XORTX Therapeutics Inc. filings document foreign issuer reports for a clinical-stage pharmaceutical company developing therapies for gout and progressive kidney disease. The records describe its XRx-026, XRx-008, XRx-101, XRx-225 and VB4-P5 programs, including disease focus, development stage and acquired intellectual property, regulatory documentation and manufacturing data for the VB4-P5 kidney anti-fibrotic asset.
The company’s Form 6-K disclosures also cover capital structure and exchange-listing matters, including a completed share consolidation, Nasdaq continued-listing compliance, preliminary stockholders’ equity information, acquisition consideration involving common shares and pre-funded warrants, and shareholder meeting results. Governance filings report director elections, auditor appointments, stock option plan approval and related voting outcomes.
XORTX Therapeutics Inc. outlined its anticipated Clinical Trial Application (CTA) submission to Health Canada for XRx-026, its proprietary oxypurinol formulation for gout. XORTX plans a two-part XRX-OXY-102 clinical study, with the first part planned in Canada; conducting that part there is expected to accelerate delivery of key clinical data supporting a planned New Drug Application (NDA) to the U.S. Food and Drug Administration. The planned CTA describes the clinical development plan and XORTX’s intention to advance the program toward regulatory approval in Canada alongside its planned U.S. NDA filing.
The first study part builds on previously reported positive clinical results for XORLO and extends characterization of the commercial tablet form. XORTX reports increased inquiries from potential commercialization partners in a number of jurisdictions but says it has not entered into an agreement with any such party.
XORTX Therapeutics Inc. (XRTX) outlines a regulatory roadmap for its XRx-026 gout program, including a planned Investigational New Drug (IND) submission to the U.S. FDA in the fourth quarter of 2026 for its XORLO™ formulation of oxypurinol. The company describes a two-part XRX-OXY-102 clinical trial intended to generate pharmacokinetic and efficacy data to support a future New Drug Application (NDA) for XRx-026, along with plans to manufacture commercial supply for the first year of marketing.
Subject to sufficient funding and successful, timely completion of XRX-OXY-102, XORTX is targeting an NDA submission in approximately one year and estimates that XRx-026 could address an annual US$700 million U.S. gout market opportunity, based in part on prior peak net sales of febuxostat. The company positions XORLO™ as an alternative oral xanthine oxidase inhibitor for gout patients, particularly those who cannot tolerate allopurinol or are affected by febuxostat’s cardiovascular boxed warning, and highlights advancement of XRx-026 as a strategic priority within a broader pipeline of kidney and metabolic disease programs.
XORTX Therapeutics Inc. (XRTX) reports that it has initiated clinical and commercial manufacturing activities for XORLO™, its proprietary oxypurinol formulation within the XRx-026 program for gout. Contract production of GMP-grade oxypurinol drug substance and commercial-scale XORLO tablets has begun to supply the planned XRX-OXY-102 clinical study and to generate data intended to support a future US FDA marketing application.
The company is working with a contract manufacturing partner to produce commercial drug batches, with validation and stability data from this work expected to support a New Drug Application. XORTX characterizes advancement of XRx-026 through NDA filing as a strategic priority and indicates that this manufacturing progress is one part of a broader plan to move XRx-026 toward potential FDA marketing approval.
The disclosure also highlights the clinical need in gout, where current oral xanthine oxidase inhibitors have tolerability and safety limitations, and positions XORLO as an alternative option with a differentiated safety and efficacy profile under development. XORTX notes additional pipeline programs targeting kidney and metabolic diseases related to purine metabolism and uric acid production.
XORTX Therapeutics Inc. (XRTX) has re-engaged IR Agency LLC under a new investor relations and marketing consulting agreement following its voluntary delisting from the TSX Venture Exchange. The revised agreement, entered into on September 2, 2026, runs for three months starting September 3, 2026 and provides for up to ten news distribution campaigns to communicate information about the company to the financial community.
In consideration for these services, XORTX agreed to pay IR Agency LLC a fee of US$2.5 million, funded from amounts previously returned to XORTX when an earlier May 2026 investor relations agreement tied to a US$5.0 million public offering was mutually terminated and rescinded in August 2026.
