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): February 11, 2021
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 February 11, 2021, VistaGen Therapeutics, Inc.
(the “Company”) issued a press release to announce the
Company’s financial results for its fiscal year 2021 third
quarter ended December 31, 2020. A copy of the press release is
attached to this Current Report on Form 8-K as Exhibit
99.1.
Disclaimer.
The information in this Current Report
on Form 8-K, including the information set forth in
Exhibit 99.1, is 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 Exhibit
99.1 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.
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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Press
Release issued by VistaGen Therapeutics, Inc., dated February 11,
2021
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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:
February 12, 2021
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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 Third Quarter Financial Results
and
Provides Update on Expected Clinical Studies in Calendar
2021
Multiple clinical studies anticipated to launch in Calendar 2021,
notably pivotal Phase 3 clinical
studies of PH94B as a potential acute treatment of anxiety in
adults with social anxiety disorder (SAD)
Strengthened Balance Sheet upon
closing of $100 million underwritten public
offering
SOUTH SAN FRANCISCO, Calif., February 11, 2021 – VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical
company committed to developing and commercializing a new
generation of medicines with the potential to go beyond the current
standard of care for anxiety, depression and other central nervous
system (CNS) disorders, today reported its financial results for
its fiscal 2021 third quarter ended December 31, 2020, and provided
an update on planned clinical advancement of its CNS pipeline
throughout the remainder of this calendar
year.
“Calendar 2020 was
transformative, highlighted by closing a PH94B partnership, a
positive meeting with the FDA regarding the key aspects of the
study design for our upcoming pivotal Phase 3 studies of our PH94B
nasal spray in social anxiety disorder and, during the most recent
quarter, closing a $100 million financing which involved
significant participation from leading healthcare institutional
investors such as Acuta Capital, New Enterprise Associates, OrbiMed
and Venrock Healthcare Capital Partners, among others. We are
encouraged by these transformative milestones. Together, they have
further advanced our tenacious pursuit to bring life-changing
medications to the millions affected by anxiety, depression and
other mental health challenges worldwide,”
said Shawn
Singh, Chief Executive Officer of VistaGen.
Mr. Singh continued, “We believe we have sufficient capital
to fund all of our currently planned nonclinical and clinical
studies across our pipeline. As a result, we expect to launch
several clinical studies this calendar year, notably our pivotal
Phase 3 clinical studies of PH94B as a potential acute treatment of
anxiety in adults with social anxiety disorder, as well several
small exploratory PH94B Phase 2 studies in adult patients
experiencing additional anxiety-related disorders. This year, we
will also complete preparations to launch Phase 2B clinical
development of PH10 as a potential rapid-onset stand-alone
treatment for major depressive disorder in early 2022. Finally,
later this year, based on successful preclinical studies involving
AV-101 alone and in combination with probenecid, we will launch
Phase 1B clinical development of the combination to enable
potential exploratory Phase 2 development of in several CNS
disorders.”
Corporate Highlights in Fiscal Q3 2021:
●
Closed $100 million underwritten public offering led by
Jefferies Group LLC and William Blair & Company involving
significant participation from key healthcare-focused institutional
investors, such as Acuta Capital, New Enterprise Associates,
OrbiMed and Venrock Healthcare Capital
Partners.
●
Expanded R&D team with appointment of Louis Monti, M.D.,
Ph.D., a pioneer in the development of neuroactive steroids known
as pherines, including PH94B and PH10, as Vice President,
Translational Medicine.
●
Appointed Senior Vice President, Head of CMC (Chemistry,
Manufacturing and Controls) with the addition of Mark J. Ginski,
Ph.D., an expert with over 25 years of broad CMC leadership
experience, spanning preclinical and clinical
development.
●
Announced publication in CNS
Spectrums detailing
proposed mechanism of action of investigational neuroactive nasal
sprays, PH94B and PH10, for anxiety and depression disorders,
respectively.
●
The Korea Intellectual Property Office (KIPO) in the Republic of Korea issued a
Decision to Grant Patent Application No. 10-2015-7020176 related to
methods of treating depressive disorder for
PH10.
Financial
Results for the Fiscal Quarter Ended December 31,
2020:
Net
loss: Net loss attributable to common stockholders for the
fiscal quarter ended December 31, 2020 decreased to approximately
$5.65 million compared to $6.28 million for the fiscal quarter
ended December 31, 2019. Net loss for the nine months ended
December 31, 2020 and 2019 was approximately $11.7 million and
$17.5 million, respectively.
Revenue: VistaGen recognized $313,600 in sublicense revenue
pursuant to its PH94B development and commercialization agreement
with EverInsight Therapeutics (now AffaMed Therapeutics) for the
quarter ended December 31, 2020 compared to none in the quarter
ended December 31, 2019. On June 24, 2020, VistaGen entered into
the agreement with EverInsight Therapeutics, pursuant to which the
Company received a non-dilutive upfront license fee payment of $5.0
million on August 3, 2020.
