Exhibit 99.1
VistaGen Therapeutics Reports Fiscal 2020 Second Quarter Financial
Results and Provides Pipeline Overview
SOUTH SAN FRANCISCO, Calif., November 7, 2019 – VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system
(CNS) diseases and disorders with high unmet need, today announced
financial results for its fiscal year 2020 second quarter ended
September 30, 2019.
“During the quarter, we achieved several important milestones
intended to advance development of each of our three differentiated
CNS drug candidates,” stated Shawn
Singh, Chief Executive Officer of VistaGen.
“We recently
achieved target enrollment and completed patient dosing in our
randomized, double-blind, placebo-controlled Phase 2 ELEVATE study
of AV-101, our novel oral NMDA receptor antagonist, in major
depressive disorder. In addition, for development of AV-101 in
suicidal ideation, with emphasis on U.S. Military Veterans, our
collaborators at Baylor University recently completed dosing in
their Phase 1b target engagement study in healthy volunteer
Veterans, a study funded by the U.S. Department of Veteran’s
Affairs. We are also encouraged by post-Phase 2 feedback from the
FDA earlier this year regarding our Phase 3 development plan for
PH94B, our first-in-class, rapid-acting neuroactive nasal spray, in
social anxiety disorder. We expect the coming months to be equally
active and potentially transformative, as we look forward to
topline readouts from two studies involving AV-101 before the end
of 2019, and potential regulatory milestones involving PH94B before
the end of fiscal 2020.”
Financial Results for the Fiscal Quarter Ended September 30,
2019:
Net loss attributable to common stockholders for the fiscal quarter
ended September 30, 2019 decreased to approximately $5.7 million
compared to $7.7 million for the fiscal quarter ended September 30,
2018, primarily attributable to research and development activities
relating to the Company’s CNS drug development
programs.
Research and development expense decreased to $4.2 million for the
fiscal quarter ended September 30, 2019, compared with $5.3 million
for the fiscal quarter ended September 30, 2018. Expense for the
quarter ended September 30, 2018 included $2.25 million noncash
expense associated with the Company’s acquisition of its
exclusive worldwide license to develop and commercialize PH94B and
an option to acquire an exclusive worldwide license to develop and
commercialize PH10, the Company’s first-in-class, rapid-onset
neuroactive nasal spray in Phase 2 development for major depressive
disorder, which option was subsequently exercised. Offsetting this
noncash expense in the quarter ended September 30, 2019 are
increased expenses for the ELEVATE study and various nonclinical
activities across the Company’s CNS pipeline.
General and administrative expense decreased to approximately $1.1
million in the fiscal quarter ended September 30, 2019, compared to
approximately $2.2 million in the fiscal quarter ended September
30, 2018. Noncash expense of $272,000 in the quarter ended
September 30, 2019, decreased from $792,000 in the quarter ended
September 30, 2018, primarily due to decreases in stock-based
compensation and other expenses.
At September 30, 2019, VistaGen had cash and cash equivalents of
$4.1 million, compared to $13.1 million at March 31,
2019.
As of November 6, 2019, there were 43,222,965 shares of common
stock outstanding.
VistaGen’s CNS Pipeline
VistaGen
is developing three new generation clinical-stage CNS drug
candidates, AV-101, PH10 and PH94B, each with a differentiated
mechanism of action, an exceptional safety profile in all clinical
studies to date, and therapeutic potential in multiple CNS markets
where current treatments are inadequate to meet high unmet patient
needs.
AV-101 belongs to a new
generation of investigational medicines in neuropsychiatry and
neurology known as NMDA (N-methyl-D-aspartate) receptor modulators.
The NMDA receptor is a pivotal receptor in the brain and abnormal
NMDA function is associated with numerous CNS diseases and
disorders. AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and
selective full antagonist of the glycine co-agonist site of
the NMDA receptor. Based on several positive preclinical studies
and its exceptional safety profile in all preclinical and clinical
studies to date, AV-101 has potential to be a new at-home,
non-sedating treatment for multiple large market CNS indications,
including major depressive disorder, neuropathic pain, suicidal
ideation, epilepsy and dyskinesia associated with levodopa therapy
for Parkinson’s disease. The FDA has granted Fast Track
designation for development of AV-101 as both a novel
potential adjunctive treatment
for MDD and a non-opioid treatment
for neuropathic pain.
