SOUTH SAN FRANCISCO, Calif.,
Nov. 12, 2020 /PRNewswire/
-- VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical
company developing new generation medicines for anxiety, depression
and other central nervous system (CNS) disorders, today reported
its financial results for the fiscal 2021 second quarter ended
September 30, 2020 and provided an
update on its CNS pipeline and business progress.
"We see a significant rise in mental health concerns as the
global COVID-19 pandemic continues to impact the daily lives of
millions of individuals. We are committed to developing innovative
therapies that provide relief to those suffering from anxiety and
depression, and we are working diligently towards that goal. We are
making significant progress in preparing PH94B for launch of a
pivotal Phase 3 study for acute treatment of anxiety in adults with
social anxiety disorder in the second quarter of 2021. After
reaching consensus with the FDA on the key components of the study
design, it will be very similar to the statistically significant
Phase 2 study of PH94B in social anxiety disorder. We are also
working with the FDA to finalize details for our Phase 2A study of
PH94B in adjustment disorder, which we are planning to initiate in
early 2021," said Shawn Singh,
Chief Executive Officer of VistaGen.
"Millions of people rely on benzodiazepines and other
prescription drugs to manage symptoms of stress and anxiety. While
some medications are safe and effective treatments, many in the
current treatment paradigm have limited therapeutic benefits and
potentially serious side effects and safety concerns. In Phase
2 clinical studies, PH94B produced rapid onset anti-anxiety effects
without requiring systemic uptake and distribution. With its
rapid-onset pharmacology, lack of systemic exposure and sedation,
and its excellent safety profile in all studies to date, we believe
PH94B has the potential to displace benzodiazepines in the drug
treatment paradigm for anxiety disorders. In addition to social
anxiety disorder, we believe PH94B also has potential as a novel
treatment for adjustment disorder, postpartum anxiety,
post-traumatic stress disorder, preprocedural anxiety, panic, and
other anxiety-related disorders, and we look forward to assessing
its potential in various controlled Phase 2 clinical studies in
parallel with our Phase 3 program to assess its potential as an
acute treatment of anxiety in adults with social anxiety disorder,"
concluded Mr. Singh.
CNS Pipeline Highlights and Updates:
PH94B
- VistaGen reached consensus with the FDA on key study design and
execution aspects of the Company's initial pivotal Phase 3 study of
PH94B for acute treatment of anxiety in adults with social anxiety
disorder (SAD):
-
- As in the statistically significant (p=0.002) Phase 2 public
speaking study of PH94B in SAD, VistaGen's Phase 3 study will
involve a laboratory-simulated anxiety-provoking public speaking
challenge.
- The Phase 3 study will be a randomized, double-blind,
placebo-controlled, parallel comparison study conducted at
approximately 15 sites in North
America.
- The Subjective Units of Distress Scale (SUDS) will be used to
assess the primary efficacy endpoint in the study.
- Dr. Michael Liebowitz, Professor
of Clinical Psychiatry at Columbia
University, director of the Medical Research Network in
New York City, and creator of the
Liebowitz Social Anxiety Scale (LSAS), will be the Principal
Investigator of the study.
- Target enrollment (completed subjects) will be approximately
182 adults with SAD.
- Study expected to initiate recruitment in 2Q 2021.
- VistaGen is currently preparing for an exploratory Phase 2A
clinical study of PH94B for acute treatment of adjustment disorder
(AjD), an emotional or behavioral reaction considered excessive or
out of proportion to a stressful event or significant life change,
occurring within three months of the stressor, and/or significantly
impairing a person's social, occupational and/or other important
areas of functioning. Given the diverse impact of the COVID-19
pandemic, including, among other things, fear and anxiety about
health and safety, economic loss, unemployment, social isolation,
disruption of established education and work practices, VistaGen
submitted its preliminary protocol for the study to the FDA through
the FDA's Coronavirus Treatment Acceleration Program (CTAP).
Following that submission, the Company has continued its
discussions with the FDA's Division of Psychiatric Products to
determine the study's appropriate next steps, including the final
study protocol.
-
- The Company is planning to conduct the proposed Phase 2A study
in New York City and enroll
approximately 25 to 30 subjects suffering from adjustment
disorder-provoking stressors, including, but not limited to,
stressors related to the diverse impact of the COVID-19 pandemic
and recent civil unrest in the U.S.
- The AjD study is expected to initiate patient recruitment in 1Q
2021.
