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 3, 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
See Item 8.01
below.
Item 8.01
Other Events.
On January 3, 2018, VistaGen Therapeutics, Inc.
(the “Company”) issued a press release announcing that
the U.S. Food and Drug Administration has granted Fast Track
Designation to AV-101, the Company’s lead central nervous
system product candidate for development as a potential adjunctive
treatment for Major Depressive Disorder. A copy of the press
release is attached to this Current Report on Form 8-K as Exhibit
99.1, and is incorporated herein by reference.
On January 8, 2018, the Company began utilizing a new corporate presentation (the
“Corporate
Presentation”). A copy of
the Corporate Presentation is attached as Exhibit 99.2 to this
Current Report on Form 8-K, and is incorporated by
reference herein.
In addition, the Company will be presenting at the
10th
Annual Biotech Showcase Conference in
San Francisco, California on Monday, January 8, 2018 at 4:00 P.M.
Pacific Time.
The information in this Current Report
on Form 8-K, including the information set forth in
Exhibit 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 it 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.
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 8, 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 3,
2018
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Corporate Presentation, dated January 2018
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Exhibit
99.1
VistaGen Therapeutics Receives FDA Fast Track Designation for
AV-101 for the Treatment of Major Depressive Disorder
South San Francisco, CA (January 3, 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, announced today that the U.S. Food and Drug
Administration (FDA) has granted Fast Track Designation to AV-101
for development as a potential adjunctive treatment for Major
Depressive Disorder (MDD). The FDA’s Fast Track process is
designed to facilitate the development and review of new treatments
for serious conditions with unmet medical need such as
MDD.
“Fast
Track Designation is another important regulatory milestone for our
AV-101 program for MDD, providing us the opportunity for frequent
interactions with the FDA focused on the most appropriate and
efficient development pathway to bring AV-101 to MDD
patients,” said Shawn Singh, Chief Executive Officer of
VistaGen. “We are on track
to dose the first patient in our AV-101 Phase 2
MDD adjunctive treatment study in the first quarter of
2018.”
About Fast Track Designation
Fast
Track is a process designed by the FDA to facilitate the
development, and expedite the review, of drugs to treat serious
conditions and fill an unmet medical need. Drugs that receive Fast
Track Designation may be eligible to be the subject of more
frequent communications and meetings with FDA to review the drug's
development plan including the design of the proposed clinical
trials, use of biomarkers and the extent of data needed for
approval. Drugs with Fast Track Designation may also qualify for
priority review to expedite the FDA review process, if relevant
criteria are met. The purpose is to get important new drugs to the
patient earlier. Fast Track addresses a broad range of serious
conditions. For more information about Fast Track, please
visit:
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.
About Major Depressive Disorder
Major
Depressive Disorder (MDD) is a common but serious mood disorder in
which individuals exhibit depressive symptoms, such as a depressed
mood or a loss of interest or pleasure in daily activities
consistently for at least a two-week period, and demonstrate
impaired social, occupational, educational or other important
functioning. Over 300 million people worldwide suffer from
depression.1 While
antidepressants are widely used for treatment, large scale studies
have suggested the U.S. drug-treated MDD market is substantially
underserved.2,3
About VistaGen
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 Major Depressive Disorder (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 and
Facebook.
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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.
1 World Health Organization, 2017; Available
at http://www.who.int/mediacentre/factsheets/fs369/en/
2 Rush AJ, et al. Am J. Psychiatry. 2006, 163(11):
1905-1917 (STAR*D Study),
3 Decision Resources 2016
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
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Exhibit
99.2
