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]

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]

Core Viewpoint - XORTX Therapeutics Inc. has successfully closed a registered direct offering, raising gross proceeds of US$1,102,500 for the sale of 1,750,000 common shares at a price of US$0.63 per share, which will be used for working capital and general corporate purposes [1][3]. Group 1: Offering Details - The offering included 572,470 common shares and 1,117,530 pre-funded warrants, with each warrant allowing the holder to acquire one common share at an exercise price of $0.001 [2]. - D. Boral Capital LLC acted as the sole placement agent for the offering and will receive 87,500 agent warrants, each exercisable into one common share at an exercise price of US$0.69 [4]. Group 2: Company Overview - XORTX 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 associated with respiratory virus infections [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 [7].

Core Points - XORTX Therapeutics Inc. has entered into a securities purchase agreement for the sale of 1,746,631 common shares at a price of US$0.63 per share, aiming to raise gross proceeds of US$1.1 million [1][2] Group 1: Offering Details - The closing of the offering is expected on or about October 22, 2025, pending customary closing conditions and TSX Venture Exchange approval [2] - The net proceeds from the offering will be used for working capital and general corporate purposes [2] - D. Boral Capital LLC is acting as the sole placement agent for the offering [3] Group 2: Regulatory Information - The common shares will be issued under an effective shelf registration statement previously filed with the SEC [4] - A prospectus supplement detailing the terms of the offering will be filed with the SEC and will be available on their website [4] Group 3: Company Overview - XORTX is 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 [6] - The company is also developing XRx-225, a pre-clinical program for Type 2 diabetic nephropathy [6] - XORTX aims to improve the quality of life for individuals with gout and related diseases by targeting purine metabolism and xanthine oxidase to reduce uric acid production [6]

Core Points - XORTX Therapeutics Inc. has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement of US$1.00 per share, now having until April 13, 2026 to meet this requirement [2][3] - If the company's common shares close at or above $1 for at least 10 consecutive business days during the extension period, Nasdaq will notify the company of compliance [3] - Failure to demonstrate compliance by the deadline may result in delisting, although the company can appeal this decision [3] Company Overview - XORTX is a late-stage clinical pharmaceutical company 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 [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 is committed to improving the quality of life for individuals suffering from gout and other significant diseases [5]

Core Insights - XORTX Therapeutics Inc. has entered into a binding term sheet to acquire a Renal Anti-Fibrotic Therapeutic Program from Vectus Biosystems Limited, which includes the novel compound VB4-P5 and associated intellectual property [1][2] - The VB4-P5 program is at the pre-IND stage and aims to address both rare and common forms of kidney disease, which have significant unmet medical needs [1][2] Company Overview - XORTX is focused on developing innovative therapies for gout and progressive kidney disease, with a mission to provide new treatment options for patients suffering from rare renal disorders [2][8] - The company has three clinically advanced products: XRx-026 for gout, XRx-008 for autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 for acute kidney injury related to respiratory virus infections [8] Acquisition Details - The acquisition consideration for Vectus is USD $3.0 million, payable in common shares or equivalents at a deemed issue price of USD $0.86 per Security [2][3] - The closing of the acquisition is expected to occur within 90 days, subject to typical conditions including regulatory approvals [3] Kidney Disease Context - Chronic kidney disease (CKD) affects approximately 14% of adults globally, translating to around 35–37 million individuals in the United States [4] - Kidney fibrosis is a key factor in CKD progression, leading to significant morbidity and mortality, with current treatments primarily focusing on blood pressure control and dietary changes [5] VB4-P5 Program Insights - Early preclinical data suggest that VB4-P5 has the potential to inhibit and possibly reverse kidney fibrosis, with patent protection covering over 30 global jurisdictions [6]

TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on September 25, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 XORTX THERAPEUTICS INC. (Exact name of registrant as specified in its charter) British Columbia (State or other jurisdiction of incorporation or organization) 2834 (Primary Standard Industrial Classification Code Number) N/A (I.R.S. Employer Identificati ...

