UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF
1934
Date of Report (Date of earliest event reported): November 12, 2020
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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000-54014
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20-5093315
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification Number)
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343 Allerton Ave.
South San Francisco, California 94090
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(Address of principal executive offices)
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(650) 577-3600
(Registrant’s telephone number, including area
code)
Not Applicable
(Former name or former address, if changed since last
report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐ Written communications
pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
☐ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a
-12)
☐ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d -2(b))
☐ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e -4(c))
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Common
Stock, par value $0.001 per share
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VTGN
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Nasdaq
Capital Market
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Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17
CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR 240.12b-2)
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act ☐
Item 2.02 Results of Operations and Financial
Condition.
On November 12, 2020, VistaGen Therapeutics, Inc.
(the “Company”) issued a press release to announce the
Company’s financial results for its fiscal year 2021 second
quarter ended September 30, 2020. A copy of the press release is
attached to this Current Report on Form 8-K as Exhibit
99.1.
Item 7.01. Regulation FD Disclosure.
On
November 13, 2020, the Company announced new in vitro electrophysiology data
demonstrating that the mechanism of action of PH94B, the
Company’s intranasal neuroactive steroid drug candidate,
which the Company is preparing for Phase 3 development as a
potential acute rapid-onset treatment of anxiety in adults with
social anxiety disorder, does not involve direct activation of
GABA-A receptors, in distinct contrast to the
mechanism of action of benzodiazepines. A copy of the press
release is attached to this Current Report on Form 8-K as Exhibit
99.2.
Disclaimer.
The information in this Current Report
on Form 8-K, including the information set forth in
Exhibits 99.1 and 99.2, are being furnished and shall not be
deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the
“Exchange
Act”), nor shall Exhibits
99.1 and 99.2 filed herewith be deemed incorporated by reference in
any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in such a filing.
Forward-Looking Statements.
This
Current Report on Form 8-K may contain, among other things, certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including, without
limitation, (i) statements with respect to the Company's plans,
objectives, expectations and intentions; and (ii) other statements
identified by words such as "may", "could", "would", should",
"believes", "expects", "anticipates", "estimates", "intends",
"plans" or similar expressions. These statements are based upon the
current beliefs and expectations of the Company's management and
are subject to significant risks and uncertainties.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Index
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Exhibit No.
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Description
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Earnings
Release issued by VistaGen Therapeutics, Inc., dated November 12,
2020
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Press
Release issued by VistaGen Therapeutics, Inc., dated November 12,
2020
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Signatures
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
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VistaGen
Therapeutics, Inc.
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Date:
November 13, 2020
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By:
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/s/ Shawn K. Singh
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Shawn
K. Singh
Chief
Executive Officer
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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)
|
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September 30,
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March 31,
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2020
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2020
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(Unaudited)
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(Note 1)
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ASSETS
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Current
assets:
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Cash
and cash equivalents
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$15,399,500
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$1,355,100
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Prepaid
expenses and other current assets
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455,700
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225,100
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Deferred
contract acquisition costs - current portion
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116,900
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-
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Total
current assets
|
15,972,100
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1,580,200
|
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Property
and equipment, net
|
257,600
|
209,600
|
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Right
of use asset - operating lease
|
3,403,000
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3,579,600
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Deferred
offering costs
|
268,500
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355,100
|
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Deferred
contract acquisition cost - non-current portion
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321,700
|
-
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Security
deposits and other assets
|
47,800
|
47,800
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Total
assets
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$20,270,700
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$5,772,300
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LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT)
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Current
liabilities:
|
|
|
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Accounts
payable
|
$1,176,400
|
$1,836,600
|
|
Accrued
expenses
|
186,900
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561,500
|
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Current
notes payable, including accrued interest
|
352,600
|
56,500
|
|
Deferred
revenue - current portion
|
1,244,000
|
-
|
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Operating
lease obligation - current portion
|
338,500
|
313,400
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Financing
lease obligation - current portion
|
3,500
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3,300
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Total
current liabilities
|
3,301,900
|
2,771,300
|
|
|
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Non-current
liabilities:
|
|
|
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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
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3,540,900
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3,715,600
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Financing
lease obligation - non-current portion
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1,300
|
3,000
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Total
non-current liabilities
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12,746,200
|
8,730,400
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Total
liabilities
|
16,048,100
|
11,501,700
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
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|
|
|
|
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
|
Exhibit 99.2
VistaGen Reports Positive Preclinical Data Differentiating
Mechanism of Action of PH94B from Risk-Ridden
Benzodiazepines
New electrophysiological data demonstrate that PH94B does not
directly modulate GABA (gamma aminobutyric acid)
receptors
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 announced new in
vitro electrophysiology data
demonstrating that the mechanism of action of PH94B, the intranasal
neuroactive steroid the Company is preparing for Phase 3
development as a potential acute rapid-onset treatment of anxiety
in adults with social anxiety disorder, does not involve direct
activation of GABA-A receptors, in distinct contrast to the
mechanism of action of benzodiazepines (“benzos”),
which act as direct positive modulators of GABA-A
receptors.
