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| 8-K - CURRENT REPORT - VistaGen Therapeutics, Inc. | vtgn8k.htm |
Exhibit
99.1
VistaGen Therapeutics Reports Fiscal 2019 Second Quarter Financial
Results
South San Francisco, Calif., October 29, 2018
– VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for central nervous
system (CNS) diseases and disorders with high unmet need, today
reported financial results for its fiscal 2019 second quarter ended
September 30, 2018.
“During
the quarter, we continued to focus our resources on AV-101
development, especially advancement of ELEVATE, our Phase 2
adjunctive treatment study for major depressive disorder, and Phase
3-enabling nonclinical and regulatory activities. ELEVATE is well
underway, and we remain confident in our target to deliver topline
results in mid-2019,” said Shawn Singh, Chief
Executive Officer of VistaGen.
“In
addition to advancing our core AV-101 development programs, we also
recently enhanced our pipeline with two complementary assets aimed
at the treatment of CNS disorders with high unmet need. We signed
exclusive license agreements to develop and commercialize these
potential first-in-class, intranasally administered, new drug
candidates, PH94B for social anxiety disorder and PH10 for major
depressive disorder. We believe adding these two potential
rapid-onset neuroactive steroid treatments, together with AV-101,
which is focused on achieving rapid-onset antidepressant effects
through NMDA and AMPA receptors, adds significant pipeline strength
and gives us the potential to provide patients with a broad range
of potential new generation solutions to treat depression and other
CNS disorders with serious unmet need, with the goal of eliminating
psychological side effects and safety concerns often associated
with current therapies” concluded Mr. Singh.
Operational Highlights:
Continued Advancements in the Clinical Development of
AV-101
●
In connection with
our initial collaboration with the U.S. Department of
Veteran’s Affairs (VA) and Baylor University (Baylor), Baylor
commenced a randomized,
double-blind, first-step, cross-over study in healthy
volunteer U.S. Military Veterans to define a dose-response
relationship between AV-101 and relevant biomarkers related to NMDA
function believed to be associated with suicidal ideation. The
results of this initial study could lead to a Phase 2 study
involving AV-101 and U.S. Military Veterans who are battling
suicidal thoughts or behaviors.
●
We received FDA
Fast Track Designation (FTD) for development of AV-101 as a
non-opioid treatment for neuropathic pain, without sedative or
psychological side effects. Together with our FTD for development
of AV-101 for major depressive disorder (MDD), this is the second
FTD we have received from the FDA for AV-101 since December 2017,
marking another milestone for our regulatory team.
License Agreements to Acquire Two First-in-Class CNS Drug
Candidates
●
Acquired a license
for exclusive worldwide rights to develop and commercialize PH94B,
a pivotal Phase 3-ready drug candidate with potential to be the
first FDA-approved acute on-demand medication for social anxiety
disorder (SAD), a widespread social phobia which, according to the Anxiety and
Depression Association of America, affects as many as 15 million
American adults.
●
Acquired a license
for exclusive worldwide rights to develop and commercialize PH10, a
potential first-in-class, intranasally administered neuroactive
steroid with rapid-onset antidepressant effects for MDD as
demonstrated in a Phase 2a study. We believe PH10 is likely to have
rapid-onset antidepressant effects within hours, not days or weeks,
similar to ketamine-based drug candidates, but potentially without
the psychological side effects, safety issues or required in-clinic
administration.
Financial Results for the Fiscal Quarter Ended September 30,
2018:
Net
loss attributable to common stockholders for the fiscal quarter
ended September 30, 2018 was approximately $7.7 million, compared
to $5.3 million for the fiscal quarter ended September 30, 2017,
primarily attributable to increased research and development
activities relating to the Company’s AV-101 programs and
noncash expense of $2.25 million to acquire the exclusive license
to PH94B and exclusive option to license PH10.
Research
and development expense totaled approximately $5.3 million for the
fiscal quarter ended September 30, 2018, compared with
approximately $2.4 million for the fiscal quarter ended September
30, 2017. The increase is primarily attributable to expenses
related to conducting ELEVATE and AV-101 Phase 3-enabling
nonclinical and regulatory activities, including manufacturing
process improvements and production of additional quantities of
AV-101 drug substance, coupled with the acquisition of the
exclusive license to PH94B and the exclusive option to licensePH10
through the issuance of our common stock, which acquisitions
resulted in $2.25 million of noncash expense.
General
and administrative expense was approximately $2.2 million in the
fiscal quarter ended September 30, 2018, compared to approximately
$2.6 million in the fiscal quarter ended September 30,
2017.
At
September 30, 2018, the Company had cash and cash equivalents of
approximately $7.8 million, compared to approximately $10.4 million
at March 31, 2018. Since September 30, 2018, as a result of
self-placed private placement transactions of unregistered
securities to accredited investors and exercises of outstanding
warrants, the Company has received aggregate cash proceeds of
approximately $2.4 million.