- The Company is also planning for additional exploratory Phase
2A studies in postpartum anxiety, post-traumatic stress disorder,
and pre-procedural anxiety (pre-MRI).
- VistaGen reported new in vitro electrophysiology data
demonstrating that the mechanism of action of PH94B, does not
involve direct activation of GABA-A receptors, in distinct contrast
to the mechanism of action of benzodiazepines, which act as direct
positive modulators of GABA-A receptors.
-
- These studies are significant because they indicate that PH94B
has no relevant benzodiazepine-like activity, confirming PH94B's
potential to produce rapid-onset benzo-like, anti-anxiety effects,
without the risky side effects and safety concerns of benzos.
AV-101
- VistaGen reported positive new data from the Company's second
preclinical study of its oral investigational drug, AV-101,
combined with probenecid, an FDA-approved drug for treatment of
gout used adjunctively to increase the therapeutic benefit of
numerous antibacterial, anticancer and antiviral drugs.
-
- The results of this new study complement previous
preclinical data demonstrating the combination's potential to
substantially increase the brain concentration of AV-101's active
metabolite, 7-Cl-KYN, a potent and selective full antagonist of the
NMDA receptor glycine co-agonist site, thereby reducing, rather
than blocking, NMDA receptor signaling.
Partnering Activity
- VistaGen received a $5 million
non-dilutive upfront license payment from EverInsight Therapeutics
(now AffaMed Therapeutics), the Company's strategic partner for
Phase 3 development and commercialization of PH94B for
anxiety-related disorders in key markets in Asia.
- Upon successful development and commercialization of PH94B in
the licensed territory, VistaGen is eligible to receive up to
$172 million in additional
development and commercial milestone payments, plus royalties on
commercial sales of PH94B.
Capital Resources
- VistaGen completed an underwritten public offering of common
stock resulting in gross proceeds of $14.29
million to the Company, before underwriting discounts and
commissions and offering expenses.
Financial Results for the Fiscal Quarter Ended September 30, 2020:
Net loss: Net loss attributable to common
stockholders for the fiscal quarter ended September 30, 2020 decreased to approximately
$3.7 million compared to $5.7 million for the fiscal quarter ended
September 30, 2019. For the six-month
period ending September 30, 2020, the
net loss attributable to common stockholders was approximately
$7.1 million, a decrease from
approximately $12.2 million reported
in the same period last year.
Revenue: Total revenue for the fiscal quarter ended
September 30, 2020 was $334,000, representing the revenue recognition
related to its agreement with EverInsight Therapeutics (now AffaMed
Therapeutics), pursuant to which the Company received a
non-dilutive upfront license fee payment of $5.0 million on August 3,
2020. VistaGen recognized $334,000 in sublicense revenue pursuant to this
agreement in the six months ended September
30, 2020 compared to no revenue in the six months ended
September 30, 2019. The Company
expects to continue recognizing revenue pursuant to this payment in
future periods during our fiscal year ending March 31, 2021 and thereafter.
Research and development (R&D) expense:
Research and development expense decreased from $4.2 million in the quarter ended September 30, 2019 to $2.4
million for the quarter ended September 30, 2020. Research and development
expense also decreased from $8.5
million to $4.1 million for
the six months ended September 30,
2019 and 2020, respectively, in both cases, primarily due to
the completion of the Company's Phase 2 study of AV-101 as a
potential adjunctive treatment of major depressive disorder in the
fourth calendar quarter of 2019. Expenses related to that study and
other nonclinical activities related to AV-101 decreased by
$4.8 million for the six months ended
September 30, 2020 compared to
similar expense in the six months ended September 30, 2019. Noncash research and
development expenses, primarily stock-based compensation and
depreciation in both periods, accounted for approximately
$391,000 and $607,000 in the six months ended September 30, 2020 and 2019, respectively.
General and administrative (G&A)
expense: General and administrative expense totaled
$1.3 million for the three months
ended September 30, 2020 as compared
to $1.2 million for the same period
in the year prior. General and administrative expense decreased to
approximately $2.7 million from
approximately $3.1 million for the
six months ended September 30, 2020
and 2019, respectively. Noncash general and administrative expense,
$804,000 in the six months ended
September 30, 2020, decreased from
$1,044,000 in the six months ended
September 30, 2019 primarily due to
decreases in stock-based compensation and the noncash components of
investor and public relations expense attributable to the
amortization of the fair value of equity securities granted to
service providers.
