Genelux Corporation · NASDAQ:GNLX
Genelux — Investor Presentation (May 2024)
40 slides from Genelux's investor presentation, May 24, 2024
Slide 1: Redefining Immuno-Oncology
Redefining Immuno-Oncology Corporate Presentation May 2024
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 G
Slide 3: Highlights
Highlights Olvi-Vec: late-stage Clinical Program focused on Platinum Resensitization in Multiple Indications Ongoing pivotal Phase 3 trial in late-stage platinum resistant/refractory ovarian cancer (PRROC) Ongoing Phase 1b/2 trial via systemic in recurrent small cell lung cancer (SCLC) Planned Phase
Slide 4: The Most Advanced Non-local Delivery Oncolytic Immunotherapy
The Most Advanced Non-local Delivery Oncolytic Immunotherapy Olvi-Vec: 7 Completed Clinical Trials (>150 Patients) Physician-preferred routes of delivery = Regional and Systemic Administration to preferentially locate, colonize and destroy ‘tumor cells, including metastatic disease © IV therapy curr
Slide 5: Program Builds on Completed Trials to Exploit Competitive Advantages
Program Builds on Completed Trials to Exploit Competitive Advantages 3 Upcoming Trial Readouts have Potential to Redefine: >» Therapy (platinum resensitization in multiple indications) >» Modality (systemic administration of an oncolytic virus) {recurrent/platinum failure) *Platinum-based regimen Ov
Slide 6: Olvi-Vec Seeks to Unleash Immune System Against Cancer
Olvi-Vec Seeks to Unleash Immune System Against Cancer Key Takeaways IN Innate Adapti ;: pve Olvi-Vec Immune Activation Immune Activation viral infection Olvi-Vec is being developed as a robust immune modulator that Oncolysisand + Increase Type IFN 5 APC oreent nglangens utilizes a triple mode of ac
Slide 7: Pro-therapeutic gene expression
Pro-therapeutic gene expression [VIRO-15 Monotherapy Data] Positive regulation of T-cell activating and trafficking! Expression profiles (e.g., STAT1) correlated to better progno: Promotion of sensitization? / response to chemotherapy‘ ea (208) 8) 86-488) Olvi-Vec-Induced Hot Tumor “Prime & Boost” O
Slide 8: A Maturing Modality with Phase Companies Validating OV Potential
A Maturing Modality with Phase 3 Companies Validating OV Potential ENELUX > Next Generation Regional & Systemic Administration Phase 2 Ovarian Cancer Phase 1b Solid Tumors Limitations of 1st Gen Viruses + Limited to local delivery and scope of addressable cancers al Advantages of Olvi-Vec AMGEN | GC
Slide 9: Regional Administration Program: Ovarian Cancer
Regional G& Administration ENELUX Program Ovarian Cancer
Slide 10: Ovarian Cancer Program Regional (intraperitoneal) Delivery
Ovarian Cancer Program Regional (intraperitoneal) Delivery Key Takeaways IN + Phase I tested condensed dosing schedule and demonstrated tolerability with evidence of anti- tumor activity + Phase 2 demonstrated promising Overall Response Rate (ORR) and Progression Free Survival (PFS), and clinical re
Slide 11: Phase 1b: Anti-tumor Activity as Monotherapy Leading into Combination
P hase 1b: Anti-tumor Activity as Monotherapy Leading into Combination Key Clinical Takeaways IN + Median progression free survival (mes) of 6.1 months (median 4 prior lines; 95%CI: 2.2-NA) for the six patients in Cohort 1 virus monotherapy - the dose used in Phase 2. 1. SOC-AURELIA regimen prior li
Slide 12: Completed Phase 2 Tested Olvi-Vec-primed Immunochemotherapy
Completed Phase 2 Tested Olvi-Vec-primed Immunochemotherapy Heavily Pretreated Patients with Platinum-Resistant or Platinum-Refractory Ovarian Cancer Interventional Single Group Assignment 1. 2020 Digital Annual Meeting of International n=27 ‘Gynecologic Cancer Society + High-grade serous, endometri
Slide 13: Phase 2 Clinically Meaningful Responses in Heavily Pretreated Patients
Phase 2 Clinically Meaningful Responses in Heavily Pretreated Patients Key Clinical Takeaways IN Promising ORR and PFS, and clinical reversal of platinum resistance and refractoriness among patients with PRROC + All patients had documented progressive disease at enrollment + The mPFS of the patients
Slide 14: Demonstrated Deep and Durable Tumor Shrinkage
