Core Points - XORTX Therapeutics Inc. is a late-stage clinical pharmaceutical company focused on developing therapies for progressive kidney disease [1] - Institutional Shareholder Services Inc. (ISS) has recommended that shareholders vote "FOR" all proposed resolutions at the upcoming Annual and Special Meeting on September 12, 2024 [1][2] - The Board of Directors of XORTX also recommends shareholders vote "FOR" all proposed items [2] Meeting Details - The Annual and Special Meeting of Shareholders will take place on September 12, 2024, at 10:00 am (Calgary Time) at the company's offices [2] - The proxy voting deadline is set for 10:00 am (Calgary time) on September 10, 2024 [2] Company Overview - XORTX has two clinically advanced products: XRx008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD) and XRx-101 for acute kidney injury related to COVID-19 [4] - The company is also developing XRx-225, a pre-clinical program for Type 2 Diabetic Nephropathy [4] - XORTX aims to improve patient quality of life by targeting purine metabolism and inhibiting uric acid production [4]

CALGARY, Alberta, Aug. 23, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the management information circular (the "Circular") for the annual and special meeting (the "Meeting") of shareholders is now available on the Company's website at https://www.xortx.com/investors/news-events/ircale ...

CALGARY, Alberta, Aug. 20, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANUA), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the acceptance of an abstract submitted to the American Society of Nephrology (the "ASN"). The abstract entitled "Xanthine oxidase in rats, mice and humans with polycystic kidney disease" was reviewed by the ASN re ...

Exhibit 99.1 CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS As at and for the three months ended March 31, 2024 and 2023 (Unaudited - expressed in U.S. Dollars) XORTX THERAPEUTICS INC. Condensed Interim Consolidated Statements of Financial Position (Unaudited - expressed in U.S. Dollars) | | | March 31, | December 31, | | --- | --- | --- | --- | | | Note | 2024 | 2023 | | | | $ | $ | | Assets | | | | | Current | | | | | Cash | 5 | 3,835,440 | 3,447,665 | | Accounts receivable | | 30,883 | 60,711 | | Pr ...

Part I [Identity of Directors, Senior Management and Advisers](index=13&type=section&id=Item%201.%20Identity%20of%20Directors%2C%20Senior%20Management%20and%20Advisers) This section identifies key individuals in leadership and names Smythe LLP as the company's auditor since 2018 - The company's leadership includes **Allen Davidoff** as President & CEO, **James Fairbairn** as CFO, and **Anthony J. Giovinazzo** as Non-Executive Chair[41](index=41&type=chunk) - **Smythe LLP**, based in Vancouver, Canada, has served as the company's auditor since 2018[43](index=43&type=chunk) [Key Information](index=13&type=section&id=Item%203.%20Key%20Information) This section details significant financial, business development, commercialization, securities, third-party dependence, and intellectual property risks [Risk Factors](index=14&type=section&id=3.D.%20Risk%20Factors) The company faces substantial financial, operational, commercialization, and intellectual property risks, requiring significant additional funding Historical Net Losses | Fiscal Year | Net Loss ($) | | :--- | :--- | | 2023 | 2,158,065 | | 2022 | 7,718,882 | | 2021 | 1,579,274 | - As of December 31, 2023, the company's accumulated deficit was approximately **$17,854,907**[51](index=51&type=chunk) - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[50](index=50&type=chunk) - The company plans to utilize the **505(b)(2) NDA pathway** for future marketing applications, which relies on FDA's prior findings for an approved product; rejection could increase time and resources for approval[87](index=87&type=chunk)[88](index=88&type=chunk) [Information on the Company](index=70&type=section&id=Item%204.%20Information%20on%20the%20Company) This section provides a comprehensive overview of XORTX Therapeutics, detailing its history, strategy, product pipeline, and regulatory landscape [History and Development of the Company](index=70&type=section&id=4.A.