Inhibikase Therapeutics, Inc.

Bu siness. Company Overview We are a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases, namely, Pulmonary Arterial Hypertension ( PAH ), in which aberrant signaling through type III receptor tyrosine kinases, including platelet derived growth factor receptors and a stem cell factor receptor, known as c-Kit , has been implicated. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate ( imatinib ), for PAH which is an orphan indication. Imatinib was first approved in the United States in 2001 for various cancers and blood disorders and, following more than 20 years of clinical use, has a well-characterized safety profile with the first reported use of imatinib in PAH occurring in 2005. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans. We have completed a non-human primate safety study and a bioequivalence clinical study in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib. Our Phase 3 clinical study, named IMPROVE-PAH ( I KT-001 for M easuring P ulmonary Vascular R esistance and O utcome V ariables in a Phase 3 E valuation of PAH ), has been initiated with the activation of a small number of sites and the recent commencement of patient pre-screening activities at those sites.