PH10 is a first-in-class,
odorless, rapid-onset CNS neuroactive nasal spray in development
for treatment of major depressive disorder. Administered in
microgram doses, PH10 activates nasal chemosensory receptors that,
in turn, engage neural circuits that lead to rapid antidepressant
effects without psychological side effects, systemic exposure or
safety concerns often associated with current oral antidepressants
and ketamine-based therapies (intravenous ketamine or esketamine
nasal spray). In an exploratory (n=30) randomized, double-blind,
placebo-controlled Phase 2a clinical study in major depressive
disorder, at microgram doses, rapid-onset antidepressant effects
were observed and sustained for 8 weeks, without psychological side
effects or systemic exposure. VistaGen is preparing for planned
Phase 2b clinical development of PH10 for major depressive
disorder.
PH94B is a first-in-class,
odorless, rapid-onset (approximately 10 to 15 minutes) CNS
neuroactive nasal spray with the potential to be the first
FDA-approved, as-needed, on-demand treatment for millions of
Americans who suffer from social anxiety disorder, with additional
potential in
peripartum anxiety,
pre/postoperative anxiety, post-traumatic stress disorder, panic
disorder and generalized anxiety disorder. Administered at
microgram doses, PH94B activates nasal chemosensory receptors that
trigger neural circuits in the brain that suppress fear and anxiety
associated with everyday social and work or performance situations.
Following successful Phase 2 development, VistaGen is preparing for
Phase 3 clinical development of PH94B for social anxiety
disorder.
About VistaGen
VistaGen
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for CNS diseases and disorders
where current treatments are inadequate, resulting in high unmet
need. VistaGen's pipeline includes
three clinical-stage CNS drug candidates, AV-101, PH10 and PH94B,
each with a differentiated mechanism of action, an exceptional
safety profile in all clinical studies to date, and therapeutic
potential in multiple large and growing CNS markets. For more
information, please visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This
release contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development and commercialization of our
three drug candidates: (i) AV-101 for major depressive disorder,
neuropathic pain, epilepsy, dyskinesia associated with levodopa
therapy for Parkinson’s disease and suicidal ideation; (ii)
PH94B for social anxiety disorder, peripartum anxiety,
pre/postoperative anxiety, post-traumatic stress disorder, panic
disorder and generalized anxiety disorder; and (iii) PH10 for major
depressive disorder. In addition, statements concerning the
Company’s future expectations may include statements
regarding intellectual property and commercial protection of our
drug candidates. Each of these statements constitute
forward-looking statements for the purposes of the safe harbor
provisions under the Private Securities Litigation Reform Act of
1995. These forward-looking statements are neither promises nor
guarantees of future performance and are subject to a variety of
risks and uncertainties, many of which are beyond our control, and
may cause actual results to differ materially from those
contemplated in these forward-looking statements. Those risks
include the following: (i) we may encounter unexpected adverse
events in patients during our clinical development of any product
candidate that cause us to discontinue further development; (ii) we
may not be able to successfully demonstrate the safety and efficacy
of our product candidates at each stage of clinical development;
(iii) success in preclinical studies or in early-stage clinical
trials may not be repeated or observed in ongoing or future
studies, and ongoing or future preclinical and clinical results may
not support further development of, or be sufficient to gain
regulatory approval to market AV-101, PH94B, and/or PH10; (iv)
decisions or actions of regulatory agencies may negatively affect
the progress of, and our ability to proceed with, further clinical
studies or to obtain marketing approval for our drug candidates;
(v) we may not be able to obtain or maintain adequate intellectual
property protection and other forms of marketing and data
exclusivity for our product candidates; (vi) we may not have access
to or be able to secure substantial additional capital to support
our operations, including our ongoing clinical development
activities; and (vii) we may encounter technical and other
unexpected hurdles in the manufacturing and development of any of
our product candidates. Certain other risks are more fully
discussed in the section entitled "Risk Factors" in our most recent
annual report on Form 10-K, and subsequent quarterly reports on
Form 10-Q, as well as discussions of potential risks,
uncertainties, and other important factors in our other filings
with the Securities and Exchange Commission (SEC). Our SEC filings
are available on the SEC's website at www.sec.gov. In addition, any
forward-looking statements represent our views only as of the
issuance of this release and should not be relied upon as
representing our views as of any subsequent date. We explicitly
disclaim any obligation to update 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
Media Contact
Caitlin
Kasunich / Lisa Lipson
KCSA
Strategic Communications
Phone:
+1 (212) 896-1241/+1 (508) 843-6428
Email:
VistaGen@KCSA.com
VISTAGEN THERAPEUTICS
Consolidated Balance Sheets
(Amounts in dollars, except share amounts)
(UNAUDITED)
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ASSETS
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Current
assets:
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Cash
and cash equivalents
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$4,072,400
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$13,100,300
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Receivable
from supplier
|
-
|
300,000
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Prepaid
expenses and other current assets
|
604,500
|
250,900
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Total
current assets
|
4,676,900
|
13,651,200
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Property
and equipment, net
|
260,600
|
312,700
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Right
of use asset - operating lease
|
3,750,200
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-
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Security
deposits and other assets
|
47,800
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47,800
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Total
assets
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$8,735,500
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$14,011,700
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LIABILITIES AND STOCKHOLDERS’ (DEFICIT)
EQUITY
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Current
liabilities:
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Accounts
payable
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$1,449,800
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$1,055,000
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Accrued
expenses
|
2,215,500
|
1,685,600
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Current
notes payable
|
159,300
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57,300
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Operating
