Ouro Medicines, LLC

Gilead - Ouro

Gilead Sciences, Inc. (Gilead), through its wholly owned subsidiary Ojas Merger Sub LLC, proposes to acquire all of the outstanding shares of Ouro Medicines, LLC (Ouro) (the Acquisition). Gilead is a biopharmaceutical company incorporated in the United States. Globally, Gilead’s activities focus on advancing medicines to prevent and treat life-threatening diseases, including HIV, liver disease, coronavirus disease 2019 (COVID-19), inflammation and cancer. Its primary subsidiary in Australia is Gilead Sciences Pty. Ltd., through which Gilead supplies Australian customers with a range of medicines. Ouro is a privately-held, U.S.-based clinical-development stage biotechnology company focused on developing T cell engager (TCE) therapies for autoimmune diseases. Ouro’s lead product candidate, OM336 (gamgertamig), is a B cell Maturation Antigen (BCMA)-directed bispecific TCE binding to CD-3 on the T cell complex. Ouro does not currently market any products anywhere in the world and it only has early-stage development programs. Both Gilead and Ouro are active in the development of T cell therapies for the treatment of autoimmune diseases. Gilead does not have any marketed products but is engaged in Phase 1 clinical and preclinical research and development (R&D) pipeline activities, which are limited to autologous chimeric antigen receptor T cell (CAR-T) early-stage programs. Gilead’s clinical pipeline trials are for KITE-363 and Anito-cel, with potential indications being Systemic Lupus Erythematosus, IIM (myositis), relapsed/refractory Lupus Nephritis, relapsed/refractory Systemic Sclerosis and Chronic Inflammatory Demyelinating Polyneuropathy, relapsed/refractory Multiple Sclerosis and Generalized Myasthenia Gravis. Gilead does not have any manufacturing or R&D facilities in Australia but runs some clinical trials in Australia and employs an operations team in Australia to support those trials. Ouro is focused on developing TCE therapies for the treatment of autoimmune diseases; Ouro has no direct activities in Australia. Ouro is conducting two ‘basket studies’ as part of Phase 1b clinical development for OM336, with potential indications being autoimmune cytopenias and seropositive autoimmune disease. One of these trials has started recruiting patients in Australia via a Contract Research Organisation.