Slide 1: enGene Corporate Presentation
Exhibit 99.2 enGene Corporate Presentation MAY 17, 2023
Slide 2: Disclaimers
Disclaimers Disclaimer This investor presentation (this “Presentation”) is being made in connection with a potential business combination (the “Business Combination”) between Forbion European Acquisition Corp. (“FEAC”) and enGene, Inc. (“enGene”) to a limited number of parties who may be interested
Slide 3: Disclaimers continued: Industry and Market Data
Disclaimers continued 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. Neither FEAC nor enGene has independently verified the
Slide 4: Cautionary Statement Regarding Forward-Looking Statements
Disclaimers continued Cautionary Statement Regarding Forward-Looking Statements Some of the statements contained in this Presentation may constitute “forward-looking statements” and “forward-looking information”, as defined under applicable U.S. and Canadian securities laws, respectively (collective
Slide 5: enGene overview
enGene overview 5 | Confidential © 2023 | enGene
Slide 6: enGene: breaking barriers in genetic medicine
enGene: breaking barriers in genetic medicine NEXT GENERATION ADDRESSING COMPELLING VALUE EXPERIENCED MANAGEMENT NON-VIRAL GENE DELIVERY HIGH UNMET NEED PORTFOLIO ENHANCING CATALYSTS TEAM Ability to transfect tissues Lead indication addressing non- “Pipeline-in-a-product” Multiple potential catalyst
Slide 7: World-class leadership, investors and board of directors
World-class leadership, investors and board of directors enGene Leadership Team Investors JASON HANSON, CEO ANTHONY CHEUNG, CTO JAMES SULLIVAN, CSO Former Roles: Co-founder, enGene (CEO through 2018) Former Roles: Chief Executive Officer, Ohana Co-inventor on all key enGene patents VP, Pulmonary Dis
Slide 8: enGene: organ-localized non-viral genetic medicines for mucosal tissues
enGene: organ-localized non-viral genetic medicines for mucosal tissues Mucosal tissues are underserved by enGene’s DDX platform turns mucosal tissues into payload gene therapy production factories Nasopharynx Carcinoma Rhinitis Mucosal vaccines Respiratory Tract Cystic Fibrosis Asthma COPD Lung can
Slide 9: Next gen medicines as a solution to historical gene therapy challenges
enGene’s next gen medicines are a potential solution to historical gene therapy challenges CLEAR ADVANTAGES AND DIFFERENTIATION Getting beyond the Repeat dosing Bringing genetic medicines Scaled and scalable liver and muscle clinically validated to the mainstream manufacturing Current scale supports
Slide 10: Platform powers deep wholly-owned pipeline
Platform powers deep wholly-owned pipeline: genitourinary cancers and beyond Therapeutic Area and Program Administration Discovery IND-Enabling Phase 1/2 Anticipated Milestones ONCOLOGY Phase 1 endpoints met (2H2022) RP2D identified (2H2022) Fast Track Designation; Actively recruiting; BCG-unrespons
Slide 11: EG-70 addressing the unmet need in NMIBC
EG-70 (detalimogene voraplasmid) addressing the unmet need in NMIBC 11 | Confidential © 2023 | enGene
Slide 12: EG-70: clinical-stage program in a blockbuster indication
EG-70 (detalimogene voraplasmid): clinical-stage program in a blockbuster indication NMIBC is a clear unmet medical need Initial EG-70 pt. population Tis (carcinoma in situ) 2 Highest cost of all cancers to treat >550,000 new cases of bladder Ta (urothelium) 1 cancer per year BCG is the only approve
Slide 13: EG-70: dual-immune activator designed for efficacy in NMIBC
EG-70 (detalimogene voraplasmid) : dual-immune activator designed to produce meaningful efficacy in NMIBC RIG-I agonists: • Stimulate T cell recruitment and neo-antigen presentation • NK cell stimulation and suppressor cell attenuation promotes tumor killing environment • Clinical data with innate i
Slide 14: EG-70 in NMIBC Patients Who Are BCG-Unresponsive and High-Risk
EG-70 in NMIBC Patients Who Are BCG-Unresponsive and High-Risk NMIBC Patients Who Have Been Incompletely Treated With BCG or Are BCG-Naïve NCT04752722 We would like to thank the patients, their families, and all staff at participating sites enGene
