UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 20-F/A

(Amendment No. 1)

(Mark One)

OR

OR

OR

Date of event requiring this shell company report .. . . . . . . . . . . . . . .

For the transition period from                    to                 

Commission file number:               001-40858                 

XORTX Therapeutics Inc.

(Exact name of Registrant as specified in its charter)

N/A

(Translation of Registrant’s name into English)

British Columbia, Canada

(Jurisdiction of Incorporation or Organization)

3710 – 33rd Street, NW Calgary, Alberta, Canada, T2L 2M1

(Address of Principal Executive Offices)

Amar Keshri, Chief Financial Officer

Telephone: 1-403-455-7727

E-mail: akeshri@xortx.com

3710 – 33rd Street, NW Calgary, Alberta, Canada, T2L 2M1

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act:

Securities registered or to be registered pursuant to Section 12(g) of the Act

None

(Title of Class)

Securities for which there is a reporting obligation pursuant to section 15(d) of the Act

None

(Title of Class)

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 12,989,678

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

¨ Yes x No

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

¨ Yes x No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

x Yes ¨ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files)

x Yes ¨ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Emerging growth company x

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. x

†The term “new or revised financial accounting standard” refers to any updated issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on an attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ¨

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

¨ Item 17 ¨ Item 18

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

¨ Yes x No

(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court ¨ Yes x No

Table of Contents

EXPLANATORY NOTE

This Amendment on Form 20-F/A (the “Amendment”) amends the Annual Report on Form 20-F of XORTX Therapeutics Inc. (“XORTX” or the “Company”) for the year ended December 31, 2021, as filed with the Securities and Exchange Commission on May 3, 2022 (the “Original Form 20-F”). This Amendment is being filed solely for the purpose of including disclosure that the Company inadvertently omitted from Item 5 of the Original Form 20-F relating to Use of Proceeds of the US IPO Financing (as defined in Item 5), a breakdown of R&D expenditures, a comparative analysis of the 12 months ended December 31, 2021, and disclosure of related party names.

This Amendment does not reflect events occurring after the filing of the Original Form 20-F and does not modify or update the disclosure therein in any way other than as required to reflect the amendments described herein and reflected below. No other changes have been made to the Original Form 20-F. The filing of this Amendment should not be understood to mean that any statements contained herein are true or complete as of any date subsequent to the date of the original filing of the Original Annual Report. Accordingly, this Amendment should be read in conjunction with our filings made with the Securities and Exchange Commission subsequent to the filing of the Original Form 20-F.

General Matters

Unless otherwise noted or the context indicates otherwise “we”, “us”, “our”, the “Company” or “XORTX” refer to XORTX Therapeutics Inc. and its subsidiaries.

Unless otherwise indicated, financial information in this Amended Annual Report has been prepared in accordance with IFRS as issued by the IASB. Unless otherwise noted herein, all references to “$,” “Canadian dollars,” or “dollars” are to the currency of Canada and “US$,” “United States dollars,” or “U.S. dollars” are to the currency of the United States.

We are an “emerging growth company” as defined in the JOBS Act, and as such, we have elected to comply with certain reduced U.S. public company reporting requirements.

The Company prepares and reports its consolidated financial statements in accordance with IFRS. However, this Amended Annual Report may make reference to certain non-IFRS measures including key ‎‎performance indicators used by management. These measures are not recognized measures under IFRS ‎‎and do not have a standardized meaning prescribed by IFRS and are therefore unlikely to be comparable ‎‎to similar measures presented by other companies. Rather, these measures are provided as additional ‎‎information to complement those IFRS measures by providing further understanding of the Company’s ‎results of ‎operations from management’s perspective. Accordingly, these measures should not be ‎considered in ‎isolation nor as a substitute for analysis of the Company’s financial information reported ‎under IFRS.

