Napo Pharmaceuticals, a Jaguar Health Family Company, Submits Funding Application to BARDA for Development of NP-300 Drug Candidate for Cholera-Related Diarrhea

• Funding for Phase 1, 2, and 3 trials sought to develop NP-300 to increase American preparedness and response time in event of exposure to cholera due to bioterrorism or advancement of cholera into US territories due to global warming
• Cholera is an acute diarrheal illness caused by infection of the intestine with the bacterium Vibrio cholerae
• Jaguar to present August 10th at Emerging Growth Conference; Individual and institutional investors as well as advisors, analysts, and members of the financial media are invited to attend Jaguar's real-time interactive presentation

SAN FRANCISCO, CA / ACCESSWIRE / August 9, 2023 / Napo Pharmaceuticals Inc. (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) family company, today announced that it has submitted a Stage 1 funding application to the Biomedical Advanced Research and Development Authority (BARDA) for development of NP-300, the company's novel drug product candidate for the symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, from bacterial, viral and parasitic infections including Vibrio cholerae, the bacterium that causes cholera. BARDA, part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, supports advanced research and development of medical countermeasures and is a component of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).

"We are seeking funding from BARDA to help fund the Phase 1, Phase 2, and Phase 3 studies for development of NP-300 with an eye toward increasing American preparedness and response time in the event of exposure to cholera due to bioterrorism or the advancement of cholera into U.S. territories due to global warming," said Steve King, PhD, Jaguar's Chief Sustainable Supply, Ethnobotanical Research, and IP Officer. "If BARDA expresses interest in this initiative, the next step would be for Napo to proceed to Stage 2 of the application process, which would involve submitting a full proposal to BARDA."

As announced, Napo's Investigational New Drug (IND) application for NP-300 was activated by the U.S. Food and Drug Administration (FDA) in September 2022. In support of the IND application filing, the company received partial financial support for certain IND-enabling preclinical toxicity studies from the National Institute of Allergy and Infectious Diseases (NIAID). NIAID is part of the National Institutes of Health.

Although cholera is an orphan indication in the US, it is estimated that, worldwide, 1.3 to 4 million cholera cases and 21,000 to 143,000 cholera-related deaths occur each year, according to the Centers for Disease Control and Prevention of the U.S. Department of Health & Human Services. Approximately one in 10 infected persons will have severe disease characterized by profuse watery diarrhea, vomiting, and leg cramps. In these people, rapid loss of body fluids leads to dehydration and shock. Without treatment, death can occur within hours. Cholera is now endemic in many countries outside the U.S. The largest cholera outbreak in recorded history occurred recently in Yemen. According to Oxfam, the number of cholera cases in Yemen in 2019 was the second largest ever recorded in a country in a single year, surpassed only by the numbers in Yemen in 2017.

NP-300 is a novel oral drug product that is sustainably derived from the Croton lechleri tree, the same source as that for crofelemer, and is planned to be developed under the FDA's Botanical Guidance. As stated on the FDA's website, crofelemer is currently one of only two drugs that have been approved under the FDA's Botanical Guidance definition of a botanical drug product.

August 10, 2023 Presentation at Emerging Growth Conference

Lisa Conte, Napo and Jaguar's founder, president, and CEO, is presenting virtually at the Emerging Growth Conference on Thursday, August 10, 2023 from 10:50 a.m. - 11:20 a.m. Eastern Daylight Time.

Please click here to register to attend the conference and receive any issued updates. An archived recording of the webcast will be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel.

About the Emerging Growth Conference

The Emerging Growth conference is focused on companies in a wide range of growth sectors, with strong management teams, innovative products and services, focused strategy, execution, and the overall potential for long term growth. The conference audience includes individual and institutional investors, as well as investment advisors and analysts.

About Jaguar Health, Napo Pharmaceuticals & Jaguar Animal Health

Jaguar Health is a commercial stage pharmaceuticals company focused on developing novel, plant-based, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar company Napo Pharmaceuticals 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 Animal Health is a tradename of Jaguar Health.

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 company management will present at the Emerging Growth Conference August 10, 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.

Contact:
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SOURCE: Jaguar Health, Inc.

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