Genelux Corporation · NASDAQ:GNLX
Genelux — Investor Presentation (November 2024)
41 slides from Genelux's investor presentation, Nov 8, 2024
Slide 1: Redefining Immuno-Oncology
MeENELU™X Redefining Immuno-Oncology Corporate Presentation November 2024 yf /
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 Ge
Slide 3: Investment Highlights
hts 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 2 trial via systemic administration in recurrent non-small cell lung cancer (NSCLC) Ong
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 Antitumor Effect Ideal Backbone of routes of delivery and Well Tolerated Combination Therapy = Regional and Systemic Administration to «Strong ORR, mPFS & mOS* data
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) Olvi-Vec Indication (platinum resistant/ refractory) +Pla
Slide 6: Olvi-Vec Seeks to Unleash Immune System Against Cancer
Olvi-Vec Seeks to Unleash Immune System Against Cancer Key Takeaways IN oli. Innate adaptive NEVE Immune Activation Immune Activation viral infection Olvi-Vec is being developed as a alse taaaaUA® ana tllaiten UinST: COncolysis and *_increase Type IFNs + APCs present (neo}antigens utilizes a triple
Slide 7: Olvi-Vec-Primed Immunochemotherapy: Reversing Platinum Resistance
Olvi-Vec-Primed Immunochemotherapy: Reversing Platinum Resistance -Vec-Induced Hot Tumor Pro-therapeutic gene expression 3 ‘ Chemotherapy synergi [VIRO-15 Monotherapy Data] ° 2 Immunogenic cell death and Positive regulation of T-cell activating Pee Ponteenis recantigens® and trafficking! Expression
Slide 8: A Maturing Modality with Phase Companies Validating OV Potential
A Maturing Modality with Phase 3 Companies Validating OV Potential ENELUX Next Generation Delivery Regional & Systemic Administration , Phase 2 Ovarian Cancer Phase lb Solid Tumors Limitations of 1st Gen Viruses + Limited to local delivery and scope of addressable cancers Potential Clinical Advantag
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 » » Phase 1 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 rev
Slide 11: 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. Key Inclusion Criteria Multi-center, randomized open-label" Sot Progression-Free Survival * High-grade s
Slide 12: Completed Phase Ib Anti-tumor Activity as Monotherapy Leading into Combination
Completed Phase Ib Anti-tumor Activity as Monotherapy Leading into Combination Key Clinical Takeaways > » Median progression free survival (mPFS) of 6.1 months (median 4 prior lines; 95%CI: 2.2-NA) for the six patients in Cohort | virus monotherapy ~ the dose used in Phase 2. mPFS: 2. ELAHERE 1-3 pr
Slide 13: 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 14: Phase 2 Clinically Meaningful Responses in Heavily Pretreated Patients
Phase 2 Clinically Meaningful Responses in Heavily Pretreated Patients Key Clinical Takeaways » 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 15: Demonstrated Deep and Durable Tumor Shrinkage
Demonstrated Deep and Durable Tumor Sh nkage Key Clinical Takeaways » 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% reducti
Slide 16: Olvi-Vec-Primed Immunochemotherapy Overcomes Refractoriness
Olvi-Vec-Primed Immunochemothera Overcomes “Refractoriness” Exemplary platinum-refractory patients, after platinum re-challenge, 15B-01: + Stage IIIB papillary serous + ECOG: 0 + BRCA negative + PD-Li negative Overall Survival: 23.2 Months ee thief, oe cA oS Regimens achieved PFS exceeding any prior
Slide 17: Durable Survival Benefit
Durable Survival Benefit Prognosis Worsens with each Successive Line Historical Data? ELAHARE? b Baling BAA MOS OSC, WBBM oe Key Clinical Takeaways 10-4 Bline-129mOS__(95%Cl, 10.4-14.6) ating _9.8mOS __(959C1, 7.1-12.25) | 11.6 mos SF line Not reported N/A . "Woakenan ata, Gmesl Oneal 2057 OGSEES En
Slide 18: Phase 2 Compared to Approved Standard of Care in Earlier Line
Phase 2 Compared to Approved Standard of Care in Earlier Line SRST Elahere Elahere Olvi-Vec iN Phase 3 Phase 3 Phase 2 ini Phase 3 Key Clinical Takeaways (AURELIA Study) | (MIRASC ) | (SORAYA Study) (VIRO-15 Study) Patient Population PTogtessed <6 months _FRa positive and FRa positive and Platinum ~
Slide 19: Self Launch Olvi-Vec for Ovarian Cancer in the US
Self Launch Olvi-Vec for Ovarian Cancer in the US GB (=a Drivers of Market Penetration 8) Partnerships e Self-Manufacturing ©) Patients oe Reimbursement Leverage partnership with GOG Foundation Preeminent US-based cooperative group in Gynecologic Oncology Composed of leading KOLs in the field Partne
Slide 20: Systemic Administration Programs: Lung Cancers
Systemic G) Administration ENELUX Programs Lung Cancers
Slide 21: Systemic Administration Program
System ic Administration Program Key Takeaways » Ongoing and Planned Clinical Trials + Funding commitment by Newsoara of ae tho US seas] Canclunitars 2 trail in Sponsor ial Stes Indeation Clinical stage | Palari® | Randomization | Status NSCLC Recurrentiplatinum- ; ; us ICI failure NSCLC Phase 2 “14
Slide 22: 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 23: 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 Crite Multi-center, randomized open-label ~Safety and tolerability n=~110 + After receiving platinu
Slide 24: Systemic Administration Demonstrated Dose-dependent OS Benefit
