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 19, 2019
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 December 26, 2019, VistaGen
Therapeutics, Inc. (the “Company”) began utilizing a new corporate presentation. A
copy of the updated corporate presentation is attached to this
Current Report on Form 8-K as Exhibit 99.1.
The
information in Item 7.01 of this Current Report
on Form 8-K, including the information set forth in
Exhibit 99.1, 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 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 8.01. Other Events.
On
December 19, 2019, the Company announced successful results from a
first-step, Phase 1b clinical study with healthy U.S.
military Veterans, which measured NMDAR (N-methyl-D-aspartate
receptor) target engagement of the Company's investigational
product candidate, AV-101, an oral NMDAR glycine site antagonist,
for potential treatment of suicidal ideation in Veterans. A
copy of the press release is attached to this Current Report on
Form 8-K as Exhibit 99.2.
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 27, 2019
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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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VistaGen
Therapeutics, Inc. Corporate Presentation, dated December
2019.
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Press
Release issued by VistaGen Therapeutics, Inc., dated December 19,
2019.
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Exhibit
99.1
Exhibit 99.2
VistaGen and Baylor College of Medicine Announce Successful Results
of First-Step Target Engagement Study with VistaGen’s AV-101
Focused on Treating Suicidal Ideation in Veterans
Multiple electrophysiological biomarkers indicate AV-101’s
NMDA receptor target engagement
Both AV-101 doses were well-tolerated and not associated with
dissociative or serious adverse events
Poster presented at 2019 Annual Meeting of American College of
Neuropsychopharmacology
SOUTH SAN FRANCISCO, Calif. and HOUSTON, Texas, December 19 ,
2019 –
VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
need, and Baylor College of Medicine (Baylor), today announced
successful results from a first-step, Phase 1b clinical study with
healthy U.S. military Veterans, which measured NMDAR
(N-methyl-D-aspartate receptor) target engagement of
VistaGen’s investigational product candidate, AV-101, an oral
NMDAR glycine site antagonist, for potential treatment of suicidal
ideation in Veterans. The findings from the study were presented in
a poster, titled “Evoked and Resting
State Gamma Mechanics to Test NMDA Receptor Engagement of
Kynurenine Pathway Modulator AV-101 in Healthy
Veterans,” at the
2019 Annual Meeting of the American College of
Neuropsychopharmacology (ACNP) on December 11, 2019.
In the
Phase 1b target engagement study, 10 healthy volunteer Veterans
from Operation Enduring Freedom, Operation Iraqi Freedom or
Operation New Dawn received single doses of AV-101 (720 mg and 1440
mg) and placebo, in a double-blind, randomized, cross-over
controlled trial. The primary goal of the study was to identify and
define a dose-response relationship between AV-101 and multiple
electrophysiological (EEG) biomarkers related to NMDAR function, as
well as blood biomarkers associated with suicidality. The findings
suggest that, in healthy Veterans, the higher dose of AV-101 (1440
mg) was associated with dose-related increase in the 40 Hz Auditory
Steady State Response (ASSR), a robust measure of the integrity of
inhibitory interneuron synchronization.
Both
doses of AV-101 were well-tolerated, and there were no dissociative
adverse events or serious adverse events.
Dr.
Marijn Lijffijt, assistant professor of psychiatry research at
Baylor and the Michael E. DeBakey VA Medical Center
(MEDVAMC) in Houston served as Principal Investigator of the study.
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 VA funding was provided for all other study
costs.
“According
to the VA, over 20 veterans take
their lives each day – a number that is alarming and
unfortunate,” said Mark A. Smith, M.D, Ph.D.,
VistaGen’s Chief Medical Officer. “Nearly every day we
hear stories in the news about how the suicide rate is increasing,
and how it’s even higher among U.S.