Slide 15: FDA guidance: single-arm registrational study for BCG-unresponsive NMIBC
FDA guidance: single-arm registrational study for BCG-unresponsive NMIBC • The Agency’s position is that no therapy exists for BCG- unresponsive NMIBC • Clearly defined patient population and entry criteria for BCG-unresponsive NMIBC • Approval is based on complete response rate, durability, and saf
Slide 16: Phase 1/2 combined registrational study design
Phase 1/2 combined registrational study design enables speed to pivotal data and registration Phase 1 – completion 2H2022 Phase 2 – interim data 1H2024 N = <24 patients N ~100 patients Patients: High-risk NMIBC failed BCG, with Cis Patients: High-risk NMIBC failed BCG, with Cis EG-70 Dosing: 2 or 4
Slide 17: 71% Complete Response rate at 3-months with EG-70
71% Complete Response rate at 3-months with EG-70 in high grade NMIBC patients with CIS that are BCG-unresponsive ALL DOSE LEVELS CR at 15* and 18* months 3-Months: 71% CR (15/21) 1 DL1 6-Months: 42% CR (8/19) 2 (2x250µg) Patients continuing past 3-Months: 3 86% (18/21) 4 DL2 5 (2x800µg) 6 7 DL3 8 (
Slide 18: 71% Complete Response rate at 3-months with EG-70 (RP2D)
71% Complete Response rate at 3-months with EG-70 in high grade NMIBC patients with CIS that are BCG-unresponsive ALL DOSE LEVELS CR at 15* and 18* months 3-Months: 71% CR (15/21) 1 DL1 6-Months: 42% CR (8/19) 2 (2x250µg) Patients continuing past 3-Months: 3 86% (18/21) 4 DL2 5 RP2D: DL2’ 4X800 UG (
Slide 19: Urinalysis demonstrates EG-70 proof-of-mechanism
Urinalysis demonstrates EG-70 proof-of-mechanism Urine IL-12 in Phase 1 dose-escalation 1000 DL1 DL2 IL-12 quantified in all patients dosed to-date* 100 DL3 Drug is administered on Days 1 and 8 10 Urine collected prior to dosing 1 Dose-response, localized to the bladder Urine IL-12 levels in DL2 are
Slide 20: Position to optimize EG-70 RP2D based on efficacy and biomarkers
Excellent position to optimize EG-70 RP2D based on efficacy and biomarkers – not based on toxicity! Reported AEs to-date are largely consistent with instrumentation/intravesical administration Grade 1 AEs Grade 2 AEs Grade 3 AEs Grade 4 AEs Grade 5 AEs (moderate) (mild) (severe) (life-threatening) (
Slide 21: LEGEND study designed to include any CIS-containing NMIBC patient
LEGEND study designed to include any CIS-containing NMIBC patient Phase 1/2, pivotal single-arm open-label clinical trial to demonstrate safety and efficacy of EG-70 • In BCG-unresponsive NMIBC patients with Cis • In BCG naïve (or incompletely treated) NMIBC patients with Cis 2021 2022 2023 2024 202
Slide 22: Urologists play a central role in care throughout the patient journey
Urologists play a central role in care throughout the patient journey Treatment Diagnosis (multi-year window) High-grade NMIBC with carcinoma Blood in urine: in situ (CIS): referred to urologist start BCG induction course Standard diagnostic work-up: Repeat standard work-up at 3- cytology, cystoscop
Slide 23: Checkpoint inhibitors – not the first choice in NMIBC
Checkpoint inhibitors – not the first choice in NMIBC “With Grade 3 and 4 AEs at 13%, a patient is just as likely to have an autoimmune SAE as a durable CR” -Max Kates, MD, Director Bladder Cancer Program Johns Hopkins Medicine, on Keytruda (pembrolizumab) use in NMIBC Patients, n (%) Treatment N=96
Slide 24: Durability of complete response can be predicted from competitors
Durability of complete response can be predicted from competitors BCG-unresponsive monotherapy comparison Historical rates of CR attrition Complete Response Rates 3-months 6-months 12-months Pembrolizumab 41% CR 36% 18% Nadofaragene 51% N/A 23% firadenovec + Syn3 CG0070 + DDM N/A 47% 27% Pembrolizum
Slide 25: enGene is well-positioned to capture the NMIBC market
enGene is well-positioned to capture the NMIBC market BCG-unresponsive monotherapy comparison Historical rates of CR attrition Complete Response Rates EG-70 3-months 6-months 12-months Pembrolizumab 41% CR 36% 18% Nadofaragene 51% N/A 23% firadenovec + Syn3 CG0070 + DDM N/A 47% 27% Pembrolizumab Vic
Slide 26: EG-70 commercial potential in BCG-unresponsive NMIBC
