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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): November 8, 2023
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 November 8, 2023, 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 May 6, 2024, 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 May 12, 2023, 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 May 6, 2024 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 November 8, 2023, 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
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: November 8, 2023
Exhibit 99.1
Jaguar Health
Receives Additional 180-day Grace Period to Regain Compliance with Nasdaq’s Bid Price Rule
San Francisco, CA (November 8, 2023):
Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced that on November 8, 2023 the Company
received formal notice that the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC has granted Jaguar
an additional 180-day grace period, through May 6, 2024, to regain compliance with the $1.00 bid price requirement for continued listing
on The Nasdaq Capital Market. The Staff noted that the Company meets all other applicable requirements for initial and 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 May 6, 2024.
“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.
“Our paramount near-term clinical activity is our Phase 3 pivotal OnTarget trial of Mytesi for the follow-on indication of the
preventative treatment of cancer therapy-related diarrhea, an indication we also refer to as chemotherapy-induced overactive bowel (CIOB)
– which includes symptoms such as chronic debilitating diarrhea, GI urgency, and GI incontinence. Top line results from this pivotal
study are expected before Thanksgiving.”
Jaguar is supporting investigator-initiated
and investigator IND proof-of-concept studies of crofelemer for the rare disease indications of microvillus inclusion disease (MVID)
and short bowel syndrome (SBS) with intestinal failure in the US, EU and Middle East/North Africa (MENA) regions, with results expected
before the end of 2023 and in 2024. In accordance with the guidelines of specific EU countries, published data from such clinical investigations
could support reimbursed early patient access to crofelemer for SBS or MVID for these debilitating conditions.
Crofelemer has been granted Orphan Drug
Designation (ODD) by the FDA and the European Medicines Agency (EMA) for both MVID and SBS with intestinal failure. The ODD programs
in the U.S. and European Union qualify sponsors to receive potential incentives to develop therapies for the diagnosis, prevention, or
treatment of rare diseases or conditions.
About the Jaguar Health Family of
Companies
Jaguar Health, Inc. (Jaguar) is a commercial
stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest
areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such
as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses
on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal
symptoms across multiple complicated disease states. Napo Pharmaceuticals’ crofelemer drug product candidate is the subject of
the OnTarget study, an ongoing pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB)
in adults with cancer on targeted therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan,
Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health
is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s
Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health
indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Visit Jaguar on LinkedIn: https://www.linkedin.com/company/jaguar-health/
Visit Jaguar on X: https://twitter.com/Jaguar_Health
Visit Jaguar on Instagram: https://www.instagram.com/jaguarhealthcommunity/
Forward-Looking Statements
Certain statements in this press release
constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that top line results
of the OnTarget study will be available before Thanksgiving 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:
hello@jaguar.health
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