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): March 29, 2017
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 8.01 Other Events.
On March 29, 2017, VistaGen Therapeutics, Inc.
(the “Company”) announced that the European Patent Office
has issued a Notice of Intention to Grant the Company's European
Patent Application for AV-101, the Company’s oral prodrug
candidate in Phase 2 development for major depressive disorder. The
granted claims covering multiple dosage forms of AV-101, treatment
of depression and reduction of dyskinesias associated with L-DOPA
treatment of Parkinson's disease will be in effect until at least
January 2034. 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:
March 29, 2017
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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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99.1
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Press
release issued by VistaGen Therapeutics Inc., dated March 29,
2017.
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Exhibit 99.1
VistaGen Therapeutics Receives European Patent Office Notice of
Intention to Grant European Patent for AV-101
South San Francisco, CA (March 29, 2017) –
VistaGen
Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other central nervous system (CNS)
disorders, announced today that the European Patent Office (EPO)
has issued a Notice of Intention to Grant the Company’s
European Patent Application for AV-101, its oral CNS prodrug
candidate in Phase 2 development for major depressive disorder
(MDD). The granted claims covering multiple dosage forms of AV-101,
treatment of depression and reduction of dyskinesias associated
with L-DOPA treatment of Parkinson’s disease will be in
effect until at least January 2034.
“We
are extremely pleased to receive the EPO’s notice of
intention to grant significant CNS-related patent claims for
AV-101, another substantial step forward in our plan to secure a
broad spectrum of intellectual property protection for AV-101
covering multiple CNS indications,” stated Shawn Singh, Chief
Executive Officer of VistaGen.
About AV-101
AV-101 (4-CI-KYN) is an oral CNS prodrug candidate in Phase 2
development in the U.S. as a new generation treatment for major
depressive disorder (MDD). AV-101 also has broad potential utility
in several other CNS disorders, including chronic neuropathic pain
and epilepsy, as well as neurodegenerative diseases, such as
Parkinson's disease and Huntington's disease.
AV-101 is currently being evaluated in a Phase 2 monotherapy study
in MDD, a study being fully funded by the U.S. National Institute
of Mental Health (NIMH) and conducted by Dr. Carlos Zarate Jr.,
Chief, Section on the Neurobiology and Treatment of Mood Disorders
and Chief of Experimental Therapeutics and Pathophysiology Branch
at the NIMH, as Principal Investigator.
VistaGen is preparing to advance AV-101 into a 180-patient, U.S.
multi-center, Phase 2 adjunctive treatment study in MDD patients
with an inadequate response to standard FDA-approved
antidepressants, with Dr. Maurizio Fava of Harvard University as
Principal Investigator.
About VistaGen
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other central nervous system (CNS)
disorders. VistaGen’s lead CNS product candidate, AV-101, is
a new generation oral antidepressant drug candidate in Phase 2
development for major depressive disorder (MDD). AV-101's
mechanism
of action is fundamentally differentiated from all
FDA-approved antidepressants and atypical antipsychotics used
adjunctively to treat MDD, with potential to drive a paradigm shift
towards a new generation of safer and faster-acting
antidepressants. AV-101 is currently
being evaluated by the U.S. National Institute of Mental Health
(NIMH) in a Phase 2 monotherapy study in MDD being fully
funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief,
Section on the Neurobiology and Treatment of Mood Disorders and
Chief of Experimental Therapeutics and Pathophysiology Branch at
the NIMH. VistaGen is preparing to launch a 180-patient Phase 2
study of AV-101 as an adjunctive treatment for MDD patients with
inadequate response to standard, FDA-approved antidepressants. Dr.
Maurizio Fava of Harvard University will be the Principal
Investigator of the Company’s Phase 2 adjunctive treatment
study. AV-101 may also have the potential to treat multiple
CNS disorders and neurodegenerative diseases in addition to MDD,
including chronic neuropathic pain, epilepsy, Parkinson’s
disease and Huntington’s disease, where modulation of the
NMDAR, AMPA pathway and/or key active metabolites of AV-101 may
achieve therapeutic benefit.
VistaStem
Therapeutics is VistaGen’s wholly owned subsidiary focused on
applying human pluripotent stem cell technology, internally and
with collaborators, to discover, rescue, develop and commercialize
proprietary new chemical entities (NCEs), including small molecule
NCEs with regenerative potential, for CNS and other diseases, and
cellular therapies involving stem cell-derived blood, cartilage,
heart and liver cells. In December 2016, VistaGen
exclusively
sublicensed to BlueRock Therapeutics LP, a next generation regenerative medicine company
established by Bayer AG and Versant Ventures, rights to
certain proprietary technologies relating to the production of
cardiac stem cells for the treatment of heart disease.
For
more information, please visit www.vistagen.com
and connect with VistaGen on Twitter,
LinkedIn and
Facebook.
Forward-Looking Statements
The statements in this press release that are not historical facts
may constitute forward-looking statements that are based on current
expectations and are subject to risks and uncertainties that could
cause actual future results to differ materially from those
expressed or implied by such statements. Those risks and
uncertainties include, but are not limited to, risks related to the
successful launch, continuation and results of the NIMH’s
Phase 2 (monotherapy) and/or the Company’s planned Phase 2
(adjunctive therapy) clinical studies of AV-101 in MDD, and other
CNS diseases and disorders, protection of its intellectual
property, and the availability of substantial additional capital to
support its operations, including the development activities
described above. These and other risks and uncertainties are
identified and described in more detail in VistaGen’s filings
with the Securities and Exchange Commission (SEC). These filings
are available on the SEC’s website at www.sec.gov.
VistaGen undertakes no obligation to publicly update or revise any
forward-looking statements.
Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: IR@vistagen.com
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