Form 8-K
8-K — enGene Therapeutics Inc.
Accession: 0001193125-26-307795
Filed: 2026-07-17
Period: 2026-07-17
CIK: 0001980845
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — engn-20260717.htm (Primary)
EX-99.1 (engn-ex99_1.htm)
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8-K
8-K (Primary)
Filename: engn-20260717.htm · Sequence: 1
8-K
0001980845false00-00000000001980845us-gaap:WarrantMember2026-07-172026-07-1700019808452026-07-172026-07-170001980845us-gaap:CommonStockMember2026-07-172026-07-17
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 17, 2026
enGene Therapeutics Inc.
(Exact name of Registrant as Specified in Its Charter)
British Columbia
001-41854
Not applicable
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
4868 Rue Levy, Suite 220
Saint-Laurent, Quebec, Canada
H4R 2P1
(Address of Principal Executive Offices)
(Zip Code)
Registrant’s Telephone Number, Including Area Code: 514 332-4888
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Shares
ENGN
The Nasdaq Stock Market LLC
Warrants, each exercisable for one Common Share, at an exercise price of $11.50 per Common Share
ENGNW
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01 Regulation FD Disclosure.
On July 17, 2026, enGene Therapeutics Inc. updated its Corporate Presentation, a copy of which is furnished with this Current Report on Form 8-K as Exhibit 99.1 and incorporated into this Item 7.01 by reference.
The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
Description of Exhibits
99.1
Corporate Presentation, dated July 2026.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ENGENE THERAPEUTICS INC.
Date:
July 17, 2026
By:
/s/ Ronald H. W. Cooper
Name: Ronald H. W. Cooper
Title: Chief Executive Officer and President
EX-99.1
EX-99.1
Filename: engn-ex99_1.htm · Sequence: 2
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, 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, 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 July 2026
Detalimogene: Investigational Next-Generation Therapy for NMIBC Designed for the Unique Needs of Community Urology Practices Potential Best-in-Class Tolerability Lowest treatment interruption and discontinuation rates based on approved products PIs 54% CR Anytime (Primary Endpoint), With Low Rate of Progression to Advanced Disease Complete Response (CR) at any time from interim analysis within the range observed from approved products Highly Differentiated Total Product Profile: Efficacy, Tolerability, Ease of Use Designed to enable treatment for NMIBC in both community and academic practices, regardless of resources/infrastructure Detalimogene With Surfactant Bladder Rinse Expected to Increase Efficacy and Durability Preclinical data from other gene therapies support enhanced transfection and efficacy with surfactant incorporation; validated in clinic Multiple Near‑Term Catalysts with the Potential to Drive Value Creation Pivotal cohort 12-month data and filing of BLA expected in 2H 2026, and potential approval and platform designation 2027 Well-Capitalized through Planned BLA Filing and Potential Approval $285M in cash expected to provide significant operating flexibility through BLA filing and potential approval Corporate Presentation July 2026 CR = complete response, NMIBC = non-muscle-invasive bladder cancer, BLA = biologics license applications, PI = product information.
