SOUTH SAN FRANCISCO, Calif.,
Nov. 14, 2016 /PRNewswire/
-- VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company focused on developing new generation
therapies for depression and other central nervous system
(CNS) disorders, today reported financial results for the
second quarter of fiscal 2017 ended September 30, 2016.
The Company also provided an update on its corporate progress,
including clinical status and anticipated milestones for AV-101,
its new generation, orally available prodrug candidate in Phase 2
development, initially for the adjunctive treatment of major
depressive disorder (MDD) in patients with an inadequate
response to standard, U.S. Food and Drug Administration
(FDA)-approved antidepressants.
"We continue to make great strides in 2016, achieving milestones
which have been fundamental to our plans for 2017, which we believe
will be another dynamic and transformative year for our
shareholders," commented Shawn Singh, Chief Executive Officer of
VistaGen.
Recent Corporate Highlights:
- Appointed Mark A. Smith M.D., Ph.D. as Chief Medical Officer,
former Clinical Lead for Neuropsychiatry at Teva Pharmaceuticals,
to lead late-stage clinical development of AV-101;
- Appointed Mark A. McPartland as Vice President, Corporate
Development and Investor Relations, to expand awareness of VistaGen
and its AV-101 development program among investors, patients,
researchers, clinicians and potential partners;
- Uplisted to the NASDAQ Capital Market; and
- Completed $10.9 million public offering, led by institutional
investors.
AV-101 is currently being evaluated in an ongoing Phase 2a
monotherapy study for the treatment of MDD. This study is being
fully funded by the U.S. National Institute of Mental Health
(NIMH), part of the U.S. National Institutes of Health
(NIH). The Principal Investigator of the study is 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.
The Company is preparing to advance AV-101 into a 280-patient,
U.S. multi-center, Phase 2b adjunctive treatment study in MDD in
the first half of 2017, prior to the completion of the ongoing
NIMH-sponsored AV-101 Phase 2a monotherapy study. Dr. Maurizio Fava of Harvard
University will be the Principal Investigator of the Phase
2b study, which will be a double-blind, placebo controlled efficacy
and safety study of AV-101 as adjunctive treatment of MDD patients
with inadequate response to standard antidepressants. The Phase 2b
study will utilize a Sequential Parallel Comparison Design
(SPCD), which is a clinical study design intended to
mitigate potential placebo effects. The Company anticipates topline
results from this Phase 2b study to be reported in the second half
of 2018.
Expected Near-Term Milestones:
- Submission of an Investigational New Drug application (IND) to
the FDA for a Phase 2b study of AV-101 as adjunctive treatment of
MDD in the first half of calendar 2017;
- Launch of AV-101 Phase 2b study as adjunctive treatment of MDD
in patients with inadequate response to standard antidepressants,
in the first half of 2017;
- FDA Fast Track designation for AV-101 as adjunctive treatment
of MDD in the first half of 2017; and
- Topline results from NIMH-sponsored AV-101 Phase 2a MDD
monotherapy study in the first half of 2017.
Summary of Financial Results for the Second Quarter of
Fiscal 2017 Ended September 30,
2016
For the second fiscal quarter ended September 30, 2016, the Company reported a net
loss of approximately $3.1 million,
or a net loss attributable to common stockholders of $0.42 per common share, compared to a net loss of
approximately $5.1 million, or a net
loss attributable to common stockholders of $0.91 per common share for the same period in the
prior year. Research and development expense totaled $1.61 million for the quarter ended September 30, 2016, a 3% decrease compared with
the $1.66 million reported for the
quarter ended September 30, 2015,
reflecting our increasing focus on the continued development of
AV-101 and preparations to launch our AV-101 Phase 2b study in MDD,
which we currently anticipate to begin in the first half of 2017,
offset by a reduction in noncash stock compensation expense
compared to the same period in the prior year. General and
administrative expense decreased to $1.5
million for the second quarter ended September 30, 2016, from $3.7 million for the same period in the prior
year. The changes in G&A are the result of a decrease in
noncash stock compensation expense attributable to option and
fully-vested warrant grants to employees, members of our Board of
Directors and consultants and noncash expense related to grants of
equity securities in payment of certain professional services,
offset by a combination of corporate expenses, including investor
relations and corporate development initiatives, our Nasdaq listing
fees and compensation and headcount increases.
