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): June 17, 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))
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued
Listing Rule or Standard; Transfer of Listing.
On June
17, 2019, VistaGen Therapeutics, Inc. (the “Company”) received a letter from
the Listing Qualifications Staff of The Nasdaq Stock Market, LLC
(“Nasdaq”)
indicating that, based upon the closing bid price of the
Company’s common stock, par value $0.001 per share
(“Common
Stock”), for the last 30 consecutive business days,
the Company is not currently in compliance with the requirement to
maintain a minimum bid price of $1.00 per share for
continued listing on the Nasdaq Capital Market, as set forth in
Nasdaq Listing Rule 5550(a)(2) (the “Notice”).
The
Notice has no immediate effect on the
continued listing status of the Company's Common Stock on
the Nasdaq Capital Market, and, therefore, the Company's listing
remains fully effective.
The Company will continue to monitor the
closing bid price of its Common Stock and seek to regain
compliance with all applicable Nasdaq requirements within the
allotted compliance periods. To regain compliance, the
closing bid price of the Company's Common Stock must be
at least $1.00 per share for 10 consecutive business days at some
point during the period of 180 calendar days from the date of the
Notice, or until December 16, 2019. If
the Company does not regain compliance with the minimum bid
price requirement by December 16, 2019, Nasdaq may grant the
Company a second period of 180 calendar days to regain compliance.
To qualify for this additional compliance period, the Company would
be required to meet the continued listing requirement for market
value of publicly held shares and all other initial listing
standards for the Nasdaq Capital Market, other than the
minimum bid price requirement. In addition, the Company
would also be required to notify Nasdaq of its intent to cure the
minimum bid price deficiency. If the Company does not
regain compliance within the allotted compliance periods, including
any extensions that may be granted by Nasdaq, Nasdaq will provide
notice that the Company's Common Stock will be subject to
delisting. The Company would then be entitled to appeal that
determination to a Nasdaq hearings panel. There can be no
assurance that the Company will regain compliance with the
minimum bid price requirement during the 180-day compliance
period, secure a second period of 180 days to regain compliance or
maintain compliance with the other Nasdaq listing
requirements.
Item 8.01 Other Events.
On June
20, 2019, the Company announced positive results of recent
preclinical studies of the effects of AV-101, the Company’s
oral NMDA receptor glycine site antagonist, in a ”gold
standard” MPTP primate model for reproducing dyskinesia
(sudden uncontrolled movements) complications of standard
Parkinson’s disease therapy with levodopa. In the new
study, AV-101 significantly reduced levodopa-induced dyskinesia
(“LID”) and did
not cause adverse effects associated with amantadine therapy for
LID. A copy of the press release is attached to this Current Report
on Form 8-K as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d)
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:
June 21, 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, dated June 20, 2019
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Exhibit
99.1
VistaGen Announces Positive
Preclinical Data Supporting AV-101's
Potential for Treating Levodopa-Induced Dyskinesia in Patients with
Parkinson’s Disease, without the Psychological Side Effects
and Safety Concerns of Amantadine
●
Significant reduction of levodopa-induced dyskinesia by AV-101
observed in “gold standard” MPTP non-human primate
model of Parkinson’s disease, while maintaining
antiparkinsonian activity of levodopa and without causing
amantadine-like adverse effects
SOUTH SAN FRANCISCO, Calif., June 20, 2019 - VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company committed to developing new generation
medicines for central nervous system (CNS) diseases and disorders
with high unmet need, today announced positive results of recent
preclinical studies of the effects of AV-101, its oral NMDA
receptor glycine site antagonist, in a widely-used MPTP non-human
primate model for reproducing motor complications of
Parkinson’s disease (PD), including dyskinesia (sudden
uncontrolled movements) observed in PD patients treated with
levodopa. In the MPTP primate model, AV-101’s antidyskinetic
effects were similar to those generally observed with amantadine
therapy, but AV-101 did not cause adverse effects experienced with
amantadine.
The MPTP primate model used in this study is the “gold
standard” for animal modeling of PD and has been used
extensively to study both antiparkinsonian therapies and
levodopa-induced dyskinesia (LID). MPTP is a neurotoxin that kills
dopaminergic neurons in the striatum, producing motor symptoms
similar to those of PD. In this study, AV-101’s efficacy
against LID was measured through behavioral scores on a dyskinesia
scale, and a Parkinsonian disability scale was used to measure
levodopa antiparkinsonian efficacy. This study demonstrated
that AV-101 significantly (p = 0.01) reduced LID without affecting
the timing, extent, or duration of the therapeutic benefits of
levodopa. This new preclinical study was conducted by Dr. Thérèse
Di Paolo, Professor in the Faculty of Pharmacy at Laval
University and among the world’s leading researchers focused
on Parkinson’s disease and LID, pursuant to VistaGen’s
research agreement with
CHU de
Québec – Université Laval Research Center in
Québec, Canada.
