UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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 7, 2018
Commission File Number: 001-37761
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter.)
(Exact name of registrant as specified in its charter.)
Nevada
(State or other jurisdiction of incorporation or organization)
(State or other jurisdiction of incorporation or organization)
205093315
(IRS Employer Identification No.)
(IRS Employer Identification No.)
343 Allerton Avenue, South San Francisco, California 94080
(Address of principal executive offices)
(Address of principal executive offices)
650-577-3600
(Registrant's Telephone number)
(Registrant's Telephone number)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
(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)
Emerging growth company [ ]
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 March 7, 2018, VistaGen Therapeutics, Inc. (the "Company") announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its U.S. patent application no. 15/018,219 related to methods of treating depression with AV-101, the Company's oral new generation glutamatergic product candidate in Phase 2 development for the treatment of Major Depressive Disorder. 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 List.
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 hereunto duly authorized.
| VistaGen Therapeutics, Inc. |
Date: March 7, 2018
| By: | /s/ Shawn K. Singh |
| Name: Shawn K. Singh | |
| Title: Chief Executive Officer |
Exhibit Index
|
Exhibit No.
|
Description
|
|
|
EX-99.1
|
Press release issued by VistaGen Therapeutics Inc., dated March 7, 2018.
|
Exhibit 99.1
VistaGen Therapeutics
Receives Notice of Allowance for a Key U.S. Patent Covering
Treatment of Depression with AV-101
South San Francisco, CA (March 7, 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. 15/018,219 related
to methods of treating depression with AV-101, its oral 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 Notice of Allowance from the USPTO is a major development,
representing one of the most significant patent applications ever
allowed to our company,” stated Shawn
Singh, Chief Executive Officer of VistaGen.
“This patent will be one of the
core components of our commercial protection strategy for AV-101 in
the U.S., the world’s largest pharmaceutical market. It will
both enhance and expand substantially our U.S. market exclusivity
for AV-101. We
are continuing to pursue additional patents for AV-101, in the U.S.
and other major pharmaceutical markets, to further fortify our
global patent portfolio for this promising CNS drug
candidate.”
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. AV-101 may also have the potential to treat
neuropathic pain, epilepsy, Parkinson's disease levodopa-induced
dyskinesia (PD LID), suicidal ideation and other CNS diseases and
disorders where modulation of the NMDA receptors, activation of
AMPA pathways 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
###