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,
2017
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
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(Commission
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(I.R.S.
Employer
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of
incorporation)
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File Number)
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Identification
No.)
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343 Allerton
Ave.
South San
Francisco, California 94090
(Address of principal executive
offices) (Zip Code)
(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 (see General Instruction A.2.
below):
☐ 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))
Item
2.02
Results of
Operations and Financial Condition.
See Item 8.01.
Item
8.01
Other Events.
Today, VistaGen Therapeutics
Inc. (the "Company")
issued a press release to provide investors with a corporate update
and to announce the Company's financial results for its fiscal year
ended March 31, 2017. A copy of the press release is attached
hereto as Exhibit 99.1.
The information furnished herein
and therein shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange
Act”), or otherwise subject to the liabilities of that
Section, or incorporated by reference in any filing under the
Exchange Act or the Securities Act of 1933, as amended, except as
shall be expressly set forth by specific reference in such
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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99.1
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Press release issued by VistaGen
Therapeutics Inc. dated June 29, 2017.
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Disclaimer.
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.
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 hereunto
duly authorized.
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VistaGen Therapeutics
Inc.
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Date: June 29,
2017
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By:
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/s/ Shawn K.
Singh
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Name:
Title:
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Shawn K.
Singh
Chief Executive
Officer
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EXHIBIT
INDEX
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Exhibit
Number
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Description
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99.1
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Press release issued by VistaGen
Therapeutics Inc. dated June 29, 2017.
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Exhibit
99.1
VistaGen Therapeutics Reports Fiscal
2017 Financial Results and Provides Corporate
Update
SOUTH
SAN FRANCISCO, CA -- (Marketwired – June 29, 2017)
-- VistaGen Therapeutics
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company focused on developing new generation medicines for
depression and other central nervous system (CNS) disorders, today
reported its financial results for its fiscal year ended March 31,
2017.
The
Company also provided an update on its corporate progress, clinical
status and anticipated milestones for AV-101, its orally available CNS
prodrug candidate in Phase 2 development, initially as a new
generation treatment for major depressive disorder
(MDD).
“With
a team of industry experts and a focused strategy in place, we have
established a strong foundation and embarked on paths to achieve
several key catalysts within the next 18 months. We anticipate our
first catalyst within the next 9 months as the NIMH completes its
AV-101 Phase 2 monotherapy study in MDD, a study being conducted
and fully funded by the NIH. Additionally, we are working closely
with the FDA and our Principal Investigator, Dr. Maurizio Fava of
Harvard University Medical School, on our AV-101 Phase 2 adjunctive
treatment study in MDD, which we anticipate will begin enrollment
in the first quarter of 2018 and be completed by the end of 2018,
with topline results available in the first quarter of 2019,”
commented Shawn Singh,
Chief Executive Officer of VistaGen.
In
addition to MDD, AV-101 may have therapeutic potential in several
other CNS indications where modulation of NMDA receptors,
activation of AMPA pathways and/or active metabolites of AV-101
play a key role, including for treatment of epilepsy, as a
non-opioid alternative for management of neuropathic pain, and to
address certain symptoms associated with Parkinson's disease and
Huntington's disease.
Mr.
Singh continued, “Our MDD clinical program is our top
priority, and will remain so. Additionally, however, recent
peer-reviewed publications suggest that AV-101 may have significant
therapeutic potential as a non-opioid treatment alternative for
pain management. We are also excited about AV-101’s potential
to reduce dyskinesia associated with standard levodopa, or L-DOPA,
therapy for Parkinson’s disease, based on results from
previous non-clinical studies. Without diverting our priority focus
on MDD, we plan to expand our AV-101 Phase 2 clinical program
during the next year to include these important CNS indications
with significant unmet need.”
