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^{(NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU)}

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Developing Orphan Drug Therapies To Slow Progressive Kidney Disease

XRTX has a strong cash position of $5.2 Million USD - runway for 14 months

First-in-class Product Candidate Ready for Ph3 Clinical Trials of Xanthine Oxidase Inhibitor for ADPKD

Short-term catalyst for the share price: signing of a global licensing deal in 2024 may provide non- dilutive funding during pivotal registration clinical trial with approximately 200 patients

Read the INVESTOR PRESENTATION HERE

Hello Everyone,

We have another profile back on our radar that moved 24% in 2 session the last time we looked at it a few months back.

We think that this is a company that you are going to want to get on your radar right away and research it.

Pull up XRTX immediately.

According to finviz, XRTX has a float under 2Mill right now.

In a series of strategic moves, XORTX Therapeutics Inc. XRTX, a small pure-play biopharmaceutical, may have just positioned itself as the next major player in the chronic kidney disease treatment market. A market currently facing enormous unmet medical needs. As recently as 2022, the chronic kidney disease treatment market, which includes conditions such as Autosomal Dominant Polycystic Kidney Disease (ADPKD), Diabetes Type-2 Nephropathy, and Acute Kidney Injury, was estimated to run at $32 billion annually. In America alone an estimated 35.5 million have chronic kidney disease, that’s more than one person per every American family! This is a massive market that is crucially in need of new solutions

XRTX has three drug development programs, two of which are clinically advanced products under development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for Coronavirus / COVID-19 infection and XRx-225 for Type 2 Diabetic Nephropathy (T2DN).

‍XORTX is working to advance its clinical development stage products – XRx-008 and XRx-101 - that target xanthine oxidase to inhibit production of uric acid. The Company has a growing portfolio of intellectual property and in some cases claims within granted patents has established proof of concept through independent clinical studies.

XORTX’s pipeline includes proprietary and novel product candidates currently in clinical development:

XRx-008 is being developed as a treatment of progressive kidney disease in Autosomal Dominant Polycystic Kidney Disease (ADPKD).

XRx-101 to treat acute kidney injury as well as health consequences associated with Coronavirus / COVID-19 infection.

The company’s senior team, led by CEO Allen W. Davidoff, Ph.D., has a track record of success in the pharmaceutical industry, having played key roles in the development of Oxypurinol in prior ventures.

Notably, Cynapsus Therapeutics was acquired for $624 million USD, and Trillium Therapeutics was bought for $2.2 billion USD by Pfizer, showcasing the leadership’s ability to create significant shareholder value.

Recent big news from the biotech sector should get XORTX shareholders quite excited. Firstlyand most recently, biopharmaceutical giant Vertex Pharmaceuticals (NASDAQ: VRTX) announcedon April 10th, 2024 it will buy Alpine Immune Sciences (NASDAQ: ALPN) for US$4.9 Billion. Thiswill grant Vertex access to the biotech firm's treatment for an autoimmune disease of the kidney, bolstering its portfolio on kidney diseases as deals in biotechnology continue to heat up. Alpine’s‘Povetacicept’ is in mid-stage development for the treatment of IgA nephropathy and will be evaluated in a late-stage trial in the second half of 2024.

Alpine is in Phase 2a of testing for its Povetacicpet with Phase 3 trials expected by the fall of this year. By comparison, XORTX Therapeutics is in a similar position, approaching Phase 3 testing expected later this year of its orphan drug designated XRx-008 drug therapy form Autosomal Dominant Polycystic Kidney Disease (ADPKD) to slow the progression of kidney damage.,Alpine has a current market capitalisation of some US$4.22 billion, whereas XORTX’ market cap is a mere US$7.2 million.

About Autosomal Dominant Polycystic Kidney Disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a common life-threatening genetic disease, affecting many individuals in all parts of the world. ADPKD is a progressive kidney and cardiovascular disease. Cardiovascular disease is the leading cause of premature mortality in patients with ADPKD, with over 80% of deaths attributable to coronary artery diseases. In ADPKD Patients high serum uric acid (hyperuricemia) and high blood pressure (hypertension) are considered independent risk factors predicting poorer prognosis.

How Hyperuricemia and Hypertension Contribute to ADPKD

Hyperuricemia and hypertension are frequently early events in the progression of ADPKD and accompany the development of kidney cyst growth and kidney volume expansion. Together these precede the development of reduced kidney function. Hypertension is present in about half of all patients ages 24-30, and in all patients who reach kidney failure.

