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): May 18, 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 May 18, 2020, VistaGen Therapeutics, Inc. (the
“Company”) announced that the Company has submitted
its proposed protocol for a Phase 2A study of PH94B, its
investigational anti-anxiety drug, for treatment of adjustment
disorder with anxiety 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”). 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 May 18,
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:
May 18, 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 Submits PH94B Phase 2A Study Protocol for Treatment of
Adjustment Disorder with Anxiety Related to the COVID-19 Pandemic
through U.S. FDA’s Coronavirus Treatment Acceleration Program
(CTAP)
The Proposed Phase 2A Open-label Study will be Conducted in New
York City
SOUTH SAN FRANCISCO, Calif., May 18, 2020 – VistaGen
Therapeutics (NASDAQ: VTGN), a
clinical-stage biopharmaceutical company developing new generation
medicines for anxiety and depression, as well as certain central
nervous system (CNS) diseases and disorders with high unmet medical
need, today announced that the Company has submitted its
proposed protocol for a Phase
2A study of PH94B, its investigational anti-anxiety drug, for
treatment of adjustment disorder with anxiety 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). Adjustment disorder is an emotional or behavioral reaction
considered excessive or disproportionate 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 recent onset of mental health stressors associated with
the COVID-19 pandemic is unprecedented and has affected nearly
every person around the world,” said Shawn Singh, Chief
Executive Officer of VistaGen. “We strongly believe in
PH94B’s potential as a first-in-class, rapid-onset
anti-anxiety drug, without systemic exposure or safety concerns of
current anti-anxiety drugs. With successful Phase 2 development of
PH94B for social anxiety disorder completed and preparations for
Phase 3 development underway, we now look forward to Phase 2
development of PH94B for adjustment order, with the goal of
achieving similarly positive treatment outcomes for individuals
struggling to cope with difficulties related to COVID-19, as well
as a wide range of other anxiety-provoking mental health
stressors.”
The proposed Phase 2A 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 patients suffering from
adjustment disorder with anxiety from stressors related to the
pandemic. Dr. Michael Liebowitz, a member of VistaGen's CNS
Clinical and Regulatory Advisory Board, Professor of Clinical Psychiatry at
Columbia University and director of the Medical Research Network in
New York City, will serve as Principal
Investigator.
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 three clinical-stage CNS drug candidates, each 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 therapeutic
potential across a broad range of anxiety-related disorders,
including social anxiety disorder (SAD), adjustment disorder with
anxiety (AjDA), peripartum anxiety, pre/postoperative or testing
(e.g., MRI) anxiety, post-traumatic stress disorder, panic disorder
and generalized anxiety disorder. Self-administered as a nasal
spray at microgram doses, PH94B activates chemosensory receptors in
the nasal passage 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 2A development for AjDA associated with
the COVID-19 pandemic. The FDA has granted Fast Track designation
for development of PH94B as a treatment for SAD, the first such
designation by the FDA for SAD.
View more background on SAD and a video on PH94B’s mechanism
of action.
About Adjustment Disorder with Anxiety
According to the Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition (DSM-5), adjustment disorder is the
development of emotional or behavioral symptoms in response to an
identifiable stressor occurring within 3 months of the onset of the
stressor. 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
(CTAP)
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-19 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 with anxiety
(AjDA), social anxiety disorder and other anxiety-related
disorders, including the Company’s expectation that its
submission to the FDA regarding its proposed Phase 2A clinical
study protocol for PH94B for treatment of AjDA related to the
COVID-19 pandemic 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 the substantial additional capital
necessary to support our operations, including our ongoing and/or
planned preclinical and/or clinical development studies; and (vii)
we may encounter technical and other unexpected hurdles and delays
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