Demonstrated Deep and Durable Tumor Shrinkage 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 Key Clinical Takeaways + 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, 158-01: Stage IIIB papillary serous ECOG: 0 BRCA negative PD-Li negative Overall Survival: 23.2 Months achieved PFS exceeding any prior lines 15B-15: Stage IIIB high- grad
Slide 16: Durable Survival Benefit
Durable Survival Benefit IN Encouraging mOS and Long- term survival data Key Clinical Takeaways 20% long-term survivors consistent with clinically beneficial immunotherapies + Onamedian 5th line of treatment, VIRO-15 Phase 2 patients achieved a mOS of 15.7 mos + 4of 6 long-term survivors were platin
Slide 17: Seeking to Reset Life Clock of Heavily Pre-treated Patients
Seeking to Reset Life Clock of Heavily Pre-treated Patients Key Clinical Takeaways IN Olvi-Vec addresses a broad and underserved pool of patients + Olvi-Vec trial inclusion criteria allows patients regardless of i) tumor biomarkers, ii) platinum refractory tumors, or (iii) number of prior lines of t
Slide 18: Phase 3 Pivotal Trial Design Founded on Phase 2 Trial Design & Results
Phase 3 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. Primary Endpoint Key Inclusion Criteria n=186 + High-grade serous, endometrioid, or Progression-Free Sur
Slide 19: Self Launch Olvi-Vec for Ovarian Cancer in the US
Self Launch Olvi-Vec for Ovarian Cancer in the US | = = | (8) (@) ©) () Partnerships Self-Manufacturing Patients Reimbursement Leverage partnership Large-Scale cGMP. Underappreciated Compelling Value with GOG Foundation Manufacturing Population Proposition for Payors + Preeminent US-based * Control
Slide 20: Systemic Administration Programs: Lung Cancers
Systemic Gs Administration ENELUX Programs Lung Cancers
Slide 21: Systemic Administration Program
Systemic Administration Program Key Takeaways IN + Funding commitment by Newsoara of the US-based Genelux Phase 2 trial in NSCLC + Genelux has worldwide commercial rights (ex-Greater China) to alll clit data generated in China! + All patients in these trials will be treated systemically and have pre
Slide 22: Key Clinical Takeaways
S) Key Clinical Takeaways Demonstrated feasibility and clinical benefit of multiple IV cycles + Median 5 prior lines of therapy + Regimen: various dosing levels and schedules (typically over 4-6 months) + Well tolerated: no-MTD reached with one DLT * Duration of Treatment (DoT): Higher cumulative-do
Slide 23: Systemic Administration + Chemo Generated Encouraging Data
ystemic Administration + Chemo Generated Encouraging Data be Expanded Access Program Key Clinical Takeaways Anti-tumor effect of IV Immunochemotherapy + High and Condensed Dosing IN (single cycle: bolus infusion on 5 consecutive days) * Well tolerated: No DLT or MTD reached - Monotherapy: Anti-tumor
Slide 24: Phase 2 Trial in Recurrent Non-small Cell Lung Cancer
Phase 2 Trial in Recurrent Non-small Cell Lung Cancer Patients with Non-small Cell Lung Cancer after First Progression while on Front-Line Immune Checkpoint Inhibitor-based Maintenance Multi-center, randomized open-label =~142 Primary Endpoint Key Inclusion Criteria . Experimental Arm Progression-Fr
Slide 25: Phase 1b/2 Trial in Recurrent Small Cell Lung Cancer
Phase 1b/2 Trial in Recurrent Small Cell Lung Cancer Heavily Pretreated Patients with Platinum-Relapse or Platinum-Refractory Small Cell Lung Cancer Phase 1b Endpoints Primary Endpoint Key Inclusion Criteria Multi-center, randomized open-label ~ safety and tolerability =~110 * Prior failure of plati
Slide 26: Industry Collaboration with Newsoara BioPharma Co., Ltd
Industry Collabora n with Newsoara BioPharma Co., Ltd JENELUX NEWSOARA WREnES Benny Li, PhD inder and Chi 20+ yrs. global and China local pharma Former VP, GM of Takeda China Development Center and SVP, Executive > GM of R&D at Hansoh Pharmaceuticals. Former Head of Clinical Development & Medical Af
Slide 27: V2ACT Therapeutics LLC: Joint Venture between GNLX and TVAX BioMedical
V2ACT Therapeutics LLC: Joint Venture between GNLX and TVAX BioMedical VACT > V2ACT Therapeutics is a joint venture between Genelux Corporation and TVAX Biomedical, Inc. established to develop and test V2ACT. Key Trial Takeaways V2ACT Immunotherapy, Vaccination increases the numbers of neoantigen-sp
Slide 28: 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 _Cell Matrix Degradative Genes Immune Modularity Immune Re
