Item 8.01 Other Events.

On January 24, 2023, Vistagen Therapeutics, Inc. (the "Company") announced that the first cohort of participants 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 the Company's plans for Phase 2B development of PH10 as a stand-alone treatment for MDD. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits Index



Exhibit No.              Description
   99.1       Press Release issued by Vistagen
              Therapeutics, Inc., dated January
              24, 2023.
    104       Cover Page Interactive Data File
              (embedded within the Inline XBRL
              document)

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses