Item 8.01 Other Events.
Recently, the Company became aware that one of its contract manufacturers of
MAT9001 suffered an explosion at its manufacturing facilities in
Forward-Looking Statements
This Report on Form 8-K contains "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995, including those
relating to the impact of the damage to one of the Company's contract
manufacturers of MAT9001 and potential impact on the commencement of the
Company's Phase 3 AMPLIFY trial, and other statements that are predictive in
nature, that depend upon or refer to future events or conditions. All statements
other than statements of historical fact are statements that could be
forward-looking statements. Forward-looking statements include words such as
"expects," "anticipates," "intends," "plans," "could," "believes," "estimates"
and similar expressions. These statements involve known and unknown risks,
uncertainties and other factors which may cause actual results to be materially
different from any future results expressed or implied by the forward-looking
statements. Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our ability to obtain additional
capital to meet our liquidity needs on acceptable terms, or at all, including
the additional capital which will be necessary to complete the clinical trials
of our product candidates; our ability to successfully complete research and
further development and commercialization of our product candidates; the
uncertainties inherent in clinical testing; the timing, cost and uncertainty of
obtaining regulatory approvals; our ability to protect the Company's
intellectual property; the loss of any executive officers or key personnel or
consultants; competition; changes in the regulatory landscape or the imposition
of regulations that affect the Company's products; and the other factors listed
under "Risk Factors" in our filings with the
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