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): December 6, 2017
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.
On December 6, 2017, VistaGen Therapeutics,
Inc. (the "Company")
announced that the U.S. Patent and Trademark Office issued U.S.
Patent No. 9,834,801 related to certain methods of production for
AV-101, the Company's lead product candidate. A copy of the press
release is attached to this Current Report on Form 8-K as Exhibit
99.1, and is incorporated herein by
reference.
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:
December 6, 2017
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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 December 6,
2017.
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Exhibit
99.1
VistaGen Therapeutics Granted U.S. Patent regarding Methods of
Production for AV-101
South San Francisco, CA (December 6, 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 announced the U.S. Patent and Trademark Office
(USPTO) has issued U.S. Patent No.
9,834,801 related to certain methods of production for
AV-101, VistaGen’s lead CNS product candidate.
"The
issuance of this U.S. patent by the USPTO advances our intellectual
property strategy for AV-101 at this vital period in its clinical
development. This issued U.S. patent, in conjunction with the
potential issuance of additional AV-101 patent applications
currently under review worldwide, provides VistaGen with added
long-term intellectual property protection for AV-101 and enhances
its commercial potential,” stated Shawn Singh, Chief
Executive Officer of VistaGen.
About VistaGen
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 major
depressive disorder (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 National Institute of Mental
Health (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
inadequate response to standard, FDA-approved antidepressants, with
Dr. Maurizio Fava of Harvard University as Principal Investigator.
AV-101 may also have the potential to treat multiple CNS disorders
and neurodegenerative diseases in addition to MDD, including
neuropathic pain, epilepsy, Huntington's disease, Parkinson’s
disease levodopa-induced dyskinesia and other disorders where
modulation of the NMDA receptors, activation of the AMPA
neurotransmitter pathways and/or key active metabolites of AV-101
may achieve therapeutic benefit.
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
securing sufficient funding for, and the launch, continuation and
results of the NIMH's Phase 2 (monotherapy) and/or the Company's
planned Phase 2 (adjunctive treatment) clinical studies of AV-101
in MDD, and other CNS diseases and disorders, including neuropathic
pain and PD LID, allowance of patent applications and continued
protection of its intellectual property, and the availability of
substantial additional capital to support its operations, including
the AV-101 Phase 2 adjunctive treatment study and other potential
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
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