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 July 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 ~24,000/year US Prevalent Bladder Cancer ~740,000 Corporate Presentation July 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 July 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
~80% of NMIBC Treated in Community Urology Practices Share of NMIBC Patients by Practice Setting Academic Medical Center-Owned Practice Health System / Hospital-Owned Practice Large Urology Group Practice Corporate Presentation July 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. Small Private Practice 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
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. 80% of NMIBC Patients in the Community Academic Medical Center-Owned Practice Health System / Hospital-Owned Practice Large Urology Group Practice 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) Small Private Practice Corporate Presentation July 2026
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 July 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 July 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 July 2026
Designed 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 July 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 Corporate Presentation July 2026 Cohort / NMIBC Indication Pre-Clinical Phase 1 Pivotal Status Enrollment Complete: 12-Month Data Update Expected 2H 2026 First Patients Enrolled: Ongoing Enrollment Complete N=30 N=46 N=47 Pivotal Cohort 1: BCG-Unresponsive /w CIS Surfactant Bladder Rinse Cohort: BCG-Unresponsive NMIBC CIS New Cohort Cohort 2a: BCG-Naïve /w CIS* Cohort 2b: BCG-Exposed /w CIS* Cohort 3: BCG-Unresponsive /w Papillary Only*
Detalimogene Without Surfactant Pivotal Cohort 1 Interim Analysis Presented at AUA Plenary Session May 2026
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 July 2026 Key Secondary Endpoint: Duration of Response
LEGEND Phase 2 Cohort 1: Baseline Demographics and High-Risk Disease Characteristics Characteristics Pivotal Cohort 1 (N=125) Age, years Median (Range) 71.0 (35.0-90.0) Sex, n (%) Female 24 (19.2%) Male 101 (80.8%) Race n (%) White 114 (91.2%) Asian 4 (3.2%) Black or African American 2 (1.6%) Not Reported 5 (4.0%) ECOG PS, n (%) 0 119 (95.2%) 1 6 (4.8%) Characteristics Pivotal Cohort 1 (N=125) Tumor stage, n, % CIS with Ta/T1 disease 49 (39.2%) CIS only 76 (60.8%) Reason for no cystectomy, % Ineligible 9 (7.2%) Declined 116 (92.8%) Prior BCG doses, n Median (Range) 12 (6-50) Prior therapy other than BCG: Total 31 (24.8%) Intravesical chemotherapy 21 (16.8%) Systemic immunotherapy 8 (6.4%) Viral gene therapy 5 (4.0%) Other 4 (3.2%) Prior NMIBC recurrence(s) Median (Range) 2 (0-11) Corporate Presentation July 2026 Note: BCG, bacillus Calmette-Guérin; CIS, carcinoma in situ; ECOG PS, Eastern Cooperative Oncology Group Performance Score; NMIBC, non-muscle invasive bladder cancer. Data as of 21 April 2026; Data collection and cleaning is ongoing.
91.0% of CRs occurred at first assessment 96.8% were free from progression to ≥T2 disease 90.4% of participants remain free from cystectomy 21 additional patients could achieve a CR at 12 months 19 are responders at various time points Any Time Complete Response* 54% (CI: 44.9%, 63.0%) CR Landmark* CR Rate, % (95% CI) CR by KM (Est %) 6 month (n=121) 43.0% (CI: 34.0%, 52.3%) 39.4% 12 month (n=98) 13.3% (CI: 7.3%, 21.6%) 24.5% Median follow-up was 5.5 months (range, 1.0-25.8 months) *Patients who discontinued without any disease evaluation or who discontinued after a CR are excluded from subsequent landmark response analysis. **Results do not include one patient with potential CR at 9 months that is currently considered a non-CR in the database. 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 21 April 2026; Data collection and cleaning is ongoing. Corporate Presentation July 2026 Detalimogene Without Surfactant Clinically Meaningful Activity, Low Progression Interim Analysis
Primary Endpoint 54% 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 (21 April 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 % 54% 41% 51% 62% 82% 76% Secondary Endpoint Duration ≥ 12-Months % TBD 46% 46% 58% 51% TBD Study Sample Size N = 124 N = 96 N = 103 N = 82 N = 85 N = 110 6-Month CR Rate % 43% (May ’26) 34% 41% 56% 59%7 63% 12-Month CR Rate % (n) TBD 19% (18) 24% (25) 45% (37) 46% (39) 46% (51) Corporate Presentation July 2026 Product Label Data Approved Products
