Full Press Release Details
VistaGen Therapeutics Reports Second Quarter 2017 Financial Results
South San Francisco, CA (November 14, 2016) VistaGen
Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company focused on developing new generation
therapies for depression and other central nervous system
(CNS) disorders, today
reported financial results for the second quarter of fiscal 2017
ended September 30, 2016.
Company also provided an update on its corporate progress,
including clinical status and anticipated milestones for AV-101,
its new generation, orally available prodrug candidate in Phase 2
development, initially for the adjunctive treatment of major
depressive disorder (MDD)
in patients with an inadequate response to standard, U.S. Food and
Drug Administration (FDA)-approved
continue to make great strides in 2016, achieving milestones which
have been fundamental to our plans for 2017, which we believe will
be another dynamic and transformative year for our
shareholders, commented Shawn Singh, Chief Executive
Officer of VistaGen.
Recent Corporate Highlights:
Mark A. Smith M.D., Ph.D. as
Chief Medical Officer, former Clinical Lead for
Neuropsychiatry at Teva Pharmaceuticals, to lead late-stage
clinical development of AV-101;
Mark A. McPartland as Vice
President, Corporate Development and Investor Relations, to
expand awareness of VistaGen and its AV-101 development program
among investors, patients, researchers, clinicians and potential
NASDAQ Capital Market; and
million public offering, led by institutional
is currently being evaluated in an ongoing Phase 2a monotherapy
study for the treatment of MDD. This study is being fully funded by
the U.S. National Institute of Mental Health (NIMH), part of the U.S. National
Institutes of Health (NIH). The Principal Investigator of
the study is Dr. Carlos Zarate Jr., Chief, Section on the
Neurobiology and Treatment of Mood Disorders and Chief of
Experimental Therapeutics and Pathophysiology Branch at the
Company is preparing to advance AV-101 into a 280-patient, U.S.
multi-center, Phase 2b adjunctive treatment study in MDD in the
first half of 2017, prior to the completion of the ongoing
NIMH-sponsored AV-101 Phase 2a monotherapy study. Dr. Maurizio Fava
of Harvard University will be the Principal Investigator of the
Phase 2b study, which will be a double-blind, placebo controlled
efficacy and safety study of AV-101 as adjunctive treatment of MDD
patients with inadequate response to standard antidepressants. The
Phase 2b study will utilize a Sequential Parallel Comparison Design
clinical study design intended to mitigate potential placebo
effects. The Company anticipates topline results from this Phase 2b
study to be reported in the second half of 2018.
Expected Near-Term Milestones:
Investigational New Drug application (IND) to the FDA for a Phase
2b study of AV-101 as adjunctive treatment of MDD in the first half
Phase 2b study as adjunctive treatment of MDD in patients with
inadequate response to standard antidepressants, in the first half
designation for AV-101 as adjunctive treatment of MDD in the first
from NIMH-sponsored AV-101 Phase 2a MDD monotherapy study in the
Summary of Financial Results for the Second Quarter of Fiscal 2017
Ended September 30, 2016
second fiscal quarter ended September 30, 2016, the Company
reported a net loss of approximately $3.1 million, or a net loss
attributable to common stockholders of $0.42 per common share,
compared to a net loss of approximately $5.1 million, or a net loss
attributable to common stockholders of $0.91 per common share for
the same period in the prior year. Research and development expense
totaled $1.61 million for the quarter ended September 30, 2016, a
3% decrease compared with the $1.66 million reported for the
quarter ended September 30, 2015, reflecting our increasing focus
on the continued development of AV-101 and preparations to launch
our AV-101 Phase 2b study in MDD, which we currently anticipate to
begin in the first half of 2017, offset by a reduction in noncash
stock compensation expense compared to the same period in the prior
year. General and administrative expense decreased to $1.5 million
for the second quarter ended September 30, 2016, from $3.7 million
for the same period in the prior year. The changes in G&A are
the result of a decrease in noncash stock compensation expense
attributable to option and fully-vested warrant grants to
employees, members of our Board of Directors and consultants and
noncash expense related to grants of equity securities in payment
of certain professional services, offset by a combination of
corporate expenses, including investor relations and corporate
development initiatives, our Nasdaq listing fees and compensation
and headcount increases.
September 30, 2016, the Company had approximately $6.3 million of
cash and cash equivalents. The Company believes it has sufficient
financial resources to fund its expected operations through the
(4-CI-KYN) is an orally
available prodrug candidate, currently in Phase 2 development,
initially for the adjunctive treatment of MDD in patients with an
inadequate response to standard, FDA-approved antidepressants.
AV-101 has broad potential utility in other CNS diseases and
disorders, including chronic neuropathic pain, epilepsy and
neurodegenerative diseases, such as Parkinson's disease and
Huntington's disease. Orally available AV-101 is rapidly absorbed
through the gut, and then actively transported across the
blood-brain barrier. Astrocytes in the brain rapidly convert AV-101
into its active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), a well-characterized,
potent and selective antagonist of N-methyl-D-aspartate
(NMDA) receptors, acting by
blocking the glycine-binding co-agonist site of the NMDA receptor.