VistaGen Therapeutics, Inc. (NASDAQ:VTGN) Files An 8-K Regulation FD Disclosure

On July 23, 2020, VistaGen Therapeutics, Inc. (the “Company”) announced the results of a positive meeting with theU.S. Food and Drug Administration(“FDA”) regarding Phase 3 development of PH94B for the acute treatment of anxiety in adult patients with social anxiety disorder (“SAD”), including consensus on key aspects of a unique initial pivotal Phase 3 clinical trial of PH94B involving a single-event, laboratory-simulated public speaking challenge in adult patients with SAD. A copy of the Company’s press release is attached hereto as Exhibit 99.1.

On July 23, 2020, the Company began utilizing a new corporate presentation, a copy of which is attached to this Current Report on Form 8-K as Exhibit 99.2.

The information in Item 7.01 of this Current Report onForm8-K,including the information set forth in Exhibit99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall Exhibit 99.1 and 99.2 filed herewith be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits Index

VistaGen Therapeutics, Inc. Exhibit
EX-99.1 2 ex99-1.htm PRESS RELEASE ex99-1   Exhibit 99.1     VistaGen Therapeutics Announces Positive Meeting with FDA Regarding Pivotal Phase 3 Study of PH94B for Acute Treatment of Anxiety in Patients with Social Anxiety Disorder   Company Reaches Consensus with FDA on Key Aspects of Novel Pivotal Phase 3 Study   Agency Guidance May Provide Significant Time- and Cost-Efficiency for Phase 3 Program   Approximately 17 Million American Adults Suffer from Social Anxiety Disorder   SOUTH SAN FRANCISCO,…
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About VistaGen Therapeutics, Inc. (NASDAQ:VTGN)

VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in developing and commercializing product candidates for patients with diseases and disorders involving the central nervous system (CNS). Its lead product candidate, AV-101, is an orally available prodrug candidate in Phase II development, initially for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressants approved by the United States Food and Drug Administration (FDA). In addition to AV-101, the Company has developed a human pluripotent stem cell (hPSC) technology platform, which includes its in-vitro bioassay system, CardioSafe 3D, to predict potential heart toxicity of new chemical entities (NCEs) long before testing in animal and human studies. The Company is focused on regenerative medicine (RM) applications using blood, cartilage, heart and/or liver cells derived from hPSCs.