCG, bacillus Calmette-Guérin; CIS, carcinoma in situ; ECOG PS, Eastern Cooperative Oncology Group Performance Score; NMIBC, non-muscle invasive bladder cancer. *Single administration of cytotoxic agents (e.g. Mytomicin C, gemcitabine, doxorubicin or epirubicin) immediately following a TURBT are not included in this % Data as of 29 October 2026. Data collection and cleaning is ongoing.
Detalimogene Without Surfactant Primary Endpoint: CR at Any Time Primary Endpoint in Range of Approved Products Corporate Presentation November 2026 Any Time Complete Response* 56% 91% of CRs occurred at first assessment& 100% of responders were free from progression to ≥T2 disease in the bladder 97% of EE patients were free from progression to ≥T2 disease^ 96% of responders remain free from cystectomy 86% of EE patients remain free from cystectomy Endpoint Data Analysis CR Rate, % (95% CI) Complete Response at Any Time Oct 2026 (n=120) 56% (CI: 47%, 65%) Apr 2026 (n=124) 54% (CI: 45%, 63%) Median follow-up of all EE Population patients was 7.5 months (range, 1.9-33.8 months). Median follow-up of responders was 12.0 months (range, 3.7-33.8 months). *Patients who discontinued without any disease evaluation or who discontinued after a CR are excluded from subsequent landmark response analysis. &One patient was censored for Cycle 1, therefore N=66 ^One additional progression was noted but not documented in the database as of the datacut date. CR=complete response defined as negative cystoscopy and negative urine cytology, or positive cystoscopy/cytology with negative bladder biopsy. CI: 95% Confidence Interval; KM = Kaplan-Meier, EE = efficacy evaluable. Data as of 29 October 2026. Data collection and cleaning is ongoing.
Key Secondary Endpoint: Kaplan-Meier Estimated Duration of Response Durability Trending Toward Approved Products, Assessments Ongoing Corporate Presentation November 2026 Duration of Response ≥ 12 months* (KM) 43% (CI: 30%, 55%) *For durability assessments, 1 year is defined as 358 to 365+ days. Nine patients are pending their response assessment. Patients are censored if have not yet had an assessment within 7 days of day 365 or beyond, or at the start of new anticancer therapy, Patients censored at start of new treatment will never be able to reach durability which leads to an overestimate in the KM model. Deta = detalimogene; CR=complete response defined as negative cystoscopy and negative urine cytology, or positive cystoscopy/cytology with negative bladder biopsy. CI: 95% Confidence Interval; KM = Kaplan-Meier, NE = not estimatable. Data is presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. 100% of patients who entered maintenance and have been assessed for durability have recorded durable responses* 9 patients are pending the DOR ≥ 12 months assessment 8 were in CR at 48-week with 1 pending 48-week Maximum potential DOR ≥ 12 months is 40% (CI: 28%, 53%) Data Analysis DOR ≥ 12 months Median Duration Oct 2026 43% (KM est) 10.1 months (7.5 to NE) Apr 2026 25% (KM est) 8.6 months
Additional Supportive Data: CR Landmark 12 months Endpoint Not Included in Approved Product Labels Corporate Presentation November 2026 Endpoint Oct 2026 Apr 2026 Complete Response at 12 months, % (95% CI) 24% CI: 16%, 33% (n=110) 13% CI: 7%, 22% (n=98) Median Follow Up of Responders (Months) 12.0 (range: 3.7, 33.8) 9.2 (range: 3.7, 25.8) 12 Month Complete Response Rate 24% ____ (CI: 16%, 33%) (1 pt pending) Median follow-up of all EE Population patients was 7.5 months (range, 1.9-33.8 months). Median follow-up of responders was 12.0 months (range, 3.7-33.8 months). *Patients are censored if they have not yet had a disease assessment, for cycles in which they had suboptimal dosing; and from subsequent analysis if they withdrew from treatment while censored or in CR. Deta = detalimogene; CR=complete response defined as negative cystoscopy and negative urine cytology, or positive cystoscopy/cytology with negative bladder biopsy. CI: 95% Confidence Interval; KM = Kaplan-Meier. Data is presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change.
Primary Endpoint 56% CR at Any Time; In Range of Approved Products These data are presented for informational purposes and are not based on any head-to-head or comparator clinical studies. Cross-trial comparisons are inherently limited and may suggest misleading similarities or differences. Accordingly, no direct comparisons should be made. *As of the LEGEND Study’s data cut from the pivotal cohort (29 October 2026). Final LEGEND Cohort 1 population may include patients from pre- and post-protocol changes, as well as patients not included in this analysis. 1: CG AUA 2023 Presentation. 2: CG oncology BOND-003 Investor Call presentation, accessed May 1, 2025. 6m CR rate derived from internal calculation based on BOND-003 investor presentation. 3: Based on Inlexzo USPI. 4: Based on Keytruda USPI. 6m CR rates based on internal calculation from data available in Balar et al., Lancet Onc 2021 Jul;22(7):919-930; 5: Based on Adstiladrin USPI. 6m & 12m rates from Boorjian et al, Lancet Onc 2021 Jan;22(1):107-117 with N=103. 6: Based on Anktiva USPI. 6m rates from Chamie et al., NEJM 2023 Jan;2(1):EVIDoa2200167 with N=82. 7: Daneshmand et al., J of Clin Oncol 2025 Jul; 00:1-11. Detalimogene Keytruda Adstiladrin Anktiva + BCG Inlexzo Cretostimogene Drug Class Non-Viral Gene Therapy CPI Viral Gene Therapy Bacterial IO Chemo-Device Viral Gene Therapy USPI Sample Size TBD N = 96 N = 98 N = 77 N = 83 TBD Primary Endpoint CR Rate, Any Time % 56% 41% 51% 62% 82% 76% Secondary Endpoint Duration ≥ 12-Months % TBD 46% 46% 58% 51% TBD Study Sample Size N = 120 N = 96 N = 103 N = 82 N = 85 N = 110 12-Month CR Rate % (n) 24% 19% 24% 45% 46% 46% Corporate Presentation November 2026 Product Label Data Approved Products
Detalimogene Demonstrated Favorable Safety and Tolerability Profile TRAEs were Generally Mild and Reversible, Consistent with Catheterization Low Dose Interruptions and Discontinuations 4% Dose Interruption (n=5) 1% Discontinuation (n=1) Corporate Presentation November 2026 Participants with events n, (%) Pivotal Cohort 1 (N=125) ≥ 1 Treatment-related adverse event 59% Most frequent TRAEs (≥10%) Fatigue Dysuria Pollakiuria Bladder spasm Micturition urgency Urinary tract infection 21% 16% 16% 13% 13% 10% Most TRAEs were localized, brief, low grade events Of those with TRAEs, percent that were Grade 1-2 93% Patients with Grade 3 TRAEs* 4% Patients with Serious TRAEs 2% Median Time for TRAE Resolution 6 days TRAE= treatment-related adverse event. *One patient had a Grade 3 treatment-related pyelonephritis that led to a dose interruption. No grade 3 TRAEs led to discontinuation. There were no Grade 4/5 TRAEs. Data as of 29 October 2026. Data collection and cleaning is ongoing.
