Slide 1: Corporate Presentation September 2023
Exhibit 99.1 Corporate Presentation September 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”). Leerink Partners LLC ( Leerink ) is acting as lead c
Slide 3: Disclaimers continued
Disclaimers continued 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, copyr
Slide 4: enGene overview
enGene overview
Slide 5: enGene: moving genetic medicine into the mainstream
enGene: moving genetic medicine into the mainstream • Highly differentiated pivotal-stage lead program for NMIBC, specifically designed for community urology clinics • Potential multi-billion dollar market opportunity, initial entry via BCG-resistant NMIBC market • Non-viral, polymeric nanoparticle
Slide 6: enGene platform: localized, non-viral delivery of genetic medicines to mucosal tissues
enGene platform: localized, non-viral delivery of genetic medicines to mucosal tissues and surfaces Mucosal tissues are underserved by Product platform tailored for streamlined, traditional gene therapy yet can be tissue-specific administration accessed via local administration Nasopharynx Carcinoma
Slide 7: DDX platform turns mucosal tissues into payload production factories
DDX platform turns mucosal tissues into payload production factories to drive local expression of therapeutic cargos Dually Derivatized Oligochitosan (DDX) • Non-immunogenic nanoparticle • Functionalized oligomeric chitosan • Proprietary to enGene with strong IP portfolio Non-viral plasmid-based the
Slide 8: Advancing genetic medicine into the mainstream through clear advantages and differentiation
Advancing genetic medicine into the mainstream through clear advantages and differentiation Clinically Tested Scaled and Scalable Designed for Use in Local Administration for Repeat Dosing Manufacturing Community Clinics Organ Localized Disease • Does not require pre-wash or • Consistent protein • L
Slide 9: Multiple near-term clinical milestones
Multiple near-term clinical milestones Therapeutic Area and Program Administration Discovery IND-Enabling Phase 1/2 Phase 3 Anticipated Milestones ONCOLOGY Phase 2 FPI (1H2023) Fast Track Designation; ** BCG-unresponsive NMIBC N/A Intravesical 68% CR rate at 3-months Phase 2 interim efficacy (Mid 20
Slide 10: EG-70 (detalimogene voraplasmid): addressing unmet needs in NMIBC
EG-70 (detalimogene voraplasmid): addressing unmet needs in NMIBC
Slide 11: Potential multi-billion dollar market opportunity in NMIBC
Potential multi-billion dollar market opportunity in NMIBC NMIBC remains a substantial unmet medical need 2 • Highest cost of all cancers to treat • >82K new diagnoses of bladder cancer per year in • 50% of patients fail BCG, only 1 USA, with 16K deaths approved first-line treatment • BCG shortage h
Slide 12: EG-70: Urologist-friendly non-viral dual-immune activator for NMIBC
EG-70: Urologist-friendly non-viral dual-immune activator for NMIBC designed to slot into the standard of care RIG-I agonists: • NK cell stimulation and suppressor cell attenuation promotes tumor killing environment • Clinical data with innate immune activators support biological rationale • Stimula
Slide 13: EG-70 in NMIBC Patients Who Are BCG-Unresponsive and High-Risk NMIBC Patients
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
Slide 14: FDA guidance: single-arm, open-label design appropriate for BCG-unresponsive NMIBC
FDA guidance: Use of a single-arm, open-label design is appropriate for approval for BCG-unresponsive NMIBC • Clearly defined patient population and entry criteria for BCG-unresponsive NMIBC provided by guidance • Approval based on complete response rate, duration of response, and safety • Pivotal P
Slide 15: Phase 1/2 registrational study design and fast track designation support BLA submission
Phase 1/2 combined registrational study design and fast track designation support BLA submission in mid-2025 Phase 1 – Primary, Secondary Endpoints Completed Phase 2 – Interim Data Mid-2024 N = <24 N ~100 : Patients: Patients High-risk NMIBC failed BCG, with Cis High-risk NMIBC failed BCG, with Cis
Slide 16: Data from ongoing Phase 1: 68% complete response rate at 3-months
