XORTX Therapeutics (XRTX)

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XORTX Therapeutics (NasdaqCM:XRTX) Update / Briefing Transcript
2025-09-10 21:17
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]
Join XORTX for an Exclusive Live Investor Webinar and Q&A Session on September 10
Globenewswire· 2025-09-04 11:00
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].
XORTX Initiates IND Preparation for XORLO™ in Gout Program
Globenewswire· 2025-09-03 11:00
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]
XORTX Therapeutics (XRTX) - 2025 Q2 - Quarterly Report
2025-08-15 13:29
[Condensed Interim Consolidated Financial Statements](index=1&type=section&id=CONDENSED%20INTERIM%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section presents the company's financial position, performance, equity changes, and cash flows for the interim period [Condensed Interim Consolidated Statements of Financial Position](index=2&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Financial%20Position) The company's total assets decreased from $4,094,527 at December 31, 2024, to $2,742,018 at June 30, 2025, primarily due to a significant reduction in cash. Total liabilities also decreased slightly, while shareholders' equity saw a substantial decline Consolidated Statements of Financial Position Summary | Item | June 30, 2025 ($) | December 31, 2024 ($) | Change ($) | Change (%) | | :--------------------------------- | :------------------ | :-------------------- | :--------- | :--------- | | Cash | 1,063,477 | 2,473,649 | (1,410,172) | -57.01% | | Total Current Assets | 1,264,520 | 2,676,698 | (1,412,178) | -52.76% | | Total Assets | 2,742,018 | 4,094,527 | (1,352,509) | -33.03% | | Total Liabilities | 711,455 | 757,990 | (46,535) | -6.14% | | Total Shareholders' Equity | 2,030,563 | 3,336,537 | (1,305,974) | -39.14% | [Condensed Interim Consolidated Statements of (Loss) Income and Comprehensive (Loss) Income](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20(Loss)%20Income%20and%20Comprehensive%20(Loss)%20Income) XORTX Therapeutics Inc. reported a net loss for the three and six months ended June 30, 2025, contrasting with a net income in the three months ended June 30, 2024. The loss for the six-month period significantly decreased compared to the prior year, driven by reduced investor relations and professional fees, despite increased R&D expenses Consolidated Statements of (Loss) Income Summary | Item | Three months ended June 30, 2025 ($) | Three months ended June 30, 2024 ($) | Six months ended June 30, 2025 ($) | Six months ended June 30, 2024 ($) | | :------------------------------------------ | :----------------------------------- | :----------------------------------- | :--------------------------------- | :--------------------------------- | | Research and development | 186,751 | 67,683 | 463,060 | 141,326 | | Investor relations | 155,859 | 502,265 | 305,902 | 941,670 | | Professional fees | 100,882 | 274,635 | 182,716 | 394,845 | | Loss before other items | (889,945) | (1,493,690) | (1,853,401) | (2,582,306) | | Fair value adjustment on derivative warrant liability | 149,000 | 1,645,548 | 395,000 | (79,244) | | Net (loss) income for the period | (717,700) | 170,066 | (1,416,373) | (2,848,870) | | Basic and diluted (loss) income per common share | (0.19) | 0.06 | (0.38) | (1.07) | [Condensed Interim Consolidated Statements of Changes in Shareholders' Equity](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) Shareholders' equity decreased from $3,336,537 at December 31, 2024, to $2,030,563 at June 30, 2025, primarily due to the comprehensive loss for the period of $(1,416,373), partially offset by share issuances and pre-funded warrant exercises Shareholders' Equity Changes | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :------------------------------------ | :------------------ | :-------------------- | | Balance, December 31, 2023 | 4,642,026 | 4,642,026 | | Shares issued pursuant to at-the-market offering | 113,547 | - | | Pre-funded warrants exercised | 2 | 3 | | Share-based payments | 15,914 | 25,362 | | Comprehensive loss for the period | (1,416,373) | (464,476) | | Balance, June 30, 2025 / December 31, 2024 | 2,030,563 | 3,336,537 | [Condensed Interim Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) Cash decreased by $1,410,172 during the six months ended June 30, 2025, primarily due to cash used in operating activities ($1,437,249), partially offset by cash provided by financing activities ($24,133). This contrasts with a smaller decrease in cash in the prior year period Consolidated Statements of Cash Flows Summary | Cash Flow Activity | Six months ended June 30, 2025 ($) | Six months