The high prevalence of hypertension is considered to contribute to the excess risk of cardiovascular disease in ADPKD patients. Experimental data from animal studies suggest that processes such as inflammation, renin-angiotensin-aldosterone system, insulin resistance, and endothelial dysfunction may be involved in the pathogenesis of the disease.

This combination of risk factors is not unlike those observed in models of hyperuricemia and may directly contribute to vascular pathology seen in these patients or may be pathway factors via which hypertension leads to kidney disease progression and cardiovascular disease. Moreover, the causative effect of high serum uric acid on high blood pressure in new-onset hypertension has been reported, in the peer-reviewed journal, ‘Hypertension’, by Feig et al.

Providing ADPKD Patients with New Opportunities

The goals of our treatment of ADPKD are to slow the progression of kidney damage and control related complications. Varied therapeutic strategies targeting ADPKD have been explored such as tight blood pressure control using various inhibitors of the renin-angiotensin-aldosterone system (RAAS) as well as preventing the progressive decline of glomerular filtration rate (GFR) – HALT trial. None of these therapies so far appear to slow the progression of kidney disease due to ADPKD. Transplantation or dialysis may be the only options available once end-stage renal disease develops. Insulin resistance and diabetes are also serious concerns for patients with ADPKD.

ADPKD – Only One Therapy is Approved While Suboptimal Treatment Options Remain

• 160,000 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 ADPKD with black box warning – “for risk of serious liver injury”.
• Annual Treatment Cost of JYNARQUE® (tolvaptan) ~156,000 USD. Otsuka reported 2022 sales of tolvaptan of $962 m USD. More than ~7,000 ADPKD patients have been treated with tolvaptan (2)
• 95% of ADPKD patients can’t take or tolerate JYNARQUE® (tolvaptan) (3)

Coveted Status...

Patients who suffer from ADPKD, an often painful genetic disease, have abnormal cyst growth in the kidneys, cardiovascular health consequences, frequently cystic livers in 40% of those diagnosed and up to 4-6X increased frequency of kidney stones. A condition that can profoundly affect quality of life and kidney health.

Additionally, those diagnosed with ADPKD also run a constant risk of high blood pressure (hypertension), cardiovascular disease, and an overall 10X increased risk of neurologic aneurysms, sentencing individuals suffering from ADPKD to increasingly deteriorating quality of life.

The genetic component of ADPKD gives the disease a built-in 50% chance of being passed from parent to child. With the majority of patients requiring regular expensive dialysis treatments or even kidney transplantation by the time they reach their mid-50s.

Achieving Orphan Drug Designation (“ODD”), similar to what was awarded to XORTX Therapeutics, means special rights and accelerated permissions have been granted from FDA and/or other drug regulatory organizations to incentivize research and development of new medical treatments for rare disease markets such as ADPKD.

Unfortunately, rare disease markets are often too small to make new drug formulation financially worthwhile for developers. The granting of Orphan Drug Designation (“ODD”) by the United States’s Food and Drug Administration FDA, combined with approved US and EU patents, helps XORTX Therapeutics fast-track recoupment of the extensive capital and time cost of bringing treatment solutions to market.

This Orphan Drug Designation (“ODD”) also grants XORTX Therapeutics the controlling right to be the sole seller in the United States of XRx-008 ADPKD treatments for seven years .

A critical position to hold considering, with 160,000 diagnosed patients in the U.S. alone, the ADPKD treatment market is estimated to be as much as $5.7 BILLION A YEAR.

Accelerated Timelines & Catalysts…

With the XRx-008 drug development program for ADPKD poised to enter Phase III trial, Orphan Drug Designation (“ODD”), granted US and EU patents, and eligibility for accelerated US FDA approval, could mean significantly reduced timeline for the initial sales of XORTX Therapeutics’ XORLO™ ADPKD treatment.

With the drug already in Phase III trial, soon entering clinical trials, Orphan Drug Designation (“ODD”), and accelerated FDA approval, initial sales of XORTX Therapeutics’ XRx-008 ADPKD treatment is estimated to begin as soon as mid-2027.

The drug's Orphan Drug Designation (“ODD”) will grant the company an exclusive seven-year selling rights window in the United States. A second orphan status petition for Europe and Japan, estimated approval mid-2024, locks-in similar sales and distribution rights over a 10-year period.

