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): August 8, 2017
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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001-37761
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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 August 8, 2017, VistaGen Therapeutics, Inc. (the
“Company”) announced that the Company
received a Notice of Allowance from the U.S. Patent and Trademark
Office (“USPTO”) for U.S. Patent
Application No. 14/359,517 regarding proprietary methods for
producing hematopoietic precursor stem cells. A copy of the press
release is attached to this Current Report on Form 8-K as Exhibit
99.1, and is incorporated herein by reference.
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:
August 9, 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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Press
release issued by VistaGen Therapeutics Inc., dated August 8,
2017.
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Exhibit
99.1
VistaGen Receives Notice of Allowance from U.S. Patent and
Trademark Office for U.S. Patent regarding Breakthrough Methods for
Producing Blood Cells, Platelets and Bone Marrow Stem Cells with
Potential to Treat Autoimmune Disorders and Cancer
South San Francisco, CA (August 8, 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 Company has received a Notice
of Allowance from the U.S. Patent and Trademark Office (USPTO) for
U.S. Patent Application No. 14/359,517 regarding proprietary
methods for producing hematopoietic precursor stem cells, which are
stem cells that give rise to all of the blood cells and most of the
bone marrow cells in the body, with potential to impact both direct
and supportive therapy for autoimmune disorders and
cancer.
The
breakthrough technology covered by the allowed U.S. patent was
discovered and developed by distinguished stem cell researcher, Dr.
Gordon Keller, Director of the UHN’s McEwen Centre for
Regenerative Medicine in Toronto, one of the world’s leading
centers for stem cell and regenerative medicine research and part
of the University Health Network (UHN), Canada’s largest
research hospital. Dr. Keller is a co-founder of VistaGen and a
member of the Company’s Scientific Advisory Board. VistaGen
holds an exclusive worldwide license from UHN to the stem cell
technology covered by the allowed U.S. patent.
“We
are pleased to report that the USPTO has allowed another important
U.S. patent relating to our stem cell technology platform, stated
Shawn Singh, Chief Executive Officer of VistaGen. “Because
the technology under this allowed patent involves the stem cells
from which all blood cells are derived, it has the potential to
reach the lives of millions battling a broad range of
life-threatening medical conditions, including cancer, with CAR-T
cell applications and foundational technology we believe ultimately
will provide approaches for producing bone marrow stem cells for
bone marrow transfusions. As we continue to expand the patent
portfolio of VistaStem Therapeutics, our stem cell
technology-focused subsidiary, we enhance our potential
opportunities for additional regenerative medicine transactions
similar to our December 2016 sublicense of cardiac stem cell
technology to BlueRock Therapeutics, while focusing
VistaStem’s internal efforts on using stem cell technology
for cost-efficient small molecule drug rescue to expand our drug
development pipeline.”
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
in Phase 2 development, initially as a new generation oral
antidepressant drug candidate for major depressive disorder (MDD).
AV-101's mechanism of action is fundamentally different 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 small 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 an
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 neuropathic pain, epilepsy, Huntington’s disease,
and levodopa-induced dyskinesia associated with Parkinson’s
disease and other disorders where modulation of the NMDA receptors,
activation of AMPA pathways and/or key active metabolites of AV-101
may achieve therapeutic benefit.
About VistaStem
VistaStem Therapeutics is VistaGen’s wholly-owned
subsidiary focused on applying human pluripotent stem cell (hPSC)
technology, internally and with third-party collaborators, to
discover, rescue, develop and commercialize (i) proprietary new
chemical entities (NCEs), including small molecule NCEs with
regenerative potential, for CNS and other diseases and (ii)
cellular therapies involving stem cell-derived blood, cartilage,
heart and liver cells. VistaStem’s internal drug rescue
programs are designed to utilize CardioSafe 3D, its customized cardiac
bioassay system, to develop small molecule NCEs for
VistaGen’s pipeline. To advance potential regenerative
medicine (RM) applications of its cardiac stem cell technology, in
December 2016, VistaStem exclusively sublicensed to BlueRock
Therapeutics LP, a next generation regenerative medicine company
established in 2016 by Bayer AG and Versant Ventures, rights to
certain proprietary technologies relating to the production of
cardiac cells for the treatment of heart disease. In a manner
similar to its exclusive sublicense agreement with BlueRock
Therapeutics, VistaStem may pursue additional collaborations and
potential RM applications of its stem cell technology platform,
including using blood, cartilage, and/or liver cells derived from
hPSCs, for (i) cell-based therapy, (ii) cell repair therapy, and/or
(iii) tissue engineering.
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, including neuropathic pain and
L-DOPA-induced dyskinesia associated with Parkinson’s
disease, the potential for the Company’s stem cell technology
to produce NCEs, cellular therapies, regenerative medicine or bone
marrow stem cells to treat any medical condition, including
autoimmune disorders and cancer, protection of its intellectual
property, and the availability of substantial additional capital to
support its operations, including the AV-101 clinical 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
Investor Contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Email: VistaGen@KCSA.com
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