vtgn8k_06292021
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): June 29, 2021
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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:
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 June 29, 2021, VistaGen Therapeutics, Inc. (the
“Company”) issued a press release to announce the
Company’s financial results for its fiscal year ended March
31, 2021 and to provide a corporate update. A copy of the press
release is attached to this Current Report on Form 8-K as Exhibit
99.1.
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
Exhibit No.
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|
Description
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|
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|
|
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Press
Release issued by VistaGen Therapeutics, Inc., dated June 29,
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:
June 29, 2021
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By:
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/s/ Shawn K. Singh
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Shawn
K. Singh, J.D.
Chief
Executive Officer
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ex99-1
VistaGen Therapeutics Reports Fiscal Year 2021 Financial Results
and Provides Corporate Update
PALISADE-1 Phase 3 trial underway to evaluate PH94B for rapid-onset
acute treatment of anxiety in adults with social anxiety disorder
(SAD)
Management to host corporate update conference call and audio
webcast today at 2:00 p.m. PT
SOUTH SAN FRANCISCO, Calif., June 29, 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 provided a
corporate update and reported financial results for its fiscal year
ended March 31, 2021.
“Our fiscal year 2021 was transformative, involving several
drug development, financial and regulatory milestones that
fortified the foundation for our very strong start this fiscal
year. Notably, we achieved an important
consensus with the U.S. Food and Drug Administration regarding our
PALISADE Phase 3 program for PH94B in social anxiety
disorder. Building on that positive meeting, we completed a PH94B
collaboration in ex-U.S. markets, strengthened our balance
sheet with substantial investment from numerous long-biased,
healthcare-focused institutional investors, and advanced several
development programs across our CNS pipeline, most notably
preparations for PALISADE-1, our U.S.
multi-center Phase 3 clinical study of PH94B as a potential
rapid-onset, acute treatment of anxiety in adults with social
anxiety disorder. If successful, PALISADE-1 is designed to be among
the studies necessary to support a potential PH94B New Drug
Application to the U.S. Food and Drug Administration in 2023. We
recently initiated PALISADE-1, moving us closer to our goal of
going beyond the current treatment paradigm for social anxiety
disorder, not only displacing antidepressants, benzodiazepines and
beta blockers, but also reaching those in need of support who find
those therapies to be undesirable or inadequate. We anticipate
topline data from PALISADE-1 in mid-2022. Later this year, we
expect to launch PALISADE-2, a second U.S. multi-center Phase 3
clinical study of PH94B designed to be substantially similar to
PALISADE-1 and equally supportive of our U.S. New Drug Application
goal.”
Singh added, “During the current fiscal year, we also expect
to prepare for and initiate several exploratory Phase 2A clinical
trials of PH94B in additional anxiety disorders, advance
preparations necessary to initiate a U.S. multi-center Phase 2B
clinical trial of PH10 as a potential rapid-onset, stand-alone
treatment for major depressive disorder, and initiate a Phase 1B
clinical trial of AV-101 with probenecid, which, if successful, has
the potential to support exploratory Phase 2A development of the
combination in several CNS disorders.”
“To develop and commercialize game-changing treatments, you
need great people. During the past year, we have strengthened our
team by adding several key personnel with deep CNS drug development
and commercial experience to drive our programs through important
late-stage development milestones and appropriately-timed
pre-commercial and commercial launch operations. We look forward to
initiating several more clinical trials this fiscal year and remain
focused on pursuing our mission to improve mental health and
well-being for individuals in the U.S. and abroad,” concluded
Singh.
Corporate Highlights
●
Reached consensus
with U.S. Food
and Drug Administration (FDA) on key aspects of the design
of Phase 3 clinical trials of PH94B for acute treatment of anxiety
in adults with SAD after a positive meeting. The Phase 3 clinical
studies of PH94B in the Company’s PALISADE Phase 3 program
will substantially mirror the public speaking challenge in the
statistically significant Phase 2 study of PH94B, providing
significant time and cost-efficiency for the program.
●
Entered into a
strategic licensing and collaboration agreement with EverInsight
Therapeutics, Inc. (now AffaMed Therapeutics, Inc.) for clinical
development and commercialization of PH94B in Greater China, South
Korea and Southeast Asia (Territory), pursuant to which VistaGen
received a non-dilutive upfront payment of $5 million. VistaGen is
eligible to receive additional development and commercial milestone
payments of up to $172 million and tiered royalties on sales of
PH94B in the Territory, if Phase 3 development efforts there are
successful.
●
Reported positive
preclinical data differentiating the mechanism of action (MOA) of
PH94B and PH10 from risk-ridden benzodiazepines, demonstrating that
the MOA of PH94B and PH10 does not involve direct activation of
GABA-A receptors, in distinct contrast to the MOA of
benzodiazepines, which act as direct positive modulators of GABA-A
receptors.
