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].

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].

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]

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]

Core Viewpoint - XORTX Therapeutics Inc. has requested a Type C meeting with the FDA to discuss the XRx-026 program for gout treatment, indicating readiness for a New Drug Application (NDA) submission for its proprietary drug formulation, XORLO [1][2]. Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on innovative 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 [6]. XRx-026 Program Details - The XRx-026 program is developing XORLO, a proprietary formulation of oxypurinol aimed at treating gout, particularly for patients intolerant to allopurinol [4]. - The program has progressed sufficiently to warrant a review with the FDA, with the meeting expected to occur within 75 days of the request [2]. Gout Prevalence and Impact - Approximately 44 million individuals in the US have elevated uric acid levels, with about 9.2 million suffering from symptomatic gout, which is linked to severe pain and increased healthcare costs [3]. - Gout is associated with serious health conditions, including myocardial infarction and chronic kidney disease, impacting quality of life and economic productivity [3]. Current Treatment Landscape - Oral xanthine oxidase inhibitors (XOIs) are the preferred treatment for gout, with allopurinol being the most commonly prescribed, totaling around 3.3 million prescriptions annually in the US [4]. - Febuxostat, another XOI, had peak sales of approximately US$450 million but faced a decline due to safety concerns, highlighting the need for alternatives like XORLO [4].

Core Viewpoint - XORTX Therapeutics Inc. is actively engaging with the investment community through its participation in the Microcap Conference, where it aims to present its innovative therapies for gout and progressive kidney disease, specifically the XRx-026 and XRx-008 programs [1][2]. Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on developing therapies for progressive kidney disease and gout, with three clinically advanced products: XRx-008 for autosomal dominant polycystic kidney disease (ADPKD), XRx-026 for allopurinol intolerant gout, and XRx-101 for acute kidney injury related to COVID-19 [3]. - The company is dedicated to improving the quality of life for patients with kidney disease and gout by targeting purine metabolism and inhibiting uric acid production [3]. Conference Participation - The Microcap Conference, held from January 28 to 30, 2025, in Atlantic City, NJ, provides XORTX with a platform to update investors on its gout program and ADPKD clinical trial preparations [1]. - The CEO of XORTX, Dr. Allen Davidoff, emphasized the importance of one-on-one meetings with potential investors and the opportunity to present the company's plans for FDA marketing approval [2].

Core Viewpoint - XORTX Therapeutics Inc. has changed its auditor from Smythe LLP to Davidson & Company LLP effective January 16, 2025, with no reservations or reportable events noted during the transition [1][2][3]. Auditor Change - The board of directors accepted the resignation of the former auditor and appointed the successor auditor effective January 16, 2025, to serve until the next annual general meeting of shareholders [2]. - There were no reservations in the former auditor's reports for any financial period, and no reportable events occurred between the company and the former auditor [3]. Compliance and Documentation - The Notice of Change of Auditor and required letters from both auditors have been reviewed by the company's audit committee and board of directors, and filed on the company's SEDAR+ profile [4]. Company Overview - XORTX Therapeutics Inc. is focused on developing innovative therapies for progressive kidney disease and gout, with three clinically advanced products: XRx-008 for ADPKD, XRx-026 for allopurinol intolerant gout, and XRx-101 for acute kidney injury related to COVID-19 [5]. - The company also has a pre-clinical program, XRx-225, targeting Type 2 Diabetic Nephropathy, aiming to improve the quality of life for patients with kidney disease and gout [5].

Core Viewpoint - XORTX Therapeutics Inc. is launching a late-stage program, XRx-026, aimed at treating gout in patients intolerant to allopurinol, with plans to discuss New Drug Application (NDA) filing with the FDA in the first half of 2025 [1][2][3] Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on innovative therapies for progressive kidney disease, with three clinically advanced products: XRx-008 for ADPKD, XRx-026 for allopurinol intolerant gout, and XRx-101 for acute kidney injury related to COVID-19 [6] Clinical Development - The clinical development of XORLO, a proprietary formulation of oxypurinol, has progressed sufficiently, leading to the initiation of discussions with the FDA regarding the XRx-026 program and potential orphan drug designation [2][3][10] Market Opportunity - In North America, approximately 3.5 million individuals suffer from gout, with 3-5% unable to tolerate allopurinol, creating a significant market opportunity for alternative treatments [5] - Febuxostat, an alternative XOI, peaked at approximately US$450 million in sales but has seen a decline due to safety concerns, highlighting the need for a new treatment option like XRx-026 [5] Health Context - Hyperuricemia affects about 14% of the global population, with 1-2% diagnosed with gout, and lowering uric acid levels is strongly correlated with improved health outcomes [4]

