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AMENDED AND RESTATED ANNUAL INFORMATION FORM

Key Takeaway: XORTX THERAPEUTICS INC. AMENDED AND RESTATED ANNUAL INFORMATION FORM FOR THE FISCAL YEAR ENDED DECEMBER 31, REFERENCE INFORMATION 1 CAUTION REGARDING FORWARD-LOOKING STATEMENTS 1 CORPORATE STRUCTURE 5 GENERAL DEVELOPMENT OF THE BUSINESS 6 DESCRIPTION OF THE BUSINESS 10 RISK FA

Full Press Release Details

XORTX THERAPEUTICS INC.
AMENDED AND RESTATED ANNUAL INFORMATION FORM
FOR THE FISCAL YEAR ENDED DECEMBER 31,
REFERENCE INFORMATION 1
CAUTION REGARDING FORWARD-LOOKING STATEMENTS 1
CORPORATE STRUCTURE 5
GENERAL DEVELOPMENT OF THE BUSINESS 6
DESCRIPTION OF THE BUSINESS 10
RISK FACTORS 12
DIVIDENDS 65
CAPITAL STRUCTURE 65
MARKET FOR SECURITIES 66
PRIOR SALES 67
ESCROWED SECURITIES AND SECURITIES SUBJECT TO CONTRACTUAL RESTRICTIONS ON TRANSFER 67
DIRECTORS AND EXECUTIVE OFFICERS 68
CEASE TRADE ORDERS, BANKRUPTCIES, PENALTIES OR SANCTIONS 72
AUDIT COMMITTEE INFORMATION 73
LEGAL PROCEEDINGS AND REGULATORY ACTIONS 74
INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS 74
TRANSFER AGENTS AND REGISTRARS 75
MATERIAL CONTRACTS 75
INTERESTS OF EXPERTS 76
ADDITIONAL INFORMATION 76
SCHEDULE "A" AUDIT COMMITTEE CHARTER 77
XORTX THERAPEUTICS INC.
ANNUAL INFORMATION FORM
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2021
REFERENCE INFORMATION
In this annual information form (the "AIF"), a reference
to the "Company", "XORTX", "we", "us", "our" and similar words refer to XORTX
Therapeutics Inc. and its subsidiaries or any one of them as the context requires.
All references herein to "dollars" and "$" are
to Canadian dollars, unless otherwise indicated.
Unless otherwise stated, the information set forth in this AIF is as
of December 31, 2021.
CAUTION REGARDING FORWARD-LOOKING
Certain statements contained in this AIF constitute forward-looking statements.
These statements relate to future events or the Company's (as defined herein) future performance. All statements other than statements
of historical fact are forward-looking statements. The use of any of the words "anticipate", "plan", "contemplate",
"continue", "estimate", "expect", "intend", "propose", "might",
"may", "will", "shall", "project", "should", "could", "would",
"believe", "predict", "forecast", "pursue", "potential" and "capable"
and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties
and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking statements.
No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this AIF should
not be unduly relied upon. These statements speak only as of the date of this AIF. In addition, this AIF may contain forward-looking statements
and forward-looking information attributed to third party industry sources.
In particular, forward-looking statements in this AIF include, but are not
limited to, statements about:
our ability to obtain additional financing;
the accuracy of our estimates regarding expenses, future revenues and
capital requirements;
the success and timing of our preclinical studies and clinical trials;
our ability to obtain and maintain regulatory approval of product candidates
we may develop, and the labeling under any approval we may obtain;
regulatory developments in the United States and other countries;
the performance of third-party manufacturers;
our plans to develop and commercialize our product candidates;
our ability to obtain and maintain intellectual property protection
for our product candidates;
the successful development of our sales and marketing capabilities;
the potential markets for our product candidates and our ability to
serve those markets;
the rate and degree of market acceptance of any future products;
the success of competing drugs that are or become available; and
the loss of key scientific or management personnel.
All forward-looking statements, including, without limitation, our examination
of historical operating trends, are based upon our current expectations and various assumptions. Certain assumptions made in preparing
the forward-looking statements include:
the availability of capital to fund planned expenditures;
prevailing regulatory, tax and environmental laws and regulations;
the ability to secure necessary personnel, equipment, supplies and
our ability to manage our growth effectively;
the absence of material adverse changes in our industry or the global
trends in our industry and markets;
our ability to maintain good business relationships with our strategic
our ability to comply with current and future regulatory standards;
our ability to protect our intellectual property rights;
our continued compliance with third-party license terms and the non-infringement
of third-party intellectual property rights;
our ability to manage and integrate acquisitions; and
our ability to raise sufficient debt or equity financing to support our continued
We believe there is a reasonable basis for our expectations and beliefs, but
they are inherently uncertain. We may not realize our expectations, and our beliefs may not prove correct. Actual results could differ
materially from those described or implied by such forward-looking statements. The following uncertainties and factors, among others (including
those set forth under "Risk Factors"), could affect future performance and cause actual results to differ materially from
those matters expressed in or implied by forward-looking statements:
our ability to obtain regulatory approval for our product candidates
without significant delays;
the predictive value of our current or planned clinical trials;
delays with respect to the development and commercialization of our
product candidates, which may cause increased costs or delay receipt of product revenue;
our ability to enroll subjects in clinical trials and thereby complete
trials on a timely basis;
the design or our execution of clinical trials may not support regulatory
the potential for our product candidates to have undesirable side effects;
our ability to face significant competition;
no regulatory agency has made a determination that any of our product
candidates are safe or effective for use by the general public or for any indication;
the competitive threat of generic or other follow-on products;
the likelihood of broad market acceptance of our product candidates;
our ability to obtain Orphan Drug Designation or exclusivity for some
or all of our product candidates;
our ability to commercialize products outside of the United States;
the outcome of reimbursement decisions by third-party payors relating
our expectations with respect to the market opportunities for any product
candidate that we or our strategic partners develop;
our ability to pursue product candidates that may be profitable or
have a high likelihood of success;
our ability to use and expand our therapeutic platforms to build a
pipeline of product candidates;
our ability to meet the requirements of ongoing regulatory review;
the threat of product liability lawsuits against us or any of our strategic
changes in product candidate manufacturing or formulation that may
result in additional costs or delay;
the potential disruption of our business and dilution of our shareholdings
associated with acquisitions and joint ventures;
the potential for foreign governments to impose strict price controls;
the risk of security breaches or data loss, which could compromise
sensitive business or health information;
Last updated: Apr 13, 2022