Workflow
XORTX Therapeutics (XRTX)
icon
Search documents
XORTX Announces Share Consolidation
Globenewswire· 2026-03-25 22:15
CALGARY, Alberta, March 25, 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’s board of directors has approved consolidating (the “Consolidation”) its common shares (“Shares”) on the basis of one post-consolidation Share for every five pre-consolidation Shares, effective March ...
XORTX Reports that Shareholders Approved the Share Consolidation at the Annual General Meeting
Globenewswire· 2026-03-24 21:00
CALGARY, Alberta, March 24, 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 that the shareholders of the Company, via ordinary resolution at the annual and special meeting of the shareholders held on March 24, 2026 (the “Meeting”), have authorized the board of directors of the Com ...
XORTX Therapeutics (XRTX) - 2025 Q4 - Annual Report
2026-03-20 21:00
Financial Compliance and Reporting - The Company refiled its management's discussion and analysis for the financial year ended December 31, 2023, and the interim period ended June 30, 2024, following a review by the Alberta Securities Commission[314]. - The Company received a notification from Nasdaq regarding non-compliance with the Minimum Bid Requirement, with a 180-day period to regain compliance[326]. Fundraising and Financial Activities - The Company closed a registered direct offering and concurrent private placement, raising gross proceeds of US$1,499,993 through the sale of 810,810 Common Shares and pre-funded warrants[317]. - The Company announced a non-brokered private placement raising US$925,000 through the issuance of 1,267,123 units at a price of US$0.73 per unit[330]. - The Company closed a registered direct offering for 1,750,000 Common Shares at a purchase price of US$0.63 per share, raising gross proceeds of US$1,102,500[336]. - The cost of preparing and submitting a New Drug Application (NDA) is substantial, currently over US$4.6 million for an NDA with clinical information[446]. Product Development and Pipeline - The Company launched a precision medicine program targeting kidney disease, combining genetic diagnostics and XO inhibition[316]. - The Company announced a new late-stage program, XRx-026, aimed at treating gout for individuals intolerant to allopurinol[320]. - The Company is approximately 12 months from filing a New Drug Application (NDA) for the XRx-026 program, targeting an estimated US$700 million annual market opportunity[331]. - The lead product candidate, XRx-026, aims to treat gout and is expected to generate peak net sales revenue exceeding US$500 million annually[356]. - The XRx-008 program targets ADPKD and is preparing for a Phase 3 registration clinical trial, with potential for accelerated approval based on FDA discussions[355]. - The company has a pipeline of four product candidates: XRx-026, XRx-008, XRx-101, and XRx-225, addressing various unmet medical needs[354]. - XRx-225 is in non-clinical development stages, with plans to advance to Phase 1 clinical testing, pending discussions with the FDA[416]. Clinical Trials and Regulatory Approval - The anticipated clinical development of XORLOTM includes a proposed two-part bridging clinical study to support FDA approval, focusing on pharmacokinetics and therapeutic equivalence to allopurinol[391]. - The FDA seeks to review applications for standard review drug products within ten months and priority review drugs within six months[448]. - The FDA may issue a Complete Response Letter (CRL) indicating deficiencies in the NDA, which could require additional clinical trials or labeling changes[450]. - The FDA may require post-approval testing and surveillance to monitor the drug's safety or efficacy[451]. - Phase 1 clinical trials focus on safety in healthy volunteers, while Phase 2 evaluates efficacy and safety in a limited patient population[443]. Market and Competitive Landscape - The company faces significant uncertainty regarding coverage and reimbursement for its product candidates, which may affect sales and profitability[495]. - The pharmaceutical industry is experiencing pricing pressures due to managed healthcare trends and legislative proposals, impacting the company's ability to maintain price levels[496]. - The Inflation Reduction Act of 2022 introduces drug pricing reforms that could reduce the prices and reimbursement rates for the company's products, adversely affecting profitability[502]. - The competitive landscape includes major pharmaceutical companies with greater resources, posing challenges for the company's product candidates[428]. Intellectual Property and Compliance - XORTX holds patents for proprietary formulations of xanthine oxidase inhibitors, with three patents granted and additional applications submitted[360]. - The patent portfolio includes five active patent families, with ongoing efforts to secure and maintain patent protection for product candidates[420]. - The company aims to expand its intellectual property holdings through in-licensing of new technologies and compositions[417]. - The company monitors emerging intellectual property that may impact its business and takes appropriate actions when necessary[418]. Healthcare Regulations and Compliance - The company must navigate complex data privacy laws, including HIPAA and state-specific regulations, to avoid penalties and ensure compliance[481]. - The company is subject to various anti-corruption laws, which prohibit improper payments to government officials and can lead to liability for third-party actions[480]. - Non-compliance with FDA regulations can lead to significant consequences, including product recalls, fines, and withdrawal of product approvals[477]. - Potential violations of federal and state laws could result in significant civil, criminal, and administrative penalties, including monetary fines and loss of eligibility for FDA approvals[511].
