Genelux Corporation · NASDAQ:GNLX
Genelux — Investor Presentation (July 2023)
38 slides from Genelux's investor presentation, Jul 19, 2023
Slide 1: Redefining Immuno-Oncology: Corporate Presentation July 2023
@HeNELUx Redefining Immuno-Oncology Corporate Presentation | July 2023
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21£ of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections, about Ge
Slide 3: Highlights of Genelux Execution
Highlights of Genelux Execution Olvi-Vec: De-risked late-stage Clinical Program ‘Ongoing pivotal trial in late-stage Ovarian Cancer and planned Phase 2 trial Adjuvant Maintenance NSCLC CHOICE™ Platform; Broad and Diverse Discovery Engine Library with over 500 novel vaccinia strains and 110+ transgen
Slide 4: The Most Advanced Non-local Delivery Oncolytic Immunotherapy
The Most Advanced Non-local Delivery Oncolytic Immunotherapy Olvi-Vec: Engineered to selectively target and eliminate tumor cells while inducing a robust patient-specific immune response Physician-preferred Routes of Delivery © Regional and systemic administration to preferentially locate, colonize
Slide 5: Diversified Designs and Indications Exploit Competitive Advantages
Diversified Designs and Indications Exploit Competitive Advantages Olvi-Vec Human Health Design _ Preclinical Phase 1 Phase 2 Phase 3 Collaborators Ovarian Cancer (piotinum-resistant/refractory) Regional Route Gove Ph3 OnPrime/GOG-3076 Study Actively Enrolling GOG: (Cooperative Group) ‘Non-Small Cel
Slide 6: Selective Replication In Tumors Unleashes Immune System Against Cancer
Selective Replication In Tumors Unleashes Immune System Against Cancer Key Takeaways IN Olvi-Vec is a robust immune modulator that utilizes a triple mode of action to mount a personalized attack against cancer cells throughout the body + Kills cancer cells directly + Enhances (neo)antigen yesamielii
Slide 7: Olvi-Vec-Primed Immunochemotherapy: Overcoming Drug Resistance
Olvi-Vec-Primed Immunochemotherapy: Overcoming Drug Resistance Pro-therapeutic gene expression ° emotherapy synergy > Positive regulation of T-cell activating Enipboeenic cell death and trafficking 5 i Depletion of suppressor cells > Inhibition of anti-virus response fnereeterstisceptibility to cyto
Slide 8: Over $4 Billion in Transactions in Active Oncolytic Space
Over $4 Billion in Transactions in Active Oncolytic Space Emerging Late-Stage Modality With its recent IPO, Genelux joined the public markets as a Phase 3 company SCG <!} Replimune ‘A maturing field with Amgen launching imlygic in 2014 and Phase 3 companies (CG Oncology, Replimune, GNLX) working to
Slide 9: Competitive Advantages of Olvi-Vec as an Oncolytic Virus
Compet ive Advantages of Olvi-Vec as an Oncolytic Virus Key Takeaways IN Oncolytic Virus Space Olvi-Vec Key Advantages: Key Players and Assets Olvi-Vec Key Advantages + Broad spectrum of activity DENELUD oWievex: . A ivi Target & Treat Metastatic Disease Tumor Galssitiiay AMGEN. Herpes 7 Sees activi
Slide 10: Creating a New Paradigm of Oncolytic Virus Drug Development
Creating a New Paradigm of Oncolytic Virus Drug Development ~@eENELUXx Our Advantage Target & Treat Metastatic Diseases AMGEN T-VEC (approved) in melanoma gains first clinical and regulatory validation of an oncolytic virus Systemic Dosing and Redosing 7 completed clinical trials 150 patients Robust
Slide 11: Phase Ib: Anti-tumor Activity as Monotherapy Leading into Combination
Phase Ib: Anti-tumor Activity as Monotherapy Leading into Combination Olvi-Vec Monotherapy (11 patients) Patient Background & >» Study Treatment Tolerabilit + No Maximum Tolerated Dose (MTD) + No Grade 4 Adverse Events (AE) & + No Dose Limiting Toxicity (DLT) Platinum-resistant / refractory ovarian
Slide 12: Completed Phase 2 Tested Olvi-Vec Immunochemotherapy
Completed Phase 2 Tested Olvi-Vec Immunochemothera Olvi-Vec Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer Data Presentations Oral Plenary Session Design + High-grade serous, endometri ae 2. JAMA Oncology eect i Olvi-Vec in comb
Slide 13: Clinically Meaningful Responses in Heavily Pretreated Patients
Clinically. Meaningful Responses in Heavily Pretreated Patients IN Promising ORR and PFS, and clinical reversal of platinum resistance and refractoriness among patients with PRROC’ Key Clinical Takeaways + All patients had documented progressive disease at enrollment * Overall response rate in 27 pa
Slide 14: Demonstrated Deep and Durable Tumor Shrinkage
