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): February 12, 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:
☐ 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))
Item 2.02
Results of Operations and
Financial Condition.
See Item 8.01.
Item 8.01
Other
Events.
Today, VistaGen Therapeutics, Inc. (the
"Company") issued a press release to announce the
Company's financial results for its third fiscal quarter ended
December 31, 2017. A copy of the press release is attached hereto
as Exhibit 99.1.
The information furnished herein and therein shall
not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the
“Exchange
Act”), or otherwise
subject to the liabilities of that Section, or incorporated by
reference in any filing under the Exchange Act or the Securities
Act of 1933, as amended, except as shall be expressly set forth by
specific reference in such filing.
Item 9.01
Financial Statements and
Exhibits.
(d) Exhibits Index
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Exhibit No.
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Description
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Press
release issued by VistaGen Therapeutics, Inc. dated February 12,
2018.
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Disclaimer.
This
Current Report on Form 8-K 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.
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:
February 12, 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 February 12,
2018.
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Exhibit
99.1
VistaGen Therapeutics Reports Third Quarter Fiscal 2018 Financial
Results
South San Francisco, CA (February 12, 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 reported financial results for its third fiscal
quarter ended December 31, 2017.
“Building
on our significant progress last quarter, our team is prepared and
eager to launch, during the current quarter, our AV-101 Phase 2
clinical development program, initially focused on adjunctive
treatment of Major Depressive Disorder patients with an inadequate
response to standard, FDA-approved antidepressants. This year has
the potential to be transformative for VistaGen and the millions of
depression patients seeking new generation treatment options that
are fundamentally different from all currently available
therapies,”
commented Shawn Singh, Chief
Executive Officer of VistaGen.
Financial Results for the Fiscal Quarter Ended December 31,
2017:
Net loss attributable to common stockholders for the fiscal quarter
ended December 31, 2017 was approximately $3.5 million, compared to
$2.9 million for the fiscal quarter ended December 31,
2016.
Research and development expense totaled approximately $1.6 million
for the fiscal quarter ended December 31, 2017, compared with
approximately $1.6 million for the fiscal quarter ended December
31, 2016. Research and development expense was primarily
attributable to the Company's development of AV-101, its oral, new
generation CNS drug candidate initially focused on displacing
adjunctive atypical antipsychotics in the current Major Depressive
Disorder (MDD) treatment paradigm, including final preparations to
launch its AV-101 MDD Phase 2 adjunctive treatment study in
patients with an inadequate response to standard FDA-approved
antidepressants.
General and administrative expense was approximately $1.3 million
in the fiscal quarter ended December 31, 2017, compared to
approximately $2.3 million in the fiscal quarter ended December 31,
2016. The decrease was primarily attributable to decreased
professional services expenses, a decrease in noncash expense
attributable to grants of common stock for services, and a decrease
in noncash warrant modification expense, partially offset by
increased salary and benefits and noncash stock compensation
expenses.
At December 31, 2017, the Company had cash and cash equivalents of
approximately $13.0 million, compared to approximately $2.9 million
at March 31, 2017.
