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): September 28, 2017
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
|
NEVADA
|
001-37761
|
20-5093315
|
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification Number)
|
|
343 Allerton Ave.
South San Francisco, California 94090
|
|
(Address of principal executive offices)
|
(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:
☐ 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))
Item 8.01
Other Events.
On September 28, 2017, VistaGen Therapeutics, Inc. (the
“Company”) announced its receipt of 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 Company’s
lead product candidate for the treatment of Major Depressive
Disorder and certain other diseases and disorders of the
central nervous system. 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
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.
|
|
VistaGen
Therapeutics, Inc.
|
|
|
|
|
|
|
Date:
October 2, 2017
|
By:
|
/s/ Shawn K. Singh
|
|
|
|
Shawn
K. Singh
Chief
Executive Officer
|
EXHIBIT INDEX
|
Exhibit Number
|
|
Description
|
|
|
|
|
|
|
Press
release issued by VistaGen Therapeutics, Inc., dated September 28,
2017.
|
Exhibit
99.1
VistaGen Receives Notice of Allowance from U.S.
Patent and Trademark Office for U.S. Patent Regarding Methods of
Production for AV-101
South San Francisco, CA (September 28, 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 receiving a Notice of Allowance from the
U.S. Patent and Trademark Office (USPTO) for U.S. Patent
Application No. 14/775,287 related to certain methods of production
for AV-101, VistaGen’s lead CNS product
candidate.
"We are
pleased that the USPTO has allowed this U.S. patent relating to
production methods for AV-101 at this significant period in its
clinical development. Together with other granted patents and
pending patent applications, this new patent will enhance our
exclusivity for AV-101,” stated Shawn Singh, Chief
Executive Officer of VistaGen. “We are
also pleased that a corresponding patent application has been
granted in China. Together with the Notice of Intention to Grant
European Patent 2948140B1, which relates to treatment of depression
with AV-101 and its use to reduce levodopa-induced dyskinesia
associated with Parkinson's disease therapy, this Notice of
Allowance in the U.S. is yet another important step forward,
further strengthening and expanding our AV-101 IP
portfolio.”
About VistaGen
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other central nervous system (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 U.S.
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. Dr.
Maurizio Fava of Harvard University will be the Principal
Investigator of the Company’s Phase 2 adjunctive treatment
study. 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,
levodopa-induced dyskinesia associated with Parkinson’s
disease therapy and other disorders where modulation of the NMDA
receptors, activation of AMPA 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 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
###