Genprex, Inc. · NASDAQ:GNPX
Genprex — Investor Presentation (September 2020)
34 slides from Genprex's investor presentation, September 2020
Slide 1: Reprogramming the Course of Cancer and Diabetes
REPROGRAMMING THE COURSE OF CANCER AND DIABETES NASDAQ: GNPX Nasdaq: GNPX 1
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS Statements contained in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual res
Slide 3: GNPX at a Glance
GNPX AT A GLANCE DATA AS OF SEPTEMBER 25, 2020 10-DAY AVG SHARES COMPANY SYMBOL EXCHANGE SHARE PRICE MARKET CAP VOLUME OUTSTANDING Genprex, Inc. GNPX Nasdaq $3.37 $130M 722K 38,870,704 Cash as of June 30, 2020: $22,127,179 Outstanding shares are as of August 7, 2020. Nasdaq: GNPX 3
Slide 4: Major Competitive Advantages
MAJOR COMPETITIVE ADVANTAGES WE HAVE A GENE THERAPY PLATFORM. Our non-viral nanoparticle delivery system is designed to deliver a variety of therapeutic genes to fight cancer. Data indicate that our lead drug candidate, GPX-001, may be combined with a number of approved cancer drugs, and that it may
Slide 5: Executive Summary
EXECUTIVE SUMMARY MAJOR COMPETITIVE ADVANTAGES • DEMONSTRATED CLINICAL ACHIEVEMENT • GENE THERAPY PLATFORM • INITIATING TWO LUNG CANCER TRIALS • LARGE MARKETS AND UNMET NEED IN 2021 • WORLD-CLASS ACADEMIC PARTNERS • COMBINATION TRIALS WITH TOP SELLING CANCER DRUGS • EXPANDING PIPELINE • FDA FAST TRA
Slide 6: Fast Track Designation
FAST TRACK DESIGNATION Genprex received Fast Track Designation for GPX-001 + EGFR inhibitor osimertinib (AstraZeneca’s Tagrisso®) for NSCLC patients that progressed on osimertinib alone. Tagrisso® had $3B+ worldwide gross sales in 2019, and it is AZ’s highest grossing product. FTD is for therapies s
Slide 7: Research and Development Pipeline
RESEARCH AND DEVELOPMENT PIPELINE PATHWAY TO APPROVAL Osimertinib is now considered a new standard of care in the United States for NSCLC patients with an EGFR mutation. Given this and receipt of FDA’s Fast Track Designation for use of GPX-001 combined with osimertinib in patients whose tumors progr
Slide 8: GPX-001 + Tagrisso Phase 1/2 Study
GPX-001 + TAGRISSO® GENERAL STUDY CHARACTERISTICS ● GPX-001 in combination with AstraZeneca’s Tagrisso (osimertinib) for NSCLC ● FDA Fast Track Designation ● Patients with Stage 4, EGFR mutant NSCLC whose disease progressed after Tagrisso PASE 1 ● ~10 U.S. sites ● ~100 patients ○ Phase I: 9-18 patie
Slide 9: GPX-001 + Tagrisso Study Components and Endpoints
COMPONENT GPX-001 + TAGRISSO® ● 3+3 dose escalation of GPX-001 PRIMARY ENDPOINT PHASE 1 in combination with Tagrisso ● Dose limiting toxicity PRIMARY ENDPOINT SECONDARY ENDPOINTS COMPONENT ● Randomized 1:1, open-label, Overall response rate Progression free survival (“PFS”) ● 2-arm study of GPX-001
Slide 10: Bridging Gaps in Modern Medicine
BRIDGING GAPS IN MODERN MEDICINE HELPING PATIENTS WITH LIMITED TREATMENT OPTIONS ONCOLOGY DIABETES ● Genprex’s oncology combination treatment ● Gene therapy drug candidate addresses Type 1 and approach utilizes targeted therapies and Type 2 diabetes. immunotherapies. ● May eliminate daily burden of
Slide 11: Oncology Program
ONCOLOGY PROGRAM Nasdaq: GNPX 11
Slide 12: Non-Small Cell Lung Cancer Market Statistics
