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 28, 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))
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) ☐
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 8.01 Other Events.
On October 28,
2019, VistaGen Therapeutics, Inc. (the “Company”) announced that the European Patent
Office has granted the Company a second patent for AV-101, the
Company's oral investigational NMDA (N-methyl-D-aspartate) receptor
glycine site antagonist, expanding the set of claims
relating to treatment of depression and dyskinesia (involuntary or
diminished voluntary muscle movements) associated with levodopa
therapy for Parkinson's disease. 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.
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
29, 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
issued by VistaGen Therapeutics, Inc., dated October 28,
2019
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Exhibit 99.1
VistaGen Therapeutics Expands European Patent Protection for AV-101
for Treatment of Depression and Dyskinesia associated with Levodopa
Therapy for Parkinson’s Disease
SOUTH SAN FRANCISCO, Calif., October 28, 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, today announced that the European Patent Office (EPO) has
granted the Company a second patent for therapeutic uses of AV-101,
its oral NMDA (N-methyl-D-aspartate) receptor glycine site
antagonist. The new patent expands the set of claims relating to
treatment of depression and dyskinesia (involuntary or diminished
voluntary muscle movements) associated with levodopa therapy for
Parkinson’s disease. The patent will be in effect until at
least 2034.
AV-101
(4-Cl-KYN) belongs to a new generation of investigational medicines
in neuropsychiatry and neurology known as NMDA receptor modulators.
The NMDA receptor is a pivotal receptor in the brain and its
abnormal function is associated with numerous CNS diseases and
disorders. AV-101 is in
Phase 2 clinical development in the United States, initially for
treatment of Major Depressive Disorder (MDD). Among
VistaGen's key objectives for AV-101 in MDD is to replace atypical
antipsychotics in the current MDD drug treatment paradigm and to
redefine the standard of care for individuals who are unable to
reduce symptoms of depression with their current oral
antidepressant alone. VistaGen recently completed patient dosing in
the ELEVATE study, its 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 their current oral antidepressant
therapy. The Company remains on track to report top line results of
the ELEVATE study before the end of 2019.
In
previously announced positive preclinical studies of the effects of
AV-101 in a widely-used non-human primate model for reproducing
motor complications of Parkinson's disease (PD) and dyskinesia
observed in PD patients treated with levodopa, AV-101 significantly
(p = 0.01) reduced levodopa-induced dyskinesia without affecting
the timing, extent, or duration of the antiparkinsonian benefits of
levodopa. AV-101's therapeutic effects were similar to those
generally observed with amantadine therapy, but AV-101 did not
cause adverse effects experienced with amantadine.
About Major Depressive Disorder (MDD)
MDD is
a serious neurobiologically-based mood disorder affecting nearly
300 million globally and is the leading cause of disability
worldwide, according to the World Health Organization. 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.
About Parkinson's Disease (PD)
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 of PD with oral
levodopa, introduced about 50 years ago, remains the gold standard
treatment.
About Levodopa-Induced Dyskinesia (LID)
LID is
a disorder that affects people with PD who are treated with the
current gold 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 diverse, 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
(N-methyl-D-aspartate) 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 co-agonist 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, non-sedating treatment for multiple
large market CNS indications where current treatments are
inadequate to meet high unmet patient needs. VistaGen is currently
focused on potential development of AV-101 for MDD, neuropathic
pain, suicidal ideation and dyskinesia associated with levodopa
treatment for PD. 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 includes
three clinical-stage CNS drug candidates, AV-101, PH10 and PH94B,
each 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
Various statements in this release concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development of AV-101, the potential of
AV-101 for the treatment of MDD, dyskinesia associated with
levodopa therapy for PD and various other CNS diseases and
disorders, and our intellectual property and commercial protection
of AV-101, 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, which could cause actual results to differ
materially from those contemplated in these forward-looking
statements. Among these risks is the possibility that we may not be
able to successfully demonstrate the safety and efficacy of AV-101
at each stage of clinical development; success in preclinical
studies or in early-stage clinical trials may not be repeated or
observed in ongoing or future AV-101 studies, and ongoing or future
preclinical and clinical results may not support further
development of AV-101 or be sufficient to gain regulatory approval
to market AV-101; decisions or actions of regulatory agencies may
negatively affect the progress of the ELEVATE study or the
initiation, timing and progress of future AV-101 clinical trials,
and our ability to proceed with further clinical studies or to
obtain marketing approval; we may not be able to obtain or maintain
adequate intellectual property protection and other forms of
marketing and data exclusivity for AV-101; we may not have access
or be able to secure substantial additional capital to support our
operations, including clinical development of AV-101 activities
described above; and we may encounter technical and other
unexpected hurdles in the manufacturing and development of AV-101
or other product candidates, as well as those risks 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 today 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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