●
Reported positive
preclinical data demonstrating the potential of the combination of
AV-101 and probenecid 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.
●
Raised $127.5
million gross proceeds from partnering and corporate finance
transactions, including a $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.
●
Appointed key
senior leadership to execute corporate initiatives through
commercialization.
CNS Pipeline Updates
PH94B
PH94B
is a synthetic investigational neurosteroid developed from
proprietary compounds called pherines. With its novel MOA, PH94B is
an odorless nasal spray administered at microgram-level doses to
achieve rapid-onset anti-anxiety, or anxiolytic, effects. The novel
pharmacological MOA of PH94B is fundamentally differentiated from
that of all FDA-approved anti-anxiety drugs, including all
antidepressants approved by the FDA for treatment of SAD, as well
as all benzodiazepines and beta blockers prescribed on an off-label
basis. PH94B engages peripheral chemosensory receptors in nasal
passages that trigger a subset of neurons in the main olfactory
bulbs (OB) at the base of the brain. The OB neurons then
stimulate inhibitory GABAergic neurons in the limbic amygdala,
decreasing the activity of the sympathetic nervous system, and
facilitating fear extinction activity of the limbic-hypothalamic
system, the main fear and anxiety center in the brain, as well as
in other parts of the brain. Importantly, PH94B does not require
systemic uptake and distribution to produce its rapid-onset
anti-anxiety effects.
VistaGen
recently initiated its PALISADE Phase 3 program with PALISADE-1, a
U.S., multi-center, randomized, double-blind, placebo-controlled
Phase 3 clinical study to evaluate the efficacy and safety of PH94B
for the acute treatment of anxiety in adults with SAD. The Company
expects to initiate PALISADE-2, the second U.S. Phase 3 study in
its PALISADE Phase 3 program, in the second half of 2021. If
successful, these clinical studies are designed to be among the
studies necessary to support a potential U.S. New Drug Application
(NDA) to the FDA. PH94B has been granted Fast Track designation
status by the FDA for development as an acute treatment of anxiety
in adults with SAD.
In
addition to SAD, the Company is also preparing for exploratory
Phase 2A clinical studies of PH94B in adults experiencing other
anxiety disorders, including adjustment disorder with anxiety,
postpartum anxiety, post-traumatic stress disorder, and
pre-procedural anxiety.
PH10
PH10 is
a synthetic investigational neurosteroid, which also was developed
from proprietary compounds called pherines. Its novel, rapid-onset
MOA is fundamentally differentiated from the MOA of all current
treatments for major depressive disorder (MDD) and other depression
disorders. PH10 is self-administered at microgram-level doses as an
odorless nasal spray. PH10 activates nasal chemosensory cells in
the nasal passages, connected to neural circuits in the brain that
produce antidepressant effects. Specifically, PH10 engages
peripheral chemosensory receptors in the nasal passages that
trigger a subset of neurons in the main OB that stimulate neurons
in the limbic amygdala. This is turn increases activity of the
limbic-hypothalamic sympathetic nervous system and increases the
release of catecholamines. Importantly, unlike all currently
approved oral antidepressants, PH10 does not require systemic
uptake and distribution to produce rapid-onset of antidepressant
effects. In all clinical studies to date, PH10 has not caused
psychological side effects (such as dissociation and
hallucinations) or safety concerns that may be associated with
rapid-onset ketamine-based therapy, including intravenous ketamine
or intranasal ketamine.
Exploratory
Phase 2A clinical development of PH10 for MDD has been completed.
VistaGen is now preparing for Phase 2B clinical development of
PH10. The Company expects to initiate a U.S. multi-center,
randomized, double-blind, placebo-controlled study to evaluate the
efficacy and safety of PH10 as a potential stand-alone treatment
for MDD in mid-2022. PH10 also has potential as a novel treatment
for treatment-resistant depression, postpartum depression and
suicidal ideation.
AV-101
AV-101
is an oral prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA) and
targets the N-methyl-D-aspartate receptor (NMDAR), an ionotropic
glutamate receptor in the brain. Abnormal NMDAR function is
associated with numerous CNS diseases and disorders. AV-101 is a
potent and selective full antagonist of the glycine co-agonist site
of the NMDAR that inhibits the function of the NMDAR. However,
unlike ketamine and many other NMDAR antagonists, 7-Cl-KYNA is not
an ion channel blocker. At doses administered in all studies to
date, AV-101 has been observed to be orally bioavailable, well
tolerated and has not exhibited dissociative or hallucinogenic
psychological side effects or safety concerns. In light of these
findings and data from preclinical studies, the Company believes
that AV-101, in combination with FDA-approved probenecid, has
potential to become a new oral treatment alternative for MDD and
certain neurological indications involving the NMDAR.
