Genprex, Inc. · NASDAQ:GNPX
Genprex — Investor Presentation (October 2022)
44 slides from Genprex's investor presentation, Oct 21, 2022
Slide 1: Pioneering Gene Therapies for Large Patient Populations
© Genprex’ PIONEERING GENE THERAPIES FOR LARGE PATIENT POPULATIONS NASDAQ: GNPX October 2022
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS Statements contained in this presentation regarding matters that are not historical facts are “forward-lookingstatements” within the meaning ofthe Private Securities Litigation Reform Actof 1995, Because such statementsare subjectto risks and uncertainties, actual results
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS MAJOR COMPETITIVE ADVANTAGES GENE THERAPY PLATFORM FIRST SYSTEMIC GENE THERAPY USED FOR CANCER IN HUMANS LARGE MARKETS AND UNMET NEED TWO FDA FAST TRACK DESIGNATIONS os SHOWN CLINICAL ACHIEVEMENT TWO LUNG CANCER CLINICAL TRIALS CURRENTLY ENROLLING NOVEL GENE THERAPY PROGRAM IN
Slide 4: Advancing Gene Therapy in Large Indications
ADVANCING GENE THERAPY IN LARGE INDICATIONS HELPING PATIENTS WITH LIMITED TREATMENT OPTIONS ONCOLOGY DIABETES * REQORSA™ is the first systemic gene therapy in © Gene therapy drug candidate addresses Type 1 and development for cancer. Type 2 diabetes. © Initially targeting solid tumors in lung cancer
Slide 5: Research and Development Pipeline
RESEARCH AND DEVELOPMENT PIPELINE DELIVERY D \ME_DISCOVERY PRECLINICAL _ENABL PHASE1 PHASE PHASE 3 NANOPARTICLE REQORSA™ IMMUNOGENE THERAPY NSCLC “ONC-001 J Monotheropy Regonsa mannocenericrary ——nscic_—=« clo 1_ SES REQORSA™ IMMUNOGENE THERAPY Nscic ‘Acclaim -2 REQORSA™INMUNOGENE THERAPY sce xcs vo
Slide 6: Oncology Program
Slide 7: Lead Program: Non-Small Cell Lung Cancer
LEAD PROGRAM: NON-SMALL CELL LUNG CANCER RECENT EXPANSION TO SCLC COVERS VIRTUALLY ENTIRE MARKET A% 5B+ MOST COMMON LUNG CANCER TAGRISSO 2021 SALES NSCLC represents the majority of all lung cancers’. AstraZeneca’s highest grossing product. 2M 17B+ WORLDWIDE LUNG CANCER CASES KEYTRUDA 2021 SALES, Mor
Slide 8: Tumor Suppressor Genes Deleted During Cancer Development
TUMOR SUPPRESSOR GENES DELETED DURING CANCER DEVELOPMENT Tumor suppressor genes such as TUSC2 are deleted early during cancer development 80% of all non-small cell lung cancers express decreased amounts of TUSC2 tumor suppressor protein Loss or reduction of TUSC2 expression is associated with signif
Slide 9: Novel Platform to Treat Cancer
NOVEL PLATFORM TO TREAT CANCER ONCOPREX® NANOPARTICLE DELIVERY SYSTEM The first systemic gene therapy delivery platform for cancer SYNERGIES Advanced approach using combination therapy GENES Multiple tumor suppressor genes CANCERS Multiple cancers Nasdag:GNPX 9
Slide 10: Oncoprex Nanoparticle Delivery System
ONCOPREX® NANOPARTICLE DELIVERY SYSTEM CATIONIC LIPID NANOPARTICLE CARRIES DRUG TO TUMORS TUSC2 REQORSA™ IMMUNOGENE THERAPY. Plasmid containing ‘tumor suppressor gene ‘Tumor suppressor gene protein Plasmid with, TUSC2 gene © non-viral, positively-charged lipid nanoparticle (LNP) is systemically deli
Slide 11: Selective Uptake of REQORSA
SELECTIVE UPTAKE OF REQORSA™ NT 1 (0.02 mg/kg) PATIENT 2 (0.06 mg/kg) PRE-TREATMENT BIOPSIES In all images, blue stain shows cell nuclei and red stain shows TUSC2 protein POST-TREATMENT BIOPSIES Seestve anc Preferential Cancer Cell Uptake ang. Nasdag:GNPX 11
