Genelux Corporation · NASDAQ:GNLX
Genelux — Investor Presentation (February 2024)
37 slides from Genelux's investor presentation, Feb 5, 2024
Slide 1: Redefining Immuno-Oncology
@HeNELUx Redefining Immuno-Oncology Corporate Presentation February 2024 / A 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 21 of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections, about Gen
Slide 3: Highlights
Highlights Olvi-Vec: De-risked late-stage Clinical Program ‘Ongoing pivotal trial in late-stage Ovarian Cancer, SCLC and planned Phase 2 trial Adjuvant Maintenance NSCLC CHOICE™ Platform; Broad and Diverse Discovery Engine Library with over 500 novel vaccinia strains and 110+ transgenes Validating S
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 trials, catheter placement i
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) Anticipated Olvi-Vec Indication Design Preclinical Phase1 © Phase2 = Phase 3. 5 Collaborators Milestones OWiVec (pe) + a : Topline results = tin een ane Plat
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 presentat
Slide 7: Olvi-Vec-Primed Immunochemotherapy: Overcoming Drug Resistance
Olvi-Vec-Primed Immunochemotherapy: Overcoming Drug Resistance Olvi-Vec-Induced Hot Tumor Pro-therapeutic gene expression ° g jhemotherapy synergy > Positive regulation of T-cell activating > i ene y rs, Immunogenic cell death > Depletion of suppressor cells > Expression profiles correlated to bette
Slide 8: A Maturing Modality with Phase Companies validating OV Potential
A Maturing Modality with Phase 3 Companies validating OV Potential “Gene_uxD> Next Generation ” Phase 2 Ovarian Cancer Phase 1b Solid Tumors Limitations of 1st Gen Viruses + Commercial/Late-stage 1 Generation viruses confirm modality’s potential + Limited to local delivery and scope of addressable c
Slide 9: Phase Ib: Anti-tumor Activity as Monotherapy Leading into Combination
Phase Ib: Anti-tumor Activity as Monotherapy Leading into Combination Olvi-Vec Monotherapy = i >» Patient Background & Study Treatment Key Clinical Takeaways A + Heavily pre-treated PRROC patients with documented 29) progressive disease + Cohort I received a Single cycle of intraperitoneal delivery
Slide 10: Completed Phase 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 Oral Plenary Session Design + High-grade serous, endometri ae 2. JAMA Oncology , . Olvi-Vee via intraperitoneal infusion in multipl
Slide 11: Phase Clinically Meaningful Responses in Heavily Pretreated Patients
Phase 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 + Allpatients had documented progressive disease at enrollment + The median PFS of the patie
Slide 12: Demonstrated Deep and Durable Tumor Shrinkage
Demonstrated Deep and Durable Tumor Shrinkage Tumor Shrinkage > y ~ - FJ So So oe Cet Peel eee ee ed ee ee eee 100 Key Clinical Takeaways 80 Baseline tumor burden as Sum of Longest Diameter of target lesions (mm) Refractory patients performed as well as resistant patients 20 ~40 -30% partial respons
Slide 13: 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 158-01; 15B-15: Stage IIIB papillary Stage IIB high- 15B-17; + Stage IlIC high- grade serous serous grade serous ECOG: 0 ECOG: 0 B
Slide 14: Durable Survival Benefit
Durable Survival Benefit Prognosis Worsens with each Successive Line Tistorcal Data ELARARE? >» Baling __2dmOS__(@5%CL 17.8-24.4) — Key Clinical Takeaways 10 Bling _129m0S (9591, 10.4-14.6) | “#7 MOS 2/3") a line ‘9.8 MOS {95% Cl, 7.1-12.25) | 11.6 mOs SFline Not reported NA Wostnan a Gyre Ona) OTT
Slide 15: Allcomers Approach May Reset Life Clock of Heavily Pre-treated Patients
“Allcomers” Approach May Reset Life Clock of Heavily Pre-treated Patients Key Clinical Takeaways IN Olvi-Vec addresses a pread 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 pri
Slide 16: Pivotal Trial Design Founded on Phase 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 Primary Endpoint Key Inclusion Criteria 4 tO) Progression-Free Survival +
Slide 17: Systemic administration demonstrated dose-dependent OS benefit
stemic admi tration demonstrated dose-dependent OS benefit na >» Dose Escalation Phase 1b Monotherapy Study in Solid Tumors Key Clinical Takeaways Progressed from Last Prior Therapy Demonstrated feasibility a, and clinical benefit of 7 multiple IV cycles 7) ey on + Median 5 prior lines of therapy fi
Slide 18: Systemic Administration + Chemo Generated Encouraging Data
Systemic Administration + Chemo Generated Encouraging Data Key Clinical Takeaways IN Anti-tumor effect of IV Immunochemotherapy * High and Condensed Dosing (single cycle: bolus infusion on 5 consecutive days) * Well tolerate No DLT or MTD reached + Monotherapy: Anti-tumor effects Virus treatment rev