As of September 30, 2016, the
Company had approximately $6.3
million of cash and cash equivalents. The Company believes
it has sufficient financial resources to fund its expected
operations through the first half of 2017.
About AV-101
AV-101 (4-CI-KYN) is an orally
available prodrug candidate, currently in Phase 2 development,
initially for the adjunctive treatment of MDD in patients with an
inadequate response to standard, FDA-approved antidepressants.
AV-101 has broad potential utility in other CNS diseases and
disorders, including chronic neuropathic pain, epilepsy and
neurodegenerative diseases, such as Parkinson's disease and
Huntington's disease. Orally available AV-101 is rapidly absorbed
through the gut, and then actively transported across the
blood-brain barrier. Astrocytes in the brain rapidly convert AV‑101
into its active metabolite, 7-chlorokynurenic acid
(7-Cl-KYNA), a well-characterized, potent and selective
antagonist of N-methyl-D-aspartate (NMDA) receptors, acting
by blocking the glycine-binding co-agonist site of the NMDA
receptor. AV-101 is a member of a new generation of fast-acting
glutamatergic drug candidates in development for adjunctive
treatment of MDD. These fast-acting drug candidates act through the
AMPA receptor pathway increasing the production of nerve
connections in the brain, often referred to as "synaptogenesis."
The increase in synaptogenesis is thought to be the mechanism by
which these new generation antidepressant drug candidates have
potential to provide therapeutic benefit for MDD.
AV-101's mechanism of action is fundamentally differentiated
from all FDA-approved antidepressants and atypical antipsychotics,
with potential to drive a paradigm shift towards new generation
safer and faster-acting antidepressants. Unlike most currently
approved antidepressants, which act on serotonin and related
neurotransmitter pathways in the brain, AV-101 works through an
entirely different mechanism, mobilizing glutamate pathways to
enhance neuronal plasticity and improve the communication between
neuronal cells. Dysfunction in these activities is increasingly
recognized by scientists as an important contributor to depression
and other serious disorders of the CNS.
About VistaGen
VistaGen Therapeutics, Inc. (NASDAQ:
VTGN) is a clinical-stage biopharmaceutical company dedicated to
developing and commercializing innovative therapies for CNS
diseases and disorders. VistaGen's lead CNS product candidate,
AV-101, is a new generation, orally available prodrug in Phase 2
development, initially for the adjunctive treatment of MDD in
patients with inadequate response to standard antidepressants.
AV-101 is currently being evaluated in an ongoing Phase 2a clinical
study being conducted by Principal Investigator, Dr. Carlos Zarate Jr., of the NIMH, and fully funded
by the NIMH. VistaGen is also preparing to initiate a Phase 2b
clinical study of AV-101 as an adjunctive treatment of MDD in
patients with inadequate response to standard, FDA-approved
antidepressants in the first half of 2017.
For more information, please visit www.vistagen.com and connect
with VistaGen on Twitter, LinkedIn and 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 Phase 2a (monotherapy) and/or Phase 2b
(adjunctive therapy) clinical studies of AV-101 in MDD, and other
CNS diseases and disorders, protection of its intellectual
property, and the availability of substantial additional capital to
support its operations, including the 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.
Condensed
Consolidated Financial Statements (Unaudited)
|
|
VISTAGEN
THERAPEUTICS, INC.