Orphan Drug Designation (“ODD”), an accelerated timeline and the massive opportunity to disrupt this multi-billion-dollar ADPKD market is what has some analysts and investors alike considering XORTX Therapeutics as the next big biotech opportunity. Multiple analysts have rated XORTX as a buy and set higher price targets, as they attempt to identify profit opportunities. Especially James Molloy as published on .

Upon successfully launching the XRx-008 program – XORLO™ – to market, XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX) now has a winning playbook to bring its other strong assets, XRx-101 and XRx-225, to similar underserved markets like diabetic nephropathy, type II diabetes, weight loss, gout, and more. XORTX is far from a one-trick pony!

Additionally, the company's strong cash position of $5.2M US and market cap of $10.9M USD gives XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX) plenty of operational runway over the next 14 months.

Ongoing discussions with big pharmaceutical developers have the potential to instantaneously change XORTX Therapeuticsvalue upon realization of a partnership. Additional interest may accelerate with the initiation of the XRX-OXY-201 clinical trial or future completion. Frequently, similar partnerships can approach values of a single year peak sales.

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XORTX Highlights Achievements of 2023 and Preparation for Registration Clinical Trial

March 19, 2024 5:00am EDT

CALGARY, Alberta, March 19, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANUA WKN: A3UNZ), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to provide a summary of Company’s achievements in 2023 and objectives planned for 2024.

Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals. Key milestones include: 1/ the grant of U.S. Orphan Drug Designation for the XRx-008 program for Autosomal Dominant Polycystic Kidney Disease (“ADPKD”) that is being developed under the US FDA 505(b)2 rules further de-risking this program; 2/ ongoing discussions with the US FDA have aligned our endpoints and other Phase 3 clinical trial elements to make XORLO™ the Company’s proprietary oxypurinol formulation, eligible for accelerated approval. These key advances on the XRx-008 program during 2023 were made possible by the exceptional efforts of our Board of Directors, employees, consultants, and vendors. We believe the goals set for 2024 will advance our lead program XRx-008 for ADPKD ever closer to conducting a registration clinical trial leading to marketing approval and value creation for XORTX and its shareholders.”

In 2023, the Company made steady progress advancing its strategic plan in key areas, including chemistry, formulation, manufacturing, and non-clinical studies using XORLO™ to attenuate polycystic kidney disease (“PKD”) progression in animal models, and topline results from the XRX-OXY-101 bridging clinical study of XORLO™. Each of these milestones permit the next step in the Company’s clinical development plan, being a “registration” clinical trial – XRX-OXY-201 in pursuit of accelerated approval and support of the Company’s lead program XRx-008 program for ADPKD.

Synopsis of 2023 Achievements

Chemistry and Manufacturing, Clinical and Pre-Clinical Highlights – Produced drug substance for oxypurinol production and produced GMP drug substance; confirmed XORLO™ formulation, produced enhanced bioavailability and produced clinical supply of tablets for clinical trials.

Regulatory Submissions to US Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) Supporting Clinical Trial Conduct

• April 21, 2023 – FDA granted Orphan Drug Designation for XRx-008 program for ADKPD, following review of February 1^st submission of a comprehensive scientific review package within an Orphan Drug Designation application for XRx-008 for treatment of progressing kidney disease due to ADPKD with the US FDA.
• May 5, 2023 – FDA confirmed the eligibility of XORLO™ for Accelerated Approval following review of March 14^th submission of type D meeting request with US FDA to discuss the clinical development plan (XRX-OXY-201 clinical trial design).
• August 29, 2023 – XORTX submitted an Orphan Drug Designation application to the EMA for the treatment of ADPKD. Following discussion and guidance from EMA, XORTX will expand data package and resubmit to gain EMA Orphan Drug Designation.
  

Technology and Patent Advancements

• January 3, 2023 – XORTX submitted a new Provisional Patent Application seeking broadened and lengthened future patent protection, in a patent entitled “Compositions and Methods for Diagnosis, Treatment and Prevention of Kidney Disease.
  
• November 2, 2023 – XORTX sponsored study results were presented at American Society of Nephrology (“ASN”) under Session Title: “Genetic Diseases of the Kidneys”, by Dr. Charles Edelstein of the University of Colorado. Results of these studies suggest that management of xanthine oxidase activity in PKD may be more important than previously appreciated and further that previously unrecognized factors related to diet, genetic factors or prescribed drugs that increase uric acid levels could potentially aggravate the progression of PKD.

