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): May 2, 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 Japanese
Patent Office has issued a Notice of Allowance for a patent related
to certain methods of production for AV-101 (L-4-chlorokynurenine), the Company’s
oral CNS drug
candidate. AV-101 is in Phase 2
clinical development in the United States as an adjunctive
treatment of Major Depressive Disorder in patients with an
inadequate response to current antidepressants approved by the U.S.
Food and Drug Administration. 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: May 2,
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 May 2,
2018
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Exhibit
99.1
VistaGen Therapeutics Receives Notice of Allowance for Japanese
Patent regarding Methods of Production for AV-101
South San Francisco, CA (May 2, 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 that
the Japanese Patent Office (JPO) has issued a Notice of Allowance
for a patent related to certain methods of production for AV-101,
the Company’s oral
CNS drug candidate. VistaGen’s ongoing Phase 2 clinical study
of AV-101, the ELEVATE study, is designed to evaluate the efficacy
and safety of oral AV-101 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).
“This
patent will be the Japanese counterpart to U.S. Patent No.
9,834,801 granted to us by the U.S. Patent and Trademark
Office (USPTO) in December 2017, and European Patent Application
14770640 for which we received a Notice of Intention to Grant from
the European Patent Office (EPO) in April 2018,”
stated Shawn Singh, Chief
Executive Officer of VistaGen. “We are pleased that
our international intellectual property protection for AV-101 now
includes Japan. We look forward to expanding our AV-101 patent
portfolio in Japan in a manner similar to recent expansions in both
the U.S. and Europe earlier this year.”
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 Major
Depressive Disorder (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 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 SSRIs and
SNRIs. AV-101’s mechanism of action (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
for at-home use 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 diseases and 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.
Forward-Looking Statements
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 to 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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