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EX-99.1 - EX-99.1 - Jaguar Health, Inc. | a21-2731_1ex99d1.htm |
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 |
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001-36714 |
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46-2956775 |
(State or other jurisdiction of |
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(Commission File Number) |
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(IRS Employer Identification No.) |
200 Pine Street, Suite 400 |
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94104 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants 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 |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, Par Value $0.0001 Per Share |
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JAGX |
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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 Companys 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 Companys full pipeline of potential crofelemer follow-on indications, and lechlemer, the Companys 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 Companys 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 Companys 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 Companys 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 Managements Discussion and Analysis of Financial Condition and Results of Operations, as well as the Companys 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. |
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Description |
99.1 |
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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.
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JAGUAR HEALTH, INC. | ||
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By: |
/s/ Lisa A. Conte | |
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Name: |
Lisa A. Conte |
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Title: |
President and Chief Executive Officer |
Date: January 11, 2021