|
|
Condensed
Consolidated Balance Sheets
|
Amounts in
Dollars
|
|
|
|
|
|
|
|
September
30,
|
|
March 31,
|
|
|
2016
|
|
2016
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
6,257,100
|
|
$
428,500
|
Prepaid
expenses and other current assets
|
|
648,900
|
|
426,800
|
Total current
assets
|
|
6,906,000
|
|
855,300
|
Property and
equipment, net
|
|
69,200
|
|
87,600
|
Security
deposits and other assets
|
|
47,800
|
|
46,900
|
Total
assets
|
|
$
7,023,000
|
|
$
989,800
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
930,200
|
|
$
936,000
|
Accrued
expenses
|
|
795,000
|
|
814,000
|
Current
portion of notes payable and accrued
interest
|
|
71,100
|
|
43,600
|
Capital lease
obligations
|
|
600
|
|
1,100
|
Total current
liabilities
|
|
1,796,900
|
|
1,794,700
|
|
|
|
|
|
Non-current
liabilities:
|
|
|
|
|
Notes
payable
|
|
-
|
|
27,200
|
Accrued
dividends on Series B Preferred Stock
|
|
1,101,600
|
|
2,089,600
|
Deferred rent
liability
|
|
37,400
|
|
55,500
|
Total
non-current liabilities
|
|
1,139,000
|
|
2,172,300
|
Total
liabilities
|
|
2,935,900
|
|
3,967,000
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity (deficit):
|
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized at September 30,
2016 and March 31, 2016:
|
|
|
|
|
Series A Preferred, 500,000 shares authorized and outstanding at
September 30, 2016 and March 31, 2016
|
|
500
|
|
500
|
Series B Preferred; 4,000,000 shares authorized
at September 30, 2016 and March 31, 2016; 1,160,240 shares and
3,663,077 shares issued and outstanding at September 30, 2016 and
March 31, 2016, respectively
|
|
1,200
|
|
3,700
|
Series C Preferred; 3,000,000 shares
authorized at September 30, 2016 and March 31,
2016; 2,318,012 shares issued and outstanding at
September 30, 2016 and March 31, 2016
|
|
2,300
|
|
2,300
|
Common stock, $0.001 par value; 30,000,000
shares authorized at September 30, 2016 and March 31,
2016; 8,405,128 and 2,623,145 shares issued at
September 30, 2016 and March 31, 2016,
respectively
|
|
8,400
|
|
2,600
|
Additional
paid-in capital
|
|
144,854,200
|
|
132,725,000
|
Treasury
stock, at cost, 135,665 shares of common stock held at September
30, 2016 and March 31, 2016
|
|
(3,968,100)
|
|
(3,968,100)
|
Accumulated
deficit
|
|
(136,811,400)
|
|
(131,743,200)
|
Total
stockholders' equity (deficit)
|
|
4,087,100
|
|
(2,977,200)
|
Total
liabilities and stockholders' equity
(deficit)
|
|
$
7,023,000
|
|
$
989,800
|
VISTAGEN
THERAPEUTICS, INC.
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
(Unaudited)
|
(Amounts in
dollars, except share amounts)
|
|
|
|
Three Months Ended
September 30,
|
|
Six Months
Ended September 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
1,606,100
|
|
1,656,100
|
|
2,431,800
|
|
2,028,700
|
|
General
and administrative
|
1,493,600
|
|
3,730,500
|
|
2,631,200
|
|
5,179,000
|
|
Total operating expenses
|
3,099,700
|
|
5,386,600
|
|
5,063,000
|
|
7,207,700
|
|
Loss from
operations
|
(3,099,700)
|
|
(5,386,600)
|
|
(5,063,000)
|
|
(7,207,700)
|
|
Other expenses,
net:
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
(1,400)
|
|
(12,200)
|
|
(2,800)
|
|
(767,300)
|
|
Change in
warrant liability
|
-
|
|
-
|
|
-
|
|
(1,894,700)
|
|
Loss on extinguishment of
debt
|
-
|
|
(1,649,300)
|
|
-
|
|
(26,700,200)
|
|
Loss before income
taxes
|
(3,101,100)
|
|
(7,048,100)
|
|
(5,065,800)
|
|
(36,569,900)
|
|
Income
taxes
|
-
|
|
-
|
|
(2,400)
|
|
(2,300)
|
|
Net loss
|
$
(3,101,100)
|
|
$
(7,048,100)
|
|
$
(5,068,200)
|
|
$
(36,572,200)
|
|
|
|
|
|
|
|
|
|
|
Accrued
dividend on Series B Preferred stock
|
(241,000)
|
|
(614,700)
|
|
(780,800)
|
|
(828,000)
|
|
Deemed
dividend on Series B Preferred Units
|
-
|
|
(886,900)
|
|
(111,100)
|
|
(1,143,100)
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(3,342,100)
|
|
$
(8,549,700)
|
|
$
(5,960,100)
|
|
$
(38,543,300)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss attributable to
common stockholders per common share
|
$
(0.42)
|
|
$
(5.26)
|
|
$
(0.91)
|
|
$
(24.21)
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing
basic and diluted net loss
attributable to common stockholders per common
share
|
8,041,619
|
|
1,624,371
|
|
6,577,769
|
|
1,592,104
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
$
(3,101,100)
|
|
$
(7,048,100)
|
|
$
(5,068,200)
|
|
$
(36,572,200)
|
|
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SOURCE VistaGen Therapeutics, Inc.