Summary results of the study will be presented at an upcoming
scientific conference.
“The
antidyskinetic activity of AV-101 that we
measured compares favorably with
our observation with amantadine in
parkinsonian monkeys,” said Dr. Di Paolo. “Better
than amantadine, with its known side effects (in humans with
Parkinson's disease and in parkinsonian monkeys), we
observed no adverse effects with AV-101.”
A
pivotal pathological hallmark of PD is a loss of dopamine neurons
in the substantia nigra.
Loss of dopamine neurons is thought to be due to neurotoxicity
associated with misfolding of proteins and is associated with
increased signaling of glutamate, the most abundant excitatory
neurotransmitter in the brain. Increased glutamate activity is
involved with aberrant neuronal signaling and excitotoxic death of
neurons.
“The
NMDA receptor plays a major role in glutamatergic signaling and has
been shown to be a therapeutic target for LID,” said
H. Ralph
Snodgrass, Ph.D.,
VistaGen’s Chief Scientific Officer. “AV-101’s
active metabolite, 7-Cl-KYNA, is a potent and selective NMDA
receptor glycine site antagonist with neuroprotective properties.
These recent results confirm our prior antidyskinesia study in this
MPTP monkey model. We believe these preclinical data and
AV-101’s positive safety profile in all clinical studies to
date support AV-101’s potential to treat LID, while both
maintaining the antiparkinsonian benefits of levodopa and without
causing hallucinations or other serious side effects that may be
associated with current amantadine-based therapy for LID,”
added Dr. Snodgrass.
About Parkinson’s Disease
PD is the second most common neurodegenerative disease worldwide,
affecting approximately one million people in the U.S. and ten
million people worldwide, according to the Parkinson’s
Foundation. Although there is no "one-size-fits-all”
description of PD, PD is a complex neurodegenerative disorder that
occurs when brain cells that make dopamine, a chemical that
coordinates movement, stop working or die, resulting in progressive
deterioration of voluntary motor control. Classic PD motor symptoms
include muscular rigidity, resting tremor, and postural and gait
impairment. Typically, PD patients present with a combination of
motor and non-motor symptoms. Non-motor symptoms may include
cognitive impairment, sleep disorders, pain and fatigue. There is
currently no medication to slow, delay, stop or cure PD, and
currently available treatments are symptomatic. Treatment of motor
symptoms with oral levodopa, introduced about 50 years ago, remains
the gold standard treatment.
About Levodopa-Induced Dyskinesia
LID is a disorder that affects people with PD who are treated with
the current standard of care, oral levodopa, for an extended period
of time. Oral levodopa remains the most effective therapy for motor
symptoms of PD. However, after continuous long-term use (longer
than five years), many PD patients experience LID. Although
clinical manifestations of LID are heterogenous, LID is commonly
associated with abnormal involuntary movements, including chorea
and dystonia. These motor complications tend to become more severe
as PD progresses and as the duration of levodopa treatment is
extended, until the impact of LID may compromise the advantage of
treatment with levodopa. PD treatment with levodopa is routinely
delayed due to concerns over LID. Once LID develops,
levodopa-treated PD patients may be faced with a choice between
immobility due to untreated and uncontrolled PD, or mobility with
the associated LID.
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 multiple CNS
diseases and disorders, including chronic neuropathic pain,
epilepsy, major depressive disorder, LID and many others. AV-101 is
an oral prodrug of 7-Cl-KYNA which binds uniquely at the glycine
site of the NMDA receptor and has potential to be a new at-home
treatment for multiple CNS indications with high unmet need.
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 VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
committed to developing new generation medicines for CNS diseases
and disorders with high unmet need. VistaGen’s
pipeline includes
three clinical-stage CNS drug candidates, AV-101, PH10 and
PH94B. 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 treatment of LID in patients with PD receiving levodopa
therapy, 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, including AV-101, that cause us to discontinue further
development, (ii) we may not be able to successfully demonstrate
the safety and efficacy of AV-101 or any of our other 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