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Jaguar Health, Inc. $JAGX Bringing Plant-based Medicines to Life™ Pharmaceutical Manufacturing San Francisco, California Jaguar Health’s organizational framework is designed to enable our product pipeline to reach the world’s interconnected marketplace, allowing for development and commercialization opportunities worldwide. Products: Mytesi Crofelemer 125mg delayed release tablets Mytesi is FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy Mytesi has a novel mechanism of action that modulates chloride secretion in the gastrointestinal tract, reducing excessive chloride and accompanying water flow and relieving watery diarrhea. Mytesi is not indicated for the treatment of infectious diarrhea. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (6%), bronchitis (4%), cough (4%), flatulence (3%), and increased bilirubin (3%). Canalevia-CA1 Crofelemer delayed release tablets CANALEVIA-CA1 is conditionally approved for the treatment of chemotherapy-induced diarrhea (CID) in dogs. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal Law to use this product other than as directed in the labeling. Lytham Partners Investor Select Conference February 1st, 2024 wsw.com Pipeline: jaguar.health About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, and bowel incontinence. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study , a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative is focused on developing novel prescription medicines derived from plants for mental health indications. Crofelemer in Cancer Cancer Therapy–related Diarrhea 9.8 million people receive chemotherapy worldwide per year Wilson B, Jacob S, Yap M, et al. Estimates of global chemotherapy demands and corresponding physician workforce requirements for 2018 and 2040: a population-based study. Lancet Oncol. 2019;20(6):769-780. doi:10.1016/S1470-2045(19)30163-9 Chemotherapy-induced diarrhea occurs in 50%-80% of treated patients Stein A, Voigt W, Jordan K. Chemotherapy-induced diarrhea: pathophysiology, frequency and guideline-based management. Ther Adv Med Oncol. 2010;2(1):51-63. doi:10.1177/1758834009355164 Patients with cancer therapy– related diarrhea (CTD) were 40% more likely to discontinue chemotherapy or targeted cancer therapy than patients without CTD Okhuysen PC, Schwartzberg LS, Roeland E, et al. The impact of cancer-related diarrhea on changes in cancer therapy patterns. J Clin Oncol. 2021;39(15):12111. doi:10.1200/JCO.2021.39.15_suppl.12111 Research & Development In October 2020, Napo Pharmaceuticals initiated a pivotal Phase 3 clinical trial This Phase 3 study is evaluating crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy The principal investigator and co-investigators identified are from MD Anderson Cancer Center Jaguar Health jaguar.health Napo Pharmaceuticals napopharma.com Napo Therapeutics napotherapeutics.com Magdalena Biosciences magdalenabiosciences.com Developing novel, natural prescription medicines derived from plants for mental health indications including attention-deficit/hyperactivity disorder (ADHD) in adults Magdalena is a joint venture formed by Jaguar Health and Filament Health. The company holds an exclusive license to Jaguar's proprietary library of approximately 2,300 highly characterized medicinal plants and 3,500 plant extracts for designated therapeutic indications. Visit Jaguar on LinkedIn: linkedin.com Visit Jaguar on Instagram: instagram.com Visit Jaguar on X: twitter.com Phone: 415-371-8300 Contact: hello@jaguar.health Press Releases: jaguarhealth.gcs-web.com What to get out of the Jaguar Conference: Market size of the FDA HIV Mytesi Crofelemer could be $25-$30 Million in the USA Cancer related Chemo Diarrhea $3 Billion Market 50% Generic Valuation Most if not all works by mechanism chloride ions into the gut then water comes and diarrhea out. Crofelemer normalizes abnormal ion flow targeting only locally in the gut. Jaguar has been putting the expense into making sure Crofelemer drug supply is ready to get into this opportunity to treat cancer related chemo patients since pharmacy’s already can get FDA approved, all ready in the in the supply chain in the pharmacy as Crofelemer for AIDs patients. Research has shown it costs 3x as much to treat a cancer patient with diarrhea. It would be better to treat the cancer patient for diarrhea with Crofelemer pending OnTarget Study and FDA approval. Since Crofelemer is FDA approved to treat dogs for Cancer Chemo related Diarrhea it has been said: If your going to have cancer and cancer related Diarrhea, it’s better to be a dog than a human right now. The companies that manufacture the cancer agents/drugs sort of point to the availability of Crofelemer because it allows them to keep their patients on their therapies thereby improving their penetration and their revenues opportunity. 3rd party market research put Short Bowel Syndrome at $5-$12 Billion opportunity because these patience are so ill, high mortality, high morbidity (the state of being unhealth for a particular disease or situation), so high of expense to manage through life. That opportunity can be reached in small trials around the world to show benefits to be able to show global development. Product already approved, already fully in the supply chain in the pharmacy. Magdalena is a joint venture formed by Jaguar Health and Filament Health. Named after a river in Columbia. The company holds an exclusive license to Jaguar's proprietary library of approximately 2,300 highly characterized medicinal plants and 3,500 plant extracts for designated therapeutic indications. Note: 20% of the plants focused on symptoms in the area of mental health or conjunctive disorders. Botanical IND ADHD with a new plant based on human use where they have done verification in some animal studies. Related to the OnTarget Study: Doggy poster coming out tomorrow in a publication with diarrhea. The goal of Crofelemer in the USA is to Commercialize. The goal of Crofelemer in the rest of the world is to Partner all around the world. Leveraging market awareness and patients voice to bring in other assets to leverage that capabilities as well. This study showed that crofelemer prophylaxis reduced the incidence/severity of neratinib-associated diarrhea in female beagle dogs without the need for any loperamide administration. Dated 2024 pubmed.ncbi.nlm.nih.gov | ||||||||||||||
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