Xortx Therapeutics, Inc. · TSXV:XRTX
Xortx Therapeutics — Investor Presentation (January 2022)
22 slides from Xortx Therapeutics's investor presentation, Jan 10, 2022
Slide 1: Redefining Kidney Disease
R e d e f i n i n g K i d n e y D i s e a s e January 10th, 2022 Investor Presentation : XR TX : ANU 1
Slide 2: Forward-looking statements
This company presentation may include “forward - looking statements . ” All forward - looking statements are subject to a number of risks, uncertainties and assumptions, and you should not rely upon forward - looking statements as predictions of future events . You can identify forward - looking sta
Slide 3: Our Mission
Developing Novel Therapies to Address the Treatment Needs of P a ti e n t s wi t h A D P K D a n d K i d n e y D i se a s e Ass o c i a t e d w i t h C O V I D - 19 Ou r M i ss i on 3
Slide 4: Company overview: end stage renal disease market and approach
▪ The global end stage renal disease market was valued at USD 74.5 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 12.7% from 2021 to 2028 (1) . ▪ Developing drug - based therapies for serious progressive kidney diseases with a high unmet medical need, including
Slide 5: XORTX Therapeutics Inc. Pipeline
Therapeutic Disease Pre - clinical Phase I Phase II Phase III Approval Polycystic Kidney Disease Coronavirus / COVID - 19 Diabetic N eph r opa t hy XORTX Therapeutics Inc. Pipeline XORTX Therapeutics holds US, EU and other national rights for all programs 505(b)2 505(b)2 F i r s t - in - C l a s s U
Slide 6: Platform Technology
Platform T e c hno l o g y Proprietary pipeline - in - a product technology Proprietary and highly scalable CMC approach Robust data supporting safety and efficacy of approach Ready to start Phase III Pivotal Trials in 2022 XORTX Technology: Xanthine Oxidase Inhibitor for A b e rr a n t P u r i n e
Slide 7: Aberrant Purine Metabolism and Increased Uric Acid Associated with Kidney Injury
1. Aberrant Purine Metabolism and Dietary Sources of Uric Acid Such As Fructose, Foods Containing Yeast, Oily Fish, Shellfish and Organ meats. 2. Uric Acid Crystals Form in Kidneys. Uric Acid Crystals 2’ “seed” Oxalate crystal formation. 3. Acute Kidney Failure is caused by elevated uric acid in pla
Slide 8: ADPKD's Disease Progression
Healthy Kidney C a pill a r ie s : N or m a l Kidney Size/Volume: Normal - 100% Cysts: Minimal to None Impaired Kidney Capillaries: Constricting and Shortening Kidney Size/Volume: Enlarging - 150% Cysts: Increasing Renal Blood Flow NORMAL IMPAIRMENT Kidney Failure Capillaries: Constricted and Shorte
Slide 9: New Definition of ADPKD Disease Progression
Both of the above support the concept that xanthine oxidase inhibition & uric acid lowering may be of benefit in the setting of ADPKD. 9 C Edelstein ( unpublished data) Newly Definition of - ADPKD’s Disease Progression New Mechanism of Injury: “ Aberrant purine metabolism” in ADPKD kidney tissue W T
Slide 10: End-Stage Renal Disease: A Life Altering Event
▪ 4 hour dialysis 3 times per week ▪ Loss of ability to work full time ▪ Dependence on family ▪ Pain and declining health are constant burden ▪ Shortened survival – only 50% of patients survive two years ▪ XRx - 008 in progressive kidney disease uric acid hastens loss of filtering capacity of kidney
Slide 11: Xanthine Oxidase Inhibition in ADPKD Patients
Xanthine Oxidase Inhibition in ADPKD Patients is Associated with a Reversal of Glomerular Filtration Rate Decline – a FDA approvable endpoint. ▪ Serum uric acid concentrations are higher in ADPKD patients than in non - ADPKD patients with CKD . (Mejias et. Al. Hyperuricemia, Gout, and Autosomal domi
