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XORTX Therapeutics Inc (4)
Symbol XRTX
Shares Issued 1,730,565
Close 2026-06-15 C$ 3.00
Market Cap C$ 5,191,695
Recent Sedar+ Documents

XORTX appoints Grasso as co-CEO

2026-06-15 16:32 ET - News Release

Mr. Allen Davidoff reports

XORTX PROVIDES CORPORATE UPDATE AND ANNOUNCES APPOINTMENT OF MIKA GRASSO AS CO-CEO

XORTX Therapeutics Inc. has provided a corporate update and discussion of the strategic path for its gout and other programs.

The company's current focus, following the recent financing and growing investor interest, is solidly aimed at restructuring its corporate and issuer status, reinitiating its drug development programs, and preparing regulatory filings associated with its lead program for gout.

Continuing evaluation of its corporate team and issuer status has provided the opportunity to further enhance its C-suite effectiveness and to optimize its public market efficiency with the addition of Mika Grasso as co-chief executive officer responsible for finance and public markets.

The recent financing and growing investor interest have permitted the company to increase activities across its drug development disciplines, specific to its lead program for gout -- XRx-026 -- the company's lead and most advanced development program.

Recently, in response to the company's Type B meeting interaction with the U.S. Food and Drug Administration, feedback clarified the remaining key steps required for submission of a new drug application using Section 505(b)(2) regulatory pathway XRx-026 program for the treatment of gout.

Currently, the company is developing an investigative new drug application that includes new data from recently completed pharmacology, toxicology, chemistry and manufacturing studies, as well as an updated clinical development plan. The updated clinical development plan includes a proposed two-part clinical study: Part 1 of the study will characterize the steady-state pharmacokinetics of Xorlo, XORTX's commercial form of oxypurinol tablet, and Part 2 of the study will evaluate the therapeutic equivalence of Xorlo compared with allopurinol in gout patients. Data generated during this study will support the planned marketing application/NDA submission. XORTX intends to advance this drug to marketing approval pending favourable study results and its FDA discussions. A commercial drug supply is also required. The XRx-026 program is being advanced to address gout in patients who are intolerant to allopurinol, targeting a $700-million (U.S.) per year market opportunity (1).

XORTX's overall strategy and goal are to apply its interdisciplinary expertise and pipeline-in-a-product strategy to further identify, develop and commercialize novel treatments for rare/orphan and broader indications related to health consequences associated with gout (XRx-026), progressive kidney disease, including autosomal dominant polycystic kidney disease (XRx-008), and the health consequences of diabetes.

To achieve this objective, it intends to pursue the following strategic path:

  1. Preparation of the IND submission will include additional data for review by the FDA including support for the 505(b)(2) development pathway and a proposed two-part bridging clinical study XRX-OXY-102. It plans to then submit an NDA to the FDA for the XRx-026 product candidate program, which it believes will address a substantial unmet medical need for gout. Increased chemistry and manufacturing activities to prepare clinical and commercial supplies of drug will be conducted in parallel to advancement of the clinical activities.
  2. Subject to discussions with FDA and following the successful completion of a phase 3 clinical registration trial of XRx-008 product candidate program, submit an NDA to the FDA, requesting review under the accelerated approval program status. The company believes introduction of this class of drug could establish a new standard of care for ADPKD.
  3. Maximize the potential of the XRx-026 and XRx-008 product candidate programs, if approved, through independent commercialization and through opportunistic collaborations with third parties.
  4. Leverage its pipeline-in-a-product strategy and experience, developing additional proprietary formulations of xanthine oxidase inhibitor, and/or uric acid lowering agents to treat select rental indications and complement its activities through acquisitions or in-licensing opportunities in nephrology and diabetes when opportunities arise.

Continuing measures to increase shareholder value through improvements to corporate and operations efficiency, combined with a strong focus on key steps, to advance its gout program through to marketing approval during the next 18 months is its aim.

Mika Grasso

Mr. Grasso, age 28, has served as a director of the company since March 24, 2026. Mr. Grasso has served as an investment manager at a family office, where he has been responsible for sourcing and evaluating the fund's direct investment and co-investment efforts. Previously, Mr. Grasso served as a finance associate at Zions Capital Markets from November, 2023, until March, 2025, as an investment banking associate at Paulson Investment Company from February, 2022, until November, 2023, as an analyst at Goldman Sachs from August, 2021, to February, 2022, and as an analyst on the real assets team at Power Systems Management from May, 2020, to August, 2021. Mr. Grasso received his MS in finance, with a concentration in investment management, and his BS in business administration from the Leeds School of Business at the University of Colorado Boulder.

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, and recently acquired VB4-P5 program, which is currently at the pre-IND stage of development and targets both rare and prevalent forms of kidney disease. 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.

(1) Inflation-adjusted Febuxostat peak sales.

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