Full Press Release Details
VistaGen Therapeutics Reports Second Fiscal Quarter 2018 Financial
Results and Provides Business Update
SOUTH SAN FRANCISCO, CA -- (Marketwired November 9, 2017)
-- VistaGen 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 reported its financial results for
its second fiscal quarter ended September 30,
The Company also provided an update on its corporate progress and
recently achieved milestone for AV-101, its oral CNS drug candidate
in Phase 2 development, initially as a new generation adjunctive
treatment for major depressive disorder (MDD).
The FDA's recent authorization to proceed under our
AV-101 IND application is a significant milestone in our Phase 2
program focused on MDD, commented Shawn Singh, Chief Executive Officer of
authorization, we are now one step closer towards our goal of
commencing our 180-patient, multi-center, double-blind,
placebo-controlled Phase 2 adjunctive treatment study in the first
Milestones achieved during the quarter:
In October 2017, the U.S. Food and Drug Administration (FDA)
authorized the Company to proceed
under its Investigational New Drug (IND) application
with its planned 180-patient,
multi-center, double-blind, placebo-controlled Phase 2 study to
assess the safety, tolerability and efficacy of AV-101 as an orally
administered adjunctive treatment for adult MDD patients with an
inadequate response to standard, FDA-approved antidepressants. Dr.
Maurizio Fava of Harvard Medical School will be the Principal
Investigator of this study, expected to begin in the first quarter
of 2018 with completion expected at the end of
Recent Operational Highlights:
Intellectual Property Accomplishments
Office granted a European
Patent for AV-101 relating to the
treatment of depression, Parkinson's disease levodopa-induced
dyskinesia (PD LID) and use of multiple dosage forms to treat these
CNS disorders. The patent has been validated in Belgium, Denmark,
France, Germany, Ireland, Italy, Portugal, Spain, Switzerland and
the United Kingdom. It will be in effect until January
The Company received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S.
Patent Application No. 14/775,287 related
to certain methods of production for AV-101.
The corresponding patent application
methods of production for AV-101 was also granted in
Bolstered Clinical Team with Industry Expert
The Company appointed David Rotella, Ph.D. to the Scientific
Advisory Board of VistaStem Therapeutics, the Company's wholly owned subsidiary focused on
utilizing the Company's stem cell technology, to assist in
advancing VistaStem's small molecule drug rescue objectives and in
evaluating other CNS-focused programs intended to expand
VistaGen's drug development pipeline. Dr. Rotella has
extensive academic research and pharmaceutical industry experience
in both medicinal chemistry and drug discovery, including key
leadership roles on teams at Wyeth, Pfizer and Bristol-Meyers
focused on drug candidates to fight cancer, cardiovascular disease,
metabolic disorders, and neurodegenerative
Financial Results for the Fiscal Quarter Ended September 30,
Net loss for the fiscal quarter ended September 30, 2017 was
approximately $5.0 million, including non-cash expenses of
approximately $2.1 million, compared to $3.1 million for the fiscal
quarter ended September 30, 2016, which included non-cash expenses
of approximately $0.7 million.
Research and development expense totaled approximately $2.4 million
for the fiscal quarter ended September 30, 2017, compared with
approximately $1.6 million for the fiscal quarter ended September
30, 2016. The increase in year-over-year research and development
expense was attributable to the Company's increased focus on
the continuing nonclinical and clinical development of AV-101 and
ongoing preparations to launch its AV-101 MDD Phase 2 adjunctive
General and administrative expense was approximately $2.6 million
in the fiscal quarter ended September 30, 2017, compared to
approximately $1.5 million in the fiscal quarter ended September
30, 2016, reflecting increased professional services expenses and
noncash expense attributable to the grant of common stock for
services, noncash warrant modification expense and, to a lesser
extent, salary and benefits and noncash stock compensation
At September 30, 2017, the Company had cash of approximately $1.76
million, compared to approximately $1.63 million as of June 30,
2017. In September 2017, the Company completed an underwritten
public offering of shares of its common stock and warrants. The
gross proceeds from this offering were approximately $2.4 million,
resulting in net proceeds of $2.0 million, after deducting the
underwriting discount and offering expenses.
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other CNS disorders. VistaGen's lead
CNS product candidate, AV-101, is in Phase 2 development, initially
as a new generation oral antidepressant drug candidate for MDD.
AV-101's mechanism of action is fundamentally different from all
FDA-approved antidepressants and atypical antipsychotics used
adjunctively to treat MDD, with potential to drive a paradigm shift
towards a new generation of safer and faster-acting
antidepressants. AV-101 is currently being evaluated by the NIMH in
a small Phase 2 monotherapy study in MDD being fully funded by the
NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the
Neurobiology and Treatment of Mood Disorders and Chief of
Experimental Therapeutics and Pathophysiology Branch at the NIMH.
VistaGen is preparing to launch a 180-patient Phase 2 study of
AV-101 as an adjunctive treatment for MDD patients with an