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): January 29, 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 7.01
Regulation FD Disclosure
Issuance of Letter to Stockholders
On January 29, 2018, Shawn Singh, Chief Executive
Officer and Director of VistaGen Therapeutics, Inc. (the
“Company”), sent a letter to the Company’s
stockholders highlighting the Company’s recent milestones and
discussing the impending launch of the Company’s Phase 2
clinical study of its lead product candidate, AV-101, for the
adjunctive treatment of Major Depressive Disorder. A copy of the
press release announcing Mr. Singh’s issuance of the letter
is attached hereto as Exhibit 99.1, and a copy of Mr. Singh’s
letter is attached hereto as Exhibit 99.2.
Use of New Corporate Presentation
On January 29, 2018, the
Company utilized
a new corporate presentation (the “Corporate
Presentation”) for
business purposes. A copy of the Corporate Presentation is attached
hereto as Exhibit 99.3.
The information in this Current Report
on Form 8-K, including the information set forth in
Exhibits 99.1, 99.2 and 99.3 are 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 any
exhibit 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.
In
addition, this Current Report on Form 8-K and the exhibit(s)
attached hereto may contain, among other things, certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including, without
limitation, (i) statements with respect to the Company's plans,
objectives, expectations and intentions; and (ii) other statements
identified by words such as "may", "could", "would", "should",
"believes", "expects", "anticipates", "estimates", "intends",
"plans" or similar expressions. These statements are based upon the
current beliefs and expectations of the Company's management and
are subject to significant risks and uncertainties.
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:
January 30, 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 January 29,
2018
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Letter to Shareholders, dated January 29, 2018
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Corporate
Presentation, dated January 29, 2018
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Exhibit
99.1
VistaGen Therapeutics Issues Letter to Stockholders as Company
Prepares to Initiate AV-101 Phase 2 Study for Major Depressive
Disorder
South San Francisco, CA (January 29, 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)
disorders, today issued a letter to stockholders as the Company
prepares to initiate its Phase 2 study of AV-101 for Major
Depressive Disorder (MDD).
The
full version of the letter to stockholders may be accessed using
the following link, or by visiting the Investor Relations section
of the Company’s website, www.vistagen.com.
https://d1io3yog0oux5.cloudfront.net/vistagen/files/docs/shareholder-letter.pdf
In the
letter to stockholders, Shawn Singh, Chief Executive Officer,
highlights the Company’s recent milestones and discusses the
impending launch of the Company’s Phase 2 clinical study of
AV-101 for MDD. VistaGen’s AV-101 is an oral new generation
antidepressant with a mechanism of action that is fundamentally
differentiated from all standard, FDA-approved
antidepressants.
“In
early-2017, I had the privilege of “Ringing the Bell”
at The Nasdaq Stock Market’s headquarters in Times Square on
behalf of our company. That exciting and unique corporate event
proved to be a symbolic prologue to the productive year for
VistaGen that followed. The milestones we accomplished in 2017 have
strongly positioned us to advance our AV-101 Phase 2 program to new
levels throughout this year and next,” commented Mr. Singh in
the letter to stockholders. “Following a productive meeting
with the U.S. Food and Drug Administration (FDA) in the fall of
2017, we achieved two key regulatory milestones before year end.
First, in October 2017, the FDA authorized us to proceed, under our
Investigational New Drug (IND) application, with our U.S.
multi-center Phase 2 clinical study of AV-101 as an oral new
generation adjunctive treatment for MDD patients with an inadequate
response to standard, FDA-approved antidepressants. In addition, in
December 2017, the FDA granted us Fast Track Designation for
development of AV-101 for treatment of MDD, providing us the
opportunity for frequent FDA interactions regarding the most
appropriate and efficient development pathway to bring AV-101 to
MDD patients. 2017 culminated with the closing of an underwritten
public offering that generated gross proceeds of $15 million,
enabling us to commence and advance through our Phase 2 study in
2018. I want to thank, again, our underwriters and our new and
existing investors for supporting our vision.”
Recent Accomplishments:
●
Received
“green light” from the FDA
to launch AV-101 Phase 2 MDD adjunctive treatment study
pursuant to our IND.
●
Received Fast Track
Designation from the FDA for development of AV-101 as an adjunctive
treatment for MDD. Fast Track Designation is designed to facilitate
the development and review of new treatments for serious
conditions, such as MDD, with unmet medical need.
●
Continued to
strengthen our intellectual property portfolio as the European
Patent Office (EPO) granted a patent related to methods of treating
depression with AV-101 and certain other neurological indications,
and the U.S. Patent and Trademark Office (USPTO) issued
U.S.
Patent No. 9,834,801 related to certain methods of
production for AV-101.
