Jaguar Health Issues Shareholder Letter: Company to Explore Approval Pathway for Crofelemer in Breast and Lung Cancer Based on Phase 3 Results - Investor Webcast August 13th Will Review Q2 Earnings and Further Review OnTarget Trial’s Clinically Meaningful

In 2022 breast cancer was the most common cancer in women in 157 countries out of 185, and lung cancer is the most common cancer worldwide.¹ Click here to register for webcast.

Import permit for crofelemer granted for independent, investigator-initiated proof-of-concept trial in Abu Dhabi of crofelemer in pediatric patients for the rare and orphan disease indications of microvillus inclusion disease (MVID) and short bowel syndrome (SBS) with intestinal failure

SAN FRANCISCO, CA / ACCESSWIRE / August 5, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today issued a letter to shareholders from the company's founder, president, and chief executive officer, Lisa Conte.

Dear Fellow Shareholders,

Jaguar will be hosting a webcast, providing a review of earnings for the second quarter of 2024, at 8:30 a.m. Eastern on Tuesday, August 13, 2024. We will also further review the data and regulatory strategy for the clinically meaningful results we reported July 23, 2024 - identified in patients with breast and respiratory cancer, including lung cancer - in the initial data from our recently completed phase 3 OnTarget trial of crofelemer. OnTarget broadly and boldly studied the prophylaxis of diarrhea in adult cancer patients with 10 distinct types of solid tumors receiving targeted therapy, with or without standard chemotherapy; yet the meaningful clinical signals are in breast and lung cancer patients, two of the three most common cancer diagnoses. We are collaborating with our clinical and scientific advisers to evaluate the significance of these clinical outcome signals in order to prepare for scientific publication submission and FDA meetings, as we plan to explore the pathway of approval to make crofelemer, our novel, oral plant-based prescription medicine, available to breast and lung cancer patients for cancer therapy-related diarrhea (CTD).

The breast and lung results in OnTarget are a responder analysis, as was the primary endpoint in the phase 3 ADVENT trial that led to FDA approval of crofelemer for its currently commercialized indication, under the brand name Mytesi, for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. As we were pleased to announce last week, the results of two independent investigator-initiated responder analysis studies of crofelemer in diarrhea-predominant inflammatory bowel syndrome (IBS-D) populations - one in functional diarrhea and one in chronic idiopathic diarrhea - showed a benefit in patients and have been accepted for poster presentations at the American College of Gastroenterology Annual Scientific Meeting, which takes place October 25-30, 2024 in Philadelphia. We are driven and motivated by the paradigm-shifting mechanism of action of crofelemer, which continues to demonstrate clinical robustness in responder analysis trials for multiple gastroenterological conditions. "The functional diarrhea study showed that crofelemer may be a particularly useful option in those patients without a significant pain component to their symptoms, and it may be safe and effective in functional diarrhea, particularly given that its mechanism of action is not constipating," commented Judy Nee, MD, the principal investigator for the study. Dr. Nee is a gastroenterologist at Beth Israel Deaconess Medical Center and an assistant professor at Harvard Medical School. She serves as co-director of the GI Motility Lab at Beth Israel, and specializes in GI motility disorders and functional GI diseases such as IBS, chronic diarrhea, and constipation, as well as movement disorders of the esophagus.