XORTX Therapeutics (XRTX)

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XORTX Completes USD $114,500 Private Placement
GlobeNewswire· 2025-08-08 23:54
Core Viewpoint - XORTX Therapeutics Inc. has successfully closed a non-brokered private placement, raising US$114,500 through the issuance of 156,849 units at a price of US$0.73 per unit, aimed at funding its gout programs and general corporate purposes [1][3]. Group 1: Offering Details - Each unit in the offering consists of one common share and one common share purchase warrant, with the warrant allowing the purchase of an additional common share at US$1.20 for a period of 60 months [2]. - If the closing price of the common shares exceeds US$2.00 for ten consecutive trading days, the warrants will be accelerated and will expire 30 business days after notice [2]. Group 2: Regulatory and Financial Information - The offering has received conditional approval from the TSX Venture Exchange, and the issued securities are subject to a four-month and one-day hold period [3]. - The proceeds from the offering will be utilized for gout programs, general corporate, and working capital purposes [3]. Group 3: Company Overview - XORTX Therapeutics is focused on developing innovative 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]. - 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 Completes Non-Brokered Private Placement of Units
Globenewswire· 2025-07-22 23:59
Core Viewpoint - XORTX Therapeutics Inc. has successfully closed 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, aimed at funding its gout and kidney disease programs [1][3]. Group 1: Offering Details - Each unit issued consists of one common share and one common share purchase warrant, with the warrant allowing the purchase of an additional common share at US$1.20 for a period of 60 months [2]. - If the closing price of the common shares exceeds US$2.00 for ten consecutive trading days, the warrants will be accelerated and will expire 30 business days after notice [2]. - The offering was approved by the TSX Venture Exchange, and the securities issued will not be subject to a statutory hold period [3]. Group 2: Use of Proceeds - The proceeds from the offering will be utilized for gout programs, general corporate purposes, and working capital [3]. Group 3: Related Party Transactions - The issuance of 8,191 units to an insider constitutes a related party transaction, with exemptions from formal valuation and minority shareholder approval requirements due to the transaction's value being below 25% of the company's market capitalization [5]. Group 4: Company Overview - XORTX Therapeutics is focused on developing therapies for gout and progressive kidney disease, with three advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury [7]. - The company is also developing XRx-225, a pre-clinical program for Type 2 diabetic nephropathy, targeting purine metabolism to reduce uric acid production [7].
XORTX Announces USD $925,000 Private Placement
Globenewswire· 2025-06-26 11:00
Core Viewpoint - XORTX Therapeutics Inc. is conducting a non-brokered private placement to raise up to USD $925,000 through the issuance of common share units, aimed at advancing its programs for gout and progressive kidney disease [1][5]. Group 1: Offering Details - The private placement will involve the issuance of up to 1,267,123 common share units at a price of USD $0.73 per unit, each unit consisting of one common share and one common share purchase warrant [1]. - Each warrant will allow the holder to purchase an additional common share at USD $1.20, valid for 60 months from the closing date, with an acceleration clause if the common shares exceed USD $2.00 for 10 consecutive trading days [1]. Group 2: Regulatory Compliance - The offering will be available to purchasers in Canada, excluding Quebec, under the Listed Issuer Financing Exemption, meaning the securities will not be subject to a hold period under Canadian securities laws [2]. - The offering document related to the placement can be accessed on the company's profile and website, and prospective investors are encouraged to review it before making investment decisions [3]. Group 3: Use of Proceeds - The net proceeds from the offering will be utilized to advance XORTX's programs for gout and for general corporate purposes [5]. Group 4: Company Overview - XORTX Therapeutics Inc. is focused on developing innovative 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 [6]. - 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 [6].
XORTX Therapeutics (XRTX) - 2025 Q1 - Quarterly Report
2025-05-16 11:50
Exhibit 99.1 CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS As at and for the three months ended March 31, 2025 and 2024 (Unaudited - expressed in U.S. Dollars) XORTX THERAPEUTICS INC. Condensed Interim Consolidated Statements of Financial Position (Unaudited - expressed in U.S. Dollars) | | | | December | | --- | --- | --- | --- | | | | March 31, | 31, | | | Note | 2025 | 2024 | | | | $ | $ | | Assets | | | | | Current | | | | | Cash | 5 | 1,895,238 | 2,473,649 | | Accounts receivable | | 17,252 | 17, ...
