XORTX Announces Closing of US$5 Million Public Offering

CALGARY, Alberta , May 19, 2026 (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 gout and progressive kidney disease, announces that it has closed its previously announced public offering of 2,659,574 common shares ("Common Shares") or common shares equivalents in lieu thereof (“Pre-Funded Warrants”) at a purchase price of US$1.88 (the “Offering”).

In connection with the Offering, the Company entered into definitive securities purchase agreements with purchasers to which the Company has issued 183,577 Common Shares and 2,475,997 Pre-Funded Warrants. Each Pre-Funded Warrant will entitle the holder to acquire one common share at an exercise price of $0.0001 per share.

The gross proceeds from the Offering were US$5 million, before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes, including investor relations related activities. The closing of the Offering remains subject to the final approval of the TSX Venture Exchange.

E.F. Hutton & Co. acted as exclusive placement agent for the Offering and was paid a cash commission of US$200,000, representing a 4% commission.

The Common Shares (and Pre-Funded Warrants in lieu thereof) were issued pursuant to a registration statement on Form F-1 (File No. 333-290512), which was declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on May 13, 2026. The Offering was made only by means of the prospectus forming part of the effective registration statement relating to the Offering. A final prospectus relating to the Offering has been filed with the SEC. Copies of the final prospectus relating to the Offering may be obtained by contacting E.F. Hutton & Co., 745 Fifth Avenue, 34th Floor and PH, New York, NY 10151, or by email at efhcapitalmarkets@efhutton.com. Investors may also obtain these documents at no cost by visiting the SEC’s website at https://www.sec.gov.

A portion of the proceeds of the Offering, in an amount equal to US$2.5 million, will be paid to IR Agency LLC for marketing and advertising services to communicate information about XORTX to the financial community, including but not limited to, creating Company profiles, media distribution and building digital community with respect to XORTX. IR Agency LLC operates out of Newark, New Jersey and is an arm’s length party to XORTX prohibited from acquiring interest in XORTX.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our 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 pre-clinical 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains express or implied forward-looking statements pursuant to applicable securities laws. These forward-looking statements, include, but are not limited to, the anticipated use of proceeds from the offering and the final approval of the TSX Venture Exchange. These forward-looking statements and their implications are based on the current expectations of the management of XORTX only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, XORTX undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting XORTX is contained under the heading “Risk Factors” in XORTX’s Registration Statement on Form F-1 (File No. 333-290512) filed with the SEC, which is available on the SEC's website, www.sec.gov (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada, which are available on www.sedarplus.ca.

Source: XORTX Therapeutics Inc.

Released May 19, 2026

XORTX Announces Election to Voluntary Delist from the TSX Venture Exchange

CALGARY, Alberta, June 12, 2026 (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 gout and progressive kidney disease, announces that the Company has elected to voluntarily delist its common shares from the TSX Venture Exchange (“TSXV”). The Company will provide additional information on timing for the completion of the delisting of its common shares in a separate press release.

This decision was taken following a comprehensive evaluation, the Company determined that maintaining a dual listing on the TSXV does not justify the associated costs and administrative requirements and presents challenges due to the different regulatory environments. It is envisioned that the voluntary delisting will eliminate duplicative exchange fees, reduce legal and accounting expenses, optimize company financing initiatives and minimize regulatory complexity, and enable greater management focus on the advancement of the XRx-026 program for the treatment of gout for long-term shareholder value creation.

All shareholders, including Canadian shareholders, will continue to maintain full trading access of their common shares on Nasdaq. No action is required by shareholders in connection with the voluntary delisting. Shareholders with account-specific questions are encouraged to contact their respective brokers.

The voluntary delisting from the TSXV was approved by the Company's Board of Directors. In accordance with TSXV policies, shareholder approval is not required as the Company’s common shares are listed on an acceptable alternative market. XORTX will continue to be a reporting issuer under applicable securities laws in Alberta, British Columbia and Ontario.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our 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 pre-clinical 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains express or implied forward-looking statements pursuant to applicable securities laws. These forward-looking statements include, but are not limited to, the Company's beliefs, plans, goals, objectives, expectations, assumptions, estimates, intentions, future performance, other statements that are not historical facts and statements identified by words such as "expects", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or words of similar meaning. These forward-looking statements and their implications are based on the current expectations of the management of XORTX only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks, uncertainties, and other factors include, but are not limited to our ongoing compliance with Nasdaq listing standards; the success and timing of our preclinical studies and clinical trials; our plans to develop and commercialize our product candidates; and our plans to advance research in other kidney disease applications. Except as otherwise required by applicable law and stock exchange rules, XORTX undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting XORTX is contained under the heading “Risk Factors” in XORTX’s Annual Report on Form 20-F filed with the SEC, which is available on the SEC's website, www.sec.gov (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada, which are available on www.sedarplus.ca.

