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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): August 18, 2022

 

 

 

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):

 

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

 

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

 

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

 

¨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 ¨

 

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.  ¨

 

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 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

 

On August 18, 2022, Jaguar Health, Inc. (the “Company”) received a notification letter from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it had been granted an additional 180 days, or until February 13, 2023, to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Marketplace Rule 5550(a)(2), requiring a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”), based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market with the exception of the bid price requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period. 

 

As previously disclosed by the Company in a Current Report on Form 8-K filed on February 18, 2022, the Company received a notification letter from the Staff notifying the Company that, because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive business days, the Company no longer met the Minimum Bid Price Requirement.

 

The Company intends to continue actively monitoring the bid price for its common stock between now and February 13, 2023 and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement.

 

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 the statement that the Company will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. 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, 2022, 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 7.01. Regulation FD Disclosure.

 

On August 19, 2022, the Company issued a press release announcing Nasdaq’s notification letter granting the Company a second 180-day compliance period to meet the Minimum Bid Price Requirement, a copy of which is furnished as Exhibit 99.1.

 

The information in Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference into any of the Company’s filings under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)  Exhibit

 

Exhibit No.   Description
99.1   Press Release, dated August 19, 2022.
104   Cover Page Interactive Data File (embedded within the inline XBRL document)

 

 

 

 

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: August 19, 2022

 

 

 

 

Exhibit 99.1 

 

 

 

Jaguar Health Receives Additional 180-day Grace Period to Regain Compliance with Nasdaq’s Bid Price Rule

 

San Francisco, CA (August 19, 2022): Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced that on August 18, 2022 the Company received formal notice that the Listing Qualifications Staff of The Nasdaq Stock Market LLC has granted Jaguar an additional 180-day grace period, through February 13, 2023, to regain compliance with the $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. To evidence compliance, the Company must report a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days on or before February 13, 2023.

 

"We are pleased to have obtained additional time from Nasdaq to evidence compliance with the bid price requirement," Lisa Conte, Jaguar's president and CEO, said. “Jaguar is focused on two late-stage clinical events in the next approximately 6 to 12 months that we expect to be transformational in terms of value creation and recognition for the Company as we seek to regain compliance with the rule. We anticipate the completion in 2022 of an investigator-initiated proof-of-concept study of crofelemer for short bowel syndrome (SBS), supporting the potential for expanded patient access to crofelemer in Europe in 2023 for this devastating and catastrophic disease. The third-party investigator is targeting the presentation in December 2022 of results from the SBS study at a global GI conference in Dubai. Our second key clinical activity is our Phase 3 pivotal OnTarget trial of crofelemer for our core follow-on indication of prophylaxis of cancer therapy-related diarrhea (CTD). We expect enrollment in this trial to complete in the first half of 2023.”

 

About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals, & Napo Therapeutics

 

Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Animal Health is a tradename of Jaguar Health. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe.

 

For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.

 

 

 

 

 

Forward-Looking Statements

 

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that two late-stage clinical events in the next approximately 6 to 12 months may be transformational in terms of value creation and recognition for Jaguar as the Company seeks to regain compliance with the bid price requirement, Jaguar’s expectation that an investigator-initiated proof-of-concept study of crofelemer for SBS will complete in 2022, supporting the potential for expanded patient access to crofelemer in Europe in 2023 for SBS, the Company’s expectation that the third-party investigator for the SBS study will present the study results in December 2022 at a GI conference in Dubai, and Jaguar’s expectation that enrollment in the Company’s OnTarget trial will complete in the first half of 2023. 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