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estimates of our expenses, capital requirements and our needs for additional financing; |
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the prospects of APR-246 and other product candidates, which are still in development; |
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outcome and results of ongoing or future preclinical studies and clinical trials of APR-246; |
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the design of our multiple clinical trials, including the sample size, trial duration, endpoint definition, event rate assumptions and eligibility criteria; |
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our expectations regarding the timing of data from our Phase 3 and additional clinical trials; |
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market acceptance or commercial success of APR-246 and the degree of acceptance among physicians, patients, patient advocacy groups, health care payors and the medical community; |
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our expectations regarding competition, potential market size, the size of the patient populations for APR-246, if approved for commercial use, and market acceptance; |
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our ability to maintain regulatory approval of APR-246, and any related restrictions, limitations and/or warnings in the label of APR-246; |
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the scope of protection we are able to establish and maintain for intellectual property rights covering APR-246; |
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potential claims relating to our intellectual property and third-party intellectual property; |
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the duration of our intellectual property estate that will provide protection for APR-246; |
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developments relating to our competitors and our industry; |
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our sales, marketing or distribution capabilities and our ability to commercialize APR-246, if we obtain regulatory approval; |
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current and future agreements with third parties in connection with the manufacturing, commercialization, packaging and distribution of APR-246; |
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our expectations regarding the ability of our current contract manufacturing partners to produce APR-246 in the quantities and timeframe that we will require; |
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our expectations regarding our future costs of goods; |
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our ability to generate sufficient or positive preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials of APR-548; |
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business interruptions, including delays in enrollment, patient follow-up and data collection of clinical trials, resulting from epidemic or pandemic disease outbreak, including those related to the novel coronavirus, COVID-19; |
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our ability to attract, retain and motivate key personnel and increase the size of our organization; |
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our ability to establish collaborations in lieu of obtaining additional financing; |
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the impact of government laws and regulations; |
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our financial performance; and |
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our expectations regarding the time during which we will be an emerging growth company under the JOBS Act or a smaller reporting company under the Exchange Act. |