Demonstrated Deep and Durable Tumor Shrinkage Key Clinical Takeaways IN Refractory patients performed as well as resistant patients Tumor Shrinkage + Overall, 86% of PRROC patients showed tumor reduction, with 91% of Platinum-refractory patients showing tumor reduction + Four patients had 100% reduc
Slide 15: Olvi-Vec-Primed Immunochemotherapy Overcomes Refractoriness
Olvi-Vec-Primed Immunochemothera Overcomes “Refractoriness” Exemplary platinum-refractory patients, after platinum re-challenge, achieved PFS exceeding any prior lines 158-01: Stage IIIB papillary serous ECOG: 0 BRCA negative PD-L1 negative Falledi0 Priorlines .. 160 140 na Yy Dy 15B-15: Stage IIIB
Slide 16: Durable Benefit of Overall Survival via Clinically-Validated Endpoint
Durable Benefit of Overall Survival via Clinically-Validated Endpoint Key Clinical Takeaways IN 20% long-term survivors consistent with commercially successful immunotherapies * Historical data in 4th line and beyond shows a median overall survival of only 9.8 months » Ona median Sth line of treatme
Slide 17: "All-comers" Approach May Reset Life Clock of Heavily Pre-treated Patients
“Allcomers” Approach May Reset Life Clock of Hea Mi Pre-treated Patients Key Trial Takeaways Olvi-Vec addresses a broad and underserved pool of patients * Olvi-Vec trial inclusion criteria allows patients regardless of 0 tumor biomarkers, (ii) platinum refractory tumors or (iii) number of prior line
Slide 18: Phase 3 Pivotal Trial Design Founded on Phase 2 Trial Design & Results
Phase 83 Pivotal Trial Design Founded on Phase 2 Trial Design & Results Trial design intends to replicate previous data showing anti-tumor activity of Olvi-Vec and reversal of platinum resistance in the tumor microenvironment Key Inclusion Criteria Multi-center, randomized open-label 86 + High-grade
Slide 19: Systemic administration demonstrated dose-dependent OS benefit
Systemic administration demonstrated dose-dependent OS benefit >» Dose Escalation Phase 1b Monotherapy Study in Solid Tumors Key Trial Takeaways Progressed from Last Prior Therapy Demonstrated feasibility and clinical benefit of multiple lV cycles * Median 5 prior lines of therapy - Regimen: various
Slide 20: Systemic Administration + Chemo Generated Encouraging Data
Systemic Administration + Chemo Generated Encouraging Data Key Trial Takeaways LN Anti-tumor effect of IV Immunochemotherapy + High and Condensed Dosing Sine cycle: bolus infusion on 5 consecutive days) * Well tolerated: No DLT or MTD reached Monotherapy: Anti-tumor effects * Combination therapy: Vi
Slide 21: Genelux has Partnered with Newsoara BioPharma Co., Ltd
Genelux has Partnered with Newsoara BioPharma Co., Ltd NEWSGARA HIGHLIGHTS 7 Pipelines 12 Indications 5 Phase IIb/III 2 Phase II @enecux NEWSGARA UR ESES $850 2023 Million Valuation Top 10 Blue-chip Biotech Investors Benny Li, PhD Founder and Chief Executive Officer 20+ yrs. global and China local p
Slide 22: Validating Industry Collaboration with Newsoara BioPharma Co., Ltd
Validating Industry Collaboration with Newsoara BioPharma Co., Ltd Key Takeaways IN - Newsoara will fully fund the US-based Genelux Phase 2 trial in NSCLC » Newsoara has development and commercialization rights in Greater China + Interim readout for _ one or more systemic administration trials expec
Slide 23: V2ACT Therapeutics LLC: Joint Venture between GNLX and TVAX BioMedical
V2ACT Therapeutics LLC: Joint Venture between GNLX and TVAX BioMedical Key Trial Takeaways IN V2ACT Immunotherapy, combines an oncolytic immunotherapy and adoptive cell therapy * Induces an acute inflammatory response in the tumor and converts tumor microenvironment from immunosuppressive to. immuno
Slide 24: Estimated Billion Dollar Plus Annual Olvi-Vec Commercial Opportunity (US)
Estimated Billion Dollar Plus annual Olvi-Vec Commercial Opportunity (us) Ovarian Cancer Market? Ovarian Cancer See A. Non-Small Cell Lung Cancer $1.8B expected CAGR growth ~23.5% Additional revenue drivers: > Re-treatment > Front-Line therapy + Additional Indications, i.e.: women in the US currentl
Slide 25: Integrated R&D and Manufacturing Capabilities For Phase 3 And Launch
Integrated R&D and Manufacturing Capabilities For Phase 3 And Launch Large-Scale cGMP Manufacturing >» Process to Optimize Production Key Takeaways Hesdouartere ‘Manufacturioe ERD y * Established ancl equipped on ee oa Ss rey 2 independent, rapoty a controlled 7,800." Manufacturin facilly ‘in san Di
