SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements. All statements other than statements of historical facts contained in or incorporated by reference into this prospectus, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing, and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that are in some cases beyond our control and may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in or incorporated by reference into this prospectus 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;
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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 competitor’s 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;
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our ability to protect or enforce our intellectual property, unpatented trade secrets, know-how and other proprietary technology;
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our ability to obtain necessary intellectual property rights from third parties;
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our ability to protect our trademarks, trade names and build our names recognition;