Item 8.01 Other Events.

On November 30, 2022, Vistagen Therapeutics, Inc. (the "Company") announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA"). The letter greenlights a U.S. Phase 1 clinical trial under the Company's newly filed Investigational New Drug ("IND") application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder ("MDD"). The small Phase 1 trial (n=12) will involve the Company's newly optimized formulation of PH10 and is intended to both confirm the favorable safety profile of PH10 established in three previous clinical studies, including a published Phase 2A study for the treatment of MDD, and 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 November
              30, 2022.
    104       Cover Page Interactive Data File
              (embedded within the Inline XBRL
              document)

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