%20History%20and%20Development%20of%20the%20Company) XORTX Therapeutics Inc. was formed in 2018, underwent share consolidations for Nasdaq compliance, and recently raised **CAD $2.7 million** - In 2021, the company completed a **1-for-11.74 share consolidation** to qualify for its Nasdaq listing and closed its US IPO, raising approximately **USD $12 million**[259](index=259&type=chunk)[260](index=260&type=chunk) - In November 2023, the company executed a **1-for-9 share consolidation** to regain compliance with the Nasdaq's minimum bid price requirement[299](index=299&type=chunk)[302](index=302&type=chunk) - In early 2024, the company raised approximately **CAD $2.7 million** through a non-brokered offering and proposed to reprice over **1 million** outstanding warrants to an exercise price of **$5.00**[244](index=244&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk) - Key milestones in 2023 included receiving **U.S. Orphan Drug Designation (ODD)** for the **XRx-008** program for ADPKD and aligning with the FDA on endpoints for a Phase 3 trial, making the program eligible for accelerated approval[248](index=248&type=chunk) [Business Overview](index=84&type=section&id=4.B.%20Business%20Overview) XORTX is a late clinical-stage biotech developing kidney disease therapies using proprietary oxypurinol formulations and a 505(b)(2) pathway Product Candidate Pipeline | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | **XRx-008** | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Pre-Phase 3 Registration Trial | | **XRx-101** | Acute Kidney Injury (AKI) in Respiratory Virus Infections | Advancing toward Phase 3 | | **XRx-225** | Type 2 Diabetic Nephropathy (T2DN) | Non-clinical Stage | - The company's core strategy is to develop proprietary formulations of **oxypurinol**, a uric acid lowering agent, to treat various kidney diseases[308](index=308&type=chunk) - XORTX plans to use the **FDA's 505(b)(2) pathway**, which allows reliance on previous clinical studies of the active ingredient (oxypurinol), potentially accelerating the approval process for its **XRx-008** and **XRx-101** programs[324](index=324&type=chunk)[349](index=349&type=chunk) - The company holds granted U.S. and European patents for its proprietary formulations of xanthine oxidase inhibitors and has licensed patents covering the use of uric acid lowering agents for insulin resistance and diabetic nephropathy[322](index=322&type=chunk) [Organizational Structure](index=134&type=section&id=4.C.%20Organizational%20Structure) The company maintains a simple organizational structure, comprising XORTX Therapeutics Inc. and its wholly owned subsidiary, XORTX Pharma Corp - XORTX Therapeutics Inc. has one wholly owned subsidiary, **XORTX Pharma Corp**[474](index=474&type=chunk) [Operating and Financial Review and Prospects](index=134&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) This section refers to the Management's Discussion and Analysis (MD&A) for the year ended December 31, 2023, included as Exhibit 15.1 - The Management's Discussion and Analysis (MD&A) for the fiscal year ended December 31, 2023, is provided as **Exhibit 15.1** in this Annual Report[476](index=476&type=chunk) [Directors, Senior Management and Employees](index=135&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) This section details the company's leadership, compensation practices, board structure, and share ownership, including executive contracts and committee roles [Compensation](index=141&type=section&id=6.B.%20Compensation) Executive compensation includes salary, bonuses, and stock options, with CEO Allen Davidoff's 2023 total compensation at **$378,436** 2023 Named Executive Officer Compensation (US$) | Name and Position | Salary | Stock Option Value | Total Compensation | | :--- | :--- | :--- | :--- | | Allen Davidoff, CEO | 337,794 | 40,642 | 378,436 | | James Fairbairn, CFO | 76,201 | — | 76,201 | | Stacy Evans, CBO | 280,000 | — | 280,000 | | Dr. Stephen Haworth, CMO | 200,229 | 15,041 | 215,270 | - Non-executive directors received **CAD $3,000** per quarter and committee meeting fees in 2023; the Board Chair received annual compensation of **$125,000**[500](index=500&type=chunk) [Board Practices](index=144&type=section&id=6.C.%20Board%20Practices) Key executives have employment agreements, and the Board operates with Audit, Compensation, and Corporate Governance & Nominating committees - CEO Allen Davidoff's employment agreement provides for a lump sum payment equal to **12 times** his monthly base salary upon termination without cause or following a change of control[508](index=508&type=chunk) - The Board of Directors has three primary committees: **Audit**, **Compensation**, and **Corporate Governance & Nominating**, each composed of independent directors[513](index=513&type=chunk)[521](index=521&type=chunk)[523](index=523&type=chunk) [Share Ownership](index=150&type=section&id=6.E.