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 9, 2016
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.
Entry in Exclusive License Agreements for Cardiac Stem Cell
Technology and certain other agreements with University Health
Network and the McEwen
Centre for Regenerative Medicine
On December
9, 2016, VistaGen Therapeutics, Inc. (the
“Company”)
entered into a series of agreements with University Health Network
(“UHN”),
including (i) two new exclusive patent license agreements related
to certain cardiac stem cell technologies discovered by Dr. Gordon Keller,
Director of UHN's McEwen Centre for Regenerative Medicine, under
the parties’ Sponsored Research Agreement, originally
executed on September 18, 2007 and set to expire in the ordinary
course on
September 18, 2017 (the “SRA”);
(ii) an amendment of two exclusive cardiac stem cell technology
patent license agreements previously entered into by the Company and
UHN under
the SRA; and (iii) a strategic early termination of the SRA to
facilitate the BlueRock Therapeutics Agreement (defined
below).
Entry into Exclusive License and Sublicense Agreement with BlueRock
Therapeutics, LP.
On December 9, 2016,
the Company entered into an Exclusive License and Sublicense
Agreement (the “BlueRock
Therapeutics
Agreement”) with BlueRock
Therapeutics LP, a company recently established by Bayer AG and
Versant Ventures, pursuant to which
BlueRock Therapeutics
received
exclusive
rights to utilize certain technologies currently and exclusively
licensed by the Company from UHN for the production of cardiac stem
cells for the treatment of heart disease (the
“Sublicensed
IP”).
The Company
retained
rights to
utilize cardiac stem cell technology licensed from UHN for small
molecule, protein and antibody drug discovery, drug rescue and drug
development, including small molecules with cardiac regenerative
potential, as well as small molecule, protein and antibody testing
involving cardiac cells.
Under the
BlueRock Therapeutics
Agreement, the Company will receive an upfront payment of $1.25
million and has the potential to receive additional payments and
royalties in the
future, in
the event certain performance-based milestones and commercial sales
are achieved.
The foregoing
description of the agreements executed by the Company, including
the BlueRock
Therapeutics
Agreement, do not purport to be complete, and are qualified in their
entirety by reference to such agreements, which, to the extent an
agreement is considered a material agreement, will be filed as an
exhibit to the Company’s next periodic report filed under the
Securities Exchange Act of 1934, as
amended.
Item 8.01 Other Events.
The Company today issued a press release announcing the execution
of the agreements with UHN and the BlueRock
Therapeutics
Agreement. A copy of the press release is attached hereto 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 14, 2016 |
By:
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/s/ Shawn K. Singh |
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Shawn K. Singh |
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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 14,
2016.
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Exhibit
99.1
VistaGen Therapeutics Grants Exclusive Sublicense of Cardiac
Stem
Cell Technologies to BlueRock Therapeutics
VistaGen to receive upfront payment of $1.25M
South San Francisco, CA (December 14, 2016) –
VistaGen
Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company focused on developing new generation
therapies for depression and other central nervous system
(CNS) disorders, today
announced it has signed an exclusive sublicense agreement with
BlueRock Therapeutics, a stem cell research company established by
Bayer AG and Versant Ventures, for VistaGen’s rights to
certain proprietary technologies relating to the production of
cardiac stem cells for the treatment of heart disease. VistaGen
licensed exclusive rights of the cardiac stem cell technologies
from University Health Network (UHN), Canada's largest research
hospital, pursuant to a strategic research agreement with UHN and
distinguished UHN researcher, Dr. Gordon Keller, Director of UHN's
McEwen Centre for Regenerative Medicine (McEwen Centre), one of the
world's leading centers for stem cell and regenerative medicine
research. Under the sublicense agreement, VistaGen will receive an
upfront cash payment of $1.25 million, as well as potential future
milestone payments and royalties.
“Cardiac cell therapy and regenerative medicine offer new
hope for patients battling heart attacks and heart disease
worldwide,” stated Shawn Singh, Chief
Executive Officer of VistaGen. “We believe BlueRock will play the leading
role in the advancement of potentially life-changing cardiac
cellular therapies, advancing these and other ground-breaking
discoveries well beyond the lab and into the clinic, while we continue to focus our efforts on
advancing AV-101 through Phase 2 clinical development for major
depressive disorder and other CNS
indications.”
About VistaGen
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage
biopharmaceutical company focused on developing new generation
therapies for depression and other central nervous system
(CNS) disorders.
VistaGen’s lead CNS product candidate, AV-101, is a new
generation, orally available prodrug in Phase 2 development,
initially for the adjunctive treatment of MDD in patients with
inadequate response to standard, FDA-approved antidepressants.
AV-101 is currently being evaluated in an ongoing Phase 2a clinical
study being conducted by Principal Investigator, Dr. Carlos Zarate
Jr., of the NIMH, and fully funded by the NIMH. VistaGen is also
preparing to initiate in the first half of 2017 a Phase 2b clinical
study of AV-101 as an adjunctive
treatment of MDD in patients with inadequate response to
standard, FDA-approved antidepressants.
VistaStem
Therapeutics is VistaGen’s wholly owned subsidiary focused on
applying human pluripotent stem cell technology to discover,
rescue, develop and commercialize proprietary new chemical entities
(NCEs), including small molecule NCEs with regenerative potential,
for CNS and other diseases, as well as potential cellular therapies
involving stem cell-derived blood, cartilage and liver
cells.
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
preclinical and/or clinical development and commercialization of
licensed and/or sublicensed cardiac stem technology for cell
therapy, drug discovery, drug rescue or regenerative medicine,
including the development and commercialization 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
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email:
jenene@jenenethomascommunications.com
Source:
VistaGen Therapeutics, Inc.
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