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): October 24, 2018
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))
Item 1.01 Entry into a Material Definitive Agreement.
On October 24, 2018,
VistaGen Therapeutics, Inc. (the “Company”)
exercised the option (the “PH10
Option”) previously
granted to the Company by Pherin Pharmaceuticals, Inc.
(“Pherin”)
to acquire an exclusive license for the worldwide rights to develop
and commercialize PH10 (the “PH10
License”), a
first-in-class investigational neuroactive steroid drug candidate
administered as a nasal spray, currently in Phase 2 development for
the treatment of major depressive disorder
(“MDD”).
As a part of the Company’s acquisition of the PH10 License,
the Company and Pherin executed the license agreement that was
previously negotiated by the parties and attached to the PH10
Option as Exhibit B (the “PH10
Agreement”).
As consideration for
the exercise of the option and acquisition of the PH10 License, the
Company issued to Pherin $2.0 million of the Company’s
unregistered common stock, par value $0.001 per share
(“Common
Stock”), or a total of
925,926 shares, which was based on the closing price of the
Company’s Common Stock on October 23, 2018, as reported on
the Nasdaq Capital Market (the “PH10
Shares”). In the event
certain regulatory-based milestones are achieved, the Company will
also pay to Pherin cash payments and royalties upon attainment of
the applicable milestones.
The foregoing
description of the PH10 Agreement, does not purport to be complete,
and is
qualified
in its entirety by reference to the PH10 Agreement, a copy of which
will be filed as an exhibit to the Company’s next periodic
report filed under the Securities Exchange Act of 1934, as amended
(the “Exchange
Act”).
Item 3.02 Unregistered Sales of Equity Securities.
See Item 1.01 above with respect to the issuance of the PH10
Shares.
The issuance of the the PH10 Shares was exempt
from the registration requirements of the Securities Act of 1933,
as amended (the “Securities
Act”), in reliance
on the exemptions provided by Section 4(a)(2) of the Securities
Act. The PH10 Shares have not been registered under the Securities
Act or any other applicable securities laws, and unless so
registered, may not be offered or sold in the United States except
pursuant to an exemption from the registration requirements of the
Securities Act.
Item 8.01 Other Events.
The Company today issued a press release announcing the acquisition
of the PH10 License. A copy of the press release is attached hereto
as Exhibit 99.1, and is incorporated by reference herein. The
information in this Item 8.01 and the press release attached hereto
as Exhibit 99.1 shall not be deemed “filed” for
purposes of Section 18 of the Exchange Act, nor shall such
information be deemed incorporated by reference in any filing under
the Securities Act or the Exchange Act.
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:
October 26, 2018
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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 October 25,
2018.
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Exhibit
99.1
VistaGen Therapeutics Acquires Worldwide Rights to Develop and
Commercialize PH10, a First-in-Class Intranasally Administered
Neuroactive Steroid with Rapid-onset Antidepressant Effects for
Major Depressive Disorder Demonstrated in Phase 2a
Study
PH10 demonstrated in Phase 2a study significant antidepressant
effects without psychological side effects after only one week of
administration
South San Francisco, Calif. (October 25, 2018) –
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 Company has exercised its option to
acquire from Pherin Pharmaceuticals, Inc. (Pherin) the exclusive
license for worldwide rights to develop and commercialize
PH10, a
first-in-class, intranasally administered neuroactive steroid (a
“pherine”), with rapid-onset antidepressant effects for
treatment of major depressive disorder (MDD) demonstrated in a
phase 2a study. The Company secured the option for PH10
concurrently with its previously announced license agreement with
Pherin for worldwide rights to develop and commercialize
PH94B, also a first-in-class neuroactive pherine, which VistaGen is
preparing for pivotal Phase 3 development as a nasal spray for
acute on-demand treatment of social anxiety disorder
(SAD).
PH10 activates
nasal chemosensory receptors that in turn engage GABA
(gamma-aminobutyric acid) and CRH (corticotropin-releasing hormone)
neurons in the limbic amygdala system. The activation of these
neural circuits is believed to have the potential to lead to a
rapid antidepressant effect.
Michael
Liebowitz, M.D., a member of VistaGen’s CNS Clinical and
Regulatory Advisory Board, has acted as an advisor to Pherin in
connection with its clinical trials of PH10 and PH94B and
previously presented results for PH10’s eight-week,
double-blind, single-center, 30-patient, Phase 2a study for MDD.
Results in the Phase 2a study demonstrated that self-administered
doses of PH10 as a nasal spray resulted in significant decreases in
depression as measured by the Hamilton Rating Scale for Depression,
a widely used clinician-administered depression assessment scale.
In this study, PH10 was very well tolerated with minimal side
effects.
“After extensive due diligence and guidance from Dr.
Liebowitz, we exercised our option to acquire exclusive rights to
develop and commercialize PH10 for depression and other CNS
diseases,” said Shawn Singh, Chief
Executive Officer of VistaGen. “Depression is a
complicated disease, without a one-size-fits-all solution.
Development of promising treatment alternatives with fundamentally
different mechanisms of action from current antidepressants is a
core competency of our team. We are excited to build upon the
notable and steadfast efforts of Dr. Louis Monti, Dr. Liebowitz and
Pherin’s entire team in developing PH10 to date. PH10 marks
yet another valuable asset in our growing pipeline, with compelling
data and complementary to our core focus on developing innovative
rapid-onset treatments for MDD beyond ketamine with convenient
administration and without debilitating or psychological side
effects and safety concerns. We
believe that having yet another potentially safe, fast-acting, new
generation mechanism of action treatment in play, in addition to
AV-101 with its NMDAR GlyB and AMPAR targets, adds strength to
strength, allowing us to provide patients with an even broader
range of potential solutions to treat MDD, and expands our
potential opportunities to monetize our assets to the benefit of
our stockholders.”
“Depression is a pervasive mental illness and currently
available treatments fall short for many individuals with the
disease. Ultra-low doses of intranasal PH10, with its novel
mechanism of action, rapid onset activity and excellent safety and
tolerability profile demonstrated in a phase 2a study, may
represent another life-changing opportunity to address the growing
unmet need among individuals suffering from MDD,” stated Dr.
Liebowitz.
Pherines inhibit nerve circuits mediating behavioral and
physiological effects of anxiety. This mechanism of action, rapid
onset of efficacy and excellent safety and tolerability profile
have been shown in multiple previous clinical trials, including a
pilot Phase 3 feasibility study evaluating the safety and efficacy
of PH94B for SAD and Phase 2 feasibility study evaluating the
safety and efficacy of PH10 for MDD.
In connection with the consummation of the license and option
agreements, VistaGen issued to Pherin $2.0 million of its
unregistered common stock (925,926 unregistered
shares).
About VistaGen
VistaGen
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. For more information, please visit
www.vistagen.com
and connect with VistaGen on Twitter,
LinkedIn and
Facebook.
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 drug candidates, including AV-101 for MDD,
neuropathic pain and suicidal ideation, PH94B for SAD, and PH10 for
MDD, as well as our intellectual property and commercial protection
of our drug candidates, all of which 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. Among these risks is the
possibility that (i) we may encounter unexpected adverse events in
patients in 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 in ongoing or 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 AV-101, PH94B, and/or PH10, (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 clinical development activities; and (vii) we
may encounter technical and other unexpected hurdles in the
manufacturing and development of any of our product ca. 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
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