UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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 26,
2018
Commission File Number: 001-37761
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its
charter.)
Nevada
(State or other jurisdiction of incorporation or
organization)
205093315
(IRS Employer Identification No.)
343 Allerton Avenue, South San Francisco, California
94080
(Address of principal executive offices)
650-577-3600
(Registrant's Telephone number)
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))
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.
See
Item 8.01.
Item 8.01
Other
Events.
On June
26, 2018, 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, 2018. 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.
See
Exhibit Index.
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.
-2-
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 27, 2018
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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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-3-
EXHIBIT INDEX
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Exhibit Number
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Description
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Press
release issued by VistaGen Therapeutics, Inc. dated June 26,
2018.
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-4-
Exhibit
99.1
VistaGen Therapeutics Reports Fiscal Year 2018 Financial Results
and Provides Year-to-Date Highlights
AV-101, VistaGen’s Oral NMDA Receptor Modulator, Granted FDA
Fast-Track Designation for Major Depressive Disorder
Key AV-101 Patents Issued in U.S., Europe and Asia
ELEVATE, AV-101 U.S. Phase 2 Major Depressive Disorder Study,
Patient Dosing Initiated and Study Continues
South San Francisco, CA (June 26, 2018)
– VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company focused on developing new generation medicines for
depression and other central nervous system (CNS) diseases and
disorders, today reported financial results for its fiscal year
ended March 31, 2018 and provided an overview of year-to-date
highlights.
“VistaGen is committed to
developing new generation medicines for millions of people
suffering from life-altering CNS diseases and disorders without
adequate treatment options. AV-101, our lead CNS product candidate, is an oral,
non-opioid, non-sedating NMDA receptor modulator. Because the NMDA
receptor is widely distributed throughout the brain and is
essential for neuronal plasticity, AV-101 has the potential to
impact a wide range of CNS indications, including transforming the
current drug treatment paradigm for depression,”
commented Shawn Singh, Chief
Executive Officer of VistaGen.
Mr. Singh continued, “We are excited about AV-101’s
potential to deliver fast-acting, ketamine-like antidepressant
effects without ketamine’s side effects or safety concerns,
first as an adjunctive treatment with current FDA-approved SSRIs
and SNRIs, as we are evaluating in our ELEVATE, and eventually as
both an at-home complement to ketamine therapy and as a
stand-alone, first-line oral therapy for depression. We believe
AV-101 also has the potential to produce gabapentin- and
amantadine-like therapeutic benefits for neuropathic pain and
Parkinson’s disease levodopa-induced dyskinesia,
respectively, in each case without involving opioid receptors or
causing sedation, hallucinations or other psychological side
effects. Overall, during Fiscal 2018, our focused strategy
and execution against our core goals resulted in achievement of
multiple major milestones that have set the stage for dynamic
outcomes in Fiscal 2019 and beyond. The significant progress we
have made presents potentially game-changing treatment options for
patients and opportunities to drive value for our
stockholders.”
Operational Highlights During Fiscal 2018 and
Year-to-Date:
AV-101 Regulatory Milestones
●
FDA
authorization to initiate
ELEVATE, our U.S. multi-center, Phase 2 study of AV-101 as
an adjunctive treatment for Major Depressive Disorder.
●
FDA Fast Track
Designation for development of AV-101 as an adjunctive
treatment for Major Depressive Disorder.
AV-101 Global Intellectual Property Milestones
●
U.S. Patent and
Trademark Office (USPTO) issuance of three key U.S. patents,
fundamentally expanding commercial exclusivity of AV-101 in the
U.S., the world’s largest pharmaceutical market:
➢
U.S. Patent
No.
9,993,453, therapeutic uses of AV-101 to treat depression.
Patent will not expire until at least 2034.
➢
U.S. Patent
No.
9,993,450, AV-101 oral
dosage formulations for neurological indications - not limited to
depression. Patent will not expire until at least
2034.
➢
U.S. Patent
No.
9,834,801, methods of
producing AV-101. Patent will not expire until at least
2034.
