Vistagen announced the first cohort of healthy volunteers has been dosed in its U.S. Phase 1 clinical trial of PH10, the Company's investigational pherine nasal spray in development for the treatment of major depressive disorder (MDD). The primary objective of this U.S. single center, randomized, double-blinded, placebo-controlled Phase 1 study is to investigate the safety and tolerability of PH10 in healthy adult subjects (n=12). The study is intended to confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including a published Phase 2A study for the treatment of MDD, as well as facilitate Vistagen's plans for Phase 2B development of PH10 as a stand-alone treatment for MDD.

Vistagen anticipates completion of the study by the end of First Quarter 2023, with top line results expected before the end of the first half of 2023.