Genelux Corporation · NASDAQ:GNLX
Genelux — IPO Roadshow (November 2022)
36 slides from Genelux's IPO roadshow presentation, Nov 4, 2022
Slide 1: Redefining Immuno-Oncology
Redefining Immuno-Oncology Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Relating to the Amended Registration Statement dated November 4, 2022 Registration File No. 333-265828
Slide 2: Forward-looking statements
This presentation contains forward-looking statements about Genelux Corporation (“Genelux,” “we,” “us” or “our”) that are based on the beliefs and assumptions of our management team, and on information currently available to such management team. These forward-looking statements are subject to numer
Slide 3: The Potential Offering
THE POTENTIAL OFFERING 3 Issuer Genelux Corporation Transaction Type Initial Public Offering Securities Offered: 2,500,000 common shares Anticipated Exchange and Ticker Symbol: Nasdaq/GNLX IPO Price Range: $6.00 – $7.00 per share Overallotment Option: 15% Post-Offering Shares Outstanding: 23,569,841
Slide 4: About Us
About Us Genelux is a Phase 3 biopharmaceutical company developing powerful therapeutics for patients suffering from difficult-to-treat cancers. Genelux is focused on the development of next-generation oncolytic viral immunotherapies that are designed to generate a personalized multi-prong attack to
Slide 5: Seasoned Leaders with Extensive Business & Clinical Development Experience
Seasoned Leaders with Extensive Business & Clinical Development Experience Thomas Zindrick, JD – Chair, President & CEO 30+ years industry experience (Former – Amgen, VP) The Genelux Team Executive Leadership Operations R&D Tony Yu, PhD – Head of Development 20+ years industry experience Qian Zhang,
Slide 6: Investment Thesis
Investment Thesis Broad Technology Platform Advanced Clinical Program Identified Commercial Strategy Large Market Opportunity Phase 3 registration trial actively recruiting patients (late-stage ovarian cancer) Proof of Concept confirmed in Phase 2 trial Phase 2 trial actively being prepared for init
Slide 7: Pipeline
Pipeline Believed to be the most-advanced, non-local delivery Oncolytic Virus clinical program. U.S. Revenue Projection (5-yr post-marketing approval) Ovarian: $250M Total: $1B+ Additional Revenue Opportunities Re-treatment Front-line cancer Additional Indications $1B+ 1 Commercial Rights 1aGenelux:
Slide 8: Near-Term Milestones: building a fully-integrated therapeutics company
Genelux is focused on building a fully-integrated therapeutics company. Late-Stage Clinical Program Initiated Phase 3 registration trial in late-stage Ovarian cancer Initiate Phase 2 trial in recurrent Non-Small-Cell Lung cancer Strategic Partnerships Newsoara anticipates initiating 3 China-based Ph
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Slide 10: Our Lead Product
Our Lead Product
Slide 11: Olvi-Vec (olvimulogene nanivacirepvec)
Olvi-Vec (olvimulogene nanivacirepvec) Physician-preferred methods of delivery locate and kill cancer cells to enhance antigen presentation and stimulate an anticancer immune response Immunostimulatory backbone, by turning the tumor “hot”, for combination therapy with other therapies, including chem
Slide 12: Intellectual Property: Freedom to Operate and Market Exclusivity
No third-party royalties due 48 patents issued Composition of matter / use United States expiry 2031 (includes PTE) Manufacturing United States expiry 2038 Marketing exclusivity biosimilar entry United States: 12 years European Union: 10+1 years/CA & JP 8 years PRC (China): (pending 6-12 years) Inte
Slide 13: Clinical Trial Results
Clinical Trial Results
Slide 14: Phase 1b: Olvi-Vec Monotherapy High & Condensed Dosing
High & Condensed Dosing All patients received a single cycle of Olvi-Vec Bolus infusions (intraperitoneal delivery) on 2 consecutive days, i.e., total dose: 6x109 pfu Heavily pre-treated with documented progressive disease at baseline No Standard of Care i.e., clinical trial or palliative care Plati
Slide 15: Ovarian Cancer Program: Platinum-resistant / refractory Ovarian Cancer
Ovarian Cancer Program: Platinum-resistant / refractory Ovarian Cancer Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Platinum-Resistant / Refractory Ovarian Cancer Olvi-Vec Platinum-based doublet +/- Bev Olvi-Vec- Primed Immuno- chemotherapy Preestablished endpoints met Robert W. Hollow
Slide 16: Olvi-Vec-Primed Immunochemotherapy: exemplary platinum-refractory patients
Olvi-Vec-Primed Immunochemotherapy 36 yrs old Stage IIIB, papillary serous ECOG: 0 BRCA negative MSI: stable # of mutations (load): 4 (low) PD-L1 negative BOR: PR by CA-125 & CT scan Overall survival: 23.2 months 15B-01: 15B-17: Patient who progressed while on last platinum, presented at time of enr
Slide 17: Rapid, Common and Durable Responses: Tumor Shrinkage
Rapid, Common and Durable Responses platinum-resistant platinum-refractory 4 patients achieved 100% reduction of target lesions (even in a platinum-refractory patient with heavy tumor burden) All PRROC Patients: 86% Platinum-refractory patients: 91% Tumor Shrinkage All PRROC Patients: 7.6 months Pla
Slide 18: Clinical Benefit: Long-term Overall Survival Benefit
Clinical benefit: Long-term Overall Survival Benefit flat tail Demonstrated Survival Tail (~20%), a hallmark of Clinically Beneficial Immunotherapies Durable Benefit: ~ 20% long-term survivors (median follow-up time: 44.5 mos) VIRO-15: Kaplan-Meier OS Curve Historical Data 2nd line 21.1 mOS (95% CI,
