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 13, 2018
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 (see General Instruction A.2.
below):
☐
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))
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) ☐
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 8.01
Other
Events.
On August 13, 2018, VistaGen Therapeutics, Inc.
(the “Company”) and Baylor College of Medicine
(“Baylor”) announced that the Company and Baylor are
collaborating on a first-step study with healthy volunteer Veterans
to test potential anti-suicidal effects of AV-101, the
Company’s oral CNS drug candidate. The Company will provide
the clinical trial material for this study, and government funding
will be provided for substantially all other study costs. AV-101 is
in Phase 2 clinical development in the United States as an
adjunctive treatment of Major Depressive Disorder in patients with
an inadequate response to current antidepressants approved by the
U.S. Food and Drug Administration. A copy of the Company’s
press release is attached to this Current Report on Form 8-K as
Exhibit 99.1 and is incorporated by reference
herein.
Item 9.01
Financial Statements and
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
14, 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
No.
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Description
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Press Release
issued by VistaGen Therapeutics, Inc., dated August 13,
2018
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Exhibit 99.1
VistaGen
Therapeutics and Baylor College of Medicine
Collaborate
on First-Step Study to Test VistaGen’s AV-101 for Potential
Anti-Suicidal Effects in Veterans
Veterans from Operation Enduring Freedom, Operation Iraqi Freedom
and Operation New Dawn to Participate in Study
South San Francisco, Calif. and Houston, Texas (August 13,
2018) – VistaGen Therapeutics, Inc. (NASDAQ:VTGN), a
clinical-stage biopharmaceutical company focused on developing new
generation medicines for depression and other central nervous
system (CNS) diseases and disorders, and Baylor College of Medicine
(Baylor), today announced that VistaGen and Baylor are
collaborating on a first-step study with healthy
volunteer Veterans to test potential anti-suicidal effects
of VistaGen’s AV-101.
A total
of 12 healthy volunteer Veterans from either Operation Enduring
Freedom, Operation Iraqi Freedom or Operation New Dawn will be
administered single doses of AV-101, at 720 mg and 1440 mg and
placebo, over three weeks in a randomized, double-blind, cross-over
study to define a dose-response relationship between AV-101 and
relevant biomarkers related to NMDA function and others possibly
related to suicidality. Dr. Marijn Lijffijt of Baylor will be
Principal Investigator. VistaGen and the U.S. Department of
Veterans Affairs (VA) entered into a Material Transfer Cooperative
Research and Development Agreement (MT CRADA) regarding clinical
trial material for this study, and government funding will be
provided for substantially all other study costs.
“The
number of Veterans who take their own life is tragic and
staggering, averaging 20 suicides per day,” said
Shawn Singh, Chief Executive Officer of VistaGen.
“These statistics are not acceptable. As suicide
prevention is a vital mission of Baylor and VistaGen, our goal for
this initial study is to set the stage to advance our collective
efforts to help Veterans fight suicidal ideation on a long-term
basis. Suicide is a national public health concern that affects
people everywhere, and we must do more to raise awareness and
pursue novel faster-acting and safe treatments to help those who
continue to suffer from both debilitating depression and suicidal
ideation. The status quo for treatment is just not working, and
individuals, especially Veterans, need better
alternatives.”
“Baylor
College of Medicine and Dr. Sanjay
Mathew, a member of VistaGen’s CNS
Clinical and Regulatory Advisory Board, share an important
mission to find better treatment alternatives for Veterans who
suffer from depression, suicidal ideation and other CNS
indications,” added Dr. Lijffijt. “The suicide rate is
two times higher in Veterans than in citizens of equivalent age and
gender. A priority for suicide prevention is to come up with novel
treatment targets for safe and rapidly acting interventions to
impact acute suicidality, which is not adequately addressed with
current treatments. This study is the first step in working to
revolutionize the way that we treat suicidal ideation and
behaviors. Our expectation is to complete the dosing by the end of
September 2018, with top-line results from the study expected by
year end. The results of this initial study in healthy volunteer
Veterans could lead to a Phase 2 study involving AV-101 and
Veterans who are battling suicidal ideation or
behaviors.”
AV-101
is currently undergoing two separate, more advanced Phase 2 clinical
studies for the treatment of major depressive
disorder.
About Suicide
According
to the World Health Organization (WHO), every year approximately
800,000 people worldwide take their own life and many more attempt
suicide.1 Suicide is a major public health concern
in the United States as rates of suicide have been increasing for
both men and women and across all age groups. Suicide is the 10th
leading cause of death in the U.S. and is one of just three leading
causes that are on the rise.2 The Center for Disease Control and
Prevention (CDC) reported that in the U.S. the age-adjusted rate of
suicide increased by 24 percent between 1999 and 2014.3 The number of U.S. citizens who die by
suicide is, since 2010, higher than those who die in motor vehicle
accidents. People of all genders, ages, and ethnicities can be at
risk for suicide and suicidal behavior is complex and there is no
single cause. In fact, many different factors contribute to someone
making a suicide attempt, including, but not limited to,
depression, other mental health disorders or substance abuse
disorder; certain other medical conditions; chronic pain; prior
suicide attempt; and family history of mental disorder or substance
abuse.4 Additionally, it has been found that the
Veteran population is at significantly higher risk for suicide.
