XORTX Therapeutics Inc. - XRTX STOCK NEWS

XORTX Therapeutics (NASDAQ: XRTX) has announced the launch of a new late-stage program, XRx-026, focused on treating individuals with gout who are intolerant to allopurinol. The company plans to initiate discussions with the FDA in the first half of 2025 regarding a New Drug Application (NDA) for this program.

The company will seek FDA orphan drug designation (ODD) for XRx-026, noting that oxypurinol was previously granted ODD for allopurinol intolerant gout. Clinical studies have demonstrated that oxypurinol is safe and effective in treating individuals with gout who cannot tolerate allopurinol, addressing an important unmet medical need for patients and physicians.

XORTX Therapeutics (NASDAQ: XRTX) has appointed Dr. Michael Bumby as its new Chief Financial Officer, replacing James Fairbairn. Dr. Bumby brings over 20 years of biotech/pharma industry experience, including a 14-year career at Eli Lilly and significant roles in public companies. He previously served as CFO at VIVO Cannabis and led Merus Labs' $340 million acquisition by Norgine B.V. in 2017.

Dr. Bumby holds a Doctor of Veterinary Medicine degree, a lean six-sigma blackbelt, and an MBA from the University of Toronto. The company has granted him 13,000 stock options at an exercise price of $1.75, valid for five years.

XORTX Therapeutics (NASDAQ: XRTX) announced a presentation at the Rare and Genetic Kidney Disease Summit in Boston on December 12, 2024. The presentation focuses on recent discoveries in Autosomal Dominant Polycystic Kidney Disease (ADPKD) and genetic factors influencing xanthine oxidase (XO) expression in kidney disease progression.

The research highlights how genetic factors affecting purine metabolism may act as a 'second hit' that accelerates ADPKD progression. This discovery explains why disease progression varies among family members and supports the development of personalized therapeutic approaches using XO inhibitors for at-risk individuals.

XORTX Therapeutics announced the acceptance of their abstract at the American Society of Nephrology, focusing on xanthine oxidase in polycystic kidney disease. The study, conducted at the University of Colorado and sponsored by XORTX, revealed significant findings in both rat and mouse PKD models. Key results showed that increased uric acid led to increased cyst growth, while xanthine oxidase inhibitor decreased serum uric acid and cyst growth. Clinical results from the Halt Clinical Trial - Group A demonstrated that patients with elevated serum uric acid experienced increased total kidney volume and faster PKD progression. Additionally, increased serum XO activity was linked to earlier onset of high blood pressure.

XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) has closed its previously announced US$1.5 million registered direct offering and concurrent private placement. The offering included the sale of 810,810 common shares (or pre-funded warrants) at US$1.85 per share and common warrants to purchase up to 810,810 common shares. The warrants have an exercise price of US$2.18, are immediately exercisable, and expire in five years.

A.G.P./Alliance Global Partners acted as the sole placement agent. The company plans to use the net proceeds for working capital and general corporate purposes. The common shares were offered through an effective shelf registration statement, while the private placement of warrants was made under exemptions from registration requirements.

XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) has announced a US$1.5 million registered direct offering and concurrent private placement. The company will sell 810,810 common shares (or equivalents) at US$1.85 per share and issue warrants to purchase up to 810,810 common shares at US$2.18 per share. The warrants will be immediately exercisable and expire in five years. The offering is expected to close around October 18, 2024, subject to conditions. A.G.P./Alliance Global Partners is acting as the sole placement agent. XORTX intends to use the net proceeds for working capital and general corporate purposes. The offering includes a registered direct offering under an effective shelf registration and a private placement of warrants.

XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) has initiated a precision medicine program following recent research linking genetic factors to xanthine oxidase (XO) over-expression in various diseases, including kidney disease. This initiative aims to combine genetic diagnostics with XO inhibition to target individuals most in need.

The company plans to develop diagnostic tools to identify specific genetic factors, which, combined with XORTX's expertise in developing unique formulations of uric acid lowering agents and XO inhibitors, will allow for tailored treatments for subpopulations with common susceptibilities or similar drug responses.

XORTX will begin evaluating individuals in their planned registration clinical trial for autosomal dominant polycystic kidney disease (ADPKD) patients, providing an opportunity to better understand the role of genetic factors in progressive kidney disease.

XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) held its annual and special meeting of shareholders on September 12, 2024. Key outcomes include:

1. Election of all seven management nominees to the board of directors
2. Appointment of Smythe LLP as auditors
3. Re-approval of the stock option plan

The meeting saw a 31% shareholder representation. Chairman Anthony Giovinazzo highlighted recent board additions and advancements in the company's intellectual property portfolio and research studies in autosomal dominant polycystic kidney disease (ADPKD). He emphasized the board's expertise in clinical trials, regulatory approvals, commercialization, and public company governance.

XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focusing on progressive kidney disease treatments, has refiled its management's discussion and analysis (MD&A) for the financial year ended December 31, 2023 and the interim period ended June 30, 2024. This action follows a continuous disclosure review by the Alberta Securities Commission.

The refiling addresses the following changes:

• Inclusion of the full definition of Disclosure Controls and Procedures as per NI 52-109
• Breakdown of use of funds for the Company's product candidates
• Estimated costs in the Outlook section

The amended MD&A documents are restated as of September 12, 2024, and should be read alongside the corresponding financial statements. They have been reviewed by the Company's Audit Committee and approved by the Board of Directors.