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| 8-K - FORM 8-K - VistaGen Therapeutics, Inc. | vsta8k_nov142016.htm |
Exhibit 99.1
VistaGen Therapeutics Reports Second Quarter 2017 Financial Results
and Business Update
South San Francisco, CA (November 14, 2016) – 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, except share amounts)
|
|
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)
|
Company Contact
Mark
A. McPartland
VistaGen
Therapeutics Inc.
Phone:
+1 (650) 577-3600
Email:
IR@vistagen.com
Investor Contact
Jenene
Thomas
Jenene
Thomas Communications, LLC
Phone:
+1 (908) 938-1475
Email:
jenene@jenenethomascommunications.com
Source:
VistaGen Therapeutics, Inc.
###