Jaguar Health Meets Financial Condition for Sale of Royalty Rights for Mytesi (Crofelemer) Indications

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) announced that it has met the financial condition for an initial $5 million tranche of a potential $16 million non-dilutive royalty financing transaction. This financing is designed to support its development pipeline, particularly funding a pivotal clinical trial for Mytesi (crofelemer) aimed at treating cancer therapy-related diarrhea. The company has initiated an at-the-market program with Ladenburg Thalmann for future financing needs and anticipates the trial to start in Q4 2020.

Positive

• Initial $5 million tranche of non-dilutive financing supports development pipeline.
• Anticipated $16 million total financing could cover costs related to pivotal trial for Mytesi.

Negative

• None.

Financial Condition for Initial $5 Million Tranche of Potential $16 Million Non-dilutive Financing Transaction Achieved through the Establishment of an At-the-Market Program Yesterday for Potential Future Financing Needs, if Any, with Ladenburg Thalmann

Aggregate Royalty Proceeds of Potential $16 Million Transaction Will Support Jaguar's Development Pipeline and Are Expected to Cover Pivotal Clinical Trial of Mytesi for Cancer Therapy-Related Diarrhea (CTD)

Crofelemer, the Active Ingredient in Mytesi and the Only Oral Plant-based Medicine Approved Under FDA's Botanical Guidance, Highlighted as Responsibly Sourced with Multiple Potential Uses in October 2 New York Times Special Opinion Section on "The Amazon has Seen our Future"

Jaguar Management to Present Thursday, October 8^th, at Lytham Partners Virtual Investor Growth Conference

SAN FRANCISCO, CA / ACCESSWIRE / October 6, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the company has met the financial condition for the initial $5 million tranche of the previously announced non-dilutive royalty financing transaction - which has the potential to total $16 million - involving the sale of royalty rights related to the future revenue stream for the company's FDA-approved drug product, Mytesi^® (crofelemer). Per the term sheet related to the transaction, the term sheet becomes binding with respect to the initial $5 million tranche upon agreement on final documents, with potential aggregate gross proceeds of $16.0 million upon mutual agreement of the parties to consummate two additional tranches of royalty financing. The financial condition was met yesterday as a result of the company putting in place an at-the-market program [ATM] for potential future financing needs, if any, with Ladenburg Thalmann & Co. Inc. As of the date hereof, no shares have been issued under the ATM program. Ladenburg is unrelated to the lender involved in the royalty transaction.

"We are extremely pleased to have met the financial condition for the initial $5 million tranche of this non-dilutive royalty transaction by putting in place an ATM program for potential future activity, not issuing any shares at this time. Upon mutual agreement, as we announced last week, Jaguar and the lender may agree to consummate additional non-dilutive royalty financings of $5 million and $6 million in February 2021 and July 2021, respectively, for a total of $16.0 million," said Lisa Conte, Jaguar's president and CEO. "We intend to use the proceeds to support advancement of regulatory activities associated with our pipeline, including funding the pivotal trial for our lead product candidate, crofelemer, for cancer therapy-related diarrhea (CTD). The trial is expected to initiate in the fourth quarter of 2020. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., has contracted with the primary clinical research organization that will support the trial, and we believe the proceeds from the aggregate royalty financing will cover anticipated trial-related costs."

"The Amazon has Seen our Future"

A special section in the October 2^nd edition of The New York Times titled "The Amazon has Seen our Future…Could the Amazon Save Your Life? The World's Medicine Chest is on Fire, and We Don't Even Know What's Inside it Yet" includes an opinion piece written by Dr. Mark J. Plotkin, an ethnobotanist who has spent more than three decades working in the Amazon. Dr. Plotkin discusses the value of crofelemer and the risk that humanity's ongoing destruction of the Amazon Rainforest poses for the discovery and development of other potential plant-based medicines. The article references the fact that crofelemer was approved by the U.S. Food and Drug Administration as the first antidiarrheal drug for HIV/AIDS patients, and mentions that the plant-based non-opioid drug is currently being evaluated for chemotherapy-induced diarrhea as well as other potential applications. The article can be viewed by clicking here.

"We are very pleased that Dr. Plotkin noted not only the value of crofelemer but also the power of Indigenous medicinal knowledge, and the importance of corporate responsibility from the standpoint of sustainable harvesting and the sharing of benefits with Indigenous and local communities," commented ethnobotanist Steven King, PhD, Jaguar's chief sustainable supply, ethnobotanical research & IP officer. "Referencing crofelemer, Dr. Plotkin states a fact that everyone at Jaguar Health and Napo are very proud of: ‘Every effort is being made to share the benefits of this drug with local communities, including generating employment through reforestation. This type of reciprocity, absent in most previous efforts where pharmaceuticals were developed from Indigenous rainforest societies, should be mandatory for all similar efforts going forward.'"

Jaguar Management to Present Thursday, October 8th at Lytham Partners Virtual Investor Growth Conference

Lisa Conte is scheduled to participate in a virtual presentation and fireside chat at the October 2020 Lytham Partners Virtual Investor Growth Conference on October 8, 2020 at 11:00 a.m. Eastern Time.

A webcast of the presentation can be accessed at https://www.webcaster4.com/Webcast/Page/2516/37791 or www.lythampartners.com/virtual. A replay of the presentation will be available following the event.

Management will also be participating in virtual one-on-one meetings. To arrange a meeting, please contact Lytham Partners at 1x1@lythampartners.com or visit www.lythampartners.com/virtual.

Mytesi is a non-opiate, plant-based, chloride ion channel modulating antidiarrheal medicine that is FDA approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy. The only oral plant-based prescription medicine approved under FDA Botanical Guidance, Mytesi has a novel mechanism of action that works locally in the gut by gently and effectively modulating and normalizing the flow of water and electrolytes with minimal systemic absorption.

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 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 use of proceeds, the expectation that the CTD trial will initiate in the fourth quarter of 2020, the expectation that Jaguar and the lender may agree to consummate additional non-dilutive royalty financings of $5 million and $6 million in February 2021 and July 2021, respectively, for a total of $16.0 million, and the belief that the proceeds from the aggregate royalty financing will cover costs related to the CTD trial. 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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FAQ

What is the significance of the $5 million tranche for JAGX?

The $5 million tranche is part of a larger potential $16 million non-dilutive financing that supports Jaguar Health's development activities, including a pivotal trial for Mytesi.

When is the pivotal trial for Mytesi expected to start?

The pivotal trial for Mytesi is expected to initiate in the fourth quarter of 2020.

Who is involved in the financing transaction for Jaguar Health?

The financing transaction involves Ladenburg Thalmann, which has helped establish an at-the-market program for potential future financing.

What will the funds from the financing be used for?

The funds will be used to support regulatory activities and costs associated with the pivotal trial for Mytesi.

What is Mytesi used for?

Mytesi (crofelemer) is FDA-approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.