%20Share%20Ownership) As of April 30, 2024, Armistice Capital, LLC holds **5.9%** of shares, while all executive officers and directors collectively own **6.4%** Beneficial Share Ownership (as of April 30, 2024) | Name / Group | Percentage of Shares Beneficially Owned | | :--- | :--- | | Armistice Capital, LLC | 5.9% | | All executive officers and directors as a group (10 persons) | 6.4% | - The company's Stock Option Plan allows for the issuance of options up to an aggregate of **10%** of the issued and outstanding Common Shares[533](index=533&type=chunk) [Major Shareholders and Related Party Transactions](index=154&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) Armistice Capital is a major shareholder with future offering participation rights, and related party transactions primarily involve management compensation - Armistice Capital is a major shareholder and has the right to participate in future offerings for up to **50%** of the offering size, until 18 months from October 7, 2022[538](index=538&type=chunk)[540](index=540&type=chunk) Management Compensation (US$) | Year Ended Dec 31 | Short-term employee benefits | Directors' fees | Share-based payments | Total | | :--- | :--- | :--- | :--- | :--- | | 2023 | 974,240 | 182,675 | 77,779 | 1,234,694 | | 2022 | 880,387 | 127,053 | 404,573 | 1,412,013 | | 2021 | 442,932 | 51,280 | 276,436 | 771,188 | [Financial Information](index=156&type=section&id=Item%208.%20Financial%20Information) This section confirms audited consolidated financial statements for 2021-2023 are in Item 18, with no significant changes since December 31, 2023 - The audited consolidated financial statements for the years ended December 31, 2023, 2022, and 2021 are located in **Item 18**[546](index=546&type=chunk) - There have been no significant changes since December 31, 2023, that are not disclosed elsewhere in the report[547](index=547&type=chunk) [Additional Information](index=158&type=section&id=Item%2010.%20Additional%20Information) This section details the company's corporate structure, material contracts, and U.S. federal income tax implications, including its **PFIC** status for 2023 - The company's authorized share capital consists of an unlimited number of common shares without par value; as of the report date, **2,903,565** common shares were issued and outstanding[561](index=561&type=chunk) - The company believes it was classified as a **Passive Foreign Investment Company (PFIC)** for the taxable year ended December 31, 2023, and may be a PFIC for 2024, which has adverse U.S. federal income tax consequences for U.S. shareholders[170](index=170&type=chunk)[594](index=594&type=chunk) - The company has not paid any dividends since its inception and does not anticipate paying any in the foreseeable future, intending to retain earnings for development and growth[632](index=632&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=181&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to credit, liquidity, and market risks, including foreign currency fluctuations from Canadian Dollar assets Financial Position Summary (US$) | Instrument | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | 3,447,665 | 10,434,196 | | Accounts payable and accrued liabilities | 283,428 | 1,445,213 | | Derivative warrant liability | 531,000 | 3,854,403 | - As of December 31, 2023, the company had a net exposure of **($136,441)** to Canadian Dollar currency fluctuations; a **10%** change in the CAD/USD exchange rate would affect net earnings by approximately **$13,664**[645](index=645&type=chunk) Part II [Material Modifications to the Rights of Security Holders and Use of Proceeds](index=185&type=section&id=Item%2014.%20Material%20Modifications%20to%20the%20Rights%20of%20Security%20Holders%20and%20Use%20of%20Proceeds) In October 2022, the company reduced warrant exercise prices, and net proceeds from the 2021 US IPO have been fully utilized for operations and R&D - In October 2022, the exercise price for certain warrants held by specific investors was reduced from **US$4.77** to **US$1.17** per share[653](index=653&type=chunk)[654](index=654&type=chunk) - The net proceeds from the 2021 US IPO have been fully utilized for general corporate purposes, including R&D and clinical trial support[657](index=657&type=chunk) [Controls and Procedures](index=185&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no auditor attestation required - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[658](index=658&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[663](index=663&type=chunk) - As an "emerging growth company," XORTX is exempt from the requirement to have its independent auditor provide an attestation report on internal controls over financial reporting[664](index=664&type=chunk) [Corporate Governance and Other Matters](index=187&type=section&id=Item%2016.