ended June 30, 2024 ($) | | :--------------------------------- | :--------------------------------- | :--------------------------------- | | Net loss for the period | (1,416,373) | (2,848,870) | | Cash provided by (used in) operating activities | (1,437,249) | (2,040,389) | | Cash provided by (used in) investing activities | (25,210) | (11,707) | | Cash provided by (used in) financing activities | 24,133 | 1,694,710 | | Decrease in cash | (1,410,172) | (369,193) | | Cash, beginning of period | 2,473,649 | 3,447,665 | | Cash, end of period | 1,063,477 | 3,078,472 | [Notes to the Condensed Interim Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20the%20Condensed%20Interim%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed interim consolidated financial statements, covering accounting policies, judgments, and specific financial instrument details [1. Nature of operations and going concern](index=6&type=section&id=1.Nature%20of%20operations%20and%20going%20concern) XORTX Therapeutics Inc. is a late-stage clinical pharmaceutical company developing therapies for gout and progressive kidney disease. The company faces significant risks related to product development, regulatory approval, and financing, indicating a material uncertainty about its ability to continue as a going concern - XORTX is a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease modulated by aberrant purine and uric acid metabolism in orphan disease indications[9](index=9&type=chunk) - The Company's ability to continue as a going concern is subject to **material uncertainty** due to the need for additional funding for future projects and operations, and the requirement for U.S. Food and Drug Administration (FDA) and equivalent organizations' approvals for its products[10](index=10&type=chunk) [2. Basis of preparation](index=6&type=section&id=2.Basis%20of%20preparation) The condensed interim consolidated financial statements are prepared in accordance with IAS 34, Interim Financial Reporting, using the historical cost convention, except for financial instruments measured at fair value. They consolidate the Company and its 100% owned subsidiary, XORTX Pharma Corp., and were approved by the Board on August 14, 2025 - These condensed interim consolidated financial statements have been prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting[11](index=11&type=chunk) - The statements use the historical cost convention except for financial instruments which have been measured at fair value, and were prepared on an accrual basis except for cash flow information[12](index=12&type=chunk) - The financial statements incorporate the Company and its **100% owned subsidiary**, XORTX Pharma Corp., with inter-company transactions eliminated[13](index=13&type=chunk) [3. Material Accounting policies](index=7&type=section&id=3.Material%20Accounting%20policies) The condensed interim consolidated financial statements adhere to the material accounting policies disclosed in the annual financial statements for the year ended December 31, 2024 - These condensed interim consolidated financial statements have been prepared on a basis consistent with the material accounting policies disclosed in the annual financial statements for the year ended December 31, 2024[15](index=15&type=chunk) [4. Critical accounting judgments and estimates](index=7&type=section&id=4.Critical%20accounting%20judgments%20and%20estimates) Management's preparation of financial statements involves significant judgments and estimates, particularly concerning share-based payments, warrant liabilities, classification of contract payments, impairment of intangible assets, functional currency, capitalization of R&D costs, lease accounting, pre-funded warrant classification, and current/deferred taxes - The preparation of condensed interim consolidated financial statements requires management to make judgments and estimates that affect the amounts reported, which are subject to change and could materially impact future periods[16](index=16&type=chunk) - Critical accounting judgments and estimates include share-based payment transactions and warrant liabilities, classification of contract payments, impairment of intangible assets, determination of functional currency, treatment of research and development costs, leases, classification of pre-funded warrants, and current and deferred taxes[17](index=17&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk)[20](index=20&type=chunk)[21](index=21&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) [Share-based payment transactions and warrant liabilities](index=7&type=section&id=Share-based%20payment%20transactions%20and%20warrant%20liabilities) Estimating fair value