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 1, 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 8.01 Other Events.
On December 1, 2020, VistaGen Therapeutics, Inc.
(the “Company”) issued a press release to announce that
Louis Monti, M.D., Ph.D., a pioneer in the research and development
of neuroactive steroids known as “pherines,” including
the Company’s intranasal drug candidates PH94B for anxiety
disorders and PH10 for depression disorders, has joined the Company
as Vice President, Translational Medicine. 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 Index
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Exhibit No.
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Description
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Press
Release issued by VistaGen Therapeutics, Inc., dated December 1,
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:
December 1, 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 Expands R&D Team with Appointment of
Louis Monti, M.D., Ph.D., Pioneer in the Development of Neuroactive
Steroids known as Pherines as Potential Treatments for Anxiety and
Depression Disorders, as Vice President, Translational
Medicine
Dr. Monti developed the innovative scientific platform that enabled
the early research and development of VistaGen’s PH94B and
PH10, intranasal neuroactive steroid drug candidates (pherines)
with potential for the rapid-onset treatment of anxiety and
depression disorders, respectively
SOUTH SAN FRANCISCO, Calif., December 1, 2020 – VistaGen Therapeutics (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 that Louis Monti, M.D., Ph.D., a
pioneer in
the research and development of neuroactive steroids known as
“pherines,” including VistaGen’s intranasal drug
candidates PH94B for anxiety disorders
and PH10 for
depression disorders,
has joined the Company as Vice President, Translational
Medicine.
“We
have had the pleasure of working closely with Dr. Monti in a
consultative capacity since 2018 to complement our efforts to
develop PH94B and PH10 to improve the lives of millions of people
worldwide who suffer from anxiety and depression disorders every
day,” stated
Shawn K. Singh, Chief Executive Officer of VistaGen. “As we
approach several potentially significant milestones for these
differentiated neuropsychiatric drug candidates in 2021 and beyond,
Dr. Monti’s unique knowledge, expertise, and insight about
their potential, as well as potential opportunities for further
expansion of our CNS pipeline, will be valuable. We are excited
that he has now joined us as a full-time member of our R&D
team.”
Dr.
Monti commented, “Driving research of neuroactive pherines to
develop innovative medicines with the potential to lift the burdens
of anxiety and depression has been a passion throughout my career.
I am truly pleased to join a team that shares that sense of
commitment and purpose. I am excited that my new role at VistaGen
will allow me both to continue to assist with the late-stage
clinical development of PH94B and PH10 and apply my R&D
experience working with neuroactive steroids to explore potential
pipeline expansion opportunities.”
Dr.
Monti has served as President and CEO of Pherin Pharmaceuticals
since July 2018. He previously served as its Executive Vice
President between 2002 and 2018 and as its Vice President of
Research from its founding in 1991 to 2002. Prior to joining
Pherin, Dr. Monti held various academic positions at the University
of Utah and the University of the Republic, Uruguay. He earned an
M.D. from the University of the Republic, Uruguay School of
Medicine, and a Ph.D. in Physiology and Pharmacology from the
University of Utah. Dr. Monti holds memberships in the New York
Academy of Sciences, the American Society of Clinical
Psychopharmacology, and the International Brain
Organization.
About PH94B
PH94B
is an innovative odorless investigational synthetic neuroactive
steroid nasal spray with therapeutic potential in multiple mental
health disorders involving anxiety or phobia and is designed to
have rapid onset. Self-administered in microgram-level doses, in
Phase 2 studies for the treatment of social anxiety disorder (SAD),
PH94B produced rapid-onset (within approximately 15 minutes)
anti-anxiety effects without sedation or systemic uptake and
distribution.
VistaGen
is currently preparing PH94B for Phase 3 development as a potential
acute treatment of anxiety in adults with SAD. The FDA has granted
Fast Track designation for the development of PH94B for this
indication.
With
rapid-onset pharmacology and favorable safety results seen in all
clinical studies to date, we believe PH94B has the potential to
provide an innovative treatment alternative to benzodiazepines and
other pharmacological alternatives in the acute drug treatment
paradigm for SAD, as well as others anxiety disorders.
About PH10
PH10 is an innovative odorless investigational synthetic
neuroactive nasal spray designed to have rapid onset and
therapeutic potential in several neuropsychiatric indications
involving depression and suicidal ideation. Following successfully
completed exploratory Phase 2A clinical development, VistaGen is
preparing for Phase 2B clinical development of PH10 as a potential
stand-alone, rapid-onset treatment for major depressive disorder
(MDD).
About VistaGen
VistaGen Therapeutics, Inc. is a clinical-stage 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 three 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 clinical development and
commercialization of PH94B for anxiety disorders and PH10 for
depression disorders. 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 and PH10 may not be achieved in any market;
the FDA may decide that the results of the Company's PH94B and PH10
clinical programs are not sufficient for regulatory approval for
acute treatment of anxiety in adult patients with SAD or MDD,
respectively, or any other anxiety- or depression-related disorder;
development of PH94B and PH10 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 or PH10; 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, including risks
related to the COVID-19 pandemic, which may include, but are not
limited to, unavailability of or delays in delivery of raw
materials for manufacture of PH94B or PH10; inadequate and/or
untimely supply of PH94B or PH10 to meet demand; entry of
competitive products; and other technical and unexpected hurdles in
the development, manufacture and commercialization of PH94B and
PH10, as well as those risks more fully discussed in the section
entitled "Risk Factors" in VistaGen's 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 and six months ended September
30, 2020, as well as discussions of potential risks, uncertainties,
and other important factors in the 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.
VistaGen Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3606
Email: IR@vistagen.com