VistaGen
is currently preparing for a Phase 1B clinical study to evaluate
AV-101 in combination with probenecid. The Company expects to
initiate the study in the second half of 2021. The FDA has granted
Fast Track designation for development of AV-101 as a potential
adjunctive treatment for MDD and as a non-opioid treatment for
neuropathic pain. AV-101 also has the potential to be developed as
a treatment for levodopa-induced dyskinesia, suicidal ideation, and
epilepsy.
Key senior leadership additions
VistaGen
strengthened its leadership by adding key personnel with extensive
CNS drug development and commercial experience to drive its
clinical and commercial programs through important late-stage
clinical development milestones and potential commercial launch and
beyond. The Company recently added key team members in multiple
areas such as clinical operations, research and development, CMC,
regulatory affairs and commercial operations. Notably, the addition
of Ann Cunningham as the Company’s Chief Commercial Officer
has advanced pre-commercial planning for PH94B in SAD, as well as
for a broad range of other anxiety and depression markets. The
Company also added pharmaceutical industry veteran Dr. Joanne
Curley to its Board of Directors. Dr. Curley has deep experience in
pharmaceutical product development, operations, and
commercialization.
Fiscal Year 2021 Financial Results
Revenue: The Company recognized $1.1 million in sublicense
revenue from its $5 million non-dilutive upfront payment pursuant
to its PH94B development and commercialization agreement with
EverInsight Therapeutics (now AffaMed Therapeutics) during the year
ended March 31, 2021, compared to none in the year ended March 31,
2020.
Research and development (R&D) expense: Research and
development expense decreased from $13.4 million to $12.5 million
for the years ended March 31, 2020 and 2021, respectively. The
decrease is primarily due to the completion of a Phase 2 clinical
study of AV-101 in MDD in Fiscal 2020, offset by increased
development expenses for PH94B and PH10 in Fiscal
2021.
General and administrative (G&A) expense: General and
administrative expense decreased to approximately $6.5 million from
approximately $7.4 million for the years ended March 31, 2021 and
2020, respectively. Cash compensation expense for the year ended
March 31, 2021 increased by approximately $0.7 million, including
the impact of new employees, and was offset by a decrease of
approximately $1.0 million in noncash stock-based compensation for
the year ended March 31, 2021 compared to those expenses in the
year ended March 31, 2020. Further, in the year ended March 31,
2020, the Company modified certain outstanding warrants and
recognized non-cash warrant modification expense of approximately
$0.8 million.
Net loss: Net loss for the fiscal years ended March 31, 2021
and 2020 was approximately $17.9 million and $20.8 million,
respectively.
Cash Position: At March 31, 2021, the Company had cash and
cash equivalents of approximately $103.1
million.
As of
June 29, 2021, the Company had 191,382,350 shares of common stock
outstanding.
Conference Call
VistaGen
will host a conference call and live audio webcast this afternoon
at 2:00 p.m. Pacific Time to provide a corporate update and discuss
its financial results for its fiscal year ended March 31,
2021.
U.S.
Dial-in (Toll Free): 1-877-407-9716
International
Dial-in Number (Toll): 1-201-493-6779
Conference
ID: 13720908
Webcast Link: http://public.viavid.com/index.php?id=145419
A
telephone playback of the conference call will be available after
approximately 5:00 p.m. Pacific Time on June 29,
2020. To listen to the replay, call toll free 1-844-512-2921
within the United States or 1-412-317-6671 when calling
internationally (toll). Please use the replay PIN number
13720908.
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 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 indications. 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;
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, 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 fiscal year ended March
31, 2021, filed earlier today, 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 Contacts
Mark
McPartland and Mark Flather
VistaGen
Therapeutics
Phone:
(650) 577-3606; (650) 577-3617
Email: IR@vistagen.com
VISTAGEN THERAPEUTICS, INC.