“We
are also pleased to have advanced our cardiac stem cell program
during fiscal 2017, through both our participation in the
FDA’s CiPA initiative focused on using novel human stem cell
models to predict cardiac toxicity of new drug candidates long
before animal and human studies, as well as our exclusive
sublicense agreement with BlueRock Therapeutics, an emerging force
in cardiac regenerative medicine, founded and funded by Bayer AG
and Versant Ventures. Our initial revenue-generating milestone with
BlueRock Therapeutics was completed during fiscal 2017. We are
optimistic about this relationship’s potential and the future
of cardiac regenerative medicine. We believe these significant
events over the past year have positioned us to create substantial
value for our stakeholders in fiscal 2018 and
beyond.”
Potential Near-Term Milestones:
●
VistaGen
is preparing to launch its study of AV-101 as a new generation
adjunctive treatment for MDD (the Phase 2 Adjunctive Treatment
Study), a 180-patient, multi-center, double-blind, placebo
controlled efficacy and safety study evaluating AV-101 in MDD
patients with an inadequate response to standard, FDA-approved
antidepressants. The Company anticipates:
o
Receiving a response and approval from the FDA on
the Company’s Investigational New Drug application
(IND) for the planned Phase 2 Adjunctive Treatment
Study in the second half of 2017;
o
Commencing
patient enrollment of the Phase 2 Adjunctive Treatment Study in
January 2018, with Dr. Maurizio Fava as Principal Investigator;
and
o
Completing the Phase 2 Adjunctive Treatment Study
by the end of 2018, with
topline results expected in the first quarter of
2019.
●
FDA
Fast Track designation for AV-101 as an adjunctive treatment of MDD
by the end of 2017.
●
Completion
of the Phase 2 monotherapy study by the NIMH in 2017, with topline
results during the first half of 2018.
Operational Highlights During Fiscal 2017:
Achievements Related to Stem Cell Technologies
●
Execution of an exclusive sublicense agreement with
BlueRock Therapeutics L.P, a next generation regenerative medicine company
established by Bayer AG and Versant Ventures, for rights to
VistaGen's proprietary stem cell technologies relating to the
production of cardiac stem cells for the treatment of heart
disease, recognizing an upfront payment of $1.25 million, with
potential additional milestone payments and royalties in the
future.
●
Additionally,
VistaGen is selectively advancing its VistaStem Therapeutics
subsidiary by:
o
Expansion of the predictive toxicology
capabilities of CardioSafe 3D for internal small molecule NCE drug rescue and
development;
o
Participation in the FDA’s Comprehensive
in-vitro Proarrhythmia Assay (CiPA) initiative designed to change the landscape of
preclinical drug development by providing a more complete and
accurate in vitro assessment of potential drug effects on cardiac
risk; and
o
Execution
of collaborative arrangements similar to the BlueRock Therapeutics
agreement to advance regenerative medicine applications of our
pluripotent stem cell technology platform.
Advancement of AV-101 as a Potential, Non-Opioid Treatment
Alternative for Chronic Pain
●
Two Phase 1 studies of
AV-101 were published in the peer-reviewed Scandinavian Journal of
Pain supporting the
effect of AV-101 as a potential non-opioid treatment for
neuropathic pain. Safety data from both the single and multi-dose
Phase 1 studies indicated that oral AV-101 was extremely safe and
well tolerated, with no meaningful difference in adverse events
(AEs) at any dose between AV-101 and placebo. These recently
published studies, statistically-significant positive results in
four well-established preclinical models of pain associated with
tissue inflammation and nerve injury, together with the excellent
clinical safety profile, pharmacokinetic (PK) characteristics and
consistent reductions in three pain measures (allodynia, mechanical
and heat hyperalgesia), support future Phase 2 clinical studies of
AV-101 as a potential non-opioid treatment alternative for
neuropathic pain.
●
AV-101
was found to have robust anti-nociceptive effects, similar to
gabapentin, but with a better side effect profile in several
preclinical models of hyperalgesia and allodynia, suggesting
AV-101’s potential for treating multiple hyperpathic pain
states.