Source: XORTX Therapeutics Inc.

Released June 12, 2026

XORTX Provides Corporate Update and Announces Appointment of Mika Grasso as Co-CEO

CALGARY, Alberta, June 15, 2026 (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 gout and progressive kidney disease, is pleased to provide a corporate update and discussion of the strategic path for our gout and other programs.

The Company’s current focus, following the recent financing and growing investor interest, is solidly aimed at restructuring our corporate and issuer status, re-initiating our drug development programs, and preparing regulatory filings associated with our lead program for gout.

Ongoing evaluation of our corporate team and issuer status has provided the opportunity to further enhance our c-suite effectiveness and to optimize our public markets efficiency with the addition of Mika Grasso as co-CEO responsible for finance and public markets.

The recent financing and growing investor interest has permitted the Company to increase activities across our drug development disciplines, specific to our 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 US Food and Drug Administration (the “FDA”), feedback clarified the remaining key steps required for submission of a new drug application (“NDA”) 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 (“IND”) 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 XORLOTM, XORTX’s commercial form of oxypurinol tablet, and Part 2 of the study will evaluate the therapeutic equivalence of XORLOTM compared to 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 favorable 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 US $700 million per year market opportunity.1

XORTX’s overall strategy and goal is to apply our 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 (“ADPKD”) (XRx-008) and the health consequences of diabetes.

To achieve this objective, we intend to pursue the following strategic path:

- 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. We plan to then submit a NDA to the FDA for the XRx-026 product candidate program, which we believe 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.

- Subject to discussions with FDA and following the successful completion of a Phase 3 clinical registration trial of XRx-008 product candidate program, submit a NDA to the FDA, requesting review under the Accelerated Approval program status. We believe introduction of this class of drug could establish a new standard of care for ADPKD.

- 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.

- Leverage our 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 our activities through acquisitions or in-licensing opportunities in nephrology and diabetes when opportunities arise.

Ongoing measures to increase shareholder value through improvements to corporate and operations efficiency, combined with a strong focus on key steps to advance our gout program through to marketing approval during the next 18 months is our 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) our 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 pre-clinical 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as well as "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "estimate," "plan," "intend," "will," "designed to," "positions," and similar expressions, and include all statements that are not statements of historical fact. These forward-looking statements include, but are not limited to, statements regarding: the ability to focus management resources on the advancement of the XRx-026 program for the treatment of gout; the appointment of Mika Grasso as Co-CEO and the allocation of responsibilities among the Company's leadership; and the advancement of the Company's development programs and its strategy.

Forward-looking statements are based on the Company's current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others: that the voluntary delisting may not be completed on the anticipated timeline or at all; the risk that the anticipated benefits of the delisting are not realized; the Company's need for, and ability to obtain, additional capital to fund its development programs and operations; the Company's ability to advance, and obtain regulatory approval for, the XRx-026 program and its other product candidates on the timelines currently anticipated, or at all; the evolving regulatory environment applicable to the Company's business in the United States and Canada; and the Company's ability to attract and retain qualified personnel, including its newly appointed officers.

For a more detailed discussion of these and other risks and uncertainties, investors should review the disclosures contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, and in the Company's subsequent Reports of Foreign Private Issuer on Form 6-K, each as filed with or furnished to the SEC and available at www.sec.gov, as well as in the Company's continuous disclosure documents filed with the Canadian securities regulatory authorities and available at www.sedarplus.ca.

The forward-looking statements in this press release speak only as of the date hereof. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned not to place undue reliance on these forward-looking statements.

_________________________________

1 Inflation-adjusted Febuxostat peak sales.

Source: XORTX Therapeutics Inc.

Released June 15, 2026

XORTX Appoints New Director

CALGARY, Alberta, July 29, 2026 (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 gout and progressive kidney disease, is pleased to announce the appointment of Depesh Narotam to the board of directors as an independent director.

Depesh Narotam has been in the financial services industry for over 20 years. He has developed considerable expertise in debt financing, delivering strategic lending solutions to a diverse client base. Over the course of his career Depesh has developed a comprehensive understanding of various sectors specifically the real estate lending landscape where he has been responsible for market expansion and strategic partnerships to those that have benefited from enhanced market presence and long term performance.