|
CONSOLIDATED BALANCE SHEETS
|
(Amounts
in dollars, except share amounts)
|
|
|
|
|
|
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ASSETS
|
|
|
Current
assets:
|
|
|
Cash
and cash equivalents
|
$103,108,300
|
$1,355,100
|
Receivable
from collaboration partner
|
40,600
|
-
|
Prepaid
expenses and other current assets
|
835,100
|
225,100
|
Deferred
contract acquisition costs - current portion
|
133,500
|
-
|
Total
current assets
|
104,117,500
|
1,580,200
|
Property
and equipment, net
|
367,400
|
209,600
|
Right
of use asset - operating lease
|
3,219,600
|
3,579,600
|
Deferred
offering costs
|
294,900
|
355,100
|
Deferred
contract acquisition costs - non-current portion
|
234,100
|
-
|
Security
deposits and other assets
|
47,800
|
47,800
|
|
$108,281,300
|
$5,772,300
|
|
|
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LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT)
|
|
|
Current
liabilities:
|
|
|
Accounts
payable
|
$838,300
|
$1,836,600
|
Accrued
expenses
|
1,562,700
|
561,500
|
Current
notes payable
|
-
|
56,500
|
Deferred
revenue - current portion
|
1,420,200
|
-
|
Operating
lease obligation - current portion
|
364,800
|
313,400
|
Financing
lease obligation - current portion
|
3,000
|
3,300
|
Total
current liabilities
|
4,189,000
|
2,771,300
|
|
|
|
Non-current
liabilities:
|
|
|
Accrued
dividends on Series B Preferred Stock
|
6,272,700
|
5,011,800
|
Deferred
revenue - non-current portion
|
2,490,300
|
-
|
Operating
lease obligation - non-current portion
|
3,350,800
|
3,715,600
|
Financing
lease obligation - non-current portion
|
-
|
3,000
|
Total
non-current liabilities
|
12,113,800
|
8,730,400
|
|
16,302,800
|
11,501,700
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
Stockholders’
equity (deficit):
|
|
|
Preferred
stock, $0.001 par value; 10,000,000 shares authorized at March 31,
2021 and 2020:
|
|
|
Series
A Preferred, 500,000 shares authorized, issued and outstanding at
March 31, 2021 and 2020
|
500
|
500
|
Series
B Preferred; 4,000,000 shares authorized at March 31, 2021 and
2020; 1,131,669 shares
|
|
|
and
1,160,240 shares issued and outstanding at March 31, 2021 and 2020,
respectively
|
1,100
|
1,200
|
Series
C Preferred; 3,000,000 shares authorized at March 31, 2021 and
2020; 2,318,012 shares
|
|
|
issued
and outstanding at March 31, 2021 and 2020
|
2,300
|
2,300
|
Series
D Preferred; 2,000,000 shares and no shares authorized at March 31,
2021 and 2020, respectively;
|
|
|
402,149
shares and no shares issued and outstanding at March 31, 2021 and
March 31, 2020, respectively
|
400
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-
|
Common
stock, $0.001 par value; 325,000,000 shares and 175,000,000 shares
authorized at March 31, 2021 and 2020,
|
|
|
respectively;
180,751,234 and 49,348,707 shares issued at March 31, 2021 and
2020, respectively
|
180,800
|
49,300
|
Additional
paid-in capital
|
315,603,100
|
200,092,800
|
Treasury
stock, at cost, 135,665 shares of common stock held at March 31,
2021 and 2020
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(3,968,100)
|
(3,968,100)
|
|
(219,841,600)
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(201,907,400)
|
Total
stockholders’ equity (deficit)
|
91,978,500
|
(5,729,400)
|
Total
liabilities and stockholders’ equity (deficit)
|
$108,281,300
|
$5,772,300
|
VISTAGEN THERAPEUTICS
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
(Amounts
in Dollars, except share amounts)
|
|
Fiscal Years Ended March 31,
|
|
|
|
Sublicense
revenue
|
$1,089,500
|
$-
|
Total
revenues
|
1,089,500
|
-
|
Operating
expenses:
|
|
|
Research
and development
|
12,476,400
|
13,374,200
|
General
and administrative
|
6,546,900
|
7,427,300
|
Total
operating expenses
|
19,023,300
|
20,801,500
|
Loss
from operations
|
(17,933,800)
|
(20,801,500)
|
Other
income and expenses, net:
|
|
|
Interest
income, net
|
1,600
|
30,100
|
Other
income
|
600
|
-
|
Loss
before income taxes
|
(17,931,600)
|
(20,771,400)
|
Income
taxes
|
(2,600)
|
(2,600)
|
Net
loss and comprehensive loss
|
$(17,934,200)
|
$(20,774,000)
|
|
|
|
Accrued
dividends on Series B Preferred stock
|
(1,385,600)
|
(1,263,600)
|
Beneficial
conversion feature on Series D
|
|
|
Preferred
stock
|
(23,000,000)
|
-
|
|
|
|
Net
loss attributable to common stockholders
|
$(42,319,800)
|
$(22,037,600)
|
|
|
|
Basic
and diluted net loss attributable to common
|
|
|
stockholders
per common share
|
$(0.49)
|
$(0.50)
|
|
|
|
Weighted
average shares used in computing
|
|
|
basic
and diluted net loss attributable to common
|
|
|
stockholders
per common share
|
86,133,644
|
43,869,523
|