8-K 1 a21-2731_18k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): January 11, 2021

 


 

JAGUAR HEALTH, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-36714

 

46-2956775

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

200 Pine Street, Suite 400
San Francisco, California

 

94104

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (415) 371-8300

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, Par Value $0.0001 Per Share

 

JAGX

 

The Nasdaq Capital Market

 

 

 


 

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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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

JAGUAR HEALTH, INC.

 

 

 

 

By:

/s/ Lisa A. Conte

 

 

Name:

Lisa A. Conte

 

 

Title:

President and Chief Executive Officer

 

 

Date: January 11, 2021

 

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