XORTX Announces Substitute Director Nominees for its Upcoming Annual and Special Meeting of Shareholders
Globenewswire· 2026-03-18 11:00
CALGARY, Alberta, March 18, 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, in connection with its upcoming annual and special meeting of shareholders to be held on March 24, 2026 (the “Meeting”), three new director nominees will be proposed for election in the place of three of the curr ...
XORTX Reports that Independent Proxy Advisory Firms Recommend XORTX Shareholders Vote “For” the Share Consolidation
Globenewswire· 2026-03-13 11:00
Core Viewpoint - XORTX Therapeutics Inc. has received recommendations from independent proxy advisory firms, including ISS, to vote "FOR" the share consolidation at the upcoming shareholder meeting on March 24, 2026, which could enhance the company's long-term growth prospects [1][2]. Share Consolidation - ISS stated that the stock consolidation should have no direct impact on shareholder value and could broaden financing alternatives for the company [2]. - The Board of Directors of XORTX recommends that shareholders vote FOR all proposed resolutions [3][6]. Voting Information - The proxy voting deadline is set for March 20, 2026, and shareholders are encouraged to vote in advance to ensure timely submission [4][6]. - Shareholders of record as of February 20, 2026, are eligible to vote at the meeting [4]. Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on developing therapies for gout and progressive kidney disease, with three clinically advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury [5][7]. - The company is also developing XRx-225, a pre-clinical program for Type 2 diabetic nephropathy, targeting purine metabolism and xanthine oxidase to reduce uric acid production [5].
XORTX Therapeutics (XRTX) - 2025 Q4 - Annual Report
2026-02-27 12:39
Exhibit 99.1 CONSOLIDATED FINANCIAL STATEMENTS AS AT AND FOR THE YEARS ENDED DECEMBER 31, 2025, 2024 AND 2023 (Expressed in U.S. Dollars) REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Shareholders and Directors of XORTX Therapeutics Inc. Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated statements of financial position of XORTX Therapeutics Inc. (the "Company") as of December 31, 2025 and 2024, and the related consolidated statements of loss and ...
XORTX Therapeutics (XRTX) - Prospectus(update)
2026-02-12 23:34
TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on February 12, 2026. Registration No. 333-290512 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 XORTX THERAPEUTICS INC. (Exact name of registrant as specified in its charter) 2834 (Primary Standard Industrial Classification Code Number) 3710 – 33rd Street NW Calgary, Alberta, Canada T2L 2M1 (403) 455-7727 (Address, including ...
XORTX Provides Update on Acquisition of Renal Anti-Fibrotic Therapeutic Program from Vectus Biosystems
Globenewswire· 2026-02-04 23:00
Core Viewpoint - XORTX Therapeutics Inc. has entered into an extension agreement with Vectus Biosystems Limited to allow additional time for the acquisition of the Renal Anti-Fibrotic Therapeutic Program, with a new closing date set for March 31, 2026 [1][2] Group 1: Acquisition Details - The acquisition involves a novel chemical entity, VB4-P5, along with its associated intellectual property, regulatory documentation, and manufacturing data [1] - The original term sheet required the acquisition to close within 90 days of execution, but an amendment has extended this deadline [1] Group 2: Regulatory and Meeting Information - The acquisition is subject to the finalization of closing documentation, satisfaction of typical transaction conditions, and receipt of all regulatory approvals [2] - XORTX has scheduled its Annual and Special Meeting of Shareholders for March 24, 2026, with shareholders of record on February 20, 2026, entitled to vote [2] Group 3: Board Appointment - In connection with the appointment of Krysta Davies Foss to the board of directors, XORTX has granted 20,000 options to purchase common shares at an exercise price of CAD $0.69 for five years [3] Group 4: Industry Context - Chronic kidney disease (CKD) affects approximately 14% of adults globally, with around 35–37 million individuals in the United States [4] - Kidney fibrosis is a significant aspect of CKD progression, leading to organ dysfunction and high morbidity and mortality rates [5] - Current treatments for kidney fibrosis primarily focus on blood pressure control and dietary interventions, with no approved therapies specifically targeting or reversing kidney fibrosis [5] Group 5: VB4-P5 Program - Early preclinical data suggest that VB4-P5 has the potential to inhibit and possibly reverse kidney fibrosis [6] - The program has patent protection across more than 30 global jurisdictions, indicating broad development and commercialization opportunities [6] Group 6: Company Overview - XORTX is developing three clinically advanced products: XRx-026 for gout, XRx-008 for autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 for acute kidney injury associated with respiratory virus infections [7] - The company is also working on XRx-225, a pre-clinical program for Type 2 diabetic nephropathy [7]
XORTX Announces Pioneering Research on Genome-Wide Pathogenic Pathways in Gout and Provides a Corporate Update
Globenewswire· 2025-12-31 23:15
