Genelux Corporation · NASDAQ:GNLX
Genelux — Investor Presentation (April 2024)
40 slides from Genelux's investor presentation, Apr 9, 2024
Slide 1: Redefining Immuno-Oncology
Redefining Immuno-Oncology Corporate Presentation April 2024 VA ye
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 21E 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: De-risked 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 via systemic in recurrent small cell lung cancer (SCLC) Planned
Slide 4: The Most Advanced Non-local Delivery Oncolytic Immunotherapy
The Most Advanced Non-local Delivery Oncol ic 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 © In Ovarian Cancer
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) Systemic Route Fars fs Foy Ant ated Indication Design Pre
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, including cancer stem cells * En
Slide 7: Olvi-Vec-Primed Immunochemotherapy: Reversing Platinum Resistance
Olvi-Vec-Primed Immunochemotherapy: Reversing Platinum Resistance Pro-therapeutic gene expression [VIRO-15 Monotherapy Data] Positive regulation of T-cell activating and trafficking! Expression profiles (e.g., STAT1) correlated to better prognosis? Promotion of sensitization? / response to chemother
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 y Phase 2 Ovarian Cancer Phase 1b Solid Tumors Limitations of 1st Gen Viruses + Limited to local delivery and scope of addressable cancers Clinical Advantages of Olvi-vec a
Slide 9: Regional Administration Program: Ovarian Cancer
Regional fs : Administration ENELUX Program Ovarian Cancer
Slide 10: Ovarian Cancer Program: Regional (Intraperitoneal) Delivery
Ovarian Cancer Program: Regional (Intraperitoneal) Delivery Key Takeaways IN + Phase | tested condensed dosing schedule and demonstrated tolerability with evidence of anti- tumor activity + Phase 2 demonstrated promising Objective Response Rate (ORR) and Progression Free Survival (PFS), and clinical
Slide 11: Phase 1b: Anti-tumor Activity as Monotherapy Leading into Combination
hase Ib: Anti-tumor Activity as Monothera Leading into Combination Key Clinical Takeaways IN * Median progression free survival (mers) of 6.1 months (median 4 prior lines; 95%C: 2.2-NA) for the six patients in Cohort I virus monotherapy - the dose used in Phase 2. 1 (-2)ptiorlines)> ~ mPFS: 6.7 mos
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 Data Presentations Interventional Single Group Assignment 1. 2020 Digital Annual Meeting of International n=27 Gynecologic Cancer Society + High-grade
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 enroliment + The mPFS of the patients
Slide 14: Demonstrated Deep and Durable Tumor Shrinkage
Demonstrated Deep and Durable Tumor Shrinkage Tumor Shrinkage wo LSS e SLL LeeLee Se Pe LL ELS 80 Baseline tumor burden as Sum of Longest Diameter of target lesions (mm) Key Clinical Takeaways IN Refractory patients performed as well as resistant patients Tumor Shrinkage * Overall, 86% of PRROC pati
Slide 15: Olvi-Vec-Primed Immunochemotherapy Overcomes "Refractoriness"
Olvi-Vec-Primed Immunochemotherapy Overcomes “Refractoriness” Exemplary platinum-refractory patients, after platinum re-challenge, 15B-01; Stage IIIB papillary serous ECOG: 0 BRCA negetive PD-L1 negative achieved PFS exceeding any prior lines 15B-15: Stage IIIB high- grade serous ECOG: 0 BRCA negati
Slide 16: Durable Survival Benefit
Durable Survival Benefit Prognosis Worsens with each Successive Line Historical Data? ELAHARE? Piling A mOS SRG TER ray Key Clinical Takeaways h» 104 Bling 129 m05__(95%€1, 10.4246) aline 98 mOS (95% C1, 7.1-12.25) | 11.6 mOS Stine Not reported N/A Basta A SRT Oa BATTS Encouraging mOS and 0.8 4 ASOR
Slide 17: Seeking to Reset Life Clock of Heavily Pre-treated Patients
Seeking to Reset Life Clock of Heavily Pre-treated Patients While clinical remissions are obtainable, a majority of patients will relapse. » Genelux looks to take an all-comers approach Key Clinical Takeaways _ 0% Olvi-Vec addresses a broad 60% [o> and underserved pool of 40% patients a L | a | | oe
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 Progression-Free Survival Key Inclusion Criteria Multi-center, randomized open-label" n
Slide 19: Self Launch Olvi-Vec for Ovarian Cancer in the US
Self Launch Olvi-Vec for Ovarian Cancer in the US ® 2") vy Self-Manufacturing Patients Reimbursement Partnerships Leverage partnership Large-Scale cGMP Underappreciated Compelling Value with GOG Foundation Manufacturing Population Proposition for Payors Preeminent US-based Control of Production + *2
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 all clinical data generated in China! + All patients in these trials will be treated systemically and have
