Jaguar Health, Pipeline Review and Progress

Jaguar Health, Inc. (NASDAQ: JAGX), is a commercial stage natural-products pharmaceuticals company that focuses on developing gastrointestinal products for human prescription use and animals worldwide.

In 2018, the Company’s animal product research and development efforts were intentionally minimal, and Jaguar’s animal-related sales have also been minimal.

On Monday, March 18, 2019, JAGX shares closed at $.47 (+192.64%) on traded volume of 66.3 million shares. While no corporate press releases indicate a reason for the bounce in share price, recent SEC filings indicate significant share activity with the company’s Series A convertible participating preferred stock. The conversion price was recently reduced by a factor of 10.

Although financial figures for the fourth quarter of 2018 have not yet been audited, the Company expects Mytesi gross sales for the fourth quarter to be approximately $2.18 million, and Mytesi net sales to be approximately $1.55 million, representing growth of 37% and 40% in gross and net sales respectively compared to the third quarter of 2018, and an acceleration of the increase of 36% and 28% of gross and net sales respectively that Jaguar achieved in the third quarter of 2018 over the second quarter of 2018. Overall, annual gross sales for 2018 are expected to be approximately $5.726 million, and annual Mytesi net sales for 2018 are expected to be approximately $4.0 million.

In January, JAGX announced that Mytesi® (crofelemer) has been added to the formulary for Florida’s AIDS Drug Assistance Program (ADAP). As a result of this addition, based on data from healthcare research firm Decision Resource Group, approximately 86% of ADAP-eligible US lives now have access to Mytesi, Jaguar’s FDA-approved drug product indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.

ADAPs provide life-saving HIV treatments to low-income, uninsured, and underinsured individuals living with HIV/AIDS in all 50 states and the territories. Annually, ADAPs provide life-saving HIV treatments to more than half a million individuals. Florida’s ADAP is the third largest in the U.S., based on enrollment. Mytesi is now on the ADAP formularies for 30 states, including the five programs with the largest enrollment.

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March 28th, 2019 Regulatory update-

Jaguar Health Issues Regulatory Update Regarding Potential Follow-on Indication for Mytesi

SAN FRANCISCO, CA / ACCESSWIRE / March 28, 2019 / Jaguar Health, Inc. (JAGX) (“Jaguar” or the “Company”), a commercial stage pharmaceutical company focused on developing novel, sustainably derived gastrointestinal products on a global basis, announced today that the Company is scheduled to meet with the U.S. Food & Drug Administration today, March 28, 2019, to discuss Jagaur’s anticipated protocol for the Company’s planned trial to evaluate Mytesi® (crofelemer) for the symptomatic relief of diarrhea related to anticancer drug therapy.

A significant proportion of patients undergoing cancer treatment experience diarrhea. Novel targeted cancer therapy (TCT) agents, such as epidermal growth factor receptor antibodies and tyrosine kinase inhibitors, with or without standard chemotherapy agents, may activate natural chloride secretion pathways in the gastrointestinal mucosa, potentially leading to secretory diarrhea.

For more information about Jaguar, please visit jaguar.health. For more information about Napo, visit napopharma.com.

Full PR- https://finance.yahoo.com/news/jaguar-health-issues-regulatory-regarding-100000434.html

Products

Mytesi® (crofelemer), is a product of Jaguar’s wholly-owned subsidiary Napo Pharmaceuticals, is approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

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.

About

Jaguar Health, Inc., a commercial stage natural-products pharmaceuticals company, focuses on developing gastrointestinal products for human prescription use and animals worldwide. The company, through its wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas. Its human health product pipelines include Mytesi, which is Phase II clinical trial for the treatment of cancer therapy-related diarrhea, as well as for the supportive care for inflammatory bowel disease; formulation of crofelemer that is Phase II clinical trial for the treatment of short bowel syndrome, congenital diarrheal disorders, and irritable bowel syndrome – diarrhea predominant diseases; and SB-300, a second-generation anti-secretory agent for multiple indications, including cholera. The company’s animal health product candidates comprise Canalevia, an animal prescription drug product candidate intended for treatment of various forms of diarrhea in dogs; and Equilevia is Jaguar’s non-prescription product for total gut health in equine athletes. In addition, the company’s products include Neonorm Calf and Neonorm Foal. Jaguar Health, Inc. is headquartered in San Francisco, California.

Financial review

Q3 2018
(In thousands except for percentages) Q3 18 Q3 17 % Change
Gross product sales $ 1,617 $ 473 242 %
Net product revenue $ 1,132 $ 446 154 %
Collaboration income $ $ 655 -100 %
Net income (loss) from operations 6,508 $7,340
                           

Stock influences and risk factors

They expect to incur significant additional costs as they continue commercialization efforts for current prescription drug candidates.

They may be unable to raise such funds when needed and on acceptable terms, which would force them to delay, limit, reduce or terminate one or more of their product development programs.

They currently generate limited revenue from the sale of products and may never become profitable.

Stock chart

On Monday, March 18, 2019, JAGX shares closed at $.47 (+192.64%) on traded volume of 66.4 million shares. The current RSI (14) is 81.22

At $.47, JSGX shares are trading above their 50 DMA of $.24 and below their 200 DMA of $.70

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