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

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

‍Hello Everyone,

We have another profile that is flying under the radar right now.

We have never profiled this one here. Actually, I haven’t seen this one on any of the industry newsletters that I follow.

Pull up XRTX immediately.

According to finviz, XRTX has a float under 3Mill right now.

This could explain as to why have seen this one take a Giant leap forward and hold it’s gains so far.

XORTX Therapeutics Inc. is a biotechnology company with 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.

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)

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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

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

Jan 15, 2024 7:00am EST

XORTX Announces $2 Million Public Offering

Jan 03, 2024 7:00am EST

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

Jan 02, 2024 7:00am EST

XORTX Welcomes New Member to the Board of Directors

Nov 30, 2023 7:30am EST

XORTX Announces US ATM Offering

Nov 29, 2023 7:00am EST

XORTX Meets Nasdaq Continued Listing Requirements

Nov 10, 2023 7:00am EST

XORTX Clarifies Timing for Share Consolidation

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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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