CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including the information incorporated by reference into this prospectus, contains “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Any statements, other than statements of historical facts, contained in this prospectus and the information incorporated by reference herein may be deemed to be forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “seeks,” “approximately,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. We believe these factors include, among other things:
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the timing, progress, and results of preclinical studies and clinical trials for RP1 or any of our other product candidates, including the timing of initiation and completion of studies or trials and related preparatory work and the period during which the results of the trials will become available;
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our ability to obtain additional funding as necessary;
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the timing, scope or likelihood of regulatory filings and approvals, including timing of our Biologics License Application, and filing for, and final approval by the U.S. Food and Drug Administration of, RP1 or any of our other product candidates;
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the timing, scope, or likelihood of foreign regulatory filings and approvals;
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our ability to develop our product candidates for use in combination with other checkpoint blockade therapies, including anti-PD-1;
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our ability to develop and advance any future product candidates into, and successfully complete, clinical trials;
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our expectations regarding the size of the patient populations for RP1 or our other product candidates if approved for commercial use;
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the costs of operating our in-house manufacturing facility;
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our estimates regarding expenses and capital requirements;
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the implementation of our business model and our strategic plans for our business, RP1 and our other product candidates;
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the rate and degree of market acceptance and clinical utility of RP1 or our other product candidates;
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the potential benefits of and our ability to establish or maintain future collaborations or strategic relationships;
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our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
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our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering RP1 and our other product candidates, claims others may make regarding rights in our intellectual property, and any potential infringement, misappropriation or other violation of any third-party intellectual property rights;
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our competitive position, and developments and projections relating to our competitors and our industry;
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negative developments in the field of immuno-oncology;
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the impact of laws and regulations;
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the impact of the COVID-19 coronavirus, or COVID-19, as a global pandemic and related public health issues;
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our ability to remediate the material weaknesses in internal control over financial reporting and to maintain effective internal control over financial reporting;