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): May 27, 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 7.01 Regulation FD Disclosure.
On May 27, 2020, VistaGen Therapeutics, Inc. (the
“Company”) announced its agreement with Nuformix plc
to develop new crystalline forms of AV-101 that may have superior
delivery, an enhanced therapeutic profile and additional
intellectual property protection. A copy of the Company’s
press release is attached hereto as Exhibit
99.1.
On June
1, 2020, the Company began utilizing a new corporate presentation,
a copy of which is attached to this Current Report on Form 8-K as
Exhibit 99.2.
The information in Item 7.01 of this Current
Report on Form 8-K, including the information set
forth in Exhibit 99.1 and 99.2, is being furnished and shall
not be deemed “filed” for purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the
“Exchange
Act”), nor shall Exhibit
99.1 and 99.2 filed herewith be deemed incorporated by reference in
any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in such a filing.
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 May 27,
2020.
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| 99.2 |
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VistaGen
Therapeutics, Inc. Corporate Presentation, dated Summer
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:
June 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 and Nuformix Announce Agreement to Develop Novel
Patentable Cocrystalline Forms of AV-101 for Treatment of Multiple
CNS Conditions
Novel Cocrystal Form of AV-101 Administered with
Probenecid
May Have Superior Delivery, an Enhanced Therapeutic
Profile
and Additional Intellectual Property Protection
SOUTH SAN FRANCISCO, Calif., May 27, 2020 – VistaGen
Therapeutics (NASDAQ: VTGN), a
clinical-stage biopharmaceutical company developing new generation
medicines for anxiety, depression and other central nervous system
(CNS) diseases and disorders with high unmet need, and Nuformix plc
(LSE: NFX.L), a pharmaceutical
development company focused on unlocking the therapeutic potential
and value of known drugs, today announced their
agreement to develop novel
cocrystal-based formulations of VistaGen’s CNS product
candidates. Under the terms of the agreement, VistaGen
and Nuformix initially will
apply Nuformix’s proprietary technology platform to
develop patentable new crystalline forms of AV-101 that may have
superior delivery, an enhanced therapeutic profile and additional
intellectual property protection. If successful, VistaGen
and Nuformix will consider opportunities to extend the
collaboration to other CNS therapeutic candidates with a view
to unlocking additional therapeutic and commercial
opportunities.
“Nuformix has a successful track record of using cocrystal
technology to re-engineer the crystalline form of small molecule
drugs for their own development and for select partners,”
said H. Ralph Snodgrass, PhD, VistaGen President and Chief
Scientific Officer. “Their team is not only highly
experienced, but also scientifically creative. We look
forward to a productive collaboration.”
“We’re very pleased to announce this collaboration with
VistaGen and the opportunity to collaborate in CNS
therapeutics,” said Dan Gooding, PhD, Nuformix Chief
Executive Officer. “VistaGen and Nuformix share similar
objectives in the development of new therapies and we look forward
to making an important contribution to VistaGen’s
comprehensive AV-101 programme and developing the relationship
further.”
AV-101
is VistaGen’s oral NMDAR
(N-methyl-D-aspartate receptor) glycine site antagonist, in
development in combination with probenecid, a safe and well-known
oral drug used to treat gout and to increase the therapeutic
benefit of numerous antibacterial, anticancer and antiviral
drugs.
Recently
reported preclinical data suggest that there is a substantially
increased brain concentration of AV-101 prodrug (4-Cl-KYN) and its
active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), when given
together with probenecid. With its exceptionally few side
effects and excellent safety profile in all clinical studies to
date, AV-101, together with probenecid, has potential to be a new
generation oral treatment for chronic neuropathic pain, epilepsy,
levodopa-induced dyskinesia associated with Parkinson’s
disease therapy, major depressive disorder, and suicidal
ideation.
About AV-101
AV-101 (4-Cl-KYN) targets the NMDAR (N-methyl-D-aspartate
receptor), an ionotropic glutamate receptor in the
brain. Abnormal NMDAR function is associated with numerous CNS
diseases and disorders. AV-101 is an oral prodrug of
7-chlorokynurenic acid (7-Cl-KYNA), which is a potent and selective
full antagonist of the glycine co-agonist site of the NMDAR that
inhibits the function of the NMDAR. Unlike ketamine and many other
NMDAR antagonists, 7-Cl-KYNA is not an ion channel blocker. In all
studies to date, AV-101 has exhibited no dissociative or
hallucinogenic psychological side effects or safety concerns
similar to those that may be caused by amantadine, esketamine and
ketamine. With its exceptionally few side effects and
excellent safety profile, AV-101 has potential to be an oral new
generation treatment for multiple large-market CNS indications
where current treatments are inadequate to meet high unmet patient
needs. The FDA has granted Fast Track designation for development
of AV-101 as both a potential adjunctive treatment
for MDD and as
a non-opioid treatment
for neuropathic pain.
About Cocrystals
Pharmaceutical cocrystals are materials composed of two or more
different molecules, usually an active pharmaceutical ingredient
together with a “co-former” molecule. Cocrystals can be
engineered to enhance the bioavailability, pharmacokinetics,
stability and manufacturing of drug products.
About VistaGen
VistaGen Therapeutics is a multi-asset, clinical-stage
biopharmaceutical company developing new generation medicines for
anxiety, depression and certain CNS diseases and disorders where
current treatments are inadequate, resulting in high unmet need.
VistaGen's pipeline is
focused on three clinical-stage CNS drug candidates, each with a
differentiated mechanism of action, an exceptional safety profile,
and therapeutic potential in multiple large and growing CNS
markets. For more information, please
visit www.vistagen.com
and connect with VistaGen on
Twitter, LinkedIn and Facebook.
About Nuformix
Nuformix is a pharmaceutical development company focused on
unlocking the therapeutic potential and value of known drugs.
Nuformix risk-mitigated development strategy has resulted in a
pipeline of discoveries through which it has developed and patented
novel forms of approved small molecules. Nuformix is targeting
high-value unmet needs via drug repurposing with a lead programme
in fibrosis (NXP002). Nuformix plc shares are traded on the London
Stock Exchange's Official List under the ticker: NFX. For more
information please visit www.nuformix.com.
VistaGen Forward-Looking Statements
This release contains various statements concerning VistaGen's
future expectations, plans and prospects, including without
limitation, our expectations regarding discovery, development and
commercialization of patentable cocrystalline forms of AV-101,
either alone or in combination with probenecid, for treatment of
CNS diseases and disorders with high unmet need, including
chronic
neuropathic pain, epilepsy, levodopa-induced dyskinesia associated
with Parkinson’s disease therapy, major depressive disorder,
and suicidal ideation. In addition, statements
concerning the Company's future expectations may include statements
regarding intellectual property and commercial protection of our
drug candidates. Each of these statements 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. Those risks
include the following: (i) we may encounter unexpected adverse
events in patients during 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 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; (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 the substantial
additional capital necessary to support our operations, including
our ongoing and/or planned preclinical and/or clinical development
studies; and (vii) we may encounter technical and other unexpected
hurdles and delays in the manufacturing and development of any of
our product candidates. 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.
VistaGen Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: IR@vistagen.com
VistaGen Investor Contact
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Email: VistaGen@KCSA.com
VistaGen Media Contact
Caitlin Kasunich / Lisa Lipson
KCSA Strategic Communications
Phone: +1 (212) 896-1241/+1 (508) 843-6428
Email: VistaGen@KCSA.com
Exhibit
99.2
