Exhibit
99.1
VistaGen Therapeutics Reports Fiscal
2020 Third Quarter Financial Results and Provides CNS Pipeline
Overview
SOUTH SAN FRANCISCO, Calif., February 13, 2020 – VistaGen Therapeutics
(NASDAQ: VTGN), a
clinical-stage biopharmaceutical company developing new generation
medicines for central nervous system (CNS) diseases and disorders
with high unmet medical need, today announced financial
results for its fiscal year 2020 third quarter ended December 31,
2019.
VistaGen has a multi-asset, clinical-stage CNS pipeline, including
three differentiated drug candidates, two of which, PH94B and PH10,
have positive human clinical data in individuals with social
anxiety disorder (SAD) and major depressive disorder (MDD),
respectively, and one of which, PH94B, is in preparation to advance
into Phase 3 clinical development for the treatment of SAD by the
end of this calendar year. Each of VistaGen’s CNS product
candidates has an exceptional safety profile, potential for
rapid-onset therapeutic benefits, and multiple shots on goal in CNS
markets where current treatments are inadequate, resulting
in high unmet
medical need.
Recent CNS Pipeline Updates:
●
The U.S. Food and Drug Administration (FDA) has granted Fast Track
designation for development of VistaGen's most advanced drug
candidate, PH94B neuroactive nasal spray for on-demand treatment of
SAD, the first such designation granted by the FDA for development
of a drug candidate for SAD.
●
VistaGen’s Investigational New Drug (IND) application for
AV-101, its oral NMDAR (N-methyl-D-aspartate receptor) antagonist
prodrug, as a potential new treatment of dyskinesia in patients
with Parkinson's disease receiving levodopa therapy, has been
cleared by the FDA, permitting VistaGen to proceed with Phase 2a
clinical development of AV-101 in this indication.
●
The U.S. Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for U.S. Patent Application 16/003,816 related to
therapeutic use of AV-101 for treatment of dyskinesia induced by
the administration of levodopa. The patent, once issued, will be in
effect until at least 2034.
●
VistaGen announced
successful results from an AV-101 first-step, Phase 1b clinical
study with healthy U.S. military Veterans, which study measured
NMDAR target engagement of AV-101 for potential treatment of
suicidal ideation in Veterans. The findings from the study were
presented in a poster, titled "Evoked and Resting
State Gamma Mechanics to Test NMDA Receptor Engagement of
Kynurenine Pathway Modulator AV-101 in Healthy Veterans," at the 2019 Annual Meeting
of the American College of Neuropsychopharmacology (ACNP) on
December 11, 2019.
●
VistaGen announced
positive preclinical data of AV-101 administered in combination
with probenecid demonstrating substantially increased brain
concentration effects of AV-101 and its active metabolite,
7-Cl-KYNA. When given together with AV-101, probenecid increased
brain concentrations of AV-101 7-fold and its active metabolite,
7-CI-KYNA, 35-fold. The resulting increased brain levels and
duration of 7-Cl-KYNA suggest the potential impact of AV-101 with
probenecid could result in far more profound therapeutic benefits
for patients with MDD than in prior clinical studies that did not
involve probenecid, as well as in other NMDAR-focused CNS diseases
and disorders. Results on AV-101 transport with adjunctive
probenecid were presented by a collaborator of VistaGen at the
British Pharmacological Society’s Pharmacology 2019 annual
conference in Edinburgh, UK, on December 17, 2019.
“During the quarter, we made significant progress across our
CNS pipeline, including milestones necessary to advance PH94B, our
first-in-class, rapid-onset neuroactive nasal spray, into Phase 3
clinical development for treatment of social anxiety disorder later
this year,“ stated Shawn
Singh, Chief Executive Officer of VistaGen.
“Social
anxiety disorder, or SAD, affects as many as 20 million American
adults and adolescents and is the third most common mental health
disorder in the U.S. With the alarming prevalence of depression,
anxiety, and suicide, driven increasingly by excessive use of
social media, and staggering increases in dependency, addiction and
even deaths associated with misuse and overuse of benzodiazepines,
the urgency for a differentiated, fast-acting, non-addictive,
non-sedating treatment for SAD and other anxiety-related disorders
is more important now than ever before.”