Unless otherwise indicated, the Company has obtained the market and industry data contained in this Amended Annual Report ‎from its internal research, management’s estimates and third-party public information and other industry ‎publications. While the Company believes such internal research, management’s estimates and third-‎party public information is reliable, such internal research and management’s estimates have not been ‎verified by any independent sources and the Company has not verified any third party public ‎information. While the Company is not aware of any misstatements regarding the market and industry ‎data contained in this Amended Annual Report, such data involves risks and uncertainties and are subject to change based on ‎various factors, including those described under “Cautionary Statement Regarding Forward-Looking ‎Information and Statements” and “Item 3.D. Risk Factors”.‎

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Amended Annual Report contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. The statements we make regarding the following matters are forward-looking by their nature and are based on certain of the assumptions noted below:

The preceding list is not intended to be an exhaustive list of all of our forward-looking statements. The forward-looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These statements are only predictions based upon our current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, those factors identified under the Risk Factors listed below in Item 3.D. of this Annual Report. Furthermore, unless otherwise stated, the forward-looking statements contained in this Annual Report are made as of the date hereof, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

GLOSSARY

In this Amended Annual Report, unless otherwise indicated or the context otherwise requires, the following terms shall have the indicated meanings. Words importing the singular include the plural and vice versa and words importing any gender include all genders. A reference to an agreement means the agreement as it may be amended, supplemented or restated from time to time.

“ACA” means the Patient Protection and Affordable Care Act;

“ADPKD” means autosomal dominant polycystic kidney disease;

“AIA” means the Leahy-Smith America Invents Act, also known as the America Invents Act;

“AKI” means acute kidney injury;

“allowable capital loss” means one-half of the amount of any capital loss;

“ANDA” means abbreviated new drug applications;

“Annual Report” means the Annual Report on Form 20-F for the year ended December 31, 2021, as filed with the Securities and Exchange Commission on May 3, 2022;

“Amended Annual Report” means this Amendment No. 1 to the Annual Report

“APAC” means APAC Resources Inc., a company incorporated under the laws of British Columbia;

“articles” means our articles of incorporation;

“ASP” means average sales price;

“Audit Committee” means the Audit Committee of the Company;

“Audit Committee Charter” means the Audit Committee Charter of the Audit Committee;

“BCBCA” means the Business Corporation Act (British Columbia);

“Board of Directors” or “Board” means the Board of Directors of the Company;

“BPCA” means the Best Pharmaceuticals for Children Act;

“bylaws” means our amended and restated bylaws;

“Canadian Resident Holder” means a Holder who, for the purposes of the Canadian Tax Act, is or is deemed to be a resident in Canada at all relevant times;

“Cardiome” means Cardiome Pharma Corp.;

“CBCA” means the Canada Business Corporations Act and the regulations made under that enactment, as amended;

“CCPA” means the California Consumer Privacy Act;

“CEO” means the Company’s principal executive officer;

“CFO” means the Company’s principal financial officer;

“Compensation Committee” means the Compensation Committee of the Company;

“GCP” means current good clinical practices;

“cGMP” means current Good Manufacturing Practices;

“CHMP” means Committee for Medicinal Products for Human Use;

“CJEU” means the Court of Justice of the European Union;

“CMC” means chemistry manufacturing and control;

“CMOs” means contract manufacturing organization;

“CMS” means Centers for Medicare & Medicaid Services;

“CNS” means central nervous system;

“Code of Conduct” means our Code of Business Conduct and Ethics;

“Common Shares” means common shares of the Company;

“Company”, “we”, “us”, “our” or “XORTX” means XORTX Therapeutics Inc. and its subsidiaries.

“CPRA” means the California Privacy Rights Act;

“CRA” means the Canada Revenue Agency;

“CREATES Act” means the Creating and Restoring Equal Access to Equivalent Samples Act of 2019;

“CRL” means a complete response letter;

“CROs” means contract research organizations;

“CRP” means Creatinine Reactive Protein;

“CSE” means the Canadian Securities Exchange;

“CTA” means clinical trial application;

“CTO” means Chief Technology Officer;

“Cures Act” means the 21st Century Cures Act;

“Davidoff Agreement” means that certain Employment Agreement dated January 1, 2018, between the Company and Dr. Allen Davidoff;

“DGCL” means the Delaware General Corporation Law;