XORTX Therapeutics (XRTX) - 2024 Q4 - Annual Report
2025-05-10 01:52
Financial Performance and Position - As of December 31, 2024, the company's cash and cash equivalents amounted to $2,473,649, a decrease of 28.2% from $3,447,665 in 2023 [661]. - The total accounts payable and accrued liabilities decreased by 48.0% from $283,428 in 2023 to $147,205 in 2024 [661]. - The lease liability increased from $11,510 in 2023 to $38,785 in 2024, indicating a significant rise in obligations [661]. - The derivative warrant liability rose from $531,000 in 2023 to $572,000 in 2024, reflecting a 7.7% increase [661]. - The company's maximum exposure to credit risk as of December 31, 2024, is the carrying value of its financial assets, which is $2,473,649 [662]. - The total financial liabilities due within three months as of December 31, 2024, is $170,329, while the total liabilities for 2023 were $294,938 [665]. - The company is exposed to a net currency risk of $573,336 as of December 31, 2024, with a potential effect of +/- 10% change in currency amounting to $57,334 [667]. - The company has implemented a planning and budgeting process to manage liquidity risk and ensure it can meet its financial obligations [663]. - The fair value of cash and cash equivalents approximates their carrying values due to their short-term nature [660]. - There have been no changes in risk management policies since December 31, 2024 [668]. Clinical Development and Programs - The Company launched a precision medicine program targeting kidney disease, linking genetic factors to the over-expression of XO [333]. - The XRx-008 program for ADPKD is in late clinical stages, with plans for a Phase 3 registration trial to support NDA submission [352]. - The Company is developing a combination therapy for AKI associated with respiratory virus infection, integrating intravenous and oral treatments [355]. - The XRx-026 program aims to decrease chronically high serum uric acid levels by inhibiting the xanthine oxidase enzyme, potentially providing a significant treatment option for gout [383]. - The XRx-008 program aims to decrease chronic kidney disease progression in patients with ADPKD, addressing symptoms like increased kidney volume and hypertension [390]. - XRx-101 is being developed for AKI associated with respiratory virus infections, with 36% of hospitalized COVID-19 patients experiencing AKI [400]. - XRx-101 aims to rapidly decrease SUA concentrations to protect kidney function during hospitalization, targeting a patient group currently without approved treatments for AKI [403]. - XRx-225 has shown potential to significantly decrease proteinuria and improve kidney function by lowering uric acid levels, even in patients receiving standard care [412]. - XRx-225 is currently in non-clinical development stages, with plans to advance to Phase 1 clinical testing pending FDA discussions [413]. Regulatory and Approval Processes - The company plans to pursue FDA approval for XRx-101 under Section 505(b)(2) of the FDCA, leveraging prior research and existing formulations [404]. - The cost of preparing and submitting a New Drug Application (NDA) is substantial, currently over $4.3 million for an NDA with clinical information [448]. - The annual program fee for an approved NDA is currently over $400,000, with fees typically increased annually [448]. - The FDA seeks to review applications for standard review drug products within ten months and priority review drugs within six months [450]. - The FDA may impose clinical holds at any time during the life of an IND due to safety concerns or non-compliance [440]. - The approval process may require substantial post-approval testing and surveillance to monitor the drug's safety or efficacy [454]. - The FDA has 60 days to determine whether an NDA will be accepted for filing, followed by an in-depth review [450]. - The FDA may issue a Complete Response Letter (CRL) detailing deficiencies in the NDA, which could require additional clinical trials [452]. - Regulatory agencies require extensive monitoring and auditing of all clinical activities and data throughout the clinical development phases [445]. - The requirement for a Risk Evaluation and Mitigation Strategy (REMS) can materially affect the potential market and profitability of the drug [454]. Market and Competitive Landscape - The competitive landscape includes major pharmaceutical and biotechnology companies, with