Slide 12: REQORSA Targets Cancer at Its Core
REQORSA TARGETS CANCER AT ITS CORE MULTIPLE ANTI-CANCER MECHANISMS OF ACTION —a z a8 e- eo 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 Nasda
Slide 13: REQORSA Monotherapy
REQORSA MONOTHERAPY ONC-001 TRIAL DOSE ESCALATION STUDY Explore toxicity and tolerability in patients. Phase 1 monotherapy results: 311 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 Highest dose use
Slide 14: REQORSA + Tarceva Combination
REQORSA + TARCEVA COMBINATION PHASE 2 DATA IN SUBJECTS WITH OR WITHOUT EGFR MUTATIONS PRIOR LINES OF PATIENT EGFR STATUS RESPONSE PRIOR THERAPY THERAPY Positive (exon 18+20) Complete Response Chemo 3 Negative 24% regression Target Lesion Chemo /anti-PD1 2 30%6 regression one Target Lesion : Negative
Slide 15: AACR 21: REQORSA + Tagrisso Reduce Tumor Growth
AACR 21: REQORSA + TAGRISSO REDUCE TUMOR GROWTH IN TAGRISSO-RESISTANT TUMORS f ee ; 1 mami I + t Osimertinib+TUSC2 combination on Osimertinib+TUSC2 combination on H1975-OsiR tumors in NSG mice 1975 tumors in NSG mice 'e E 00. z E 5 2 2 5 id 3 200 g 3 5 2 Fe 2 ° 021 025 029 032 036 039 043 (021 025 0
Slide 16: Acclaim-1 Phase 1/2 Study
PHASE 1 GENERAL STUDY CHARACTERISTICS i ] ] 1 * + FDA Fast Track Designation ee «Patients with advanced, EGFR mutant NSCLC whose disease progressed after Tagrisso ccidIm - + ~15US. sites + ~92 patients Phase 1:9-18 patients - Cohort 1 Complete REQORSA in combination with Astrazeneca’s Tagrisso for N
Slide 17: Acclaim-1 Study Design
“sl flt Acclaim - 1 STUDY DESIGN PRIMARY ENDPOINT - 313 dose escalation of + Dose limiting toxicity REQORSA in combination with Tagrisso PHASE 1 COMPONENT 5 STUDY DESIGN PRIMARY ENDPOINT _ SECONDARY ENDPOINTS cg + Randomized 1:1, open- + Progression free survival (PFS) + Overall response rate ae lab
Slide 18: REQORSA Shows Synergy with Immunotherapies
REQORSA SHOWS SYNERGY WITH IMMUNOTHERAPIES REQORSA |S SYNERGISTIC WITH ANTI-PD1 IN A SYNGENEIC MOUSE MODEL OF LUNG CANCER ‘Survival on Lung Metastasis Model sicicnisana silaea vealed Control TUSC2+PDI+CTLAS thE 40 18 20 2s Days TUSC2+anti-PD1 combination significantly prolonged survival in a lung me
Slide 19: REQORSA Modulates the Immune System
REQORSA MODULATES THE IMMUNE SYSTEM REQORSA IS SYNERGISTIC WITH ANTI-PD1 IN A HUMANIZED MOUSE MODEL OF LUNG CANCER REQORSA + Keytruda cone srr gon) ramen, fries sams) ramos, & Setamie) ‘The independent immunologic effects of REQORSA and Keytruda create synergy by adding increased immunologic attack
Slide 20: AACR 21: REQORSA May Enhance First-Line Standard of Care
AACR 21: REQORSA MAY ENHANCE FIRST-LINE STANDARD OF CARE REQORSA + Keytruda + Chemo + REQORSA enhances the efficacy of chemo-immunotherapy on KL-mutant lung metastases in humanized mice. * Triple combination demonstrated strong antitumor efficacy and induced robust antitumor immunity in KRAS-LKB1 (K
Slide 21: Acclaim-2 General Study Characteristics
GENERAL STUDY CHARACTERISTICS Te. + FDA Fast Track Designation (received December 2021) 2 i | i | ie «Patients with advanced NSCLC whose disease progressed after Pole treatment with Keytruda + ~10 U.S. sites of of ail Y ) e + ~156 patients Phase 1: Phase Sepa, REQORSA in combination with Merck & Co'