for share-based transactions and warrant liabilities requires determining the most appropriate valuation model and inputs - Estimating fair value for share-based transactions and warrant liabilities requires determining the most appropriate valuation model and inputs, including expected life, volatility, and dividend yield[17](index=17&type=chunk) [Classification of contract payments](index=7&type=section&id=Classification%20of%20contract%20payments) Contract payments are classified as a non-current asset based on management's assessment of future program completion timelines - Contract payments are classified as a **non-current asset** based on management's assessment that future regulatory and clinical trial programs would not be completed within **12 months**[18](index=18&type=chunk) [Impairment of intangible assets](index=7&type=section&id=Impairment%20of%20intangible%20assets) Patents and licenses are reviewed for impairment at each financial reporting date, with impairment recognized if carrying value exceeds recoverable value - Patents and licenses are reviewed for impairment at each financial reporting date, with impairment recognized if the carrying value exceeds the recoverable value[19](index=19&type=chunk) [Determination of functional currency](index=7&type=section&id=Determination%20of%20functional%20currency) The U.S. dollar is determined to be the functional currency of the Company and its subsidiary, based on its influence on costs and financing - The **U.S. dollar** is concluded to be the functional currency of the Company and its subsidiary, based on the currency mainly influencing costs and financing[20](index=20&type=chunk) [Treatment of research and development costs](index=8&type=section&id=Treatment%20of%20research%20and%20development%20costs) Development costs are capitalized only if they meet IAS 38 criteria for recognition as intangible assets, including technical and economic viability - Costs to develop products are capitalized only if they meet the criteria for recognition as intangible assets in IAS 38, including technical and economic viability and future benefit generation[21](index=21&type=chunk) - The Company has **not capitalized any development costs** as at June 30, 2025[21](index=21&type=chunk) [Leases](index=8&type=section&id=Leases) Valuing right-of-use assets and lease obligations requires judgment in determining lease terms, identifying the underlying asset, and estimating the incremental borrowing rate - Valuing right-of-use assets and lease obligations requires judgment in determining lease terms, identifying the underlying asset, and estimating the incremental borrowing rate[22](index=22&type=chunk) [Classification of pre-funded warrants](index=8&type=section&id=Classification%20of%20pre-funded%20warrants) Management classified pre-funded warrants as an equity instrument after considering the characteristics of derivative instruments - Management classified pre-funded warrants as an **equity instrument** after considering the characteristics of derivative instruments[23](index=23&type=chunk) [Current and deferred taxes](index=8&type=section&id=Current%20and%20deferred%20taxes) Measurement of income taxes payable and deferred income tax assets and liabilities requires management judgment in interpreting tax laws and estimating future taxable income - Measurement of income taxes payable and deferred income tax assets and liabilities requires management judgment in interpreting tax laws and estimating future taxable income or loss and taxation rates[24](index=24&type=chunk) [5. Cash](index=8&type=section&id=5.Cash) The Company's cash, held in bank and brokerage accounts, decreased significantly from $2,473,649 at December 31, 2024, to $1,063,477 at June 30, 2025. Interest-bearing deposits constitute the majority of cash, earning an annual rate of 4.10% as of June 30, 2025 Cash and Interest-Bearing Deposits | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------- | :------------------ | :-------------------- | | Cash | 115,753 | 53,686 | | Interest-bearing deposits | 947,724 | 2,419,963 | | Total Cash | 1,063,477 | 2,473,649 | - The current annual interest rate earned on interest-bearing deposits is **4.10%** as of June 30, 2025, up from **3.62%** at December 31, 2024[25](index=25&type=chunk) [6. Prepaid expenses](index=9&type=section&id=6.Prepaid%20expenses) Prepaid expenses decreased from $185,412 at December 31, 2024, to $97,589 at June 30, 2025, primarily due to a reduction in prepaid insurance Prepaid Expenses Breakdown | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------------ | :-------------------- | | Research and development | — | 1,167 | | Insurance | 52,250 | 158,007 | | Investor relations conferences and services | 35,301 | 19,490 | | Administrative services and other | 10,038 | 6,748 | | Total Prepaid Expenses | 97,589 | 185,412 | [7. Contract payments](index=9&type=section&id=7.Contract%20payments) The Company holds $1,200,000 in contract payments from an agreement with Prevail InfoWorks Inc. (entered in 2020), which are to be applied to future regulatory and clinical trial programs - The Company has **$1,200,000** in contract payments to be applied to future regulatory and clinical trial programs, stemming from an agreement with Prevail InfoWorks Inc. in 2020[28](index=28&type=chunk) [8. Intangible assets](index=9&type=section&id=8.Intangible%20assets) Intangible assets, primarily licensed intellectual property, increased in carrying value from $183,108 at December 31, 2024, to $195,008 at June 30, 2025, due to additions of $25,210, partially offset by amortization. The company has various licensing agreements for patents related to hypertension, metabolic syndrome, and insulin resistance Intangible Assets Carrying Values | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :---------------------- | :------------------ | :-------------------- | | Cost | 400,937 | 375,727 | | Accumulated amortization | 205,929 | 192,619 | | Carrying values | 195,008 | 183,108 | - Additions to intangible assets for the six months ended June 30, 2025, totaled **$25,210**, while amortization was **$13,310**[29](index=29&type=chunk) - Intangible assets relate solely to licensed intellectual property, including patents for allopurinol in hypertension, intellectual property for metabolic syndrome, and an exclusive license for insulin resistance treatment[30](index=30&type=chunk)[32](index=32&type=chunk) [Licensed patents for hypertension treatment](index=10&type=section&id=Licensed%20patents%20for%20hypertension%20treatment) The Company licensed patents for allopurinol for hypertension treatment, agreeing to future royalties on net revenues - The Company licensed patents for allopurinol for hypertension treatment, paying **$40,000** and agreeing to future royalties on net revenues, with **no royalties accrued or paid** as of June 30, 2025[30](index=30&type=chunk) [Licensed IP for metabolic syndrome treatment](index=10&type=section&id=Licensed%20IP%20for%20metabolic%20syndrome%20treatment) The Company licensed intellectual property for using uric acid lowering agents to improve metabolic syndrome treatment, with future royalty payments - The Company licensed intellectual property for the use of uric acid lowering agents to improve metabolic syndrome treatment, with future royalty payments based on net revenues, and **no royalties accrued or paid** as of June 30, 2025[32](index=32&type=chunk) [Exclusive license for insulin resistance treatment](index=10&type=section&id=Exclusive%20license%20for%20insulin%20resistance%20treatment) The Company acquired an exclusive license from UFRF for a patent claiming the use of any uric acid lowering agent to treat insulin resistance - The Company acquired an **exclusive license** from the University of Florida Research Foundation, Inc. (UFRF) for a patent claiming the use of any uric acid lowering agent to treat insulin resistance[32](index=32&type=chunk) - Obligations include an annual license fee of **$1,000**, reimbursement for patent maintenance costs, issuance of **180,397 common shares** (**160,783 issued**, **$24,746 obligation** for remaining), milestone payments upon regulatory approvals, and royalty payments of up to **1.5% of net sales**[32](index=32&type=chunk) - **No royalties have been accrued or paid** to UFRF as of June 30, 2025[32](index=32&type=chunk) [9. Property and equipment](index=11&type=section&id=9.Property%20and%20equipment) The carrying value of property and equipment increased from $34,721 at December 31, 2024, to $82,490 at June 30, 2025, primarily due to an $88,074 addition to the right-of-use asset from an office lease extension Property and Equipment Carrying Values | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------- | :------------------ | :-------------------- | | Cost | 323,004 | 234,930 | | Accumulated amortization | 240,514 | 200,209 | | Carrying values | 82,490 | 34,721 | - An **$88,074** right-of-use asset addition was recognized for the six months ended June 30, 2025, due to an office lease extension[33](index=33&type=chunk) - Amortization for the six months ended June 30, 2025, was **$40,305**[33](index=33&type=chunk) [10. Accounts payable and accrued liabilities](index=11&type=section&id=10.