Data from ongoing Phase 1: 68% complete response rate at 3-months Data cutoff 8.22.2023; **E means ‘expansion’; † , Patient or physician declined to continue on investigational agent to pursue other modes of treatment (e.g., surgery) † † , One additional patient was dosed in this group but later dee
Slide 17: Data from ongoing Phase 1: 68% complete response rate at 3-months
Data from ongoing Phase 1: 68% complete response rate at 3-months Data cutoff 8.22.2023; **E means ‘expansion’; † , Patient or physician declined to continue on investigational agent to pursue other modes of treatment (e.g., surgery) † † , One additional patient was dosed in this group but later dee
Slide 18: EG-70 proof-of-mechanism: organ-localized production of IL-12
EG-70 proof-of-mechanism: Urine and plasma analysis demonstrates organ-localized production of IL-12 Urine IL-12 in Phase 1 dose-escalation 1000 Dose Level 1 Dose Level 2 Dose Level 3 100 Dose response, localized to the bladder • No clinically significant IL-12 detected in 10 plasma • Urine IL-12 le
Slide 19: EG-70's safety profile allowed dose selection based on efficacy and biomarkers
EG-70’s safety profile allowed dose selection based on efficacy and biomarkers – not toxicity (no DLTs observed) Grade 1 AEs Grade 2 AEs Grade 3 AEs Grade 4 AEs Grade 5 AEs (mild) (moderate) (severe) (life-threatening) (result in death) Aggregate Data 99 29 4 0 0 (N, all dose-levels) • UTI (17%) • R
Slide 20: Urologists play a central role in the multi-year patient journey
Urologists play a central role in the multi-year patient journey from diagnosis onward, with the goal of avoiding radical cystectomy Urology Referral and Diagnosis High-grade NMIBC with carcinoma in situ (CIS): Begin intravesical therapies Treatment: Surveillance: Exhaustion of intravesical options,
Slide 21: Patient / clinician-friendly profile ideal for community urology clinics
Patient / clinician-friendly profile ideal for community urology clinics Product Attribute EG-70 CG0070+DDM Adstiladrin TAR-200 Does not require repeated burdensome placement and ü ü X ü removal of indwelling intravesical device Active ingredient not used in earlier lines of therapy ü ü X ü Common s
Slide 22: EG-70's profile potentially makes it ideal for use in community urology clinics
EG-70’s patient- and clinician-friendly profile potentially makes it ideal for use in community urology clinics Designed to slot into standard of care: Requires no shift in practice for ✓ community urologists Non-viral, lyophilized drug product: No heightened exposure risks to clinicians, ✓ ◦ staff,
Slide 23: LEGEND study will act as launchpad for an expansive EG-70 franchise
LEGEND study will act as launchpad for an expansive EG-70 franchise • Potent yet local immune system stimulation • Stimulation of adaptive and innate immune system via dual IL-12/RIG-I activation • Strong preclinical evidence of immunological memory Intermediate st • Favorable safety profile based o
Slide 24: Combination: Pro forma valuation and ownership
Combination: Pro forma valuation and ownership Illustrative Pro Forma Valuation Transaction Overview (mm, except per share values) • Forbion European Acquisition Corp. to combine with enGene at an Share Price $10.25 (1) implied $90 mm pre-money equity value (5) (2) Pro Forma Shares Outstanding 33.6
Slide 25: World-class leadership and investors
World-class leadership and investors enGene Leadership Team Selected Investors JASON HANSON, JD ANTHONY CHEUNG, Ph.D JAMES SULLIVAN, Ph.D Chief Executive Officer Chief Technology Officer Chief Scientific Officer Chief Executive Officer, Ohana Co-founder, enGene (CEO through 2018) VP, Pulmonary Disco
Slide 26: Summary
Summary • Highly differentiated pivotal-stage lead program for NMIBC, specifically designed for community urology clinics • Potential multi-billion dollar market opportunity, initial entry via BCG-resistant NMIBC market • Non-viral, polymeric nanoparticle with streamlined, scalable manufacturing and
Slide 27: Corporate Presentation September 2023
Corporate Presentation September 2023