Slide 29: Intellectual Property: Market Exclusivity & Freedom to Operate
Intellectual Property: Market Exclusivity & Freedom to Operate Patent Portfolio: 33 issued patents & 7 pending; HHA olvi-Vec covered by Composition of Matter (2031*) ++) and Manufacturing (2038) St ng IP . & Olvi-Vec: No third-party royalties due Regulatory Designations Long Duration of Regulatory /
Slide 30: Integrated R&D and Manufacturing Capabilities For Phase 3 And Launch
Integrated R&D and Manufacturing Capabilities For Phase 3 And Launch Facilities and Operations based in Southern California | Headquarters Westlake village CA; USA Key Takeaways IN + Large-scale manufacturing rocess + Capacity for clinical studies and commercial launch needs Translational Research *
Slide 31: Accomplished Leadership Team
Accom lished Leadershi Team Executive Team Board of Directors THOMAS ZINDRICK, JD (AMGEN. 2eromics Chairman ofthe Board ome ames L-TvREE, Me Bete nee Lead independent Director “SH anvote Thomas Zindrick, JD Lourie Zak Paul Scigalla, MD, PhD ‘Sean Ryder, JD hf Chief Executive Officer Chiet Financial
Slide 32: Genelux Has Executed on Multiple Milestones and is Positioned for the Future
Genelux Has Executed on Multiple Milestones and is Positioned for the Future Expected Operating Runway into 2Q 2025 — Regular Cadence of Important Program Milestones starting 2H, 2024 Executed Milestones IN / Executed on go public strategy and follow on, $41.7M raised 2H, 2025 me iin 2H, 2024 Toplin
Slide 33: Appendix
@HeNeELUx Redefining Immuno-Oncology Corporate Presentation | May 2024 Appendix
Slide 34: Accomplished Clinical Advisory Board
Accom lished Clinical Advisory Board oil Director, eynecoiogie ncaa astntioasn Concerns Robert Holloway, MD CHAIRMAN Chiat ect ffeee venium as Robert Coleman, MD ‘co-Diroctor, Bynccogie ‘oneoogy 00g emer fost resbyteran Albert A. Mendivil, MD Deputy rector ot ‘reunvarty cincmed cance Thomas J. Herzo
Slide 35: Olvi-Vec-primed Immunochemotherapy Anti-tumor Activity: CA-125 Biomarker
Olvi-Vec- primed Immunochemotherapy Anti-tumor Activity: CA-125 Biomarker Rapid, Common and Durable Responses CA-125 Decrease ORR by CA-125 © All PRROC Patients: 96% (25/26) © All PRROC Patients: 85% (22/26) © Platinum refractory patients: 85% (11/13) © Platinum refractory patients: 85% (11/13) ‘coa
Slide 36: Olvi-Vec-Primed Immunochemotherapy Overcomes Refractoriness
Olvi-Vec-Primed Immunochemotherapy Overcomes “Refractoriness” Exemplary platinum-refractory patients, after platinum re-challenge, achieved PFS exceeding any prior lines 158-15: Pt.158-15 (primary platinum-refractory HGSOC) sage hi trade serous 6 soto + £cog:0 Y start chemoyBevacumab BRCA negative F
Slide 37: Olvi-Vec Monotherapy Demonstrated Oncolysis and Immune Activation
Olvi-Vec Monotherapy Demonstrated Oncol Data from Phase Ib Monotherapy portion of VIRO-15 trial and Immune Activation Key Takeaways IN (PLHSAO) (PeHI5At1) Elimination of Cancer Cells after Increased Lymphocyte Infiltration in different cavities Olvi-Vec monotherapy shows J peritoneal fluid pleural f
Slide 38: CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response/Survival
CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response/Survival Data from Phase Ib Monotherapy portion of VIRO-15 trial Pee 154-16 Pt 154-18 Pti 154-23 —_ Le BS aoa as cDB+ cp4+ coB+ cp4+ css cD4+ Post-Olvi-Vee (prior to subsequent chemotherapy) Endogenous Tits (intra-tumoral and stromal
Slide 39: Long-lasting, Tumor-specific T cell Response Corresponds to Tumor Reduction
Long-lasting, Tumor-specific T cell Response Corresponds to Tumor Reduction Data from Phase Ib Monotherapy portion of VIRO-15 trial Key Takeaways IN Off-the-Shelf Personalized Medicine: Single Agent generates Individualized Results + Olvi-Vec induces favorable & long-lasting Tumor-specific T- cell R
Slide 40: Olvi-Vec: Ideal Backbone for Combination Therapy
Olvi-Vec: Ideal Backbone for Combination Thera Converts Tumor Microenvironment to Inflammatory “Hot Spot” NCT01443260/TUE Study Induction of acute inflammatory cytokines (ThI-type related) VIRO-15 Study ‘Massive inflammatory response after (C1D24) Baseline W105 w2010 W3017 single dose of virus Fold-