Trending to Potential Best-in-Class Tolerability for Detalimogene Investigational Agents based on TRAEs*** Detalimogene n=125 Creto n = 112 Any Grade 59% 63% Serious 2% 1.8% Fatal 0 0 Dose Interruptions 4% Not reported Dose Discontinuations 1% 0 Source Oct 2026 Data Analysis* CG Investor Deck** Approved Products based on ADRs*** Keytruda n=148 Adstiladrin n=157 Anktiva + BCG n=88 Inlexzo n=85 66% Not disclosed Not disclosed 84% 28% 11% 16% 24% None noted None noted 1.1% 1.2% 22% 34% 34% 41% 11% 2% 7% 7% USPI USPI USPI USPI *Data Cutoff: October 29, 2026; Data collection and cleaning is ongoing. ** September 9, 2025 Investor Deck. *** TRAEs: Treatment-related Adverse Events; ADRs: Adverse Drug Reactions Corporate Presentation November 2026
Detalimogene With Surfactant Potential to Enhance Efficacy and Durability
Goal: Enhance Detalimogene Profile While Maintaining Differentiated Ease of Use, Tolerability, and Patient Experience Corporate Presentation November 2026 Design for Detalimogene without Surfactant Bladder Rinse Design for Detalimogene + Surfactant Bladder Rinse Simple logistics and administration Differentiated tolerability CR any time ≈ approved products Simple logistics and administration Differentiated tolerability Improve CR any time & durability ? ?
Surfactants Increase Transfection of Gene Therapies Preclinical Evaluation Before and After Surfactant Incorporation Corporate Presentation November 2026 Cretostimogene1 Adstiladrin3 1: Cretostimogene developed with a pre-wash surfactant, DDM, before administration of drug. 2: Ramesh et al. Molecular Therapy Vol. 10, No. 4, 2004. doi:10.1016/j.ymthe.2004.07.002, same serotype adenovirus as cretostimogene, different genetic payload; 3: Approved with a surfactant, Syn 3, mixed in with the viral vector. 4: Yamashita, et al. Cancer Gene Therapy (2002) 9, 687–691. doi:10.1038/sj.cgt.7700488, same serotype adenovirus as Adstiladrin, different genetic payload. Cretostimogene-like2 virus: <5% transfection Adstiladrin-like virus4: Negligible transfection Surfactant (DDM) + Cretostimogene-like virus: Surfactant (Syn3) + Adstiladrin-like virus: >90% transfection Transfection Most Urothelial Cells Bladders Harvested Bladder
Detalimogene + Surfactant: Broad, Deep Urothelial Nanoparticle Distribution Increased Gene Expression >10X and Improved Efficacy in Preclinical Murine Models Detalimogene Only Detalimogene + Surfactant Significant Efficacy Increase deta + surfactant >10× Increase IL-12 expression deta + surfactant Corporate Presentation November 2026 Deeper urothelial penetration allows the nanoparticles to access the intermediate and basal layers, which have significantly higher transfectability
IL-12 Expression Increases: >9X Magnitude and >50% Distribution Murine Model Findings Validated in Non-Human Primate Model Detalimogene Only Surfactant + Detalimogene Corporate Presentation November 2026 No Pretreatment Detalimogene 60m 5-min Pretreatment Detalimogene 15m Increase Mean hIL-12 expression (pg/mg of total protein) 0.294 2.725 9X Magnitude % of positive samples 29% (7/24) 81% (29/36) +52% Distribution
EG-70 (15’) EG-70 (60’) mIL-12 in Plasma pDNA in Plasma Corporate Presentation November 2026 Clinical Development of a Surfactant Bladder Rinse: 0.25% polidocanol Established Clinical and Safety Profile of Polidocanol: Clinical Use: 1-4% IV sclerosing agent for varicose veins, telangiectasias and hemorrhoids Consumer Use: Used in shampoos and other products at 1% Safety: NOAEL 10 mg/kg/day (13-week IV rat study); ≤1% is non-irritating in rabbit eye Polidocanol Surfactant: Commercially Available, No Systemic Exposure Preclinical Evaluation in Murine and Non-Human Primate Models Polidocanol in Plasma* *Polidocanol in non-human primate model was below limit of quantification (BLQ), the lower limit of quantification (LLOQ) of the assay is set to detect down to 3% of NOAEL
LEGEND Detalimogene + Polidocanol Surfactant Cohort First Patients Enrolled Study Design Target Population: Patients with BCG-unresponsive HR NMIBC with CIS +/- Papillary Enrollment: Up to 80 patients 1w 2w 3w 4w 5w 6w 7w 8w 9w 10w 11w 12w Corporate Presentation November 2026 50 mL bladder rinse (5 min) 50 mL detalimogene (30 min) Urine collection for IL-12 Single-catheterization 5 min bladder rinse with 50 mL of 0.25% polidocanol prior to detalimogene administration Intravesical dwell time for detalimogene reduced from 60 to 30 minutes 29 active enrolling sites; expanding to 35-40 sites across North America and Europe Cycle 2-4 x4
Future Market Dynamics
Eligible Patient Pool Exceeds the Annual BCG-Unresponsive Incidence Patients will Sequence Therapies Creating a Compounding Effect on the Eligible Pool Note: Interviews n=22 urologists. The rate of patients requiring a 3L/4L therapy could be anywhere from 75% - 35% depending on which therapy they receive and rate of radical cystectomy. Source: enGene market research (interviews, surveys, and claims data), other NMIBC company estimates, Harris Poll NMIBC Patient Preference Survey (November 2025, n=200 patients). HR NMIBC Diagnosis BCG Non-Viral Gene Therapy Chemotherapy/Other Viral Gene Therapy Checkpoint Radical Cystectomy Referral to Academic Presents at Community Y0 Y1 Y2 2L 3L 4L 2L 3L 2L Patients who respond to 2L treatment in Y1 may fail in later years and require sequencing through therapies reflecting an additional potential +3,000 – 5,000 patients =10,000 pts + 5,000 pts + 2,500 pts = 10,000 pts = 10,000 pts + 5,000 pts ~50% ~50% ~50% Patients will need a new therapy by EOY Illustration of Patient Sequencing All interviewed urologists will sequence patients through 3-4L of therapy before radical cystectomy 89% patients would try anything to avoid radical cystectomy Corporate Presentation November 2026 Potential Future State
NCCN Guideline 2A Dictates Payer Coverage At New Price Point Note: WAC = wholesale acquisition cost. Keytruda®, Adstiladrin®, Anktiva®, Inlexzo® are trademarks of their respective owners. New price point assumes price of ~$650K-$700K/per patient per year. Assume gross-to-net discount of 21% and therefore a net price of $545,000 per year. Source: enGene market research. Annual WAC ($ USD) Launch Year New Price Benchmark Interviewed payers will cover therapies at parity assuming NCCN guideline category 2A Corporate Presentation November 2026 $1 Billion Net Sales with ≈2,000 Patients at New Price Point
Sizeable Future Market Opportunity for Detalimogene Corporate Presentation November 2026 40 - 75K 25 - 30K 50 - 80K Future Potential Total Addressable Market*of 120K+ High Risk BCG-Unresponsive / Exposed High Risk BCG-Naive Intermediate Risk Total Population 120K+ *Detalimogene pivotal study is for high-risk BCG-unresponsive NMIBC. Detalimogene has other cohorts in Phase 2 studies and may pursue additional indications such as intermediate risk in the future. Sources: 2022 cancer prevalence proportions from the SEER 12 Areas and 1/1/2022 U.S. population estimates based on average of 2021 & 2022 from the U.S. Bureau of the Census, National Cancer Institute. (n.d.). SEER Program. Bladder cancer—Cancer Stat Facts. Retrieved August 11, 2025, from https://seer.cancer.gov/statfacts/html/urinb.html; Soria et el., Euro Urol Oncol 7 (6), 1497-1503 (2024); enGene Quantitative Market Research (2,390 patient claims and n=100 HCP survey), other company estimates.