-1-
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 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
-2-
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VISTAGEN
THERAPEUTICS
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Condensed
Consolidated Balance Sheets
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Amounts in
Dollars
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December
31,
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March 31,
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2017
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2017
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(Unaudited)
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ASSETS
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Current
assets:
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Cash and cash
equivalents
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$13,031,800
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$2,921,300
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Prepaid
expenses and other current assets
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940,400
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456,600
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Total current
assets
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13,972,200
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3,377,900
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Property and
equipment, net
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222,800
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286,500
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Security
deposits and other assets
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47,800
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47,800
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Total
assets
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$14,242,800
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$3,712,200
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
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Current
liabilities:
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Accounts
payable
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$509,300
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$867,300
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Accrued
expenses
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770,900
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443,000
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Current notes
payable
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43,700
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54,800
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Capital lease
obligations
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2,600
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2,400
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Total current
liabilities
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1,326,500
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1,367,500
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Non-current
liabilities:
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Accrued
dividends on Series B Preferred Stock
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2,344,400
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1,577,800
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Deferred rent
liability
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299,100
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139,200
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Capital lease
obligations
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10,000
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11,900
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Total
non-current liabilities
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2,653,500
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1,728,900
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Total
liabilities
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3,980,000
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3,096,400
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Commitments
and contingencies
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Stockholders’
equity:
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Preferred
stock, $0.001 par value; 10,000,000 shares authorized at December
31, 2017 and March 31, 2017:
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Series
A Preferred, 500,000 shares authorized, issued and outstanding at
December 31, 2017 and March 31, 2017
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500
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500
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Series
B Preferred; 4,000,000 shares authorized at December 31, 2017 and
March 31, 2017; 1,160,240
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shares
issued and outstanding at December 31, 2017 and March 31,
2017
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1,200
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1,200
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Series
C Preferred; 3,000,000 shares authorized at December 31, 2017 and
March 31, 2017;
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2,318,012
shares issued and outstanding at December 31, 2017 and March 31,
2017
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2,300
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2,300
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Common stock,
$0.001 par value; 100,000,000 and 30,000,000 shares authorized at
December 31, 2017 and
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March
31, 2017, respectively; 22,723,504 and 8,974,386 shares issued and
outstanding at December 31, 2017
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and
March 31, 2017, respectively
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22,700
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9,000
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Additional
paid-in capital
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166,669,200
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146,569,600
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Treasury
stock, at cost, 135,665 shares of common stock held at December 31,
2017 and March 31, 2017
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(3,968,100)
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(3,968,100)
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Accumulated
deficit
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(152,465,000)
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(141,998,700)
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Total
stockholders’ equity
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10,262,800
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615,800
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Total
liabilities and stockholders’ equity
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$14,242,800
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$3,712,200
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-3-
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VISTAGEN
THERAPEUTICS
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STATEMENT
OF OPERATIONS
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Amounts in Dollars,
except share amounts
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UNAUDITED
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Three
Months Ended December 31,
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Nine
Months Ended December 31,
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2017
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2016
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2017
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2016
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Revenues:
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Sublicense
revenue
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$-
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$1,250,000
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$-
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$1,250,000
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Total
revenues
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-
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1,250,000
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-
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1,250,000
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Operating
expenses:
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Research and
development
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1,601,800
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1,611,000
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5,124,600
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4,042,800
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General and
administrative
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1,266,000
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2,276,600
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4,997,400
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4,907,800
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Total
operating expenses
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2,867,800
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3,887,600
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10,122,000
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8,950,600
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Loss from
operations
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(2,867,800)
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(2,637,600)
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(10,122,000)
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(7,700,600)
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Other expenses,
net:
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Interest
expense, net
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(2,000)
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(900)
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(7,700)
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(3,700)
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Loss on
extinguishment of accounts payable
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(135,000)
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-
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(135,000)
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-
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Loss before income
taxes
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(3,004,800)
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(2,638,500)
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(10,264,700)
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(7,704,300)
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Income
taxes
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-
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-
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(2,400)
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(2,400)
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Net loss and
comprehensive loss
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(3,004,800)
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(2,638,500)
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(10,267,100)
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(7,706,700)
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Accrued
dividend on Series B Preferred stock
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(263,000)
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(237,700)
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(766,600)
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(1,018,500)
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Deemed
dividend from trigger of down round
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provision
feature
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(199,200)
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-
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(199,200)
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-
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Deemed
dividend on Series B Preferred Units
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-
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-
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-
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(111,100)
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Net loss
attributable to common stockholders
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$(3,467,000)
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$(2,876,200)
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$(11,232,900)
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$(8,836,300)
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Basic and diluted
net loss attributable to common
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stockholders
per common share
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$(0.25)
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$(0.34)
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$(1.03)
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$(1.23)
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Weighted average
shares used in computing basic
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and diluted
net loss attributable to common
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stockholders
per common share
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13,895,642
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8,381,824
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10,947,556
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7,181,307
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-4-