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, 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
July 23, 2020, VistaGen Therapeutics, Inc. (the “Company”) announced the results
of a positive meeting with the U.S. Food and Drug
Administration ("FDA")
regarding Phase 3 development of PH94B for the acute treatment of
anxiety in adult patients with social anxiety disorder ("SAD"), including consensus on key
aspects of a unique initial pivotal Phase 3 clinical trial of PH94B
involving a single-event, laboratory-simulated public speaking
challenge in adult patients with SAD. A copy of the Company’s press release is
attached hereto as Exhibit 99.1.
On July
23, 2020, the Company began utilizing a new corporate presentation,
a copy of which is attached to this Current Report on Form 8-K as
Exhibit 99.2.
The information in Item 7.01 of this Current
Report on Form 8-K, including the information set
forth in Exhibit 99.1 and 99.2, 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 and 99.2 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 July 23,
2020.
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| 99.2 |
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VistaGen
Therapeutics, Inc. Corporate Presentation, dated Summer
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:
July 24, 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 Announces Positive Meeting with FDA Regarding
Pivotal Phase 3 Study of PH94B for Acute Treatment of Anxiety in
Patients with Social Anxiety Disorder
Company Reaches Consensus with FDA on Key Aspects of Novel
Pivotal Phase 3 Study
Agency Guidance May Provide Significant Time- and Cost-Efficiency
for Phase 3 Program
Approximately 17 Million American Adults Suffer from Social Anxiety
Disorder
SOUTH SAN FRANCISCO, Calif., July 23, 2020 – VistaGen
Therapeutics (NASDAQ: VTGN), a
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS)
disorders, announced the
results of a positive meeting with the U.S. Food and Drug
Administration (FDA) regarding Phase 3 development of PH94B
for the acute treatment of anxiety in adult patients with social
anxiety disorder (SAD).
VistaGen and the FDA reached consensus on key aspects of a unique
initial pivotal Phase 3 clinical trial of PH94B involving a
single-event, laboratory-simulated public speaking challenge in
adult patients with SAD.
PH94B is an investigational rapid-onset neurosteroid nasal spray
that is fundamentally differentiated from all FDA-approved
treatments for anxiety disorders. According to the U.S. National
Institute of Mental Health (NIMH), there are approximately 17
million adults in the U.S. with SAD.
“Much like a rescue inhaler is used in an asthma attack or a
migraine drug is used in an acute migraine episode, PH94B is a
potential fit for the acute treatment of anxiety symptoms in
anticipation of an often predictable, anxiety-provoking situation
for individuals suffering from SAD,” said Shawn Singh, Chief
Executive Officer of VistaGen.
“Notably, the FDA concurred that our initial pivotal Phase 3
efficacy study may be conducted in a manner substantially similar
to the highly statistically significant Phase 2 study of PH94B,
which study involved a single event, laboratory-simulated public
speaking challenge in adult patients with SAD. The FDA’s
specific guidance will enable us to simplify the process of
assessing efficacy among SAD patients in our Phase 3 studies and
contribute to significant time- and cost-efficiency in the
clinic,” Singh added.
Key Aspects of Consensus with FDA Regarding the Initial Pivotal
Phase 3 Study of PH94B
VistaGen’s initial pivotal Phase 3 study of PH94B for acute
treatment of anxiety in adult patients with SAD will be a
randomized, double-blind, placebo-controlled, parallel comparison
study conducted at approximately 12 to 15 sites in North
America.
Dr. Michael Liebowitz, Professor of Clinical Psychiatry at Columbia
University, director of the Medical Research Network in New York
City, and creator of the Liebowitz Social Anxiety Scale (LSAS),
will be the Principal Investigator of the study. Target enrollment
will be approximately 182 adult patients with SAD.
As in the successful Phase 2 study of PH94B in SAD, the study will
involve a single laboratory-simulated anxiety-provoking public
speaking challenge. The Subjective Units of Distress Scale (SUDS)
will be used to assess the primary efficacy endpoint in the
study.
About PH94B
PH94B is a first-in-class, odorless, rapid-onset (within
approximately 15 minutes) synthetic neurosteroid nasal spray with
therapeutic potential across a broad range of anxiety-related
disorders. Easily self-administered in microgram-level doses, PH94B
does not require systemic uptake and distribution to produce its
rapid-onset anti-anxiety effects.
VistaGen is preparing for Phase 3 clinical development of PH94B as
a potential new generation fast-acting, non-sedating, non-addictive
acute treatment of anxiety in adults with social anxiety disorder
(SAD). The FDA has granted Fast Track designation for development
of PH94B for this indication, the first such designation by the FDA
for a drug candidate for SAD.
With its rapid-onset pharmacology, lack of systemic exposure and
excellent safety profile in earlier studies, PH94B has potential as
a novel treatment for multiple anxiety-related disorders. VistaGen
is also preparing for Phase 2A development of PH94B for adjustment
disorder related to the diverse impact of the COVID-19
pandemic. View more background
information on SAD and a video on PH94B's mechanism of
action.
About VistaGen
VistaGen Therapeutics is a 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. Each of VistaGen's three
drug candidates has a differentiated mechanism of action, an
exceptional safety profile, and therapeutic potential in several
large global 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 are “forward-looking
statements” concerning VistaGen's future expectations, plans
and prospects, including the potential for successful New Drug
Application (NDA)-enabling Phase 3 development of PH94B. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties which could cause actual results to differ materially
from those contemplated in these forward-looking statements,
including the risks that: development and approval of PH94B may not
be achieved in any market; the FDA may decide that the results of
the Company’s PH94B Phase 3 clinical program are not
sufficient for regulatory approval for acute treatment of anxiety
in adult patients with SAD or any other anxiety-related disorder;
development of PH94B may not be successful in any indication;
success in nonclinical studies or in earlier-stage clinical trials
may not be repeated or observed in future studies which may not
support further development or be sufficient to gain regulatory
approval to market PH94B; adverse events may be encountered at any
stage of development that negatively impact further development.
Other risks and uncertainties include, but are not limited to,
issues related to: adverse healthcare reforms and changes of laws
and regulations; general industry and market conditions;
manufacturing and marketing risks, which may include, but are not
limited to, unavailability of or delays in delivery of raw
materials for manufacture of PH94B; inadequate and/or untimely
supply of PH94B to meet demand; entry of competitive products; and
other technical and unexpected hurdles in the development,
manufacture and commercialization of PH94B, as well as those risks
more fully discussed in the section entitled "Risk Factors" in
VistaGen’s most recent Annual Report on Form 10-K for the
year ended March 31, 2020, as well as discussions of potential
risks, uncertainties, and other important factors in either
company’s other filings with the Securities and Exchange
Commission. In addition, any forward-looking statements represent
the Company’s views only as of today, and should not be
relied upon as representing its views as of any subsequent date.
The Company explicitly disclaims 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
Exhibit
99.1