Veterans than non-Veterans. Better therapies are needed for
Veterans who are suffering from suicidal ideation. We interpret the
findings of this biomarker study to mean that the high dose of
AV-101 was sufficient to reduce NMDA function. Based on our recent
preclinical studies demonstrating the ability of the transport
inhibitor probenecid to markedly increase concentrations of AV-101
(approximately 7-fold) and its active metabolite 7-chloro-kynurenic
acid (approximately 35-fold) in the rodent brain, it may be
possible to increase and prolong NMDA antagonism even further when
AV-101 and probenecid are combined. These human target engagement
findings represent our first-step collaboration with Baylor and the
VA, and they increase our confidence in AV-101’s safety and
its potential, especially with adjunctive probenecid, to treat this
major health concern. We look forward to future discussions with
Baylor and the VA regarding a second-step program involving
Veterans who are battling suicidal ideation.”
“Overall,
this study is a promising start on the path to explore
AV-101’s potential to address the morbidity and mortality
associated with suicidal depression,” said Sanjay J. Mathew,
M.D., vice chair for research and professor of psychiatry and
behavioral sciences at Baylor, and a Staff Psychiatrist at MEDVAMC.
“Substantially increased concentrations of 7-Cl-KYNA in
VistaGen’s recent preclinical studies of AV-101 with
adjunctive probenecid are notable. Future clinical studies in
military veterans could examine the effect of AV-101, at the 1440
mg dose combined with probenecid, in suicide risk. We look forward
to further collaborations with VistaGen and the
VA.”
About VistaGen
VistaGen
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for CNS diseases and disorders
where current treatments are inadequate, resulting in high unmet
need. VistaGen's pipeline is
focused on clinical-stage CNS drug candidates with a differentiated
mechanism of action, an exceptional safety profile in all clinical
studies to date, 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 Baylor College of Medicine
Baylor College of Medicine in Houston is recognized as
health sciences university 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 22nd among
medical schools for research and 4th for primary care by U.S. News
& World Report. Baylor is listed 20th among all U.S. medical
schools for National Institutes of Health funding and No. 1 in
Texas. The Baylor pediatrics program ranked 8th among all pediatric
programs, reflecting the strong affiliation with Texas
Children’s Hospital where our faculty care for pediatric
patients and our students and residents train. Nationally our
physician assistant program was ranked 3rd in the health
disciplines category and our nurse anesthesia program ranked 2nd.
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 has more than 3,000 trainees in medical,
graduate, nurse anesthesia, physician assistant, orthotics and
genetic counseling as well as residents and postdoctoral fellows.
Follow Baylor College of Medicine on Facebook and
Twitter.
About AV-101
AV-101 (4-Cl-KYN) belongs to a new generation of investigational
medicines in neuropsychiatry and neurology known as NMDA
(N-methyl-D-aspartate) receptor modulators. The NMDA receptor is a
pivotal receptor in the brain and abnormal NMDA function is
associated with numerous CNS diseases and disorders. AV-101 is an
oral prodrug of 7-Cl-KYNA, a potent and selective full antagonist
of the glycine co-agonist site of the NMDA receptor. With its
exceptional safety profile in all studies to date, AV-101 has
potential to be a new at-home, non-sedating treatment for multiple
large market CNS indications where current treatments are
inadequate to meet high unmet patient needs. VistaGen is currently
focused on potential development of AV-101 for MDD, neuropathic
pain, suicidal ideation and dyskinesia associated with levodopa
treatment for PD. 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 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.
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
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.
Forward-Looking Statements
This
release contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development and commercialization of our
three drug candidates: (i) PH94B for social anxiety disorder and
multiple other anxiety disorders; (ii) PH10 for MDD and multiple
additional depression disorders and suicidal ideation, and (iii)
AV-101 for MDD, neuropathic pain, epilepsy, dyskinesia associated
with levodopa therapy for Parkinson's disease 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 PH94B, PH10 and/or
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 substantial additional
capital to support our operations, including our ongoing
preclinical and clinical development activities; and (vii) we may
encounter technical and other unexpected hurdles 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.
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