Slide 1: Free writing prospectus legend and registration statement notice
The issuer has filed a registration statement (including a prospectus) (File No. 333-219386) with the SEC for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for m
Slide 2: Developing 21st Century Gene Therapies for Cancer
Filed Pursuant to Rule 433 under the Securities Act of 1933 Issuer Free Writing Prospectus dated September 15, 2017 Relating to Preliminary Prospectus dated September 15, 2017 Registration No. 333-219386 st Developing 21 Century Gene Therapies for Cancer September 2017
Slide 3: Disclaimer | Forward Looking Statements
Disclaimer | Forward Looking Statements This presentation may contain projections or other forward-looking statements regarding future events, the safety and efficacy of our product candidates or the future financial performance of our company. These forward-looking statements may contain forward -l
Slide 4: Free Writing Prospectus Statement
Free Writing Prospectus Statement This presentation highlights basic information about our company. Because it is a summary, it does not contain all of the information you should consider before investing. Except as otherwise indicated, this presentation speaks only as of the date hereof. This offer
Slide 5: Reprogramming the Course of Cancer
st 21 Century Gene Therapy for Cancer Mission: Reprogramming the Course of Cancer 4
Slide 6: Management Team and Board of Directors
Management Team and Board of Directors Rodney Varner, JD – CEO, Chairman of the Board Bob Pearson, MBA – Board Director - 30+ years of expertise in corporate law, including Vice Chairman and Chief Innovation Officer, W2O - corporate governance, in biotech industry Group - Former owner of securities
Slide 7: Scientific Advisory Board
Scientific Advisory Board Jack A. Roth, MD, FACS, Chairman - Professor and Bud Johnson Clinical Distinguished Chair, Department of Thoracic and Cardiovascular Surgery; Professor of Molecular and Cellular Oncology; Director, W.M. Keck Center for Innovative Cancer Therapies; and Chief, Section of Thor
Slide 8: 21st Century Gene Therapy for Cancer: Reprogramming the Course of Cancer
st 21 Century Gene Therapy for Cancer Reprogramming the Course of Cancer • Significant market gaps and unmet medical need for patients whose cancer molecular profiles make them resistant or poor candidates for targeted therapies and immunotherapies • Lead candidate Oncoprex™, a unique, first-in-clas
Slide 9: The Genprex Platform
The Genprex Platform Novel approach to cancer treatment grounded in a cutting edge platform that has broad application to: – Utilize multiple tumor suppressor genes – Provide multiple drug synergies – Address multiple cancer indications 30+ peer-reviewed publications 30 patents issued & 2 pending 8
Slide 10: R&D Pipeline and Path to Approval
R&D Pipeline and Path to Approval 9
Slide 11: Lung Cancer: Significant Unmet Medical Need
Lung Cancer: Significant Unmet Medical Need • 225,000 new cases per year in U.S. • 1.8 million new cases worldwide • Non-small cell lung cancer (NSCLC) represents 80% of all lung cancers • 5-year survival rate for Stage IV NSCLC is approx. 1% • Median survival is approx. 4 months • Popular targeted
Slide 12: Oncoprex Targets Cancer at its Core
Oncoprex Targets Cancer at its Core Combination of DOTAP: chol + TUSC2 gene • Expression of TUSC2 gene is decreased in many cancer types, particularly lung cancers • TUSC2 (Tumor Suppressor Candidate 2) shown to: - Have a pan-kinase inhibitory effect when activated in the cell - Inhibit key cell sig
Slide 13: Nanovesicle Delivery System
Nanovesicle Delivery System • Developed at NIH and optimized at MD Anderson • Non-viral biodegradable (+) lipid nanovesicle with affinity to (-) cancer cell • Efficient gene/plasmid transfer to lung cancer cells while minimizing off-target exposure • 10- to 25-fold uptake in cancer cells vs. normal
Slide 14: Oncoprex Inhibits Key Cell Signaling Pathways
Oncoprex Inhibits Key Cell Signaling Pathways TUSC2 shown to upregulate NK and CD8 T cells and downregulate PD-L1 receptors Intracellular blockade or activation of key cellular growth and apoptosis signaling pathways Immune modulation and effect on tumor micro- environment, including upregulation of
Slide 15: Development Overview (NSCLC)
Development Overview (NSCLC) Pre-Clinical Phase1 Phase 2/ Pivotal Oncoprex Oncoprex • Specificity of targeting • Maximum Tolerated Dose (MTD) • Decreased tumor load • Favorable safety profile, dose response in • Sensitization to erlotinib (EGFR+/- EFGR+/-patients NSCLC) Regulatory pathway • Awaiting
Slide 16: Oncoprex Monotherapy (Phase I)
Oncoprex Monotherapy (Phase I) • Dose escalation study to explore toxicity and tolerability in patients (Responses in late-stage metastatic lung cancer patient) • Phase I monotherapy results: - 31 Stage IV patients with at least 1 of 6 trial doses - Cancer growth halted in 5 of 23 patients - Stable
Slide 17: Oncoprex + erlotinib Combination (Phase I/II)
Oncoprex + erlotinib Combination (Phase I/II) Preliminary evidence of efficacy in subjects with EGFR +/- mutations • Combination therapy (re)sensitizes lung cancer cells and/or overcomes resistance to targeted therapies and other classes of drugs (i.e. checkpoint inhibitors; CPI) • Slowed tumor prog
Slide 18: Oncoprex Combination Approach
Oncoprex Combination Approach In addition to our current trial of Oncoprex + erlotinib, MD Anderson researchers conducted preclinical studies combining Oncoprex with the following investigational and marketed drugs: • TKI gefitinib (marketed as Iressa® by AstraZeneca Pharmaceuticals) in animals and
Slide 19: Oncoprex Synergy with anti-PD1 in Syngeneic Mice
Oncoprex Synergy with anti-PD1 in Syngeneic Mice TUSC2 is synergistic with anti-PD1 in syngeneic mouse models of lung cancer • Two Kras-mutant mouse models: low (4.5%) and moderate (23.7%) PD-L1 expression at baseline • Modulation of innate immune response in tumor micro-environment • Upregulation o
Slide 20: Strategic Objectives and Upcoming Milestones
Strategic Objectives and Upcoming Milestones Strategic Objectives • Conduct ongoing and new clinical trials • Investigate the effectiveness of Oncoprex in other cancers • Prepare to commercialize Oncoprex • Pursue strategic partnerships • Further develop platform technology Upcoming Milestones • Opt
Slide 21: 21st Century Gene Therapy for Cancer
st 21 Century Gene Therapy for Cancer • Cutting-edge gene therapy platform provides therapeutic synergies and expands patients’ access to available targeted and immunotherapies • Lead candidate Oncoprex™, a unique, first-in-class, multimodal immunogene therapy packaged in proprietary nanovesicle del