VistaGen Therapeutics Reports Fiscal 2020 Second Quarter Financial Results and Provides Pipeline Overview

VistaGen Therapeutics Reports Fiscal 2020 Second Quarter Financial

Results and Provides Pipeline Overview

SOUTH SAN FRANCISCO, Calif., November 7, 2019 VistaGen

Therapeutics (NASDAQ: VTGN), a clinical-stage

biopharmaceutical company developing new generation medicines for

central nervous system

(CNS) diseases and disorders with high unmet need, today announced

financial results for its fiscal year 2020 second quarter ended

During the quarter, we achieved several important milestones

intended to advance development of each of our three differentiated

CNS drug candidates, stated Shawn

Singh, Chief Executive Officer of VistaGen.

achieved target enrollment and completed patient dosing in our

randomized, double-blind, placebo-controlled Phase 2 ELEVATE study

of AV-101, our novel oral NMDA receptor antagonist, in major

depressive disorder. In addition, for development of AV-101 in

suicidal ideation, with emphasis on U.S. Military Veterans, our

collaborators at Baylor University recently completed dosing in

their Phase 1b target engagement study in healthy volunteer

Veterans, a study funded by the U.S. Department of Veteran's

Affairs. We are also encouraged by post-Phase 2 feedback from the

FDA earlier this year regarding our Phase 3 development plan for

PH94B, our first-in-class, rapid-acting neuroactive nasal spray, in

social anxiety disorder. We expect the coming months to be equally

active and potentially transformative, as we look forward to

topline readouts from two studies involving AV-101 before the end

of 2019, and potential regulatory milestones involving PH94B before

the end of fiscal 2020.

Financial Results for the Fiscal Quarter Ended September 30,

Net loss attributable to common stockholders for the fiscal quarter

ended September 30, 2019 decreased to approximately $5.7 million

compared to $7.7 million for the fiscal quarter ended September 30,

2018, primarily attributable to research and development activities

relating to the Company's CNS drug development

Research and development expense decreased to $4.2 million for the

fiscal quarter ended September 30, 2019, compared with $5.3 million

for the fiscal quarter ended September 30, 2018. Expense for the

quarter ended September 30, 2018 included $2.25 million noncash

expense associated with the Company's acquisition of its

exclusive worldwide license to develop and commercialize PH94B and

an option to acquire an exclusive worldwide license to develop and

commercialize PH10, the Company's first-in-class, rapid-onset

neuroactive nasal spray in Phase 2 development for major depressive

disorder, which option was subsequently exercised. Offsetting this

noncash expense in the quarter ended September 30, 2019 are

increased expenses for the ELEVATE study and various nonclinical

activities across the Company's CNS pipeline.

General and administrative expense decreased to approximately $1.1

million in the fiscal quarter ended September 30, 2019, compared to

approximately $2.2 million in the fiscal quarter ended September

30, 2018. Noncash expense of $272,000 in the quarter ended

September 30, 2019, decreased from $792,000 in the quarter ended

September 30, 2018, primarily due to decreases in stock-based

compensation and other expenses.

At September 30, 2019, VistaGen had cash and cash equivalents of

$4.1 million, compared to $13.1 million at March 31,

As of November 6, 2019, there were 43,222,965 shares of common

VistaGen's CNS Pipeline

is developing three new generation clinical-stage CNS drug

candidates, AV-101, PH10 and PH94B, each with a differentiated

mechanism of action, an exceptional safety profile in all clinical

studies to date, and therapeutic potential in multiple CNS markets

where current treatments are inadequate to meet high unmet patient

AV-101 belongs to a new

generation of investigational medicines in neuropsychiatry and

neurology known as NMDA (N-methyl-D-aspartate) receptor modulators.

The NMDA receptor is a pivotal receptor in the brain and abnormal

NMDA function is associated with numerous CNS diseases and

disorders. AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and

selective full antagonist of the glycine co-agonist site of

the NMDA receptor. Based on several positive preclinical studies

and its exceptional safety profile in all preclinical and clinical

studies to date, AV-101 has potential to be a new at-home,

non-sedating treatment for multiple large market CNS indications,

including major depressive disorder, neuropathic pain, suicidal

ideation, epilepsy and dyskinesia associated with levodopa therapy

for Parkinson's disease. The FDA has granted Fast Track

designation for development of AV-101 as both a novel

potential adjunctive treatment

for MDD and a non-opioid treatment

for neuropathic pain.

PH10 is a first-in-class,

odorless, rapid-onset CNS neuroactive nasal spray in development

for treatment of major depressive disorder. Administered in

microgram doses, PH10 activates nasal chemosensory receptors that,

in turn, engage neural circuits that lead to rapid antidepressant

effects without psychological side effects, systemic exposure or

safety concerns often associated with current oral antidepressants

and ketamine-based therapies (intravenous ketamine or esketamine

nasal spray). In an exploratory (n=30) randomized, double-blind,

placebo-controlled Phase 2a clinical study in major depressive

disorder, at microgram doses, rapid-onset antidepressant effects

were observed and sustained for 8 weeks, without psychological side

effects or systemic exposure. VistaGen is preparing for planned

Phase 2b clinical development of PH10 for major depressive

PH94B is a first-in-class,

odorless, rapid-onset (approximately 10 to 15 minutes) CNS

neuroactive nasal spray with the potential to be the first

FDA-approved, as-needed, on-demand treatment for millions of

Americans who suffer from social anxiety disorder, with additional