Depesh Narotam

Mr. Narotam, age 43, was appointed as a director of the Company effective July 27, 2026. The board of directors has determined that Mr. Narotam is an independent director under applicable Nasdaq listing standards and Canadian securities laws. Mr. Narotam has also been appointed to serve as a member of the Compensation, Governance and Nominating Committee of the board of directors. Mr. Narotam is a resident of British Columbia, Canada and has served as a Mortgage Development Manager since December 2020 at Vancity, Canada's largest community-based credit union and a member-owned financial co-operative. Prior to joining Vancity, Mr. Narotam spent 16 years with Westminster Savings Credit Union (now Prospera Credit Union) where he held various positions in financial services including Mortgage Specialist and Business Development Manager.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our 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 pre-clinical 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as well as "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "estimate," "plan," "intend," "will," "designed to," "positions," and similar expressions, and include all statements that are not statements of historical fact. These forward-looking statements include, but are not limited to, statements regarding: the appointment of Mr. Narotam to the Company's board of directors; his anticipated contributions to the Company; and the advancement of the Company's development programs and its strategy.

Forward-looking statements are based on the Company's current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others: the Company's need for, and ability to obtain, additional capital to fund its development programs and operations; the Company's ability to advance, and obtain regulatory approval for, the XRx-026 program and its other product candidates on the timelines currently anticipated, or at all; the evolving regulatory environment applicable to the Company's business in the United States and Canada; and the Company's ability to attract and retain qualified personnel, including its newly appointed director.

For a more detailed discussion of these and other risks and uncertainties, investors should review the disclosures contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, and in the Company's subsequent Reports of Foreign Private Issuer on Form 6-K, each as filed with or furnished to the SEC and available at www.sec.gov, as well as in the Company's continuous disclosure documents filed with the Canadian securities regulatory authorities and available at www.sedarplus.ca.

The forward-looking statements in this press release speak only as of the date hereof. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned not to place undue reliance on these forward-looking statements.

Source: XORTX Therapeutics Inc.

Released July 29, 2026

XORTX Announces Director Resignation

CALGARY, Alberta, July 31, 2026 (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 gout and progressive kidney disease, announces that Anthony Giovinazzo is stepping down from the board of directors for personal reasons and to pursue other interests.

Dr. Allen Davidoff, co-CEO of XORTX, stated, “XORTX management and the board of directors extends our heartfelt appreciation for Mr. Giovinazzo’s efforts as chairman of the board during the past several years. Anthony’s contribution to XORTX spans leadership and ethics of the highest standards as Board chairman, and on key committees. We personally thank him for his time with the Company.”

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our 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 pre-clinical 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as well as "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "estimate," "plan," "intend," "will," "designed to," "positions," and similar expressions, and include all statements that are not statements of historical fact. These forward-looking statements include, but are not limited to, statements regarding the advancement of the Company's development programs and its strategy.

Forward-looking statements are based on the Company's current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others: the Company's need for, and ability to obtain, additional capital to fund its development programs and operations; the Company's ability to advance, and obtain regulatory approval for, the XRx-026 program and its other product candidates on the timelines currently anticipated, or at all; the evolving regulatory environment applicable to the Company's business in the United States and Canada; and the Company's ability to attract and retain qualified personnel, including its newly appointed director.

For a more detailed discussion of these and other risks and uncertainties, investors should review the disclosures contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, and in the Company's subsequent Reports of Foreign Private Issuer on Form 6-K, each as filed with or furnished to the SEC and available at www.sec.gov, as well as in the Company's continuous disclosure documents filed with the Canadian securities regulatory authorities and available at www.sedarplus.ca.

The forward-looking statements in this press release speak only as of the date hereof. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned not to place undue reliance on these forward-looking statements.

Source: XORTX Therapeutics Inc.

Released July 31, 2026

XORTX Announces Termination and Postponement of Investor Relations Program

CALGARY, Alberta, Aug. 28, 2026 (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 gout and progressive kidney disease, announces that, effective August 7, 2026, it terminated its previously announced investor relations and marketing agreement dated May 13, 2026 with IR Agency LLC (the “IR Agreement”). The IR Agreement had a 90-day term commencing May 18, 2026 and provided for 10 individual marketing days of news distribution campaigns for an aggregate fee of US$2.5 million, payable in advance. The fee was fully earned upon receipt and non-refundable. Under the mutual agreement of the parties, the arrangement has been rescinded, all services contemplated under the agreement have been discontinued and the funds previously paid to IR Agency LLC in connection with the agreement were returned to the Company on August 14, 2026. The original arrangement was disclosed in connection with the Company's US$5 million public offering completed on May 19, 2026. A portion of the offering proceeds, in an amount equal to US$2.5 million, had been allocated to IR Agency LLC for marketing and advertising services.