Core Insights - Recent research has identified 410 genetic factors associated with gout, including 149 new factors, which supports the link between genetic predisposition and the over-expression of xanthine oxidase (XO) in gout and related diseases [3] - XORTX Therapeutics is focused on developing therapies that inhibit XO to treat gout and progressive kidney diseases, leveraging these genetic insights to guide treatment decisions [4][10] Company Updates - XORTX has appointed Krysta Davies Foss as a director, bringing over 25 years of experience in biotechnology and pharmaceutical strategy [5][6] - The company clarified details regarding a US$1.1 million Registered Direct Offering, correcting the number of pre-funded warrants issued [7] - XORTX is in the process of acquiring the Renal Anti-Fibrotic Therapeutic Program from Vectus Biosystems, with a closing date expected by January 13, 2026, pending ASX approval [8]
XORTX Therapeutics (XRTX) - 2025 Q3 - Quarterly Report
2025-11-17 21:17
Financial Performance - Total assets decreased to $2.81 million as of September 30, 2025, down from $4.09 million at the end of 2024, representing a decline of approximately 31%[2] - Cash reserves fell to $1.19 million from $2.47 million, a decrease of 52%[2] - Net loss for the nine months ended September 30, 2025, was $2.07 million, compared to a loss of $3.44 million for the same period in 2024, reflecting a 40% improvement[3] - The company reported a basic and diluted loss per common share of $0.50 for the nine months ended September 30, 2025, compared to $1.25 in 2024, a reduction of 60%[3] - Cash used in operating activities for the nine months ended September 30, 2025, was $2.07 million, an improvement from $2.79 million in 2024, reflecting a 26% reduction[6] Shareholder Equity and Liabilities - Shareholders' equity decreased to $1.97 million as of September 30, 2025, down from $3.34 million at the end of 2024, a decline of 41%[2] - The company’s total liabilities increased to $837,408 as of September 30, 2025, from $757,990 at the end of 2024, an increase of 10%[2] - The company reported trade payables of $480,068 and accrued liabilities of $197,246 as of September 30, 2025, compared to $84,020 and $63,185 respectively as of December 31, 2024, indicating a significant increase in liabilities[34] Research and Development - Research and development expenses increased to $520,071 for the nine months ended September 30, 2025, up from $176,067 in 2024, indicating a growth of 195%[3] - The company is focused on developing therapies for gout and progressive kidney disease, with ongoing clinical studies and a need for additional funding to support research and development activities[10] - The company has not capitalized any development costs as of September 30, 2025, despite ongoing research and development efforts[21] Equity and Financing Activities - Proceeds from the issuance of equity instruments amounted to $1.15 million for the nine months ended September 30, 2025, compared to $2.00 million in 2024, a decrease of 43%[6] - The company entered into an agreement with Prevail InfoWorks Inc., paying $1,200,000 for future regulatory and clinical trial programs, with units issued valued at CAD $14.76 each[28] - The company raised gross proceeds of $113,547 from the issuance of 73,871 common shares on January 15, 2025, incurring issuance costs of $19,064[39] - A non-brokered private placement on July 22, 2025, generated $925,000 from the sale of 1,267,123 units at $0.73 per unit, with additional cash issuance costs of $407,702[41] - The company closed a registered direct offering on October 29, 2025, raising gross proceeds of $1,102,488 through the sale of 572,470 common shares and 1,177,530 pre-funded warrants[78] Assets and Intangible Assets - Total intangible assets increased from $375,727 as of December 31, 2024 to $406,423 as of September 30, 2025, with carrying values rising from $183,108 to $193,997[29] - The company’s accumulated amortization for intangible assets increased from $192,619 as of December 31, 2024 to $212,426 as of September 30, 2025[29] - The company has recognized a right-of-use asset of $299,660 and equipment valued at $23,344 as of September 30, 2025, reflecting ongoing investments in property and equipment[33] Stock Options and Warrants - The company had a total of 4,254,709 warrants outstanding as of September 30, 2025, with a weighted average exercise price of $2.82[48] - The exercise prices of outstanding stock options range from CAD $1.75 to CAD $22.86, with a total of 129,761 options outstanding as of September 30, 2025[12] - The diluted weighted average number of common shares outstanding increased to 4,856,493 for the three months ended September 30, 2025, compared to 2,903,565 for the same period in 2024[47] - The company issued warrants with an estimated fair value of $nil during the nine months ended September 30, 2025, compared to $968,000 in 2024, indicating a significant decrease in the value of these financial instruments[63] Management and Compensation - The company incurred total management compensation of $719,914 for the nine months ended September 30, 2025, a decrease from $818,009 in the same period of 2024[67] - The company has committed to payments totaling $228,348 related to clinical trials and manufacturing activities expected to occur over the next two years, down from $323,000 at December 31, 2024[74] Risk Management - The company has no changes in risk management policies since December 31, 2024, and continues to monitor various financial risks including foreign currency and liquidity risks[70]