●
European Patent
Office grant of European Patent for
AV-101, treatment of depression, Parkinson's disease
levodopa-induced dyskinesia (PD LID) and use of multiple dosage
forms to treat these CNS disorders. This patent has been validated
in Belgium, Denmark, France, Germany, Ireland, Italy, Portugal,
Spain, Switzerland and the United Kingdom. It will be in effect
until January 2034.
●
European Patent
Office issuance of Notice of Intention to
grant European Patent counterpart to U.S. Patent
No.
9,834,801, methods of producing AV-101.
●
Japanese Patent
Office issuance of Notice of Allowance for the Japanese counterpart
to U.S. Patent No. 9,834,801,
methods of producing AV-101.
●
Chinese Patent
Office issuance of Chinese counterpart to U.S. Patent No. 9,834,801,
methods of producing AV-101.
AV-101 Peer-Reviewed Publications
●
Journal of
Pain, featuring
AV-101 on the cover and highlighting AV-101’s gabapentin-like
potential for treating multiple hyperpathic pain states, without
sedation, supporting a future Phase 2 clinical study of AV-101 as a
potential oral, non-opioid, non-sedating at-home treatment
alternative for neuropathic pain.
●
Scandinavian Journal
of Pain, discussing
the two first-in-human AV-101 Phase 1 safety studies that
demonstrated statistically-significant positive results in four
well-established preclinical models of pain.
-1-
Stem Cell Technology Intellectual Property Milestones
●
USPTO issuance
of:
➢
U.S. Patent No.
9,834,754 related to proprietary methods for producing
hematopoietic precursor stem cells, which are stem cells that give
rise to all blood cells and most bone marrow cells in the body,
with potential to impact both direct and supportive therapy for
autoimmune disorders and cancer, with CAR-T cell applications, and
foundational technology which may provide approaches for producing
bone marrow stem cells for bone marrow transfusions.
➢
U.S. Patent
Application No. 14/782,070 related
to methods of producing pluripotent stem cell-derived chondrocytes,
chondrocyte lineage cells, cartilage-like tissue and cartilage. The
patent covers claims to the therapeutic administration of these
cells and tissues to treat osteoarthritis, the most common chronic
condition of the joints, and joint injuries affecting
cartilage.
➢
In a manner similar
to our sublicense agreement with BlueRock Therapeutics involving
cardiac stem cell technology, the foregoing patents may enable
strategic collaborations involving our intellectual property
relating to blood, cartilage and/or liver cells for cell-based
therapy, cell repair therapy, regenerative medicine and/or tissue
engineering.
●
Japanese Patent Office
issuance of a Notice of Allowance for the Japanese
counterpart to U.S. Patent No. 9,834,754,
methods for producing blood cells, platelets and bone marrow stem
cells.
Anticipated Milestones Over Next 12 Months
●
Second Half of
2018:
➢
NIMH completion of
NIMH-sponsored AV-101 Phase 2 MDD monotherapy study
➢
FDA authorization
to initiate U.S. Phase 2 study of AV-101 for neuropathic
pain
➢
FDA Fast Track
designation of AV-101 for development as a non-opioid, non-sedating
treatment for neuropathic pain
●
First Half of
2019:
➢
Initiate AV-101
Phase 2 study in neuropathic pain
➢
FDA authorization
to initiate U.S. Phase 2 study of AV-101 for Parkinson’s
disease levodopa-induced dyskinesia
➢
Topline results of
ELEVATE, AV-101 Phase 2 study for adjunctive treatment of Major
Depressive Disorder
Financial Results for the Fiscal Year Ended March 31,
2018:
Net
loss attributable to common stockholders for the fiscal year ended
March 31, 2018 (“Fiscal Year 2018”) was approximately
$14.3 million, compared to $10.3 million for the fiscal year ended
March 31, 2017 (“Fiscal Year 2017”).
Research
and development expense totaled approximately $7.8 million for
Fiscal Year 2018, compared with approximately $5.2 million for
Fiscal Year 2017. The increase in research and development expense
in Fiscal Year 2018 reflects expanded nonclinical and clinical
development of AV-101, particularly preparations for and initiation
of our ELEVATE, our AV-101 Phase 2 study in MDD in the fourth
quarter of Fiscal Year 2018.