Systemic Administration Demonstrated Dose-dependent OS Benefit Key Clinical Takeaways » Demonstrated feasibility and clinical benefit of multiple IV cycles = Median 5 prior lines of therapy . i : various dosing levels and schedules (typically over 4-6 months) Higher cumnulative-dose patients assigne
Slide 25: Systemic Administration + Chemo Generated Encouraging Data
Systemic Administration + Chemo Generated Encouraging Data 3 Cancer - ) AdventHealth | Institute * Expanded Access Program Key Clinical Takeaways Platinum refractory metastatic High-grade pancreatic cancer with cervical cancer with lung mets lung & liver mets a, Case Report PE #214-06) Case Report (
Slide 26: Industry Collaboration with Newsoara BioPharma Co., Ltd
Industry Collaboration with Newsoara BioPharma Co., Ltd NEWSGARA HIGHLIGHTS, 7 5 ENELUX > NEWSGARA BREDES Pipelines Phase IIb/III Indications Phase II Top 10 Blue-chip Biotech Investors Benny Li, PhD Founder and Chief Executive Officer 20+ yrs. global and China local pharma Former VP, GM of Takeda C
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 Key Trial Takeaways Biomedical, Inc. established to develop and test V2ACT. V2ACT Immunotherapy, Vaccination increases the numbers of neoantigen-sp
Slide 28: CHOICE Platform Library: 500+ Vectors with 110+ Transgenes
Choice Platform rary: 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 _ C
Slide 29: Intellectual Property: Market Exclusivity & Freedom to Operate
Intellectual Property: Market Exclusivity & Freedom to Operate Patent Portfolio: 20 issued patents & 7 pending applications; Olvi-Vec covered by Composition of Matter (2031*) and Manufacturing (2038) a Olvi-Vec: No third-party royalties due Regulatory Designations Long Duration of Regulatory / Marke
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 » Facilities and Operations based in Southern California + Large-scale manufacturing process + Capacity for clinical studies and commercial launch needs Translational Research * Clinical Science capabilities to suppor
Slide 31: Accomplished Leadership Team
Accomplished Leadership Team Executive Team Board of Directors THOMAS ZINDRICK, JD AMGEN. acromics Chairman ofthe Board noe JAMES L. TYREE, MBA 2 Semone kas Lead independent Director Fer Sano Thomas Zindrick, JD Lourie Zak Paul Scigalla, MD, PhD Sean Ryder, JD hf Chief Executive Officer Chief Financ
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 Regular Cadence of Important Program Milestones starting 2H, 2024 Executed Milestones IN Runway past expected PRROC topline results, and recurrent SCLC and NSCLC interim readouts Syndicate of healthcare institutions for lat
Slide 33: Appendix
MeENELU™X Redefining Immuno-Oncology Corporate Presentation | November 2024 \ \ Appendix
Slide 34: Accomplished Clinical Advisory Board
Accom lished Clinical Advisory Board Robert Holloway, MD CHAIRMAN Robert Coleman, MD Albert A. Mendivil, MD Memorial Hospital Presbyterian =(® Thomas J. Herzog, MD Gani awe Professor ona Dhision rector, ‘oho Stete ‘niversty ‘comprehensive David M. O'Malley, MD Forsyte & Beer, Alan Forsythe, PhD ie D
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) o Platinum refractory patients: 85% (11/13) o Platinum refractory patients: 85% (11/13) es pS
Slide 36: Olvi-Vec-Primed Immunochemotherapy Overcomes Refractoriness
Olvi-Vec-Primed Immunochemothera Exemplary platinum-refractory patients, after platinum re-challenge, achieved PFS exceeding any prior lines 1SB-15: + Stage IIB high- grade serous ECOG: 0 BRCA negative + PD-Li negative Overall Survival: 12.3 Months Overcomes “Refractoriness” ” Failed 6 Prior PFS (mo
Slide 37: Olvi-Vec Demonstrated Oncolysis and Immune Activation
Olvi-Vec Demonstrated Oncoly and Immune Activation Data from Phase Ib Monotherapy portion of VIRO-15 trial Key Takeaways » (Pt.#15A-01) (Pt.#15A-11) Elimination of Cancer Cells after Increased Lymphocyte Infiltration in different cavities peritoneal fluid pleural fluid i wave Olvi-Vec monotherapy sh
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 tria Pt# 15A-16 Pti# 15A-18 Pre-Olvi-Vec Post-Olvi-Vee (prior to subsequent chemotherapy) Endogenous TiLs (intra-tumoral and stromal) are very low in ovarian Pti 150-16 cance
Slide 39: Long lasting Tumor-specific T cell Response Corresponds to Tumor Reduction
Long lasting Tumo pecific T cell Response Corresponds to Tumor Reduction Data from Phase Ib Monotherapy portion of VIRO-15 trial co Confirms tumorantigen presentation Case Report (Pt #15A-05) 00 4 le — Key Takeaways IN - z Foie gimens of chemo+Avastin; BS M ia) no pre-existing tumor-specific T-cells
Slide 40: Olvi-Vec Demonstrated Anti-Tumor Response & Disease Control Observed
Olvi-Vec Demonstrated Anti-Tumor Response & Disease Control Observed Data from Phase Ib Monotherapy portion of VIRO-15 trial Target lesion SLD change overtime Individual target lesion change 40 —eP es —e— PR 30 lesion size from ba: Best change of in Patient ID # Overtime change of SLD from baseline
Slide 41: Olvi-Vec: Ideal Backbone for Combination Therapy
Olvi-Vec: Ideal Backbone for Combination Thera Converts Tumor Microenvironment to Inflammatory “Hot Spot” NCT01443260/TUE Study 6 a5 Induction of acute inflammatory a, cytokines 5, (Thi-type related) r ; VIRO-I15 Study i f ssc ‘mute ery single dose of virus PD-L1: VIRO-15 Study (monotherapy) Endogen