The Company has elected to postpone the investor relations and marketing program while it completes its previously announced voluntary delisting from the TSX Venture Exchange (the “TSXV”). As previously disclosed, the Company determined that maintaining a dual listing on the TSXV does not justify the associated costs and administrative requirements and presents challenges arising from different regulatory environments. The Company believes that postponing the investor relations program during the delisting process is consistent with its objective of reducing regulatory complexity and focusing management resources on advancing the Company's business and clinical development programs.

The Company intends to re-engage IR Agency LLC following completion of the voluntary delisting process and when deemed appropriate by management and the board of directors. Until that time, the investor relations and marketing program has been postponed and all funds previously paid under the arrangement were returned to the Company on August 7, 2026.

The Company expects the voluntary delisting to take effect on September 1, 2026, subject to final approval by the TSXV.

The Company also announces that, effective September 1, 2026, Computershare Investor Services Inc. will become the Company’s transfer agent and registrar, replacing TSX Trust Company. Shareholders are not required to take any action in connection with the transfer agent change.

Vectus Transaction Finder's Fee Disclosure

As a corrective disclosure relating to the Company’s acquisition of Vectus Biosystems Limited’s Renal Anti-Fibrotic Therapeutic Program, which closed on April 13, 2026, the Company advises that aggregate cash finder’s fees of US$240,000 were paid in connection with the transaction. This disclosure was inadvertently omitted from the Company’s April 13, 2026 news release announcing the closing of the acquisition.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our 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 pre-clinical 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains express or implied forward-looking statements pursuant to applicable securities laws. These forward-looking statements include, but are not limited to, statements regarding the termination and rescission of the investor relations agreement, the refund of amounts previously paid to IR Agency LLC, the timing and completion of the voluntary delisting from the TSX Venture Exchange, the anticipated benefits of the delisting, and the possibility of future investor relations activities following completion of the delisting. These forward-looking statements and their implications are based on the current expectations of management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to, the completion of the refund process, the timing and completion of the voluntary delisting, the Company's ongoing compliance with Nasdaq listing standards, and the risks described in the Company's filings with the U.S. Securities and Exchange Commission and Canadian securities regulators. Except as otherwise required by applicable law and stock exchange rules, XORTX undertakes no obligation to publicly update any forward-looking statements. More detailed information about the risks and uncertainties affecting XORTX is contained in the Company's public filings available on the SEC's website and on SEDAR+.

Source: XORTX Therapeutics Inc.

Released August 28, 2026

XORTX Re-Engages Investor Relations Program

CALGARY, Alberta, Sept. 08, 2026 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) announces that, following completion of its previously announced voluntary delisting from the TSX Venture Exchange, XORTX has re-engaged IR Agency LLC pursuant to a consulting agreement providing for investor relations and marketing services on substantially the same terms previously disclosed by the Company in its news releases dated May 19, 2026 and August 28, 2026.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our 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 pre-clinical 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Neither Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains express or implied forward-looking statements pursuant to applicable securities laws. These forward-looking statements include, but are not limited to, statements regarding the investor relations and marketing agreement with IR Agency LLC, the services to be provided thereunder, the anticipated duration of the engagement, the news distribution campaigns contemplated by the agreement, and the Company's investor relations and marketing activities. These forward-looking statements and their implications are based on the current expectations of management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks, uncertainties and other factors include, but are not limited tothe effectiveness and results of the investor relations and marketing program, the Company's ongoing compliance with Nasdaq listing standards, and the risks described in the Company's filings with the U.S. Securities and Exchange Commission and Canadian securities regulators. Except as otherwise required by applicable law and stock exchange rules, XORTX undertakes no obligation to publicly update any forward-looking statements. More detailed information about the risks and uncertainties affecting XORTX is contained in the Company's public filings available on the SEC's website and on SEDAR+.

Source: XORTX Therapeutics Inc.

Released September 8, 2026

XORTX Announces Initiation of Clinical and Commercial Manufacturing of XORLO™

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

CALGARY, Alberta, Sept. 10, 2026 (GLOBE NEWSWIRE) -- 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 XORLOTM, 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 XORLOTM, 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 XORLOTM 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.