Organizational Highlights

• In addition to substantial technological advancement, the Company continued to bolster the XORTX team with the following appointments:
  
  • June 26, 2023 - James Fairbairn was appointed Chief Financial Officer of XORTX Therapeutics. Mr. Fairbairn has more than 20 years of experience with publicly-traded companies. He is a Chartered Professional Accountant, and an Institute-certified Director.
    
  • December 31, 2023 – Patrick Treanor was appointed as a member of the XORTX Board of Directors. Patrick Treanor is a seasoned pharmaceutical industry executive with over 25 years experience. He is the current Chief Operating Officer of Pathalys Pharma, Inc., a private company specializing in advanced therapeutics for late-stage chronic kidney disease management.   Mr. Treanor earned a BS in Management from Bryant University and an MBA from Rensselaer Polytechnic Institute.
    
• On November 29, 2023, XORTX returned to NASDAQ compliance following a reverse split to increase share price to greater than $1.00.
  

XRx-008 Program Highlights – Independent Commercial Assessment

In support of ongoing pharmaceutical partnership discussions, XORTX initiated an independent commercial assessment of the XRx-008 program for ADPKD with Bluestar BioAdvisors. This evaluation included interviews with 30 Nephrologists and 10 “Payers” with Large national Plans that cover greater than 290 million lives. Outcome of this assessment suggests that the XRx-008 program for ADPKD worldwide peak net sales per year that may exceed $1B, with a total product life estimated to surpass 7 to 10 years.

2024 Corporate Objectives

• March 4, 2024 – XORTX completed an oversubscribed financing of $2.7 million.
• The Company will provide guidance, in the near future, regarding 2024 Corporate Objectives including announcements regarding clinical and regulatory submissions in support of the XRX-OXY-201 clinical “registration” trial designed to demonstrate the benefit of XORLO™ in slowing the progression of declining filtering capacity in ADPKD.

XORTX Announces Publication of Key Research in ADPKD

April 22, 2024 7:00am EDT

CALGARY, Alberta, April 22, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANUA WKN: A3UNZ), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce a research paper titled “Raising serum uric acid with a uricase inhibitor worsens PKD in rat and mouse models" has been accepted for publication in the peer-reviewed American Journal of Physiology-Renal Physiology and published online April 19, 2024.

This study reports health consequences associated with increasing serum uric acid (“SUA”) in mice or rat models of Autosomal Dominant Polycystic Kidney Disease (“ADPKD”), specifically the effects of increasing SUA on cyst growth and kidney size. Cyst genesis and cyst growth (together “cyst index”) and their rates of change are important indicators of disease progression and are correlated with declining filtering capacity and end stage renal disease (“ESRD”). This study shows, for the first time, that chronically increased SUA can significantly increase cyst index and increase kidney size in ADPKD.

According to the study’s findings, saturating concentrations of SUA contributing to “crystal injury” were not necessary to negatively alter both structure and function of the ADPKD kidney. Moderately high SUA concentrations were also found to be associated with an increased inflammatory state (cytokine profile) in both serum and kidney tissue. Independent of the modifying effects of chronically increased SUA, a fundamental new discovery from this study was that over expression of xanthine oxidase (“XO”) in kidney tissue was present, suggesting aberrant purine metabolism may be present in ADPKD and suggesting a possible role of XO in disease progression.

When considered together, SUA above the normal range and overexpression of XO, especially in the location of cysts, in an ADPKD kidney represents a strong impetus for the use of XO inhibition to attenuate this newly described mechanism of injury. Inhibition of XO using XORLO^™, XORTX’s proprietary formulation of oxypurinol, substantially lowered uric acid concentrations, attenuated the effects of chronically increased SUA on cyst index and kidney size in the RC/RC mouse model of ADPKD in this study.

Dr. Allen Davidoff, CEO of XORTX, stated, “We are pleased to have supported this pioneering research in polycystic kidney disease by Dr. Charles Edelstein of the University of Colorado. Identifying for the first time that increased serum uric acid and possibly overexpression of xanthine oxidase in the ADPKD kidney can accelerate disease progression has substantial implications. This study provides important novel insight into one modifying factor that has the potential to accelerate ADPKD progression. In human ADPKD, kidney size and declining kidney filtering capacity are correlated and are key indicators of disease progression and prognosis. Identifying any modifiable factor that explains variable outcomes in individuals with ADPKD is a seminal step forward in our understanding of this disease. XORLO^TM was shown to attenuate this effect. In concept, XORLO^TM should be capable of attenuating both of these modifiable factors. These mechanistic studies are important for the planning of future clinical studies of xanthine oxidase inhibition in patients with ADPKD.”