the company facing challenges in securing market position against established therapies [429]. - The company’s commercial opportunity may be impacted if competitors develop safer or more effective therapies, or if they obtain regulatory approval more rapidly [432]. - Third-party payors may deny coverage or reimbursement if products are deemed not medically necessary, affecting sales potential [496]. - The pharmaceutical industry faces pricing pressures due to managed healthcare trends and legislative proposals, impacting reimbursement rates from third-party payors [497]. - Legislative changes at the state level may impose additional pricing constraints and affect demand for approved products [505]. Intellectual Property and Patent Strategy - The company aims to secure patent protection for its product candidates and expand its intellectual property holdings through in-licensing and new compositions [414]. - The patent portfolio includes five active patent families, with claims covering various therapeutic applications including diabetic nephropathy and insulin resistance [418]. - Owners of relevant drug patents may apply for up to a five-year patent term extension after NDA approval [462]. - The Orphan Drug Act allows for a seven-year exclusivity period for drugs approved for rare diseases affecting fewer than 200,000 individuals in the U.S. [466]. Healthcare Regulations and Compliance - The company is subject to various healthcare laws and regulations that could impact marketing and sales of approved products [506]. - The company must ensure compliance with the federal Anti-Kickback Statute and other healthcare laws to avoid significant liabilities [507]. - Compliance with evolving EU data export laws is critical, especially following the Schrems II decision, which complicates data transfers to the U.S. [495]. - Non-compliance with foreign regulatory requirements may result in fines, suspension of clinical trials, or withdrawal of regulatory approvals [493]. - The FDA and other agencies enforce laws prohibiting the promotion of off-label uses, with significant penalties for violations [475]. Research and Development Insights - Key findings from a study on Polycystic Kidney Disease indicated that elevated serum uric acid worsens kidney conditions, while XO inhibitors can reduce uric acid levels and cyst growth [335]. - Approximately 2-4% of patients treated with allopurinol develop adverse reactions, creating an unmet medical need for alternative treatments for chronic gout [367]. - Oxypurinol has the potential to benefit approximately 70-75% of allopurinol-intolerant patients, estimated to be between 120,000 to 150,000 patients in the U.S. [367]. - Clinical findings suggest that the proprietary formulation of oxypurinol, XORLOTM, may reduce adverse events and improve tolerability compared to allopurinol [386]. - Over 600 patients have been treated with oxypurinol, showing a reduced rate of adverse events compared to allopurinol, suggesting superior tolerability [395].
XORTX Provides Update on FDA Type B Meeting Request
Globenewswire· 2025-04-30 11:00
Core Viewpoint - XORTX Therapeutics Inc. is advancing its new drug application (NDA) for XORLO™, a proprietary formulation of oxypurinol aimed at treating gout, following guidance from the FDA on key steps necessary for the filing [2][4]. Company Developments - XORTX has received responses from the FDA clarifying the steps needed for the NDA submission for its XRx-026 program targeting gout [2][4]. - The company plans to finalize meeting minutes with the FDA, prepare an Investigational New Drug (IND) application, characterize pharmacokinetics, manufacture commercial supplies, and file the NDA [3][4]. - The NDA for XORLO™ is anticipated to be filed in the first half of 2026, emphasizing the company's commitment to addressing the unmet medical needs of gout patients [4]. Market Context - Approximately 44 million individuals in the US have elevated uric acid levels, with gout affecting about 9.2 million people, indicating a significant market opportunity for gout treatments [5]. - Current treatments include xanthine oxidase inhibitors (XOIs) like allopurinol, which is prescribed to around 3.3 million patients annually in North America, but some patients cannot tolerate it [6]. - XORLO™ aims to fill the gap left by existing treatments, particularly after the decline in the use of Febuxostat due to safety concerns [6].
