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): November 14, 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
November 14, 2019, VistaGen Therapeutics, Inc. (the
“Company”)
announced topline results from the ELEVATE study, a Phase 2 study
of AV-101, the Company’s NMDA (N-methyl-D-aspartate) receptor
glycine site antagonist, as an adjunctive treatment of major
depressive disorder. A copy of the press release 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 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:
November 14, 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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Press
Release issued by VistaGen Therapeutics, Inc., dated November 14,
2019.
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EXHIBIT 99.1
VistaGen
Reports Topline Phase 2 Results for AV-101 as an Adjunctive
Treatment of Major Depressive Disorder
SOUTH SAN FRANCISCO, Calif., November 14, 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, today announced topline results from the ELEVATE study, a
Phase 2 study of AV-101, its NMDA (N-methyl-D-aspartate) receptor
glycine site antagonist, as an adjunctive treatment of major
depressive disorder (MDD). In this study, the AV-101 treatment arm
did not differentiate from placebo on the primary endpoint (change
in the Montgomery-Åsberg Depression Rating Scale (MADRS-10)
total score compared to baseline). As in prior clinical studies,
AV-101 was well tolerated, with no psychotomimetic side
effects or serious adverse
events.
"While
we are disappointed with the topline results of the study, it is
possible that efficacy may have been compromised by either
insufficient transport of AV-101 across the blood brain barrier or
subsequent inadequate concentrations of its active metabolite,
7-Cl-KYNA, in the brain. We will continue to examine the full
dataset from this study to evaluate effects on other endpoints and
pharmacokinetics, as well as consider both the upcoming results
from a target engagement study and the potential impact of
compelling new evidence from recent preclinical studies
demonstrating substantial concentration increases of AV-101
(approximately a 7-fold increase) and 7-Cl-KYNA (approximately a
35-fold increase) in the brain in rodent studies when AV-101 is
administered in combination with probenecid, an FDA-approved anion
transport inhibitor used adjunctively with numerous
well-established medications to enhance efficacy,” said
Shawn Singh, Chief Executive Officer of
VistaGen.
“The rigorous conduct of the study makes us confident that
AV-101, at the concentrations used, was not effective, but will
also allow us to interrogate the database without the confound of
excessive placebo responses. There is a clear need for new and safe
agents that can be used for augmentation among depressed patients
with inadequate response to antidepressant therapies,”
said Dr. Maurizio Fava,
Psychiatrist-in-Chief of Massachusetts General
Hospital.
“We
remain excited by and focused on continued execution of our Phase 3
program for PH94B in social anxiety disorder and our Phase 2
program for PH10 in major depressive disorder,” added Mr.
Singh. “Each of these first-in-class compounds is further
along in development than AV-101, as they have already demonstrated
clinical proof of concept in Phase 2 studies, and, thus, in 2020,
we will be proceeding into Phase 3 and Phase 2b studies,
respectively. During 2020, we also will review the total body of
preclinical and clinical work on AV-101, across all indications
(depression, epilepsy, levodopa-induced dyskinesia, neuropathic
pain and suicidal ideation), as well as additional preclinical
studies involving AV-101 and probenecid, and then determine the
most appropriate path forward for potential clinical development of
AV-101. We deeply appreciate the patients, their caregivers, and
the investigators who supported the ELEVATE study, including Dr.
Fava as principal investigator. Our determination to develop safe,
life-changing new generation medications for mental health
disorders and neurological conditions with high unmet need remains
firm and unchanged.”
Study Overview
The
ELEVATE study was a Phase 2, double-blind, placebo-controlled,
multi-center, sequential parallel comparison design (SPCD) study
that evaluated the safety, tolerability, and efficacy of AV-101 as
an adjunctive treatment in patients with MDD who had an inadequate
response to a stable dose of standard antidepressant therapy
(either a selective serotonin reuptake inhibitor (SSRI) or a
serotonin norepinephrine reuptake inhibitor (SNRI)). The study
randomized 199 patients across 25 clinical research centers in the
United States. Consistent with the SPCD, the study was
conducted in two, two-week sequential stages. Eligible subjects
continued receiving their SSRI or SNRI antidepressant at a stable
dose for the duration of the study. Patients were randomly assigned
(1:3) to AV-101 1440 mg/day or placebo in Stage 1. Placebo
non-responders (defined as a < 50% reduction from baseline in
MADRS-10 total score at the end of Stage 1) were re-randomized
(1:1) in Stage 2 to receive AV-101 1440 mg/day or placebo for 2
weeks. The primary efficacy endpoint was the absolute change from
baseline to end of treatment in the MADRS-10 score of AV-101
compared to placebo, both in combination with ongoing therapy with
an SSRI or SNRI. Treatment differences from Stage 1 and Stage 2
were combined as weighted averages.
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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.
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) AV-101 for MDD, neuropathic pain,
epilepsy, dyskinesia associated with levodopa therapy for
Parkinson’s disease and suicidal ideation; (ii) PH94B for
social anxiety disorder and other anxiety disorders; and (iii) PH10
for MDD. 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, PH94B,
and/or PH10; (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
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