Research and development
(R&D) expense: Research and
development expense increased from $3.0 million to $3.5 million for
the quarters ended December 31, 2019 and 2020, respectively. Cash
compensation for the quarter ended December 31, 2020 increased by
approximately $0.3 million and was offset by a similar decrease in
noncash stock-based compensation for the same period compared to
expenses in the quarter ended December 31, 2019. PH94B and PH10
development expenses increased by approximately $1.5 million in the
quarter ended December 31, 2020 compared to expense for the quarter
ended December 31, 2019 as drug substance and drug product
manufacturing preceding clinical trials advanced. AV-101-related
expenses decreased primarily due to the completion of the
Company’s multi-center Phase 2 study of AV-101 for the
adjunctive treatment of major depressive disorder in the quarter
ended December 31, 2019.
General and administrative
(G&A) expense: General and
administrative expense decreased to approximately $2.1 million from
approximately $2.9 million for the quarters ended December 31, 2020
and 2019, respectively. Cash compensation for the quarter ended
December 31, 2020 increased by approximately $0.6 million and was
offset by a similar decrease in noncash stock-based compensation
for the same period compared to expenses in the quarter ended
December 31, 2019. Further, in the quarter ended December 31, 2019,
VistaGen completed certain modifications to outstanding warrants
and recognized non-cash warrant modification expense of
$826,900.
Cash Position: At December 31, 2020, the
Company had cash and cash equivalents of approximately $104.3 million. The
Company believes its current cash position is sufficient to advance
an important stream of potential clinical and regulatory catalysts,
including, among others: its Phase 3 development program for PH94B
for the acute treatment of anxiety in adults with SAD and, upon
successful Phase 3 development, submission of its New Drug
Application to the U.S. Food and Drug Administration and potential
U.S. market approval of PH94B; exploratory Phase 2 clinical
development of PH94B in multiple additional anxiety-related
disorders; Phase 2B clinical development of PH10 as a potential
stand-alone treatment for major depressive disorder; and Phase 1B
and potential exploratory Phase 2 clinical development of AV-101 in
combination with probenecid for CNS disorders involving the NMDA
(N-methyl-D-aspartate) receptor.
As of February 11, 2021, the
Company had 141,694,413 shares of common stock
outstanding.
About
VistaGen
VistaGen Therapeutics is a
biopharmaceutical company committed to developing and
commercializing innovative medicines with the 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 potential mechanism of action, has been
well-tolerated in all clinical studies to date and has 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
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,”
“could,” “expect,” “project,”
“outlook,” “strategy,”
“intend,” “plan,” “seek,”
“anticipate,” “believe,”
“estimate,” “predict,”
“potential,” “strive,” “goal,”
“continue,” “likely,” “will,”
“would” and variations of these terms and similar
expressions, or the negative of these terms or similar expressions.
Such forward-looking statements are necessarily based upon
estimates and assumptions that, while considered reasonable by us
and our management, are inherently uncertain. Our actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Factors that may cause such a
difference include, without limitation, risks and uncertainties
relating to delays in launching and/or conducting our planned
clinical trials, including delays due to the impact of the COVID-19
pandemic; fluctuating costs of materials and other resources
required to conduct our planned clinical and non-clinical trials;
continued uncertainty with respect to the COVID-19 pandemic; market
conditions; the impact of general economic, industry or political
conditions in the United States or internationally; adverse
healthcare reforms and changes of laws and regulations;
manufacturing and marketing risks, including risks related to the
COVID-19 pandemic, which may include, but are not limited to,
unavailability of or delays in delivery of raw materials for
manufacture of our CNS drug candidates and difficulty in initiating
or conducting clinical trials; inadequate and/or untimely supply of
one or more of our CNS drug candidates to meet demand; entry of
competitive products; and other technical and unexpected hurdles in
the development, manufacture and commercialization of our CNS drug
candidates; and the risks more fully discussed in the section
entitled "Risk Factors" in our most recent Annual Report on Form
10-K for the year ended March 31, 2020, and in our most recent
Quarterly Report on Form 10-Q for the quarter ended December 31,
2020, as well as discussions of potential risks, uncertainties, and
other important factors in our other filings with the U.S.
Securities and Exchange Commission (SEC). Our SEC filings are
available on the SEC’s website at www.sec.gov. You should not
place undue reliance on these forward-looking statements, which
apply only as of the date of this press 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, other than as may be required by law. If we do update
one or more forward-looking statements, no inference should be made
that we will make additional updates with respect to those or other
forward-looking statements.
VistaGen Company
Contact
Mark McPartland
VistaGen
Therapeutics
Phone: (650)
577-3606
Email: IR@vistagen.com
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VISTAGEN THERAPEUTICS, INC.