Slide 28: Appendix
Appendix
Slide 29: Checkpoint inhibitors – not the first choice in NMIBC due to toxicity
Checkpoint inhibitors – not the first choice in NMIBC due to toxicity “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 (%
Slide 30: EG-70 preclinical and CMC data
EG-70 preclinical and CMC data
Slide 31: Multiple MoA of EG-70 result in profound antitumor efficacy in mouse model
Multiple MoA of EG-70 result in profound antitumor efficacy in mouse model 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 Inst
Slide 32: EG-70 cured animals are protected from re-challenge
EG-70 cured animals are protected from re-challenge: demonstrates generation of antigen specific anti-tumor immunity Treatment with mEG-70 results in long-lasting anti-tumor response as demonstrated by protection from tumor re-challenge 32 Quantifiable total flux signal below background radiance
Slide 33: 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 Bladder weight Survival D
Slide 34: EG-70 induces dose-dependent target engagement in bladders of tumor-bearing mice
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 35: EG-70 mechanism of action: increased NK cell and reduced 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 Cytokine profile NK cells activation/maturation CD69+/KLR
Slide 36: EG-70 mechanism of action: T-cell recruitment and infiltration
EG-70 mechanism of action: T-cell recruitment and infiltration into tumor microenvironment CD4 CD8 CD4 CD8 **** **** 15 25 30 30 *** **** 20 10 20 20 Bladder 15 Lymph node 10 5 10 10 5 0 0 0 0 Sham mEG-70 Sham mEG-70 Sham mEG-70 Sham mEG-70 CD3 H&E CD4 CD8 Sham mEG-70 mEG-70 promotes an anti-tumor a
Slide 37: EG-70 induces strong target engagement of RIG-I and IL-12 signaling across species
EG-70 induces strong target engagement of RIG-I and IL-12 signaling: biomarkers translate across species Ifng Ifnb1 Irf7 Tnfa 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 38: EG-70 Preclinical Profile: efficacy coupled to a clean safety profile
EG-70 Preclinical Profile: 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 transi
Slide 39: Additional lung program detail
Additional lung program detail
Slide 40: DDX platform versatility creates potential for partnerships around new indication spaces
enGene’s DDX platform versatility creates potential for partnerships around new indication spaces CFTR mRNA expression in mouse lung Membrane depolarization in HEK293 cells transfected with CFTR construct and a dose-response of CFTR channel inhibitor 5 10 1000 4 10 800 hCFTR hCFTR 3 10 hCFTR + DMSO
Slide 41: DDX platform versatility creates potential for partnerships around new indication spaces
enGene’s DDX platform versatility creates potential for partnerships around new indication spaces DNA copies in mouse lung Cell-type transfection in mouse lung 8 10 7 10 6 10 5 10 4 10 3 10 2 Pneumocytes type 1 10 1 10 0 10 -1 10 Dose (µg DNA/mL) 0 0.125 1.25 12.5 125 1000 RNA copies in mouse lung 6
Slide 42: Risk factors
Risk factors
Slide 43: Risk factors
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 44: Risk factors continued
Risk factors continued • Our most advanced product candidates are complex to manufacture and we may encounter difficulties in production, particularly with respect to scaling our manufacturing capabilities. If we or any of our third-party manufacturers with whom we contract encounter these types of
Slide 45: Risk factors continued
Risk factors continued • Global economic uncertainty, changes in geopolitical conditions and weakening product demand caused by political instability, changes in trade agreements and disputes, such as the conflict between Russia and Ukraine and other macroeconomic factors, could adversely affect our
Slide 46: Risk factors continued
Risk factors continued Risks Related to Being a Public Company • The combined company’s management team is expected to have limited experience managing a public company, and the additional requirements for public companies may strain resources and divert management’s attention. • There are risks to
Slide 47: enGene
enGene