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 30, 2020
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 3.01 Notice of Delisting or Failure to
Satisfy a Continued Listing Rule or Standard; Transfer of
Listing.
On
January 31, 2020, 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 is provided a compliance period of 180 calendar days from
the date of the Notice, or until July 29, 2020, to regain
compliance with the minimum closing bid requirement, pursuant to
Nasdaq Listing Rule 5810(c)(3)(A). If at any time before July 29,
2020, the closing bid price of the Company’s Common Stock
closes at or above $1.00 per share for 10 consecutive business
days, Nasdaq will provide written notification that the Company has
achieved compliance with the minimum bid price requirement, and the
matter would be resolved. If the Company does not regain compliance
during the compliance period ending July 29, 2020, then Nasdaq may
grant the Company a second 180 calendar day period to regain
compliance, provided the Company (i) meets 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 closing bid price requirement and (ii)
notifies Nasdaq of its intent to cure the deficiency.
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. 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
January 30, 2019, the Company announced that its Investigational
New Drug application for AV-101, the Company’s oral NMDAR
(N-methyl-D-aspartate receptor) glycine site antagonist, as a
potential treatment of dyskinesia in patients with
Parkinson’s disease receiving levodopa-based therapy has been
cleared by the U.S. Food and Drug Administration. The Company also
announced that it has received a notice of allowance from the U.S.
Patent and Trademark Office for a new AV-101 U.S. Patent for
treatment of dyskinesia induced by the administration of levodopa.
A copy of the press release is attached to this Current Report on
Form 8-K as Exhibit 99.1.
Item 9.01. Exhibits.
(d)
Exhibits
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Exhibit Number
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Description
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Press Release issued
by VistaGen Therapeutics, Inc., dated January 30,
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: January 31,
2020
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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 99.1
VistaGen Therapeutics Receives FDA Clearance of IND for Phase 2
Clinical Study of AV-101 as a Potential Treatment of Dyskinesia in
Parkinson's Disease Patients
Company also Receives a Notice of Allowance from the USPTO for a
New AV-101 U.S. Patent for Treatment of Dyskinesia Induced by
Levodopa Therapy
SOUTH SAN FRANCISCO, Calif., January 30, 2020 – VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
medical need, today
announced
that its Investigational New Drug (IND) application for AV-101, the
Company’s oral NMDAR (N-methyl-D-aspartate receptor) glycine
site antagonist, as a potential treatment of dyskinesia in patients
with Parkinson’s disease receiving levodopa-based therapy has
been cleared by the U.S. Food and Drug Administration (FDA). The
FDA’s IND clearance permits VistaGen to proceed with Phase 2
clinical development of AV-101 in this indication. The Company also
announced that the U.S. Patent and Trademark Office (USPTO) has
issued a Notice of Allowance for U.S. Patent Application 16/003,816
related to therapeutic use of AV-101 for treatment of dyskinesia
induced by the administration of levodopa. The patent, once issued,
will be in effect until at least 2034.
“Current drug treatment options for levodopa-induced
dyskinesia, or LID, may cause serious side effects, including
hallucinations and sedation. In all clinical studies to date,
AV-101 has not been associated with any psychotomimetic side
effects or drug-related serious adverse events. With its
exceptional safety profile, recently successful preclinical studies
in the leading primate model for LID, and the successful Phase 1b
NMDAR target engagement clinical study conducted by Baylor College
of Medicine in healthy volunteer U.S. military Veterans, we are
excited by AV-101’s potential as a novel therapy for
LID,” said
Shawn Singh, Chief Executive Officer of VistaGen. “These are
important milestones for our AV-101 program, both a key regulatory
advance and expanded commercial protection for AV-101 in the U.S.
market.”
AV-101 Preclinical Data in LID
In November 2019, at the 7th International
Conference on Parkinson’s and Movement Disorders in
London,
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, presented preclinical data involving
AV-101 in the “gold standard” MPTP non-human primate
model for reproducing motor complications of Parkinson's disease,
including dyskinesia observed in Parkinson’s disease patients
treated with levodopa. In the MPTP primate model, the
antidyskinetic activity of AV-101 compared favorably with prior
observations with amantadine in parkinsonian monkeys. However,
better than amantadine, with its known side effects (in humans with
Parkinson's disease and in parkinsonian monkeys), no adverse
effects with AV-101 were observed. In the 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. Importantly, 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.
About Parkinson's Disease and LID
Parkinson’s
disease 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. There is no "one-size-fits-all" description of
Parkinson’s disease. Rather, it 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 motor symptoms of Parkinson’s disease
include muscular rigidity, resting tremor, and postural and gait
impairment. Typically, patients with Parkinson’s disease
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 Parkinson’s disease, and currently
available treatments are symptomatic. Treatment of motor symptoms
with oral levodopa, introduced about 50 years ago, remains the
“gold standard” treatment.
Dyskinesia
in patients with Parkinson’s disease receiving levodopa-based
therapy is a disorder that is characterized by unpredictable,
involuntary and purposeless movements after continuous long-term
use (often longer than five years). Although clinical
manifestations of LID are heterogenous, these motor complications
tend to become more severe as a patient’s Parkinson’s
disease progresses and as the duration of levodopa treatment is
extended, until the impact of LID may compromise the advantage of
treatment with levodopa. Once LID develops, Parkinson’s
disease patients treated with levodopa may be faced with a choice
between immobility due to untreated and uncontrolled
Parkinson’s disease, or mobility with the associated
dyskinesia.
About AV-101
AV-101 (4-Cl-KYN) belongs to a new generation of investigational
medicines in neuropsychiatry and neurology known as NMDAR
(N-methyl-D-aspartate receptor) modulators. The NMDAR is a pivotal
receptor in the brain and abnormal NMDAR function is associated
with numerous CNS diseases and disorders. AV-101 is an oral prodrug
of 7-chloro-kynurenic
acid (7-Cl-KYNA), a
potent and selective full antagonist of the glycine site of the
NMDAR. With its exceptional side effect and safety profile in all
studies to date (no psychological side effects or safety concerns
similar to those that may be caused by amantadine and ketamine),
AV-101 has potential to be a new oral, at-home, non-sedating
treatment for multiple large market CNS indications where current
treatments are inadequate to meet high unmet patient needs. 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
developing new generation medicines for CNS diseases and disorders
where current treatments are inadequate, resulting in high unmet
need. VistaGen's pipeline is
focused on clinical-stage CNS drug candidates with a differentiated
mechanism of action, 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
AV-101 for various therapeutic purposes, including dyskinesia in
patients with Parkinson's disease receiving levodopa-based therapy,
epilepsy, major depressive
disorder, neuropathic pain and suicidal ideation. In
addition, statements concerning the Company’s future
expectations may include statements regarding intellectual property
and commercial protection of each 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. Those risks include the following: (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 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, 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 preclinical and 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