FORWARD-LOOKING STATEMENTS
This prospectus and the information incorporated by reference herein and therein include “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements, other than statements of historical facts, contained or incorporated by reference in this prospectus, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, clinical development programs, regulatory filings and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
These forward-looking statements include, among other things, statements about:
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our expectations regarding the potential significance of the results from the Phase 1a clinical trial of STAR-0215;
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our expectations regarding the timing, nature, goals and results of the ALPHA-STAR Phase 1b/2 clinical trial of STAR-0215, including the expected timing of release of proof-of-concept data from such trial, and that favorable results from such trial could allow us to move directly into a Phase 3 pivotal trial of STAR-0215 as a potential treatment for hereditary angioedema (“HAE”);
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our expectations about the design and anticipated timing of a Phase 3 pivotal trial for STAR-0215 as a potential treatment for HAE, assuming positive data from the Phase 1b/2 trial;
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our expectations about the unmet medical need for HAE, the potential differentiating attributes of STAR-0215 as a potential treatment for HAE, along with the potential market impact of such differentiation, the potential of STAR-0215 to be a best-in-class monoclonal antibody inhibitor of plasma kallikrein able to provide long-acting, effective attack prevention for HAE, and our vision for STAR-0215 to become the first-choice preventative treatment for HAE with administration every three or six months with the goal of normalizing the lives of people living with HAE;
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the nature and anticipated growth of the global HAE market and HAE therapies;
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our plans to optimize the formulation of STAR-0215 and corresponding work to develop a drug-device combination for STAR-0215 for potential use in late-stage clinical trials and commercially, if approved;
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our expectations that we have scaled the manufacturing process for STAR-0215 in a manner to generate sufficient material for our planned STAR-0215 nonclinical and clinical studies;
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the potential therapeutic benefits and potential attributes of STAR-0310, a preclinical stage product candidate which we licensed in October 2023, and our plans to develop STAR-0310 as a treatment for atopic dermatitis (“AD”);
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our expectations regarding the timing of regulatory submissions for STAR-0310;
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our expectations about the design and anticipated timing of planned clinical trials of STAR-0310;
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our expectations regarding the timing and nature of anticipated data for planned clinical trials of STAR-0310;
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the potential commercial opportunity for STAR-0310 in AD and the likelihood that it can effectively compete in AD, assuming it is approved;
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the estimated size and anticipated growth of the AD market and the need for treatments for AD;
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the potential to pursue the development of STAR-0310 in additional indications;
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our goals and visions for the STAR-0310 program;
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our expectations regarding our ability to expand our pipeline;
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the potential benefits of any future acquisition, in-license, collaboration or preclinical development activities;
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our manufacturing plans, capabilities and strategy;
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our intellectual property position and strategy;