XORTX Therapeutics, Inc. · TSXV:XRTX
XORTX Therapeutics — Investor Presentation (June 2019)
24 slides from XORTX Therapeutics's investor presentation, June 2019
Slide 1: Redefining How Kidney Disease Is Treated
REDEFINING HOW KIDNEY DISEASE IS TREATED INVESTOR PRESENTATION June 2019 Non Confidential
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This document contains forward-looking information pursuant to applicable securities law. All information that addresses activities or developments that XORTX expects to occur in the future are forward-looking statements. Forward-looking statements are based on the estimat
Slide 3: Key Highlights
KEY HIGHLIGHTS Focused on XORTX development stage products target uric acid lowering, which has been shown to developing clinical stage have an important clinical effect. assets to treat 1st generation xanthine oxidase inhibitors have potency and side effect issues that prevent use in broad kidney d
Slide 4: Uric Acid (UA): A Bad Actor in Kidney Disease
URIC ACID (UA): A BAD ACTOR IN KIDNEY DISEASE HIGH UA LEVELS LOWER UA LEVELS Predict Diabetic Nephropathy Protects Kidney Health Endothelial NO Depletion High Blood Pressure Normalized Blood Pressure Oxidative Stress Vascular Damage Soletsky B et. al., Uric Acid Reduction Rectifies Prehypertension i
Slide 5: Decreasing Uric Acid Levels in Diabetes Patients May Delay Progression to ESRD
Decreasing Uric Acid levels in Diabetes Patients may delay progression to ESRD and the need for dialysis or transplant XORTX Therapies are designed to delay or reverse progression of kidney disease, to prevent ESRD ESRD – A Life Altering Event • 4 hours per day on dialysis • Uric acid hastens loss o
Slide 6: Strong Patent Protection – Covering All Uric Acid Lowering Agents
STRONG PATENT PROTECTION – COVERING ALL URIC ACID LOWERING AGENTS USE IN PROGRESIVE KIDNEY DISEASE Patent Claims Term US 9,155,740 Method of use claims covering uric acid lowering 2025 * agents (Xanthine Oxidase Inhibitors) in the * estimated GATT treatment of “Diabetic Nephropathy” Acid extension o
Slide 7: Competitive Landscape Analysis
COMPETITIVE LANDSCAPE ANALYSIS Well Differentiated Compared to Landscape Current Agents are Ineffective at Best CLASS IP ADVANTAGES LIMITATIONS Uricosurics Varied Decrease uric acid absorption/ reuptake Inappropriate: Increase kidney stone formation Uricase Off Patent Acute IV use Cannot be used chr
Slide 8: XRx-008 in Polycystic Kidney Disease (PKD)
XRx-008 in POLYCYSTIC KIDNEY DISEASE (PKD) XRx-008: A Novel Formulation of Oxypurinol • XRx-008 - a proprietary formulation of Oxypurinol with 3X increased bioavailability – wholly owned by XORTX Therapeutics Inc. and developed “In-house” • Increased tolerability increases compliance and supports ch
Slide 9: Uric Acid Lowering in ADPKD Provides Clinically Meaningful Benefit
PCT 2014 – URIC ACID LOWERING IN ADPKD PROVIDES CLINICALLY MEANINGFUL BENEFIT Serum uric acid (SUA) concentrations Decreasing uric acid in ADPKD patients reverses the are higher in APDKD patients than rate of glomerular filtration rate decline. controls. (Mejias et al. Hyperuricemia, gout, and (Han
Slide 10: Autosomal Dominant Polycystic Kidney Disease (ADPKD) Development Timeline
PCT 2014 – AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Development Timeline: ** Planning to Initiate Pivotal Study under SPA in first half of 2020 ** 2019 2020 2021 2022 2023 2024 GMP Mfg. (9 months) Finalize IND Finalize ODD BA Study Protocol/SPA Ph III Ph3 Pivotal Study under SPA - (30 mo
Slide 11: XRx-221 (TMX-049) to Treat Progressive Kidney Disease
XRx-221 (TMX-049) TO TREAT PROGRESSIVE KIDNEY DISEASE XRx-221 (TMX-049): A Proprietary “Next Generation” Xanthine OxidoReductase Inhibitor • Type 2 Diabetic Nephropathy (T2DN) • High Potency inhibits production of uric acid, thus decreasing and maintaining SUA levels at low- normal target range • Re
Slide 12: Uric Acid Levels Are Highly Correlated to Progressive Kidney Disease