%20Corporate%20Governance%20and%20Other%20Matters) This section covers corporate governance, including the audit committee financial expert, Code of Conduct, principal accountant fees, and foreign private issuer quorum practices - The Board of Directors has determined that **Paul Van Damme** is an "audit committee financial expert"[666](index=666&type=chunk) Principal Accountant Fees (2023 vs 2022) | Service Type | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Audit Fees | 80,126 | 61,459 | | Audit-Related Fees | 528 | 530 | | Tax Fees | 3,090 | 3,846 | | Other Fees | 8,793 | 7,307 | | **Total** | **92,536** | **73,142** | - As a foreign private issuer, the company follows its home country practice for shareholder meeting quorum, which requires two shareholders present in person or by proxy, differing from the Nasdaq requirement of **33 1/3%** of outstanding shares[679](index=679&type=chunk) Part III [Financial Statements](index=192&type=section&id=Item%2018.%20Financial%20Statements) This section presents audited consolidated financial statements for 2021-2023, showing a reduced net loss in 2023 due to fair value adjustments and lower R&D expenses [Consolidated Statements of Financial Position](index=200&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) Total assets decreased from **$12.37 million** to **$5.47 million** in 2023, driven by reduced cash and liabilities, leading to lower shareholders' equity Consolidated Balance Sheet Highlights (US$) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **5,467,964** | **12,374,026** | | Cash | 3,447,665 | 10,434,196 | | **Total Liabilities** | **825,938** | **5,377,215** | | Derivative warrant liability | 531,000 | 3,854,403 | | **Total Shareholders' Equity** | **4,642,026** | **6,996,811** | [Consolidated Statements of Comprehensive Loss](index=202&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported a net loss of **$2.16 million** in 2023, a significant reduction from **$7.72 million** in 2022, driven by fair value adjustments and lower R&D expenses Consolidated Income Statement Highlights (US$) | Account | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Research and development | (2,418,715) | (6,761,818) | (677,576) | | Fair value adjustment on derivative warrant liability | 3,641,403 | 3,396,137 | 2,636,391 | | **Net loss for the year** | **(2,158,065)** | **(7,718,882)** | **(1,579,274)** | | **Basic and diluted loss per common share** | **(1.09)** | **(5.22)** | **(1.44)** | [Consolidated Statements of Cash Flows](index=204&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash decreased by **$6.99 million** in 2023, ending at **$3.45 million**, primarily due to cash used in operations and a shift from financing inflows to outflows Consolidated Cash Flow Highlights (US$) | Account | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | (6,583,165) | (8,963,557) | | Net cash used in investing activities | (46,363) | (45,701) | | Net cash (used in) provided by financing activities | (361,044) | 4,709,739 | | **(Decrease) increase in cash** | **(6,986,531)** | **(4,435,665)** | | **Cash, end of year** | **3,447,665** | **10,434,196** |

Financial Performance - The net loss for the year 2023 was $2,158,065, a significant improvement compared to a net loss of $7,718,882 in 2022, indicating a reduction of about 72%[11] - The company reported a basic and diluted loss per common share of $1.09 for 2023, compared to $5.22 in 2022, showing an improvement of about 79%[11] - For the year ended December 31, 2023, XORTX reported a net loss of $2,158,065, a significant improvement compared to a net loss of $7,718,882 in 2022, representing a reduction of approximately 72%[15] - The company recognized a share-based payment expense of $120,984 during the year ended December 31, 2023, down from $487,940 in 2022[112] - Management compensation for the year ended December 31, 2023, totaled $1,234,694, an increase from $1,412,013 in 2022[123] Assets and Liabilities - As of December 31, 2023, total assets decreased to $5,467,964 from $12,374,026 in 2022, representing a decline