Segmentation and Value Pillars Inform Field Force Deployment 11,000 Bladder Cancer Urologists Academic Medical Center Health System / Hospital Clinical Excellence Practices Economics-Focused Practices Workflow-Constrained Practices Resource-Limited Practices 14,600 Practicing Urologists Field Force Planning: 40-60 Reps 40 Reps ~270 urologists / rep 60 Reps ~180 urologists / rep Mapping out top accounts 01 Clinical value 02 Practice value 03 Patient value 04 Economic value Account Characterization Value Pillars Field Force Bladder-sparing, tolerable, differentiated non-viral profile Office-ready workflow with limited new infrastructure Supports sequencing and keeps patients in community care Favorable net cost recovery with flexible terms 75% treat bladder cancer Clinical value references data presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. Corporate Presentation November 2026
Experience Developing and Commercializing Highly Successful Medicines Ron Cooper Chief Executive Officer Chief Executive Officer, Albireo Pharma President, Europe, Bristol Myers Squibb Joan Connelly Chief Technology Officer Chief Technology Officer, Albireo Pharma SVP Technical Operations, Stemline Therapeutics Amy Pott Chief Global Commercialization Officer Head, Rare Disease & Ophthalmology, Global Commercial, Astellas Head, Internal Medicine & Oncology, Commercial, Shire Jill Buck Chief Development Officer Head, Clinical Development Operations, Rare Disease, Ipsen Albireo Pharma, Ziopharm Oncology, Synageva Biopharma Erik Goluboff, MD Chief Medical Officer SVP, Clinical Development, Tyra Biosciences Principal Medical Lead, Urologic Cancers, Genentech Matthew Boyd Chief Regulatory Officer VP, Head of Regulatory Affairs, Zambon USA VP, Regulatory Affairs, Albireo Pharma Constantine Chinoporos Interim Chief Business Officer Chief Operating / Business Officer, Applied Therapeutics Chief Business Officer, Albireo Pharma Corporate Presentation November 2026 Jason Duncan Chief Legal and Administrative Officer Chief Legal and Administraitve Officer, Neumora Chief Legal Officer and Head of Program Management, Albireo Pharma
Detalimogene: Next Gen NMIBC Treatment Designed for Community Use Large Total Addressable Market Differentiated Total Product Profile Lifecycle Management Near-Term Planned Catalysts NMIBC market forecasted to be >$20B Surfactant Bladder Rinse has Potential to Improve Efficacy, Duration of Response and Reduce Patient Burden BLA Initiation: Q4 2026 Potential Approval Decision & Platform Designation: 2027 Surfactant Cohort 6-month Data: Mid-2027 Demonstrated Clinical Activity, Favorable Safety, and a Streamlined Patient and Practice Experience $245.8M Cash Expect to Provide Operating Flexibility through Potential BLA Filing and Approval Corporate Presentation November 2026 Cash as of October 31, 2026. Sources: Transparency market research NMIBC Market Outlook 2034.
November 2026
LEGEND Pivotal Cohort Interim Data Update November 11, 2026
Disclaimers Cautionary Statement Regarding Forward-Looking Statements This Presentation contains certain forward-looking statements within the meaning of the federal securities laws, including the Private Securities Litigation Reform Act of 1995, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements may be identified by the use of the words such as “forecast”, “intend”, “develop”, “expect”, “anticipate”, “become”, “believe”, “continue”, “could”, “estimate”, “goal”, “intends”, “may”, “might”, “plan”, “possible”, “project”, “should”, “strategy”, “future”, “potential”, “opportunity”, “target”, “term”, “will”, “would”, “will be” or similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding detalimogene’s potential efficacy, durability, safety, tolerability and ease of use profile, our current views and market research on the non-muscle invasive bladder cancer market, the depth, breadth and quality of our market research, our conclusions, implications or take-aways from the results of our market research, estimates, projections or forecasts of payer coverage of therapies, projected revenues for detalimogene at pricing parity with new therapies, the size of the addressable BCG unresponsive population, our expectations regarding the frequency or manner in which healthcare providers may use detalimogene, potential growth of the potential patient population, sequencing of products the development of detalimogene, the potential benefits of detalimogene, plans regarding regulatory interactions and potential biologics license application (“BLA”) submission for detalimogene, plans regarding updates on the LEGEND study, including clinical data and engagement with the FDA, the development of detalimogene, projections of market opportunity and market share, and the anticipated market acceptance of detalimogene, if approved, the potential benefits of combining a surfactant bladder wash with detalimogene, including the potential for increased efficacy and durability, estimates and forecasts of financial and performance metrics, projections of market opportunity and market share, the anticipated market acceptance of detalimogene, expectations and timing related to regulatory submissions and commercial product launches and the prospects for regulatory approval of detalimogene. These forward-looking statements are based on various estimates and assumptions, whether or not identified in this presentation, and on the current expectations of the management of enGene Therapeutics Inc. ("enGene"), are not predictions of actual performance, and are subject to risks and uncertainties. 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 presentation 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 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 carefully consider the risks and uncertainties described in the “Risk Factors” section of such Annual Report, as well as other documents if and when filed by enGene from time to time with the SEC and Canadian securities regulators. If any of these risks materialize or our assumptions prove incorrect, actual events and results could differ materially from those contained in the forward-looking statements. There may be additional risks that enGene does not presently know or that enGene currently believes are immaterial that could also cause actual events and results to differ. In addition, forward-looking statements reflect enGene’s expectations, plans, or forecasts of future events and views as of the date of this presentation. 