Slide 22: Systemic Administration Demonstrated Dose-dependent OS Benefit
stemic Administration Demonstrated Dose-dependent OS Benefit » Dose Escalation Phase 1b Monotherapy Study in Solid Tumors Key Clinical Takeaways Progressed from Last Prior Therapy Demonstrated feasibility and clinical benefit of multiple IV cycles + Median 5 prior lines of therapy 7) Powe + Regimen:
Slide 23: Systemic Administration + Chemo Generated Encouraging Data
Systemic Administration + Chemo Generated Encouraging Data Cancer - AdventHealth | Incttute - Expanded Access Program Key Clinical Takeaways IN Platinum refractory metastatic High-grade pancreatic cancer with cervical cancer z mets lung & liver mets ay Gas Report Case Report (PEAZ1A-04) Anti-tumor e
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 n=~142 Primary Endpoint Progression-Free Survival Key Inclusion Criteria Experi
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 ~ Safety and tolerability Key Inclusion Criteria Multi-center, randomized open-label n=~110 + Prior failure of plat
Slide 26: Validating Industry Collaboration with Newsoara BioPharma Co., Ltd
Validating Industry Collaboration with Newsoara BioPharma Co., Ltd NEWSGARA HIGHLIGHTS 7 5 @Genevcux NEWSGARA URESERS Pipelines. Phase IIb/II Indications Phase I! $850 Million Valuation Top 10 Blue-chip Biotech Investors Benny Li, PhD Founder and Chief Executive Officer 20% yrs. global and China loc
Slide 27: 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 immunos
Slide 28: 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 Metastasis Suppressor Genes Therapeutic Genes
Slide 29: Intellectual Property: Market Exclusivity & Freedom to Operate
Intellectual Property: Market Exclusivity & Freedom to Operate Patent Portfolio: 33 issued patents & 7 pending; Hl olvi-Vec covered by Composition of Matter (2031*) Strong IP and Manufacturing (2038) ~< Olvi-Vec: Worldwide operating freedom; o No third-party royalties due Regulatory Designations (9
Slide 30: Integrated R&D and Manufacturing Capabilities For Phase 3 And Launch
Integrated R&D and Manufacturing Capabilities For Phase 3 And Launch Key Takeaways IN ES Facilities and Operations based in Southern California | Headquarters Westlake * Large-scale manufacturing process + Capacity for clinical studies and commercial launch needs Translational Research * Clinical Sc
Slide 31: Accomplished Leadership Team
Accomplished Leadership Team Executive Team Board of Directors THOMAS ZINDRICK JD aygey. aeromnics Chatman ofthe Board NX {JAMES L. TYREE, MBA & Marista yers Squid Lead Independent Director SZ) anvote Thomas Zindrick, JD Lourie Zak Paul Scigalla, MD, PhD ‘Sean Ryder, JD ira Chief Executive Officer C
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 NANA Executed on go public strategy and follow on, $41.7M raised Initiation of Phase 3 Trial in
Slide 33: Appendix
@eNeELUx Redefining Immuno-Oncology Corporate Presentation | April 2024 Appendix
Slide 34: Accomplished Clinical Advisory Board
Accomplished Clinical Advisory Board edies 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 principa
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) ‘one
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 Pt.158-15 (primary platinum-refractory HGSOC) 158-15: + Stage HIB high- grade serous 160 5000 + Ec0s:0 Y sar of cemo/sevacitumab +
Slide 37: Olvi-Vec Monotherapy Demonstrates Oncolysis and Immune Activation
Olvi-Vec Monotherapy Demonstrates Oncolysis and Immune Activation Data from Phase 1b Monotherapy portion of VIRO-15 trial Key Takeaways LN Olvi-Vec monotherapy shows decreased tumor cells and increase immune activation * Olvi-Vec treatment was able to dramatically decrease or eliminate tumor cells i
Slide 38: CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response/Survival
CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response/Survival Monotherapy portion Ptit 154-16 Pre-Olvi-Vec Post-Olvi-Vec {prior to subsequent chemotherapy) Endogenous Tits (intra-tumoral and stromal) are very low in ovaria cancer, ie, immunologically ‘cok = = H { 69 Baseline i 7 screen
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 1b Monotherapy portion of VIRO-15 trial = Canis tomaranigan presentation Case Report (Pt #15A-05) “= 1 le tivation “ Key Takeaways IN Heavily pre-treated: * ge J 9 prior regimens of chemotAvasti ” zs no pre-e
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 ye zg a5 Induction of acute inflammatory 3 4 cytokines i (ThI-type related) & > VIRO-15 Study an eo Baseline ‘Massive inflammatory Baseline W105 W2D10 w3017 respons ter (i0