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 26, 2021
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 8.01 Other Events.
On May 26, 2021, VistaGen Therapeutics, Inc.
(the Company) issued a press release to announce the
initiation of its PALISADE Phase 3 clinical program with the
PALISADE-1 Phase 3 clinical trial, a randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of
PH94B, the Company's investigational pherine nasal spray, for the
acute treatment of anxiety in adults with Social Anxiety
Disorder. 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.
(d)
Exhibits.
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Exhibit
No.
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Description
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Press Release
issued by VistaGen Therapeutics, Inc., dated May 26,
2021
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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 27, 2021
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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 May 26,
2021
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Exhibit
99.1
VistaGen Therapeutics Initiates PALISADE Phase 3 Trial of PH94B in
Social Anxiety Disorder
PALISADE Phase 3 Program focused on acute treatment of anxiety in
adults with Social Anxiety Disorder
FDA Fast Track designation granted
Topline results anticipated in mid-2022
SOUTH SAN FRANCISCO, Calif., – May 26, 2021
– VistaGen
Therapeutics Inc. (NASDAQ:
VTGN), a biopharmaceutical company committed to developing a new
generation of medicines with the potential to go beyond the current standard of care for
anxiety, depression and other central nervous system (CNS)
disorders, today announced the initiation of its PALISADE Phase 3
clinical program with the PALISADE-1 Phase 3 trial, a randomized,
double-blind, placebo-controlled study to evaluate the efficacy and
safety of PH94B for the acute treatment of anxiety in adults with
Social Anxiety Disorder (SAD). PH94B is an odorless, rapid-onset,
investigational pherine nasal spray with a unique mechanism of
action, working differently than all existing therapies for SAD.
There is currently no U.S. Food and Drug Administration (FDA)
approved acute treatment of anxiety for adults with
SAD.
PALISADE-1 is being conducted across approximately 18 sites in the
U.S., with a target of approximately 200 randomized subjects. Dr.
Michael Liebowitz, a Columbia University psychiatrist, former
director and founder of the Anxiety Disorders Clinic at the New
York State Psychiatric Institute, director of the Medical Research
Network in New York City, and creator of the Liebowitz Social
Anxiety Scale (LSAS), is serving as Principal Investigator of the
trial. Topline results from PALISADE-1 are anticipated in
mid-2022.
“Initiation of PALISADE-1 is a major milestone for our
PALISADE Phase 3 clinical program for PH94B, a program aimed at
supporting a potential New Drug Application to the FDA. The trial
is an essential next step in our efforts to confirm the positive
efficacy and safety results we have seen in all PH94B Phase 2
trials to date,” stated Shawn Singh, Chief
Executive Officer of VistaGen. “PH94B has the potential to be
a life-changing acute, as-needed treatment of anxiety for adults
with SAD, similar to how a rescue inhaler is used to prevent an
asthma attack. At a time of continuing increase in the number of
Americans suffering from SAD and other anxiety disorders, and a
current treatment paradigm that falls short of delivering necessary
relief, a new fast-acting treatment alternative is imperative.
Initiation of our PALISADE-1 trial further reflects our commitment
to go beyond the current standard of care for SAD. If successfully
developed, PH94B has the potential to be the first fast-acting,
non-systemic, non-sedating acute treatment of anxiety for more than
23 million Americans who suffer from
SAD.”
“Social Anxiety Disorder is the third most common
mental health disorder among Americans, and it can turn everyday social interactions
into debilitating, fearful experiences for people who continue to
suffer from this growing mental health condition,” said Dr.
Liebowitz. “Existing treatments, such as approved
antidepressants, have not been effective acute treatment solutions for
this large patient population. In addition, the negative side
effects and safety concerns associated with benzodiazepines
prescribed off-label are a
significant cause for concern, as demonstrated by the
FDA’s
Drug Safety Communication detailing the risks of benzodiazepines
issued last Fall. The start of this Phase 3 trial is a major
step forward in the clinical development of PH94B, an
investigational drug with the potential to displace antidepressants
and benzodiazepines in the treatment paradigm for SAD, as well as
several other anxiety disorders.”
