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): October 8, 2019
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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000-54014
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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))
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each
class
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Trading
Symbol(s)
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Name of each
exchange on which registered
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Common
Stock, par value $0.001 per share
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VTGN
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Nasdaq
Capital Market
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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 7.01. Regulation FD Disclosure.
On
October 8, 2019, VistaGen Therapeutics, Inc. (the
“Company”)
began utilizing a new corporate presentation, a copy of which is
attached to this Current Report on Form 8-K as Exhibit
99.1.
The
information in 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
October 8, 2019, the Company issued a press release announcing that
the last patient completed dosing in the Company's ELEVATE Phase 2
clinical study of AV-101 as an adjunctive treatment with an
FDA-approved oral antidepressant for major depressive disorder. The
Company remains on track to report top line results of the ELEVATE
study before the end of 2019. A copy of the press release is
attached to this Current Report on Form 8-K as Exhibit
99.2.
This
Current Report on Form 8-K and the exhibit(s) attached hereto 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.
Item 9.01. 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:
October 8, 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 Number
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Description
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VistaGen
Therapeutics, Inc. Corporate Presentation, dated October
2019.
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Press
Release issued by VistaGen Therapeutics, Inc., dated October 8,
2019.
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Exhibit 99.1
Exhibit 99.2
VistaGen Therapeutics Announces Last Patient Completes Dosing in
the ELEVATE Phase 2 Study of AV-101 for Major Depressive
Disorder
Company on Track to Report Top Line Results Before Year
End
SOUTH SAN FRANCISCO, Calif., October 08, 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, announced today that the last patient has
completed dosing in the ELEVATE Phase 2 clinical study of AV-101,
the Company’s novel, oral NMDA (N-methyl-D-aspartate)
receptor glycine site antagonist, as an adjunctive (add-on)
treatment with an FDA-approved oral antidepressant for major
depressive disorder (MDD). The Company remains on track to report
top line results of the ELEVATE study before the end of
2019.
About AV-101
AV-101
(4-Cl-KYN) belongs to a new generation of investigational medicines
in neuropsychiatry and neurology known as NMDA glutamate receptor
modulators. The NMDA receptor is a pivotal receptor in the brain
and abnormal NMDA function is associated with numerous CNS diseases
and disorders. AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and
selective full antagonist of the glycine coagonist site of the NMDA
receptor. With its exceptional safety profile in all studies to
date, AV-101 has potential to be a new at-home treatment for
multiple large market CNS indications where current treatments are
inadequate to satisfy high unmet patient needs. VistaGen is
currently focused on AV-101’s potential to treat depression,
dyskinesia associated with levodopa therapy for Parkinson’s
disease, epilepsy, neuropathic pain and suicidal ideation. The FDA
has granted Fast Track designation for development of AV-101 as a
potential adjunctive treatment for MDD and as
a non-opioid treatment for neuropathic pain.
About the ELEVATE Study
Among VistaGen's key objectives for AV-101 in MDD is to replace
atypical antipsychotics in the current MDD drug treatment paradigm
and redefine the standard of care for individuals who are unable to
reduce their symptoms of depression with their current oral
antidepressant alone. The ELEVATE study is VistaGen’s U.S.
multi-center, randomized, double-blind, placebo-controlled Phase 2
clinical study to evaluate the efficacy and safety of adjunctive
use of AV-101 in adult MDD patients who have an inadequate response
to standard FDA-approved oral antidepressant therapy. VistaGen
achieved target enrollment (n = 180) in the ELEVATE study in August
2019. The primary endpoint of the ELEVATE study is the change from
baseline on the Montgomery-Åsberg Depression Rating Scale
(MADRS-10) total score.
About Major Depressive Disorder (MDD)
MDD is a serious neurobiologically-based mood disorder, affecting
approximately 17.3 million adults in the U.S., or 7.1% of the U.S.
adult population, according to the U.S. National Institute of
Mental Health. Individuals diagnosed with MDD exhibit depressive
symptoms, such as a depressed mood or a loss of interest or
pleasure in daily activities, for more than a two-week period, as
well as impaired social, occupational, educational or other
important functioning which has a negative impact on their quality
of life. Globally, MDD affects nearly 300 million people of all
ages and is the leading cause of disability according to the World
Health Organization.
About VistaGen
VistaGen
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for CNS diseases and disorders
where current treatments are inadequate, resulting in high unmet
need. VistaGen's pipeline includes three
differentiated, clinical-stage CNS drug candidates, AV-101, PH10
and PH94B, each with an exceptional safety profile in all clinical
studies to date and therapeutic potential in multiple large and
growing CNS markets. 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 three drug candidates, (i) AV-101 for
depression, dyskinesia associated with levodopa therapy for
Parkinson’s disease, epilepsy, neuropathic pain and suicidal
ideation ; (ii) PH94B for social anxiety disorder, generalized
anxiety disorder, peripartum anxiety, preoperative anxiety, panic
disorder and post-traumatic stress disorder; and (iii) PH10 for
MDD, peripartum depression and suicidal ideation. In addition,
statements concerning the Company’s future expectations may
include statements regarding intellectual property and commercial
protection of our drug candidates. Each of these statements
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,
including for AV-101 during the ELEVATE study, (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, (iv) decisions or actions of regulatory agencies may
negatively affect the progress of, and our ability to proceed with,
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
required 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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