●
AV-101 was featured
on the cover of The Journal of
Pain in October 2017, a peer-reviewed publication of
nonclinical studies of the effects of AV-101 in well-established
nonclinical models of pain. This article is available at the
following link: http://dx.doi.org/10.1016/j.jpain.2017.03.014).
●
Closed underwritten
public offering that generated gross proceeds of $15 million.
Proceeds from the offering enable us to continue research and
development, primarily related to our Phase 2 clinical
study of AV-101 for MDD.
-1-
Mr.
Singh continued, “As a result of receiving a “green
light” from the FDA, we
anticipate launching our AV-101 Phase 2 MDD adjunctive
treatment study during the current quarter, with topline data
expected to be available during the first half of 2019. In
addition, we expect one of our principal collaborators, the U.S.
National Institute of Mental Health, to complete its Phase 2
monotherapy study of AV-101 in treatment-resistant MDD patients
during 2018. This Phase 2 study is being conducted by Dr. Carlos
Zarate Jr., Chief, Section on the
Neurobiology and Treatment of Mood Disorders and Chief of the
Experimental Therapeutics and Pathophysiology Branch at the NIMH.
AV-101 caught the attention of Dr. Zarate, widely considered a
pioneer in ketamine research for MDD, and his team after
head-to-head preclinical studies of AV-101 vs. ketamine, ultimately
resulting in a Cooperative Research and Development Agreement
between VistaGen and the U.S. National Institutes of Health,
whereby the NIMH is fully funding and conducting the NIMH Phase 2
monotherapy MDD study of AV-101.”
Anticipated Milestones over next 12 to 18 Months:
●
First
Quarter of 2018:
o
Launch our Phase 2
clinical study of AV-101 for MDD with Dr. Maurizio Fava of Harvard
University as Principal Investigator;
a 180-patient, U.S. multi-center, double-blind, placebo controlled
efficacy and safety study evaluating AV-101 as an adjunctive
treatment in MDD patients with an inadequate response to standard,
FDA-approved antidepressants.
●
Second
Half of 2018:
o
NIMH AV-101 Phase 2
MDD monotherapy study topline results.
o
Completion of our
AV-101 Phase 2 MDD adjunctive treatment study.
●
First
Half of 2019:
o
Launch of AV-101
Phase 2 studies in neuropathic pain and Parkinson’s disease
levodopa-induced dyskinesia.
o
AV-101 Phase 2 MDD
adjunctive treatment study topline results.
VistaGen
kicked off 2018 by hosting meetings with current investors,
prospective institutional investors and potential strategic
partners during the 36th Annual J.P. Morgan Healthcare Conference
and 10th
Annual Biotech Showcase in San Francisco. Additionally, Mr. Singh
participated on a panel with distinguished scientists and
clinicians focused on the neuroscience of depression and addiction
during the Healthcare Innovation Forum held at the University of
California, San Francisco (UCSF) Medical Center in San
Francisco.
Mr.
Singh concluded, “Reflecting on
a productive week in San Francisco, it is apparent to us that a
paradigm shift towards a new generation of faster-acting
antidepressants, particularly those targeting NMDA and AMPA
receptors, is emerging. Throughout 2018, we will remain
focused on our core mission - to develop new generation medicines
for depression and other CNS disorders affecting millions of people
worldwide who do not currently have adequate treatment
alternatives. Personally, and professionally, I am motivated and
passionate about our mission. I maintain the highest confidence in
our strategy and our team, and I anticipate that 2018 will yield
even more exciting achievements intended to deliver both
life-changing benefits to CNS patients and extraordinary value to
our stockholders.”
-2-
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other CNS disorders. VistaGen’s
lead CNS product candidate, AV-101, is in Phase 2 development,
initially as a new generation oral antidepressant drug candidate
for MDD AV-101's mechanism of
action is fundamentally different from all FDA-approved
antidepressants and atypical antipsychotics used adjunctively to
treat MDD, with potential to drive a paradigm shift towards a new
generation of safer and faster-acting antidepressants. AV-101 is
currently being evaluated by the U.S. National Institute of Mental
Health (NIMH) in a
small Phase 2 monotherapy study in MDD being fully funded by the
NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the
Neurobiology and Treatment of Mood Disorders and Chief of
Experimental Therapeutics and Pathophysiology Branch at the NIMH.
VistaGen is preparing to launch a 180-patient Phase 2 study of
AV-101 as an adjunctive treatment for MDD patients with an
inadequate response to standard, FDA-approved antidepressants. Dr.