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. These forward-looking statements should not be relied upon as representing enGene’s assessments as of any date subsequent to the date of this presentation. Accordingly, undue reliance should not be placed upon the forward-looking statements contained herein. Intellectual Property This Presentation contains trademarks, service marks, trade names, copyrights, and products of enGene and other companies, which are the property of their respective owners. The use or display of third parties’ trademarks, service marks, trade names, copyrights, or products in this Presentation is not intended to, and does not, imply a relationship with enGene, or an endorsement of or sponsorship by enGene. Solely for convenience, the trademarks, service marks, and trade names referred to in this Presentation may appear without the ®, TM or SM symbols, but such references are not intended to indicate, in any way, that enGene will not assert, to the fullest extent permitted under applicable law, its rights or the rights of the applicable licensor in such trademarks, service marks and trade names. Industry and Market Data This Presentation relies on and refers to certain information and statistics based on estimates by enGene’s management and/or obtained from third party sources which enGene believes to be reliable. enGene has not independently verified the accuracy or completeness of any such third party information, which involves elements of subjective judgment and analysis that may or may not prove to be accurate. None enGene, or its affiliates or any third parties that provide information to enGene or its affiliates, such as market research firms, guarantees the accuracy, completeness, timeliness, or availability of any information. Neither enGene nor its affiliates nor any third parties that provide information to enGene and its affiliates, such as market research firms, is responsible for any errors or omissions (negligent or otherwise), regardless of the cause, or the results obtained from the use of such content. enGene may have supplemented such information where necessary, taking into account publicly available information about other industry participants and enGene management’s best view as to information that is not publicly available. Neither enGene nor its affiliates give any express or implied warranties with respect to the information included herein, including, but not limited to, any warranties regarding its accuracy or of merchantability or fitness for a particular purpose or use, and they expressly disclaim any responsibility or liability for direct, indirect, incidental, exemplary, compensatory, punitive, special, or consequential damages, costs, expenses, legal fees, or losses (including lost income or profits and opportunity costs) in connection with the use of the information herein. Lead Program (detalimogene voraplasmid) The lead program described herein is an investigational drug therapy that has not been subject to testing designed to demonstrate that the therapy is effective in humans or to provide a basis to predict in advance whether an adequate level of efficacy in humans will be demonstrated in further testing. Although the FDA has indicated that the Phase 2 portion of the current LEGEND study may potentially support BLA approval, that outcome will depend entirely on the final results of Phase 2 clinical testing and other factors. November 2026: LEGEND Pivotal Cohort Interim Data Update
Agenda 01 Welcome PRESENTER Ron Cooper Chief Executive Officer 02 New Interim Data Cohort 1: Detalimogene Without Surfactant PRESENTER Ashish Kamat, MD 03 NMIBC Market Insights PRESENTER Amy Pott Chief Global Commercialization Officer 04 Q&A ALL PRESENTERS MD Anderson November 2026: LEGEND Pivotal Cohort Interim Data Update
Introductory Remarks
Unlocking Community Practices Unique Non-Viral Offering More treatment options are expected to increase sequencing which will expand treatable population Detalimogene non-viral approach provides a unique MOA for when doctors sequence therapies Low treatment burden for patients Simple storage and handling designed to support broad community adoption Provides opportunity to redefine community care 75% of the patients are in community practices 4Q 2026 Initiate BLA Filing; 2027 Potential BLA Approval; Detalimogene + Surfactant Data Mid 2027 Detalimogene: Only Non-Viral Gene Investigational Therapy for NMIBC Compelling Clinical Profile* Pre-BLA Meeting 56% CR at any time (primary endpoint) within the range observed from approved products Durability trending towards range of approved products Lowest rates of discontinuations or dose interruptions due to treatment related adverse events** Successful pre-BLA meeting Alignment on definition of efficacy evaluable CDRP supports BLA readiness Plan to initiate BLA filing by end of year with potential approval in 2027 *Reflective of data as available in the database as of 29 October 2026. Data Collection and Cleaning is ongoing and is subject to change. ** Compared to approved products USPI which references dose discontinuations and interruptions due to adverse reactions. Differences in compounds and trial designs require data comparisons to be interpreted with caution TRAEs = treatment-related adverse events, CR = complete response, NMIBC = non-muscle-invasive bladder cancer, BLA = biologics license applications, PI = product information, CDRP = Chemistry, Manufacturing, and Controls Development and Readiness Pilot, DOR = duration of response. November 2026: LEGEND Pivotal Cohort Interim Data Update
LEGEND Principal Investigator Ashish Kamat, MD Dr. Kamat is an Endowed Professor of Urologic Oncology and Cancer Research at MD Anderson Cancer Center and founding President of the International Bladder Cancer Group. Dr. Kamat specializes in genitourinary cancers, with a particular focus on immunotherapy for urothelial cancers, he has authored over 610 publications and champions patient advocacy.
No “Winner Takes All”: HR BCG-UR NMIBC Patients Need Multiple Options Unmet Need Persists as No Current Therapy Meets All Patient Needs Bladder preservation Multiple options after persistence/recurrence may delay cystectomy, an invasive surgery with substantial morbidity. Tolerability Side effects disrupt care. More tolerable options remain an unmet need. Treatment burden Options with lower burden dosing schedule and fewer post-treatment precautions are needed to accommodate patient lifestyle. Community access Storage and handling needs limit local availability and require referral. Physicians need more options for shared decision-making with patients Based on lifestyle, goals, priorities and fears Physician & Patient Choose Treatment Together HR, High Risk; BCG-UR, Bacillus Calmette-Guérin Unresponsive November 2026: LEGEND Pivotal Cohort Interim Data Update
LEGEND: Multi-Cohort Study of Detalimogene In High-Risk NMIBC Treatment Schedule Phase 2: Ongoing Detalimogene 0.8 mg/mL (50 mL) IVI via catheter with 60-min dwell time2 Year 1 (induction) (Q12W) Re-induction at week 12 (persistent/ recurrent disease)3 Years 2-3 (maintenance) (Q12W) Week 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 Pivotal Cohort BCG-unresponsive NMIBC with CIS1 (n=125) CIS ± HG Ta/T1 with persistent or recurrent disease within 12 months of adequate BCG Key Eligibility Criteria Age ≥18 years ECOG PS of 0, 1, or 2 Ineligible for or not electing cystectomy Adequate bladder function and can retain study drug for ≥60 minutes Other Cohorts BCG-naïve NMIBC with CIS1 (n=30) BCG-exposed NMIBC with CIS1 (n=46) BCG-unresponsive HG Ta/T1 papillary disease without CIS1 (n=47) BCG-unresponsive with CIS1 utilizing a bladder rinse4 Endpoints Primary Complete response (CR) rate at any time Key Secondary Duration of response (DOR) and DOR ≥ 12 months rate CR at landmark timepoints Safety PFS 1NMIBC with CIS with or without co-existing papillary (Ta/T1 tumors), protocol requires re-resection of T1 tumors prior to enrollment. 2Investigational intravesical therapy. 3Reinduction occurs may occur after the first 12-week cycle of the induction phase. 4Bladder rinse cohort dosing instructions Polidocanol 0.25% in 50 ml IVI via catheter, 5-minute bladder rinse, prior to detalimogene voraplasmid administration. BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; HG, high grade; IVE, intravesical instillation; NMIBC, non-muscle invasive bladder cancer; PFS, progression-free survival; Q12W, every 12 weeks. November 2026: LEGEND Pivotal Cohort Interim Data Update