About Hyperuricemia and Gout

In the United States, approximately 44 million individuals have uric acid levels above the normal range, with 9.2 million individuals living with gout1. Gout is associated with severe pain, reduced quality of life2, decreased physical function3, increased healthcare costs4, and lost economic productivity5. It is also strongly associated with metabolic syndrome5, myocardial infarction6,7, Type 2 diabetes mellitus8, chronic kidney disease9, and premature mortality6,10,11. Importantly, the global prevalence of gout is increasing, with cases expected to increase 70% over the next 25 years*.

__________________

* https://pubmed.ncbi.nlm.nih.gov/38996590/

About the XRx-026 Program and XORLO™

The XRx-026 program is developing XORLO™, a proprietary formulation of oxypurinol, to treat individuals with gout. Oral xanthine oxidase inhibitors (XOIs) are the current standard of care, but limitations remain: approximately 3–5% of patients cannot tolerate allopurinol, and febuxostat, while once achieving >US$450 million in annual sales, now carries a boxed warning for cardiovascular risk. XORLO™ is designed to address this unmet need by providing an alternative therapeutic option with a differentiated safety and efficacy profile. Advancement of XRx-026 through NDA filing is a strategic priority for XORTX.

References

- Chen-Xu M, et al. Prevalence of Gout and Hyperuricemia in the US. Arthritis Rheumatol. 2019;71(6):991–999.

- Singh JA. Quality of life and quality of care for patients with gout. Curr Rheumatol Rep. 2009;11(2):154–60.

- Burke BT, et al. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res. 2015;67(12):1730–8.

- Rai SK, et al. The economic burden of gout: a systematic review. Semin Arthritis Rheum. 2015;45(1):75–80.

- Choi HK, et al. Prevalence of the metabolic syndrome in individuals with hyperuricemia. Am J Med. 2007;120(5):442–7.

- Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation. 2007;116(8):894–900.

- Liu S-C, et al. Gout and Risk of Myocardial Infarction: A Systematic Review. PLoS ONE. 2015;10(7):e0134088.

- Choi HK, et al. Gout and the risk of type 2 diabetes among men with high cardiovascular risk profile. Rheumatology. 2008;47(10):1567–70.

- Roughley MJ, et al. Gout and risk of chronic kidney disease and nephrolithiasis: meta-analysis. Arthritis Res Ther. 2015;17(1).

- Kuo C-F, et al. Gout: an independent risk factor for all-cause and cardiovascular mortality. Rheumatology. 2010;49(1):141–6.

- Fisher MC, et al. Premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017;76(7):1289–94.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead 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 pre-clinical stage program for Type 2 diabetic nephropathy, and the 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as well as "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "estimate," "plan," "intend," "will," "designed to," "positions," and similar expressions, and include all statements that are not statements of historical fact. These forward-looking statements include, but are not limited to, statements regarding the initiation and completion of manufacturing of GMP oxypurinol drug substance and clinical and commercial-scale supply of XORLO™ tablets; the timing, design, and conduct of the planned XRX-OXY-102 clinical study; the expected contribution of validation and stability data to a future NDA filing and FDA marketing approval; and the advancement of the Company's XRx-026 program, its other development programs, and its strategy.

Forward-looking statements are based on the Company's current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others: the Company's need for, and ability to obtain, additional capital to fund its development programs and operations; the Company's reliance on third-party contract manufacturers, and the risk of delays, failures, or increased costs in the production of GMP drug substance and clinical or commercial supply tablets; the risk that validation and stability data do not support an NDA filing or FDA marketing approval; the Company's ability to initiate, conduct, and complete the planned XRX-OXY-102 clinical study on the timelines currently anticipated, or at all; the Company's ability to advance, and obtain regulatory approval for, the XRx-026 program and its other product candidates on the timelines currently anticipated, or at all; the evolving regulatory environment applicable to the Company's business in the United States and Canada; and the Company's ability to attract and retain qualified personnel.

For a more detailed discussion of these and other risks and uncertainties, investors should review the disclosures contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, and in the Company's subsequent Reports of Foreign Private Issuer on Form 6-K, each as filed with or furnished to the SEC and available at www.sec.gov, as well as in the Company's continuous disclosure documents filed with the Canadian securities regulatory authorities and available at www.sedarplus.ca.

The forward-looking statements in this press release speak only as of the date hereof. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned not to place undue reliance on these forward-looking statements.