Slide 19: Genelux has Partnered with Newsoara BioPharma Co., Ltd
Genelux has Partnered with Newsoara BioPharma Co., Ltd NEWSGARA HIGHLIGHTS, 7 5 @enecux NEWSGARA UR ESES Pipelines Phase IIb/III 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 local pharma Form
Slide 20: Validating Industry Collaboration with Newsoara BioPharma Co., Ltd
Validating Industry Collaboration with Newsoara BioPharma Co., Ltd >» Systemic Program: Clinical Trials Key Takeaways sponser | Thal ues Irseaton cineasane | Pala | mandoisaion | snus » Newsoara will fund the US~ Recurrent/Adjuvant Regulat a ecurrent/Adjuvant - egulatory based Genelux Phase 2 trial
Slide 21: 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 22: Self Launch Olvi-Vec for Ovarian Cancer in the US
Self Launch Olvi-Vec for Ovarian Cancer in the US Drivers of Market Penetration 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 ‘OnPri
Slide 23: Facilities and Operations: Based in Southern California
n Key Takeaways IN Facilities and Operations based tegrated R&D and Manufacturing Capabilities For Phase 3 And Launch iS in Southern California [Headquarters Translational Research Westlake Village, CAS USA, + large-scale manufacturing rocess + Capacity for clinical studies and commercial launch nee
Slide 24: 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 ¥ Cel! Growth & Differentiation Regulators Hormones Genes Metastasis Suppressor Gene
Slide 25: Intellectual Property: Market Exclusivity & Freedom to Operate
Intellectual Property: Market Exclusivity & Freedom to Operate T| Patent Portfolio: 33 issued patents; 7 pending a Olvi-Vec covered by Composition of Matter (2031*) and Manufacturing (2038) Strong IP & “< Olvi-Vec: Worldwide operating freedom; Regulatory = No third-party royalties due Designations L
Slide 26: Accomplished Leadership Team
Accomplished Leadership Team Executive Team Board of Directors THOMAS ZINDRICK, 1D aan ceo Cchattman ofthe Board DNX saMes L-TvRee, MAA Beene Lead Independent Director SJ anoote Thomas Zindrick, JD Lourie Zak Paul Scigalla, MD, PhD Sean Ryder, JD hf Chief Executive Officer Chief Financial Officer Ch
Slide 27: Expected Operating Runway into 2Q 2025
Expected Operating Runway into 2Q 2025 Capitalization Summary Stock Symbol GNLX Share Price $12.84 Shares Outstanding 26.7M Market Capitalization! $328.3M Cash & Equivalents” $29.9M PIPE Commitments Due $ 2M” Insider Ownership ruuyouuten 25.4% Analyst Coverage * Kemp Dolliver CFA + Emily Bodner + Ja
Slide 28: Genelux Has Executed on Multiple Milestones and is Positioned for the Future
Genelux Has Executed on Multiple Milestones and is Positioned for the Future 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 License agreement with Newsoara Initiation
Slide 29: Highlights
Highlights Olvi-Vec: De-risked late-stage Clinical Program ‘Ongoing pivotal trial in late-stage Ovarian Cancer, SCLC and planned Phase 2 trial Adjuvant Maintenance NSCLC CHOICE™ Platform; Broad and Diverse Discovery Engine Library with over 500 novel vaccinia strains and 110+ transgenes Validating S
Slide 30: Appendix
@HeNELUx Redefining Immuno-Oncology Corporate Presentation | February 2024 Appendix
Slide 31: 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 princip
Slide 32: 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) © Platinum refractory patients: 85% (11/13) oF o
Slide 33: 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.15B-15 (primary platinum-refractory HGSOC) + Stage IIIB high- grade serous 16 5000 + Ecos:0 Y ssa of cemo/sevactumab +
Slide 34: Olvi-Vec Monotherapy Demonstrates Oncolysis and Immune Activation
Olvi-Vec Monotherapy Demonstrates Oncolysis and Immune Activation b (W015: monotherapy) Key Takeaways (PL#ISA-O1T) (PL#5A-11) Elimination of Cancer Cells after Increased Lymphocyte Infiltration in different cavities peritoneal fluid pleural fluid Priorto 1 Olvi-Vec monotherapy shows decreased tumor
Slide 35: 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-0lv-Vee (prior to subsequent chemotherapy) Endogenous TiLs (intra- tumoral and stromal) are very low in ovarian cancer Pt# 15A-18 426 45 Baseline Screening 109 35
Slide 36: Long-lasting Tumor-specific T cell response corresponds to tumor reduction
Long-lasting Tumor-specific T cell response corresponds to tumor reduction Key Takeaways Off-the-Shelf Personalized Medicine: Single Agent generates Individualized Results * Olvi-Vec induces favorable & long-lasting Tumor-specific T-cell Response (TSTcR) by ELISPOT analysis in patient in heavily tre
Slide 37: 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, BS virus treatment E