LEGEND Pivotal Cohort 1: Baseline Demographics and Disease Characteristics Characteristics Pivotal Cohort 1 (N=125) Age, years Median (Range) 71.0 (35.0-90.0) Sex, n (%) Female 24 (19%) Male 101 (81%) Race n (%) White 114 (91%) Asian 4 (3%) Black or African American 2 (2%) Not Reported 5 (4%) ECOG PS, n (%) 0 119 (95%) 1 6 (5%) Characteristics Pivotal Cohort 1 (N=125) Tumor stage, n, % CIS with Ta/T1 disease 50 (40%) CIS only 75 (60%) Reason for no cystectomy, % Ineligible 9 (7%) Declined 116 (93%) Prior BCG doses, n Median (Range) 12 (6-50) Patients with prior therapy other than BCG: Total 32 (26%) Intravesical chemotherapy* 22 (18%) Systemic immunotherapy 8 (6%) Viral gene therapy 5 (4%) Other 4 (3%) Prior NMIBC recurrence(s) Median (Range) 2 (1-11) Note: BCG, bacillus Calmette-Guérin; CIS, carcinoma in situ; ECOG PS, Eastern Cooperative Oncology Group Performance Score; NMIBC, non-muscle invasive bladder cancer. *Single administration of cytotoxic agents (e.g. Mytomicin C, gemcitabine, doxorubicin or epirubicin) immediately following a TURBT are not included in this % Data as of 29 October 2026. Data collection and cleaning is ongoing. November 2026: LEGEND Pivotal Cohort Interim Data Update
Cohort 1 Data: Detalimogene Without Surfactant
FDA Aligned Efficacy Evaluable Population Alignment on Critical Items in Proposed Statistical Analysis Plan (SAP) 125 5 120 − = Trial patients Excluded from efficacy analysis Efficacy evaluable (EE) Patient 1 Did not have a post baseline disease assessment Patient 2 Did not have CIS within 1 year of receiving adequate BCG dosing Patient 3 Did not have CIS within 1 year of receiving adequate BCG dosing Patient 4 Did not receive adequate BCG dosing Patient 5 Did not receive adequate BCG dosing and had a disallowed cancer (melanoma) Data as of 29 October 2026. Data collection and cleaning is ongoing. November 2026: LEGEND Pivotal Cohort Interim Data Update
Any Time Complete Response* 56% Detalimogene Without Surfactant Primary Endpoint: CR at Any Time Primary Endpoint in Range of Approved Products 91% of CRs occurred at first assessment& 100% of responders were free from progression to ≥T2 disease in the bladder 97% of EE patients were free from progression to ≥T2 disease^ 96% of responders remain free from cystectomy 86% of EE patients remain free from cystectomy Endpoint Data Analysis CR Rate, % (95% CI) Complete Response at Any Time Oct 2026 (n=120) 56% (CI: 47%, 65%) Apr 2026 (n=124) 54% (CI: 45%, 63%) Median follow-up of all EE Population patients was 7.5 months (range, 1.9-33.8 months). Median follow-up of responders was 12.0 months (range, 3.7-33.8 months). *Patients who discontinued without any disease evaluation or who discontinued after a CR are excluded from subsequent landmark response analysis. &One patient was censored for Cycle 1, therefore N=66 ^One additional progression was noted but not documented in the database as of the datacut date. CR=complete response defined as negative cystoscopy and negative urine cytology, or positive cystoscopy/cytology with negative bladder biopsy. CI: 95% Confidence Interval; KM = Kaplan-Meier, EE = efficacy evaluable. Data as of 29 October 2026. Data collection and cleaning is ongoing. November 2026: LEGEND Pivotal Cohort Interim Data Update
Duration of Response ≥ 12 months* (KM) 43% (CI: 30%, 55%) Key Secondary Endpoint: Kaplan-Meier Estimated Duration of Response Durability Trending Toward Approved Products, Assessments Ongoing *For durability assessments, 1 year is defined as 358 to 365+ days. Nine patients are pending their response assessment. Patients are censored if have not yet had an assessment within 7 days of day 365 or beyond, or at the start of new anticancer therapy, Patients censored at start of new treatment will never be able to reach durability which leads to an overestimate in the KM model. Deta = detalimogene; CR=complete response defined as negative cystoscopy and negative urine cytology, or positive cystoscopy/cytology with negative bladder biopsy. CI: 95% Confidence Interval; KM = Kaplan-Meier, NE = not estimatable. Data is presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. 100% of patients who entered maintenance and have been assessed for durability have recorded durable responses* 9 patients are pending the DOR ≥ 12 months assessment 8 were in CR at 48-week with 1 pending 48-week Maximum potential DOR ≥ 12 months is 40% (CI: 28%, 53%) Data Analysis DOR ≥ 12 months Median Duration Oct 2026 43% (KM est) 10.1 months (7.5 to NE) Apr 2026 25% (KM est) 8.6 months November 2026: LEGEND Pivotal Cohort Interim Data Update
Endpoint Oct 2026 Apr 2026 Complete Response at 12 months, % (95% CI) 24% CI: 16%, 33% (n=110) 13% CI: 7%, 22% (n=98) Median Follow Up of Responders (Months) 12.0 (range: 3.7, 33.8) 9.2 (range: 3.7, 25.8) Additional Supportive Data: CR Landmark 12 months Endpoint Not Included in Approved Product Labels 12 Month Complete Response Rate 24% ____ (CI: 16%, 33%) (1 pt pending) Median follow-up of all EE Population patients was 7.5 months (range, 1.9-33.8 months). Median follow-up of responders was 12.0 months (range, 3.7-33.8 months). *Patients are censored if they have not yet had a disease assessment, for cycles in which they had suboptimal dosing; and from subsequent analysis if they withdrew from treatment while censored or in CR. Deta = detalimogene; CR=complete response defined as negative cystoscopy and negative urine cytology, or positive cystoscopy/cytology with negative bladder biopsy. CI: 95% Confidence Interval; KM = Kaplan-Meier. Data is presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. November 2026: LEGEND Pivotal Cohort Interim Data Update
Detalimogene Demonstrated Favorable Safety and Tolerability Profile TRAEs were Generally Mild and Reversible, Consistent with Catheterization Participants with events n, (%) Pivotal Cohort 1 (N=125) ≥ 1 Treatment-related adverse event 59% Most frequent TRAEs (≥10%) Fatigue Dysuria Pollakiuria Bladder spasm Micturition urgency Urinary tract infection 21% 16% 16% 13% 13% 10% Most TRAEs were localized, brief, low grade events Of those with TRAEs, percent that were Grade 1-2 93% Patients with Grade 3 TRAEs* 4% Patients with Serious TRAEs 2% Median Time for TRAE Resolution 6 days TRAEs leading to dose interruption or discontinuation were rare 4% dose interruptions (n=5) 1% discontinuation (n=1) TRAE= treatment-related adverse event. *One patient had a Grade 3 treatment-related pyelonephritis that led to a dose interruption. No grade 3 TRAEs led to discontinuation. There were no Grade 4/5 TRAEs. Data as of 29 October 2026. Data collection and cleaning is ongoing. November 2026: LEGEND Pivotal Cohort Interim Data Update
Detalimogene Compelling Efficacy and Tolerability Profile CR Any Time Rate DOR ≥12 months Rate^ KM for Detalimogene Lack of Dose Interruptions* Lack of Related Serious AEs* Detalimogene Approved Drugs Efficacy of Detalimogene vs. Approved Drugs Tolerability of Detalimogene vs. Approved Drugs * Detalimogene dose interruptions associated with treatment related adverse events. Approved drugs interruptions associated with adverse drug reactions. ^For durability assessments, 1 year is defined as 358 to 365+ days. Nine patients are pending their response assessment. Patients are censored if have not yet had an assessment within 7 days of day 365 or beyond, or at the start of new anticancer therapy. Deta = detalimogene; CR=complete response defined as negative cystoscopy and negative urine cytology, or positive cystoscopy/cytology with negative bladder biopsy. CI: 95% Confidence Interval; KM = Kaplan-Meier. Data as of 29 October 2026. Data collection and cleaning is ongoing. November 2026: LEGEND Pivotal Cohort Interim Data Update
