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 ContactMark A. McPartland VistaGen
Therapeutics Inc. Phone: +1 (650) 577-3600
Email: IR@vistagen.com
Investor ContactValter Pinto / Allison Soss
KCSA Strategic Communications Phone: +1 (212) 896-1254/+1 (212)
896-1267 Email: VistaGen@KCSA.com
Media ContactCaitlin Kasunich / Lisa Lipson
KCSA Strategic Communications Phone: +1 (212) 896-1241/+1 (508)
843-6428 Email: VistaGen@KCSA.com
VISTAGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS(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 |
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
(Unaudited) |
|
(Amounts in dollars, except share
amounts) |
|
|
|
|
|
|
|
|
|
|
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 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss attributable to common |
|
|
|
|
|
|
|
|
stockholders per
common share |
$ |
(0.30 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.82 |
) |
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
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