Genelux Corporation · NASDAQ:GNLX
Genelux — Investor Presentation (April 2024)
39 slides from Genelux's investor presentation, Apr 2, 2024
Slide 1: Redefining Immuno-Oncology
HeNELUXx Redefining immuno-Oncology Corporate Presentation April 2024 / Ve J
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
Highlights Ongoing pivotal Phase 3 trial in late-stage platinum resistant/refractory ovarian cancer (PRROC) Ongoing Phase 1b/2 trial in recurrent small cell lung cancer (SCLC) Planned Phase 2 trial in recurrent non-small-cell lung cancer (NSCLC) Gi Olvi-Vec: De-risked late-stage Clinical Program foc
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 © In Ovarian Cancer trial, catheter placement is p
Slide 5: Program Builds on Completed Trials to Exploit Competitive Advantages
Program Builds on Completed Trials to Exploit Competitive Advantages Estimated Billion Dollar Plus annual Olvi-Vec Commercial Opportunity (US) Olvi-Vec Systemic Route pect a cy Anticipated Indication Design Preclinical Phase 1 Phase 2 Phase 3 ee Collaborators Milestones Ovarian Cancer aiieedt | (pla
Slide 6: Selective Replication In Tumors Unleashes Immune System Against Cancer
Selective Replication In Tumors Unleashes Immune System Against Cancer Key Takeaways IN Innate ‘Adaptive Olvi-Vec Immune Activation Immune Activation viral infection Olvi-Vec is a robust immune Modulator that utilizes a triple mode of action to mount a personalized attack against cancer cells throug
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 chemoth
Slide 8: A Maturing Modality with Phase Companies Validating OV Potential
A Maturing Modality with Phase 3 Companies Validating OV Potential ENELUX > Next Generation Best-in-Class\ Phase 2 Ovarian Cancer Phase 1b Solid Tumors Limitations of 1st Gen Viruses + Commercial/Late-stage I* Generation viruses confirm modaltty’s potential + Limited to local delivery and scope of a
Slide 9: 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 10: Phase 1b: Anti-tumor Activity as Monotherapy
Phase lb: Anti-tumor Activity as Monothera 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 I virus monotherapy ~ the dose used in Phase 2. i (-2priorlines)® = mPFS: 6.7 mos,
Slide 11: 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 + High-grade serous, endometrioid or Data Presentations Interventional Single Group Assignment 1. 2020 Digital Annual Meeting of International n=27 Gy
Slide 12: Phase 2 Clinically Meaningful Responses in Heavily Pretreated Patients
Phase Clinically Meaningful Responses in Heavily Pretreated Patients Key Clinical Takeaways > Overall Response Rate (ORR) & Progression-Free Survival (PFS)* Median Promising ORR and PFS, and Racisti1” Response. caze PFS exer clinical reversal of platinum Z surety (OS) resistance and refractoriness A
Slide 13: Demonstrated Deep and Durable Tumor Shrinkage
Demonstrated Deep and Durable Tumor Shrinkage Key Clinical Takeaways » Refractory patients performed as well as resistant patients + Overall, 86% of PRROC patients showed tumor reduction, with 91% of platinum-refractory patients showing tumor reduction + Four patients had 100% reduction of target le
Slide 14: 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 negative PD-Li negative Overall Survival: 23.2 Months Failed 10 Prior Lines ,,, achieved PFS exceeding any prior lines 1S
Slide 15: Durable Survival Benefit
Durable Survival Benefit IN Key Clinical Takeaways Encouraging mOSs and Long-term survival data 20% long-term survivors consistent with commercially successful immunotherapies + Ona median 5th line of treatment, VIRO-15 Phase 2 patients achieved a mos of 15.7 mos + 4of 6 long-term survivors were pla
Slide 16: “All-comers” Approach May Reset Life Clock of Heavily Pre-treated Patients
“All-comers” Approach May Reset Life Clock of Heavily Pre-treated Patients IN Key Clinical Takeaways Olvi-Vec addresses a broad and underserved pool of patients + Olvi-Vec trial inclusion criteria allows patients regardless of {) tumor biomarkers, ii) platinum refractory tumors, or (iii) number of p
Slide 17: 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 in the tumor microenvironment Primary Endpoint Key Inclusion Criteria n=186 + High-grade serous, endometr
Slide 18: Self Launch Olvi-Vec for Ovarian Cancer in the US
Self Launch Olvi-Vec for Ovarian Cancer in the US Drivers of Market Penetration Self-Manufacturing Patients Reimbursement ©) Partnerships Leverage partnership Large-Scale cGMP Underappreciated Compelling Value with GOG Foundation Manufacturing Population Proposition for Payors Preeminent US-based Co
Slide 19: 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 commerci rights (ex-Greater China) to all clinical data generated in China! + All patients in these trials will be treated systemically and have pr
Slide 20: Systemic Administration Demonstrated Dose-dependent OS Benefit
Systemic Administration Demonstrated Dose-dependent OS Benefit ae >» 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 Q H oop * Re
Slide 21: Systemic Administration + Chemo Generated Encouraging Data