XORTX Therapeutics Inc. (XRTX) reports that it has re-engaged IR Agency LLC under a new consulting agreement following the voluntary delisting of its common shares from the TSX Venture Exchange. The delisting was approved on August 28, 2026 and took effect after close of business on September 1, 2026, while the Company’s shares remain listed on the Nasdaq Capital Market under the symbol XRTX.
On September 2, 2026, XORTX entered into a revised investor relations and marketing consulting agreement with IR Agency. The agreement runs for three months starting September 3, 2026 and provides for up to ten news distribution campaigns, with possible extension by mutual consent. In return, XORTX will pay IR Agency a US$2,500,000 fee, payable in advance and fully earned upon receipt, which is non-refundable even if the agreement is terminated. This fee is being funded from the US$2,500,000 previously returned by IR Agency when the prior agreement was rescinded in August 2026 and had been reserved for future investor relations expenditures.
XORTX Therapeutics Inc. (XRTX) reports that it has terminated and rescinded its investor relations and marketing agreement with IR Agency LLC, originally tied to a US$5 million public offering completed on May 19, 2026. The full US$2.5 million fee for planned news distribution campaigns has been returned to XORTX, and the investor relations and marketing program has been postponed.
The company plans to re-engage IR Agency LLC after completing its voluntary delisting from the TSX Venture Exchange, which is expected to take effect on September 1, 2026, subject to final TSXV approval. On that date, Computershare Investor Services Inc. will replace TSX Trust Company as transfer agent and registrar. XORTX also provides corrective disclosure that aggregate cash finder’s fees of US$240,000 were paid in connection with its April 13, 2026 acquisition of Vectus Biosystems Limited’s Renal Anti-Fibrotic Therapeutic Program.
XORTX Therapeutics Inc., a late-stage clinical pharmaceutical company focused on kidney and uric-acid–related diseases, reported an interim net loss of $2.50 million for the six months ended June 30, 2026, compared with $1.42 million a year earlier. Total assets increased to $6.18 million from $2.68 million, mainly due to capitalizing the acquired VB4-P5 renal anti-fibrotic program as an intangible asset.
Cash was $0.99 million with working capital of $1.76 million, while management discloses a monthly cash burn of about $296,000 and states there is a material uncertainty casting significant doubt on the company’s ability to continue as a going concern. During the period XORTX issued equity and 3.17 million pre-funded warrants, and completed the VB4-P5 acquisition using 154,544 shares and pre-funded warrants valued at $1.87 million. The company plans to prioritize its XRx-026 gout program and XRx-008 ADPKD program, and continues to seek additional financing and potential partnerships.
XORTX Therapeutics Inc., a late-stage clinical pharmaceutical company focused on therapies for gout and progressive kidney disease, reports that director and board chair Anthony Giovinazzo is stepping down from the board for personal reasons and to pursue other interests, as disclosed in a July 31, 2026 announcement.
The company thanks him for his leadership and ethical contributions over several years and continues advancing its pipeline, including XRx-026 for gout, XRx-008 for ADPKD, XRx-101 for acute kidney and organ injury linked to respiratory virus infections, and earlier-stage kidney disease programs XRx-225 and VB4-P5.
XORTX Therapeutics Inc., a late-stage clinical pharmaceutical company focused on therapies for gout and progressive kidney disease, appointed Depesh Narotam, age 43, to its board of directors as an independent director effective July 27, 2026.
He will also serve on the board’s Compensation, Governance and Nominating Committee. Narotam has over 20 years of financial services experience, including 16 years at Westminster Savings Credit Union and his current role at Vancity. XORTX highlights a pipeline of three clinically advanced programs and additional earlier-stage kidney disease programs, and notes forward-looking risks around capital needs, regulatory approvals and talent retention.
XORTX Therapeutics outlines a strategic plan centered on its lead gout candidate XRx-026 and expands its leadership team. Following a recent financing and a Type B meeting with the FDA, the company is preparing an investigational new drug application and a new drug application using the 505(b)(2) pathway for gout.
The updated clinical plan includes a two-part bridging study, XRX-OXY-102, to assess pharmacokinetics and therapeutic equivalence versus allopurinol, targeting a roughly $700 million-per-year gout market. XORTX also highlights its broader kidney-disease pipeline and appoints investment professional Mika Grasso, age 28, as co-CEO responsible for finance and public markets, aiming to advance the gout program toward marketing approval over the next 18 months.