VistaGen Therapeutics Issues Letter to Stockholders as Company Prepares to Initiate AV-101 Phase 2 Study for Major Depressive Disorder South San Francisco, CA (

VistaGen Therapeutics Issues Letter to Stockholders as Company

Prepares to Initiate AV-101 Phase 2 Study for Major Depressive

South San Francisco, CA (January 29, 2018)

Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage

biopharmaceutical company focused on developing new generation

medicines for depression and other central nervous system (CNS)

disorders, today issued a letter to stockholders as the Company

prepares to initiate its Phase 2 study of AV-101 for Major

Depressive Disorder (MDD).

full version of the letter to stockholders may be accessed using

the following link, or by visiting the Investor Relations section

of the Company's website, www.vistagen.com.

letter to stockholders, Shawn Singh, Chief Executive Officer,

highlights the Company's recent milestones and discusses the

impending launch of the Company's Phase 2 clinical study of

AV-101 for MDD. VistaGen's AV-101 is an oral new generation

antidepressant with a mechanism of action that is fundamentally

differentiated from all standard, FDA-approved

early-2017, I had the privilege of Ringing the Bell

at The Nasdaq Stock Market's headquarters in Times Square on

behalf of our company. That exciting and unique corporate event

proved to be a symbolic prologue to the productive year for

VistaGen that followed. The milestones we accomplished in 2017 have

strongly positioned us to advance our AV-101 Phase 2 program to new

levels throughout this year and next, commented Mr. Singh in

the letter to stockholders. Following a productive meeting

with the U.S. Food and Drug Administration (FDA) in the fall of

2017, we achieved two key regulatory milestones before year end.

First, in October 2017, the FDA authorized us to proceed, under our

Investigational New Drug (IND) application, with our U.S.

multi-center Phase 2 clinical study of AV-101 as an oral new

generation adjunctive treatment for MDD patients with an inadequate

response to standard, FDA-approved antidepressants. In addition, in

December 2017, the FDA granted us Fast Track Designation for

development of AV-101 for treatment of MDD, providing us the

opportunity for frequent FDA interactions regarding the most

appropriate and efficient development pathway to bring AV-101 to

MDD patients. 2017 culminated with the closing of an underwritten

public offering that generated gross proceeds of $15 million,

enabling us to commence and advance through our Phase 2 study in

2018. I want to thank, again, our underwriters and our new and

existing investors for supporting our vision.

Recent Accomplishments:

green light from the FDA

to launch AV-101 Phase 2 MDD adjunctive treatment study

pursuant to our IND.

Designation from the FDA for development of AV-101 as an adjunctive

treatment for MDD. Fast Track Designation is designed to facilitate

the development and review of new treatments for serious

conditions, such as MDD, with unmet medical need.

strengthen our intellectual property portfolio as the European

Patent Office (EPO) granted a patent related to methods of treating

depression with AV-101 and certain other neurological indications,

and the U.S. Patent and Trademark Office (USPTO) issued

Patent No. 9,834,801 related to certain methods of

production for AV-101.

on the cover of The Journal of

Pain in October 2017, a peer-reviewed publication of

nonclinical studies of the effects of AV-101 in well-established

nonclinical models of pain. This article is available at the

following link: http://dx.doi.org/10.1016/j.jpain.2017.03.014).

public offering that generated gross proceeds of $15 million.

Proceeds from the offering enable us to continue research and

development, primarily related to our Phase 2 clinical

study of AV-101 for MDD.

Singh continued, As a result of receiving a green

light from the FDA, we

anticipate launching our AV-101 Phase 2 MDD adjunctive

treatment study during the current quarter, with topline data

expected to be available during the first half of 2019. In

addition, we expect one of our principal collaborators, the U.S.

National Institute of Mental Health, to complete its Phase 2

monotherapy study of AV-101 in treatment-resistant MDD patients

during 2018. This Phase 2 study is being conducted by Dr. Carlos

Zarate Jr., Chief, Section on the

Neurobiology and Treatment of Mood Disorders and Chief of the

Experimental Therapeutics and Pathophysiology Branch at the NIMH.

AV-101 caught the attention of Dr. Zarate, widely considered a

pioneer in ketamine research for MDD, and his team after

head-to-head preclinical studies of AV-101 vs. ketamine, ultimately

resulting in a Cooperative Research and Development Agreement

between VistaGen and the U.S. National Institutes of Health,

whereby the NIMH is fully funding and conducting the NIMH Phase 2

monotherapy MDD study of AV-101.

Anticipated Milestones over next 12 to 18 Months:

clinical study of AV-101 for MDD with Dr. Maurizio Fava of Harvard

University as Principal Investigator;

a 180-patient, U.S. multi-center, double-blind, placebo controlled

efficacy and safety study evaluating AV-101 as an adjunctive

treatment in MDD patients with an inadequate response to standard,

FDA-approved antidepressants.

MDD monotherapy study topline results.

AV-101 Phase 2 MDD adjunctive treatment study.

Phase 2 studies in neuropathic pain and Parkinson's disease

levodopa-induced dyskinesia.

adjunctive treatment study topline results.

kicked off 2018 by hosting meetings with current investors,

prospective institutional investors and potential strategic

partners during the 36th Annual J.P. Morgan Healthcare Conference