Nasdaq's Listing and Hearing Review Council Stays Panel Determination Requiring Jaguar Health's Compliance with the Bid Price Requirement by December 23, 2020

Rhea-AI Summary

Jaguar Health, Inc. (JAGX) has received notice from the Nasdaq Listing Council regarding its compliance with the $1.00 minimum bid price requirement. The Council will review the decision made by the Nasdaq Listing Qualifications Panel, which granted Jaguar until December 23, 2020, to remedy the bid price deficiency. The Listing Council has stayed the Panel's decision during its review. CEO Lisa Conte expressed optimism, citing efforts to improve financial prospects through expanded patient access programs and a recent $6 million capital infusion.

Positive

• Received $6 million royalty-based capital infusion to bolster financial position.
• Initiated pivotal Phase 3 clinical trial for crofelemer targeting cancer therapy-related diarrhea.

Negative

• Pending compliance with Nasdaq's minimum bid price requirement raises uncertainty.
• Only granted an extension until December 23, 2020, which may not be sufficient to regain compliance.

The Nasdaq Listing Council, on its own motion, will consider if the Company should have been granted a longer period within which to evidence compliance with the $1.00 per share minimum bid price requirement

SAN FRANCISCO, CA / ACCESSWIRE / December 7, 2020 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that the Company received an unsolicited letter on December 2, 2020 from the Office of Appeals and Review of The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Nasdaq Listing and Hearing Review Council (the "Listing Council") had exercised its discretion to call for review the October 28, 2020 decision of the Nasdaq Listing Qualifications Panel (the "Panel"). By its decision, the Panel granted the Company an extension to remedy the bid price deficiency, but only through December 23, 2020. Pursuant to the Nasdaq Listing Rules, the Panel had the discretion to grant Jaguar an extension through March 10, 2021.

The Listing Council stated that it will consider whether the Panel should have granted Jaguar a longer period to regain compliance with the bid price requirement and that, during the pendency of the Listing Council's review, the terms of the Panel's October 28, 2020 decision have been stayed.

"We were very happy to learn that the Listing Council has exercised its discretion to review the Panel's decision," Lisa Conte, Jaguar's president, and CEO said. "We believe our efforts since the second quarter of 2020 to implement our expanded patient access programs for Mytesi^® (crofelemer) and our focus on long-term investors and non-dilutive financings, including our recent royalty-based capital infusion of $6.0 million, are improving our long-term financial prospects. Additionally, with the initiation this past October by our wholly-owned subsidiary, Napo Pharmaceuticals, Inc., of the pivotal Phase 3 clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy ("cancer therapy‑related diarrhea" (CTD)), and our recently announced plans to develop and commercialize crofelemer for the possible 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 - we believe the value generated in the Company will be realized as we work to regain compliance with the Nasdaq bid price requirement."

About Jaguar Health, Inc. and Napo Pharmaceuticals, Inc.

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, specifically chronic, debilitating diarrhea. Our wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from 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 and the only oral plant-based prescription medicine approved under FDA Botanical Guidance.

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

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.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding the anticipated date of the Company's receipt of the Listing Counsel's decision, the belief that the Company's efforts since the second quarter of 2020 to implement the expanded patient access programs for Mytesi, and Jaguar's focus on long-term investors and non-dilutive financings, including the Company's recent royalty-based capital infusion of $6.0 million, are improving Jaguar's long-term financial prospects, and the belief that with the initiation, this past October by Napo of the pivotal Phase 3 clinical trial of crofelemer (Mytesi) for CTD, and the Company's plans to develop and commercialize crofelemer for the possible 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 value generated in the Company will be realized as Jaguar plans to regain compliance with the Nasdaq minimum bid price requirement. 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.

CONTACT:
Peter Hodge
Jaguar Health, Inc.
phodge@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

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https://www.accesswire.com/619590/Nasdaqs-Listing-and-Hearing-Review-Council-Stays-Panel-Determination-Requiring-Jaguar-Healths-Compliance-with-the-Bid-Price-Requirement-by-December-23-2020

FAQ

What is the current status of Jaguar Health's compliance with Nasdaq listing requirements?

Jaguar Health is under review by the Nasdaq Listing Council regarding its compliance with the minimum bid price requirement, with a stay on the previous decision until further notice.

What does the $6 million capital infusion mean for Jaguar Health (JAGX)?

The $6 million capital infusion is aimed at improving Jaguar Health's long-term financial prospects and supporting its patient access programs.

What clinical trials is Jaguar Health (JAGX) currently involved in?

Jaguar Health has initiated a pivotal Phase 3 clinical trial for crofelemer aimed at treating cancer therapy-related diarrhea.

When is the deadline for Jaguar Health (JAGX) to comply with Nasdaq's bid price requirement?

Jaguar Health has until December 23, 2020, to remedy the bid price deficiency as per the latest ruling from the Nasdaq Listing Council.