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): December 10, 2019
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
December 10, 2019, VistaGen
Therapeutics, Inc. (the “Company”) announced that
the U.S. Food and Drug Administration has granted Fast Track
designation for development of PH94B, the Company's neuroactive
nasal spray, for on-demand treatment of 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. 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:
December 12, 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 Number
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Description
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Press
Release issued by VistaGen Therapeutics, Inc., dated December 10,
2019.
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Exhibit
99.1
U.S. FDA Grants VistaGen Therapeutics Fast Track Designation for
PH94B for Treatment of Social Anxiety Disorder
VistaGen’s PH94B is the first drug candidate to be granted
U.S. FDA Fast Track designation
for treatment of social anxiety disorder
South San Francisco, Calif., (December 10, 2019) –
VistaGen
Therapeutics, Inc. (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. Food and Drug Administration
(FDA) has granted Fast Track designation for development of the
Company’s PH94B neuroactive nasal spray for on-demand
treatment of social anxiety disorder (SAD).
The
FDA’s Fast Track process is designed to facilitate the
development and review of new treatments for serious conditions
with unmet medical need, such as SAD, with the purpose of getting
innovative new treatment options to patients sooner. After
successful Phase 2 development, VistaGen is preparing PH94B for
Phase 3 development. PH94B has potential to be the first
fast-acting, non-sedating, as-needed treatment for as many as 20
million individuals in the U.S. suffering from SAD.
“The
FDA’s grant of Fast Track designation for development of
PH94B for SAD, which to our knowledge is the FDA’s first Fast
Track designation for a SAD drug candidate, is another important
regulatory milestone for VistaGen and a key step forward in our
development program for PH94B as a new generation anxiolytic. With
a high global prevalence of anxiety disorders, including SAD, and
alarming increases in dependency, addiction and even deaths
associated with misuse of benzodiazepines, the urgency for a new
non-addictive, non-sedating, fast-acting, as-needed treatment for
SAD and other anxiety disorders is more important now than ever
before. Based on clinical studies to date, PH94B, at non-systemic
microgram doses, has strong potential to fill the large current
treatment gap,” said
Shawn Singh, Chief Executive Officer of VistaGen.
About VistaGen
VistaGen
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for 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 differentiated
mechanisms of action, exceptional safety profiles in all clinical
studies to date, 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 peripartum anxiety,
pre/postoperative anxiety, 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
associated with everyday social and work or performance situations.
Following successful Phase 2 development, VistaGen is preparing for
Phase 3 clinical development of PH94B for social anxiety 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 Social Anxiety Disorder
Social
anxiety disorder (SAD) affects as many as 20 million Americans and
is the second most commonly diagnosed anxiety disorder.1,2 A person with SAD
feels symptoms of extreme anxiety or fear in certain social
situations, such as meeting new people, dating, being on a job
interview, answering a question in class, or making small talk to a
cashier in a store or a networking event at work. Doing everyday
things in front of people - such as eating or drinking in front of
others or using a public restroom - also causes anxiety or fear.
The person is afraid that he or she will be humiliated, judged, and
rejected. SAD can significantly compromise academic, social and
work life and can predispose individuals to other anxiety
disorders, depression and substance use disorders.3 There is no
FDA-approved medication for as-needed, on-demand treatment of SAD.
While three antidepressants (two SSRIs and one SNRI) are
FDA-approved for treatment of SAD, they take many weeks to work, if
they work at all, must be taken chronically, and often present
troubling side effects. Individuals affected by SAD need novel
treatment alternatives with fast onset therapeutic benefits and far
fewer side effects.
About Fast Track Designation
Fast
Track is a process designed by the FDA to facilitate the
development, and expedite the review, of drugs to treat serious
conditions and fill an unmet medical need. Drugs that receive Fast
Track Designation may be eligible to be the subject of more
frequent communications and meetings with FDA to review the drug's
development plan including the design of the proposed clinical
trials, use of biomarkers and the extent of data needed for
approval. Drugs with Fast Track Designation may also qualify for a
priority, expedited FDA review process, if relevant criteria are
met. The purpose is to get important new drugs to the patient
earlier. Fast Track addresses a broad range of serious conditions.
For more information about Fast Track, please visit:
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.
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 three drug candidates: (i) PH94B for
social anxiety disorder and multiple other anxiety disorders; (ii)
PH10 for MDD and multiple additional depression disorders and
suicidal ideation, and (iii) AV-101 for MDD, neuropathic pain,
epilepsy, dyskinesia associated with levodopa therapy for
Parkinson's disease and suicidal ideation;. 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, PH10 and/or AV-101; (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 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.
1 Harvard Medical School, 2007.
National Comorbidity Survey (NCS). (2017, August 21); Kessler, et
al, US National Comorbidity Survey Replication,
2005.
2 Anxiety and Depression
Association of America, https://adaa.org/understanding-anxiety/social-anxiety-disorder
3 American Psychiatric
Association. (2013). Diagnostic and statistical manual of mental
disorders (5th ed.). Arlington, VA: American Psychiatric
Publishing.
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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