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): June 13, 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.
VistaGen Therapeutics, Inc. (the "Company") announced today that the U.S. Patent and Trademark Office has issued two U.S. patents related to AV-101, the Company's oral new generation central nervous system ("CNS") product candidate in Phase 2 development for treatment of Major Depressive Disorder ("MDD"), consisting of U.S. Patent No. 9,993,453 related to AV-101's therapeutic uses to treat depression and U.S. Patent No. 9,993,450 related to AV-101's oral dosage formulations. 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 hereunto duly authorized.
| VistaGen Therapeutics, Inc. |
Date: June 13, 2018
| By: | /s/ Shawn K. Singh |
| Name: Shawn K. Singh | |
| Title: Chief Executive Officer |
Exhibit Index
|
Exhibit No.
|
Description
|
|
|
EX-99.1
|
Press Release
|
VistaGen Therapeutics Issued Two Key U.S. Patents for Treatment of
Depression with AV-101
South San Francisco, CA (June 13, 2018) – VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for depression and
other central nervous system (CNS) diseases and disorders, today
announced that the U.S. Patent and Trademark Office (USPTO) has
issued the following two key U.S. patents related to AV-101,
VistaGen’s oral new generation CNS product candidate in Phase
2 development for treatment of Major Depressive Disorder
(MDD):
●
U.S. Patent No.
9,993,453 related to AV-101’s therapeutic uses to
treat depression; and
●
U.S. Patent No.
9,993,450 related to AV-101’s oral dosage
formulations.
The two new AV-101 U.S. patents above will not expire until at
least 2034.
"The
issuance of these U.S. patents is a fundamental advancement of our
plan to secure commercial exclusivity for AV-101 in the
world’s major pharmaceutical markets," stated Shawn Singh, Chief
Executive Officer of VistaGen. “Our primary goal is to
develop and commercialize AV-101 as an oral new generation
antidepressant for convenient at-home use. We believe oral
administration provides greater flexibility for location of care,
which is optimal for people suffering with MDD, and the potential
of rapid onset of symptom reduction can provide life-changing
benefits for millions of people. Today’s U.S. patent
issuances and the initiation earlier this year of ELEVATE, our U.S.
multi-center Phase 2 study of AV-101 in MDD, are milestones in our
AV-101 MDD program, each a significant step forward in our efforts
to provide new treatment alternatives to millions of people
battling depression and its consequences every
day.”
About AV-101
AV-101
is an oral N-methyl-D-aspartate receptor glycine B (NMDAR GlyB)
antagonist in Phase 2 clinical development in the United States.
ELEVATE is
VistaGen’s ongoing Phase 2, multi-center, randomized,
double-blind, placebo-controlled clinical trial designed to
evaluate the efficacy and safety of adjunctive use of oral AV-101
for 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). Dr. Maurizio Fava of Massachusetts General Hospital
and Harvard Medical School is the Principal Investigator of
VistaGen’s ELEVATE study.
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 for a given patient, take many weeks to achieve
therapeutic benefits. AV-101 targets a receptor for 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 as 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. is a clinical-stage biopharmaceutical company
developing new generation medicines for depression and other CNS
diseases and disorders with high unmet need. VistaGen's lead CNS
product candidate, AV-101, is an oral NMDAR GlyB antagonist in
Phase 2 clinical development in the United States for MDD and other
CNS indications.
For
more information, please visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
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Forward-Looking Statements
This release contains various statements 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, and may cause
actual results to differ materially from those contemplated in
these forward-looking statements. Among these risks is the
possibility that (i) we may encounter unexpected adverse events in
patients in our ELEVATE study that cause us to discontinue further
development of AV-101, (ii) we may not be able to successfully
demonstrate the safety and efficacy of AV-101 at each stage of
clinical development, (iii) 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, (iv)
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, (v) we may not be able to obtain or maintain adequate
intellectual property protection and other forms of marketing and
data exclusivity for AV-101, (vi) 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 (vii) we may encounter technical and
other unexpected hurdles in the manufacturing and development of
AV-101 or other product candidates. Certain other risks are 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 the
issuance of this release 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
Media Contact
Caitlin
Kasunich / Lisa Lipson
KCSA
Strategic Communications
Phone:
+1 (212) 896-1241/+1 (508) 843-6428
Email:
VistaGen@KCSA.com
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