SOUTH SAN FRANCISCO, Calif.,
Feb. 13, 2020 /PRNewswire/ --
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 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.
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
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' (DEFICIT) EQUITY
|
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
|
|
|
|
|
|
|
|
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)
|
Accumulated
deficit
|
(198,640,700)
|
|
(181,133,400)
|
Total
stockholders' (deficit) equity
|
(6,094,600)
|
|
7,075,200
|
Total
liabilities and stockholders' (deficit) equity
|
$
5,330,800
|
|
$
14,011,700
|
VISTAGEN
THERAPEUTICS
|
STATEMENT OF
OPERATIONS
|
Amounts in Dollars,
except share amounts
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
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SOURCE VistaGen Therapeutics