About VistaGen
VistaGen
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. 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 drug candidates, including AV-101 for MDD,
neuropathic pain and suicidal ideation, PH94B for SAD, and PH10 for
MDD, as well as our intellectual property and commercial protection
of our drug candidates, all of which 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. Among these risks is the
possibility that (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
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Consolidated Balance Sheets
|
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(Amounts
in dollars, except share amounts)
|
|
|
September
30,
|
March
31,
|
|
|
2018
|
2018
|
|
|
(Unaudited)
|
(Note
2)
|
|
|
|
|
|
ASSETS
|
||
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$7,831,600
|
$10,378,300
|
|
Prepaid
expenses and other current assets
|
648,000
|
644,800
|
|
Total current
assets
|
8,479,600
|
11,023,100
|
|
Property and
equipment, net
|
361,800
|
207,400
|
|
Security deposits
and other assets
|
47,800
|
47,800
|
|
Total
assets
|
$8,889,200
|
$11,278,300
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$590,100
|
$1,195,700
|
|
Accrued
expenses
|
599,700
|
206,300
|
|
Current notes
payable
|
115,600
|
53,900
|
|
Capital lease
obligations
|
2,800
|
2,600
|
|
Total current
liabilities
|
1,308,200
|
1,458,500
|
|
|
|
|
|
Non-current
liabilities:
|
|
|
|
Accrued
dividends on Series B Preferred Stock
|
3,165,400
|
2,608,300
|
|
Deferred rent
liability
|
418,500
|
285,600
|
|
Capital lease
obligations
|
7,900
|
9,300
|
|
Total
non-current liabilities
|
3,591,800
|
2,903,200
|
|
Total
liabilities
|
4,900,000
|
4,361,700
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized at September 30,
2018 and March 31, 2018:
|
|
|
|
Series A Preferred,
500,000 shares authorized, issued and outstanding at September 30,
2018 and March 31, 2018
|
500
|
500
|
|
Series B Preferred;
4,000,000 shares authorized at September 30, 2018 and March 31,
2018; 1,160,240 shares issued and
outstanding at September 30, 2018 and March 31, 2018
|
1,200
|
1,200
|
|
Series C Preferred;
3,000,000 shares authorized at September 30, 2018 and March 31,
2018; 2,318,012 shares issued and
outstanding at September 30, 2018 and March 31, 2018
|
2,300
|
2,300
|
|
Common stock,
$0.001 par value; 100,000,000 shares authorized at September 30,
2018 and March 31, 2018; 28,676,715 and
23,068,280 shares issued and outstanding at September 30, 2018 and
March 31, 2018, respectively
|
28,700
|
23,100
|
|
Additional paid-in
capital
|
176,117,900
|
167,401,400
|
|
Treasury stock, at
cost, 135,665 shares of common stock held at September 30, 2018 and
March 31, 2018
|
(3,968,100)
|
(3,968,100)
|
|
Accumulated
deficit
|
(168,193,300)
|
(156,543,800)
|
|
Total
stockholders’ equity
|
3,989,200
|
6,916,600
|
|
Total liabilities
and stockholders’ equity
|
$8,889,200
|
$11,278,300
|
|
VISTAGEN THERAPEUTICS
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CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE
LOSS
|
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|
(Unaudited)
|
|
|||||||
|
Amounts in Dollars, except share amounts
|
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|
|
Quarters
Ended
September
30,
|
Six
Months Ended
September
30,
|
||
|
|
2018
|
2017
|
2018
|
2017
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
$5,261,100
|
$2,426,600
|
$8,004,800
|
$3,522,800
|
|
General and
administrative
|
2,171,000
|
2,567,100
|
3,637,300
|
3,731,400
|
|
Total operating
expenses
|
7,432,100
|
4,993,700
|
11,642,100
|
7,254,200
|
|
Loss from
operations
|
(7,432,100)
|
(4,993,700)
|
(11,642,100)
|
(7,254,200)
|
|
Other expenses,
net:
|
|
|
|
|
|
Interest expense,
net
|
(2,900)
|
(3,300)
|
(5,000)
|
(5,700)
|
|
|
|
|
|
|
|
Loss before income
taxes
|
(7,435,000)
|
(4,997,000)
|
(11,647,100)
|
(7,259,900)
|
|
Income
taxes
|
-
|
-
|
(2,400)
|
(2,400)
|
|
Net loss and
comprehensive loss
|
(7,435,000)
|
(4,997,000)
|
(11,649,500)
|
(7,262,300)
|
|
|
|
|
|
|
|
Accrued dividend on
Series B Preferred stock
|
(283,600)
|
(256,300)
|
(557,100)
|
(503,600)
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders
|
$(7,718,600)
|
$(5,253,300)
|
$(12,206,600)
|
$(7,765,900)
|
|
|
|
|
|
|
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Basic and diluted
net loss attributable to common
|
|
|
|
|
|
stockholders per
common share
|
$(0.30)
|
$(0.53)
|
$(0.50)
|
$(0.82)
|
|
|
|
|
|
|
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Weighted average
shares used in computing basic
|
|
|
|
|
|
and diluted net
loss attributable to common
|
|
|
|
|
|
stockholders per
common share
|
25,815,245
|
9,892,016
|
24,267,816
|
9,465,459
|