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the success, cost and timing of our product development activities and clinical trials, including statements regarding the timing of our ongoing Phase 3 clinical trial of nirogacestat, the initiation of our planned Phase 2b clinical trial of mirdametinib and the initiation and completion of any other clinical trials and related preparatory work, the expected timing of the availability of results of the clinical trials and the potentially registrational nature of the single Phase 3 clinical trial and the Phase 2b clinical trial; |
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the potential attributes and benefits of our product candidates; |
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our plans to commercialize any of our product candidates that achieve approval either alone or in partnership with others; |
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our ability to obtain funding for our operations, including funding necessary to complete further development of our product candidates, and if approved, commercialization; |
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the period over which we anticipate our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements; |
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the potential for our business development efforts to maximize the potential value of our portfolio; |
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our ability to identify, in-license or acquire additional product candidates; |
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the ability and willingness of our third-party collaborators to continue research and development activities relating to our product candidates that we are developing as combination therapies; |
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our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings in the label of an approved product candidate; |
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the potential benefit of Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation for nirogacestat, mirdametinib and any other of our product candidates that may receive one or more of these designations; |
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our ability to compete with companies currently marketing or engaged in the development of treatments for desmoid tumors or NF1-PN; |
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our expectations regarding our ability to obtain and maintain intellectual property protection or market exclusivity for our product candidates and the direction of such protection; |
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our ability and the potential to successfully manufacture our product candidates for preclinical studies, clinical trials and, if approved, for commercial use, the capacity of our current contract manufacturing organizations, or CMOs, to support clinical supply and commercial-scale production for product candidates and our potential election to pursue additional CMOs for manufacturing supplies of drug substance and finished drug product in the future; |
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the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others; |
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the rate and degree of market acceptance of our product candidates, if approved; |
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regulatory developments in the United States and foreign countries; |
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our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
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the success of competing products that are or may become available; |
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our ability to attract and retain key scientific, medical, commercial or management personnel; |
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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and |
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our expectations regarding the time during which we will continue to be an emerging growth company or smaller reporting company as defined in federal securities regulations;. |
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our financial performance; and |
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developments and projections relating to our competitors or our industry. |