“DHHS” means the Department of Health and Human Services;

“DSCSA” means the Drug Supply Chain Security Act;

“EMA” means the European Medicines Agency;

“ESRD” means end stage renal disease;

“ETASU” means elements to assure safe use;

“EU” means the European Union;

“EUA” means the FDA Emergency Use Authorization;

“EU Centralized Procedure” means the procedure for the authorization of medicines, where there is a single application, a single evaluation and a single authorization throughout the European Union;

“Exchange Act” means the Securities Exchange Act of 1934, as amended;

“Fairbairn Consulting Agreement” means the contract the Company entered into with 1282803 Ontario Inc., dated March 1, 2021, for consulting services to the Company to appoint James Fairbairn as the appointed consultant to act in the capacity as chief financial officer;

“FCPA” means the U.S. Foreign Corrupt Practices Act of 1977, as amended;

“FDA” means the U.S. Food and Drug Administration;

“FDCA” means the Federal Food, Drug, and Cosmetic Act;

“GCPs” means good clinical practices;

“GDPR” means the European Union General Data Protection Regulation;

“GLPs” means good laboratory practices;

“Haworth Consulting Agreement” means the contract the Company entered into with Haworth Biopharmaceutical Consulting Services Inc., dated July 1, 2021 and effective July 1, 2021, for consulting services to the Company to appoint Stephen Haworth as the appointed consultant to act in the capacity as chief medical officer;

“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, as amended;

“HITECH” means the Health Information Technology for Economic and Clinical Health Act.

“Holder” means a holder of the Company’s shares;

“IASB” means International Accounting Standards Board;

“ICU” means intensive care units;

“IFRS” means International Financial Reporting Standards;

“IL-6” means interleukin-6;

“IMM” means irreversible morbidity or mortality;

“IND” means Investigational New Drug application;

“IRB” means institutional review board;

“IRS” means the Internal Revenue Service;

“JAMA” means the Journal of the American Medical Association;

“JOBS Act” means the Jumpstart Our Business Startups Act of 2012;

“Keshri Consulting Agreement” means the contract the Company entered into with Next Level Consultants Inc., dated July 1, 2021, for consulting services to the Company to appoint Amar Keshri as the appointed consultant to act in the capacity as chief financial officer;

“MAA” means marketing authorization application;

“MRP” means mutual recognition procedure;

“MSI” means MSI Methylation Sciences Inc., a clinical-stage pharmaceutical company;

“Nasdaq” means the Nasdaq Stock Market;

“Nasdaq Rules” means the Nasdaq Stock Market LLC Rules;

“NDA” means New Drug Application;

“NIH” means the United States National Institutes of Health;

“ODD” means orphan drug designation;

“Orange Book” means the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations;

“PBMs” means pharmaceutical benefit managers;

“PCAOB” means the Public Company Accounting Oversight Board;

“PCT” means Patent Cooperation Treaty;

“PDMA” means the Prescription Drug Marketing Act;

“PPACA” means the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (commonly referred to as the “ACA”);

“PREA” means the Pediatric Research Equity Act;

“pre-IND” means pre-investigational new drug application;

“Prevail” means Prevail Partnerships LLC;

“Prior FDA Review” means the approvable letter for oxypurinol for allopurinol intolerant hyperuricemia that Cardiome announced it had received via a press release dated June 24, 2004;

“Proposed Amendments” means specific proposals to amend the Tax Act and Regulations publicly announced by or on behalf of the Minister of Finance (Canada) prior to the date hereof;

“PSP” means the Pediatric Study Plan;

“R&D” means research and development;

“Regulations” the regulations under the Tax Act;

“REMS” means risk evaluation and mitigation strategies;

“RLD” means reference listed drug;

“Rowlands” means William Bruce Rowlands, an individual;

“Rowlands Consulting Agreement” means the contract the Company entered into with W.B. Rowlands & Co. Ltd. for consulting services to the Company, dated March 1, 2018;

“RTO” means the reverse take-over transaction on January 10, 2018;

“Sans Consulting Agreement” means the contract the Company entered into with Mr. David Sans for consulting services to the Company in the capacity as executive adviser, dated February 1, 2021;

