XRTX News & Events

XORTX Therapeutics entered into a securities purchase agreement with an institutional investor for the purchase and sale of 1,746,631 common shares in a registered direct offering at a purchase price of 63c per common share. The closing of the Offering is expected to occur on or about October 22, subject to the satisfaction of customary closing conditions and approval from the TSX Venture Exchange. The gross proceeds from the Offering are expected to be $1.1M, 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. D. Boral Capital is acting as sole placement agent for the Offering.

XORTX Therapeutics entered into a binding term sheet to acquire a Renal Anti-Fibrotic Therapeutic Program from Vectus Biosystems. The program includes a novel new chemical entity, VB4-P5, along with its associated intellectual property, regulatory documentation, and manufacturing data. The program is currently at the pre-IND stage of development and targets both rare and prevalent forms of kidney disease - areas with substantial unmet medical need. The Term Sheet provides for XORTX to acquire from Vectus the intellectual property specifically related to the VB4-P5 compound and the data generated by Vectus from its work on the VB4-P5 small molecule and related assets. The consideration receivable by Vectus is $3M, payable in common shares or common share equivalents of XORTX at a deemed issue price of $0.86 per Security with the Issue Price subject to adjustment in certain circumstances provided, however, that the Issue Price will not below lower than the Discounted Market Price on the last trading day prior to this issuance of this press release. The Term Sheet is subject to finalization of closing documentation, satisfaction of conditions that are typical for a transaction of this type including receipt of all regulatory approvals, and compliance with applicable stock exchange requirements and applicable securities laws. Closing of the acquisition will occur no more than 90 days from the execution of the Term Sheet. If requested by Vectus, XORTX will use its reasonable commercial efforts to register the Securities with the Securities and Exchange Commission of the United States. In addition, Vectus will enter into a voluntary lockup agreement that, among other things, restricts sales of the Securities by Vectus for 180 days after the Closing Date.

XORTX Therapeutics announced the initiation of Investigational New Drug, IND, preparation for its lead program, XRx-026, focused on the treatment of gout. In support of this milestone, XORTX has engaged Allucent, a global contract research organization specializing in regulatory and clinical development. Preparation of the IND will include a comprehensive review of non-clinical, pharmacologic, toxicological, and regulatory progress, and will incorporate the clinical development plan and protocol for a pharmacologic characterization study of XORLO, the Company's proprietary formulation of oxypurinol, in fed and fasted states. XORTX anticipates submission of the IND in the second half of 2025.

XORTX Therapeutics provides a comprehensive update on its 2025 progress and strategic goals for 2026. The company said, "Looking ahead, XORTX is focused on advancing XORLO within the XRx-026 program toward a NDA filing and market approval within approximately 12 months. Our key objectives include: Investigational New Drug Application:We will prepare and submit an INDapplication to the FDA, incorporating novel formulation data, pharmacology, toxicology, and clinical results from the XRX-OXY-101 trial to support further clinical studies. XRX-OXY-102 Clinical Trial:We plan to initiate a clinical trial in the second half of 2025 to study XORLO pharmacokinetics in fed and fasted states... Chemistry, Manufacturing, and Controls:In parallel with items 1 and 2, we will produce clinical drug supplies under the IND, scale up commercial supplies, and conduct validation and stability testing for XORLO, adhering to GMP standards to support our planned NDA filing. Commercialization Preparations:To prepare for a potential 2026 NDA filing under the FDA's 505(b)(2) pathway, we will conduct commercialization studies, including interviews with nephrologists, patients, and payers to analyze pricing, reimbursement, and branding strategies... European Market Strategy:We will engage with the EMA to define the regulatory path for XORLO approval in the European Union, including necessary clinical studies and reimbursement conditions, with activities ongoing through 2025/2026."