of approximately 56%[10] - Total current liabilities decreased to $294,938 in 2023 from $1,511,303 in 2022, a reduction of about 81%[10] - Shareholders' equity as of December 31, 2023, was $4,642,026, down from $6,996,811 in 2022, indicating a decline of approximately 34%[10] - Cash and cash equivalents decreased to $3,447,665 in 2023 from $10,434,196 in 2022, a decline of approximately 67%[10] - The company ended 2023 with cash of $3,447,665, down from $10,434,196 at the end of 2022, reflecting a decrease of approximately 67%[15] - The company has committed to payments totaling $446,000 for clinical trials and other business activities, down from $1,994,232 in 2022[140] - As of December 31, 2023, total accounts payable and accrued liabilities amount to $283,428, a significant decrease from $1,445,213 in 2022[132] - The lease liability as of December 31, 2023, is $11,510, compared to $77,599 in 2022, indicating a reduction in lease obligations[132] Research and Development - Research and development expenses for 2023 were $2,418,715, down from $6,761,818 in 2022, reflecting a decrease of approximately 64%[11] - The company has not capitalized any research and development costs as of December 31, 2023[68] - Research and development costs are expensed as incurred until a drug product receives regulatory approval, with all current research and development costs having been expensed to date[45] - The company plans to raise necessary capital to finance its research and development activities and clinical studies, indicating a focus on future funding strategies[20] - XORTX is focused on developing therapies for progressive kidney disease, particularly targeting conditions like autosomal dominant polycystic kidney disease and type 2 diabetic nephropathy[19] Currency and Financial Reporting - The company changed its presentation currency from Canadian dollars to U.S. dollars effective January 1, 2023[3] - The company has changed its functional and presentation currency from CAD to USD, effective January 1, 2023, to align with its increased presence in the U.S. market[25] - The fair value adjustment on derivative warrant liability for 2023 was a loss of $3,641,403, compared to a loss of $3,396,137 in 2022, showing an increase in losses of about 7%[15] - The company has Canadian non-capital losses carried forward of approximately CAD $21,561,000, with various expiry dates extending to 2043[125] - The risk-free interest rate used in the fair value assessment of derivative warrant liabilities ranged from 3.25% to 3.91% as of December 31, 2023[119] Shareholder Information - The weighted average number of common shares outstanding increased to 1,981,734 in 2023 from 1,479,914 in 2022, an increase of about 34%[11] - The company issued 328,777 common shares for the exercise of pre-funded warrants at $0.0009 per share, raising $296 in January 2023[85] - The total number of outstanding warrants as of December 31, 2023, was 1,125,210, with a weighted average exercise price of CAD $22.31[101] - The company has not declared dividends in the past, and the expected volatility for stock options was 100%[110] - The company plans to amend the exercise price of outstanding warrants from original prices ranging from $10.98 to $42.93 down to $5.00[145] Audit and Compliance - The company has not identified any critical audit matters during the audit process[7] - The company recognizes deferred tax assets for unused tax losses and credits to the extent that it is probable future taxable profits will be available[60] - The company assesses impairment of intangible assets and equipment when events indicate that the carrying amount may not be recoverable, recognizing impairment losses when necessary[48] - The company has no exposure to the ongoing banking crisis, as all cash is held with major financial institutions in Canada[128] - There have been no changes in risk management policies since December 31, 2023, indicating stability in financial risk management[134]

Exhibit 99.1 CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS As at and for the three and nine months ended September 30, 2023 and 2022 (Unaudited - expressed in U.S. Dollars) XORTX THERAPEUTICS INC. Condensed Interim Consolidated Statements of Financial Position (Unaudited - expressed in U.S. Dollars) | | | | December 31, | January 1, | | --- | --- | --- | --- | --- | | | | | 2022 | 2022 | | | | September 30, | Restated | Restated | | | Note | 2023 | (Note 2) | (Note 2) | | | | $ | $ | $ | | Assets | | ...

