OUR NEW PROFILE IS: (NASDAQ: JAGX)
Mytesi® is approved by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy
Mytesi® net revenue of $2.6 million increased approximately 24% over the fourth quarter of 2021 and increased approximately 112% over Mytesi net revenue in the first quarter of 2021
CHECK OUT THE CORPORATE PRESENTATION HERE
Jaguar Health Enters Exclusive Crofelemer License and Commercialization Agreement with SynWorld Technologies for Canalevia for Treatment of Diarrhea in Dogs in China https://t.co/aRqaijNsGs #crofelemer pic.twitter.com/oMzPqk3vIB
— Jaguar Health (@Jaguar_Health) June 29, 2022
Our last profile saw a bit of a gap and a strong double digit move before hitting resistance at .05.
Before that we dropped a MONSTER Nasdaq on you. The company that closed at .48 the night before. It opened at .61 after a big gap up and hit .70.
On Thursday it hit .80 for a 33% move off of the opening price the day we profiled. (Just 6 sessions)
How about another low priced Nasdaq profile for today?
Pull up JAGX immediately on your screen.
Right now this one is sitting under .30, well off of its 52 week high, giving it a LONG runway with two near-term potentially value enhancing and transformative clinical milestones.
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. Jaguar Animal Health is a tradename of Jaguar Health. Jaguar Health’s wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Napo Pharmaceuticals’ Mytesi® (crofelemer) product is approved by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and is the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Crofelemer 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 Health is the majority shareholder of Napo Therapeutics S.p.A., an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on a rare disease business model, including an initial focus on the orphan designation of crofelemer for short bowel syndrome for which proof of concept data is expected in the next 6 months. Napo Therapeutics is pursuing the rare disease strategy to bring crofelemer to patients in need, potentially in 2023, under the reimbursed expanded patient access program that exists in EU.
Most people I know are dog people. How how could you not be? My most recent dogs were small and both lived a long time. I spent tens of thousands of dollars on each of them to keep them alive at different points in their lives. We had to go the the vet for everything from cut paws to pancreas surgery and then some. Think about how many people you know who’s pets are part of their family. Unfortunately, roughly 1 in 4 dogs will, at some stage in their life, develop neoplasia. Almost half of dogs over the age of 10 will develop cancer. According to theNational Cancer Institute, roughly 6 million new cancer diagnoses are made in dogs each year in the U.S.
The market is substantial.
Jaguar Health Enters Exclusive Crofelemer License and Commercialization Agreement with SynWorld Technologies for Canalevia for Treatment of Diarrhea in Dogs in China
License fees of $5.0 million, and up to $5.0 million in unregistered equity infusion, over next 24 months
Service agreement of up to $5.0 million payable in unregistered Jaguar stock to SynWorld to support approval of crofelemer in China, providing Jaguar Health with up to 80% of profits
SAN FRANCISCO, CA / ACCESSWIRE / June 29, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that the company has entered an exclusive license and services agreement with Ontario, Canada-based SynWorld Technologies Corporation(SynWorld) for the treatment of diarrhea in dogs in the China market with Jaguar’s Canalevia® (crofelemer delayed-release tablets) prescription drug product.
“We are very excited about the possibility of making Canalevia available in China as part of the license we have provided to SynWorld for crofelemer for treatment of diarrhea in dogs in this territory,” said Lisa Conte, Jaguar’s founder, president, and CEO. “Per the terms of the agreement, Jaguar is engaging SynWorld as a service provider to obtain regulatory approval of the product for Jaguar in China and granting SynWorld a license to commercialize and sell this product following such approval in China. As consideration for the license, Jaguar is entitled to receive 60% of any profits from sales of the product in China. If Jaguar reimburses SynWorld for the direct expense of obtaining regulatory approval in China, the profit sharing will be 80% and 20%, respectively, for Jaguar and SynWorld.”
