CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying base prospectus and the documents that we incorporate by reference herein and therein, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 2 IE of the Exchange Act. Any statements in this prospectus supplement, the accompanying base prospectus and the documents that we incorporate by reference herein and therein about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as “believe,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and “would.” For example, statements concerning financial condition, possible or assumed future results of operations, growth opportunities, industry ranking, plans and objectives of management, markets for our common stock and future management and organizational structure are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from any results, levels of activity, performance or achievements expressed or implied by any forward-looking statement.
Any forward-looking statements are qualified in their entirety by reference to the risk factors discussed throughout this prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include, but are not limited to:
•
our sales strategy for IGALMI™;
•
strategy relating to, anticipated benefits from, and cost savings from our strategic reprioritization of our commercialization and development efforts;
•
our ability to raise additional capital and continue as a going concern;
•
developments relating to our TRANQUILITY program;
•
the size of our total addressable markets and related underlying estimates;
•
our plans relating to clinical trials and marketing applications for our product candidates;
•
our plans to research, develop and commercialize our current and future product candidates;
•
our plans to seek to enter into collaborations for the development and commercialization of certain product candidates;
•
the potential benefits of any future collaboration;
•
the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;
•
the timing of and results of discussions we have with regulators;
•
the rate and degree of market acceptance, clinical utility, number of prescribers and formulary wins of IGALMITM and any product candidates for which we receive marketing approval;
•
our commercialization, marketing and manufacturing capabilities and strategy, including the potential benefits from any advertising campaigns;
•
our participation in, and any potential benefits from, events, conferences, presentations and conventions;
•
our intellectual property position and strategy;
•
our estimates regarding expenses, future revenue, capital requirements and need for additional financing;
•
potential investments in, or other strategic options for, our subsidiary, OnkosXcel;
•
developments relating to our competitors and our industry;
•
compliance with covenants under our financing arrangements;