“We
are very pleased with the results of these studies that suggest
PH94B’s mechanism of action may not have benzodiazepine-like
side effects, such as sedation and cognitive impairment, or abuse
liability,” stated Shawn K.
Singh, Chief Executive Officer of VistaGen. “While
benzodiazepines provide relief for many Americans struggling with
anxiety, their extremely risky safety profile does not lend itself
to long term use. The mechanism of action contributes to the safety
profile. As we have seen in Phase 2 clinical studies, while PH94B
is able to produce rapid-onset benzo-like, anti-anxiety effects,
this study demonstrates that PH94B does not have a benzo-like
mechanism of action. As we approach Phase 3 development of PH94B,
especially given the FDA’s recent public announcement about
safety concerns associated with benzo use, these new data make us
even more excited about PH94B’s potential to change lives
without the risky side effects and safety concerns of
benzos.”
Recently,
the U.S. Food and Drug Administration (FDA) released a Drug Safety
Communication (DSC) detailing the risks associated with use of
benzodiazepines, a class of drugs commonly prescribed for treatment
of anxiety disorders and other conditions. According to the FDA
communication, 92 million benzodiazepine prescriptions were filled
in 2019. The FDA’s DSC detailed safety concerns regarding the
serious risks of abuse, addiction, physical dependence, and
withdrawal reactions linked to long-term use of benzodiazepines,
and the FDA announced that it is requiring an updated Boxed
Warning, the FDA’s most prominent type of safety warning, for
all benzodiazepine medications.
“We thought it was important to conduct a study to help
differentiate the mechanism of action of PH94B from that of
benzodiazepines, therefore, we contracted with EuroFins Discovery
to determine whether PH94B has positive modulatory effects on GABA
receptors using in
vitro patch clamp
electrophysiology,” noted Mark A. Smith, M.D., Ph.D.,
Chief Medical Officer of VistaGen. “Benzodiazepines
such as alprazolam and diazepam mediate their anti-anxiety effects
by acting as positive modulators at GABA receptors to make them
more responsive to GABA and thereby increase inhibitory neuronal
activity in the brain. PH94B had no agonist or antagonist effects
on GABA receptors. While PH94B may regulate endogenous GABA
circuits in the brain, it does not appear to directly bind to or
modulate GABA receptors at concentrations
<10mM,
which differentiates its mechanism of action from
benzodiazepines.”
These studies are significant because they indicate that PH94B has
no relevant benzodiazepine-like activity. With widespread
anxiety-provoking stressors related to the COVID-19 pandemic, civil
unrest, election results, the economy, and distance learning during
2020, the number of individuals facing anxiety disorders is rising
and a safer treatment alternative to benzodiazepines is imperative.
PH94B may have the potential to displace benzodiazepines and become
the safer alternative in the drug treatment paradigm for anxiety
disorders.
About PH94B
PH94B is an innovative odorless synthetic neuroactive steroid nasal
spray with therapeutic potential in a wide range of mental health
disorders involving anxiety or phobia. Self-administered in
microgram-level doses, PH94B produces rapid onset (within
approximately 15 minutes) anti-anxiety effects and does not require
systemic uptake and distribution to generate these
effects.
VistaGen is currently preparing PH94B for pivotal Phase 3
development as a potential acute treatment of anxiety in adults
with Social Anxiety Disorder (SAD). The FDA has granted Fast Track
designation for development of PH94B for this indication, believed
to be the first such designation by the FDA for a drug candidate
for SAD.
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 potential to provide a safe alternative to
benzodiazepines and other pharmacological alternatives in the drug
treatment paradigm for anxiety disorders. View more background
information on SAD and a video on PH94B's mechanism of
action.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing and commercializing differentiated new generation
medicines that 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,
including the potential for successful Phase 3 development of
PH94B. 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: development and approval of
PH94B may not be achieved in any market; the FDA may decide that
the results of the Company's PH94B Phase 3 clinical program are not
sufficient for regulatory approval for acute treatment of anxiety
in adult patients with SAD or any other anxiety-related disorder;
development of PH94B may not be successful in any indication;
success in nonclinical studies or in earlier-stage clinical trials
may not be repeated or observed in future studies which may not
support further development or be sufficient to gain regulatory
approval to market PH94B; adverse events may be encountered at any
stage of development that negatively impact further development.
Other risks and uncertainties include, but are not limited to,
issues related to: adverse healthcare reforms and changes of laws
and regulations; general industry and market conditions;
manufacturing and marketing risks, which may include, but are not
limited to, unavailability of or delays in delivery of raw
materials for manufacture of PH94B; inadequate and/or untimely
supply of PH94B to meet demand; entry of competitive products; and
other technical and unexpected hurdles in the development,
manufacture and commercialization of PH94B, as well as those risks
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, as well as discussions of potential risks,
uncertainties, and other important factors in either company's
other filings with the Securities and Exchange Commission. In
addition, 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) 577-3606
Email: IR@vistagen.com