Detalimogene Demonstrated Favorable Safety and Tolerability Profile TRAEs were Generally Mild and Reversible, Consistent with Catheterization Corporate Presentation July 2026 TRAE= treatment-related adverse event. *One patient had a treatment-related pyelonephritis/sepsis that led to a dose interruption. No grade ≥ 3 TRAEs led to discontinuation. As of April 21, 2026 one participant had a grade 4 TRAE (elevated ALT) which has since been determined to not be treatment related following consultation with a hepatologist. Data as of 21 April 2026; Data collection and cleaning is ongoing Participants with events n, (%) Pivotal Cohort 1 (N=125) ≥ 1 Treatment-related adverse event 55.2% Most frequent TRAEs (≥10%) Fatigue Dysuria Micturition urgency Pollakiuria Bladder spasm 21.6% 13.6% 12.0% 12.0% 11.2% Most TRAEs were localized, brief, low grade events Of those with TRAEs, percent that were Grade 1-2 91.3% Patients with grade ≥ 3 TRAEs* 4.8% Median Time for TRAE Resolution 8 days Low Dose Interruptions and Discontinuations 2.4% Dose Interruption (n=3) 2.4% Discontinuation (n=3)
Trending to Potential Best-in-Class Tolerability for Detalimogene Investigational Agents based on TRAEs*** Detalimogene n=125 Creto n = 112 Any Grade 55% 63% Serious 1.6% 1.8% Fatal 0 0 Dose Interruptions 2.4% Not reported Dose Discontinuations 2.4% 0 Source AUA P2 Presentation* 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: April 21, 2026; Data collection and cleaning is ongoing. ** September 9, 2025 Investor Deck. *** TRAEs: Treatment-related Adverse Events; ADRs: Adverse Drug Reactions Corporate Presentation July 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 July 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 July 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 July 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 July 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
Polidocanol Surfactant: Commercially Available, No Systemic Exposure Preclinical Evaluation in Murine Models EG-70 (15’) EG-70 (60’) mIL-12 in Plasma pDNA in Plasma Corporate Presentation July 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
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 Cycle 2-4 x4 Corporate Presentation July 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
Future Market Dynamics
Logical Sequencing - Critical Future Consideration for Long-Term Treatment Detalimogene ±Surfactant Would Provide a Viable Option for Community Urologists Referral Future Community Practice Sequencing Academic Practice Sequencing HR NMIBC Diagnosis BCG Chemotherapy, CPI & Clinical Trials Radical Cystectomy Past HR NMIBC Diagnosis BCG Non-Viral Gene Therapy Chemotherapy/Other Viral Gene Therapy Checkpoint Radical Cystectomy Corporate Presentation July 2026
Sizeable Future Market Opportunity for Detalimogene Corporate Presentation July 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.
Experience Developing and Commercializing Highly Successful Medicines RON COOPER Chief Executive Officer Chief Executive Officer, Albireo Pharma President, Europe, Bristol Myers Squibb ANTHONY CHEUNG, Ph.D. Chief Scientific Officer Co-founder, enGene Co-inventor All Key enGene Patents JOAN CONNOLLY 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 William Grossman, M.D., Ph.D Interim Chief Medical Officer SVP, Oncology Clinical Development, Therapeutic Area Head, Gilead MATTHEW BOYD Chief Regulatory Officer VP, Head of Regulatory Affairs, Zambon USA VP, Regulatory Affairs, Albireo Pharma Corporate Presentation July 2026 Constantine Chinoporos Interim Chief Business Officer Chief Operating / Business Officer, Applied Therapeutics Chief Business Officer, Albireo Pharma
Detalimogene: Next Gen NMIBC Treatment Designed for Community Use Large Total Addressable Market Differentiated Total Product Profile Enhancing Detalimogene Near-Term Planned Catalysts $285M Cash Expect to Provide Operating Flexibility through Potential BLA Filing and Approval Corporate Presentation July 2026 NMIBC market forecasted to be >$20B Surfactant Bladder Rinse has Potential to Improve Efficacy, Duration and Reduce Patient Burden Pivotal Cohort 12-month Data Update Expected: 2H 2026 BLA Initiation Expected: 2H 2026 Potential Approval Decision & Platform Designation 2027 Demonstrated Clinical Activity, Favorable Safety, and a Streamlined Patient and Practice Experience Sources: Transparency market research NMIBC Market Outlook 2034.
July 2026
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