NON-SMALL CELL LUNG CANCER MARKET STATISTICS 84% MOST COMMON LUNG CANCER NSCLC represents the majority of all lung cancers. $3B+ TAGRISSO® 2019 SALES AstraZeneca’s highest grossing product. 2M WORLDWIDE CASES Almost two million cases per year worldwide. $11B+ KEYTRUDA® 2019 SALES Merck’s highest gro
Slide 13: Problem: Few Patients Benefit from Modern Therapies
PROBLEM: FEW PATIENTS BENEFIT FROM MODERN THERAPIES LIMITATIONS TO NSCLC TREATMENT TARGETED THERAPIES IMMUNOTHERAPIES PATIENT ELIGIBILITY 10% 12% Of patients have an activating Of patients are eligible for EGFR mutation and can benefit and benefit from from targeted therapies1 immunotherapies2 “Few
Slide 14: Solution: Novel Platform to Treat Cancer
SOLUTION: NOVEL PLATFORM TO TREAT CANCER ONCOPREX™ NANOPARTICLE DELIVERY PLATFORM GENES Multiple tumor SYNERGIES suppressor genes Modern approach using combination therapy CANCERS Genetic mutations found in other cancers Nasdaq: GNPX 14
Slide 15: Oncoprex Nanoparticle Delivery Platform
ONCOPREX™ NANOPARTICLE DELIVERY PLATFORM CATIONIC LIPID NANOVESICLE CARRIES DRUG TO TUMORS Positively charged nanovesicle Our non-viral, biodegradable, positively-charged lipid nanovesicle has affinity to negatively-charged cancer cells, with a 10- to 25-fold uptake in cancer cells vs. normal cells
Slide 16: GPX-001 Targets Cancer at Its Core
GPX-001 TARGETS CANCER AT ITS CORE DOTAP: CHOL-TUSC2 CONTROLS CELL SIGNALING STIMULATES APOPTOTIC PATHWAYS MODULATES IMMUNE RESPONSE Pan-kinase inhibition decreases cell Leads to programmed cell death Promotes immune activity against proliferation cancer Nasdaq: GNPX 16
Slide 17: GPX-001 Inhibits Key Cell Signaling
GPX-001 INHIBITS KEY CELL SIGNALING TUSC2 TUMOR SUPPRESSOR GENE HAS PAN-KINASE ACTIVITY THAT CAN OVERCOME CANCER RESISTANCE PATHWAYS Nasdaq: GNPX 17
Slide 18: GPX-001 Affects Tumor Immunogenicity
GPX-001 AFFECTS TUMOR IMMUNOGENICITY TUSC2 ALSO SHOWN TO UPREGULATE NK AND CD8+ T CELLS, AND DOWNREGULATE PD-L1 RECEPTORS Nasdaq: GNPX 18
Slide 19: GPX-001 Monotherapy
GPX-001 MONOTHERAPY ONC-001 TRIAL DOSE ESCALATION STUDY Explore toxicity and tolerability in patients. Phase I monotherapy results: ● 31 Stage IV patients with at least 1 of 6 trial doses ● 23 patients evaluable ● Cancer growth halted in 5 of 23 patients ● Stable disease n=5; responses n=3 ● Maximum
Slide 20: GPX-001 + Erlotinib Combination
GPX-001 + ERLOTINIB COMBINATION PHASE II PRELIMINARY DATA IN SUBJECTS WITH OR WITHOUT EGFR MUTATIONS LINE OF PATIENT EGFR STATUS RESPONSE PRIOR THERAPY THERAPY Positive (exon 18+20) CR Chemo 3 Negative 24% regression Target Lesion Chemo / anti-PD1 2 30% regression one Target Lesion Negative Chemo /
Slide 21: GPX-001 + Erlotinib Combination
GPX-001 + ERLOTINIB COMBINATION Nasdaq: GNPX 21
Slide 22: GPX-001 Shows Synergy with Immunotherapies
GPX-001 SHOWS SYNERGY WITH IMMUNOTHERAPIES TUSC2 IS SYNERGISTIC WITH ANTI-PD1 IN A SYNGENEIC MOUSE MODEL OF LUNG CANCER TUSC2+anti-PD1 combination significantly prolonged TUSC2+anti-PD1 exhibit greater antitumor activity than survival in a lung metastasis model refractory to either agent alone or co
Slide 23: GPX-001 Shows Synergy with Immunotherapies
GPX-001 SHOWS SYNERGY WITH IMMUNOTHERAPIES TUSC2 IS SYNERGISTIC WITH ANTI-PD1 IN A HUMANIZED MOUSE MODEL OF LUNG CANCER TUSC2 + PEMBRO TUSC2 + PEMBRO + CHEMO Strong antitumor immune responses of anti-PD1 TUSC2+anti-PD1+chemo combination resulted were found against PDX tumors developed in in metastas