EG-70 commercial potential in BCG-unresponsive NMIBC Novel non-viral Potential for superior Potential for highly Ease of use enables EG-70 intravesical efficacy against leading favorably safety access to community ✓✓✓✓ Target Profile monotherapy competitors profile urology clinics While the data are
Slide 27: LEGEND study is a platform to create an expansive oncology franchise
LEGEND study is a platform designed to create an expansive oncology franchise with EG-70 EG-70 provides a significant therapeutic advantage: locally harnessing the power of both arms of the immune system without systemic toxicity * (potential to accelerate with additional capital) Commercial Launch
Slide 28: EG-70 cured animals are protected from re-challenge
EG-70 cured animals are protected from re-challenge: demonstrates generation of anti-tumor immunity Bioluminescence after local intravesical rechallenge 85-days post-cure Naive control re-challenge 10 13 days post rechallenge 10 Naïve re-challenge mEG-70-cured re-challenge 8 10 6 10 4 10 mEG-70-cure
Slide 29: EG-70 systemic and antigen-specific protection
EG-70 systemic and antigen-specific protection Opens advanced disease: MIBC and Metastatic Disease MB49-Luc IVI IVI Re-challenge IVIS IVIS IVIS IVIS IVIS MB49-Luc instillation Tx1 Tx2 Study Day 1 10 17 73 80 86 94 101 108 mEG-70-cured : MB49-Luc SC re-challenge Disease mEG-70 induction mEG-70-cured
Slide 30: Opportunities for EG-70 expansion demonstrated
Opportunities for EG-70 expansion demonstrated Development of the route of POC Pharmacokinetics/ Efficacy administration For Pharmacodynamics Expression Peritoneal cavity (ovarian and other peritoneal cancers) Cervix Prostate Upper urinary tract Distal Colon Glioblastoma (Intratumoral Injection) Wit
Slide 31: Intraperitoneal administration in mice produces physiologically relevant IL-12
Intraperitoneal administration in mice produces physiologically relevant levels of IL-12 that produce desired downstream biology of immune activation Ovarian Cancer Disease Model Assessment Ongoing 200 200 8 0 190 PEG-RXG-N9 100 150 mEG-70 6 0 80 Dosed at 1mg DNA 100 4 0 60 40 2 0 50 20 0 0 0 Naive
Slide 32: Direct prostate injection in mice produces relevant IL-12 levels
Direct prostate injection in mice produces physiologically relevant levels of IL-12 that produce desired downstream biology of immune activation Prostate * ** 100 100 *** * ** * * * 10 10 1 1 0.1 0.1 0.01 0.001 0.01 Naive 0.6 ug 0.6 ug 0.6 ug 0.06 ug 0.6 ug 6 ug 60 ug Naive 0.6 ug 0.6ug 0.6 ug 0.06
Slide 33: Glioblastoma: preclinical rationale for EG-70 in additional solid tumors
Glioblastoma: Compelling preclinical rationale for EG-70 in additional solid tumor indications with high unmet medical need Survival in GL261 high- Survival after stereotactic re- grade glioma challenge with GL261 cells EG-70 mediates 80% survival in mice EG-70 mediates 100% survival in with high-gr
Slide 34: enGene platform is ideal for delivery to the lungs
enGene platform is ideal for delivery to the lungs CFTR mRNA expression in mouse lung Membrane depolarization in HEK293 cells transfected with CFTR construct and a dose-response of CFTR channel inhibitor 1000 800 hCFTR hCFTR hCFTR + DMSO (ctrl) hCFTR - DMSO ctrl 600 +10µM FSK hCFTR + 20µM Inh-172 hC
Slide 35: Combination enables achievement of major milestones
Combination enables achievement of major milestones Cash runway into 2025* Therapeutic Area and Program Administration Discovery IND-Enabling Phase 1/2 Anticipated Milestones ONCOLOGY Phase 1 endpoints met (2H2022) RP2D identified (2H2022) Fast Track Designation; Actively recruiting; BCG-unresponsiv
Slide 36: Appendix
Appendix 36 | Confidential © 2023 | enGene
Slide 37: Phase 1 study schema - design, dosing, and analysis
Phase 1 study schema - design, dosing, and analysis Overview Cohorts, dosing, and analysis Patients: High-risk NMIBC with CIS – failed BCG Dose-level 1 (N=3) - 250µg DNA/mL Dose-level 2 (N=3-6) - 800µg DNA/mL Treatment Cycle (SoC): 12 weeks Dose-level 3 (N=3-6) - 2,500µg DNA/mL EG-70 Dosing: -1 1 3
Slide 38: Prime dosing schedule - doses per 12-week cycle