Detalimogene Efficacy Profile has Meaningfully Improved Detalimogene has the potential to be a valuable treatment option for all patients *Fewer visits and pre- post-treatment precautions compared to BCG. Data is presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. Reduce patient burden*: fewer visits, procedures, pre- or post-treatment precautions Simplify urologist workflow: administration, storage, handling CR rate of 56% at any time CR rate of 24% at 12 months KM DOR ≥12 months est. 43% 100% of responders were free from progression to ≥T2 disease in the bladder 96% of responders remain free from cystectomy Detalimogene is a next-generation non-viral gene therapy in development for HR NMIBC, designed to: Detalimogene showed encouraging activity in heavily pre-treated participants with BCG-unresponsive NMIBC Most TRAEs were brief, low-grade, lower urinary tract symptoms Serious TRAEs (2%) and grade 3 TRAEs (4%) were highly infrequent TRAEs leading to dose interruption (4%) or discontinuation (1%) were rare Detalimogene was safe and very well tolerated November 2026: LEGEND Pivotal Cohort Interim Data Update
Commercial Opportunity
Grounded in Where Care Happens & How Decisions are Made Detalimogene Go-to-Market Strategy Avoiding Cystectomy Settings of Care Shared Decision Making Treatment Options Redefining Care Pathway HR NMIBC is often “chronic” and highly recurrent - patients will do anything to avoid cystectomy 75% of HR BCG-UR NMIBC patients are seen in community settings Urologists understand patients' priorities and select treatment together Community urology practices do not have access to as many treatments as academic centers No winner-takes-all. Recurrence will drive sequencing through multiple bladder-sparing therapies. HR BCG-UR = High Risk BCG-Unresponsive. Source: enGene market research, New Faces of Bladder Cancer Report 2025 (BCAN). November 2026: LEGEND Pivotal Cohort Interim Data Update
Vision: Detalimogene to Redefine Care in Community Practices 01 Clinical value A meaningful and tolerable bladder-sparing option for all patients, supported by a differentiated non-viral MOA profile. 02 Practice value Economic value Potential for favorable net cost recovery with manufacturer support and flexible terms to support practices facing increasing financial and capacity pressures. 04 Patient value Alignment with future sequencing and the desire to keep appropriate patients in community care. Designed for real-world community practice, enabling more patients to remain on a bladder-sparing path. 03 Office-ready workflow, requires no new infrastructure and lower post-treatment burden. Designed to meet real world community treatment challenges. Clinical value references data presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. November 2026: LEGEND Pivotal Cohort Interim Data Update
Urology Segment NMIBC Patients 19% (~3,800) 11% (~2,200) 11% (~2,200) 6% (~1,200) 29% (~5,800) Academic Medical Center 24% (~4,800) Note: Assumes ~20,000 addressable NMIBC BCG-unresponsive patients. Resource-Limited, Workflow-Constrained, Economics-Focused, and Clinical-Excellence all represent urology private practice. Source: enGene market research (third party claims analysis of real-world data of >2,000 patient claims). Academic Medical Center Prioritize efficacy and safety Health System / Hospital Prioritize efficacy and safety Clinical Excellence Practices Prioritize efficacy and safety Economics-Focused Practices Net cost recovery drives treatment selection Workflow-Constrained Practices Logistical burden is gating Resource-Limited Practices Acquisition cost and logistical burden are gating Private Practices 2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway 75% of High-Risk BCG-Unresponsive NMIBC Patients are Treated in Community Urology Practices Detalimogene Value Could Be Demonstrated Across All Segments Safe Handling, Standard Storage and Simple Logistics May Promote Adoption November 2026: LEGEND Pivotal Cohort Interim Data Update
Urology Segment NMIBC Patients 19% (~3,800) 11% (~2,200) 11% (~2,200) 6% (~1,200) 29% (~5,800) Academic Medical Center 24% (~4,800) Note: Assumes ~20,000 addressable NMIBC BCG-unresponsive patients. Resource-Limited, Workflow-Constrained, Economics-Focused, and Clinical-Excellence all represent urology private practice. Source: enGene market research (third party claims analysis of real-world data of >2,000 patient claims). Academic Medical Center Prioritize efficacy and safety Health System / Hospital Prioritize efficacy and safety Clinical Excellence Practices Prioritize efficacy and safety Economics-Focused Practices Net cost recovery drives treatment selection Workflow-Constrained Practices Logistical burden is gating 2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway Shared Decision Making with Patients Occurs Across All Practice Settings Shared Decision Making Private Practices Resource-Limited Practices Acquisition cost and logistical burden are gating November 2026: LEGEND Pivotal Cohort Interim Data Update
High Risk NMIBC is a Long Journey Trusted Urologist-Patient Relationship Built Over Time to Maintain Treatment Goals 2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway JAN 2024 | INITIAL PRESENTATION June 2025 | RECURRENCE JULY 2025 - NOV 2025 Gem/doce induction IVI × 6 2x monthly maint. NOV 2025 | RECURRENCE (BCG-exposed – relevant) July 2024 Lost to follow up for 1 yr JAN 2024 - May 2024 BCG Induction + 1 maint. SEP 2026 | RECURRENCE BCG Unresponsive CIS DEC 2025 – SEP 2026 BCG Induction IVI x 6 + 2 Maint. Cycles Patients to seek effective bladder-sparing options that allows them to maintain their lifestyle November 2026: LEGEND Pivotal Cohort Interim Data Update
Treatment Selection Guided by Patient Priorities and Practice Capabilities No Winner Takes All – Patients and Urologists Consider Many Factors First, understand the patient and the practice, then, discuss all options Treatment Burden Weigh visit frequency, doses, and duration against the patient's daily life and the practice's capacity to deliver Efficacy Compare bladder-preserving options in the context of long-term disease management and sequencing Safety & Tolerability Consider tolerability in an already-irritated bladder, and what monitoring the practice can support Care Setting Compare community care with referral to an academic center, considering continuity of care, convenience, and access Insurance Coverage Confirm which treatments the patient’s insurance will cover 2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway November 2026: LEGEND Pivotal Cohort Interim Data Update
Detalimogene’s Profile To Date Aligns with Key Treatment Considerations Treatment Burden Shorter treatment time (1hr vs. 2hr dwell) and fewer doses (4 vs. 6) in 12-week cycle than required for BCG Efficacy Unique MOA with complete response rate at any time and duration of response similar to approved options Safety & Tolerability Potentially best in class tolerability with the lowest reported rates of treatment related serious AEs, dose interruptions, and dose discontinuations Care Setting One of the few therapies that could be offered across all settings of care due to favorable handling & logistics Coverage / Access Coverage and NCCN guideline unknown, but insurance coverage parity expected across options assuming NCCN 2A status 2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway DETALIMOGENE OFFERING Data is presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. November 2026: LEGEND Pivotal Cohort Interim Data Update