-2-
General
and administrative expense in Fiscal Year 2018 was relatively flat
at approximately $6.4 million, including approximately $2.9 million
of noncash expense, compared to approximately $6.3 million,
including $3.1 million of noncash expense, in Fiscal Year
2017.
At
March 31, 2018, the Company had cash and cash equivalents of
approximately $10.4 million, compared to approximately $2.9 million
at March 31, 2017.
About ELEVATE
ELEVATE is VistaGen’s U.S. multi-center Phase 2,
randomized, double-blind, placebo-controlled clinical trial
designed to examine the efficacy and safety of oral AV-101 as an
adjunctive treatment for MDD in patients with an inadequate
response to standard antidepressant therapy with either an
FDA-approved selective serotonin reuptake inhibitor (SSRI) or
serotonin norepinephrine reuptake inhibitor (SNRI). Approximately
180 patients will be randomized to receive either AV-101 or
placebo, orally, once daily, in conjunction with their ongoing
antidepressant. The primary endpoint of the study is the change
from baseline as measured by the Montgomery-Asberg Depression
Rating Scale (MADRS). Dr. Maurizio Fava of Massachusetts General
Hospital and Harvard Medical School is the Principal Investigator
of the ELEVATE study. Top-line results are expected in the first
half of 2019.
About Major Depressive Disorder (MDD)
MDD is
a serious biologically-based mood disorder, affecting approximately
16 million adults in the United States.2 Individuals
with MDD exhibit depressive symptoms, such as a depressed mood or a
loss of interest or pleasure in daily activities, for more than a
two-week period, as well as impaired social, occupational,
educational or other important functioning which has a negative
impact on their quality of life. About one in eight Americans aged
12 and over takes an FDA-approved antidepressant.3 While current
FDA-approved antidepressants are widely used, about two-thirds of
patients with MDD do not respond to their initial antidepressant
treatment.4 Inadequate
response to current antidepressants is among the key reasons MDD is
one of the leading public health concerns in the United States,
creating a significant unmet medical need for new agents with
fundamentally different mechanisms of action.
--------------------------
1 Zanos, P., et al. (2015) "The Prodrug
4-Chlorokynurenine Causes Ketamine-Like Antidepressant Effects, but
Not Side Effects, by NMDA/GlycineB-Site Inhibition." J
Pharmacol Exp Ther 355:76-85
2 Nat. Inst. of Mental Health website, 2017; Available
at https://www.nimh.nih.gov/health/statistics/major-depression.shtml.
3 Pratt LA, Brody DJ, Gu Q. Antidepressant use among
persons aged 12 and over: United States, 2011-2014. NCHS data
brief, no 283 (2017). www.cdc.gov/nchs/products/databriefs/db283.htm
4 Rush AJ, et al. Am J. Psychiatry. 2006, 163(11):
1905-1917 (STAR*D Study)
-3-
About AV-101
AV-101
is an oral, non-opioid, non-sedating NMDA receptor glycine B (NMDAR
GlyB) antagonist that offers the potential to be a new at-home
treatment for multiple CNS indications with high unmet medical
need. AV-101 is currently in Phase 2 clinical development in the
United States. ELEVATE is
VistaGen’s ongoing Phase 2 clinical trial designed to
evaluate the efficacy and safety of adjunctive use of oral AV-101
for MDD in patients with an inadequate response to standard
antidepressant therapy with either an FDA-approved selective
serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine
reuptake inhibitor (SNRI).