The agreement also entails monthly license fee payments by SynWorld to Jaguar amounting to US $5.0 million in total during the initial two-year term of the agreement, and a commitment by SynWorld to make quarterly purchases of Jaguar common stock (purchased at market price in unregistered stock at the time of purchase), amounting to US $5.0 million of Jaguar stock purchased in total, during the initial two-year term of the agreement. As consideration for the regulatory services to be provided by SynWorld, Jaguar will pay SynWorld a monthly service fee up to U.S. $5.0 million in total over the initial two-year term of the agreement in the form of unregistered Jaguar stock, with the value of such stock equal to market price at the time of such issuance. Under no circumstances will stock under the agreement be issued below market price on the commencement date of the license agreement. Additionally, under no circumstances will the number of shares of common stock issued under the agreement (i) exceed 19.99% of the total Jaguar shares outstanding as of the date of the agreement or (ii) result in the total number of shares of common stock held by SynWorld and its affiliates exceeding 19.99% of total Jaguar shares outstanding at any given time, in each case unless stockholder approval is obtained. The agreement includes customary termination provisions including the right of either party to terminate the agreement for material breach of the agreement by the other party.
“We are especially pleased with the infusion of capital into Jaguar expected over time from this agreement. This anticipated contribution to Jaguar’s financial health not only supports these efforts to expand Canalevia availability to China, it will support Jaguar’s goal of realizing value from progress in the development of the human pipeline of crofelemer, specifically: (i) the targeted completion of enrollment by the end of Q2, 2023 for the OnTarget Phase 3 study of crofelemer for the prophylaxis of cancer therapy-related diarrhea; and (ii) the completion and publication of proof-of-concept data for the orphan indications of short bowel syndrome (SBS) and potentially congenital diarrheal disorders (CDD) in 2022, supporting potential approval from the European Medicines Agency for early patient access to product in the European Union for SBS and CDD – an effort led by Napo Therapeutics, the rare disease-focused company Jaguar established in Europe in 2021 that has an exclusive license to crofelemer in Europe,” said Conte.
Crofelemer, under the name Canalevia®-CA1, received conditional approval from the U.S. Food and Drug Administration on December 21, 2021 for the treatment of chemotherapy-induced diarrhea (CID) in dogs in the United States, and Jaguar is currently pursuing FDA conditional approval of Canalevia for treatment of exercise-induced diarrhea (EID) in dogs in the US. This license agreement has the potential to significantly improve and/or expand the value of Jaguar’s Canalevia-related intellectual property portfolio.
According to Frost & Sullivan’s 2018 China Pet Industry Report, there were approximately 74 million pet dogs in China at the end of 2018, the number of pet-owner households in China increased from 69.3 million in 2013 to 99.8 million in 2018, and the market size of China’s overall pet industry is projected to reach an estimated RMB472.3 billion (US $70.5 billion) by 2023 – an 800 percent increase compared to 2013.
“The Chinese pet market has been expanding very rapidly, thanks to fast-rising pet ownership driven by a younger generation of consumers who view dogs and cats as embedded members of the family,” said Tao Wang, SynWorld’s General Manager, “and this growth is projected to continue. We look forward to creating a sales channel for the Chinese pet market and plan to directly sell Canalevia through already-existing sales and distribution partnerships in China following approval of the product in this territory.”
About SynWorld Technologies Corporation
SynWorld Technologies Corporation employs cutting edge technology to facilitate opportunities for companies in the U.S. to reach international markets, specifically, China. This is particularly important for publicly traded U.S. based companies who need distribution and Chinese compliance-related logistic partnerships.
PRODUCTS AND PIPELINE
Mytesi® (crofelemer), 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.
Mytesi is a novel, first‑in‑class anti‑secretory agent which has a basic normalizing effect locally on the gut, and this mechanism of action has the potential to benefit multiple gastrointestinal disorders. Jaguar, through Napo, holds extensive global rights for Mytesi. Mytesi is in development for multiple possible follow‑on indications, including diarrhea related to targeted cancer therapy; orphan‑drug indications for infants and children with congenital diarrheal disorders and short bowel syndrome; supportive care for inflammatory bowel disease; irritable bowel syndrome; and for idiopathic/functional diarrhea. In addition, a second‑generation proprietary anti‑secretory agent is in development for cholera.
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.
The term ethnobotanical refers to the use of plants by indigenous people in the course of their everyday lives, including the use of plants for medicine. Crofelemer, the active pharmaceutical ingredient in Mytesi, is derived from the Amazonian tree species, Croton lechleri, and has a rich history of medicinal use by indigenous peoples in the Western Amazon rainforests of South America. The tree produces a blood red latex from which crofelemer is isolated and purified. The tree is commonly called “Sangre de drago” in Spanish, which translates to “Dragon’s blood” in English.