Mr. Singh continued, “During the quarter, we were very
pleased that PH94B received the FDA’s first ever Fast Track
designation for development of a drug candidate for treatment of
SAD. We look forward to further advancing our ongoing efforts to
meet the needs of millions of individuals with SAD for whom current
treatments fall short, while in parallel advancing development of
our other first-in-class neuroactive nasal spray, PH10, for major
depressive disorder, and our oral prodrug, AV-101, for treatment of
CNS indications involving the NMDA receptor.”
Financial Results for the Fiscal Quarter Ended December 31,
2019:
Net
loss attributable to common stockholders for the fiscal quarter
ended December 31, 2019 decreased to approximately $6.3 million
compared to $7.5 million for the fiscal quarter ended December 31,
2018, primarily resulting from the $2.0 million noncash expense
associated with the stock-based acquisition of the license to
develop and commercialize PH10 in the 2018 quarter.
Research
and development expense decreased to $3.0 million for the fiscal
quarter ended December 31, 2019, compared with $5.3 million for the
fiscal quarter ended December 31, 2018, primarily due to the 2018
noncash expense associated with the acquisition of the PH10
license. Expenses related to the Elevate study of AV-101 in MDD and
other AV-101 related nonclinical activities decreased in the
quarter ended December 31, 2019 compared to 2018, as the Elevate
study reached its conclusion following final patient dosing in
September 2019. Increased spending for nonclinical activities,
including manufacturing expense for PH94B and PH10, generally
offset the reduction in AV-101 expenses. In addition to the noncash
PH10 license acquisition in the quarter ended December 31, 2018,
other noncash expenses, primarily stock-based compensation and
depreciation, accounted for approximately $503,000 and $297,000 in
the quarters ended December 31, 2019 and 2018,
respectively.
General
and administrative expense increased to approximately $2.9 million
in the fiscal quarter ended December 31, 2019, compared to
approximately $1.9 million in the fiscal quarter ended December 31,
2018. Noncash general and administrative expense, $2.0 million in
the quarter ended December 31, 2019, increased from $597,000 in the
quarter ended December 31, 2018 primarily due to increased noncash
stock-based compensation and noncash warrant modification expenses
offset by decreased noncash investor and public relations
expenses.
At
December 31, 2019, VistaGen had cash and cash equivalents of $1.1
million, compared to $13.1 million at March 31, 2019. Subsequent to
December 31, 2019, on January 24, 2020, the Company received $2.75
million in gross proceeds from its successful self-placed
registered direct offering of common stock and concurrent private
placement of warrants.
As of
February 12, 2020, there were 47,963,042 shares of common stock
outstanding.
VistaGen’s Clinical-Stage CNS Pipeline
VistaGen
is developing three new generation clinical-stage CNS drug
candidates, PH94B, PH10, and AV-101, 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.
PH94B is an investigational first-in-class, odorless,
fast-acting synthetic neurosteroid with therapeutic potential in a
wide range of neuropsychiatric indications involving anxiety or
phobia. VistaGen is initially developing PH94B as a potential
fast-acting, non-sedating, non-addictive new generation treatment
of social anxiety disorder (SAD). Upon easy self-administration, a
non-systemic microgram-level dose PH94B sprayed into the nose binds
to nasal chemosensory receptors that activate neural circuits in
the brain that suppress fear and anxiety associated with everyday
social and work or performance situations. Following successfully
completed Phase 2 development for SAD, VistaGen is now preparing
for Phase 3 clinical development of PH94B for SAD. The FDA has
granted Fast Track designation for development of PH94B for
treatment of SAD, the FDA’s first ever Fast
Track designation for development of a drug candidate for treatment
of SAD.