Prime dosing schedule - 4 doses per 12-week cycle Hypothesis Frequency dose-escalation will lead to sustained exposure of the urothelium to EG-70 therapeutic payloads th Urinary IL-12 is sustained through the 4 dose Cohort, dosing, and analysis Drug is administered on weeks 1, 2, 5, and 6 Dose-level
Slide 39: DL2 prime 4-instillation regimen sustains urinary IL-12
DL2 prime 4-Instillation regimen results in sustained urinary IL-12 throughout the treatment cycle th Matched-pairs pre-post dosing Matched-pairs pre-post dosing (4 (first two doses) dose of 2-prime) 1000 1000 1000 DL2 (solid) DL2’ (dashed) 100 100 100 10 10 10 1 1 1 0.1 0.1 0.1 0.01 0.01 0.01 BLOQ
Slide 40: CXCL-10: urinalysis demonstrates EG-70 proof-of-mechanism
CXCL-10: urinalysis demonstrates EG-70 proof-of-mechanism Critical chemokine downstream of RIG-I activation important for T cell recruitment to the tumor microenvironment th Matched-pairs pre-post dosing Matched-pairs pre-post dosing (4 (first two doses) dose of 2-prime) 10000 10000 10000 DL2 (solid
Slide 41: Recommended Phase 2 dose selection parameters
Recommended Phase 2 dose selection parameters: safety, efficacy, and biomarkers SAFETY EFFICACY BIOMARKERS Primary endpoint (safety): A priori internal criteria for efficacy within a dose-level at Hypothesis: Week 12: • No observed dose-limiting toxicities in the • Increased dosing frequency with DL
Slide 42: EG-70 beyond mucosa
EG-70 beyond mucosa 42 | Confidential © 2023 | enGene
Slide 43: EG-70 efficacy by intra-tumoral injection in subcutaneous tumors
EG-70 exerts robust efficacy by intra-tumoral injection in subcutaneous tumors Expression & pharmacodynamic effect Efficacy Twice weekly intra-tumoral injections for three weeks Tumors collected 48 h after first the dose Tumor volume monitored as efficacy endpoint IL-12 protein IFNg protein Sham mEG
Slide 44: EG-70 preclinical and CMC data
EG-70 preclinical and CMC data 44 | Confidential © 2023 | enGene
Slide 45: EG-70 long term storage stability
EG-70 long term storage stability enables standard fridge and freezer usage for streamlined handling and logistics EG-70 stability EG-70 stability (-20°C) (5°C) Acceptance criteria Acceptance criteria Process used for Ph1 material Process used for Ph2 and launch material Lot 1 Lot 2 Lot 3 Lot 1 Lot
Slide 46: Multiple MoA of EG-70 result in profound antitumor efficacy
Multiple MoA of EG-70 result in profound antitumor efficacy Bioluminescence Experimental Design Survival (bladder tumor luciferase) Induction – 9 days Treatment Monitoring ns 10 10 Sham – 1% Mannitol 9 10 8 10 mEG-70 (5µg DNA/mL) 7 10 Luc-MB49 Cells 6 10 mEG-70 (20µg DNA/mL) 5 10 Instilled to induce
Slide 47: Expanded focus: EG-70 in bladder cancer patients with intact bladders
Expanded focus: EG-70 in patients with bladder cancer and intact bladders To prevent radical cystectomy, EG-70 could be used in all disease states non-muscle invasive disease • T1 • T2 • T3 • Possibly T4 when newly diagnosed Unique combination potential with expanded EG-70 focus Schematic created us
Slide 48: EG-70 induces dose-dependent target engagement in bladders
EG-70 induces dose-dependent target engagement in bladders of tumor-bearing mice Ifnb Ifna2 Ddx58 Irf7 Isg15 Cxcl10 Ifit1 Ccl5 Tnfa Ifng Strong dose-dependent induction of RIG-I and IL-12 signaling in bladders of tumor-bearing mice treated with EG-70 n=8/group; data are mean +/- SEM; Mann Whitney t-
Slide 49: Mechanism of action: NK cells, MDSC and TAM ratios
EG-70 mechanism of action: increased NK cell and reduced MDSC and TAM ratios in bladder tissue MDSC NK cells Myeloid Macrophage *** **** *** **** 10 80 40 40 60 30 30 5 40 20 20 20 10 10 0 0 0 0 Sham mEG-70 Sham mEG-70 Sham mEG-70 Sham mEG-70 NK cells activation/maturation Cytokine profile CD69+/KLR
Slide 50: Mechanism of action: T-cell recruitment and infiltration
EG-70 mechanism of action: T-cell recruitment and infiltration into tumor microenvironment Bladder Lymph node CD4 CD8 CD4 CD8 **** **** 15 25 30 30 *** **** 20 10 20 20 15 10 5 10 10 5 0 0 0 0 Sham mEG-70 Sham mEG-70 Sham mEG-70 Sham mEG-70 H&E CD3 CD4 CD8 Sham mEG-70 mEG-70 promotes an anti-tumor a