XORTX Announces Grant of European Patent
Globenewswire· 2025-04-28 11:00
Core Viewpoint - XORTX Therapeutics Inc. has received notification of a patent grant for "Xanthine Oxidase Inhibitor Formulations" by the European Patent Office, which enhances its intellectual property portfolio and supports its programs for gout and autosomal dominant polycystic kidney disease (ADPKD) [1][2]. 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 [1][6]. Patent Details - The newly granted patent covers formulations using proprietary xanthine oxidase inhibitors (XOIs) aimed at treating health issues related to high uric acid levels, including gout, kidney stones, and cardiovascular diseases [2]. - With this patent, XORTX now holds five granted patents in the US and EU related to uric acid-lowering agents for gout and progressive kidney disease [2]. Market Opportunity - In North America, approximately 3.5 million people suffer from gout due to elevated uric acid levels, with XOIs being the preferred first-line treatment [5]. - Allopurinol is the most commonly prescribed XOI, with around 3 million prescriptions annually, but 3-5% of patients cannot tolerate it, creating a market opportunity for alternative XOIs like XRx-026 [5]. Health Implications of Hyperuricemia - An estimated 14% of the adult population has hyperuricemia, leading to various health issues, including gout, kidney stones, and cardiovascular diseases [3]. - Lowering uric acid levels in gout patients is strongly correlated with improved health outcomes, highlighting the need for effective treatments [3]. Genetic Factors and Precision Medicine - Recent studies suggest a link between genetic factors and the overexpression of xanthine oxidase, advocating for a precision medicine approach in treating conditions associated with hyperuricemia [4].
XORTX Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency
Newsfilter· 2025-04-17 23:45
Core Viewpoint - XORTX Therapeutics Inc. has received notification from Nasdaq regarding non-compliance with the minimum bid price requirement, as its common shares have been below US$1.00 for 30 consecutive business days [1][2]. Group 1: Compliance Status - The notification does not currently impact the Company's listing on the Nasdaq Capital Market, and it has 180 calendar days to regain compliance [2]. - If the bid price closes at or above US$1.00 for at least 10 consecutive business days within this period, Nasdaq will notify the Company of compliance [2]. Group 2: Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on developing therapies for progressive kidney disease and gout, with three advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury [4]. - 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 [4].
XORTX Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency
Globenewswire· 2025-04-17 23:45
Core Points - XORTX Therapeutics Inc. has received notification from Nasdaq that it is not in compliance with the minimum bid price requirement, as its common shares have closed below US$1.00 for 30 consecutive business days [1] - The company has 180 calendar days from the notification date to regain compliance, during which its shares will continue to trade on the Nasdaq Capital Market [2] - If the bid price closes at or above US$1.00 for at least 10 consecutive business days, Nasdaq will notify the company of compliance [2] - The notification does not affect the company's listing status on the TSX Venture Exchange [3] - XORTX is evaluating options to resolve the deficiency and regain compliance with Nasdaq Rule 5550(a)(2) [3] Company Overview - XORTX Therapeutics is focused on developing therapies for progressive kidney disease and gout, with three clinically advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury [4] - The company is also developing XRx-225, a pre-clinical program for Type 2 diabetic nephropathy [4] - XORTX aims to improve the quality of life for individuals with gout and other diseases by targeting purine metabolism and xanthine oxidase to reduce uric acid production [4]
XORTX Announces Update for Discussion with the FDA
Newsfilter· 2025-03-19 11:00
Core Insights - XORTX Therapeutics Inc. is preparing for a Type B meeting with the FDA to discuss the XRx-026 program for gout, aiming to confirm its readiness for a New Drug Application (NDA) submission [1][2] - The XRx-026 program focuses on XORLOTM, a proprietary formulation of oxypurinol, which addresses unmet medical needs in gout treatment [4] - The company anticipates that advancing the XRx-026 program will lead to a revenue-positive state for XORTX [2] Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on innovative therapies for progressive kidney disease and gout [1] - The company has three clinically advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury [8] Gout and Hyperuricemia Context - Approximately 44 million individuals in the US have elevated uric acid levels, with gout affecting about 9.2 million people [3] - Gout is linked to significant morbidity, including severe pain and reduced quality of life, and is associated with various health conditions such as metabolic syndrome and chronic kidney disease [3] XRx-026 Program Details - The XRx-026 program is developing XORLOTM, which aims to provide an alternative to existing xanthine oxidase inhibitors (XOIs) like Allopurinol and Febuxostat [4] - Allopurinol is commonly prescribed but not tolerated by 3-5% of patients, while Febuxostat faced a decline in use due to safety concerns [4] FDA Meeting Insights - Type B meetings with the FDA are designed to discuss the development status of drug applications and confirm any additional information needed for marketing approval [5]