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): October 29, 2018

 

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.)

 

201 Mission Street, Suite 2375
San Francisco, California

 

94105

(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

 

 

 


 

Item 7.01.                                        Other Events.

 

On October 29, 2018, Jaguar Health, Inc. (the “Company”) issued a press release announcing that it will conduct a conference call on Thursday, November 15, 2018 at 8:00 a.m. ET / 5:00 a.m. PT to discuss third quarter 2018 results and current and planned commercial, educational and product development activities related to Mytesi (crofelemer), the Company’s first-in-class, FDA-approved anti-secretary human prescription drug, and conduct an education session regarding the distinct first-in-class mechanism of action of Mytesi.

 

A copy of the press release is furnished as Exhibit 99.1 to this report.

 

Item 9.01   Financial Statements and Exhibits

 

(d)  Exhibits

 

Exhibit No.

 

Description

99.1

 

Press Release, dated October 29, 2018.

 

2


 

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.

 

 

Date: October 29, 2018

By:

/s/ Karen S. Wright

 

Name: Karen S. Wright

 

Title: Chief Financial Officer

 

3


Exhibit 99.1

 

Jaguar Health, Inc. Expects to File Third-Quarter 2018 Financial Results November 14th

 

Company to Host Conference Call Thursday, November 15, 2018 at 8:00 a.m. Eastern Time to Review Q3 Results and Provide Updates Regarding Mytesi® Commercial, Educational & Product Development Activities

 

San Francisco, CA (October 29, 2018): Jaguar Health, Inc. (NASDAQ: JAGX) (“Jaguar” or the “Company”), a commercial stage pharmaceutical company focused on developing novel, sustainably derived gastrointestinal products on a global basis, today announced that it expects to file its third-quarter 2018 financial results on Wednesday, November 14, 2018 on Form 10-Q with the U.S. Securities and Exchange Commission. The Company will host a conference call on Thursday, November 15, 2018 at 8:00 a.m. Eastern Time to discuss third-quarter results as well as current and planned commercial, educational and product development activities related to Mytesi (crofelemer), Jaguar’s first-in-class, FDA-approved anti-secretory human prescription drug. The call will also include an education session conducted by Dr. Pravin Chaturvedi regarding the distinct first-in-class mechanism of action of Mytesi. Dr. Chaturvedi is the Company’s chief scientific officer and chair of the Company’s Scientific Advisory Board.

 

Dial-In Instructions for Conference Call on November 15, 2018 at 8:00 a.m. Eastern Time Investors interested in listening to the live call should dial 800-289-0438 (Toll Free), 323-794-2423 (International). Please ask the operator to connect you to the call or provide the conference ID number: 3492327. A live webcast of the conference call will be available online which can be accessed on the investor relations section of the Jaguar website (click here). Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

 

For interested individuals unable to join the conference call, a replay of the webcast will be available on the investor relations section of Jaguar’s website (click here) for one year following the call. Also, a dial-in replay of the call will be available through November 29, 2018, at 844-512-2921 (U.S. Toll Free) or 412-317-6671 (International). Participants must use the following code to access the dial-in replay of the call: 3492327.

 

About Mytesi®

 

Mytesi® (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi®. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).

 

More information and complete Prescribing Information are available at Mytesi.com. Crofelemer, the active ingredient in Mytesi®, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

 


 

About Jaguar Health, Inc.

 

Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis. Our wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

 

For more information about Jaguar, please visit jaguar.health. For more information about Napo, visit napopharma.com.

 

Forward-Looking Statements

 

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expectation that Jaguar will file its third-quarter 2018 financial results on Wednesday, November 14, 2018 on Form 10-Q with the U.S. Securities and Exchange Commission, and the expectation that the Company will host a conference call on Thursday, November 15, 2018. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

 

Source: Jaguar Health, Inc.

 

Contact:

Peter Hodge

Jaguar Health, Inc.

phodge@jaguar.health

 

Jaguar-JAGX