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): July 23, 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 July 23, 2019, VistaGen Therapeutics, Inc. (the
“Company”) announced that the U.S. Patent and
Trademark Office has granted U.S. Patent No. 10,322,138 related to
methods of treating major depressive disorder (“MDD”) with the Company's PH10
neuroactive nasal spray, a potential first-in-class, neurosteroid
administered in microgram doses for treatment of MDD. 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:
July 23, 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 July 23,
2019
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Exhibit
99.1
VistaGen Therapeutics Announces USPTO Grant of Patent for Treatment
of Depression with Fast-Acting PH10 Neuroactive Nasal
Spray
Previously
completed Phase 2a clinical study of PH10 demonstrated significant
antidepressant effects without psychological side effects or safety
concerns after only one week of administration Phase 2b clinical
trial for treatment of Major Depressive Disorder (MDD) planned for
second half 2020
SOUTH SAN FRANCISCO, Calif., July 23, 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 U.S. Patent and Trademark Office
(USPTO) has granted
U.S. Patent No.
10,322,138 related to methods of treating major depressive
disorder (MDD) with VistaGen’s PH10 neuroactive nasal spray,
a potential first-in-class, neurosteroid administered in microgram
doses for treatment of MDD. The newly granted
patent will not expire until at least 2034. Counterpart foreign
patents have already been issued in China, Europe, Japan and
several other countries.
“We
continue to assemble a strong portfolio of patents related to our
CNS drug pipeline. This newly granted patent is a key component of
our commercial protection strategy for PH10 in the U.S.,”
stated
Shawn Singh, Chief Executive Officer of VistaGen.
“Based on positive results of an exploratory Phase 2a study
of PH10 as a stand-alone therapy for MDD, during which rapid-onset
antidepressant effects were observed at microgram doses, without
systemic exposure, psychological side effects or safety concerns,
we are preparing for Phase 2b clinical development of PH10 in 2020,
initially as a novel, fast-acting, at-home stand-alone treatment
for MDD.”
“MDD
affects approximately 16 million adults in the U.S. and is a common
and potentially debilitating illness that can have profound
emotional, functional and economic impact on both those who suffer
from the disorder and their loved ones. The impact of depression is
greatest for those who do not benefit from standard treatments
currently available. With both PH10 and AV-101, our novel oral NMDA
receptor antagonist currently in Phase 2 development as an add-on
treatment for MDD, our goal is to help fill the void of inadequate
current therapies for MDD and transform the treatment landscape for
individuals with MDD. Unfortunately, there is no ‘one size
fits all’ solution for depression. With their unique
mechanisms of action, we believe both AV-101 and PH10 have
potential for multiple applications in global depression markets,
as stand-alone therapies, or as add-on therapies to augment current
FDA-approved antidepressants, and to prevent relapse following
successful treatment with ketamine-based therapies,”
continued Mr. Singh.
PH10 for MDD, Phase 2a Study and Next Steps:
In an
exploratory 30-patient Phase 2a clinical study, PH10 was
well-tolerated and, at microgram doses, demonstrated rapid-onset
antidepressant effects, as measured by the Hamilton Depression
Rating Scale (HAM-D), without psychological side effects or safety
concerns. VistaGen is planning Phase 2b clinical development of
PH10 in 2020 initially as a new stand-alone treatment for MDD. With
its exceptional safety profile during clinical development to date,
PH10 also has potential to change the current paradigm for
treatment of treatment-resistant depression (TRD) with
ketamine-based therapy (intravenous ketamine or esketamine nasal
spray, both of which must be administered in a clinical setting),
by enabling those who respond to such therapy to transition to more
convenient at-home administration of PH10 to maintain the
therapeutic benefits of ketamine or esketamine.
About PH10
PH10 is a novel, rapid-acting CNS neuroactive nasal spray
administered in microgram doses. PH10 activates nasal chemosensory
receptors that, in turn, engage neural circuits that lead to rapid
antidepressant effects without psychological side effects, systemic
exposure or safety concerns often associated with current
antidepressants and ketamine-based therapy (intravenous
ketamine or esketamine nasal spray). Based on positive results of an
exploratory 30-patient Phase 2a clinical study in MDD in which
rapid-onset antidepressant effects were observed without
psychological side effects or systemic exposure, VistaGen is
preparing for planned Phase 2b clinical development of PH10 in
2020, initially as a new stand-alone treatment for
MDD.
About Major Depressive Disorder (MDD)
MDD 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 VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for CNS diseases and disorders
with high unmet need. VistaGen’s
pipeline includes
three 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 PH10 and 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 PH10, AV-101 or our other drug candidates, (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, 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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