XRx-221 (TMX-049) – URIC ACIF LEVELS ARE HIGHLY CORRELATED TO PROGRESSIVE KIDNEY DISEASE Individuals with Diabetes have kidneys sensitive to high “normal” or high Q1< 3.2 mg/dL serum uric acid, indicating enhanced Q2= 4.4 mg/dL NORMAL Range risk of kidney disease. Q3 =5.0 mg/dL Q4 > 6.2 mg/dL HIGH R
Slide 13: XRx-221 (TMX-049) – Type 2 Diabetic Nephropathy (T2DN)
XRx-221 (TMX-049) – TYPE 2 DIABETIC NEPHROPATHY (T2DN) Decreasing serum uric acid in T2DN patients substantially decreases proteinuria in patients with T2DN. (p=0.02) (p=0.049) (n=20,20) Momeni A, Effect of Allopurinol on Decreasing Proteinuria in Type 2 Diabetic Patients, Int J Kid Dis, 4(128), 201
Slide 14: XRx-221 (TMX-049) – Type 2 Diabetic Nephropathy (T2DN)
XRx-221 (TMX-049) – TYPE 2 DIABETIC NEPHROPATHY (T2DN) Decreasing serum uric acid in T2DN patients has the potential to halve the number of individual who need dialysis! Chronic Kidney Disease (2-yrs) Effects of SUA lowering on CKD - ( ~50% diabetic patients) DURABILITY after Seven Years 25 Renal Ev
Slide 15: XRx-221 (TMX-049) Development Timeline
XRx-221 (TMX-049) DEVELOPMENT TIMELINE Development Timeline: 2019 2020 2021 2022 2023 2024 2025 I---Phase 2a-- ---I Phase 2a results Phase 2b Proof of Concept- (400 patients) Ph2b results DDI Study FDA Meeting QT/QTc (if necessary) End of Ph2b **Pilot Adolescent Study Pilot results I-------Phase 3a
Slide 16: Two Significant Market Opportunities
TWO SIGNIFICANT MARKET OPPORTUNITIES Progressive Kidney Disease Opportunity #1: Opportunity #2: Orphan Disease Diabetic Kidney Disease XRx-008 in Autosomal Dominant XRx-221 (TMX-049) in Polycystic Kidney Disease (ADPDK) Type 2 Diabetic Nephropathy ~150,000 Individuals ~10,000,000 Individuals U.S. U.
Slide 17: Capital Structure
CAPITAL STRUCTURE Market Capitalization ~$11 million Common Shares Outstanding 62,919,691 Warrants 4,004,740 Options 2,174,000 Fully-diluted Shares Outstanding 69,098,431 Public Listings XRX : CSE | XRTXF : OTCQB Longer term plan for NASDAQ listing 17
Slide 18: Key Takeaways
KEY TAKEAWAYS Scarce Assets Addressing a Large Market Opportunity Strong Intellectual Property Portfolio Initial Data Strongly Positions the Company For Clinical Success Important interim data readouts Experienced Management Team With Significant Expertise in Drug Development 18
Slide 19: Contact Information
Contact Information: Dr. Allen Davidoff adavidoff@xortx.com 1-403-455-7727 INVESTOR PRESENTATION Non Confidential
Slide 20: Action Item Plan for Value Creation / Recognition
ACTION ITEM PLAN FOR VALUE CREATION / RECOGNITION In 2018 and 2019, XORTX focused In 2019 and 2020, XORTX will focus on on program value creation: value recogntion: 1. Advanced and accelerated ADPKD 1. Investor Relations program with FDA Roadshows - North America, EU, US Market makers 2. Type 2
Slide 21: Appendix
APPENDIX INVESTOR PRESENTATION Non Confidential
Slide 22: Management Team
MANAGEMENT TEAM Dr. Allen W. Davidoff, James Fairbairn, CPA, Dr. Alan Moore, Brian Mangal Ph.D. ICD.D Ph.D. Co-founder, CEO CFO Co-founder, Senior Director, Business Clinical and Development Regulatory Consultant • 15 years drug development • 20+ years in senior finance • Extensive clinical • 15 yea
Slide 23: Board of Directors
BOARD OF DIRECTORS W. Bruce Rowlands – Chairman, Audit Committee Member • Biotechnology and investment banking background • Former Senior VP, Lorus Therapeutics, a leading Canadian biotechnology company and VP and Director, Dominick and Dominick Securities Canada • Former Chairman and CEO, Eurocontr
Slide 24: Advisory Board
ADVISORY BOARD Dr. Petter Bjornstad, MD • Clinical Researcher and Assistant Professor of Pediatrics and Medicine, University of Colorado School of Medicine • NIH and NDRF funded translational research with a track record of research potential and success • Authored over 70 peer reviewed manuscripts
XORTX Therapeutics — Investor Presentation (June 2019) on 6ix