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CONSOLIDATED BALANCE SHEETS
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(Amounts
in dollars, except share amounts)
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December
31,
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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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ASSETS
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Current
assets:
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Cash and cash
equivalents
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$104,331,100
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$1,355,100
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Prepaid expenses and other current
assets
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547,500
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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
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104,995,500
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1,580,200
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Property and equipment,
net
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382,200
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209,600
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Right of use asset -
operating lease
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3,312,100
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3,579,600
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Deferred offering
costs
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241,300
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355,100
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Deferred contract
acquisitions cost - non-current portion
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292,200
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-
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Security deposits and other
assets
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47,800
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47,800
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Total
assets
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$109,271,100
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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
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$776,400
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$1,836,600
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Accrued
expenses
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507,200
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561,500
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Current notes
payable
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98,400
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56,500
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Deferred revenue - current
portion
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1,244,000
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-
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Operating lease obligation -
current portion
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351,500
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313,400
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Financing lease obligation -
current portion
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3,600
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3,300
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Total current
liabilities
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2,981,100
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2,771,300
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Non-current
liabilities:
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Accrued dividends on Series B
Preferred Stock
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5,923,700
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5,011,800
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Deferred revenue -
non-current portion
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3,108,400
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-
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Operating lease obligation -
non-current portion
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3,446,900
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3,715,600
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Financing lease obligation -
non-current portion
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300
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3,000
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Total non-current
liabilities
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12,479,300
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8,730,400
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Total
liabilities
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15,460,400
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11,501,700
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Commitments and
contingencies
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Stockholders’ equity
(deficit):
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Preferred
stock, $0.001 par value; 10,000,000 shares authorized at December
31, 2020 and March 31, 2020:
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Series
A Preferred, 500,000 shares authorized, issued and outstanding at
December 31, 2020 and March 31, 2020
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500
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500
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Series
B Preferred; 4,000,000 shares authorized at December 31, 2020 and
March 31, 2020; 1,131,669 shares
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and
1,160,240 shares issued and outstanding at December 31, 2020 and
March 31, 2020, respectively
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1,100
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1,200
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Series
C Preferred; 3,000,000 shares authorized at December 31, 2020 and
March 31, 2020; 2,318,012 shares
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issued
and outstanding at September 30, 2020 and March 31,
2020
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2,300
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2,300
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Series
D Preferred; 2,000,000 shares and no shares authorized, issued and
outstanding at December 31, 2020
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and
March 31, 2020, respectively
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2,000
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-
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Common stock, $0.001 par
value; 175,000,000 shares authorized at December 31, 2020 and March
31, 2020;
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138,800,137
and 49,348,707 shares issued and outstanding at December 31, 2020
and March 31, 2020, respectively
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138,800
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49,300
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Additional paid-in
capital
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311,264,800
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200,092,800
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Treasury stock, at cost,
135,665 shares of common stock held at December 31, 2020 and March
31, 2020
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(3,968,100)
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(3,968,100)
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Accumulated
deficit
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(213,630,700)
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(201,907,400)
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Total stockholders’
equity (deficit)
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93,810,700
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(5,729,400)
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Total liabilities and
stockholders’ equity (deficit)
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$109,271,100
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$5,772,300
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VISTAGEN THERAPEUTICS
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
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(Amounts
in Dollars, except share amounts)
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(Unaudited)
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Three
Months Ended December 31,
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Nine
Months Ended December 31,
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2020
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2019
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2020
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2019
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Sublicense
revenue
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$313,600
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$-
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$647,600
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$-
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Total
revenues
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313,600
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-
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647,600
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-
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Operating
expenses:
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Research and
development
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3,496,100
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3,014,500
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7,585,500
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11,533,600
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General and
administrative
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2,116,800
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2,948,300
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4,776,900
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6,004,500
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Total operating
expenses
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5,612,900
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5,962,800
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12,362,400
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17,538,100
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Loss from
operations
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(5,299,300)
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(5,962,800)
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(11,714,800)
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(17,538,100)
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Other income (expenses),
net:
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Interest income (expense),
net
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600
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1,500
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(6,500)
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33,400
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Other
income
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-
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-
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600
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-
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Loss before income
taxes
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(5,298,700)
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(5,961,300)
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(11,720,700)
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(17,504,700)
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Income taxes
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-
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(200)
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(2,600)
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(2,600)
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Net loss and comprehensive
loss
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$(5,298,700)
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$(5,961,500)
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$(11,723,300)
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$(17,507,300)
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Accrued dividends
on Series B Preferred stock
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(353,600)
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(321,800)
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(1,036,600)
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(938,100)
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Net loss attributable to common
stockholders
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$(5,652,300)
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$(6,283,300)
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$(12,759,900)
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$(18,445,400)
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Basic and diluted net loss
attributable to common
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stockholders per common
share
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$(0.07)
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$(0.15)
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$(0.19)
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$(0.43)
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|
|
|
|
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|
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Weighted average shares used in
computing
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basic and diluted net loss
attributable to common
|
|
|
|
|
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stockholders per common
share
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81,086,105
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43,158,889
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66,551,962
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42,802,256
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