FORWARD-LOOKING STATEMENTS
This prospectus includes and incorporates by reference “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and releases issued by the SEC and within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. All statements other than statements of historical fact are “forward-looking statements” for purposes of this prospectus. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “project,” “continue,” “potential,” “ongoing,” “goal,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
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our ability to continue to operate as an integrated company subsequent to our acquisition of Atrin Pharmaceuticals Inc.;
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estimates of our expenses, capital requirements and our needs for additional financing;
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business interruptions, including delays in enrollment, patient follow-up and data collection of clinical trials, resulting from a public health emergency or pandemic;
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the prospects of our product candidates, all of which are still in development;
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outcome and results of ongoing or future preclinical studies and clinical trials of our product candidates;
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our expectations regarding our ability to identify, discover or acquire additional suitable product candidates;
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the design of our ongoing and planned clinical trials, including the sample size, trial duration, endpoint definition, event rate assumptions and eligibility criteria;
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our ability to enroll patients in clinical trials, to timely and successfully complete those trials and to receive necessary regulatory approvals;
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our expectations regarding the timing of initiation of data readout from our clinical trials;
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market acceptance or commercial success of any product candidate we develop and the degree of acceptance among physicians, patients, patient advocacy groups, healthcare payors and the medical community;
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our expectations regarding competition, potential market size, the size of the patient populations for our product candidates, if approved for commercial use, and market acceptance;
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our ability to obtain regulatory approval of our product candidates, and any restrictions, limitations and/or warnings in their labels, if approved;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates;
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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 our product candidates;
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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 our product candidates, if we obtain regulatory approval;
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current and future agreements with third parties in connection with conducting clinical trials, as well as the manufacturing of our product candidates;
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our expectations regarding the ability of our current contract manufacturing partners to produce our product candidates 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 attract, retain and motivate key personnel and increase the size of our organization;