%20Accounts%20payable%20and%20accrued%20liabilities) Accounts payable and accrued liabilities significantly increased from $147,205 at December 31, 2024, to $453,982 at June 30, 2025, driven by increases in both trade payables and accrued liabilities Accounts Payable and Accrued Liabilities Breakdown | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :------------------ | :-------------------- | | Trade payables | 356,405 | 84,020 | | Accrued liabilities | 97,577 | 63,185 | | Total | 453,982 | 147,205 | [11. Lease obligation](index=12&type=section&id=11.%20Lease%20obligation) The lease obligation increased from $38,785 at December 31, 2024, to $80,473 at June 30, 2025, primarily due to an $88,074 addition for an office lease extension to May 31, 2026, partially offset by lease payments Lease Obligation Details | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :------------------------------------ | :------------------ | :-------------------- | | Balance, December 31, 2023 | 11,510 | 11,510 | | Additions | 88,074 | 96,998 | | Lease payments | (46,386) | (69,723) | | Balance, June 30, 2025 / December 31, 2024 | 80,473 | 38,785 | | Total minimum lease payments | 83,618 | 39,535 | | Less: imputed interest | (3,145) | (750) | | Total present value of minimum lease payments | 80,473 | 38,785 | - The **$88,074** lease obligation addition recognized in the six months ended June 30, 2025, relates to an extension of the office lease to May 31, 2026[35](index=35&type=chunk) [12. Share capital and reserves](index=12&type=section&id=12.%20Share%20capital%20and%20reserves) Share capital and reserves experienced various changes, including new share issuances from an at-the-market offering and pre-funded warrant exercises, alongside a reclassification of derivative warrant liability. The total number of common shares outstanding increased to 3,788,246 at June 30, 2025 - The number of common shares issued increased to **3,788,246** at June 30, 2025, from **3,481,375** at December 31, 2024[37](index=37&type=chunk) - During the six months ended June 30, 2025, the Company issued **73,871 common shares** for gross proceeds of **$113,547** through an at-the-market offering[38](index=38&type=chunk) - **233,000 common shares** were issued for the exercise of pre-funded warrants, resulting in **$324,643** transferred from reserves to share capital[39](index=39&type=chunk) [a) Authorized and issued](index=12&type=section&id=a)%20Authorized%20and%20issued) The Company has unlimited common shares authorized, with 3,788,246 shares issued at June 30, 2025 - The Company has **unlimited common shares authorized**, with **3,788,246 shares issued** at June 30, 2025 (compared to **3,481,375** at December 31, 2024)[37](index=37&type=chunk) [b) Issuances](index=12&type=section&id=b)%20Issuances) The Company issued common shares through an at-the-market offering and pre-funded warrant exercises, and previously closed non-brokered offerings - Six months ended June 30, 2025: Issued **73,871 common shares** in an at-the-market offering for **$113,547 gross proceeds**, incurring **$19,064** in issuance costs[38](index=38&type=chunk) - Six months ended June 30, 2025: Issued **233,000 common shares** for the exercise of pre-funded warrants at **US$0.00001 per share**, transferring **$324,643** from reserves to share capital[39](index=39&type=chunk) - Six months ended June 30, 2024: Closed two tranches of a non-brokered offering of **899,717 common share units** for aggregate gross proceeds of **$2,000,549**, with proceeds allocated to derivative warrant liability (**$968,000**) and common shares (**$1,032,549**)[40](index=40&type=chunk)[41](index=41&type=chunk) [c) Diluted Weighted Average Number of Common Shares Outstanding](index=13&type=section&id=c)%20Diluted%20Weighted%20Average%20Number%20of%20Common%20Shares%20Outstanding) The basic and diluted weighted average common shares outstanding are presented, with potential conversions excluded due to net loss Weighted Average Common Shares Outstanding | Item | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Basic weighted average common shares outstanding | 3,788,246 | 2,903,565 | 3,762,815 | 2,666,417 | | Diluted weighted average common shares outstanding | 3,788,246 | 2,903,565 | 3,762,815 | 2,666,417 | - Due to a **net loss**, the diluted loss per share calculation for the six months ended June 30, 2025, excludes any potential conversion of options and warrants that would decrease loss per share[44](index=44&type=chunk) [d) Common Share Purchase Warrants](index=13&type=section&id=d)%20Common%20Share%20Purchase%20Warrants) The Company's common share purchase warrants include various grants and exercises, with a weighted average contractual remaining life of 2.09 years Common Share Purchase Warrants Activity | Item | Number of Warrants | Weighted