Dr. Allen Davidoff reports

XORTX ANNOUNCES UPDATE FOR DISCUSSION WITH THE FDA

XORTX Therapeutics Inc. has provided an update regarding communications with the United States Food and Drug Administration (the FDA). At the request of the FDA a Type B meeting package will be provided by the company during the next week, and accompanying FDA communications are expected by April 26, 2025. The company has prepared a broad Type B meeting review at the request of the FDA, including review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence regarding the company's XRx-026 program for the treatment of gout. Drug development of XORLO, the company's proprietary drug formulation of oxypurinol, has advanced substantially to a state where a Type B meeting and discussion with the FDA to confirm the developmental state of each element of the program is warranted. The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a new drug application (NDA) to gain marketing approval for XORLO in the U.S. using the FDA 505(b)2 development pathway. The company believes that a Type B meeting will facilitate a broader discussion toward market approval.

Dr. Allen Davidoff, chief executive officer of XORTX, commented: "We look forward to FDA feedback the last week in April and advancing the XRx-026 program, thereafter. Many key elements of the XRx-026 program have advanced sufficiently to warrant this robust program review with the FDA to define any additional information needed to complete this marketing approval. We believe that the XRx-026 program provides a much needed therapeutic option for individuals with gout and that advancing with the XRx-026 program will transform XORTX to a revenue positive state."

The company will provide further updates following communications with the FDA when additional information is available.

About hyperuricemia and gout

In the United States it is estimated that approximately 44 million individuals have circulating uric acid above the normal range. The prevalence of gout was 3.9 per cent or 9.2 million individuals. Mean serum urate levels were 6.0 mg/dL (milligrams per decilitre) among men and 4.8 mg/dL among women, with hyperuricemia prevalences of 20.2 per cent and 20.0 per cent, respectively. The prevalence of ULT use among patients with gout was 33 per cent during 2007 to 2014 and remained stable over time (P for trend greater than 0.05). Gout is an inflammatory arthritis that is triggered by the crystallization of monosodium urate inside the joints and is preceded by hyperuricemia. Gout flares lead to substantial morbidity by causing severe pain, reduced quality of life, decreased physical function, increased health care costs and lost economic productivity. Furthermore, gout is strongly associated with the metabolic syndrome, and may contribute to myocardial infarction, Type 2 diabetes mellitus, chronic kidney disease and premature mortality.

About the XRx-026 program and XORLO

The XRx-026 program is developing XORLO, a proprietary formulation of oxypurinol to treat individuals suffering from gout. At present, oral xanthine oxidase inhibitors (XOIs) are the preferred therapeutic option used to inhibit the production of uric acid and decrease chronically high uric acid in the circulation. Allopurinol is the most commonly prescribed XOI, with approximately 3.3 million prescriptions written per year in North America, however 3 to 5 per cent of patients cannot tolerate Allopurinol. An alternative XOI, Febuxostat, was launched in the United States in 2009 with the hope of treating individuals with gout, however while Febuxostat achieved peak sales greater than $450-million (U.S.) after its launch, a black box warning due to its associated risk of sudden cardiovascular death resulted in a decline in its use. XORLO can address this unmet medical need and accelerating advancement of the XRx-026 program through an NDA filing is now a priority for XORTX.

About Type B meetings with the FDA

Type B meetings for each potential application (that is, investigational new drug application (IND), NDA, biologics licence application (BLA)) or combination of closely related products developed by the same sponsor or applicant (that is, same active ingredient but different dosage forms being developed concurrently). Typically, it may be appropriate to conduct more than one of some of the Type B meetings for concurrent development of a product for unrelated claims.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) the comapny's lead program XRx-026 program for the treatment of gout; 2) XRx-008 program for ADPKD; and 3) XRx-101 for acute kidney and other acute organ injury associated with respiratory virus infections. In addition, the company is developing XRx-225, a preclinical stage program for Type 2 diabetic nephropathy. XORTX is working to advance products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, the company is dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

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