Maurizio Fava of Harvard University is the Principal Investigator
of the VistaGen’s AV-101 MDD Phase 2 adjunctive treatment
study. AV-101 may also have the potential to treat multiple CNS
disorders and neurodegenerative diseases in addition to MDD,
including neuropathic pain, epilepsy, Huntington’s disease,
Parkinson’s disease levodopa-induced dyskinesia (PD LID) and
other CNS diseases and disorders where modulation of the NMDA
receptors, activation of AMPA pathways and/or key active
metabolites of AV-101 may achieve therapeutic benefit.
For
more information, please visit www.vistagen.com
and connect with VistaGen on:
Twitter
LinkedIn
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
successful launch, continuation and results of the NIMH’s
Phase 2 (MDD monotherapy) and/or the Company’s planned Phase
2 (MDD adjunctive treatment) clinical studies of AV-101, allowance
of patent applications and continued protection of its intellectual
property, and the availability of substantial additional capital to
support its operations, including the AV-101 Phase 2 clinical
development 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:
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
Phone:
+1 (212) 896-1254/+1 (212) 896-1267
Email:
VistaGen@KCSA.com
###
-3-
Exhibit
99.2
January
29, 2018
Dear
Fellow Stockholders:
In
early-2017, I had the privilege of “Ringing the Bell”
at The Nasdaq Stock Market’s headquarters in Times Square on
behalf of our company. That exciting and unique corporate event
proved to be a symbolic prologue to the productive year for
VistaGen that followed. The milestones we accomplished in 2017 have
strongly positioned us to advance our AV-101 Phase 2 program to new
levels throughout this year and next.
Regulatory and Clinical Development
We
refer to AV-101 as a “new generation” antidepressant
because its mechanism of action (the way it works in the brain) is
fundamentally different from all FDA-approved antidepressants, as
well as all FDA-approved atypical antipsychotics often used
together with standard antidepressants. Investment, innovation,
industry expertise and a lot of hard work by our focused and
passionate teams, teams committed to making a game-changing impact
in the treatment of multiple diseases and disorders involving the
central nervous system (CNS), have advanced us to the threshold of
launching our potentially transformative Phase 2 study of AV-101
for treatment of Major Depressive Disorder (MDD). Our primary goal
is to develop and ultimately receive regulatory approval to
commercialize AV-101 worldwide for multiple CNS diseases and
disorders. Our initial regulatory and commercial strategies to
accomplish that goal are focused on developing AV-101 as an oral,
safe, and faster-acting new generation treatment alternative for
millions of MDD patients with inadequate therapeutic results from
standard antidepressants, displacing atypical antipsychotics in the
current MDD drug treatment paradigm. It is a potentially
game-changing goal indeed, and our teams are well-suited for the
challenge.
Following
a productive meeting with the U.S. Food and Drug Administration
(FDA) in the Fall of 2017, we achieved two key regulatory
milestones before year end. First, in October 2017, the FDA
authorized us to proceed, under our Investigational New Drug (IND)
application, with our U.S. multi-center Phase 2 clinical study of
AV-101 as an oral new generation adjunctive treatment for MDD. This
study will focus on treatment of MDD patients with an inadequate
response to standard, FDA-approved antidepressants. In addition, in
December 2017, the FDA granted us Fast Track Designation for
development of AV-101 for treatment of MDD, providing us the
opportunity for frequent FDA interactions regarding the most
appropriate and efficient development pathway to bring AV-101 to
MDD patients.
As a
result of receiving a “green light” from the FDA,
we anticipate launching our
AV-101 Phase 2 MDD adjunctive treatment study during the current
quarter, with topline data expected to be available during the
first half of 2019.
During
2018, we expect one of our principal collaborators, the U.S.
National Institute of Mental Health (NIMH), to complete its Phase 2
monotherapy study of AV-101 in treatment-resistant MDD patients.
This Phase 2 study is being conducted by Dr. Carlos Zarate Jr.,
Chief, Section on the Neurobiology and
Treatment of Mood Disorders and Chief of the Experimental
Therapeutics and Pathophysiology Branch at the NIMH. AV-101 caught
the attention of Dr. Zarate, widely considered a pioneer in
ketamine research for MDD, and his team after head-to-head
preclinical studies of AV-101 vs. ketamine, ultimately resulting in
a Cooperative Research and Development Agreement (CRADA) between
VistaGen and the U.S. National Institutes of Health (NIH), whereby
the NIMH is fully funding and conducting the NIMH Phase 2
monotherapy MDD study of AV-101.
-1-
Manufacturing and Patents
In
connection with our AV-101 Phase 2 program, as well as potential
Phase 3 development and commercialization, we, together with our
contract manufacturing organization, developed a novel process for
the production of AV-101 drug substance. We believe our new
proprietary AV-101 production process will significantly improve
manufacturing efficiency.