Slide 26: Commercial Strategy
Commercial Strategy Self Launch Olvi-Vec for Ovarian Cancer in the US Partnerships Self-Manufacturing Patients Reimbursement Leverage partnership with GOG Foundation + Preeminent US-based cooperative group in Gynecologic Oncology + Composed of leading KOLs in the field * Partners in the ‘OnPrime/GOG
Slide 27: CHOICE Platform Library: 500+ Vectors with 110+ Transgenes
Choice Platform Library: 500+ Vectors with 110+ Transgenes Engineered and selected clonal isolated (non-GMO) viral strains identified from in vitro and in vivo selection criteria Virus-encoded transgenes Cell Growth & Differentiation Regulators Hormones Therapeutic Genes Metastasis Suppressor Genes
Slide 28: Intellectual Property: Market Exclusivity & Freedom to Operate
Intellectual Property: Market Exclusivity & Freedom to Operate T| Patent Portfolio: 39 issued patents; a Olvi-Vec covered by Composition of Matter (2031) and Manufacturing (2038) Strong IP “< Olvi-Vec: Worldwide operating freedom; Regulatory S No third-party royalties due Designations Long Duration
Slide 29: Accomplished Leadership Team
Accomplished Leadership Team Executive Team ®) Board of Directors ‘ THOMAS ZINDRICK, 1D fea. SS Thomas Zindrick, JD Paul Scigalla, MD, PhD Doug Samuelson ‘Sean Ryder, JD ‘Chairman of the Board DNX Chief Executive Officer Chie Medical oicer Chief Financial Officer General Counsel SPficer ATHELSINN JA
Slide 30: Genelux Has Executed on Multiple Milestones and is Positioned for the Future
Genelux Has Executed on Multiple Milestones and is Positioned for the Future Executed Milestones IN Executed on go public strategy e and follow on with $60M raised @ Initation of Phase 3 Trial in ( } PRROC Phase 2 results published in JAMA Oncology e Collaboration and License agreement with Newsoara
Slide 31: Expected Operating Runway into 1Q 2026
Expected Operating Runway into 1Q 2026 Capitalization Summary Analyst Coverage Stock Symbol GNLX * Bruce Jackson M.S., MBA Share Price) $28.89 The Benchmark Company Shares Outstanding 25.98M * Kemp Dolliver CFA BROOKLINE CAPITAL MARKETS. Market Capitalization $750M 2023 Financing Events Cash & Equiv
Slide 32: Highlights of Genelux Execution
Highlights of Genelux Execution Olvi-Vec: De-risked late-stage Clinical Program ‘Ongoing pivotal trial in late-stage Ovarian Cancer and planned Phase 2 trial Adjuvant Maintenance NSCLC CHOICE™ Platform; Broad and Diverse Discovery Engine Library with over 500 novel vaccinia strains and 110+ transgen
Slide 33: Appendix
@HeNELUx Redefining Immuno-Oncology Corporate Presentation | July 2023 Appendix
Slide 34: Accomplished Clinical Advisory Board
Accomplished Clinical Advisory Board ‘uodical oreetor Robert Holloway, MD CHAIRMAN Robert Coleman, MD. Member Albert A. Mendivil, MD Member ‘Thomas J. Herzog, MD Chief Executive Officer David M. O'Malley, MD Chief Medical Officer ‘Alan Forsythe, PhD Chief Financial Officer Dr. Holloway is the princi
Slide 35: Olvi-Vec Demonstrates Monotherapy Oncolysis and Immune Activation
Olvi-Vec Demonstrates Monotherapy Oncolysis and Immune Activation b {VIRO-15: monotherapy) Key Takeaways (PL#IBA-O1) (PL#5A-11) Elimination of Cancer Cells after Increased Lymphocyte Infiltration in different cavities peritoneal fluid pleural fluid Priorto1" 4 Olvi-Vec monotherapy shows decreased tu
Slide 36: CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response/Survival
CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response/Survival Pt# 15A-16 Pt# 154-18 Pt# 15A-23 Pre-Olvi-Vec Post-Olv-Vee (prior to subsequent chemotherapy) Endogenous TiLs (intra- tumoral and stromal) are very low in ovarian cancer Pt# 15A-16 Pt# 15A-18 14 426 45 Baseline Screening 109
Slide 37: Long-lasting Tumor-specific T cell response corresponds to tumor reduction
Long-lasting Tumor-specific T cell response corresponds to tumor reduction (VIRO-15: monotheraay) ‘TilansTumaraniigenpreseniaion Case Report (Pt #15A-05) = ‘& immune activationir pd Heavily pre-treated: = . Key Takeaways 9 prior regimens of chemo+Avastin; a no pre-existing tumor-specific T-cells p z
Slide 38: Olvi-Vec: Ideal Backbone for Combination Therapy
n Thera Olvi-Vec: Ideal Backbone for Combina Converts Tumor Microenvironment to Inflammatory “Hot Spot” NCT01443260/TUE Study g gs Induction of acute inflammatory a, cytokines §, (ThI-type related) on = VIRO-15 Study 30 a, Baseline Massive inflammatory Baseline W1DS w2D10 w3017, amore after oyce 1 o