Slide 51: Depletion of helper T cells results in loss of anti-tumor activity
Depletion of helper T cells results in loss of anti-tumor activity Study MB49-Luc IVI IVI Termination instillation Tx1 Tx2 FACS to confirm depletion (blood) Study timeline -3 -2 -1 1 3 6 10 13 17 20 24 27 29 Anti-mouse CD4/CD8α intraperitoneal injection CD4 depleted animals Survival Bladder weight D
Slide 52: EG-70 target engagement: biomarkers translate across species
EG-70 induces strong target engagement of RIG-I and IL-12 signaling: biomarkers translate across species Ifng Tnfa Ifnb1 Irf7 Mouse Non-human primate Empty EG-70 Empty EG-70 Empty EG-70 Empty EG-70 Vector Vector Vector Vector Mouse data: n=8/group; data are mean +/- SEM; Mann Whitney t-test; tumor b
Slide 53: EG-70: profound efficacy with a clean safety profile
EG-70: profound efficacy coupled to a remarkably clean safety profile Toxicology studies did not reveal a maximum tolerated dose (MTD) • Mice - no adverse findings attributable to mEG-70 • Monkeys - very well-tolerated with no systemic findings; • Local findings limited to transient mild inflammatio
Slide 54: Additional lung program detail
Additional lung program detail 54 | Confidential © 2023 | enGene
Slide 55: Platform expansion to lung – Cystic Fibrosis
Platform expansion to lung – Cystic Fibrosis Significant number of patients lack Market need: functional CFTR for patients treatment despite Vertex agents with loss of function mutations not amenable to standard of care Cystic Fibrosis patients worldwide (86,430) EG-i08 Kalydeco-eligible on treatmen
Slide 56: enGene platform is ideal for delivery to the lungs
enGene platform is ideal for delivery to the lungs DNA copies in mouse lung Cell-type transfection in mouse lung Pneumocytes type 1 Dose (µg DNA/mL) 0 0.125 1.25 12.5 125 1000 RNA copies in mouse lung Pneumocytes type 2 Dose (µg DNA/mL) 0 0.125 1.25 12.5 125 1000 Dose-responsive transfection and exp
Slide 57: enGene breaking barriers in genetic medicine
enGene breaking barriers in genetic medicine
Slide 58: Risk factors
Risk factors 58 | Confidential © 2023 | enGene
Slide 59: Risk factors: Key Risks Relating to enGene Inc.
Risk factors Key Risks Relating to enGene Inc. Certain factors may have a material adverse effect on our business, financial condition, and results of operations. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or
Slide 60: Risk factors continued
Risk factors continued • Use of our novel gene therapy platform and therapeutic product candidates could result in or be associated with harmful side effects, adverse events or other safety risks, which could cause us to delay, suspend or discontinue their clinical trials and/or development or aband
Slide 61: Risk factors continued
Risk factors continued • We may not obtain or maintain regulatory approval in all jurisdictions in which such approval may be required. Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will obtain and/or maintain regulatory approval of
Slide 62: Risk factors continued
Risk factors continued • We expect certain of our research and development and manufacturing activities will take place in non-U.S jurisdictions, such as China, through third-party CROs, collaborators or manufacturers. A significant disruption in the operation of those CROs, collaborators or manufac
Slide 63: Risk factors continued: Acquisitions, Collaborations and Owning Our Stock
Risk factors continued Risks Related to Acquisitions and Collaborations • We may need to grow the size of our organization, both organically and through acquisitions, and we may experience difficulties identifying and hiring the right employees and successfully managing this growth. • Acquisitions,
Slide 64: Risk factors continued: Risks Related to Being a Public Company
Risk factors continued Risks Related to Being a Public Company • Our management team has no experience managing a public company. • We will incur increased costs as a result of operating as a public company, and our management will devote substantial time to new compliance initiatives. • Our managem