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): March 19, 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 received a Notice of Allowance from
the U.S. Patent and Trademark Office (USPTO) for its U.S. patent
application no. 14/762,015 related to oral formulations of AV-101,
its new generation glutamatergic product candidate in Phase 2
development for treatment of Major Depressive Disorder. A copy of
the Company’s press release announcing the receipt of the
Notice of Allowance 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:
March 19, 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 March 19,
2018
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Exhibit
99.1
VistaGen Therapeutics Receives a Notice of Allowance for Another
Key
U.S. Patent Covering Oral Formulations of AV-101
South San Francisco, CA (March 19, 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 receiving a Notice of Allowance from the U.S. Patent and
Trademark Office (USPTO) for U.S. patent application no. 14/762,015
related to oral formulations of AV-101, its new generation
glutamatergic product candidate in Phase 2 development for
treatment of Major Depressive Disorder (MDD). When issued, the U.S.
patent will not expire until at least 2034.
"This
additional Notice of Allowance from the USPTO is yet another major
development for our company,” stated Shawn Singh, Chief
Executive Officer of VistaGen.
“Following on the heels of the highly significant Notice of
Allowance for methods of treating depression that we received from
the USPTO on March 7, 2018, this patent is another of the core
components of our commercial protection strategy for AV-101 in the
U.S., further enhancing and expanding substantially our foundation
for U.S. market exclusivity for AV-101."
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 glycine B antagonist in
Phase 2 development, initially as a new adjunctive treatment for
Major Depressive Disorder (MDD) patients with an inadequate
response to current FDA-approved antidepressants. AV-101's
mechanism
of action is fundamentally different from all current
antidepressants and atypical antipsychotics often used adjunctively
to augment them. Most current antidepressants target the
neurotransmitters serotonin (SSRIs) and/or norepinephrine (SNRIs)
and, if effective, take many weeks to achieve therapeutic benefits.
VistaGen's AV-101 targets glutamate, the most prevalent
neurotransmitter in the brain, and, similar to ketamine, also a
NMDA receptor antagonist, has potential to drive a paradigm shift
towards a new generation of faster-acting glutamatergic
antidepressants. VistaGen’s orally available AV-101 may also
have potential in conjunction with ketamine treatment for MDD and
suicidal ideation, as a non-opioid alternative to gabapentin for
neuropathic pain and epilepsy, to reduce dyskinesia associated with
Huntington’s disease and levodopa therapy for Parkinson's
disease (PD LID), and for other CNS diseases and disorders where
modulation of the NMDA receptors, activation of AMPA receptors
and/or key active metabolites of AV-101 may achieve therapeutic
benefits.
For
more information, please visit www.vistagen.com
and connect with VistaGen on Twitter,
LinkedIn and
Facebook.
Forward-Looking Statements
The statements in this press release that are not historical facts
may constitute forward-looking statements that are based on current
expectations and are subject to risks and uncertainties that could
cause actual future results to differ materially from those
expressed or implied by such statements. Those risks and
uncertainties include, but are not limited to, risks related to the
successful launch, continuation and results of the NIMH’s
Phase 2 (monotherapy) and/or the Company’s planned Phase 2
(adjunctive therapy) clinical studies of AV-101 in MDD, and other
CNS diseases and disorders, including neuropathic pain and
levadopa-induced dyskinesia associated with Parkinson’s
disease therapy, protection of its intellectual property, and the
availability of substantial additional capital to support its
operations, including the AV-101 clinical development activities
described above. These and other risks and uncertainties are
identified and described in more detail in VistaGen’s filings
with the Securities and Exchange Commission (SEC). These filings
are available on the SEC’s website at www.sec.gov.
VistaGen undertakes no obligation to publicly update or revise 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