About ADPKD

ADPKD is a rare disease that affects more that 10 million individuals worldwide.^1,2 ADPKD is typically diagnosed based upon expansion of fluid-filled cysts in the kidneys. Over time, the increasing number and size of cysts can contribute to structural and functional changes to kidneys and is frequently accompanied by chronic pain which is a common problem for patients with ADPKD.³ Expansion of cysts is thought to compress healthy functioning tissue surrounding the cysts and contribute to further loss of kidney function, fibrosis, impaired nutrient exchange and impaired kidney function, accompanied later by end-stage renal disease.¹ For individuals with progressing ADPKD, treatment recommendations include anti-hypertensive treatment, dietary restrictions, and, for a limited percentage of suitable patients, pharmacotherapy.⁴ New, more broadly applicable therapies to effectively slow decline of kidney function in ADPKD are needed.

XORTX Submits a New Patent for the Treatment of Chronic Kidney Disease

PUBLISHED

JAN 3, 2024 7:00AM EST

CALGARY, Alberta, Jan. 03, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, announces submission of a new patent for the treatment of chronic kidney disease (“CKD”). This patent is designed to protect new discoveries and strategies for the treatment of individuals with varied degrees of kidney function in the setting of CKD. Importantly, this patent entitled “Oral and Sublingual Formulations of Xanthine Oxidase Inhibitors and Methods of Treating Disease” outlines new formulations and methods for safer and more effective the use of xanthine oxidase inhibitors (XOI) in the setting of CKD in particular autosomal dominant polycystic kidney disease (ADPKD), diabetic nephropathy (DN), IgA nephropathy, lupus nephritis and focal segmental glomerulosclerosis.

The positive topline results from the XRX-OXY-101 bridging pharmacokinetic clinical study reported in Q1 2023 (the “Study”) characterized the pharmacokinetics of the Company’s proprietary formulation of oral oxypurinol, XORLO™. Results from the Study showed that XORLO™ was well tolerated by the 88 subjects who received the drug. There were no safety concerns during the testing of drug across the various dosing regimens used. Overall results were positive and showed: i) a substantial increase in the bioavailability of oxypurinol with the XORLO™ formulation platform; (ii) a substantially increased dose proportionality compared to non-formulated oxypurinol; (iii) a multiple dosing regimen that achieved therapeutic target values. In simple terms, substantially increased early oral absorption of XORLO™, and increased circulating concentrations of oxypurinol necessary to inhibit production of uric acid across the desired therapeutic range and thereby slow down the advancements of CKD. Each of these results will provide key data to facilitate precise dosing recommendations for upcoming registration trials in individuals with progressing kidney disease due to ADPKD as well as other causes of CKD.

Dr. Allen Davidoff, CEO of XORTX, commented, “The Bridging Pharmacokinetic Study reported this year provided a wealth of clinical data regarding the potential substantive benefit of the novel formulations of the xanthine inhibitor class of drugs. Analysis of this data set, the use of in silico based pharmacokinetic modeling of data from the XRX-OXY-101 clinical trial, and further innovation, resulted in a deeper understanding of how to address the challenges of dosing in progressing kidney disease. This patent application is intended to claim new opportunities to enhance how the xanthine oxidase inhibitor class of drugs may be dosed in the future. Importantly, how to further improve the safe and effective administration of this class of drugs, including oxypurinol.”

About the XRx-008 program

Oxypurinol is a purine based XOI with important pharmacologic characteristics ideal for administration to individuals with ADPKD. Key pharmacologic attributes include:

1/ the ability to act in the circulation, kidney and cardiovascular tissue and inhibit the production of uric acid and so attenuate the mechanism of injury and accelerating effect of XO on progressing diseases.

2/ XORTX’s proprietary formulation of oxypurinol, XORLO™, provides substantially increased absorption of oxypurinol. Metabolism of oxypurinol is minimal and it is eliminated by the kidneys unchanged. This approach provides an effective, well tolerated drug with an extensive clinical safety experience suggesting the Company’s XRx-008 program has the capacity to provide superior XOI to slow the accelerating decline kidney function in patients ADPKD with coexistent hyperuricemia.

