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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): May 2, 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))
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. [ ]
Securities registered pursuant to Section 12(b) of the
Act:
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Title
of each class
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Trading
Symbol
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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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Item 7.01 Regulation FD
Disclosure.
VistaGen Therapeutics, Inc.
(the “Company”) today 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 Items.
The Company today announced topline results from an
exploratory clinical study of AV-101 as a monotherapy in patients
with treatment-resistant depression (“TRD”). The 19-patient study was sponsored and
conducted by the U.S National Institute of Mental Health
(“NIMH”). A copy of the press release is attached
to this Current Report on Form 8-K as Exhibit
99.2.
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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Corporate Presentation, dated May
2, 2019
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Press Release issued by VistaGen
Therapeutics, Inc., dated May 2, 2019.
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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:
May 2, 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 May 2,
2019
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Press Release issued by VistaGen
Therapeutics, Inc., dated May 2, 2019.
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Exhibit
99.1
Exhibit 99.2
AV-101 Monotherapy for Treatment-Resistant Depression
SOUTH SAN FRANCISCO, Calif., May 2, 2019 - VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
depression, social anxiety disorder and other central nervous
system (CNS) diseases and disorders with high unmet need, today
announced top line results from an exploratory Phase 2 clinical
study of AV-101 as a monotherapy (which is treatment without a
concurrent FDA-approved antidepressant) in patients with
treatment-resistant depression (TRD). In the 19-patient study
sponsored and conducted by the U.S National Institute of Mental
Health (NIMH), AV-101 did not demonstrate significant separation
from placebo on the primary outcome measure, the change from
baseline in the Hamilton Depression Rating Scale (HDRS) total score
compared to placebo. A key objective of the study was to evaluate
safety in TRD patients, and, consistent with VistaGen’s Phase
1 studies, AV-101 was very well-tolerated with no ketamine-like
psychological side effects or safety concerns and no
treatment-related serious adverse events.
“Although
this small NIMH monotherapy study did not meet its primary endpoint
in this very difficult-to-treat TRD population, we remain firmly
committed to developing novel treatments for those suffering from
MDD. In contrast to the NIMH study, our ongoing ELEVATE study is
designed to evaluate AV-101 as a novel adjunctive therapy in a
significantly different population of MDD patients, namely those
whose current depressive episode is less than 2 years. ELEVATE is
on track and we will announce top line results later this
year,” stated Shawn Singh, VistaGen’s CEO. “We
greatly appreciate our long-standing relationship with the NIMH and
are grateful for their efforts conducting and providing financial
sponsorship for this exploratory study. In addition, we appreciate
receiving additional positive safety data from this study and are
encouraged that AV-101 was very well-tolerated, without any
troubling side effects or safety concerns, in TRD patients
suffering from one of the most debilitating forms of
depression.”
The
double-blind, placebo-controlled, crossover study was conducted at
the National Institutes of Health (NIH) Clinical Center in
Bethesda, Maryland. Patients with TRD were required to taper off
all antidepressant medications, including all adjunctive atypical
antipsychotics, for 2 to 5 weeks, and then remain medication free
for an additional 2 weeks prior to dosing. Patients were then
randomized to receive either a daily dose of AV-101 for 14 days
(1080 mg for 7 days followed by 1440 mg for 7 days) or placebo for
14 days. After a 2- to 3-week washout period following the initial
14-day dosing phase, patients were crossed over to the opposite arm
of the study.
People
who are currently struggling with Major Depressive Disorder (MDD)
are considered to have TRD if they have not responded adequately to
at least 2 different antidepressants of adequate dose and duration
in their current depressive episode. Patients in this NIMH study
had serious, long-lasting episodes of depression. The average
length of the current depressive episode of the TRD patients in
this study was 8.6 years. Prior to participating in this study,
patients had undergone an average of 7.8 attempts to treat their
TRD over their lifetime, using multiple different antidepressant
drugs.
The
NIMH plans to present detailed results from this study at a
scientific meeting later this year.
About Major Depressive Disorder (MDD)
Major
depressive disorder is a serious neurobiologically-based mood
disorder, affecting approximately 16 million adults in the U.S.,
according to the NIMH. 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 worldwide.
About Treatment-Resistant Depression (TRD)
People who are currently struggling with MDD are considered to have
TRD if they have not responded adequately to at least 2 different
antidepressants of adequate dose and duration in their current
depressive episode. TRD
is a chronic condition that places an ongoing emotional,
functional, and economic burden on the individual, their loved ones
and society.
About AV-101
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 a Phase 2
clinical study (the ELEVATE study) for adjunctive treatment of MDD
and a first-step target engagement study in healthy
volunteer U.S. military Veterans. The 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 ELEVATE
Among VistaGen’s core objectives for AV-101 is to displace
atypical antipsychotics, such as aripiprazole and brexpiprazole, in
the current MDD drug treatment paradigm. The Company’s
ELEVATE study is designed to advance on that objective. The ELEVATE
study is an ongoing randomized, double-blind, placebo-controlled,
multi-center U.S. 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 antidepressant
therapy, either a selective serotonin reuptake inhibitor (SSRI), a
serotonin norepinephrine reuptake inhibitor (SNRI), or bupropion.
Only patients whose current depression episode is less than 2 years
will be randomized to receive either AV-101 or placebo, in addition
to their ongoing standard FDA-approved antidepressant. The primary
endpoint of the study is the change from baseline on the
Montgomery-Åsberg Depression Rating Scale (MADRS) total
score.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for depression, social anxiety
disorder and other CNS diseases and disorders with high unmet need.
VistaGen’s current CNS pipeline includes three drug
candidates, AV-101, PH10, and PH94B, with potential for at-home
use, rapid-onset therapeutic benefits and exceptional
safety. 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 drug candidates, including AV-101 for MDD,
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, including AV-101, (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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