We
strengthened our intellectual property around AV-101 in 2017. In
Europe, the European Patent Office (EPO) granted our patent related
to methods of treating depression with AV-101 and certain other
neurological indications. Additionally, the U.S. Patent and
Trademark Office (USPTO) granted a patent related to certain
methods of production of AV-101. These issued patents, together
with the potential issuance of additional AV-101 patent
applications currently under review in the US, European Union and
other key pharmaceutical markets, provide VistaGen with added
long-term intellectual property protection for AV-101 and enhance
its commercial potential.
Additional Highlights
AV-101 for Neuropathic Pain and Parkinson’s Disease
Levodopa-induced Dyskinesia (PD LID)
In addition to MDD, we believe AV-101 may also have the potential
to treat multiple CNS disorders and neurodegenerative diseases,
including neuropathic pain, PD LID and other CNS diseases and
disorders where modulation of NMDA receptors, activation of AMPA
pathways and/or key active metabolites of AV-101 may achieve
therapeutic benefit. In October 2017, a peer-reviewed publication
of nonclinical studies of the effects of AV-101 in four
well-established nonclinical models of pain was featured on the
cover of The Journal of Pain
(http://dx.doi.org/10.1016/j.jpain.2017.03.014).
In these studies, AV-101 was found to have robust anti-nociceptive
effects, similar to gabapentin, but with a better side effect
profile in several pre-clinical models of hyperalgesia and
allodynia, with results suggesting AV-101's potential for treating
multiple pain states. We believe the positive results published in
these studies, taken together with successful AV-101 Phase 1a and
1b clinical safety studies and the epidemic abuse of prescription
opioid pain medicines, support further investment in Phase 2
clinical studies to assess efficacy and safety of AV-101 as a new
non-opioid treatment alternative for patients suffering from
neuropathic pain. We are also excited about the opportunity to
explore AV-101’s potential to reduce dyskinesia associated
standard levodopa, or L-DOPA, therapy for Parkinson's disease,
based on results from non-clinical studies. Without diverting our
priority focus on MDD, we plan to expand our AV-101 Phase 2
clinical program during the next year to include these important
CNS indications with significant unmet need.
Capital Markets
2017
culminated with the closing of an underwritten public offering that
generated gross proceeds of $15 million. This financing enables us
to commence and advance our Phase 2 study in 2018. I want to thank,
again, our underwriters and our new and existing investors for
supporting our vision.
-2-
2018 J.P. Morgan Healthcare Conference
and University of California, San Francisco Panel
Discussion
Earlier
this month, our team kicked off 2018 by hosting numerous meetings
with current investors, prospective institutional investors and
potential strategic partners during the 36th Annual J.P. Morgan
Healthcare Conference and 10th Annual Biotech
Showcase in San Francisco. Additionally, I was honored to
participate on a panel with distinguished scientists and clinicians
focused on the neuroscience of depression and addiction during the
Healthcare Innovation Forum held at the University of California,
San Francisco (UCSF)
Medical Center in San Francisco. Our in-depth panel discussions
were not only encouraging and motivating, but also eye-opening
regarding potential advances in neuropsychiatry on the horizon at
UCSF.
Reflecting on a productive week in San Francisco, it is apparent
that a paradigm shift towards a new generation of faster-acting
antidepressants, particularly those targeting NMDA and AMPA
receptors, is emerging. The positive effects on depression and pain
through the IV administration of ketamine is well documented, and
significant investment has been made by big Pharma to explore its
benefits. For example, Janssen Research & Development, one of
the Janssen Pharmaceutical Companies of Johnson & Johnson, has
made a significant investment in esketamine, an
intranasally-administered NMDA receptor antagonist currently in
Phase 3 development with a mechanism of action similar to ketamine
treatment currently administered by injection. If approved by the
FDA, esketamine would be one of the first new approaches to treat
patients with MDD in the last 50 years. Similar to ketamine and
esketamine, AV-101 targets the NMDA and AMPA receptors, however
AV-101 is oral and it inhibits the NMDA receptor activity rather
than blocking it, thereby producing ketamine-like antidepressant
effects without safety concerns associated with
ketamine.
I am as
eager and passionate as I have ever been to see what transpires
from our AV-101 Phase 2 program, especially our impending Phase 2
adjunctive treatment study in MDD patients with an inadequate
response to standard antidepressants. Throughout 2018, we will
remain focused on our core mission - to develop new generation
medicines for depression and other CNS disorders affecting millions
of people worldwide who do not currently have adequate treatment
alternatives. I maintain the highest confidence in our strategy and
our teams, and I anticipate that 2018 will yield even more exciting
achievements intended to deliver both life-changing benefits to CNS
patients and extraordinary value to our stockholders.
Very truly yours,
Shawn Singh,
Chief Executive Officer and Director
VistaGen Therapeutics, Inc.
-3-
