CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including the information incorporated by reference into this prospectus, contains, and any applicable prospectus supplement may contain, “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 and Exchange Act of 1934, as amended, or the Exchange Act. Any statements, other than statements of historical facts, contained in this prospectus, any applicable prospectus supplement and any information incorporated by reference herein and therein 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 our 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 BLA, and filing for, and final approval by the FDA, 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, RP2 and/or RP3 or any other product candidates from our RPx platform if approved for commercial use;
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our ability to obtain and maintain sufficient quantities of raw material supplies or access single or limited sources of goods or services needed to build or maintain our product candidate supplies or otherwise operate our in-house manufacturing facility;
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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 and 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;