“SEC” means the U.S. Securities and Exchange Commission;

“Section 404” means Section 404 of the Sarbanes-Oxley Act of 2002;

“Section 505(b)(2)” or “505(b)(2)” means section 505(b)(2) of the FDCA;

“Securities Act” means the Securities Act of 1933, as amended;

“SEDAR” means the System for Electronic Document Analysis and Retrieval for Canadian public companies;

“Share Consolidation” means the Company’s consolidation of its shares on a one (1) post-consolidated share for 11.74 pre-consolidated shares basis which took effect on September 23, 2021;

“SPA” means special protocol assessment;

“SUA” means a serum uric acid;

“Tax Treaty” means the Canada-U.S. Tax Convention (1980);

“taxable capital gain” means one-half of the amount of any capital gain;

“T2DN” means type 2 diabetic nephropathy;

“Treaty” means the Canada-United States Income Tax Convention (1980), as amended;

“TSX” means Toronto Stock Exchange;

“TSXV” means TSX Venture Exchange;

“UK” means United Kingdom;

“UR” means uric acid;

“UFRF” means the University of Florida Research Foundation, Inc.;

“UFRF License Agreement” means the amended and restated license agreement dated June 23, 2014, between the Company and the University of Florida Research Foundation, Inc;

“United States Holders” means a holder who, at all relevant times, (a) for the purposes of the Tax Act (i) is not resident, or deemed to be resident, in Canada, (ii) deals at “arm’s length” with the Company, and is not “affiliated” with the Company (each as defined in the Tax Act), (iii) holds Common Shares as capital property, (iv) does not use or hold Common Shares in the course of carrying on, or otherwise in connection with, a business carried on or deemed to be carried on in Canada, and (v) is not an insurer that carries on an insurance business in Canada and elsewhere or “authorized foreign bank” (as defined in the Tax Act), or other holder of special status, and (b) for the purposes of the Tax Treaty, is a resident of the United States, has never been a resident of Canada, does not have and has not had, at any time, a “permanent establishment” (as defined in the Tax Treaty) of any kind in Canada, and otherwise qualifies for the full benefits of the Tax Treaty;

“UofC” means University of Colorado;

“U.S.” means United States;

“US Offering” means the Company’s underwritten public offering of 2,906,000 units, with each unit consisting of one Common Share, no par value, and one warrant to purchase one Common Share at a public offering price of US$4.13 per unit, for aggregate gross proceeds of approximately US$12,000,000, prior to deducting underwriting discounts and other offering expenses;

“USPTO” means United States Patent and Trademark Office;

“Vendors” means Dr. Richard Johnson and Dr. Takahiko Nakagawa;

“Vendors Agreement” means an agreement, dated as of December 2012, between the Company, Dr. Richard Johnson and Dr. Takahiko Nakagawa;

“WBR Consulting Agreement” means the contract the Company entered into with W.B. Rowlands & Co. Ltd. and Rowlands for consulting services to the Company, dated December 20, 2021;

“XRx-008” means product candidate in development for ADPKD;

“XRx-101” means product candidate in development for AKI associated with COVID-19;

“XRx-225” means product candidate in development for diabetic nephropathy;

PART I

The amended management’s discussion and analysis of the Company for the year ended December 31, 2021 is included in this Amended Annual Report as Exhibit 15.1.

PART III

The following Exhibits are being filed as part of this Amended Annual Report, or are incorporated by reference where indicated:

* Filed herewith.

** Previously filed with the Company’s Annual Report on Form 20-F for the year ended December 31, 2021 (File No. 001-40858), filed with Securities and Exchange Commission on May 3, 2022.

# Indicates management contract or compensatory plan.

% Portions of this exhibit (indicated by asterisks) have been omitted as the Company has determined that (1) the omitted information is not material and (2) the omitted information would likely cause competitive harm to the Company if publicly disclosed.

Signatures

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F/A and that it has duly caused and authorized the undersigned to sign this amended annual report on its behalf.

Date: January 26, 2023