Source: XORTX Therapeutics Inc.

Released September 10, 2026

XORTX Announces Planned FDA IND Submission for XRx-026 Gout Program Using XORLO™, Targeting USD$700M+ U.S. Gout Market Opportunity

Investigational New Drug application planned for submission to the U.S. FDA in the fourth quarter of 2026, advancing the Company’s regulatory path toward NDA filing for gout program XRx-026

CALGARY, Alberta, Sept. 18, 2026 (GLOBE NEWSWIRE) -- 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, outlines its anticipated Investigational New Drug application (“IND”) submission to the U.S. Food and Drug Administration (the “FDA”) for the XRx-026 gout program. XORTX’s drug development plan is to seek FDA marketing approval for XRx-026 and provide patients with a new therapeutic option. The key steps the Company anticipates will be necessary to file a marketing application with the FDA include meetings with the agency, a two-part clinical study to characterize the pharmacokinetics and efficacy of the XORLO™ formulation of oxypurinol, and manufacture of a commercial supply of XORLO™ for the first year of marketing.

Recent drug development team activities include preparation of a new IND for submission to the FDA in the fourth quarter of 2026. The application describes the Company’s clinical development plan and its intention to file a New Drug Application (“NDA”) with the FDA following completion of the planned two-part XRX-OXY-102 clinical trial, which is being advanced based on positive and supportive prior clinical trial results and discussions with the FDA. The focus of the XRX-OXY-102 clinical trial is to characterize key information needed by the FDA in its evaluation of a future NDA filing by XORTX for marketing approval.

If the XRX-OXY-102 clinical trial is successfully completed, the Company anticipates requesting a pre-NDA meeting with the FDA and preparing an NDA submission, in parallel with pre-commercialization activities. Subject to the availability of sufficient funding and the timely completion of the XRX-OXY-102 clinical trial, XORTX is targeting an NDA submission in approximately one year. Based on prior peak net sales for febuxostat, XORTX estimates the XRx-026 program addresses an estimated US$700M market opportunity per annum.

“Our planned IND submission to the FDA next quarter is a defining step for the XRx-026 program,” stated Allen Davidoff, Co-Chief Executive Officer of XORTX, who added, “It reflects the strength of our prior clinical results and moves us closer to potentially offering gout patients a differentiated treatment option.”

This planned submission is one part of XORTX’s broader regulatory strategy for XRx-026, and the Company looks forward to providing further updates on its international development plans.

About Hyperuricemia and Gout

In the United States, approximately 44 million individuals have uric acid levels above the normal range, with 9.2 million individuals living with gout1. Gout is associated with severe pain, reduced quality of life2, decreased physical function3, increased healthcare costs4, and lost economic productivity5. It is also strongly associated with metabolic syndrome5, myocardial infarction6,7, Type 2 diabetes mellitus8, chronic kidney disease9, and premature mortality6,10,11. Importantly, the global prevalence of gout is increasing, with cases expected to increase 70% over the next 25 years*.

About the XRx-026 Program and XORLO™

The XRx-026 program is developing XORLO™, the Company’s proprietary formulation of oxypurinol, to treat individuals with gout. Oral xanthine oxidase inhibitors (XOIs) are the current standard of care, but limitations remain: approximately 3–5% of patients cannot tolerate allopurinol, and febuxostat, while once achieving >US$450 million in annual sales, now carries a boxed warning for cardiovascular risk. XORLO™ is designed to address this unmet need by providing an alternative therapeutic option with a differentiated safety and efficacy profile. Advancement of XRx-026 through NDA filing is a strategic priority for XORTX.

References

- Chen-Xu M, et al. Prevalence of Gout and Hyperuricemia in the US. Arthritis Rheumatol. 2019;71(6):991–999.

- Singh JA. Quality of life and quality of care for patients with gout. Curr Rheumatol Rep. 2009;11(2):154–60.

- Burke BT, et al. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res. 2015;67(12):1730–8.

- Rai SK, et al. The economic burden of gout: a systematic review. Semin Arthritis Rheum. 2015;45(1):75–80.

- Choi HK, et al. Prevalence of the metabolic syndrome in individuals with hyperuricemia. Am J Med. 2007;120(5):442–7.

- Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation. 2007;116(8):894–900.

- Liu S-C, et al. Gout and Risk of Myocardial Infarction: A Systematic Review. PLoS ONE. 2015;10(7):e0134088.

