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): November 12,
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:
☐ 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 November 12, 2018, VistaGen Therapeutics,
Inc. (the “Company”) announced that the
Company received Notices of Allowance from IP Australia and the
Japan Patent Office related to methods of treating depression with
AV-101, the Company’s oral NMDA
(N-methyl-D-aspartate) receptor glycine B antagonist
in Phase 2
development for adjunctive treatment of major depressive
disorder. 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. The information in this Item 8.01
and the press release attached hereto as Exhibit 99.1 shall not be
deemed “filed” for purposes of Section 18 of the
Exchange Act, nor shall such information be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as
amended.
Item 9.01 Financial
Statements and Exhibits.
(d) Exhibits Index
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Exhibit
No.
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Description
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Press release
issued by VistaGen Therapeutics Inc. dated November 12,
2018.
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Disclaimer.
This
Current Report on Form 8-K may contain, among other things, certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including, without
limitation, (i) statements with respect to the Company's plans,
objectives, expectations and intentions; and (ii) other statements
identified by words such as "may", "could", "would", should",
"believes", "expects", "anticipates", "estimates", "intends",
"plans" or similar expressions. These statements are based upon the
current beliefs and expectations of the Company's management and
are subject to significant risks and
uncertainties.
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:
November 13, 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 November 12,
2018.
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Exhibit
99.1
VistaGen Therapeutics Receives Notices of Allowance in Australia
and Japan for AV-101 Patents Covering Treatment of
Depression
SOUTH SAN FRANCISCO, Calif., Nov. 12, 2018 – VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for central nervous
system (CNS) diseases and disorders with high unmet need, today
announced receiving Notices of Allowance from IP Australia and the
Japan Patent Office (JPO) related to methods of treating depression
with AV-101, VistaGen’s oral NMDA (N-methyl-D-aspartate) receptor
glycine B antagonist in Phase 2 development for adjunctive
treatment of major depressive disorder (MDD).
“These
patents, when issued, will extend our commercial protection of
AV-101 into Australia and Japan, two additional major
pharmaceutical markets,” stated Shawn
Singh, Chief Executive Officer of VistaGen. “As we continue to move
forward with our clinical development of AV-101 for adjunctive
treatment of MDD, having important AV-101 intellectual property
outside of the U.S. and Europe is essential for potential strategic
partnering opportunities in selected regional markets and to
support our mission to bring new treatment alternatives for CNS
conditions with unmet need to individuals around the
world."
About VistaGen
VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing new generation medicines for multiple CNS
diseases and disorders with high unmet need. For more information,
please visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
About AV-101
AV-101 is an investigational, orally bioavailable, small molecule
NMDA (N-methyl-D-aspartate) receptor glycine B antagonist with the
potential to be a treatment for multiple CNS indications with high
unmet need. AV-101 is currently in Phase 2 clinical development in
the United States for adjunctive treatment of
MDD. The
FDA has granted
Fast Track designation for
development of AV-101 as both a potential adjunctive treatment of
MDD and as a non-opioid treatment for neuropathic
pain.
Forward-Looking Statements
This release contains various statements concerning VistaGen's
future expectations, plans and prospects, including without
limitation, our expectations regarding development and
commercialization of our drug candidates, including AV-101 for
adjunctive treatment of MDD and as a non-opioid treatment for
neuropathic pain, as well as our intellectual property and
commercial protection of AV-101, all of which 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 during our clinical development of any product
candidate that cause us to discontinue further development, (ii) we
may not be able to successfully demonstrate the safety and efficacy
of our product candidates 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
studies, and ongoing or future preclinical and clinical results may
not support further development of, or be sufficient to gain
regulatory approval to market our drug candidates, (iv) decisions
or actions of regulatory agencies may negatively affect the
progress of, and our ability to proceed with, further clinical
studies or to obtain marketing approval for our drug candidates,
(v) we may not be able to obtain or maintain adequate intellectual
property protection and other forms of marketing and data
exclusivity for our product candidates, (vi) we may not have access
to or be able to secure substantial additional capital to support
our operations, including our ongoing clinical development
activities; and (vii) we may encounter technical and other
unexpected hurdles in the manufacturing and development of any of
our 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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