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EX-99.2 - PRESS RELEASE - VistaGen Therapeutics, Inc. | ex99-2.htm |
8-K - CURRENT REPORT - VistaGen Therapeutics, Inc. | vtgn8k_nov122020.htm |
Exhibit 99.1
VistaGen Therapeutics Reports Fiscal 2021 Second Quarter Financial
Results and Provides Highlights on its CNS Pipeline and Business
Progress
--
Positive FDA Meeting Sets Key Pathway for Pivotal PH94B Phase 3
Study in the Second Quarter of 2021
Received Over $17.5 Million Net Proceeds from PH94B Upfront License
Payment and Public Offering of Common Stock
Positive New Data from Second Preclinical Study of AV-101 in
Combination with Probenecid
Positive Preclinical Data Differentiating Mechanism of Action of
PH94B from Risk-Ridden Benzodiazepines
--
SOUTH SAN FRANCISCO, Calif., November 12, 2020 – 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):
o
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.
o
The Phase 3 study will be a randomized, double-blind,
placebo-controlled, parallel comparison study conducted at
approximately 15 sites in North America.
o
The Subjective Units of Distress Scale (SUDS) will be used to
assess the primary efficacy endpoint in the study.
o
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.
o
Target enrollment (completed subjects) will be approximately 182
adults with SAD.
o
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.
o
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.
o
The AjD study is expected to initiate patient recruitment in 1Q
2021.
o
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.
o
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.
o
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 Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: IR@vistagen.com
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
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
|