Item 7.01.Regulation FD Disclosure.
As of
This information, including the Exhibit attached hereto, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K and oral statements made with respect to
information contained in this report may contain certain disclosures that
contain "forward-looking statements," including, without limitation, statements
regarding the success, cost and timing of our product development activities and
clinical trials, our plans to research, develop and commercialize our product
candidates, our plans to submit regulatory filings, and our ability to obtain
and retain regulatory approval of our product candidates. You can identify
forward-looking statements because they contain words such as "believes,"
"will," "may," "aims," "plans," "model," and "expects." Forward-looking
statements are based on the Company's current expectations and
assumptions. Because forward-looking statements relate to the future, they are
subject to inherent uncertainties, risks, and changes in circumstances that may
differ materially from those contemplated by the forward-looking statements,
which are neither statements of historical fact nor guarantees or assurances of
future performance. Important factors that could cause actual results to differ
materially from those in the forward-looking statements include, but are not
limited to, (i) the timing, costs, conduct, and outcome of our clinical trials
and future preclinical studies and clinical trials, including the timing of the
initiation and availability of data from such trials; (ii) the timing and
likelihood of regulatory filings and approvals for our product candidates; (iii)
whether regulatory authorities determine that additional trials or data are
necessary in order to obtain approval; (iv) the potential market size and the
size of the patient populations for our product candidates, if approved for
commercial use, and the market opportunities for our product candidates; and (v)
other factors set forth in the Company's filings with the
Item 9.01.Financial Statements and Exhibits.
Exhibit Number Description 99.1* Company slides. Cover Page Interactive Data File (embedded within the Inline XBRL 104 document). * Furnished herewith.
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