Systemic Administration + Chemo Generated Encouraging Data Key Clinical Takeaways » Anti-tumor effect of 1V iImmunochemotherapy + High and Condensed Dosing (single cycle: bolus infusion on 5 consecutive days) Well tolerated: No DLT or MTD reached Anti-tumor effects Virus treatment revitalized tumors
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 Key Inclusion Criteria i i y ExponmentalAmn Progression
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 4b Endpoints 7 - Primary Endpoint Key Inclusion Criter Multi-center, randomized open-label “Safety and tolerability | | =~110 + Prior failure of
Slide 24: Validating Industry Collaboration with Newsoara BioPharma Co., Ltd
Validating Industry Collaboration with Newsoara BioPharma Co., Ltd NEWSGARA HIGHLIGHTS, 7 5 “@Benecux NEWSOARA GuEbEn Pipelines Phase IIb/III Indications Phase II $850 Million Valuation Top 10 Blue-chip Biotech Investors Benny Li, PhD Founder and Chief Executive Officer 20+ yrs. global and China loc
Slide 25: V2ACT Therapeutics LLC: Joint Venture between GNLX and TVAX BioMedical
V2ACT Therapeutics LLC: Joint Venture between GNLX and TVAX BioMedical Key Trial Takeaways » 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 immunost
Slide 26: 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 Therapeutic Well Growth & Differentiation Regulators Hormones Genes Metastasis Suppressor Genes
Slide 27: Intellectual Property: Market Exclusivity & Freedom to Operate
Intellectual Property: Market Exclusivity & Freedom to Operate Patent Portfolio: 33 issued patents & 7 pending; leEe Olvi-Vec covered by Composition of Matter (2031*) and Manufacturing (2038) St ng IP Olvi-Vec: Worldwide operating freedom; e No third-party royalties due Regulatory Designations sq Lo
Slide 28: 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 Headquarters ‘Westlake + Large-scale manufacturing process + Capacity for clinical studies and commercial launch needs * Clinical Science capabilities to suppor
Slide 29: Accomplished Leadership Team
Accomplished Leadership Team Executive Team Board of Directors THOMAS ZINDRICK, 1D pao BEOTTICS Chairman ofthe Board a Aecamyessias JAMES L. TYREE, MBA Bhfer Lead independent Director Hee) anwar Thomas Zindrick, JD Lourie Zak Paul Scigalla, MD, PhD ‘Sean Ryder, JD Chief Executive Officer Chief Finan
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 Expected Operating Runway into 2Q 2025 IN Executed on go public strategy and follow on, $41.7M raised Executed Milestones Initiation of Phase 3 Trial in PRROC. Phase 2 results published in JAMA Oncology Collaboration and Li
Slide 31: Highlights
Highlights Ongoing pivotal Phase 3 trial in late-stage platinum resistant/refractory ovarian cancer (PRROC) Ongoing Phase 1b/2 trial in recurrent small cell lung cancer (SCLC) Planned Phase 2 trial in recurrent non-small-cell lung cancer (NSCLC) Gi Olvi-Vec: De-risked late-stage Clinical Program foc
Slide 32: Appendix
HeNELUXx Redefining Immuno-Oncology Corporate Presentation | April 2024 Appendix
Slide 33: Accomplished Clinical Advisory Board
Accom lished Clinical Advisory Board Gon Robert Holloway, MD CHAIRMAN Robert Coleman, MD Member Albert A. Mendivil, MD Member Thomas J. Herzog. MD roa Chief Executive Officer David M. O'Malley, MD Comprehensive Chief Medical Officer ‘Canent Costar Alan Forsythe, PhD Chief Financial Officer Forte soe
Slide 34: Olvi-Vec-primed Immunochemotherapy Anti-tumor Activity: CA-125 Biomarker
OWvi-Vec-primed Immunochemotherapy Anti-tumor Activity: CA-125 Biomarker Rapid, Common and Durable Responses CA-125 Decrease > All PRROC Patients: 96% (25/26) © Platinum refractory patients: 85% (11/13) ORR by CA-125 © All PRROC Patients: 85% (22/26) © Platinum refractory patients: 85% (11/13) Cones
Slide 35: 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.15B-15 (primary platinum-refractory HGSOC) grade serous 160 $000 + ECOG:0 J start ofchemoysevaciumab 1 BRCA negative zi 4500 —
Slide 36: 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 » PLEAD (PLADAtD) Elimination of Cancer Cells after Increased Lymphocyte infiltrationin different cavities Olvievecmonetherapy shows | te] aa peritoneal fluid pleur
Slide 37: CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response/Survival
CD8+ T-cells: infiltrating Lymphocytes are Prognostic for Response/Survival Data from Phase 1b Monotherapy portion of VIRO-15 tr PU 150-16 co4+ Pf 158-23 Pre-Olvi-Vec Post-Olvi-Vec (prior to subsequent chemotherapy) tra-tumoral and Pt 154-18 stromal) are very low in ov PUe 154-16 cancer, ie, immunol
Slide 38: 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 Case Report (Pt #15A-05) si ee Danese nacint: - 9 prior regimens of chemo+ Avastin; bey no pre-existing tumor-specific T-cells : H ' Off-the-Shelf Personalized es (Fees
Slide 39: Olvi-Vec: Ideal Backbone for Combination Therapy
Olvi-Vec: Ideal Backbone for Combination Thera Converts Tumor Microenvironment to Inflammatory “Hot Spot” NCT01443260/TUE Study —us rane Induction of acute inflammatory cytokines (ThI-type related) Fold-change from Baseline VIRO-I5 Study ‘Massive inflammatory response after (C1024) Baseline WiDS w20