Core Viewpoint - XORTX Therapeutics Inc. has appointed Dr. Michael Bumby as the new Chief Financial Officer, replacing James Fairbairn, which is expected to enhance the company's financial leadership and strategic direction in developing therapies for progressive kidney disease [1][3]. Company Overview - XORTX Therapeutics Inc. is a late-stage clinical pharmaceutical company focused on innovative therapies for progressive kidney disease [1]. - The company has two clinically advanced products: XRx008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD) and XRx-101 for acute kidney injury associated with COVID-19 [4]. - XORTX is also developing a pre-clinical program, XRx-225, targeting Type 2 Diabetic Nephropathy [4]. Leadership Background - Dr. Bumby has over 20 years of experience in finance and leadership within the biotech/pharma industry, including a 14-year tenure at Eli Lilly [2]. - He has served as CFO for MediPharm Labs and Merus Labs, where he co-led a $340 million acquisition [2]. - Dr. Bumby holds a Doctor of Veterinary Medicine degree and an MBA, along with a lean six-sigma blackbelt [3]. Strategic Implications - The appointment of Dr. Bumby is anticipated to support XORTX in achieving its near and long-term objectives, leveraging his dual science-finance background [3]. - The company has granted Dr. Bumby 13,000 stock options at an exercise price of $1.75, aligning his interests with the company's performance [3].

Financial Performance - The company reported a net loss of $3,435,881 for the nine months ended September 30, 2024, compared to a loss of $4,857,289 for the same period in 2023, representing a 29.2% improvement[6] - Basic and diluted loss per common share improved to $(1.25) for the nine months ended September 30, 2024, compared to $(2.46) for the same period in 2023[6] - For the nine months ended September 30, 2024, XORTX reported a net loss of $3,435,881, a decrease of 29.2% compared to a net loss of $4,857,289 for the same period in 2023[10] - Cash provided by operating activities for the nine months ended September 30, 2024, was $(2,792,240), an improvement from $(5,285,098) in 2023, indicating a 47.1% reduction in cash outflow[10] - Management compensation for the nine months ended September 30, 2024, totaled $612,749, a decrease from $753,401 in the same period of 2023[78] Assets and Liabilities - Total current assets decreased to $2,410,394 as of September 30, 2024, down 40.8% from $4,068,783 on December 31, 2023[3] - Shareholders' equity decreased to $2,133,580 as of September 30, 2024, down 54.1% from $4,642,026 on December 31, 2023[3] - The company’s cash balance was $2,300,747 as of September 30, 2024, a decrease of 33.3% from $3,447,665 on December 31, 2023[3] - Total liabilities increased to $1,716,751 as of September 30, 2024, up 107.5% from $825,938 on December 31, 2023[3] - The total accounts payable and accrued liabilities increased to $326,283 as of September 30, 2024, compared to $283,428 at December 31, 2023[42] Research and Development - Research and development expenses for the nine months ended September 30, 2024, were $176,067, a decrease of 92.3% from $2,284,583 in the same period of 2023[6] - The company has not capitalized any development costs as of September 30, 2024, indicating a focus on maintaining liquidity while pursuing R&D[27] - XORTX is focused on developing therapies for progressive kidney disease, with ongoing clinical studies and potential future product launches[13] - The company plans to raise additional capital to finance its research and development activities and clinical studies, emphasizing the need for future funding[14] Capital and Financing - The company issued 899,717 shares pursuant to a private placement, raising $1,032,549[8] - The company raised $2,000,549 from the issuance of equity instruments during the nine months ended September 30, 2024, compared to no such proceeds in the same period of 2023[10] - The company closed a registered direct offering on October 18, 2024, raising aggregate gross proceeds of $1,500,000 through the sale of 320,000 common share units at $1.85 each and 490,810 pre-funded warrant units at $1.8499 each[87] - The company intends to use the net proceeds from the recent offering for working capital and general corporate purposes[87] Stock and Equity - The weighted average number of common shares outstanding increased to 2,903,565 as of September 30, 2024, compared to 2,746,043 for the same period in 2023[6] - The company issued 2,903,565 common shares as of September 30, 2024, an increase from 1,998,848 shares at December 31, 2023[45] - The company has a total of 2,019,927 outstanding warrants as of September 30, 2024, with a weighted average exercise price of $4.26[54][56] - The company recorded share-based payments of $15,857 for the three months and $113,022 for the nine months ended September 30, 2024, compared to $21,850 and $92,169 in the same periods of 2023, respectively[62] Obligations and Commitments - The company has a total lease obligation of $61,468 as of September 30, 2024, which includes a $96,998 addition due to an office lease extension[43][44] - The company has committed payments totaling $173,000 for clinical trials and other business activities, down from $446,000 as of December 31, 2023[85] - The company has milestone payments of $500,000 upon FDA approval and $100,000 for each additional jurisdiction's regulatory approval for licensed products[38] Financial Instruments and Valuation - The fair values of the company's financial instruments approximate their carrying values due to their short-term nature as of September 30, 2024[80] - The balance of derivative warrant liabilities as of September 30, 2024, is $1,329,000, reflecting a fair value adjustment of $(164,756) during the period[70] - The carrying value of right-of-use assets increased to $47,018 as of September 30, 2024, from $10,913 at December 31, 2023[40] Risk Management - The company has not made any changes to its risk management policies since December 31, 2023, and continues to monitor various financial risks[80] - The company has no external capital requirements imposed by regulatory agencies[82] - The company has not reported any changes in its capital management strategy during the nine months ended September 30, 2024[82]