PH10
is an
investigational first-in-class, odorless, fast-acting synthetic
neurosteroid with therapeutic potential in a wide range of
neuropsychiatric indications involving depression and suicidal
ideation. VistaGen is initially developing PH10 as a potential
fast-acting, non-sedating, non-addictive new generation treatment
of major depressive disorder (MDD) that can be conveniently
self-administered at home. Upon self-administration, a non-systemic
microgram-level dose of PH10 sprayed into the nose binds to nasal
chemosensory receptors that, in turn, activate neural circuits in
the brain that lead to rapid-onset antidepressant effects, without
side effects, systemic exposure or safety concerns that may be
caused by FDA-approved drug treatments for MDD, including oral
antidepressants and esketamine. Following successfully completed Phase 2a
development for MDD, VistaGen is now
preparing for planned Phase 2b clinical development of PH10 for
MDD.
AV-101 (4-Cl-KYN)
targets the NMDAR (N-methyl-D-aspartate receptor), an ionotropic
glutamate receptor in the brain. Abnormal NMDAR function is
associated with numerous CNS diseases and disorders. AV-101 is an
oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), which is a
potent and selective full antagonist of the glycine co-agonist site
of the NMDAR that inhibits the function of the NMDAR. Unlike
ketamine and many other NMDAR antagonists, 7-Cl-KYNA is not an ion
channel blocker. In all studies to date, AV-101 has exhibited no
dissociative or hallucinogenic psychological side effects or safety
concerns similar to those that may be caused by drugs such as
amantadine, esketamine and ketamine. With its exceptionally few
side effects and excellent safety profile, AV-101 has potential to
be an oral new generation treatment for multiple large-market CNS
indications where current treatments are inadequate to meet high
unmet patient needs. Following positive preclinical efficacy
studies of AV-101 in multiple CNS indications, as well as recent
positive preclinical studies of AV-101 in combination with
probenecid, VistaGen is conducting additional AV-101 preclinical
studies and assessing opportunities for potential Phase 2a clinical
development of AV-101. The FDA has granted Fast Track designation
for development of AV-101 as both a
potential adjunctive
treatment for MDD and as a non-opioid
treatment for neuropathic pain.
About VistaGen
VistaGen
Therapeutics is a multi-asset, 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 is focused on
clinical-stage CNS drug candidates with a differentiated mechanism
of action, an exceptional safety profile, 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 for various therapeutic purposes, including
(i) PH94B for social anxiety disorder and multiple other
anxiety-related disorders; (ii) PH10 for MDD and multiple
additional depression-related disorders and suicidal ideation, and
(iii) AV-101 for dyskinesia in patients with Parkinson's disease
receiving levodopa therapy, epilepsy, major depressive disorder,
neuropathic pain and suicidal ideation. In addition,
statements concerning the Company’s future expectations may
include statements regarding intellectual property and commercial
protection of each 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
studies may not be repeated or observed 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 any of our product candidates; (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 nonclinical and 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)
|
||
|
|
December
31,
|
March 31,
|
|
|
2019
|
2019
|
|
ASSETS
|
||
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$1,063,300
|
$13,100,300
|
|
Receivable
from supplier
|
-
|
300,000
|
|
Prepaid
expenses and other current assets
|
319,000
|
250,900
|
|
Total current
assets
|
1,382,300
|
13,651,200
|
|
Property and
equipment, net
|
235,100
|
312,700
|
|
Right of use
asset - operating lease
|
3,665,600
|
-
|
|
Security
deposits and other assets
|
47,800
|
47,800
|
|
Total
assets
|
$5,330,800
|
$14,011,700
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LIABILITIES
AND STOCKHOLDERS’ (DEFICIT) EQUITY
|
