Jaguar Health Pipeline Review, Progress and Regulatory Update

Jaguar Health Pipeline Review, Progress and Regulatory Update

For help with the FDA Calendar, timing and catalyst for trading biotech stocks visit our FDA resources page 

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.

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 Press Release from Jaguar Health

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.

Mytesi jaguar Health

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

JAGX stock chart, Jaguar Health
 

Traders News Source Recent Track Record

 
Disclaimer
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Mark Roberts. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
17B Disclosure
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.