Genelux Corporation · NASDAQ:GNLX
Genelux — Investor Presentation (August 2021)
25 slides from Genelux's investor presentation, Aug 1, 2021
Slide 1: Redefining Immuno-Oncology
Redefining Immuno-Oncology
Slide 2: Safe Harbor Statement
Safe Harbor Statement + This presentation and the accompanying oral presentation also contain statistical data, estimates and forecasts that are based on independent industry publications or other publicly available information, as well as other information based on our internal sources. This inform
Slide 3: Executive Summary
Executive Summary A clinical-stage biopharmaceutical company advancing a novel immunotherapeutic platform ▪ Immuno-oncology company Overview ▪ Preparing to initiate a Phase 3 trial in platinum-resistant / refractory ovarian cancer ▪ CHOICE™ discovery platform and large oncolytic vaccinia virus portf
Slide 4: Executive Summary
Executive Summary Genelux is committed to addressing unmet needs within the current I-O treatment paradigm Advanced, non-local delivery oncolytic virus program o Completed proof-of-concept Phase 2 in platinum-resistant / refractory ovarian cancer (PRROC) o Early-stage clinical trials in solid tumors
Slide 5: Recent Milestones & Accomplishments
Recent Milestones & Accomplishments Completed Recognized Expansion of Phase 2 Scientific Manufacturing Trial Presentations Facilities o Platinum- o International Gynecologic o In-house cGMP resistant/refractory Cancer Society (2020 Annual production facility ovarian cancer Meeting) awarded Oral Plen
Slide 6: Pipeline Overview
Pipeline Overview Robust clinical pipeline: extensive future scientific potential o Olvi-Vec is administered through physician-preferred methods to locate and kill cancer cells throughout the body o Regional (I.P.E.) routes maximize PK & tumor tissue exposure in body cavities o Systemic (I.V.) route
Slide 7: Our Work
Our Work
Slide 8: Olvi-Vec Overview: Activating the Immune System
Olvi-Vec Overview Engineered to selectively target and eliminate tumor cells while inducing a robust immune response leveraging patient- and tumor-specific neoantigens Activating the Immune System: Innate and Adaptive Immune Priming & Changes of Gene Expression Profile Tumor antigen release, innate
Slide 9: Olvi-Vec Overview: A differentiated immuno-oncology approach
Olvi-Vec Overview A differentiated immuno-oncology approach o Olvi-Vec is designed to drive immune activation, enhance tumor-specific neoantigen presentation, and manifest clinically meaningful changes in the tumor microenvironment (TME), turning cold tumors “hot” Modular Administration Profile Intr
Slide 10: Differentiated Clinical Development Program
Differentiated Clinical Development Program Genelux aims to provide an elegant oncolytic virus approach First- Olvi-Vec Immuno-Therapy Generation Chemotherapy (platinum) refractory and/or resistant cancers Oncolytic Virus Regional Intravenous Local (Advantages) (Advantages) (Limitations) o Ability t
Slide 11: Olvi-Vec Phase 2 VIRO-15 Trial: PRROC
Olvi-Vec Phase 2 VIRO-15 Trial: PRROC Platinum-resistant / refractory Ovarian Cancer (PRROC) Patient Population High & Condensed Dosing o Heavily pre-treated with documented progressive o Single round bolus infusions on 2 consecutive disease at baseline days o No Standard of Care – i.e., clinical tr
Slide 12: Olvi-Vec: Exciting Signals of Differentiated Therapeutic Potential
Olvi-Vec: Exciting Signals of Differentiated Therapeutic Potential High, condensed IP dosing with subsequent chemotherapy Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Platinum-Resistant / Refractory Ovarian Cancer Robert W. Holloway, et al Olvi-Vec Olvi-Vec –Primed Immunochemotherapy:
Slide 13: Olvi-Vec Phase 3 program: Platinum-resistant/refractory ovarian cancer
Olvi-Vec Phase 3 program: Platinum-resistant/refractory ovarian cancer (PRROC) Planned Phase 3 registrational-stage clinical trial design o Patient Population; N=174 (estimated): o No standard of care therapy o Number of prior lines of therapy: ≥2, including bevacizumab o Progression on last platinu
Slide 14: Olvi-Vec Systemic Delivery – A Potentially Transformative Evolution
Olvi-Vec Systemic Delivery – A Potentially Transformative Evolution Olvi-Vec demonstrates a dose-dependent overall survival benefit Ph1B Monotherapy Dose Escalation Study in Solid Tumors Progressed from Last Prior Therapy Multiple I.V. Cycles via various dosing levels and schedules o Well tolerated:
Slide 15: Olvi-Vec Phase 2 program: Non-Small Cell Lung Cancer
Olvi-Vec Phase 2 program: Non-Small Cell Lung Cancer (NSCLC) Planned Phase 2 clinical trial design o Patient Population; N=50 (estimated): o Last prior line is platinum-base therapy o Metastatic on or after platinum-based chemotherapy o Had treatment with immune checkpoint inhibitor o ECOG: 0 – 1; o
Slide 16: Platform & Pipeline
Platform & Pipeline
Slide 17: The CHOICE discovery platform
The CHOICE™ discovery platform CHOICE™ has generated a library of 500+ novel constructs & strains to-date o Regression and elimination of a wide range of tumor types (pre-clinical signals of antitumor activity against 20 tumor types) Tissue Therapeutic Imaging Genes Payloads Genes Regenerating Genes
Slide 18: Competitive Landscape
Competitive Landscape
Slide 19: Olvi-Vec-Primed Immunochemotherapy: Driver of Market Penetration
Olvi-Vec-Primed Immunochemotherapy: Driver of Market Penetration Platinum-resistant / refractory patients exhibit similar outcomes to platinum-sensitive patients o Currently 250,000+ ovarian cancer patients in the United States o While clinical remissions are obtainable, a majority of patients will
Slide 20: About Genelux
About Genelux
Slide 21: Leadership Team
Leadership Team Genelux has assembled a seasoned leadership team with extensive experience in developing and manufacturing biological, viral and gene therapies The Genelux Team Management Executive o Thomas Zindrick, JD – President & CEO o Paul Scigalla, MD, PhD – Chief Medical Officer o 30+ years i
Slide 22: Facilities and Manufacturing
Facilities and Manufacturing Genelux has facilities in several locations in Southern California. Headquarters Manufacturing Facility Research and Development Investor Relations Office Westlake Village, CA, USA San Diego, CA, USA San Diego, CA, USA Redlands, CA, USA Genelux has developed a large-scal
Slide 23: Intellectual Property
Intellectual Property Positioned for long-term success o No third-party royalties due o 47 patents issued o Composition of matter / use ▪ United States expiry 2031 (includes PTE) o Manufacturing ▪ United States expiry 2038 Worldwide Extensive Operating Patent Freedom Estate Long-Duration Proprietary
Slide 24: Executive Summary
Executive Summary Genelux is committed to addressing unmet needs within the current I-O treatment paradigm Advanced, non-local delivery oncolytic virus program o Completed proof-of-concept Phase 2 in platinum-resistant / refractory ovarian cancer (PRROC) o Early-stage clinical trials in solid tumors
Slide 25: Thank You
THANK YOU