On May 20, 2021, Sorrento Therapeutics announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 Pivotal clinical trial of COVI-MSCﾙ, an injectable infusion of mesenchymal stem cells, for the treatment of hospitalized COVID-19 patients suffering from ARDS.

The Brazil study is a Phase 2 Pivotal, multi-center, randomized, controlled study to evaluate the safety and efficacy of three infusions of COVI-MSCﾙ, administered every other day, to hospitalized patients experiencing moderate or severe COVID-19 with ARDS.