Election Results - Allen Davidoff received 3,432,152 votes (52.65%) for his election as director, while 3,087,324 votes (47.36%) were withheld[2] - William Farley was elected with 5,679,271 votes (87.11%), and 840,205 votes (12.89%) were withheld[2] Auditor Appointment - Smythe LLP was appointed as the auditor with 7,359,275 votes (99.78%) in favor, and 16,117 votes (0.22%) were withheld[3] Stock Option Plan - The stock option plan was re-approved with 6,048,425 votes (94.33%) in favor, while 363,453 votes (5.67%) were against[4]

Financial Performance - Net loss for the period was $1,832,035 for Q1 2023, compared to a net loss of $2,703,693 in Q1 2022, indicating an improvement of about 32%[3] - Basic and diluted loss per common share improved to $(0.11) in Q1 2023 from $(0.21) in Q1 2022[3] - The net loss for the three months ended March 31, 2023, was $2,703,693, compared to a net loss of $3,423,262 for the same period in 2022, indicating a reduction of approximately 21%[22] - The Company incurred a loss before other items of $2,875,983 for the three months ended March 31, 2022, compared to a loss of $3,641,406 in the same period of 2023[22] Cash and Assets - Cash and cash equivalents decreased to $7,908,461 as of March 31, 2023, down from $10,434,196 at the end of 2022, representing a decline of approximately 24%[2] - Total assets decreased to $9,658,813 as of March 31, 2023, down from $12,374,026 at the end of 2022, reflecting a reduction of about 22%[2] - The Company reported total current assets of $10,895,568 and total assets of $12,374,026 as of December 31, 2022, reflecting a decrease from $14,750,412 and $16,752,929 respectively[21] Liabilities and Equity - Total liabilities decreased significantly to $599,788 as of March 31, 2023, compared to $5,377,215 at the end of 2022, a reduction of approximately 89%[2] - Shareholders' equity increased to $9,059,025 as of March 31, 2023, up from $6,996,811 at the end of 2022, representing an increase of about 30%[2] - The Company’s total liabilities were reported at $5,377,215 as of December 31, 2022, compared to $7,286,499 previously reported[21] Research and Development - Research and development expenses were $1,046,957 in Q1 2023, a decrease of approximately 46% from $1,927,681 in Q1 2022[3] - The Company has not capitalized any development costs as of March 31, 2023, despite ongoing product development efforts[30] - The company plans to continue raising necessary capital to support its research and development activities and clinical studies[10] - XORTX Therapeutics is focused on developing therapies for progressive kidney disease, with ongoing efforts to secure funding for future projects[9] Shareholder Information - The weighted average number of common shares outstanding increased to 17,365,009 in Q1 2023, up from 12,989,687 in Q1 2022, reflecting an increase of approximately 34%[3] - The Company issued 2,959,000 common shares for the exercise of Pre-Funded Warrants at $0.0001 per share, raising $296 during the three months ended March 31, 2023[46] - The Company has a total of 17,989,687 common shares issued as of March 31, 2023, an increase from 15,030,687 at December 31, 2022[45] Obligations and Payments - The Company has an obligation to pay UFRF an annual license fee of $1,000 and milestone payments of $500,000 upon FDA approval for marketing in the U.S.[41] - The Company is obligated to pay royalties of up to 1.5% of net sales of products covered by the license until the expiration of patent claims or 10 years from the first commercial sale[41] - The company has committed to payments totaling $1,514,514 for clinical trials and other business activities expected to occur over the next two years, down from $1,994,232 as of December 31, 2022[79] Other Financial Metrics - The Company recognized a share-based payment expense of $39,550 during the three months ended March 31, 2023, compared to $68,078 in the same period of 2022[61] - The Company incurred issuance costs of $1,067,153 in connection with a public offering that closed on October 7, 2022[49] - The Company has a total of 10,127,076 warrants outstanding as of March 31, 2023, with a weighted average exercise price of $2.47[51] - The total present value of minimum lease payments related to the office lease obligation was $61,536 as of March 31, 2023[44] Currency and Reporting Changes - The Company changed its functional and presentation currency from CAD to USD effective January 1, 2023, to better reflect its business activities in the U.S.[17] Related Party Transactions - The company incurred related party transactions totaling $125,229 for wages and benefits for key executives during the three months ended March 31, 2023, compared to $155,399 in the same period of 2022[69] - Research and development fees paid to related parties amounted to $52,979 for the three months ended March 31, 2023, compared to $56,250 in 2022[74] Management and Executive Compensation - The company’s management services for officers amounted to $472,800 as of March 31, 2023, compared to $441,754 as of December 31, 2022[77]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...