CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements contained in this prospectus 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 prospectus should not be unduly relied upon. These statements speak only as of the date of this prospectus. In addition, this prospectus may contain forward-looking statements and forward-looking information attributed to third party industry sources.
In particular, forward-looking statements in this prospectus include, but are not limited to, statements about:
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our ability to obtain additional financing;
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the accuracy of our estimates regarding expenses, costs associated with clinical trials, regulatory and commercial activities, future revenues and capital requirements;
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the success and timing of our preclinical studies and clinical trials;
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our ability to obtain and maintain regulatory approval of XRx-008, also sometimes referred to by its trademarked name XORLOTM. XORTX’s proprietary formulation of oxypurinol, and any other product candidates we may develop, and the labeling under any approval we may obtain;
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regulatory approvals and discussions and other regulatory developments in the United States, the EU and other countries;
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the performance of third-party manufacturers and contract research organizations;
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our plans to develop and commercialize our product candidates, if approved;
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our plans to advance research in other kidney disease applications;
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our ability to obtain and maintain intellectual property protection for our product candidates;
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the successful development of our sales and marketing capabilities;
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the potential markets for our product candidates and our ability to serve those markets;
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the rate and degree of market acceptance of any future products;
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the success of competing drugs that are or become available; and
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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:
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the availability of capital to fund planned expenditures;
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prevailing regulatory, tax and environmental laws and regulations;
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the ability to secure necessary personnel, equipment, supplies and services;
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our ability to manage our growth effectively;
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the absence of material adverse changes in our industry or the global economy;
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trends in our industry and markets;
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our ability to maintain good business relationships with our strategic partners;