Item 8.01 Other Events.
On
Forward-Looking Statements
This Current Report on Form 8-K contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995 that involve
substantial risks and uncertainties, including statements regarding the
development status of the Company's product candidates and the timing of
availability of clinical trial data. All statements, other than statements of
historical facts, contained in this Current Report on Form 8-K, including
statements regarding the Company's strategy, future operations, future financial
position, prospects, plans and objectives of management, are forward-looking
statements. The words "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict," "project," "should,"
"target," "will," "would" and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements contain
these identifying words. Any forward-looking statements are based on
management's current expectations of future events and are subject to a number
of risks and uncertainties that could cause actual results to differ materially
and adversely from those set forth in, or implied by, such forward-looking
statements. These risks and uncertainties include, but are not limited to, risks
relating to the COVID-19 pandemic; risks associated with Fulcrum's ability to
obtain and maintain necessary approvals from the FDA and other regulatory
authorities; continue to advance its product candidates in clinical trials;
replicate in later clinical trials positive results found in preclinical studies
and early-stage clinical trials of losmapimod and its other product candidates;
advance the development of its product candidates under the timelines it
anticipates in current and future clinical trials; obtain, maintain or protect
intellectual property rights related to its product candidates; manage expenses;
and raise the substantial additional capital needed to achieve its business
objectives. For a discussion of other risks and uncertainties, and other
important factors, any of which could cause the Company's actual results to
differ from those contained in the forward-looking statements, see the "Risk
Factors" section, as well as discussions of potential risks, uncertainties and
other important factors, in the Company's most recent filings with the
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