Average Exercise price ($) | | :------------------------------------ | :----------------- | :---------------------------------- | | Balance, December 31, 2023 | 1,125,210 | 22.31 | | Granted – February 9, 2024 | 824,767 | 3.30 | | Granted – February 23, 2024 | 74,950 | 3.30 | | Granted – October 18, 2024 | 810,810 | 2.18 | | Exercised | (5,000) | 3.30 | | Balance, June 30, 2025 and December 31, 2024 | 2,830,737 | 3.65 | - The weighted average contractual remaining life of unexercised warrants was **2.09 years** at June 30, 2025, down from **2.58 years** at December 31, 2024[48](index=48&type=chunk) - Warrants issued in 2024 include an acceleration expiry provision if the Company's shares trade above **$6.50** for **10 consecutive days**[47](index=47&type=chunk) [e) Pre-Funded Warrants](index=14&type=section&id=e)%20Pre-Funded%20Warrants) All pre-funded warrants were exercised during the six months ended June 30, 2025, resulting in a zero balance at period end Pre-Funded Warrants Activity | Item | Number of Warrants | Weighted Average Exercise price ($) | | :-------------------------- | :----------------- | :---------------------------------- | | Balance, December 31, 2023 | - | - | | Granted – October 18, 2024 | 490,810 | 0.00001 | | Exercised | (257,810) | 0.00001 | | Balance, December 31, 2024 | 233,000 | 0.00001 | | Exercised | (233,000) | 0.00001 | | Balance, June 30, 2025 | - | - | - **All pre-funded warrants were exercised** during the six months ended June 30, 2025, resulting in a **zero balance** at period end[50](index=50&type=chunk) [f) Finders' and Underwriters Warrants](index=15&type=section&id=f)%20Finders'%20and%20Underwriters%20Warrants) The Company holds 50,298 finders' and underwriters' warrants with a weighted average exercise price of $23.57 and a remaining life of 1.75 years Finders' and Underwriters' Warrants | Item | Number of Warrants | Weighted Average Exercise price ($) | | :------------------------------------------ | :----------------- | :---------------------------------- | | Balance, June 30, 2025 and December 31, 2024 | 50,298 | 23.57 | - The weighted average contractual remaining life of unexercised finders' and underwriters' warrants was **1.75 years** at June 30, 2025, down from **2.24 years** at December 31, 2024[51](index=51&type=chunk) [g) Stock Options](index=15&type=section&id=g)%20Stock%20Options) Stock options decreased to 129,761 at June 30, 2025, with a weighted average exercise price of $10.51 and a remaining life of 2.78 years Stock Option Activity | Item | Number of Options | Weighted Average Exercise price (CAD) | | :-------------------------- | :---------------- | :------------------------------------ | | Balance, December 31, 2023 | 103,922 | 16.60 | | Granted – March 4, 2024 | 39,483 | 4.50 | | Granted – April 8, 2024 | 8,000 | 5.00 | | Granted – December 18, 2024 | 13,000 | 1.75 | | Expired | (16,642) | 22.22 | | Balance, December 31, 2024 | 147,763 | 10.80 | | Expired | (18,002) | 12.86 | | Balance, June 30, 2025 | 129,761 | 10.51 | | Vested and exercisable, June 30, 2025 | 101,408 | 12.48 | - Share-based payments recorded for the six months ended June 30, 2025, were **$15,914**, a **significant decrease** from **$97,165** in the prior year[56](index=56&type=chunk) - The weighted average contractual remaining life of unexercised options was **2.78 years** at June 30, 2025, down from **3.02 years** at December 31, 2024[57](index=57&type=chunk) [h) Derivative Warrant Liability](index=16&type=section&id=h)%20Derivative%20Warrant%20Liability) Derivative warrant liability decreased due to fair value adjustments, as warrants are classified as liabilities when their exercise price is in a non-functional currency or allows cashless settlement Derivative Warrant Liability Movement | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :------------------------------------ | :------------------ | :-------------------- | | Balance at December 31, 2023 | 531,000 | 531,000 | | Warrants issued February 9, 2024 | - | 865,000 | | Warrants issued February 23, 2024 | - | 103,000 | | Warrants exercised | - | (5,244) | | Fair value adjustment | (395,000) | 79,244 | | Balance at June 30, 2024 | - | 1,573,000 | | Reclassified to reserves | - | (123,651) | | Fair value and other adjustments | - | (877,349) | | Balance at June 30, 2025 / December 31, 2024 | 177,000 | 572,000 | - Warrants are recorded as **derivative financial liabilities** because their exercise price is denominated in a currency other than the functional currency (USD) or they allow for cashless settlement[59](index=59&type=chunk)[61](index=61&type=chunk) - The fair value adjustment for the six months ended June 30, 2025, was **$(395,000)**, contributing to the decrease in liability[63](index=63&type=chunk) [13. Related party transactions](index=18&type=section&id=13.