Eton Pharmaceuticals, Inc.

Eton is a pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently has eight commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, KHINDIVI TM , GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. Eton also has five additional product candidates in late-stage development: ET-600, Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. INCRELEX® is a biologic product approved by the FDA in August 2005 for treating children with severe primary insulin-like growth factor 1 deficiency (SPIGFD). It is approved in 40 territories, including the United States and the European Union. Eton acquired and launched INCRELEX® in December 2024. ALKINDI SPRINKLE® was approved by the FDA in September 2020 as a replacement therapy for Adrenocortical Insufficiency ("AI") in children under 17 years of age. It is the first and only FDA-approved granule hydrocortisone formulation designed for accurate dosing in newborns and children with AI. Eton acquired U.S. marketing rights in March 2020 and launched ALKINDI SPRINKLE® in December 2020. The product is protected by three issued patents extending to 2032, 2033, and 2034. KHINDIVI TM was approved by the FDA in May 2025 as a replacement therapy for adrenocortical insufficiency in pediatric patients five years of age and older. It is the only FDA-approved oral solution formulation of hydrocortisone, available in a 1mg/ml strength. KHINDIVI is a ready-to-use oral liquid solution that does not require refrigeration, mixing, or shaking.