Cash Position: At September
30, 2020, the Company had cash and cash equivalents of
approximately $15.4 million. During
the quarter ended September 30, 2020,
the Company received net proceeds totaling approximately
$17.5 million from (i) the
$5.0 million gross non-dilutive
upfront license fee payment from EverInsight Therapeutics (now
AffaMed Therapeutics), and (ii) the gross proceeds of approximately
$14.29 million from the sale of
shares of its common stock in an underwritten public offering.
As of November 12, 2020, the
Company had 73,998,057 shares of common stock outstanding.
About VistaGen
VistaGen Therapeutics, Inc. is a
clinical-stage biopharmaceutical company committed to developing
and commercializing innovative medicines with potential to go
beyond the current standard of care for anxiety, depression, and
other CNS disorders. Each of VistaGen's three drug candidates has a
differentiated mechanism of action, an exceptional safety profile
in all studies to date, and therapeutic potential in multiple CNS
markets. For more information, please visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward Looking Statements
Various statements in this release are "forward-looking statements"
concerning VistaGen's future expectations, plans and prospects.
These forward-looking statements are neither promises nor
guarantees of future performance, and are subject to a variety of
risks and uncertainties which could cause actual results to differ
materially from those contemplated in these forward-looking
statements, including the risks that: successful development,
including, but not limited to Phase 3 development, and approval of
one or more of the Company's drug candidates may not be achieved in
any market for any indication, and, if approved, may not be
differentiated from the standard of care; the FDA and other
regulatory authorities may decide that the results of one or more
of the Company's development programs are not sufficient for
regulatory approval; development of the Company's drug candidates
may not be successful in any indication; success in nonclinical
studies or in earlier-stage clinical studies may not be repeated or
observed in future studies; and other adverse events or market
conditions may be encountered, at any stage of development, that
negatively impact further development, including entry of
competitive products or other technical and unexpected hurdles in
the development, manufacture and commercialization of the Company's
drug candidates. Additional risks are more fully discussed in the
section entitled "Risk Factors" in VistaGen's most recent Annual
Report on Form 10-K for the year ended March
31, 2020, and in its subsequent quarterly reports on Form
10-Q, as well as discussions of potential risks, uncertainties, and
other important factors in the Company's other filings with the
Securities and Exchange Commission. Any forward-looking statements
represent the Company's views only as of today and should not be
relied upon as representing its views as of any subsequent date.
The Company explicitly disclaims any obligation to update any
forward-looking statements.
VISTAGEN
THERAPEUTICS, INC.
|
CONSOLIDATED
BALANCE SHEETS
|
(Amounts in dollars,
except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
March 31,
|
|
|
|
2020
|
|
2020
|
|
|
|
(Unaudited)
|
|
(Note
1)
|
|
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
15,399,500
|
|
$
1,355,100
|
Prepaid
expenses and other current assets
|
|
|
455,700
|
|
225,100
|
Deferred contract acquisition costs - current
portion
|
|
|
116,900
|
|
-
|
Total current
assets
|
|
|
15,972,100
|
|
1,580,200
|
Property and
equipment, net
|
|
|
257,600
|
|
209,600
|
Right of use
asset - operating lease
|
|
|
3,403,000
|
|
3,579,600
|
Deferred
offering costs
|
|
|
268,500
|
|
355,100
|
Deferred
contract acquisition cost - non-current portion
|
|
|
321,700
|
|
-
|
Security
deposits and other assets
|
|
|
47,800
|
|
47,800
|
Total
assets
|
|
|
$
20,270,700
|
|
$
5,772,300
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
|
$
1,176,400
|
|
$
1,836,600
|
Accrued
expenses
|
|
|
186,900
|
|
561,500
|