Bolstered Team with Industry Experts
●
Clinical
and Regulatory Advisory Board appointments include Dr. Maurizio
Fava (Harvard University) as Chairman, Dr. Sanjay Matthew (Baylor
University) and Dr. Thomas Laughren (former director, FDA’s
Division of Psychiatry), all distinguished opinion leaders in the
field of depression.
●
Jerry
Gin, Ph.D., MBA, a veteran healthcare executive, was elected to
serve as a member of VistaGen’s Board of
Directors.
●
Key additions to
VistaGen’s management team include Mark A. Smith, MD, Ph.D.,
former Clinical Lead for Neuropsychiatry at Teva Pharmaceuticals,
as Chief Medical Officer to lead
clinical development of AV-101, and Mark A. McPartland as Vice
President, Corporate Development, to expand awareness of VistaGen
and its AV-101 development program among investors and potential
partners.
Intellectual Property Accomplishments
●
The European Patent Office issued a Notice of Intention to Grant
VistaGen's European Patent Application for AV-101. The granted
claims covering treatment of depression, reduction of dyskinesia
associated with L-DOPA treatment of Parkinson's disease and
multiple dosage forms of AV-101 will be in effect until at least
January 2034.
Capital Market Highlights
●
VistaGen’s largest institutional stockholder, holding both
common stock and 99.3% of VistaGen’s outstanding preferred
stock, entered into a 6-month lock-up agreement. Under the
agreement, the stockholder and its affiliates agreed to not enter
into any transaction involving VistaGen's securities during the
term of the agreement, which runs through late-October 2017 and
covers approximately 36% of the issued and outstanding equity
securities on an as converted basis.
●
Completed $10M public offering in the first quarter of fiscal 2017,
and listed our common stock for trading on the NASDAQ Capital
Market.
Financial Results for the Fiscal Year Ended March 31,
2017:
Revenue for the fiscal year ended March 31, 2017 totaled $1.25
million and was attributable to a sublicense agreement with
BlueRock Therapeutics, for certain rights to the Company’s
proprietary technologies relating to the production of cardiac stem
cells for the treatment of heart disease.
Research and development expense totaled $5.2 million for the
fiscal year ended March 31, 2017, an increase of approximately 33%
compared with the $3.9 million incurred for the fiscal year ended
March 31, 2016. The increase in year-over-year research and
development expense was attributable to increased focus on
development of AV-101, including preparations to launch the Phase 2
Adjunctive Treatment Study in MDD.
General and administrative expense decreased to $6.3 million in the
fiscal year ended March 31, 2017, from $13.9 million in the fiscal
year ended March 31, 2016, primarily as a result of the decrease in
non-cash stock compensation expense, partially offset by an
increase in non-cash expense related to grants of equity securities
in payment of certain professional services during fiscal 2017. Of
the amounts reported, non-cash expenses, related primarily to
grants or modifications of equity securities, totaled approximately
$3.1 million in fiscal 2017 and $11.9 million in fiscal
2016.
Net
loss for the fiscal years ended March 31, 2017 and 2016 was
approximately $10.3 million and $47.2 million, respectively, the
latter amount including a non-recurring, non-cash expense of
approximately $26.7 million attributable to the extinguishment of
approximately $15.9 million carrying value of prior indebtedness,
including then-outstanding Senior Secured Convertible Notes, and
conversion of such indebtedness into equity securities between May
and September 2015 at a conversion price (stated value of the
equity received) of $7.00 per share.
At March 31, 2017, the Company had a cash and cash equivalents
balance of $2.9 million. Since
late-March 2017, the Company sold units consisting of unregistered
common stock and common stock warrants to accredited investors in a
self-placed private placement, yielding approximately $1 million in
cash proceeds to the Company.
About VistaGen
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other central nervous system (CNS)
disorders. VistaGen’s lead CNS product candidate, AV-101, is
in Phase 2 development, initially as a new generation oral
antidepressant drug candidate for major depressive disorder (MDD).