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|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$1,610,400
|
$1,055,000
|
|
Accrued
expenses
|
951,300
|
1,685,600
|
|
Current notes
payable
|
70,500
|
57,300
|
|
Operating
lease obligation
|
301,400
|
-
|
|
Financing
lease obligation
|
3,200
|
3,000
|
|
Total current
liabilities
|
2,936,800
|
2,800,900
|
|
|
|
|
|
Non-current
liabilities:
|
|
|
|
Accrued
dividends on Series B Preferred Stock
|
4,686,300
|
3,748,200
|
|
Deferred rent
liability
|
-
|
381,100
|
|
Operating
lease obligation
|
3,798,400
|
-
|
|
Financing
lease obligation
|
3,900
|
6,300
|
|
Total
non-current liabilities
|
8,488,600
|
4,135,600
|
|
Total
liabilities
|
11,425,400
|
6,936,500
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
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Stockholders’
(deficit) equity:
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized at December 31, 2019
and March 31, 2019:
|
|
|
|
Series A Preferred, 500,000 shares
authorized, issued and outstanding at December 31, 2019 and March
31, 2019
|
500
|
500
|
|
Series B Preferred; 4,000,000
shares authorized at December 31, 2019 and March 31, 2019;
1,160,240 shares issued and outstanding at December 31, 2019 and
March 31, 2019
|
1,200
|
1,200
|
|
Series C Preferred; 3,000,000
shares authorized at December 31, 2019 and March 31, 2019;
2,318,012 shares issued and outstanding at December 31, 2019 and
March 31, 2019
|
2,300
|
2,300
|
|
Common stock, $0.001 par value;
175,000,000 and 100,000,000 shares authorized at December 31, 2019
and March 31, 2019, respectively; 44,228,630 and 42,758,630 shares
issued and outstanding at December 31, 2019 and March 31,
2019, respectively
|
44,200
|
42,800
|
|
Additional paid-in
capital
|
196,466,000
|
192,129,900
|
|
Treasury stock, at
cost, 135,665 shares of common stock held at December 31, 2019 and
March 31, 2019
|
(3,968,100)
|
(3,968,100)
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|
Accumulated
deficit
|
(198,640,700)
|
(181,133,400)
|
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Total
stockholders’ (deficit) equity
|
(6,094,600)
|
7,075,200
|
|
Total liabilities
and stockholders’ (deficit) equity
|
$5,330,800
|
$14,011,700
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VISTAGEN
THERAPEUTICS
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Statement of
Operations
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||||
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Amounts in Dollars,
except share amounts
|
||||
|
(Unaudited)
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|
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|
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|
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Three
Months Ended December 31,
|
Nine
Months Ended December 31,
|
||
|
|
2019
|
2018
|
2019
|
2018
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
$3,014,500
|
$5,335,500
|
$11,533,600
|
$13,340,300
|
|
General and
administrative
|
2,948,300
|
1,856,800
|
6,004,500
|
5,494,100
|
|
Total
operating expenses
|
5,962,800
|
7,192,300
|
17,538,100
|
18,834,400
|
|
Loss from
operations
|
(5,962,800)
|
(7,192,300)
|
(17,538,100)
|
(18,834,400)
|
|
Other income
(expenses), net:
|
|
|
|
|
|
Interest
income (expense), net
|
1,500
|
(1,800)
|
33,400
|
(6,800)
|
|
Loss on
extinguishment of accounts payable
|
-
|
(22,700)
|
-
|
(22,700)
|
|
Loss before income
taxes
|
(5,961,300)
|
(7,216,800)
|
(17,504,700)
|
(18,863,900)
|
|
Income
taxes
|
(200)
|
-
|
(2,600)
|
(2,400)
|
|
Net loss and
comprehensive loss
|
$(5,961,500)
|
$(7,216,800)
|
$(17,507,300)
|
$(18,866,300)
|
|
|
|
|
|
|
|
Accrued
dividend on Series B Preferred stock
|
(321,800)
|
(290,900)
|
(938,100)
|
(848,000)
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders
|
$(6,283,300)
|
$(7,507,700)
|
$(18,445,400)
|
$(19,714,300)
|
|
|
|
|
|
|
|
Basic and diluted
net loss attributable to common
|
|
|
|
|
|
stockholders
per common share
|
$(0.15)
|
$(0.24)
|
$(0.43)
|
$(0.75)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing
|
|
|
|
|
|
basic and
diluted net loss attributable to common
|
|
|
|
|
|
stockholders
per common share
|
43,158,889
|
30,696,312
|
42,802,256
|
26,418,440
|