Detalimogene is a Potential Low Burden & Convenient Option for Patients Treatment Time Dosing Schedule (First 3 Months) Keytruda Adstiladrin Anktiva + BCG Inlexzo Cretostimogene 60 minutes IVI treatment dwell 30min IV infusion 48hr urine bleaching 60min IVI treatment dwell 25min to 5hr vial thaw 6hr urine bleaching 120min IVI treatment dwell Cystoscope device removal 7 days urine bleaching 60min IVI treatment dwell 1 or 4 steps of bladder washes Source: Derived from product SOPIs and clinical trial publications. Not based on head-to-head or comparator studies, Cretostimogene Grenadenorepvec in Urology Practice Workflows (SUNA Urology Alliance, accessed Oct 27, 2026) IVI = Intravesical. Urine contact precautions Approved Therapies Device insertion 2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway Detalimogene Anticholineric treatment November 2026: LEGEND Pivotal Cohort Interim Data Update
A Future Where Recurrent NMIBC Patients Can Keep Their Bladders Longer Patients will Sequence Therapies Resulting in Enhanced Long-Term Care Note: Interviews n=22 urologists. The rate of patients requiring a 3L/4L therapy could be anywhere from 75% - 35% depending on which therapy they receive and rate of radical cystectomy. Source: enGene market research (interviews, surveys, and claims data), other NMIBC company estimates, Harris Poll NMIBC Patient Preference Survey (November 2025, n=200 patients). Y0 Y1 Y2 2L 3L 4L 2L 3L 2L Patients who respond to 2L treatment in Y1 may fail in later years and require sequencing through therapies reflecting an additional potential +3,000 – 5,000 patients =10,000 pts + 5,000 pts + 2,500 pts = 10,000 pts = 10,000 pts + 5,000 pts ~50% ~50% ~50% Patients will need a new therapy by EOY Illustration of High-Risk BCG-Unresponsive Patient Sequencing All interviewed urologists will sequence patients through 3-4L of therapy before radical cystectomy 89% patients would try anything to avoid radical cystectomy ~20,000 addressable HR BCG-unresponsive NMIBC patients 2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway November 2026: LEGEND Pivotal Cohort Interim Data Update
2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway 2024 2025 2026 Sequencing & Shared Decision Making Creates a New Care Pathway 2030+ JAN 2024 | INITIAL PRESENTATION June 2025 | RECURRENCE JULY 2025 - NOV 2025 Gem/doce induction IVI × 6 + 2x monthly maint. NOV 2025 | RECURRENCE July 2024 Lost to follow up for 1 yr JAN 2024 - May 2024 BCG Induction + 1 maint. DEC 2025 – SEP 2026 BCG Induction IVI x 6 + 2 Maint. Cycles SEP 2026 | RECURRENCE BCG Unresponsive CIS Non-Viral Gene Therapy Chemotherapy Viral Gene Therapy RECURRENCE RECURRENCE POTENTIAL FUTURE TREATMENT PARADIGM November 2026: LEGEND Pivotal Cohort Interim Data Update
NCCN Guideline 2A Dictates Payer Coverage at New Price Point Interviewed Payers Cover Therapies at Parity at New Price Point Assuming Category 2A Note: WAC = wholesale acquisition cost. Keytruda®, Adstiladrin®, Anktiva®, Inlexzo® are trademarks of their respective owners. New price point assumes price of ~$650K-$700K/per patient per year. Assume gross-to-net discount of 21% and therefore a net price of $545,000 per year. Source: enGene market research. Annual WAC ($ USD) Launch Year New Price Benchmark $1 Billion Net Sales with ≈2,000 Patients at New Price Point 2. Avoiding Cystectomy 1. Settings of Care 3. Share Decision Making 4. Treatment Options 5. Redefining Care Pathway November 2026: LEGEND Pivotal Cohort Interim Data Update
Vision: Detalimogene to Redefine Care in Community Practices 01 Clinical value A meaningful and tolerable bladder-sparing option for all patients, supported by a differentiated non-viral MOA profile. 02 Practice value Economic value Potential for favorable net cost recovery with manufacturer support and flexible terms to support practices facing increasing financial and capacity pressures. 04 Patient value Alignment with future sequencing and the desire to keep appropriate patients in community care. Designed for real-world community practice, enabling more patients to remain on a bladder-sparing path. 03 Office-ready workflow, requires no new infrastructure and lower post-treatment burden. Designed to meet real world community treatment challenges. Clinical value references data presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. November 2026: LEGEND Pivotal Cohort Interim Data Update
Segmentation and Value Pillars Inform Field Force Deployment ~11,000 Bladder Cancer Urologists Academic Medical Center Health System / Hospital Clinical Excellence Practices Economics-Focused Practices Workflow-Constrained Practices Resource-Limited Practices ~14,600 Practicing Urologists Field Force Planning: 40-60 Reps 40 Reps ~270 urologists / rep 60 Reps ~180 urologists / rep Mapping out top accounts 01 Clinical value 02 Practice value 03 Patient value 04 Economic value Account Characterization Value Pillars Field Force Bladder-sparing, tolerable, differentiated non-viral profile Office-ready workflow with limited new infrastructure Supports sequencing and keeps patients in community care Favorable net cost recovery with flexible terms 75% treat bladder cancer Clinical value references data presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. November 2026: LEGEND Pivotal Cohort Interim Data Update
Value Pillars Inform enGene Commercialization Strategy Practice Value Patient Value Economic Value Clinical Value DETALIMOGENE HYPOTHESIS Commercial potential is driven by our broad alignment to the needs of all urologists Clear Differentiation Evaluation of precise and efficient field organization Following a positive pre-BLA meeting enGene is working towards initiating BLA filing Q4 2026 FDA Identifying key sites and account characterization engagement strategy MSLs in field, education and scientific engagement FDA FDA Prescribers FDA Education & Awareness FDA Field Clinical Efficacy Tolerability Operational Simplicity Practice Economics Low Patient Burden November 2026: LEGEND Pivotal Cohort Interim Data Update
Closing Remarks
Detalimogene: Next Gen NMIBC Treatment Designed for Community Use Large Total Addressable Market Differentiated Total Product Profile Lifecycle Management Near-Term Planned Catalysts NMIBC market forecasted to be >$20B Surfactant Bladder Rinse has Potential to Improve Efficacy, Duration of Response and Reduce Patient Burden BLA Initiation: Q4 2026 Potential Approval Decision & Platform Designation: 2027 Surfactant Cohort 6-month Data: Mid-2027 Demonstrated Clinical Activity, Favorable Safety, and a Streamlined Patient and Practice Experience Detalimogene product profile references data presented as available in the database as of 29October2026. Data Collection and Cleaning is ongoing and is subject to change. Sources: Transparency market research NMIBC Market Outlook 2034. November 2026: LEGEND Pivotal Cohort Interim Data Update
Exhibit 99.3
enGene to Initiate a BLA Submission for Detalimogene by Year End and Reports New Data from LEGEND Trial Pivotal Cohort 1 in BCG-Unresponsive NMIBC
Improvements reported across all efficacy endpoints for pivotal cohort over April 2026 data analysis