AV-101's mechanism of action is fundamentally differentiated from
all FDA-approved antidepressants and atypical antipsychotics used
adjunctively to treat MDD, with potential to drive a paradigm shift
towards a new generation of safer and faster-acting
antidepressants. AV-101 is currently being evaluated by the U.S.
National Institute of Mental Health (NIMH) in a Phase 2
monotherapy study in MDD being fully funded by the NIMH and
conducted by Dr. Carlos Zarate Jr., Chief, Section on the
Neurobiology and Treatment of Mood Disorders and Chief of
Experimental Therapeutics and Pathophysiology Branch at the NIMH.
VistaGen is preparing to launch a 180-patient Phase 2 study of
AV-101 as an adjunctive treatment for MDD patients with inadequate
response to standard, FDA-approved antidepressants. Dr. Maurizio
Fava of Harvard University will be the Principal Investigator of
the Company’s Phase 2 adjunctive treatment study. AV-101 may
also have the potential to treat multiple CNS disorders and
neurodegenerative diseases in addition to MDD, including
neuropathic pain, epilepsy, Huntington’s disease,
L-Dopa-induced dyskinesia associated with Parkinson’s disease
and other disorders where modulation of the NMDA receptors,
activation of AMPA pathways and/or key active metabolites of AV-101
may achieve therapeutic benefit.
VistaStem Therapeutics is VistaGen’s wholly owned subsidiary
focused on applying human pluripotent stem cell technology,
internally and with collaborators, to discover, rescue, develop and
commercialize proprietary new chemical entities (NCEs), including
small molecule NCEs with regenerative potential, for CNS and other
diseases, and cellular therapies involving stem cell-derived blood,
cartilage, heart and liver cells.
For more information, please visit www.vistagen.com and
connect with VistaGen
on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
The
statements in this press release that are not historical facts may
constitute forward-looking statements that are based on current
expectations and are subject to risks and uncertainties that could
cause actual future results to differ materially from those
expressed or implied by such statements. Those risks and
uncertainties include, but are not limited to, risks related to the
successful financing, launch, continuation and results of the
NIMH’s Phase 2 (monotherapy) and/or the Company’s
planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in
MDD, and other CNS diseases and disorders, including neuropathic
pain and L-DOPA-induced dyskinesia associated with
Parkinson’s disease, protection of its intellectual property,
and the availability of substantial additional capital to support
its operations, including the Phase 2 clinical development
activities described above. These and other risks and uncertainties
are identified and described in more detail in VistaGen’s
filings with the Securities and Exchange Commission (SEC). These
filings are available on the SEC’s website at www.sec.gov.
VistaGen undertakes no obligation to publicly update or revise any
forward-looking statements.
Company Contact:
Mark A.
McPartland
VistaGen
Therapeutics Inc.
Phone:
+1 (650) 577-3600
Email:
IR@vistagen.com
VISTAGEN
THERAPEUTICS, INC.