Summary of XORTX Therapeutics Webinar Company Overview - **Company**: XORTX Therapeutics (NasdaqCM:XRTX) - **Focus Areas**: Development of therapies for gout and autosomal dominant polycystic kidney disease (ADPKD) [9][12] Core Points and Arguments Gout Program - **Primary Focus**: Developing a formulation of oxypurinol for gout treatment, targeting allopurinol-intolerant patients [9][11] - **Market Opportunity**: Estimated at $700 million for allopurinol-intolerant gout patients, filling a gap left by febuxostat [11][15] - **Clinical Background**: The drug has a safe and effective clinical record established in over 800 patients [12] - **Regulatory Path**: Preparing to file a New Drug Application (NDA) within the next 12 to 14 months, with a review period of 9 to 12 months [19][26] - **Patient Demographics**: Approximately 50 million individuals have high uric acid levels, with 7 to 9 million diagnosed with gout [14] - **Pricing Strategy**: Projected launch price between $6,000 and $8,000 per patient per year [15] ADPKD Program - **Market Opportunity**: Estimated at $1 to $1.5 billion, with a focus on patients with high uric acid levels [12][24] - **Regulatory Path**: A single small registration trial may suffice for FDA approval [12] - **Current Treatment Landscape**: Tolvaptan is the only approved drug, costing $156,000 per patient per year, treating only 5% of patients [23][25] - **Potential Market Size**: Estimated peak net sales could exceed $1 billion by treating around 18,000 individuals [25] Development and Manufacturing - **Key Activities**: Preparing an Investigational New Drug (IND) application and conducting pharmacokinetic studies [10][20] - **Manufacturing Plans**: A year of stability testing is required before NDA filing [21][26] - **Team Expertise**: Strong developmental team with experience in drug development and commercialization [27][28] Additional Important Information - **Patent Protections**: Recent EU patent grants cover major countries, with U.S. patents extending through 2034 and additional layers through 2041 and 2043 [34][35] - **Commercialization Strategy**: Plans to establish manufacturing and distribution contracts in preparation for the product launch [36] - **Market Capitalization**: Currently around $4 million to $5 million, with potential for significant value creation as the NDA is submitted [38][39] Conclusion - **Investment Opportunity**: XORTX Therapeutics is positioned for growth with low-risk activities planned over the next 12 to 24 months, aiming to transition from a research-focused company to a revenue-generating entity [39]

Core Viewpoint - XORTX Therapeutics Inc. is advancing its late-stage clinical programs aimed at treating gout and progressive kidney disease, with a focus on innovative therapies for underserved conditions [2][4]. Group 1: Company Overview - XORTX Therapeutics Inc. is a late-stage clinical pharmaceutical company specializing in treatments for gout and progressive kidney disease [1][4]. - The company has three clinically advanced products: XRx-026 for gout, XRx-008 for autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 for acute kidney injury [4]. Group 2: Upcoming Events - XORTX is hosting a webinar on September 10, 2025, featuring Dr. Allen Davidoff, the CEO, who will discuss the company's mission and product pipeline [1][2]. - A live Q&A session will follow the presentation, allowing investors to engage directly with management [3]. Group 3: Product Pipeline and Market Opportunity - The lead program, XRx-026 (XORLO™), targets allopurinol-intolerant gout, with a New Drug Application (NDA) filing expected in the first half of 2026 [2]. - The market opportunity for XORLO™ is estimated at USD $700 million annually, with a diversified pipeline addressing multi-billion-dollar renal markets [2]. - Additional programs include XRx-008 for ADPKD, XRx-101 for acute kidney injury, and XRx-225 for Type 2 diabetic nephropathy [2][4].

Core Insights - XORTX Therapeutics Inc. has initiated the preparation for an Investigational New Drug (IND) application for its lead program, XRx-026, aimed at treating gout, with support from Allucent, a global contract research organization [1][3] - The IND preparation will involve a thorough review of non-clinical, pharmacologic, toxicological, and regulatory progress, and is expected to be submitted in the second half of 2025 [2][3] - The FDA has outlined four critical requirements for the New Drug Application (NDA) submission for XORLO™, the proprietary formulation of oxypurinol [3][6] Company Developments - XORTX has confirmed the issuance of 73,871 common shares at US$1.54 per share, resulting in gross proceeds of approximately USD $113,547.11 during the quarter ended March 31, 2025, under its at-the-market offering [4] - The company is focused on developing innovative therapies for gout and progressive kidney disease, with three clinically advanced products in development [9] Market Context - Approximately 44 million individuals in the U.S. have elevated uric acid levels, with 9.2 million living with gout, indicating a significant market need for effective treatments [5] - The global prevalence of gout is expected to double over the next 25 years, highlighting the growing demand for new therapeutic options [5] Product Insights - The XRx-026 program is developing XORLO™, which aims to provide an alternative for patients who cannot tolerate existing xanthine oxidase inhibitors, addressing a notable gap in current treatment options [6][7] - Current standard treatments for gout have limitations, with 3-5% of patients unable to tolerate allopurinol, and febuxostat carrying cardiovascular risk warnings [6][7]