The Croton lechleri tree is one of the most widely used plant-derived medicines in the western hemisphere. Red latex from Croton lechleri trees continues to be part of rural and urban traditional medicine in multiple countries including Peru, Colombia, Ecuador, and Bolivia.
Indigenous people utilize the red latex to treat a variety of medical conditions. Its most common uses are taking small quantities of the latex orally to treat diarrhea, stomach ulcers, coughs, and flu. The red latex is also applied topically as a wound healing agent for cuts and open sores, and for healing the gums after tooth extractions. It has been and continues to be used to treat humans as well as dogs and livestock.
Because of its widespread medicinal use, there has been extensive research conducted on the chemistry and pharmacology of this red latex. Mytesi is the result of decades of research that began with the expertise of traditional healers of the Amazon Rainforest.
The Croton lechleri tree is rapidly growing and abundant in multiple countries. Jaguar and its predecessor companies always focus on the long-term sustainable management of the tree as part of our commitment to helping local communities both conserve their natural resources while also earning income for the basic needs of their families, such as food, clothing, health care and education. Jaguar employees have been collaborating with local communities, business partners and scientists for the past 30 years to make certain that the development and sale of this product provides benefit to local communities. Large numbers of these trees have been planted, and re-planted upon harvesting, across Peru in collaboration with communities and small local businesses.
JAGUAR ANIMAL HEALTH
Jaguar Animal Health is an animal health company focused on creating plant-based gastrointestinal products for companion and production animals, foals, and high-value horses. Jaguar Animal Health is committed to discovering, developing, and commercializing plant-based prescription medicines and non-prescription products for animal health needs on a global basis. Each of our products are first-in-class and sustainably derived to ensure the highest degree of quality and ecological integrity.
Jaguar Animal Health continues to support the discovery and development of medicines from its proprietary library of 2,300 plants; presenting its four-legged patients with an increasing number of options for effective bio-based treatments.
Canalevia-CA1 is the lead prescription drug product for Jaguar Animal Health and is intended for the treatment of chemotherapy-induced diarrhea (CID) in dogs.
Lisa Conte: Founder & CEO
Ms. Conte is the founder, president and chief executive officer, and a member of the board of directors, of Jaguar Health, a commercial-stage pharmaceuticals company committed to discovering, developing and commercializing plant-based prescription medicines for urgent global health needs. Mytesi®, the company’s FDA-approved drug product indicated for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, is a first-in-class, plant-based anti-secretory agent and the first oral drug approved under FDA Botanical Guidance. In July 2017, two companies founded by Ms. Conte—Napo Pharmaceuticals, a human-focused pharmaceuticals company, and Jaguar Animal Health, the veterinary-focused licensor of all of Napo’s technology—merged and now comprise Jaguar Health. In 1989, Ms. Conte also founded Shaman Pharmaceuticals, Inc. and has pioneered plant-based prescription medicine investigation and development for more than 30 years, including a recent Entheogen Therapeutics Initiative, looking at psychoactive plants for novel cures for mood disorders and CNS neurodegenerative diseases. Ms. Conte is currently a member of the board of directors of Healing Forest Conservatory, and serves on the Editorial Advisory Board of Life Science Leader magazine. She holds an M.S. in Physiology and Pharmacology from the University of California, San Diego, and an M.B.A. and A.B. in Biochemistry from Dartmouth College.
Carol Lizak: Chief Financial Officer
Ms. Lizak is an accomplished, high-performing finance, operations, and strategic executive with more than twenty-five years of leadership experience in private and public life science and technology companies. Prior to serving as Jaguar’s CFO, she was the company’s Chief Accounting Officer. Before joining Jaguar, she served in executive director and corporate controller roles at Zosano Pharma Corp, Alexza Pharmaceuticals, Inc., LaserCard Corporation, and subsidiaries of HID Global, and in other senior finance leadership roles in both private and public companies. She holds an MBA from Pepperdine Graziadio Business School’s Executive MBA program.
Steven King, PhD: Chief Sustainable Supply, Ethnobotanical Research & IP Officer
Dr. King has served as our head of sustainable supply, ethnobotanical research and intellectual property since 2004. Prior to that, Dr. King served as the Vice President of Ethnobotany and Conservation at Shaman Pharmaceuticals, Inc. Dr. King has been recognized by the International Natural Products and Conservation Community for the creation and dissemination of research on the long-term sustainable harvest and management of Croton lechleri, the widespread source of crofelemer. Dr. King is currently a member of the board of directors of Healing Forest Conservatory, a California not-for-profit public benefit corporation. Dr. King holds an M.S. and Ph.D. in biology from the City University of New York (CUNY), and he received the first doctoral fellowship granted by the Institute of Economic Botany of the New York Botanical Garden.