Condensed Consolidated Balance
Sheets
Amounts in
Dollars
|
|
March
31,
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March 31,
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|
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2017
|
2016
|
|
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ASSETS
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||
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Current
assets:
|
|
|
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Cash and cash
equivalents
|
$2,921,300
|
$428,500
|
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Prepaid expenses
and other current assets
|
456,600
|
426,800
|
|
Total
current assets
|
3,377,900
|
855,300
|
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Property and
equipment, net
|
286,500
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87,600
|
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Security deposits
and other assets
|
47,800
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46,900
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Total
assets
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$3,712,200
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$989,800
|
|
|
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|
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LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
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Current
liabilities:
|
|
|
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Accounts
payable
|
$867,300
|
$936,000
|
|
Accrued
expenses
|
443,000
|
814,000
|
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Current portion of
notes payable and accrued interest
|
54,800
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43,600
|
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Capital lease
obligations
|
2,400
|
1,100
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Total current
liabilities
|
1,367,500
|
1,794,700
|
|
|
|
|
|
Non-current
liabilities:
|
|
|
|
Notes
payable
|
-
|
27,200
|
|
Accrued dividends
on Series B Preferred Stock
|
1,577,800
|
2,089,600
|
|
Deferred rent
liability
|
139,200
|
55,500
|
|
Capital lease
obligations
|
11,900
|
-
|
|
Total
non-current liabilities
|
1,728,900
|
2,172,300
|
|
Total
liabilities
|
3,096,400
|
3,967,000
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders’
equity (deficit):
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized at March 31, 2017
and March 31, 2016:
|
|
|
|
Series A Preferred;
500,000 shares authorized and outstanding at March 31, 2017 and
March 31, 2016
|
500
|
500
|
|
Series B Preferred;
4,000,000 shares authorized at March 31, 2017 and March 31, 2016;
1,160,240 shares and 3,663,077 shares issued and outstanding at
March 31, 2017 and March 31, 2016,respectively
|
1,200
|
3,700
|
|
Series C Preferred:
3,000,000 shares authorized at March 31, 2017 and March 31, 2017;
2,318,012 shares issued and outstanding at March 31, 2017 and March
31, 2016
|
2,300
|
2,300
|
|
Common stock,
$0.001 par value; 30,000,000 shares authorized at March 31, 2017
and March 31, 2016;
|
|
|
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8,974,386 and
2,623,145 shares issued at March 31, 2017 and March 31, 2016,
respectively
|
9,000
|
2,600
|
|
Additional paid-in
capital
|
146,569,600
|
132,725,000
|
|
Treasury stock, at
cost, 135,665 shares of common stock held at March 31, 2017 and
March 31, 2016
|
(3,968,100)
|
(3,968,100)
|
|
Accumulated
deficit
|
(141,998,700)
|
(131,743,200)
|
|
Total
stockholders’ equity (deficit)
|
615,800
|
(2,977,200)
|
|
Total
liabilities and stockholders’ equity (deficit)
|
$3,712,200
|
$989,800
|
VISTAGEN THERAPEUTICS, INC.
STATEMENT OF OPERATIONS
Amounts in dollars, except share amounts
|
|
Fiscal
Years Ended
March
31,
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|
|
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2017
|
2016
|
|
Revenues:
|
|
|
|
Sublicense
fees
|
$1,250,000
|
$-
|
|
Total
revenues
|
1,250,000
|
-
|
|
Operating
expenses:
|
|
|
|
Research and
development
|
5,203,700
|
3,931,600
|
|
General and
administrative
|
6,294,800
|
13,918,600
|
|
Total operating
expenses
|
11,498,500
|
17,850,200
|
|
Loss from
operations
|
(10,248,500)
|
(17,850,200)
|
|
Other expenses,
net:
|
|
|
|
Interest expense,
net
|
(4,600)
|
(770,800)
|
|
Change in warrant
liability
|
-
|
(1,894,700)
|
|
Loss on
extinguishment of debt
|
-
|
(26,700,200)
|
|
Other
expense
|
-
|
(2,300)
|
|
Loss before income
taxes
|
(10,253,100)
|
(47,218,200)
|
|
Income
taxes
|
(2,400)
|
(2,300)
|
|
Net loss and
comprehensive loss
|
(10,255,500)
|
(47,220,500)
|
|
|
|
|
|
Accrued dividend on
Series B Preferred stock
|
(1,257,000)
|
(2,140,500)
|
|
Deemed dividend on
Series B Preferred Units
|
(111,100)
|
(2,058,000)
|
|
|
|
|
|
Net loss
attributable to common stockholders
|
$(11,623,600)
|
$(51,419,000)
|
|
|
|
|
|
Basic and diluted
net loss attributable to common stockholders
|
|
|
|
per common
share
|
$(1.54)
|
$(29.08)
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss
attributable
|
|
|
|
to common
stockholders per common share
|
7,531,642
|
1,767,957
|