Jaguar Health, Inc. announced that the results of an independent pilot phase 2 study of crofelemer for the management of neratinib-associated diarrhea in patients with HER2+ early-stage breast cancer indicate that crofelemer, the Company's FDA approved drug, may be effective for the management of Neratinib-induced diarrhea. The results of the study, which was designed by the study's principal investigator, Jo Chien, MD, and published in the peer-reviewed journal Clinical Breast Cancer, are consistent with the results of a preclinical dog study evaluating the effects of crofelemer in improving diarrhea associated with neratinib, a tyrosine kinase inhibitor (TKI), presented at the American Association for Cancer Research Virtual Annual Meeting II in June 2020. These results also provide support for the Company's ongoing phase 3 OnTarget trial evaluating crofelemer for the prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without chemotherapy.

The OnTarget trial evaluates crofelemer prophylaxis in cancer patients with different tumor types receiving different targeted therapies and recently completed enrollment. Top line results from the Company's ongoing phase 3 InTarget clinical trial are expected in late October 2023. A significant proportion of patients undergoing cancer therapy experience diarrhea, and diarrhea has the potential to cause dehydration, potential infections, and non-adherence to treatment in this population.

novel "targeted cancer therapy" agents, such as epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs), with or without cycle chemotherapy agents, may cause increased electrolyte and fluid content in the gut lumen, which results in passage of loose/watery stools (i.e., diarrhea). Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors. Patients with CTD are 40% more likely to discontinue their chemotherapy or targeted therapy than patients without CTD, and the cost of care of CTD patients is estimated to be 2.9 times higher than for patients who are not experiencing CTD.