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

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

Approximately 17 Million American Adults Suffer from Social Anxiety

SOUTH SAN FRANCISCO, Calif., July 23, 2020 VistaGen

Therapeutics (NASDAQ: VTGN), a

biopharmaceutical company developing new generation medicines for

anxiety, depression and other central nervous system (CNS)

disorders, announced the

results of a positive meeting with the U.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).

VistaGen and the FDA reached 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.

PH94B is an investigational rapid-onset neurosteroid nasal spray

that is fundamentally differentiated from all FDA-approved

treatments for anxiety disorders. According to the U.S. National

Institute of Mental Health (NIMH), there are approximately 17

million adults in the U.S. with SAD.

Much like a rescue inhaler is used in an asthma attack or a

migraine drug is used in an acute migraine episode, PH94B is a

potential fit for the acute treatment of anxiety symptoms in

anticipation of an often predictable, anxiety-provoking situation

for individuals suffering from SAD, said Shawn Singh, Chief

Executive Officer of VistaGen.

Notably, the FDA concurred that our initial pivotal Phase 3

efficacy study may be conducted in a manner substantially similar

to the highly statistically significant Phase 2 study of PH94B,

which study involved a single event, laboratory-simulated public

speaking challenge in adult patients with SAD. The FDA's

specific guidance will enable us to simplify the process of

assessing efficacy among SAD patients in our Phase 3 studies and

contribute to significant time- and cost-efficiency in the

clinic, Singh added.

Key Aspects of Consensus with FDA Regarding the Initial Pivotal

Phase 3 Study of PH94B

VistaGen's initial pivotal Phase 3 study of PH94B for acute

treatment of anxiety in adult patients with SAD will be a

randomized, double-blind, placebo-controlled, parallel comparison

study conducted at approximately 12 to 15 sites in North

Dr. Michael Liebowitz, Professor of Clinical Psychiatry at Columbia

University, director of the Medical Research Network in New York

City, and creator of the Liebowitz Social Anxiety Scale (LSAS),

will be the Principal Investigator of the study. Target enrollment

will be approximately 182 adult patients with SAD.

As in the successful Phase 2 study of PH94B in SAD, the study will

involve a single laboratory-simulated anxiety-provoking public

speaking challenge. The Subjective Units of Distress Scale (SUDS)

will be used to assess the primary efficacy endpoint in the

PH94B is a first-in-class, odorless, rapid-onset (within

approximately 15 minutes) synthetic neurosteroid nasal spray with

therapeutic potential across a broad range of anxiety-related

disorders. Easily self-administered in microgram-level doses, PH94B

does not require systemic uptake and distribution to produce its

rapid-onset anti-anxiety effects.

VistaGen is preparing for Phase 3 clinical development of PH94B as

a potential new generation fast-acting, non-sedating, non-addictive

acute treatment of anxiety in adults with social anxiety disorder

(SAD). The FDA has granted Fast Track designation for development

of PH94B for this indication, the first such designation by the FDA

for a drug candidate for SAD.

With its rapid-onset pharmacology, lack of systemic exposure and

excellent safety profile in earlier studies, PH94B has potential as

a novel treatment for multiple anxiety-related disorders. VistaGen

is also preparing for Phase 2A development of PH94B for adjustment

disorder related to the diverse impact of the COVID-19

pandemic. View more background

information on SAD and a video on PH94B's mechanism of

VistaGen Therapeutics is a clinical-stage biopharmaceutical company

developing new generation medicines for anxiety, depression and

certain CNS diseases and disorders where current treatments are

inadequate, resulting in high unmet need. Each of VistaGen's three

drug candidates has a differentiated mechanism of action, an

exceptional safety profile, and therapeutic potential in several

large global CNS markets. For more information, please

visit www.vistagen.com

and connect with VistaGen on

Twitter, LinkedIn and Facebook.

Forward-Looking Statements

Various statements in this release are forward-looking

statements concerning VistaGen's future expectations, plans

and prospects, including the potential for successful New Drug

Application (NDA)-enabling Phase 3 development of PH94B. These

forward-looking statements are neither promises nor guarantees of

future performance, and are subject to a variety of risks and

uncertainties which could cause actual results to differ materially

from those contemplated in these forward-looking statements,

including the risks that: development and approval of PH94B may not

be achieved in any market; the FDA may decide that the results of

the Company's PH94B Phase 3 clinical program are not

sufficient for regulatory approval for acute treatment of anxiety

in adult patients with SAD or any other anxiety-related disorder;

development of PH94B may not be successful in any indication;

success in nonclinical studies or in earlier-stage clinical trials