UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of February 2023
Commission File Number: 001-40858
XORTX Therapeutics Inc.
3710 – 33rd Street NW, Calgary, Alberta, T2L 2M1
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
XORTX Therapeutics Inc. | |||
(Registrant) | |||
Date: February 7, 2023 | By: | /s/ Allen Davidoff | |
Name: | Allen Davidoff | ||
Title: | Chief Executive Officer | ||
EXHIBIT INDEX
99.1 | News Release dated February 7, 2023 |
EXHIBIT 99.1
XORTX Provides Update on 2022 Achievements and 2023 Planned Milestones
CALGARY, Alberta, Feb. 07, 2023 (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 provide a summary of Company’s progress in 2022 and milestones planned for 2023.
Dr. Allen Davidoff stated, “2022 marked a year of substantial technological and clinical progress and established the foundation for the Company’s 2023 goals. The advancements and accomplishments made could not have happened without the efforts of our Board of Directors, employees, consultants, vendors, and shareholders. During 2023 we believe the goals set for 2023 will advance our technology closer to marketing approval and transform XORTX into a high value company.”
In 2022, the Company made substantial progress advancing its strategic plan in key areas, including chemistry, manufacturing, formulation development, non-clinical studies using XORLOTM to attenuate PKD progression in animal models and completion of the first clinical study XRX-OXY-101 in support of the XRx-008 program for autosomal dominant polycystic kidney disease (“ADPKD”).
2022 Synopsis
Chemistry and Manufacturing, Clinical and Pre-Clinical Highlights – Confirmed new synthetic pathway for oxypurinol production and produced GMP drug substance; finalized XORLOTM formulation and produced clinical supply of tablets for clinical trials.
Technology and Patent Advancements
Organizational Highlights
In addition to substantial technology advancement, the Company continued to bolster its management team with the following appointments:
Financial Highlights
In summary, activity during 2022 advances the Company’s intellectual property portfolio, characterizes the XORLOTM formulation pharmacokinetics for dose modeling and dose selection in individuals with kidney disease. The XRX-OXY-101 data gathered provides key understanding for communications with the FDA, EMA and Health Canada to advance the optimal design of XORTX’s registration trial for ADPKD. These communications continue to de-risk the XRx-008 program and drug candidate for treating ADPKD and sets up XORTX for more in-depth and meaningful partnering discussions in the near future.
Goals for 2023
In 2023, XORTX will be focused on advancing XORLOTM as part of the XRx-008 for ADPKD into a Phase 3 registration clinical trial, the submission of an Orphan Drug Designation (“ODD”), initiation of special protocol assessment discussions with the FDA and initiation of commercialization activities for XORLOTM as well as advancing research in other kidney disease applications. To achieve these objectives, XORTX’s action plan includes:
To achieve the above goals, XORTX will continue to pursue non-dilutive and dilutive funding and expand discussions to partner with a major pharma / biotech companies with a global reach. XORTX will also increase financial and healthcare conference participation to further strengthen and expand our investor base.
About XORTX Therapeutics Inc.
XORTX is a pharmaceutical company with two clinically advanced products in development: 1) our lead, XRx-008 program for ADPKD; and 2) our secondary program in XRx-101 for acute kidney and other acute organ injury associated with Coronavirus / COVID-19 infection. In addition, XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy. XORTX is working to advance its clinical development stage products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, we are dedicated to developing medications to improve the quality of life and future health of patients. Additional information on XORTX is available at www.xortx.com.
For more information, please contact:
Allen Davidoff, CEO | Nick Rigopulos, Director of Communications |
adavidoff@xortx.com or +1 403 455 7727 | nick@alpineequityadv.com or +1 617 901 0785 |
Media Inquiries, David Melamed, Ph.D. | |
david.melamed@russopartnersllc.com or +1 212 845 4225 |
Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.
Forward Looking Statements
This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of XORTX only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, XORTX undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting XORTX is contained under the heading “Risk Factors” in XORTX’s Registration Statement on Form F-1 filed with the SEC, which is available on the SEC's website, www.sec.gov (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada, which are available on www.sedar.com.