Slide 22: Acclaim-2 Study Design
lt: Acclaim -2 STUDY DESIGN PRIMARY ENDPOINT + 3+3 dose escalation of + Dose limiting toxicity REQORSA in combination with Keytruda PHASE 1 COMPONENT = STUDY DESIGN PRIMARY ENDPOINT SECONDARY ENDPOINTS, ag + Randomized 2:1, open- «Progression free survival (PFS) + Overall response rate wz label, 2-a
Slide 23: REQORSA in Small Cell Lung Cancer
REQORSA IN SMALL CELL LUNG CANCER Targeting Small Cell Lung Cancer (in addition to NSCLO) allows Genprex to address virtually the entire lung cancer market. ‘Small Cell Lung Cancer: + Consistently has low TUSC2 protein levels + Documented to often have deletion of one TUSC2 gene allele + Extensive s
Slide 24: Scaled-Up Clinical Grade Manufacturing
SCALED-UP CLINICAL GRADE MANUFACTURING POSITIONS COMPANY FOR SUCCESS IN LUNG CANCER THERAPEUTICS MARKET FOCUS ON Achievement highlighted by important process improvements and significantly improved economies y of scale. LEAD WITH + Successful completion of technology transfer INNOVATION and scale-up
Slide 25: Diabetes Program
DIABETES PROGRAM
Slide 26: Diabetes Program
DIABETES PROGRAM COLLABORATION WITH UNIVERSITY OF PITTSBURGH TO TREAT DIABETES 37.3M or 11.3% of Americans Have Diabetes’ Type 1 Diabetes: An auto-immune condition where the body's immune system destroys pancreatic beta cells that make insulin. Generally occurs in children and adolescents. Type 2 Di
Slide 27: Diabetes: A Global Epidemic
DIABETES: A GLOBAL EPIDEMIC 537M DIABETES PREVELANCE - GLOBAL" Expected to rise to 643M by 2030 and 783M by 2045. 37.3M DIABETES PREVELANCE - USA? 96M U.S. adults (38% population) have prediabetes. 6.7M ANNUAL MORTALITY - GLOBAL* Approximately 1 death every 5 seconds in 2021. ‘931k deaths in the U.S
Slide 28: Diabetes Causes Serious Complications
DIABETES CAUSES SERIOUS COMPLICATIONS HEART DISEASE Leading cause of death for men and women in U.S. Diabetics are 2xas likely to have heart disease or a stroke. CHRONIC KIDNEY DISEASE (CKD) Approximately 1 in 3 adults with diabetes have CKD. Kidney diseases are the 9% leading cause of death in U.S.
Slide 29: Diabetic Patients in Need of Advanced Therapy
DIABETIC PATIENTS IN NEED OF ADVANCED THERAPY GPX-002 HOLDS POTENTIAL TO ADDRESS DISEASE AT ITS CORE FOR LONG-TERM EFFECTIVENESS. 1889 - Removal of pancreas '~ Insulin fit i i ii indogs leads to diabetes EAU ri eer Despite certain advancements in treatment, quality of life remains highly compromised
Slide 30: 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 ra, AAV vector to deliver the Pdx1 + MafA (PM) genes to Hypershcemia ig the pancreas. Intraductal infusion of Pdxt- and Mofo: In T1D, it transforms alpha cells in the pancreas
Slide 31: GPX-002 Reversed Drug-Induced Diabetes in Mice
Blood glucose (mg/l) GPX-002 REVERSED DRUG-INDUCED DIABETES IN MICE Glucose Tolerance Test 2 600 = S-+i— 43 aave-crP beta cell mass (mg) ** 200 _ = AAV8-PM ° o 7 4 2 28 35 ot i AoA Untreated — ajioxan+ ——_alloxan+ Control Aave-GrP AAV8-PM alloxan AAV-8 injection Group GFP = Green Fluorescent Protein
Slide 32: GPX-002 Restored Blood Glucose in T1D Mouse Model
GPX-002 RESTORED BLOOD GLUCOSE IN T1D MOUSE MODEL FOR FOUR MONTHS 0.3 GFP= Green Furescent Protein cs = (fluorescent marker) £ . = PM= Poel + Mat 8 8 ae = i = 2 B oot g meer g Bod fe 2 a aS 8 = z a a ee) O00! “Vaalnsion ven ood gues > 20a Tine ed AAVE-PM AAVE-GFP + One week in a mouse tends to corre
