XORTX to prepare new drug filing for XRx-026

Mr. Allen Davidoff reports XORTX INITIATES IND PREPARATION FOR XORLO IN GOUT PROGRAM XORTX Therapeutics Inc. has initiated an investigational new drug preparation for its lead program, XRx-026, focused on the treatment of gout. In support of this milestone, XORTX has engaged Allucent, a global contract research organization specializing in regulatory and clinical development. Preparation of the IND will include a comprehensive review of non-clinical, pharmacologic, toxicological and regulatory progress, and will incorporate the clinical development plan and protocol for a pharmacologic characterization study of XORLO, the company's proprietary formulation of oxypurinol, in fed and fasted states. XORTX anticipates submission of the IND in the second half of 2025. The submission of the IND follows the Type B meeting that was held in April, 2025, with the U.S. Food and Drug Administration, where the FDA provided guidance on the path toward a new drug application for XORLO. The FDA outlined four critical requirements prior to an NDA submission: Filing of an IND; Preparation of clinical and commercial drug supply with supporting stability data; A pharmacologic study characterizing absorption of XORLO in fasted versus fed individuals; and Compilation of data from steps 2 and 3 above, and then submission of the NDA. "The initiation of IND preparation marks a pivotal step toward regulatory submission and ultimately bringing XORLO to individuals with gout," stated Dr. Allen Davidoff, chief executive officer of XORTX, who added, "Partnering with Allucent ensures we have the depth of regulatory expertise needed to deliver a high-quality submission and advance this important program with rigour and speed." Dr. Stephen Haworth, chief medical officer of XORTX, added: "Gout continues to impose a substantial burden on patients worldwide, and the limitations of current therapies leave many individuals undertreated. We believe that XORLO has the potential to provide a differentiated option for those who cannot tolerate or do not respond adequately to existing xanthine oxidase inhibitors." Issuance of shares under ATM offering In other news, the company confirms the issuance of 73,871 common shares at $1.54 (U.S.) ($2.21 (Canadian)) per share for gross proceeds of $113,547.11 (U.S.) ($163,178.55 (Canadian)) and net proceeds of $109,665.93 (U.S.) ($157,600.91 (Canadian)) during the quarter ended March 31, 2025, under the at-the-market offering announced Nov. 30, 2023. The ATM offering is being made in the United States pursuant to a registration statement on Form F-3 (file No. 333-269429) filed under the Securities Act of 1933, as amended, with the Securities and Exchange Commission and declared effective on Feb. 3, 2023, and the related prospectus dated Feb. 3, 2023, and the prospectus supplement dated Nov. 29, 2023, filed with the commission. About XORTX Therapeutics Inc. XORTX is a pharmaceutical company with three clinically advanced products in development: (1) its 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, it is dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases. We seek Safe Harbor.