CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate by reference, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or 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, and in particular those factors referenced in the section “Risk Factors.”
This prospectus contains forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. 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, levels of activity, performance or achievements to be materially different from any future results, levels of activity, 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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the success, cost and timing of our product development activities and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;
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our ability to advance any product candidate into or successfully complete any clinical trial;
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our ability or the potential to successfully manufacture our product candidates for clinical trials or for commercial use, if approved;
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our plans to renovate, customize and operate our manufacturing facility purchased in 2018;
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the potential for our identified research priorities to advance our technologies;
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our ability to maintain regulatory approval, if obtained, of any of our current or future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate;
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the ability to license additional intellectual property relating to our product candidates and to comply with our existing license agreements;
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our ability to commercialize our products in light of the intellectual property rights of others;
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developments relating to cellular therapies, including red blood cell therapies;
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the success of competing therapies that are or become available;
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our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;
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the commercialization of our product candidates, if approved;
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our plans to research, develop and commercialize our product candidates;
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our ability to attract collaborators with development, regulatory and commercialization expertise;
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future agreements with third parties in connection with the commercialization of our product candidates and any other approved product;
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the size and growth potential of the markets for our product candidates, and our ability to serve those markets;
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the rate and degree of market acceptance of our product candidates;
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regulatory developments in the United States and foreign countries;