PH94B Phase 2 Study Results – Public Speaking
Challenge
The
PALISADE-1 Phase 3 trial design is substantially based upon the
design of the laboratory-simulated public speaking challenge in the
Phase 2 multi-center, randomized, double-blind, placebo-controlled
trial of PH94B for the acute treatment of anxiety in adults with
SAD. In that Phase 2 study, PH94B rapidly reduced (within 15
minutes) anxiety in response to both the public speaking challenge
(p=0.002) and a social interaction challenge
(p=0.009).
About Social Anxiety Disorder (SAD)
Social
Anxiety Disorder affects as many as 23.7 million Americans and,
according to the National Institutes of Health, is the third most
common psychiatric condition after depression and substance use. A
person with SAD feels intense, persistent symptoms of anxiety or
fear in certain social situations, such as meeting new people,
dating, being on a job interview, answering a question in class, or
talking to a cashier in a store. Doing common, everyday things in
front of people causes profound anxiety or fear of being
humiliated, evaluated, judged, or rejected. SAD can get in the way
of going to work, attending school, or doing a wide variety of
things in a situation that has the potential for interpersonal
interaction. It can lead to avoidance and opportunity cost that can
significantly impact a person's employment and social activities
and be very disruptive to overall quality of life. SAD is commonly
treated chronically with certain FDA-approved antidepressants,
which have a slow onset of effect (several weeks) and limited
therapeutic benefits, and benzodiazepines, which are not
FDA-approved for treatment of SAD but are prescribed for off-label
use. Both antidepressants and benzodiazepines have known side
effects and safety concerns that may make them unattractive to
individuals affected by SAD.
About PH94B
PH94B is a first-in-class, odorless, rapid-onset
(approximately 10 to 15 minutes) CNS pherine nasal spray with the
potential to be the first FDA-approved, fast-acting, on-demand
treatment for millions of Americans who suffer from SAD, with
additional potential in adjustment disorder, postpartum anxiety,
pre-procedural anxiety, post-traumatic stress disorder, panic
disorder and generalized anxiety disorder. Administered at
microgram doses, PH94B activates nasal chemosensory neurons that
trigger neural circuits in the brain that suppress fear and
anxiety. Following successful Phase 2 development, VistaGen has
recently initiated its PALISADE-1 Phase 3 clinical trial of PH94B
for acute treatment of anxiety in adults with SAD. The FDA has
granted Fast Track designation for the development of PH94B as a
treatment for SAD. View more background on SAD and PH94B's
unique mechanism of action.
About VistaGen Therapeutics
VistaGen Therapeutics is a biopharmaceutical company committed to
developing and commercializing innovative medicines with the
potential to go beyond the current standard of care for anxiety,
depression and other CNS disorders. Each of VistaGen's drug
candidates has a differentiated potential mechanism of action, has
been well-tolerated in all clinical studies to date and has
therapeutic potential in multiple 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 Phase 3 development of PH94B
for the acute treatment of anxiety in adults with SAD. 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 PALISADE-1 trial and the Company's PALISADE PH94B Phase 3
clinical program are not sufficient to support a New Drug
Application, or for regulatory approval for the acute treatment of
anxiety in adults 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 at any time during the PALISADE
Phase 3 program, including during PALISADE-1, or future trials,
which trials 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 the
Company’s most recent Annual Report on Form 10-K for the year
ended March 31, 2020, and in its most recent Quarterly Report on
Form 10-Q for the quarter ended December 31, 2020 as well as
discussions of potential risks, uncertainties, and other important
factors in its 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.
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VistaGen Company Contacts
Mark
McPartland / Mark Flather
VistaGen
Therapeutics
Phone:
(650) 577-3606
Email: IR@vistagen.com