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): April 28, 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 7.01 Regulation FD Disclosure.
On April 28, 2020, VistaGen Therapeutics, Inc.
(the “Company”) announced plans to expand its clinical
development of PH94B, the Company’s first-in-class
rapid-onset neuroactive nasal spray, to include treatment of
adjustment disorder, an emotional or behavioral reaction considered
excessive or out of proportion to a stressful event or major life
change, occurring within three months of the stressor, and/or
significantly impairing a person’s social, occupational
and/or other important areas of functioning. The Company plans to
submit its proposed protocol for a Phase 2 study of PH94B for
treatment of adjustment disorder due to stressors related to the
COVID-19 pandemic to the U.S. Food and Drug Administration
(“FDA”) through the FDA’s new Coronavirus
Treatment Acceleration Program (“CTAP”). The proposed Phase 2 study will be
conducted in New York City on an open-label basis and involve
approximately 30 subjects suffering from adjustment disorder from
stressors related to the pandemic. A copy of the Company’s
press release is attached hereto as Exhibit
99.1.
The information in 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 9.01 Financial Statements and Exhibits.
(d) Exhibits Index
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Exhibit No.
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Description
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Press
Release issued by VistaGen Therapeutics, Inc., dated April 28,
2020
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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:
April 28, 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 Expands PH94B Clinical Development to Include Adjustment
Disorder Related to COVID-19
Proposed Phase 2 Study to Take Place in New York City Under U.S.
FDA’s
Coronavirus Treatment Acceleration Program
(CTAP)
SOUTH SAN FRANCISCO, Calif., April 28, 2020 – VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS) diseases
and disorders with high unmet medical need, today announced plans
to expand clinical development of PH94B, its first-in-class
rapid-onset neuroactive nasal spray, to include treatment of
adjustment disorder due to stressors related to the COVID-19
pandemic. Adjustment disorder is an emotional or behavioral
reaction considered excessive or out of proportion to a stressful
event or major life change, occurring within three months of the
stressor, and/or significantly impairing a person’s social,
occupational and/or other important areas of
functioning.
VistaGen plans to submit its proposed protocol for a Phase 2 study
of PH94B for treatment of adjustment disorder to the U.S. Food and
Drug Administration (FDA) through the FDA’s new Coronavirus
Treatment Acceleration Program (CTAP). The proposed Phase 2 Part A
study will be conducted in New York City, the epicenter of the
COVID-19 pandemic in the U.S., on an open-label basis and involve
approximately 30 subjects suffering from adjustment disorder from
stressors related to the pandemic. Based on the results of the
Phase 2 Part A study, VistaGen plans to advance development to a
Phase 2 Part B randomized, double-blind, placebo-controlled study
of approximately 150 subjects. The FDA previously designated PH94B
for Fast Track development for treatment of social anxiety disorder
(SAD), the first such designation by the FDA for a drug candidate
for SAD. VistaGen is currently preparing for Phase 3 development of
PH94B for treatment of SAD.
Dr. Michael Liebowitz, a member of VistaGen’s CNS Clinical
and Regulatory Advisory Board, will serve as Principal Investigator
of the Phase 2 Part A study of PH94B for treatment of adjustment
disorder. Dr. Liebowitz is a Professor of Clinical Psychiatry at
Columbia University and directs the Medical Research Network LLC in
New York City. He directed the Anxiety Disorders Clinic at the New
York State Psychiatric Institute from 1982 to 2006 and is also
creator of the Liebowitz Social Anxiety Scale, or LSAS, a widely
used primary outcome measure in clinical research on SAD, as well
as for evaluation in clinical practice.
“The
COVID-19 pandemic has created fear, anxiety and uncertainty about
our health and the economy that have caused mental health
challenges worldwide,” said
Shawn Singh, Chief Executive Officer of VistaGen. “After
the immediate medical threats associated with COVID-19 pass, the
pandemic is expected to have a lasting impact on millions of
people. With increases in anxiety-related disorders to be expected,
the need for new, fast-acting and safe treatment alternatives is
greater now than ever before. With its exceptional safety profile
and positive data from Phase 2 development for treatment of social
anxiety disorder, PH94B has significant potential to make a
meaningful difference across the treatment landscape for multiple
anxiety-related disorders.”
“Mental health-related disorders have escalated and continue
to be overwhelmingly underserved indications as a result of the
current crisis,” concluded
Dr. Liebowitz. “Today, more
than ever, I am concerned over the suffering of those who are
experiencing debilitating, heightened symptoms of adjustment
disorder and anxiety as a result of the COVID-19 pandemic –
and how those individuals are coping and receiving treatment. The
alternatives in the market, both prescribed and not prescribed,
have significant limitations in efficacy and problematic side
effects. We need better alternative treatments as we approach a
vastly different social environment in the near
future.”
About VistaGen
VistaGen
Therapeutics is a multi-asset, clinical-stage biopharmaceutical
company developing new generation medicines for anxiety, depression
and certain 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, 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.
About PH94B
PH94B is a first-in-class, odorless, rapid-onset
(approximately 10 to 15 minutes) CNS neuroactive nasal spray with
the potential to be the first FDA-approved, fast-acting, on-demand
treatment for millions of Americans who suffer from social anxiety
disorder (SAD), with additional potential in adjustment disorder,
peripartum anxiety, pre/postoperative anxiety or anxiety related to
certain testing such as an MRI, post-traumatic stress disorder,
panic disorder and generalized anxiety disorder. Administered at
microgram doses, PH94B activates nasal chemosensory receptors that
trigger neural circuits in the brain that suppress fear and
anxiety. Following successful Phase 2 development, VistaGen is
preparing for Phase 3 clinical development of PH94B for SAD and
Phase 2 development for adjustment disorder. The FDA has granted
Fast Track designation for development of PH94B as a treatment for
SAD. View
more background on SAD and PH94B’s mechanism of
action.
About Adjustment Disorder
According
to the DSM-5, published by the American Psychiatric Association,
adjustment disorder is the development of emotional or behavioral
symptoms in response to an identifiable stressor(s) occurring
within 3 months of the onset of the stressor(s). These symptoms or
behaviors are clinically significant, as evidenced by one or both
of the following:
marked
distress that is out of proportion to the severity or intensity of
the stressor, considering the external context and the cultural
factors that might influence symptom severity and presentation; or
significant impairment in social, occupational, or other important
areas of functioning. The stress-related
disturbance does not represent normal bereavement or meet the
criteria for another mental disorder and is not merely an
exacerbation of a preexisting mental disorder.
About the U.S. FDA Coronavirus Treatment Acceleration
Program
FDA has created a special emergency program for possible therapies
called the Coronavirus Treatment Acceleration Program (CTAP). The
FDA’s CTAP uses every available method to move new treatments
to patients as quickly as possible, while at the same time finding
out whether they are helpful or harmful. The FDA continues to
support clinical trials that are testing new treatments for COVID
so that it gains valuable knowledge about their safety and
effectiveness.
To learn more about Coronavirus Treatment Acceleration Program
(CTAP), please use the following link: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
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 PH94B for adjustment disorder, social anxiety
disorder and other anxiety disorders, including the Company’s
expectation that its planned submission to the FDA regarding its
proposed Phase 2 Part A clinical development of PH94B for treatment
of adjustment disorder will qualify for expedited review under the
FDA’s CTAP. In addition, statements concerning the Company's
future expectations may include statements regarding intellectual
property and commercial protection 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 PH94B; (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
PH94B and/or our other 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