Current notes
payable, including accrued interest
|
|
|
352,600
|
|
56,500
|
Deferred
revenue - current portion
|
|
|
1,244,000
|
|
-
|
Operating lease
obligation - current portion
|
|
|
338,500
|
|
313,400
|
Financing lease
obligation - current portion
|
|
|
3,500
|
|
3,300
|
Total current
liabilities
|
|
|
3,301,900
|
|
2,771,300
|
|
|
|
|
|
|
Non-current
liabilities:
|
|
|
|
|
|
Non-current
portion of notes payable
|
|
|
87,300
|
|
-
|
Accrued
dividends on Series B Preferred Stock
|
|
|
5,694,700
|
|
5,011,800
|
Deferred
revenue - non-current portion
|
|
|
3,422,000
|
|
-
|
Operating lease
obligation - non-current portion
|
|
|
3,540,900
|
|
3,715,600
|
Financing lease
obligation - non-current portion
|
|
|
1,300
|
|
3,000
|
Total
non-current liabilities
|
|
|
12,746,200
|
|
8,730,400
|
Total
liabilities
|
|
|
16,048,100
|
|
11,501,700
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity (deficit):
|
|
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized at September 30,
2020 and March 31, 2020:
|
|
|
|
|
|
Series A Preferred, 500,000 shares authorized, issued and
outstanding at September 30, 2020 and March 31,
2020
|
|
|
500
|
|
500
|
Series
B Preferred; 4,000,000 shares authorized at September 30, 2020 and
March 31, 2020; 1,160,240 shares issued and outstanding at
September 30, 2020 and March 31, 2020
|
|
|
1,200
|
|
1,200
|
Series
C Preferred; 3,000,000 shares authorized at September 30, 2020 and
March 31, 2020; 2,318,012 shares issued and outstanding at
September 30, 2020 and March 31, 2020
|
|
|
2,300
|
|
2,300
|
Common
stock, $0.001 par value; 175,000,000 shares authorized at September
30, 2020 and March 31, 2020; 74,133,722 and 49,348,707 shares
issued and outstanding at September 30, 2020 and March 31, 2020,
respectively
|
|
|
74,100
|
|
49,300
|
Additional
paid-in capital
|
|
|
216,444,600
|
|
200,092,800
|
Treasury stock,
at cost, 135,665 shares of common stock held at September 30, 2020
and March 31, 2020
|
|
|
(3,968,100)
|
|
(3,968,100)
|
Accumulated
deficit
|
|
|
(208,332,000)
|
|
(201,907,400)
|
Total
stockholders' equity (deficit)
|
|
|
4,222,600
|
|
(5,729,400)
|
Total
liabilities and stockholders' equity (deficit)
|
|
|
$
20,270,700
|
|
$
5,772,300
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: Derived
from audited Consolidated Balance Sheet at March 31,
2020
|
|
|
-
|
|
-
|
VISTAGEN
THERAPEUTICS
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(Amounts in Dollars,
except share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended September 30,
|
|
Six Months
Ended September 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
Sublicense
revenue
|
$
334,000
|
|
$
-
|
|
$
334,000
|
|
$
-
|
|
Total
revenues
|
334,000
|
|
-
|
|
334,000
|
|
-
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
2,358,200
|
|
4,205,200
|
|
4,089,400
|
|
8,519,100
|
|
General and
administrative
|
1,269,500
|
|
1,146,100
|
|
2,660,100
|
|
3,056,200
|
|
Total
operating expenses
|
3,627,700
|
|
5,351,300
|
|
6,749,500
|
|
11,575,300
|
|
Loss from
operations
|
(3,293,700)
|
|
(5,351,300)
|
|
(6,415,500)
|
|
(11,575,300)
|
|
Other income
(expenses), net:
|
|
|
|
|
|
|
|
|
Interest income
(expense), net
|
(3,900)
|
|
15,400
|
|
(7,100)
|
|
31,900
|
|
Other
income
|
-
|
|
-
|
|
600
|
|
-
|
|
Loss before income
taxes
|
(3,297,600)
|
|
(5,335,900)
|
|
(6,422,000)
|
|
(11,543,400)
|
|
Income
taxes
|
(200)
|
|
-
|
|
(2,600)
|
|
(2,400)
|
|
Net loss and
comprehensive loss
|
$
(3,297,800)
|
|
$
(5,335,900)
|
|
$
(6,424,600)
|
|
$
(11,545,800)
|
|
Accrued
dividends on Series B Preferred stock
|
(347,200)
|
|
(313,800)
|
|
(683,000)
|
|
(616,300)
|
|
Net loss attributable
to common stockholders
|
$
(3,645,000)
|
|
$
(5,649,700)
|
|
$
(7,107,600)
|
|
$
(12,162,100)
|
|
Basic and diluted net
loss attributable to common stockholders per common
share
|
$
(0.05)
|
|
$
(0.13)
|
|
$
(0.12)
|
|
$
(0.29)
|
|
Weighted average
shares used in computing basic and diluted net loss attributable to
common stockholders per common share
|
67,082,935
|
|
42,622,965
|
|
59,245,209
|
|
42,622,965
|
|
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SOURCE VistaGen Therapeutics