Pravin Chaturvedi, PhD: Chief Scientific Officer; Chair of Scientific Advisory Board
Dr. Chaturvedi has served as our Chief Scientific Officer in addition to continuing his responsibilities as the Chair of the company’s Scientific Advisory Board (SAB) since March 1, 2022. He joined the Company in May 2017 as Chair of the SAB of Jaguar and Napo. Over his 30+ year career in the pharmaceutical industry, Dr. Chaturvedi has participated in the successful development and commercialization of multiple drugs in the therapeutic areas of epilepsy, HIV, hepatitis C, memory and gastrointestinal disorders. Dr. Chaturvedi served as the President and Chief Scientific Officer of Napo from 2006 to 2013 and remained a scientific adviser of Napo from 2013 through 2017. Dr. Chaturvedi has co-founded and led multiple biotech enterprises. From 2001 through 2004, he served as the President, Chief Executive Officer and Director of Scion Pharmaceuticals, Inc. He is the founder of IndUS Pharmaceuticals, where he has served as Chairman and Director since 2017, and held the same roles from 2005 through 2007 and from 2010 through 2015. IndUS Pharmaceuticals merged with Pivot Pharmaceuticals in 2015 and Dr. Chaturvedi served as the President and CEO of Pivot Pharmaceuticals from 2015 to 2017, prior to assuming his role as the Chair of the SAB for Napo and Jaguar. Dr. Chaturvedi also co-founded Oceanyx Pharmaceuticals, where he has served as Chief Executive Officer and Director since 2011, and he continues to serve on the boards of IndUS, Oceanyx, Enlivity and Cellanyx. He has been an adjunct faculty member at Georgetown University since 2013. Earlier in his career, from 1994 through 2001, Dr. Chaturvedi served in various roles as the head of lead evaluation at Vertex Pharmaceuticals, and from 1993 through 1994 he was in the preclinical group at Alkermes Inc. He started his career in the product development group at Parke-Davis/Warner-Lambert Company (now Pfizer) in 1988, where he worked through 1993. Dr. Chaturvedi holds a Ph.D. in Pharmaceutical Sciences from West Virginia University and a Bachelor’s in Pharmacy from the University of Bombay.
Darlene Horton, M.D.: Chief Medical Officer, Napo Pharmaceuticals
Dr. Horton brings 25 years of clinical research and development, medical affairs, senior executive, and consulting experience in the development of investigational and commercialized biopharmaceutical and drug-device combination products. She has extensive clinical development experience in multiple therapeutic areas including cardiology, oncology, immunology, orthopedics, gastroenterology, women’s health, and endocrinology. Prior to joining Napo, she led clinical development and regulatory strategy as CMO at Coherus Biosciences, Itero Biopharmaceuticals, and SMC Biotechnology. As Head of Clinical and Medical Affairs at Scios, she led the clinical development program that led to the approval of Natrecor® and was on the senior executive team when Scios was acquired by JNJ for $2.4B. At JNJ, she co-led (with strategic marketing) the cardiovascular therapeutic area when JNJ in-licensed and began developing the blockbuster drug Xarelto®. She also served as CEO at Nile Therapeutics and TulangCo Inc. Dr. Horton completed her Pediatric Cardiology fellowship and Pediatrics Residency at UCSF. She holds M.D. and B.S. in Microbiology degrees from the University of Florida.
David Sesin, PhD: Chief Manufacturing Officer
David is a pharmaceutical scientist with more than 30 years of experience ranging from drug discovery through manufacturing. He is the developer of the crofelemer manufacturing process. Prior to serving as Jaguar’s CMO, he was Director of Chemistry and QHSE at Bayer CropScience, Director of Chemistry at AgraQuest, Inc., and he spent nine years with Shaman Pharmaceuticals.