- Choi HK, et al. Gout and the risk of type 2 diabetes among men with high cardiovascular risk profile. Rheumatology. 2008;47(10):1567–70.

- Roughley MJ, et al. Gout and risk of chronic kidney disease and nephrolithiasis: meta-analysis. Arthritis Res Ther. 2015;17(1).

- Kuo C-F, et al. Gout: an independent risk factor for all-cause and cardiovascular mortality. Rheumatology. 2010;49(1):141–6.

- Fisher MC, et al. Premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017;76(7):1289–94.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead 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 pre-clinical stage program for Type 2 diabetic nephropathy, and the 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as well as "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "estimate," "plan," "intend," "will," "designed to," "positions," and similar expressions, and include all statements that are not statements of historical fact. These forward-looking statements include, but are not limited to, statements regarding the timing and content of the Company's planned IND submission to the FDA for the XRx-026 program; the design, initiation, conduct, and completion of the planned XRX-OXY-102 clinical trial; the timing of a pre-NDA meeting and the preparation and submission of an NDA, including the Company's target of submitting an NDA in approximately one year; the manufacture of commercial supply of XORLO™; the Company's estimate of the size of the U.S. market opportunity for XRx-026; the Company's international development plans; and the advancement of the Company's XRx-026 program, its other development programs, and its strategy.

Forward-looking statements are based on the Company's current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others: the Company's need for, and ability to obtain, additional capital to fund its development programs and operations; the risk that the Company's IND submission is delayed or, once submitted, is placed on clinical hold or otherwise not permitted to proceed by the FDA; the Company's ability to initiate, conduct, and complete the planned XRX-OXY-102 clinical trial on the timelines currently anticipated, or at all, and the risk that the results of that trial are not positive or do not support an NDA submission; the risk that the FDA does not agree with the Company's proposed clinical development plan or regulatory pathway, or requires additional studies or data; the Company's reliance on third-party contract research organizations and contract manufacturers; the risk that the Company's estimates of market size, which are based on third-party data and the historical sales of other products, prove to be inaccurate; competition from existing and future therapies for gout; the Company's ability to advance, and obtain regulatory approval for, the XRx-026 program and its other product candidates on the timelines currently anticipated, or at all; the evolving regulatory environment applicable to the Company's business in the United States and Canada; and the Company's ability to attract and retain qualified personnel.

For a more detailed discussion of these and other risks and uncertainties, investors should review the disclosures contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, and in the Company's subsequent Reports of Foreign Private Issuer on Form 6-K, each as filed with or furnished to the SEC and available at www.sec.gov, as well as in the Company's continuous disclosure documents filed with the Canadian securities regulatory authorities and available at www.sedarplus.ca.

The forward-looking statements in this press release speak only as of the date hereof.

XORTX Outlines Anticipated Health Canada Clinical Trial Application for XRx-026 for Gout

● Clinical Trial Application planned for filing with Health Canada, extending the Company’s international regulatory strategy for gout program XRx-026 ●

CALGARY, Alberta, Oct. 08, 2026 (GLOBE NEWSWIRE) -- 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, is pleased to provide an outline of its anticipated Clinical Trial Application (“CTA”) submission to Health Canada for the XRx-026 gout program. The filing supports the Company’s planned two-part clinical study, XRX-OXY-102, evaluating XORLOTM, the Company’s proprietary formulation of oxypurinol, a xanthine oxidase inhibitor, for the treatment of gout. Conducting the first part of the XRX-OXY-102 clinical study in Canada is expected to enable the Company to accelerate the delivery of key clinical data in support of its planned New Drug Application (“NDA”) filing with the U.S. Food and Drug Administration (the “FDA”) for marketing approval.

Recent drug development team activities have included parallel preparation of the CTA for filing with Health Canada. The application describes the Company’s clinical development plan for XRx-026 and its intention to advance the program toward regulatory approval in Canada in parallel with its planned NDA filing with the FDA. Part one of the XRX-OXY-102 clinical trial builds upon the previously reported positive clinical results for the proprietary XORLO™ formulation and extends characterization of the commercial tablet form.

“Advancing our Clinical Trial Application with Health Canada is expected to enable more efficient clinical plan execution and extends our regulatory strategy for XRx-026 globally,” said Dr. Allen Davidoff, Co-Chief Executive Officer of XORTX, who added, “Gout is a growing global burden, and approaches that make more efficient use of our capital, personnel and time are expected to accelerate the availability of XORLO™ to patients wherever the need exists. This, in turn, is anticipated to enhance the overall value of the XRx-026 program for the Company and its shareholders.”

