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): March 13, 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 7.01 Regulation FD
Disclosure.
On March 13, 2019, VistaGen Therapeutics, Inc.
(the “Company”) began utilizing a new corporate
presentation. A copy of the Corporate Presentation is attached
hereto as Exhibit 99.1.
The information in this Item 7.01 of this Current
Report on Form 8-K, including the information set
forth in Exhibit 99.1, is being furnished and shall not be
deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the
“Exchange
Act”), nor shall Exhibit
99.1 filed herewith be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in such a filing.
Item 8.01 Other Events.
On March 13, 2019, the Company announced
that the U.S. Patent and Trademark Office has issued a Notice of
Allowance for U.S. Patent
Application 15/812,599 related to certain methods of production for
AV-101, the Company’s oral NMDA receptor glycine site
antagonist in Phase 2 development for major depressive disorder.
A copy of this press release is
attached to this Current Report on Form 8-K as Exhibit
99.2.
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 thereunto duly authorized.
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VistaGen
Therapeutics, Inc.
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Date:
March 14, 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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Corporate
Presentation, dated March 13, 2019
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Press
Release issued by VistaGen Therapeutics, Inc., dated March 13,
2019
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Exhibit
99.2
VistaGen Therapeutics Receives Notice of Allowance for Additional
U.S. Patent Regarding Methods of Production for AV-101
SOUTH SAN FRANCISCO, Calif., March 13, 2019 - VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other central nervous system (CNS) diseases and
disorders with high unmet need, today announced that the U.S.
Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for U.S. Patent
Application 15/812,599 related to certain methods of
production for AV-101, VistaGen's oral NMDA receptor glycine site
antagonist in Phase 2 development for major depressive disorder
(MDD). The patent, once
issued, will expand upon the related claims obtained in
U.S. Patent No. 9,834,801 granted
to VistaGen by the USPTO in December 2017 and will not expire until
at least 2034.
VistaGen’s AV-101 (4-Cl-KYN) is an investigational, oral NMDA
receptor glycine site antagonist with potential to be a treatment
for multiple CNS indications with high unmet need. AV-101 is
currently in Phase 2 clinical development in the U.S. for MDD and
in a first-step target
engagement study in healthy volunteer U.S. military Veterans for
suicidal ideation. The
U.S. Food and Drug Administration
(FDA) has granted
Fast Track designation for development of
AV-101 as
both a potential adjunctive treatment for MDD and as a
non-opioid treatment for neuropathic pain.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines with for multiple CNS diseases
and disorders with high unmet need. Each of VistaGen’s CNS
pipeline candidates, AV-101, PH10 and PH94B, has potential for
convenient, at-home use, rapid-onset therapeutic benefits, and
exceptional safety. As noted above, AV-101 is an oral NMDA receptor
glycine site antagonist (a full antagonist) in Phase 2 development
in the U.S. for treatment of MDD and in a first-step target
engagement study in healthy volunteer U.S. military Veterans for
suicidal ideation. PH10 nasal spray is a potential
first-in-class CNS neuroactive steroid with rapid-onset
antidepressant effects observed at microgram doses and without
systemic exposure. PH10 is in Phase 2 development for MDD. PH94B
nasal spray is a potential first-in-class CNS neuroactive steroid
with rapid-onset effects observed at microgram doses and without
systemic exposure. Phase 2 development for PH94B for social anxiety
disorder (SAD) has been completed successfully, and PH94B is now
being prepared for Phase 3 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,
our expectations regarding development and commercialization of our
CNS pipeline, including AV-101 for MDD, neuropathic pain and
suicidal ideation, PH94B for SAD, and PH10 for MDD, as well as our
intellectual property and commercial protection 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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