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): January 31,
2019
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 January 31, 2019, VistaGen Therapeutics,
Inc. (the “Company”) announced data from
nonclinical studies indicating that its orally available CNS drug
candidate, AV-101 (4-chlorokynurenine), promotes hippocampal
neurogenesis, the process by which new neurons are formed in a
region of the brain that involves high-level functions such as
emotions, memory, and spatial navigation and
exploration. A copy of the Company's press
release is attached to this Current Report on Form 8-K as Exhibit
99.1.
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 January 31,
2019.
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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: January
31, 2019
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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 January 31,
2019.
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Exhibit
99.1
AV-101
Stimulates the Formation of New Brain Cells in Nonclinical
Studies
SOUTH SAN FRANCISCO, Calif., Jan 31, 2019 – 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 data from nonclinical studies indicating that its orally
available CNS drug candidate, AV-101 (4-chlorokynurenine), promotes
hippocampal neurogenesis, the process by which new neurons are
formed in a region of the brain that involves high-level functions
such as emotions, memory, and spatial navigation and
exploration.
“The
development of new neurons is a vital part of our mental growth
during adulthood, and the exciting results of these nonclinical
studies highlight AV-101’s potential to promote
adult hippocampal neurogenesis. We believe these results are
potentially far-reaching, especially given that enhanced
hippocampal cell proliferation provides protection against
stress-related psychiatric disorders, including depression,”
stated Shawn Singh, Chief
Executive Officer of VistaGen.
Robert
Schwarcz, Ph.D., Professor of Psychiatry, University of Maryland,
Baltimore, and Gloria Hoffman, Ph.D., Professor of Biology, Morgan
State University, Baltimore, conducted the rodent studies, which
showed increased neurogenesis in the hippocampus following oral
daily dosing of AV-101 for 14 -16 days. Neurogenesis was
demonstrated by detecting an increased number of cells containing
Ki67, a marker of dividing cells, scored by scientists blinded to
the treatment groups. These results are consistent with recent
observations that sustaining the therapeutic activity of other new
generation fast-acting antidepressants, such as ketamine, is
dependent on a neurogenic effect. The detailed results of these
studies will be presented at an upcoming psychiatry
conference.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. Each of VistaGen’s CNS
pipeline candidates, AV-101, PH10 and
PH94B, has potential to provide rapid-onset therapeutic benefits
without the psychological and other side effects, safety concerns
or inconvenient clinical administration associated with many
current and potential new generation medications for CNS diseases
and disorders such as major depressive disorder (MDD) and social
anxiety disorder (SAD). Each drug candidate in VistaGen’s
pipeline is either currently in or has completed Phase 2 clinical
development in the United States. AV-101, an oral NMDA receptor
glycine B antagonist, is in Phase 2 development, initially as an
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. PH10
intranasal, a first-in-class neuroactive steroid with rapid onset
effects, is in Phase 2 development for MDD. PH94B intranasal, also a first-in-class
neuroactive steroid with rapid onset effects, has completed Phase 2
development and is now being prepared for pivotal Phase 3 clinical
development as an on-demand PRN treatment of
SAD.
For
more information, please visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This release contains various statements concerning VistaGen's
future expectations, plans and prospects, including without
limitation, potential benefits connected to our drug candidates and
our expectations regarding development and commercialization of our
drug candidates, 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 AV-101, PH94B, and/or PH10, (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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