%20Related%20party%20transactions) Total compensation to directors and officers decreased to $481,401 for the six months ended June 30, 2025, from $590,198 in the prior year, with specific amounts paid to the CEO, CFO, CMO, CBO, and other directors. Various amounts were also payable to related parties at period end Related Party Compensation | Item | Six months ended June 30, 2025 ($) | Six months ended June 30, 2024 ($) | | :-------------------------- | :--------------------------------- | :--------------------------------- | | Directors and officers compensation | 481,401 | 590,198 | | Wages and benefits to CEO | 164,394 | 212,711 | | Fees to CFO | 79,895 | 75,584 | | R&D fees to CMO | 48,000 | 62,445 | | Consulting fees to CBO | 75,000 | 82,500 | | Directors' fees | 105,154 | 85,532 | - As at June 30, 2025, **$26,686** was payable to directors, **$28,174** to the CFO, **$16,000** to the CMO, and **$25,000** to the CBO[67](index=67&type=chunk) [14. Financial instruments and risk management](index=19&type=section&id=14.%20Financial%20instruments%20and%20risk%20management) The Company's financial instruments include cash, accounts receivable, accounts payable, lease obligation, and derivative warrant liability. Fair values of short-term instruments approximate carrying values, while derivative warrant liability is classified as Level 3 fair value. The Board monitors foreign currency, interest rate, market, credit, and liquidity risks, with no changes in risk management policies since December 31, 2024 - The Company's financial instruments consist of cash, accounts receivable, accounts payable and accrued liabilities, lease obligation, and derivative warrant liability[68](index=68&type=chunk) - Derivative warrant liability is carried at fair value and is classified within **Level 3** of the fair value hierarchy[68](index=68&type=chunk) - The Board of Directors reviews and monitors foreign currency risk, interest rate risk, market risk, credit risk, and liquidity risk, with **no changes in risk management policies** since December 31, 2024[69](index=69&type=chunk) [15. Capital management](index=19&type=section&id=15.%20Capital%20management) The Company manages its capital (shareholders' equity) to ensure sufficient liquidity for research and development, general and administrative expenses, intellectual property protection, and capital expenditures, aiming to continue as a going concern and optimize shareholder returns. There were no changes in capital management objectives during the six months ended June 30, 2025 - The Company defines capital as shareholders' equity and manages its capital structure to fund research and development, sustain business development, ensure going concern, and optimize shareholder returns[70](index=70&type=chunk) - The objective is to ensure sufficient liquidity for R&D activities, general and administrative expenses, intellectual property protection, and capital expenditures[71](index=71&type=chunk) - There were **no changes in capital management** during the six months ended June 30, 2025, and the Company is **not exposed to external regulatory capital requirements**[71](index=71&type=chunk) [16. Commitments](index=19&type=section&id=16.%20Commitments) The Company has long-term commitments not recognized as liabilities, including a $321,000 annual employment agreement for the CEO and $121,793 in payments related to clinical trial, manufacturing, and other business activities expected over the next two years Contractual Commitments | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :------------------ | :-------------------- | | Management services – officers | 321,000 | 321,000 | | Clinical trial, manufacturing, and other activities | 121,793 | 323,000 | - The President, CEO, and a director has a long-term employment agreement entitling him to an annual salary of **$321,000**, with a **12-month termination clause**[72](index=72&type=chunk) [17. Segmented information](index=20&type=section&id=17.%20Segmented%20information) The Company operates as a single reportable operating segment focused on developing and commercializing therapies for hyperuricemia-related diseases. All long-term assets of the Company are located in Canada - The Company operates in **one reportable operating segment**: the development and commercialization of therapies to treat hyperuricemia related diseases[74](index=74&type=chunk) - **All long-term assets** of the Company are located in Canada[74](index=74&type=chunk) [18. Subsequent events](index=20&type=section&id=18.