Slide 24: Diabetes Program
DIABETES PROGRAM Nasdaq: GNPX 24
Slide 25: Diabetic Patients in Need of Modern Therapy
DIABETIC PATIENTS IN NEED OF MODERN THERAPY GPX-002 MAY ELIMINATE NEED FOR INSULIN IN DIABETIC PATIENTS Type 1 and Type 2 diabetes affect approximately 34 million people in the U.S, or 10 percent of the U.S. population. May replace daily burden of blood glucose monitoring and insulin replacement the
Slide 26: GPX-002 Replenishes Levels of Insulin
GPX-002 REPLENISHES LEVELS OF INSULIN REPROGRAMS AND RESTORES CELL FUNCTION Novel infusion process uses an endoscope and an AAV vector to deliver the Pdx1 and MafA genes to the pancreas. Transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinc
Slide 27: Key Milestones Through Early 2021
KEY MILESTONES THROUGH EARLY 2021 MANUFACTURING CLINICAL • Complete preparation of lipid nanoparticle • Continue preparations for combination delivery system and TUSC2 DNA plasmid clinical trials of GPX-001 with Tagrisso® for clinical expansion and Keytruda®, respectively, while planning to initiate
Slide 28: Some Targeted Therapy Company Valuations
SOME TARGETED THERAPY COMPANY VALUATIONS DRUG COMPANY SYMBOL EXCHANGE INDICATION PHASE VALUATION CANDIDATE/TARGET Melanoma, Head and Neck, Iovance Tumor-Infiltrating IOVA Nasdaq Cervical, NSCLC, Chronic Phase 3(1) $4.713 Bil Biotherapeutics Lymphocytes Lymphocytic Leukemia NSCLC, Colorectal, Renal M
Slide 29: Meet Our Team
MEET OUR TEAM COMPANY MANAGEMENT RODNEY VARNER, JD CATHERINE VACZY Chairman & Chief Executive Officer Executive VP & Chief Strategy Officer • 30+ years of expertise in corporate law, including • 20+ years of experience in senior executive, business corporate governance, in biotech industry and legal
Slide 30: Meet Our Team
MEET OUR TEAM COMPANY MANAGEMENT THOMAS GALLAGHER, JD WILLIAM GANNON, JR., MD MBA Senior Vice President, IP and Licensing Vice President of Regulatory Affairs • 20+ years of expertise in biotech IP law, business • 30+ years of experience in biotech and pharma development, licensing transactions regu
Slide 31: Meet Our Team: Scientific Advisory Board
MEET OUR TEAM SCIENTIFIC ADVISORY BOARD JACK A. ROTH PASI ANTERO JÄNNE MD, FACS, Chairman MD, PhD • Professor and Bud Johnson Distinguished Clinical • Professor of Medicine, Harvard Medical School; Chair, Department of Thoracic and Cardiovascular Director of Dana Farber Cancer Institute Lowe Center
Slide 32: Meet Our Team: Board of Directors
MEET OUR TEAM BOARD OF DIRECTORS RODNEY VARNER, JD Chairman of the Board BRENT LONGNECKER • 30+ years of expertise in corporate law, including Board Director corporate governance, in biotech industry • Former owner of securities broker dealer firm • Chief Executive Officer, Longnecker & Associates •
Slide 33: Transformational 21st Century Gene Therapies
21ST CENTURY GENE THERAPIES WE BELIEVE MARKET GAPS AND UNMET NEED IN A FUTURE OF COMBINATION TRIALS WITH TOP TRANSFORMATIONAL SELLING DRUGS SCALING UP MANUFACTURING PATIENT CARE EXPLORING NEW INDICATIONS AND PARTNERSHIPS Nasdaq: GNPX 33
Slide 34: Nasdaq: GNPX Contact
NASDAQ: GNPX 1601 Trinity St, Bldg B, #3.312.09, Austin, Texas 78712 (877) 774 - GNPX | investors@genprex.com Nasdaq: GNPX