lease oligation
|
289,600
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-
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Financing
lease obligation
|
3,100
|
3,000
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Total
current liabilities
|
4,117,300
|
2,800,900
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Non-current
liabilities:
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Accrued
dividends on Series B Preferred Stock
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4,364,500
|
3,748,200
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Deferred
rent liability
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-
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381,100
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Operating
lease obligation
|
3,879,400
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-
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Financing
lease obligation
|
4,700
|
6,300
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Total
non-current liabilities
|
8,248,600
|
4,135,600
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Total
liabilities
|
12,365,900
|
6,936,500
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Commitments
and contingencies
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Stockholders’
(deficit) equity:
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Preferred
stock, $0.001 par value; 10,000,000 shares authorized at September
30, 2019 and March 31, 2019:
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Series
A Preferred, 500,000 shares authorized, issued and outstanding at
September 30, 2019 and March 31, 2019
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500
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500
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Series
B Preferred; 4,000,000 shares authorized at September 30, 2019 and
March 31, 2019; 1,160,240 shares
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issued
and outstanding at September 30, 2019 and March 31,
2019
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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 September 30, 2019 and
March 31, 2019; 2,318,012 shares
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issued
and outstanding at September 30, 2019 and March 31,
2019
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2,300
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2,300
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Common
stock, $0.001 par value; 175,000,000 and 100,000,000 shares
authorized at September 30, 2019 and
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March
31, 2019, respectively; 42,758,630 shares issued and outstanding at
September 30, 2019 and March 31, 2019
|
42,800
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42,800
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Additional
paid-in capital
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192,970,100
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192,129,900
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Treasury
stock, at cost, 135,665 shares of common stock held at September
30, 2019 and March 31, 2019
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(3,968,100)
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(3,968,100)
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Accumulated
deficit
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(192,679,200)
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(181,133,400)
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Total
stockholders’ (deficit) equity
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(3,630,400)
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7,075,200
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Total
liabilities and stockholders’ (deficit) equity
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$8,735,500
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$14,011,700
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VISTAGEN THERAPEUTICS
STATEMENT OF OPERATIONS
Amounts in Dollars, except share amounts
(Unaudited)
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Three Months Ended September 30,
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Six Months Ended September 30,
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Operating
expenses:
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Research
and development
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$4,205,200
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$5,261,100
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$8,519,100
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$8,004,800
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General
and administrative
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1,146,100
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2,171,000
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3,056,200
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3,637,300
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Total
operating expenses
|
5,351,300
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7,432,100
|
11,575,300
|
11,642,100
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Loss
from operations
|
(5,351,300)
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(7,432,100)
|
(11,575,300)
|
(11,642,100)
|
Other
income (expenses), net:
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Interest
income (expense), net
|
15,400
|
(2,900)
|
31,900
|
(5,000)
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Loss
before income taxes
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(5,335,900)
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(7,435,000)
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(11,543,400)
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(11,647,100)
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Income
taxes
|
-
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-
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(2,400)
|
(2,400)
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Net
loss and comprehensive loss
|
$(5,335,900)
|
$(7,435,000)
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$(11,545,800)
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$(11,649,500)
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Accrued
dividend on Series B Preferred stock
|
(313,800)
|
(283,600)
|
(616,300)
|
(557,100)
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Net
loss attributable to common stockholders
|
$(5,649,700)
|
$(7,718,600)
|
$(12,162,100)
|
$(12,206,600)
|
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Basic
and diluted net loss attributable to common
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stockholders
per common share
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$(0.13)
|
$(0.30)
|
$(0.29)
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$(0.50)
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Weighted
average shares used in computing
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basic
and diluted net loss attributable to common
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stockholders
per common share
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42,622,965
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25,815,245
|
42,622,965
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24,267,816
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