Item 7.01 Regulation FD Disclosure.
On January 11, 2021, Jaguar Health, Inc. (the "Company") issued a press release
announcing its plans to explore the possibility of obtaining conditional
marketing authorization in Europe to support development and commercialization
of crofelemer, the Company's novel proprietary drug, for the proposed indication
of prophylaxis and/or symptomatic relief of inflammatory diarrhea, initially to
be studied in a "long-hauler" COVID-19 recovery patient population in Europe
(the "COVID-related indication"). The Company also announced that it will
conduct a conference call on Thursday, January 14, 2021 at 11:30 a.m. ET / 8:30
a.m. PT to provide updates on the status of the proposed COVID-related
indication for crofelemer, the Company's full pipeline of potential crofelemer
follow-on indications, and lechlemer, the Company's second generation
anti-secretory drug product candidate for the symptomatic relief of diarrhea in
cholera patients. A copy of the press release is furnished as Exhibit 99.1.
The information under Item 7.01 and in Exhibit 99.1 to this Current Report on
Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the
Securities and Exchange Act of 1934, or otherwise subject to the liabilities
thereof, nor shall it be deemed to be incorporated by reference in any filing
under the Securities and Exchange Act of 1934 or under the Securities Act of
1933, except to the extent specifically provided in any such filing.
This Current Report on Form 8-K contains "forward-looking" statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, including statements related to the Company's
plan to explore the possibility of obtaining conditional marketing authorization
in Europe to support development and commercialization of the COVID-related
indication for crofelemer. The words "may," "will," "could," "would," "should,"
"expect," "intend," "plan," "anticipate," "believe," "estimate," "predict,"
"project," "potential," "continue," "ongoing" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. While the Company
believes its plans, intentions and expectations reflected in those
forward-looking statements are reasonable, these plans, intentions or
expectations may not be achieved. The Company's actual results, performance or
achievements could differ materially from those contemplated, expressed or
implied by the forward-looking statements. For information about the factors
that could cause such differences, please refer to the Company's Annual Report
on Form 10-K for the year ended December 31, 2019, including the information
discussed under the captions "Item 1 Business," "Item 1A. Risk Factors" and
"Item 7 Management's Discussion and Analysis of Financial Condition and Results
of Operations," as well as the Company's various other filings with the SEC.
Given these uncertainties, you should not place undue reliance on these
forward-looking statements. The Company assumes no obligation to update any
forward-looking statement.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press Release, dated January 11, 2021
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