After adjusting for differences in age, risk for suicide was 19
percent higher among male Veterans compared with U.S. civilian
adult men and 2.5 times higher among female Veterans compared with
U.S. civilian adult women.5 Despite these many risk factors, suicide
is not inevitable for those that have one or more risk factor(s).
Starting a conversation, reducing stigma, providing support and
resources and working to develop safe and novel treatments for
those in need can help prevent suicide and save the lives of
many.
Veterans
who are in crisis or having thoughts of suicide, and those who know
a Veteran in crisis, should call the Veterans Crisis
Line for confidential support 24 hours a day, seven days a
week, 365 days a year at 800-273-8255 and press 1, chat online at
VeteransCrisisLine.net/Chat
or send a text message to 838255.
To
reach the National Suicide
Prevention Lifeline network, please call 1-800-273-8255
(available 24 hours every day). Learn more about VA’s
suicide-prevention resources and programs at www.mentalhealth.va.gov/suicide_prevention/.
Additional
materials can be found on VistaGen’s Resources page
here.
About AV-101
AV-101
is an oral, non-opioid, non-sedating NMDA receptor glycine B (NMDAR
GlyB) antagonist that offers the potential to be a new at-home
treatment for multiple CNS indications with high unmet medical
need. AV-101 is currently in Phase 2 clinical development in the
United States for treatment of major depressive disorder.
ELEVATE is
VistaGen’s ongoing Phase 2 clinical trial designed to
evaluate the efficacy and safety of adjunctive use of AV-101 for
MDD in patients with an inadequate response to standard
antidepressant therapy with either an FDA-approved selective
serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine
reuptake inhibitor (SNRI). AV-101’s mechanism of
action (MOA) is fundamentally different from that of all
current FDA-approved SSRIs and SNRIs, most of which, if effective
for a given patient, take many weeks to achieve therapeutic
benefits.
AV-101
may also have the potential to treat neuropathic pain, epilepsy,
Parkinson's disease levodopa-induced dyskinesia, suicidal ideation
and other CNS diseases and disorders where NMDA receptor modulation
and AMPA pathway activation may achieve therapeutic benefits. The
FDA has granted Fast Track
designation to AV-101 for development as a potential
adjunctive treatment of MDD.
About VistaGen
VistaGen
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for depression and other 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.
About Baylor College of Medicine
Baylor
College of Medicine (www.bcm.edu) in
Houston is recognized as a premier academic health sciences center
and is known for excellence in education, research and patient
care. It is the only private medical school in the greater
southwest and is ranked 16th among medical schools for research and
5th for primary care by U.S. News & World Report. Baylor is
listed 21st among all U.S. medical schools for National Institutes
of Health funding and number one in Texas. Located in the Texas
Medical Center, Baylor has affiliations with seven teaching
hospitals and jointly owns and operates Baylor St. Luke’s
Medical Center, part of CHI St. Luke’s Health. Currently,
Baylor trains more than 3,000 medical, graduate, nurse anesthesia,
physician assistant and orthotics students, as well as residents
and post-doctoral fellows. Follow Baylor College of Medicine on
Facebook (http://www.facebook.com/BaylorCollegeOfMedicine)
and Twitter (http://twitter.com/BCMHouston).
Forward-Looking Statements
This
release contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development of AV-101, the potential of
AV-101 for the treatment of MDD and various other CNS diseases and
disorders and our intellectual property and commercial protection
of AV-101 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 ELEVATE study or other clinical
studies, including the VA-sponsored first-step study of AV-101 for
suicidal ideation, that cause us to discontinue further development
of AV-101, (ii) we may not be able to successfully demonstrate the
safety and efficacy of AV-101 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 AV-101 studies, and ongoing or future preclinical and
clinical results may not support further development of AV-101 or
be sufficient to gain regulatory approval to market AV-101, (iv)
decisions or actions of regulatory agencies may negatively affect
the progress of the ELEVATE study, the VA-sponsored first step
study or the initiation, timing and progress of future AV-101
clinical trials, and our ability to proceed with further clinical
studies or to obtain marketing approval, (v) we may not be able to
obtain or maintain adequate intellectual property protection and
other forms of marketing and data exclusivity for AV-101, (vi) we
may not have access to or be able to secure substantial additional
capital to support our operations, including clinical development
of AV-101 activities described above; and (vii) we may encounter
technical and other unexpected hurdles in the manufacturing and
development of AV-101 or other 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.
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
1 http://www.who.int/news-room/fact-sheets/detail/suicide
2 https://www.cdc.gov/media/releases/2018/p0607-suicide-prevention.html
3 Curtin SC, Warner M,
Hedegaard H. Increase in suicide in the United States,
1999–2014. NCHS data brief, no, 241. Hyattsville, MD:
National Center for Health Statistics. 2016.
4 https://www.nimh.nih.gov/health/topics/suicide-prevention/index.shtml
5 https://www.mentalhealth.va.gov/docs/2016suicidedatareport.pdf