Slide 19: Systemic Program: Dose-dependent survival benefit
Systemic Program: Dose-dependent survival benefit of Heavily Pre-treated Patients Dose Escalation Phase 1b Monotherapy Study in Solid Tumors Progressed from Last Prior Therapy Median 5 prior lines of therapy Regimen: various dosing levels and schedules (typically over 4-6 months) Well tolerated: no
Slide 20: Systemic Program: Condensed Dosing followed by Chemotherapy
Systemic Program: Condensed Dosing followed by Chemotherapy Case Report (Pt #21A-06) SLD of nontarget lesions (mm) Recurrent metastatic cervical cancer with lung mets Received 5 consecutive daily i.v. doses Transient adverse reactions: fever, nausea, bone pain (Hx arthritis) Stable disease with no t
Slide 21: CHOICE Discovery Platform
CHOICE™ Discovery Platform
Slide 22: CHOICE discovery platform: viral vectors selection
Viral vectors selected based on multiple in vitro and in vivo selection criteria Extensive library of viral vectors with a variety of anti-tumor attributes Regression and elimination of a wide range (20+) of tumor types in pre-clinical models Comprehensive Approach Highly Productive Broad Utility CH
Slide 23: Unique Attributes of Vaccinia Virus
CHOICE™ discovery platform Unique Attributes of Vaccinia Virus No genomic integration Robust lytic capabilities, high replication and proliferation Highly modular, customizable Broad spectrum Powerful immune activator (Th1-type immune response) = In vitro & in vivo tested: GLP Tox ready ✓ Library Th
Slide 24: Competitive Landscape
Competitive Landscape
Slide 25: VIRO-15 Phase 2 Results: Comparison with Seminal Trials in Ovarian Cancer
VIRO-15 Phase 2 Results: Comparison with Seminal Trials in Ovarian Cancer Currently 230,000+ ovarian cancer patients in the United States While clinical remissions are obtainable, a majority of patients will relapse (~80%) 54% 85% 77% 0% 20% 40% 60% 80% 100% RECIST1.1 CA-125 PFS-6-month Study # or p
Slide 26: Facilities and Operations
Facilities and Operations
Slide 27: Facilities and Operations: Based in Southern California
Facilities and Operations: Based in Southern California Established and equipped an independent, Company-controlled 7,500+ Sq. Ft manufacturing facility in San Diego to secure material for pivotal studies and potential commercial supply Genelux maintains agreements with raw material and equipment su
Slide 28: Cap Table Summary
Cap Table Summary Share Count Note Common Stock 21,069,841 (1) Common Stock – IPO 2,500,000 Excluding Overallotment Basic Shares Outstanding Post-IPO 23,569,841 Plus: Other Issued Dilutive Instruments Stock Options Outstanding 3,962,719 Warrants Outstanding 751,745 Issuable upon the optional convers
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Slide 30: Anti-tumor Activity: CA-125 Biomarker
platinum-resistant platinum-refractory Baseline CA-125 value (U/mL) All 11 patients with > 90% decrease of CA-125 achieved RECIST response RECIST responses correlate to CA-125 responses (p = 0.007) All PRROC Patients: 96% (25/26) Platinum-refractory patients: 92% (12/13) CA-125 Decrease All PRROC Pa
Slide 31: Meaningful clinical benefit relative to immediately preceding line of therapy
Meaningful clinical benefit: Relative to Patients’ Immediately Preceding Line of Therapy (Von Hoff et al., J Clin Oncol. 2010;28(33):4877-83) Historically, the proportion of patients achieving a response and duration of response decreases with each subsequent line of therapy ‘PFS ratio’ [= (PFS+1 on
Slide 32: Modulating the Tumor Microenvironment: Overcoming Chemoresistance
Olvi-Vec Gene expression analysis (NanoString RNA profiling) Chemotherapy + Avastin Immunogenic cell death Vascular collapse Immune activation Increased TILs & memory T cells Inhibition of anti-viral response Immunogenic cell death Depletion of suppressor cells Increase susceptibility to CTLs Positi
Slide 33: Mechanism of Action: Oncolysis & Immune Activation
Activation of Immunosurveillance baseline Day 5 Olvi-Vec Treatment on Days 3 & 4 Day 10 Clusters of tumor cells Limited immune cells Drastic reduced tumor cells Large increase of immune cells Oncolysis Immune activation (VIRO-15: monotherapy) peritoneal fluid Prior to 1st dose W2D17 W2D12 pleural fl
Slide 34: CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response and Survival
Pre-Olvi-Vec Post-Olvi-Vec (prior to subsequent chemotherapy) Pt# 15A-16 CD8+ CD4+ Pt# 15A-18 CD8+ CD4+ Pt# 15A-23 CD8+ T-cells: Infiltrating Lymphocytes are Prognostic for Response and Survival Induced Infiltration of CD8+ cells into Tumors Endogenous TILs (intra-tumoral and stromal) are very low i
Slide 35: Off-the-Shelf Personalized Medicine: Single Agent generates Individualized Results
Off-the-Shelf Personalized Medicine: Single Agent generates Individualized Results Long-lasting, Tumor-specific T cell response corresponds to tumor reduction Heavily pre-treated 9 prior regimens of chemo+Avastin; no pre-existing tumor-specific T-cells Post treatment Consequential amount (~3%) of al
Slide 36: Ovarian Cancer Program: Phase 3 registrational-stage clinical trial design
Ovarian Cancer Program: Phase 3 registrational-stage clinical trial design in PRROC patients Olvi-Vec Clinical program: Olvi-Vec-primed Immunochemotherapy trials Progression on last platinum: 0-6 mos Time from last platinum: 3-15 mos Patient Population: N=186 No standard of care therapy Number of pr