CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement and the accompanying prospectus, including the documents incorporated by reference herein and therein, contain certain statements that are “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act and applicable securities laws. All statements contained herein that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “may,” “will,” “could,” “leading,” “intend,” “contemplate,” “shall,” and similar expressions are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. These forward-looking statements include, among other things, statements about:
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our ability to obtain additional financing;
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the accuracy of our estimates regarding expenses, 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 “XORLO™,” our proprietary formulation of oxypurinol for use in our XRx-008 program to treat autosomal dominant polycystic kidney disease (“ADPKD”), and any other product candidates we may develop, and the labeling under any approval we may obtain;
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regulatory approvals and other regulatory developments in the United States 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;
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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 reflect our beliefs and assumptions based on information available at the time the assumption was made. These forward-looking statements are not based on historical facts but rather on management’s expectations regarding future activities, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities.
By their nature, forward-looking statements involve numerous assumptions, inherent risks and uncertainties, both general and specific, known and unknown, that contribute to the possibility that the predictions, forecasts, projections or other forward-looking statements will not occur. In evaluating forward-looking statements, readers should specifically consider various factors, including the risks outlined under the heading “Risk Factors” in this prospectus supplement, the accompanying prospectus, and in the documents incorporated by reference herein. Some of these risks and assumptions include, among others:
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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;