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NEWS

Apr 30, 2024 1:54pm EDT

XORTX Reprices Warrants Issued in Connection with Previous Private Placements

Apr 22, 2024 7:00am EDT

XORTX Announces Publication of Key Research in ADPKD

Apr 08, 2024 7:30am EDT

XORTX Welcomes New Member to the Board of Directors

Apr 08, 2024 7:00am EDT

XORTX Announces Participation in Spring 2024 Investor Conferences

Mar 27, 2024 5:00am EDT

XORTX Announces New Clinical Advisory Board Member

Mar 19, 2024 5:00am EDT

XORTX Highlights Achievements of 2023 and Preparation for Registration Clinical Trial

Mar 11, 2024 7:00am EDT

XORTX Reprices Warrants Issued in Connection with Previous Private Placements

Mar 04, 2024 7:00am EST

XORTX Finalizes $2.7 Million Prospectus Supplement and Concurrent Private Placement for the Offering of Units

Feb 15, 2024 7:00am EST

XORTX Raises $2.5 Million Under Prospectus Supplement and Concurrent Private Placement for the Offering of Units

Feb 01, 2024 8:46pm EST

XORTX Files an Amended and Restated Prospectus Supplement for the Offering of Units

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MANAGEMENT

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Dr. Allen W. Davidoff, PhD

Chief Executive Officer

Dr. Allen Davidoff (15 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 two investigational new drug (“IND”) applications or supplemental IND’s, two phase I studies (four of which were multi-country), seven phase II studies, and one NDA. Prior to forming XORTX, Allen was the Chief Scientific Officer, VP Product Development and co-founder of Stem Cell Therapeutics Corp. (seven years) ( Trillium TRIL:NASDAQ) and Senior Scientist and Head of Pharmacology at Cardiome Pharma Corp.

James Fairbairn

Interim Chief Financial Officer

James Fairbairn was the Company’s Chief Financial Officer from November 2018 through July 2021. He has more than 20 years of experience with publicly-traded companies. He is a Chartered Professional Accountant, having obtained his CPA designation in 1987 and an Institute-certified Director. Jim Fairbairn holds a B.A. from the University of Western Ontario.

Dr. Stephen Haworth

Chief Medical Officer

Dr. Haworth brings to XORTX 25+ years of successful global drug development and senior leadership in both start up and Fortune 500 pharmaceutical firms in both the US and Europe. Stephen has a broad clinical and regulatory experience that ranges from infectious disease through nephrology, cardiovascular disease and most recently on programs for treatment and prevention of SARS-CoV infection. He has held key roles in numerous FDA and EMA submissions and has been involved in several licensing and M&A transactions. Dr. Haworth holds a medical degree from University College Hospital Medical School, University of London having graduated with Honors.

Dr. David MacDonald

Chief Technology Officer

Dr. MacDonald has an over 30-year record of achievement in drug development and leadership in pharma and biotech, achieving critical, value-inflection milestones for those companies. Prior to XORTX, Dr. MacDonald held positions as CTO and later President of MSI Methylation Sciences Inc. a clinical-stage pharmaceutical company (“MSI”). As CTO David led R&D, pharmaceutical product and clinical development. Prior to his position at MSI, David acted as President and CEO of Active Pass Pharmaceutics. In addition, he has held leadership positions in several small and large pharma biotech companies during which he was responsible for a broad range of technical departments and stages of development covering basic research, IND-enabling studies, formulation, CMC, clinical trials, intellectual property, and regulatory submissions and inspections. Dr. MacDonald is an inventor on over 20 patents issued globally and has published 14 manuscripts in peer reviewed journals. He obtained his Ph.D. in Chemistry from the University of Alberta where his research was focused on enzymology.

Dr. Stacy Evans

Chief Business Officer

Stacy Evans, M.D., MBA, is an executive consultant with nearly 25 years of commercial development and business development experience, including 12 years at Pfizer where he led multiple transactions for Pfizer, including significant deal experience in the rare disease space. For the past seven years, Dr. Evans has consulted at an executive level with small to mid-size private and public biopharmaceutical companies, including acting as Chief Business Officer for many clients. Dr. Evans holds a M.D. from McGill University and an Executive MBA from Columbia University.

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Sincerely,

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