%20Subsequent%20events) After June 30, 2025, the Company completed two non-brokered private placements in July and August 2025, raising aggregate gross proceeds of $1,039,500 through the issuance of units (common shares and warrants). Deferred share issue costs of $92,594 were incurred in connection with these financings as of June 30, 2025 - On July 22, 2025, the Company closed a private placement of **1,267,123 units** at **$0.73 per unit**, raising **$925,000**[75](index=75&type=chunk) - On August 8, 2025, the Company closed another private placement of **156,849 units** at **$0.73 per unit**, raising **$114,500**[76](index=76&type=chunk) - Each unit in these offerings consists of one common share and one common share purchase warrant, with warrants exercisable at **$1.20** for **sixty months**, subject to an acceleration clause if the Nasdaq closing price exceeds **$2.00** for **ten consecutive trading days**[75](index=75&type=chunk)[76](index=76&type=chunk) - As of June 30, 2025, the Company had incurred **$92,594** of deferred share issue costs in connection with these financings[77](index=77&type=chunk)
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 Provides Corporate Update and Planned Activities for 2025 / 2026
Globenewswire· 2025-08-07 11:00
Core Insights - XORTX Therapeutics Inc. is advancing its lead gout program, XRx-026, with a focus on filing a New Drug Application (NDA) within approximately 12 months, targeting a market opportunity of USD $700 million annually [3][6][8] Group 1: Strategic Focus and Achievements - The company has prioritized the XRx-026 gout program, leveraging advancements in the proprietary XORLO™ formulation, which demonstrates increased oral bioavailability [2][4] - Significant achievements in 2025 include the validation of the XORLO™ formulation and progress in both the XRx-026 and XRx-008 programs [5][6] - Engagement with the FDA through a Type B meeting has clarified the regulatory path for NDA submission via the 505(b)(2) pathway [6] Group 2: Goals and Future Plans - Key objectives for 2025/2026 include advancing the XRx-026 program and preparing for NDA filing, alongside conducting clinical trials to support regulatory submissions [6][12] - The company plans to pursue both non-dilutive and dilutive funding, and is actively seeking partnerships with major pharmaceutical and biotech companies to accelerate commercialization [7][8] - Preparations for commercialization will include market studies and engagement with healthcare professionals to analyze pricing and branding strategies [12]
XORTX Announces USD $114,500 Private Placement
Globenewswire· 2025-07-31 11:00
Core Viewpoint - XORTX Therapeutics Inc. is conducting a non-brokered private placement to raise up to USD $114.5 million through the issuance of common share units at a price of USD $0.73 per unit, aimed at funding its gout and kidney disease treatment programs [1][3]. Group 1: Offering Details - The private placement will consist of up to 156,849 common share units, each unit comprising one common share and one common share purchase warrant [1]. - Each warrant allows the holder to purchase an additional common share at USD $1.20 for 60 months, with an acceleration clause if the share price exceeds USD $2.00 for 10 consecutive trading days [1]. - The closing date for the offering is expected around August 5, 2025, subject to necessary approvals [3]. Group 2: Use of Proceeds - Proceeds from the offering will be allocated to gout programs, general corporate purposes, and working capital [3]. Group 3: Company Overview - XORTX Therapeutics is focused on developing innovative therapies for gout and progressive kidney disease, with three advanced clinical 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 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 Announces USD $3 Million Offering
Globenewswire· 2025-05-19 11:00
Core Viewpoint - XORTX Therapeutics Inc. is conducting a non-brokered private placement to raise up to USD $3,000,000 to advance its gout treatment programs and for general corporate purposes [1][3]. Group 1: Offering Details - The private placement will involve the issuance of up to 3,409,090 common share units at a price of USD $0.88 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 a price of 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: Use of Proceeds - The net proceeds from the offering will be allocated to advancing XORTX's programs for gout, as well as for working capital and general corporate purposes [3]. Group 3: Company Overview - XORTX is focused on developing 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 related to respiratory virus infections [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].