SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All statements contained or incorporated by reference in this prospectus, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding:
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our sales strategy for IGALMI™;
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strategy relating to, anticipated benefits from, and cost savings from our reprioritization of certain indications for BXCL501 and the deprioritization of certain other indications of BXCL501, including as a potential adjunctive treatment for major depressive disorder, as well as our BXCL701 immuno-oncology program;
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developments relating to our SERENITY At-Home and TRANQUILITY In-Care trials;
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our ability to extend our cash runway;
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our plans relating to clinical trials for our product candidates;
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our plans to research, develop and commercialize our current and future product candidates;
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our plans to seek to enter into collaborations for the development and commercialization of certain product candidates;
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the potential benefits of any future collaboration;
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the timing of and our ability to obtain and maintain regulatory approvals, including 505(b)(2) regulatory approval, for our product candidates;
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the rate and degree of market acceptance, clinical utility, number of prescribers and formulary wins of IGALMI and any product candidates for which we receive marketing approval;
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our commercialization, marketing and manufacturing capabilities and strategy, including the potential benefits from any advertising campaigns;
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our participation in, and any potential benefits from, events, conferences, presentations and conventions;
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our intellectual property position and strategy;
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our estimates regarding expenses, future revenue, capital requirements and need for additional financing;
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potential investments in, or other strategic options for, our subsidiary, OnkosXcel Therapeutics, LLC;
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developments relating to our competitors and our industry;
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the impact of government laws and regulations; and
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our relationship with BioXcel LLC.
The foregoing list sets forth some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. You should read this prospectus and the documents incorporated by reference herein completely and with the understanding that our actual future results may be materially different from what we expect. You should assume that the information appearing in this prospectus is accurate as of the date on the front cover of this prospectus only. Because the risk factors referred to in this prospectus and incorporated herein by reference could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you