AV-101
belongs to a new generation of investigational medicines in
neuropsychiatry known as glutamate receptor modulators having the
potential to treat MDD faster than current FDA-approved SSRIs and
SNRIs. AV-101’s mechanism of
action (MOA) is fundamentally different from that of
all current FDA-approved SSRIs and SNRIs for depression, most of
which, if effective for a given patient, take many weeks to achieve
therapeutic benefits. VistaGen believes AV-101 has potential as a
first line oral monotherapy and as an adjunctive oral therapy. As
an adjunctive therapy, AV-101 may have potential both to displace
atypical antipsychotics such as aripiprazole in the current MDD
drug treatment paradigm for patients with an inadequate response to
current antidepressants approved by the FDA and to prevent relapse
of MDD following successful treatment with the FDA-approved
anesthetic, ketamine hydrochloride, an ion-channel blocking NDMA
receptor antagonist (ketamine), whether administered by intravenous
(IV) injection or as an intranasal spray formulation. AV-101 may
have potential to deliver ketamine-like antidepressant effects on
an at-home basis, without the requirement for inconvenient
administration in a medical setting, and without causing
psychological or other side effects and safety concerns associated
with ketamine therapy.
AV-101
may also have the potential to treat neuropathic pain, epilepsy,
Parkinson's disease levodopa-induced dyskinesia, suicidal ideation
and other CNS diseases and disorders where NMDA receptor modulation
and AMPA pathway activation may achieve therapeutic benefits. The
FDA has granted Fast Track
designation to
AV-101 for development as a potential adjunctive treatment of
MDD.
About VistaGen
VistaGen
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for depression and other CNS
diseases and disorders with high unmet need.
For
more information, please visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
-4-
Forward-Looking Statements
This
release contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development of AV-101, the potential of
AV-101 for the treatment of MDD and various other CNS diseases and
disorders and our intellectual property and commercial protection
of AV-101 constitute forward-looking statements for the purposes of
the safe harbor provisions under the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are
neither promises nor guarantees of future performance and are
subject to a variety of risks and uncertainties, many of which are
beyond our control, and may cause actual results to differ
materially from those contemplated in these forward-looking
statements. Among these risks is the possibility that (i) we may
encounter unexpected adverse events in patients in our ELEVATE
study that cause us to discontinue further development of AV-101,
(ii) we may not be able to successfully demonstrate the safety and
efficacy of AV-101 at each stage of clinical development, (iii)
success in preclinical studies or in early-stage clinical trials
may not be repeated or observed in ongoing or future AV-101
studies, and ongoing or future preclinical and clinical results may
not support further development of AV-101 or be sufficient to gain
regulatory approval to market AV-101, (iv) decisions or actions of
regulatory agencies may negatively affect the progress of the
ELEVATE study or the initiation, timing and progress of future
AV-101 clinical trials, and our ability to proceed with further
clinical studies or to obtain marketing approval, (v) we may not be
able to obtain or maintain adequate intellectual property
protection and other forms of marketing and data exclusivity for
AV-101, (vi) we may not have access to or be able to secure
substantial additional capital to support our operations, including
clinical development of AV-101 activities described above; and
(vii) we may encounter technical and other unexpected hurdles
in the manufacturing and development of AV-101 or other product
candidates. Certain other risks are more fully discussed in the
section entitled "Risk Factors" in our most recent annual report on
Form 10-K, and subsequent quarterly reports on Form 10-Q, as well
as discussions of potential risks, uncertainties, and other
important factors in our other filings with the Securities and
Exchange Commission (SEC). Our SEC filings are available on the
SEC's website at www.sec.gov.
In addition, any forward-looking statements represent our views
only as of the issuance of this 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.
Company Contact
Mark A.
McPartland
VistaGen
Therapeutics, Inc.
