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Jaguar Health, Inc.


Jaguar Health is a commercial stage pharmaceuticals company that develops novel, plant-based, sustainably derived prescription medicines for GI distress. Our Mytesi® (crofelemer) product (tablet) is FDA-approved for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Our key near-term clinical activity is our ongoing global Phase 3 pivotal OnTarget trial of crofelemer for our core follow-on indication of prophylaxis of cancer therapy-related diarrhea (CTD). Enrollment in this trial completed in May 2023 and the primary endpoint is expected in October 2023. The trial is evaluating the effectiveness of crofelemer's novel mechanism of action – the modulation of two chloride ion channels in the gastrointestinal tract – to mitigate or substantially reduce chronic cancer therapy-related diarrhea. Jaguar’s expectation is that this placebo-controlled trial will provide evidence that diarrhea associated with targeted cancer therapies is chronic, not acute, and impacts the patient's ability to remain on their cancer therapy regimens at proven doses for better outcomes. Crofelemer is currently approved for a chronic use in HIV/AIDS patients, providing a potential opportunity for a paradigm shift for prophylaxis of CTD compared to the management of severe chronic diarrhea with constipating agents such as antimotility drugs, which are predominantly opioids. The company’s second prioritized clinical program centers around the evaluation of crofelemer for short bowel syndrome (SBS) with intestinal failure and for microvillus inclusion disease (MVID), a rare congenital diarrheal disorder (CDD). SBS with intestinal failure and MVID are devastating and often catastrophic diseases for patients, who are frequently on parenteral nutrition for as long as 20 hours a day, seven days a week.