Contract manufacturing of GMP drug substance and commercial-scale tablets to support the XRX-OXY-102 clinical study and future US FDA marketing approval ●

XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, announces the launch of production of drug material and tablet manufacturing to support the Company’s XRx-026 program for the treatment of gout. This manufacturing supports a planned two-part clinical study of XORLO^TM, the Company’s proprietary formulation of oxypurinol, a xanthine oxidase inhibitor. The clinical trial, XRX-OXY-102, is being advanced based on positive and supportive prior clinical trial results and discussions with the US Food and Drug Administration (the “FDA”).

The two-part clinical study will require production of GMP drug and clinical supply tablets representative of material intended for FDA marketing approval. Contract production of pure oxypurinol drug substance, the active pharmaceutical ingredient in XORLO^TM, using the Company’s proprietary synthetic pathway, has begun.

XORTX is now working closely with its contract manufacturing partner toward the manufacture of commercial drug batches. Validation and stability data from this work is expected to provide key support for FDA marketing approval in the future.

“Advancing our clinical manufacturing and the work underway with our commercial manufacturing partner is a foundational step toward bringing XORLO^TM to patients,” stated Dr. Allen Davidoff, Co-Chief Executive Officer of XORTX, who added, “This progress provides the material we require for the XRX-OXY-102 clinical trial and builds the validation and stability record that we expect will support our NDA filing.”

This manufacturing progress is one part of the Company’s broader plan to advance XRx-026 toward FDA marketing approval, and XORTX looks forward to providing further updates on its regulatory and clinical strategy in the coming weeks.