As the XRx-026 program has advanced, the Company has received increased inquiries from potential commercialization partners in a number of jurisdictions. The Company has not entered into any agreement with any such party, and there can be no assurance that any of these discussions will result in a transaction. XORTX looks forward to providing further updates regarding the XRx-026 drug development program as it advances toward the planned CTA and NDA filings.

About Hyperuricemia and Gout

In the United States, approximately 44 million individuals have uric acid levels above the normal range, with 9.2 million individuals living with gout1. Gout is associated with severe pain, reduced quality of life2, decreased physical function3, increased healthcare costs4, and lost economic productivity5. It is also strongly associated with metabolic syndrome5, myocardial infarction6,7, Type 2 diabetes mellitus8, chronic kidney disease9, and premature mortality6,10,11. Importantly, the global prevalence of gout is increasing, with cases expected to increase 70% over the next 25 years*.

* https://pubmed.ncbi.nlm.nih.gov/38996590/

About the XRx-026 Program and XORLO™

The XRx-026 program is developing XORLO™, the Company’s proprietary formulation of oxypurinol, to treat individuals with gout. Oral xanthine oxidase inhibitors (“XOIs”) are the current standard of care for treating hyperuricemia-associated gout. Allopurinol is the recommended first-line therapy for gout; however, limitations remain: approximately 3–5% of patients cannot tolerate allopurinol. An alternative XOI, febuxostat, at one time achieved annual peak net sales >US$450 million, and now carries a boxed warning for cardiovascular risk which has substantially decreased its use and sales. XORLO™ is designed to address this unmet need by providing an alternative therapeutic option with a differentiated safety and efficacy profile. Advancement of XRx-026 through the planned CTA and NDA filings is a strategic priority for XORTX.

References

- Chen-Xu M, et al. Prevalence of Gout and Hyperuricemia in the US. Arthritis Rheumatol. 2019;71(6):991–999.

- Singh JA. Quality of life and quality of care for patients with gout. Curr Rheumatol Rep. 2009;11(2):154–60.

- Burke BT, et al. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res. 2015;67(12):1730–8.

- Rai SK, et al. The economic burden of gout: a systematic review. Semin Arthritis Rheum. 2015;45(1):75–80.

- Choi HK, et al. Prevalence of the metabolic syndrome in individuals with hyperuricemia. Am J Med. 2007;120(5):442–7.

- Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation. 2007;116(8):894–900.

- Liu S-C, et al. Gout and Risk of Myocardial Infarction: A Systematic Review. PLoS ONE. 2015;10(7):e0134088.

- Choi HK, et al. Gout and the risk of type 2 diabetes among men with high cardiovascular risk profile. Rheumatology. 2008;47(10):1567–70.

- Roughley MJ, et al. Gout and risk of chronic kidney disease and nephrolithiasis: meta-analysis. Arthritis Res Ther. 2015;17(1).

- Kuo C-F, et al. Gout: an independent risk factor for all-cause and cardiovascular mortality. Rheumatology. 2010;49(1):141–6.

- Fisher MC, et al. Premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017;76(7):1289–94.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead 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 pre-clinical stage program for Type 2 diabetic nephropathy, and the 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, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as well as “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “intend,” “will,” “designed to,” “enable,” “accelerate,” “extend,” “potential,” “looks forward,” and similar expressions, and include all statements that are not statements of historical fact. These forward-looking statements include, but are not limited to, statements regarding the preparation, timing, content and submission of the Company’s planned CTA to Health Canada for the XRx-026 program; the design, initiation, conduct and completion of the planned two-part XRX-OXY-102 clinical study, including the Company’s plan to conduct the first part of the study in Canada; the Company’s expectation that conducting the first part of the study in Canada will accelerate the delivery of clinical data in support of its planned NDA filing with the FDA; the Company’s regulatory strategy in the United States, Canada and other jurisdictions, including the timing and content of its planned regulatory submissions to the FDA and its intention to advance the XRx-026 program toward regulatory approval in Canada; the Company’s expectations regarding the more efficient use of its capital, personnel and time and the potential to accelerate the availability of XORLO™ to patients; interest from, and the potential for arrangements with, commercialization partners; statements regarding the prevalence of hyperuricemia and gout and the projected growth in the prevalence of gout, which are based on third-party data; and the advancement of the Company’s XRx-026 program, its other development programs, and its strategy.

Forward-looking statements are based on the Company’s current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements.