CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying base prospectus, the documents that we incorporate by reference herein or therein, and any related free writing prospectus contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking. These statements are often, but are not always, made through the use of words or phrases such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “continue,” and similar expressions, or the negative of these terms, or similar expressions. Accordingly, these statements involve estimates, assumptions, risks and uncertainties which could cause actual results to differ materially from those expressed in them. Any forward-looking statements are qualified in their entirety by reference to the factors discussed throughout this prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein, and, in particular, those factors referenced in the section “Risk Factors” in such documents.
This prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein contain forward-looking statements that are based on our management’s belief and assumptions and on information available to our management as of their respective dates. These statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
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our ability to raise financing in the future;
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our success in retaining or recruiting, or changes required in, our officers, key employees or directors;
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our ability and/or the ability of third-party vendors and partners to manufacture our product candidates;
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our ability to source critical components or materials for the manufacture of our product candidates;
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our ability to achieve and sustain profitability;
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our ability to achieve our projected development and commercialization goals;
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the rate of progress, costs and results of our clinical studies and research and development activities;
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market acceptance of our product candidates, if approved;
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our ability to compete successfully with larger companies in a highly competitive industry;
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changes in our operating results, which make future operations results difficult to predict;
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serious adverse events, undesirable side effects that could halt the clinical development, regulatory approval or certification, of our product candidates;
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our ability to manage growth or control costs related to growth;
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economic conditions that may adversely affect our business, financial condition and stock price;
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our reliance on third parties to drive successful marketing and sale of our initial product candidates, if approved;
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our reliance on third parties to manufacture and provide important materials and components for our products and product candidates;
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our and our partners’ abilities to obtain necessary regulatory approvals and certifications for our product candidates in an uncomplicated and inexpensive manner;
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our ability to maintain compliance with regulatory and post-marketing requirements;
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adverse medical events, failure or malfunctions in connection with our product candidates and possible subjection to regulatory sanctions;
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healthcare costs containment pressures and legislative or administrative reforms which affect coverage and reimbursement practices of third-party payors;