Slide 33: a l lil inti ee
a l 7 lil inti ee
Slide 34: Rejuvenates and Replenishes Beta Cells in T2D
REJUVENATES AND REPLENISHES BETA CELLS IN T2D + T2D stresses beta cells and their insulin production. + GPX-002 appears to replenish and rejuvenate beta cells and insulin production. + Sponsored Research Agreement supports ongoing non-human primate studies in T2D. + Opportunity to lead disease modif
Slide 35: Corporate
Slide 36: Meet Our Team
MEET OUR TEAM COMPANY MANAGEMENT RODNEY VARNER, JD Chairman, President & Chief Executive Officer + 30+ years of expertise in corporate law, including corporate governance, in biotech industry + Former owner of securities broker dealer firm RYAN CONFER, MS Chief Financial Officer + 10+ years of C-Lev
Slide 37: Meet Our Team
MEET OUR TEAM COMPANY MANAGEMENT THOMAS GALLAGHER, JD Senior Vice President, Intellectual Property and Licensing + 20+ years of expertise in biotech IP law, business development, licensing transactions + Seasoned IP executive and attorney DAVID SCHLOSS, JD Senior Vice President, Human Resources + 25
Slide 38: Meet Our Team: Scientific Advisory Board
MEET OUR TEAM SCIENTIFIC ADVISORY BOARD JACK A. ROTH MD. FACS, Chairman Professor and Bud Johnson Distinguished Clinical Chair, Department of Thoracic and Cardiovascular Surgery; Chief, Section of ThoracicMolecular Oncology; Professor of Molecular and Cellular Oncology; UT MD Anderson Cancer Center
Slide 39: Meet Our Team: Clinical Advisory Board
MEET OUR TEAM CLINICAL ADVISORY BOARD. MICHAEL MORSE MD, MHS, FACP. + Professor of Medicine, Division of Medical Oncology in the Department of Surgery at Duke University + Research expertise in targeted therapies and immunotherapies for cancer ANDREW BECKER MD, PHD + President and Founder, Becker Ph
Slide 40: Meet Our Team: Board of Directors
Coming Soon MEET OUR TEAM BOARD OF DIRECTORS RODNEY VARNER, JD Chairman of the Board MM BRENT LONGNECKER Board Director + 30+ years of expertise in corporate law, including corporate governance, in biotech industry + Former owner of securities broker dealer firm +: Chief penteornten lenpriet teres e
Slide 41: GNPX at a Glance
GNPX AT A GLANCE 30-DAY AVG SHARES COMPANY SYMBOL, EXCHANGE | SHAREPRICE | MARKET CAP ecu CURING Genprex, Inc. GNPX Nasdaq $1.37 65M 96K 47,878,351 All data are as of October 7, 2022, except for shares outstanding and cash which are as of june 30, 2022. Genprex Nasdag:GNPX 41
Slide 42: Achievements and Upcoming Milestones
ACHIEVEMENTS AND UPCOMING MILESTONES RECENT ACHIEVEMENTS LOOKING AHEAD Y Dose the first patientin Acclaim-2 mm = File protocol for reviewwith FDA for REQORSA (combination) for small cell Y Approval from Safety Review Committee to escent (EON cte22) advanceAcclaim-1 to higher dosing in Complete Phase
Slide 43: In a Future of Transformational Patient Care
IN A FUTURE OF TRANSFORMATIONAL PATIENT CARE 21ST CENTURY GENE THERAPIES LARGE MARKETS AND UNMET NEED COMBINATION TRIALS WITH TOP SELLING DRUGS TWO FDA FAST TRACK DESIGNATIONS EXPLORING NEW INDICATIONS AND PARTNERSHIPS Nasdaq: GNPX
Slide 44: Genprex
oO Genprex’ NASDAQ: GNPX (877)774-GNPX | investors@genprex.com Nasdaq: GNPX