Phone:
+1 (650) 577-3600
Email: IR@vistagen.com
Investor Contact
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
Phone:
+1 (212) 896-1254/+1 (212) 896-1267
Email: VistaGen@KCSA.com
Media Contact
Caitlin
Kasunich / Lisa Lipson
KCSA
Strategic Communications
Phone:
+1 (212) 896-1241/+1 (508) 843-6428
Email: VistaGen@KCSA.com
-5-
VISTAGEN THERAPEUTICS
Consolidated Balance Sheets
(Amounts in dollars, except share
amounts)
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March 31,
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March 31,
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2018
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2017
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ASSETS
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Current
assets:
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Cash
and cash equivalents
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$10,378,300
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$2,921,300
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Prepaid
expenses and other current assets
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644,800
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456,600
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Total
current assets
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11,023,100
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3,377,900
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Property
and equipment, net
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207,400
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286,500
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Security
deposits and other assets
|
47,800
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47,800
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Total
assets
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$11,278,300
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$3,712,200
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|
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|
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current
liabilities:
|
|
|
|
Accounts
payable
|
$1,195,700
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$867,300
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|
Accrued
expenses
|
206,300
|
443,000
|
|
Current
notes payable
|
53,900
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54,800
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|
Capital
lease obligations
|
2,600
|
2,400
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Total
current liabilities
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1,458,500
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1,367,500
|
|
|
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Non-current
liabilities:
|
|
|
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Accrued
dividends on Series B Preferred Stock
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2,608,300
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1,577,800
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Deferred
rent liability
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285,600
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139,200
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Capital
lease obligations
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9,300
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11,900
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Total
non-current liabilities
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2,903,200
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1,728,900
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Total
liabilities
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4,361,700
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3,096,400
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Commitments
and contingencies
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Stockholders’
equity:
|
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Preferred
stock, $0.001 par value; 10,000,000 shares authorized at March 31,
2018 and 2017:
|
|
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Series
A Preferred, 500,000 shares authorized, issued and outstanding at
March 31, 2018 and 2017
|
500
|
500
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Series
B Preferred; 4,000,000 shares authorized at March 31, 2018 and
2017; 1,160,240 shares
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issued
and outstanding at March 31, 2018 and 2017
|
1,200
|
1,200
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Series
C Preferred; 3,000,000 shares authorized at March 31, 2018 and
2017; 2,318,012 shares
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|
|
|
issued
and outstanding at March 31, 2018 and 2017
|
2,300
|
2,300
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Common
stock, $0.001 par value; 100,000,000 and 30,000,000 shares
authorized at March 31, 2018 and
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March
31, 2017, respectively; 23,068,280 and 8,974,386 shares issued and
outstanding at March 31, 2018
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and
March 31, 2017, respectively
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23,100
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9,000
|
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Additional
paid-in capital
|
167,401,400
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146,569,600
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Treasury
stock, at cost, 135,665 shares of common stock held at March 31,
2018 and 2017
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(3,968,100)
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(3,968,100)
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Accumulated
deficit
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(156,543,800)
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(141,998,700)
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Total
stockholders’ equity
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6,916,600
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615,800
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Total
liabilities and stockholders’ equity
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$11,278,300
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$3,712,200
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-6-
VISTAGEN THERAPEUTICS
CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE
LOSS
Amounts in Dollars, except share amounts
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Fiscal Years Ended March 31,
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2018
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2017
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Revenues:
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Sublicense
revenue
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$-
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$1,250,000
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Total
revenues
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-
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1,250,000
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Operating
expenses:
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Research
and development
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7,762,500
|
5,203,700
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General
and administrative
|
6,437,100
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6,294,800
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Total
operating expenses
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14,199,600
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11,498,500
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Loss
from operations
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(14,199,600)
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(10,248,500)
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Other
expenses, net:
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Interest
expense, net
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(8,900)
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(4,600)
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Loss
on extinguishment of accounts payable
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(135,000)
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-
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Loss
before income taxes
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(14,343,500)
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(10,253,100)
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Income
taxes
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(2,400)
|
(2,400)
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|
Net
loss and comprehensive loss
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(14,345,900)
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(10,255,500)
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|
|
|
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Accrued
dividend on Series B Preferred stock
|
(1,030,400)
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(1,257,000)
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Deemed
dividend from trigger of down round
|
|
|
|
provision
feature
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(199,200)
|
-
|
|
Deemed
dividend on Series B Preferred Units
|
-
|
(111,100)
|
|
|
|
|
|
Net
loss attributable to common stockholders
|
$(15,575,500)
|
$(11,623,600)
|
|
|
|
|
|
Basic
and diluted net loss attributable to common
|
|
|
|
stockholders
per common share
|
$(1.12)
|
$(1.54)
|
|
|
|
|
|
Weighted
average shares used in computing basic
|
|
|
|
and
diluted net loss attributable to common
|
|
|
|
stockholders
per common share
|
13,890,041
|
7,531,642
|
-7-