Primary endpoint of complete response (CR) at any time improved to 56% from 54%
Preliminary Kaplan-Meier estimate of duration of response (DoR) ≥ 12-months, a key secondary endpoint, improved to 43% from 25%
Preliminary median duration of response improved to 10.1 months from 8.6 months
Landmark 12-month CR rate improved to 24% from 13%
Detalimogene continues to demonstrate a favorable tolerability profile, with just 2% of patients experiencing a serious treatment-related adverse event (TRAE)
Positive pre-BLA meeting with FDA resulting in alignment on efficacy evaluable population
If approved, detalimogene would be the first and only non-viral plasmid gene therapy suitable for integration into any urology practice setting
Webcast and conference call scheduled for November 11, 2026 at 4:30 p.m. ET
BOSTON & MONTREAL – enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced updated results from the pivotal Cohort 1 of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene). Data from Cohort 1, which enrolled 125 patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without concomitant papillary disease, are expected to form the basis for a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).
“For patients with high-risk BCG-unresponsive NMIBC, we need therapies that provide meaningful and durable disease control while minimizing treatment-related toxicity and burden,” said Ashish M. Kamat, MD, Professor of Urologic Oncology at The University of Texas MD Anderson Cancer Center and Primary Investigator of the LEGEND trial. “The updated LEGEND data are encouraging, demonstrating clinically meaningful antitumor activity with a favorable tolerability profile. Combined with its straightforward administration and handling requirements, detalimogene has the potential to become a valuable addition to our bladder-preserving treatment options, particularly in community urology practices where ease of administration and practical considerations can influence treatment selection.”
Exhibit 99.3
“The updated results from Cohort 1 demonstrate encouraging improvements across all key efficacy measures as the data have matured, bringing detalimogene’s efficacy profile to date within range of approved products for this indication,” said Ron Cooper, President and Chief Executive Officer, enGene. “Importantly, our recent interactions with the FDA provide a clear path to initiate a BLA submission before year-end 2026, representing a significant step toward bringing detalimogene to patients, with potential approval in 2027.”
Mr. Cooper continued, “In parallel, we are preparing for commercialization, with a focus on positioning detalimogene for broad adoption across community urology practices, where more than 75% of high-risk, BCG-unresponsive NMIBC patients receive care. We believe detalimogene’s differentiated ease of use and handling could facilitate integration into existing treatment settings, helping expand access to a new bladder-preserving treatment option for patients.”
LEGEND Pivotal Cohort Update
The following efficacy data are based on 120 efficacy-evaluable patients enrolled in Cohort 1 as of the data cutoff date, October 29, 2026.
Efficacy Overview:
Exhibit 99.3
Safety Overview:
The overall tolerability profile associated with detalimogene has been favorable. Of the 125 patients assessed for safety in Cohort 1, 59% experienced at least one TRAE, which were mainly
Grade 1/2 in severity. The most common TRAEs were fatigue (21%), dysuria (16%),
pollakiuria (16%), and bladder spasm (13%), micturition urgency (13%), and urinary tract infection (10%). Only 4% of patients experienced Grade 3 TRAE, with just 2% of patients experiencing a serious TRAE. No Grade 4 or Grade 5 TRAEs were reported. TRAEs leading to dose discontinuation (1%) or dose interruption (4%) were rare.
Regulatory Update and Anticipated Milestones:
Following the Company’s pre-BLA meeting with the FDA, enGene reached alignment on key components of the planned BLA for detalimogene, including the efficacy evaluable patient population. The Company expects to initiate the submission by year-end 2026 and plans to complete the BLA submission in the first half of 2027, with potential FDA approval in 2027. In addition, the Company expects to provide an update on the detalimogene plus surfactant bladder rinse cohort mid- 2027.
Conference Call and Webcast
enGene will host a conference call and webcast on November 11, 2026, at 4:30 p.m. Eastern Time to discuss the updated LEGEND data and provide an overview of the regulatory path for detalimogene. Details for the conference call and webcast are included below.
Conference Call Dial-in Numbers:
North America Toll-Free: +1 833-461-5787
International Toll: +1 585-542-9983
Additional International Dial-Ins can be found here
Meeting ID: 485 327 198
Webcast Link: https://events.q4inc.com/attendee/485327198
A link to the webcast will also be available on the Investors section of enGene’s website. A replay of the webcast will be available at this same link within two hours of the event’s conclusion.
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 generally 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.
Exhibit 99.3
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 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 or refuse 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.
Exhibit 99.3
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 “forecast”, “intend”, “develop”, “expect”, “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “goal”, “intends”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “strategy”, “future”, “potential”, “opportunity”, “target”, “term”, “will”, “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, the potential benefits of detalimogene, plans regarding regulatory interactions and the potential BLA submission and potential approval of detalimogene, plans regarding updates on the LEGEND study or on the detalimogene plus surfactant bladder rinse cohort, including clinical data and engagement with the FDA, our current views and market research on the non-muscle invasive bladder cancer market, the depth, breadth and quality of our market research, our conclusions, implications or take-aways from the results of our market research, estimates, projections or forecasts of payer coverage of therapies, projected revenues for detalimogene at pricing parity with new therapies, the size of the addressable BCG unresponsive population, our expectations regarding the frequency or manner in which healthcare providers may use detalimogene, potential growth of the potential patient population, sequencing of products, the potential benefits of combining a surfactant bladder rinse with detalimogene, including the potential for increased efficacy and durability, estimates and forecasts of financial and performance metrics, projections of market opportunity and market share, the anticipated market acceptance of detalimogene, expectations and timing related to regulatory submissions and commercial product launches and the prospects for regulatory approval of 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.
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
Exhibit 99.3
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 Quarterly Report on Form 10-Q for the third quarter ended July 31, 2026 (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 and Investor Contact
Lauren Stival Hopfer
Executive Director, Investor Relations
lhopfer@engene.com