UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF
1934
Date of Report (Date of earliest event reported): April 10, 2018
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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001-37761
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20-5093315
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification Number)
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343 Allerton Ave.
South San Francisco, California 94090
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(Address of principal executive offices)
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(650)
577-3600
(Registrant’s telephone number, including area
code)
Not Applicable
(Former name or former address, if changed since last
report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
☐
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
☐
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities
Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR 240.12b-2) ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended
transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the
Exchange Act ☐
Item 8.01
Other Events.
VistaGen Therapeutics, Inc. (the
“Company”) today announced that the European Patent
Office has issued a Notice of Intention to grant a patent related
to certain methods of production for AV-101, the Company’s
oral CNS drug candidate. AV-101 is in Phase 2 clinical development
in the United States under ELEVATE, the Company's ongoing
randomized, double-blind, multi-center, placebo-controlled Phase 2
clinical study to evaluate the efficacy and safety of AV-101
(L-4-chlorokynurenine) as an adjunctive treatment of Major
Depressive Disorder (“MDD”) in patients with an
inadequate response to current antidepressants approved by the U.S.
Food and Drug Administration (“FDA”). A copy of the
Company’s press release is attached to this Current Report on
Form 8-K as Exhibit 99.1 and is incorporated by reference
herein.
Item 9.01
Financial Statements and
Exhibits.
See
Exhibit Index.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
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VistaGen Therapeutics, Inc.
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Date:
April 10, 2018
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By:
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/s/ Shawn K. Singh
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Shawn
K. Singh
Chief
Executive Officer
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EXHIBIT INDEX
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Exhibit No.
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Description
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Press
Release issued by VistaGen Therapeutics, Inc., dated April 10,
2018
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Exhibit
99.1
VistaGen Therapeutics Receives European Patent regarding Methods of
Production for AV-101
South San Francisco, CA (April 10, 2018) –
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other central nervous system (CNS) disorders, today
announced the European Patent Office has issued a Notice of
Intention to grant a patent related to certain methods of
production for AV-101, the Company’s oral CNS drug candidate. AV-101 is in
Phase 2 clinical development in the United States as a new
adjunctive treatment of Major Depressive Disorder in patients with
an inadequate response to current antidepressants that have been
approved by the U.S. Food and Drug Administration
(FDA).
AV-101, an oral N-methyl-D-aspartate (NMDA) receptor glycine B
(GlyB) antagonist, belongs to a new generation of investigational
medicines in neuropsychiatry known as glutamate receptor modulators
having the potential to treat MDD faster than current FDA-approved
antidepressants commonly known as SSRIs and SNRIs, which target the
neurotransmitters serotonin and/or norepinephrine,
respectively.
“This
patent will be the European counterpart to U.S. Patent No.
9,834,801 granted to us by the U.S. Patent and Trademark
Office (USPTO) in December 2017,” stated Shawn Singh, Chief
Executive Officer of VistaGen. “We are pleased that
VistaGen will also have multiple patents relating to AV-101 in
Europe. This is another important step in our strategy to secure
long-term intellectual property protection for AV-101 in the
world’s major pharmaceutical markets, thereby enhancing its
commercial potential."
About AV-101
AV-101
is an oral N-methyl-D-aspartate (NMDA) receptor glycine B (GlyB)
antagonist in Phase 2 clinical development in the United States.
ELEVATE, VistaGen’s
ongoing Phase 2, randomized, double-blind, multi-center,
placebo-controlled clinical trial, is designed to evaluate the
efficacy and safety of adjunctive use of oral AV-101 for MDD in
patients with an inadequate response to standard antidepressant
therapy with either an FDA-approved selective serotonin reuptake
inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor
(SNRI).
AV-101
has a novel mechanism of action (MOA), meaning its MOA is
fundamentally different from all current FDA-approved SSRIs and
SNRIs for depression, most of which, if effective, take many weeks
to achieve therapeutic benefits. AV-101 targets glutamate, the most
prevalent neurotransmitter in the brain. AV-101 inhibits NMDA
receptor activity, activates AMPA pathways and has the potential to
achieve ketamine-like antidepressant effects with an oral drug
candidate that does not cause ketamine’s side effects and
safety concerns. AV-101 may also have the potential to treat
neuropathic pain, epilepsy, Parkinson's disease levodopa-induced
dyskinesia, suicidal ideation and other CNS diseases and disorders
where modulation of the NMDA receptors and activation of AMPA
pathways may achieve therapeutic benefits. The FDA has granted Fast Track
designation to AV-101 for development as a potential adjunctive
treatment of MDD.
About VistaGen
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other CNS disorders. VistaGen’s lead CNS
product candidate, AV-101, is an oral NMDA receptor GlyB antagonist
in Phase 2 clinical development in the United States, initially as
a new adjunctive treatment of MDD in patients with an inadequate
response to current FDA-approved antidepressants.
For
more information, please visit www.vistagen.com
and connect with VistaGen on Twitter,
LinkedIn and
Facebook.
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Various
statements in this release concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development of AV-101, the potential of
AV-101 for the treatment of MDD and various other CNS diseases and
disorders and our intellectual property and commercial protection
of AV-101 constitute forward-looking statements for the purposes of
the safe harbor provisions under the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are
neither promises nor guarantees of future performance, and are
subject to a variety of risks and uncertainties, many of which are
beyond our control, which could cause actual results to differ
materially from those contemplated in these forward-looking
statements. Among these risks is the possibility that we may
encounter unexpected adverse events in patients in our ELEVATE
study that cause us to discontinue further development of AV-101;
we may not be able to successfully demonstrate the safety and
efficacy of AV-101 at each stage of clinical
development; success in preclinical studies or in early-stage
clinical trials may not be repeated or observed in ongoing or
future AV-101 studies, and ongoing or future preclinical and
clinical results may not support further development of AV-101 or
be sufficient to gain regulatory approval to market AV-101;
decisions or actions of regulatory agencies may negatively affect
the progress of the ELEVATE study or the initiation, timing and
progress of future AV-101 clinical trials, and our ability to
proceed with further clinical studies or to obtain marketing
approval; we may not be able to obtain or maintain adequate
intellectual property protection and other forms of marketing and
data exclusivity for AV-101; we may not have access or be able to
secure substantial additional capital to support our operations,
including clinical development of AV-101 activities described
above; and we may encounter technical and other unexpected
hurdles in the manufacturing and development of AV-101 or other
product candidates, as well as those risks more fully discussed in
the section entitled "Risk Factors" in our most recent annual
report on Form 10-K, and subsequent quarterly reports on Form 10-Q,
as well as discussions of potential risks, uncertainties, and other
important factors in our other filings with the Securities and
Exchange Commission (SEC). Our SEC filings are available
on the SEC's website at www.sec.gov. In
addition, any forward-looking statements represent our views only
as of today, and should not be relied upon as representing our
views as of any subsequent date. We explicitly disclaim any
obligation to update any forward-looking statements.
Company Contact
Mark A.
McPartland
VistaGen
Therapeutics Inc.
Phone:
+1 (650) 577-3600
Email:
IR@vistagen.com
Investor Contact:
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
Phone:
+1 (212) 896-1254/+1 (212) 896-1267
Email:
VistaGen@KCSA.com
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