Slide 12: Therapy Summary
T h e r a p y S u mm ar y ▪ Novel, proprietary, safe and well tolerated oral formulation of oxypurinol. ▪ Past recipient of NDA Approvable Letter. ▪ Eligible for Orphan Drug Designation (140,000 patients with ADPKD). ▪ Eligible for Special Protocol Assessment from FDA in ADPKD. Differentiation ▪ Oxy
Slide 13: ADPKD: Only One Therapy Approved, Suboptimal Options Remain
▪ 140,000 patients diagnosed with ADPKD in the US (1) ▪ ADPKD is the largest kidney disease market with a genetic origin ▪ A majority of ADPKD patients require dialysis or kidney transplantation ▪ Otsuka's JYNARQUE® (tolvaptan) was approved in 2018 for the treatment of AKPKD with black box warning ▪
Slide 14: Competitive Landscape
DRUG STATUS Tolvaptan (oral vasopressin V2 antagonist) Otsuka Pharma FDA - APPROVED Lixivaptan (oral vasopressinV2 antagonist) Centessa Pharma I N D E V E L O P M ENT P h a s e II I Bardoxolone (oral Nrf2 activator) Reata Pharmaceuticals Inc. S A FE T Y CONCE R NS P h a s e II I Venglustat (inhibito
Slide 15: Clinical and Regulatory Timeline
Initiation of ADPKD Phase III trial 15 Clinical and Regulatory Timeline: H1, 2022 H2, 2022 GMP Oxypurinol Mfg. Completed PK Study #1 Clinical Trial Application XRx - 008; XRx - 101 Initiate PK Study #1 XRx - 008; XRx - 101 Complete PK Study #1 XRx - 008; XRx - 101 ADPKD IND with US FDA ADPKD Registr
Slide 16: Strong Patent Protection
Patent Claims Term US 9,155,740 Method of use claims covering uric acid lowering agents (Xanthine Oxidase Inhibitors) in the treatment of “Diabetic Nephropathy” Acid 2025 * * es t i ma t ed G A TT e xt e n s i on of 4 - 5 years PCT/US14/30292 Formulation's patent covering Xanthine Oxidase Inhibitors
Slide 17: Capitalization Table
C a p i t a l i z a t i o n T a b le 17 C a p i t a l i z a t i o n a s of O c t obe r 1 5 , 2 0 2 1 # of Shares WAEP C$ Value % o f F u l l y Diluted Common Shares Outstanding (Insiders): 1,644,166 8.90% Common Shares Outstanding (Other): 10,990,521 59.46% W a rr a n t s Ou t s t a nd i ng : 5,329,
Slide 18: Management team
Dr. Allen W. Davidoff, Ph.D. Chief Executive Officer Dr . Allen Davidoff has over 19 years drug development experience) is the founder and CEO of XORTX . Allen has a broad range of clinical and regulatory experience and senior management experience in pharmaceutical R&D including four investigationa
Slide 19: Board of directors
Paul Van Damme B.COMM., CPA, MBA - Chairman Held senior positions with a number of Canadian and US public companies . His experience focused on the biotech industry in Toronto when he joined GlycoDesign, a private biotech company . While at Allelix Pharmaceuticals Inc . , he participated in the sale
Slide 20: Scientific advisors
Dr. Petter Bjornstad, M.D . University of Colorado Denver School of Medicine Barbara Davis Center. Dr. Richard Johnson, M.D Professor of Medicine and the Chief of the Renal Division and Hypertension at the University of CO. Dr. Anjay Rastogi, M.D., Ph.D . Professor and Clinical Chief of Nephrology a
Slide 21: Investment Summary
▪ The global end stage renal disease market was valued at USD 74.5 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 12.7% from 2021 to 2028. ▪ XORTX is developing a therapeutic solution for ADPKD, with a unique mechanism of action, focused on slowing the progressi
Slide 22: Contact Us
Cont ac t U s X O R T X T h e r a p e ut i c s I n c . 4000, 421 7th Avenue SW Calgary, Alberta T2P 4K9 Ph: +1 (403) 455 - 7727 i n f o @ x o r t x . c om ww w . x o r t x . c om X O R T X T her a p e u t ic s I nc. R ed e f i n i n g K i dne y D i s e a s e 22 : XR TX : ANU 1
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