Jonathan Wolin, JD, MBA, CPA: Chief of Staff, Chief Compliance Officer & General Counsel
Mr. Wolin joined Jaguar’s team in November 2018. He brings more than 25 years of compliance, legal, and business experience with a number of life science, biotech and healthcare companies. Prior to joining Jaguar, Mr. Wolin was the Chief Administrative Officer for Pacific Pulmonary Services. He also served as the Chief Compliance Officer at other public and private companies, including Natera, Inc. Pacific Pulmonary Services, and Celera, Inc. Additionally, Mr. Wolin was General Counsel for Berkeley HeartLab, Inc. and a healthcare partner at the Mintz Levin law firm (Washington, DC). Jon has been part of leadership teams during three acquisitions, an IPO, and a turnaround. He is also certified in Healthcare Compliance and Healthcare Privacy Compliance.
Ian H. Wendt, MBA: Chief Commercial Officer
Prior to joining Jaguar, Mr. Wendt was at Gilead Sciences in a variety of field leadership and marketing roles in the HIV and hepatitis C therapeutic areas. Most recently, he led strategy and tactical development for a national team focused on policy and protocol development within key HIV treatment and prevention accounts, capacity building, and direct patient education. Mr. Wendt was also responsible for Gilead’s efforts to increase hepatitis C virus screening and treatment among non-specialist health care practitioners in support of Gilead’s market development efforts for a $10 billion brand franchise. Before Gilead, Mr. Wendt was at Boehringer Ingelheim, where he led HIV and oncology sales teams across the US, and led commercial operations at Roxane Laboratories, which included sales operations, analytics, incentive compensation, and training. He received a BSc from Acadia University and an MBA from Dalhousie University in Nova Scotia.
Karen Brunke, PhD: Executive Vice President, Corporate & Business Development
Dr. Brunke brings to Jaguar over 30 years of scientific, operational, clinical, senior executive, and corporate development experience in both large and small biotechnology companies. Following her post-doctoral fellowship at the Institute for Cancer Research in Fox Chase, Dr. Brunke joined the seeds division of Sandoz, with her most recent position having been Research Director, overseeing a department whose successes included recombinant insect-resistant plants (GMOs) which have been an important backbone for the greater than $3 billion seed business of the now Syngenta Seeds. She was next part of the executive team that merged Mercator Genetics with Progenitor and helped take the resultant company public. Dr. Brunke was COO of Anexus Pharmaceuticals, a subsidiary of the Japanese public company MediBic, responsible for in- and out-licensing assistance for Japanese companies, and was next founding CEO of Cardeus Pharmaceuticals, a neuroscience company. In business and corporate development, Dr. Brunke has had primary responsibility for negotiating multiple partnerships and licenses, including with MedImmune and Astellas, and assisted in closing a deal with GlaxoSmithKline, among others. Dr. Brunke received her BA degree in Biochemistry as well as PhD in Microbiology from the University of Pennsylvania.
Brian Sutton: National Business Director
Mr. Sutton previously served as western regional business director for Napo. Prior to joining Napo, he was an executive cardiovascular hospital account manager with Novartis, an executive institutional business manager with Bristol-Myers Squib in HIV, and an institutional diabetes account Manager with Novo Nordisk A/S, and held roles with Shire, Johnson & Johnson and other companies in the pharmaceutical and medical device industries. He has a B.S. in Marketing from Penn State University and an M.S. in Information Systems Engineering from the CHUBB Institute.
Michael K. Guy, DVM, MS, PhD: Vice President, Preclinical & Nonclinical Studies
‘Dr. Mike’ joined Jaguar in September 2015 with over 20 years of experience in animal and human pharmaceutical development. Dr. Guy has worked in clinical development, manufacturing, regulatory and pre-clinical drug discovery, and he has worked at Amgen, Heska, Colorado Serum Company, Lloyd Pharmaceuticals, Virbac Animal Health, and most recently, the Morris Animal Foundation, where he created and recruited the largest and longest clinical trial ever done in dogs – the 3,000 dog Golden Retriever Lifetime Study. In addition, Dr. Mike has over 12 years of experience as a practicing veterinarian, and his patients have included everything from dogs, cats, horses and ferrets to birds, wildlife and zoo animals. Dr. Guy still maintains his veterinary license and volunteers as a spay/neuter surgeon at a local animal shelter. At Jaguar, Dr. Mike supervises all animal health clinical studies, is involved in regulatory, safety assessment and manufacturing, and he advises on the many other scientific and medical activities within the company.