SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements about us and our industry within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this prospectus, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “should,” “will,” “project,” “target,” “contemplate” or the negative of these terms or other similar expressions.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, factors and assumptions described under the section titled “Risk Factors” and elsewhere in this prospectus regarding, among other things:
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our ability to continue as a going concern;
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the progress, timing, costs and results of our clinical trials;
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the timing of meetings with and feedback from regulatory authorities as well as any submission of filings for regulatory approval of brivoligide or any of our product candidates;
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the potential advantages and differentiated profile of our product candidates compared to existing therapies or other product candidates in development;
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our ability to successfully commercialize any of our product candidates, if approved;
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the rate and degree of market acceptance of any of our product candidates, if approved;
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our expectations regarding the size of the patient populations for and opportunity for and clinical utility of brivoligide or any other product candidates, if approved for commercial use;
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our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;
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our ability to identify, acquire or in-license and develop new product candidates;
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our ability to maintain intellectual property protection for our product candidates;
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the uncertainty regarding the adequacy of our liquidity to pursue or complete business objectives;
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our ability to comply with Current Good Manufacturing Practices, or cGMPs;
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loss or retirement of key executives;
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our plans to make significant additional outlays of working capital before we expect to generate significant revenues and the uncertainty regarding when we will begin to generate significant revenues, if we are able to do so;
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adverse economic conditions and/or intense competition;
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loss of a key supplier;
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entry of new competitors;
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adverse federal, state and local government regulation;
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technical problems with our research and products;
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risks of mergers and acquisitions including the time and cost of implementing transactions and the potential failure to achieve expected gains, revenue growth or expense savings;
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price increases for supplies;