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): August 14, 2017
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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001-37761
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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))
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 quarter ended June 30, 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 August 14,
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 thereunto duly authorized.
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VistaGen
Therapeutics, Inc.
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Date:
August 14, 2017
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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 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 August 14,
2017.
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Exhibit 99.1
VistaGen Therapeutics Reports First Fiscal Quarter 2018 Financial
Results and Provides Business Update
SOUTH
SAN FRANCISCO, CA -- (Marketwired – August 14, 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 first fiscal quarter ended
June 30, 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).
“We
anticipate several catalytic milestones in our clinical
development, intellectual property and regulatory programs for
AV-101 within the next 6 to 18 months. We remain highly focused on
satisfying standard regulatory requirements and completing
preparations for our planned AV-101 Phase 2 adjunctive treatment
study in MDD. Our primary goal is to launch the study in January
2018 and complete it during 2018 to advance our efforts to provide
a new generation treatment alternative to millions battling
depression every day,” commented Shawn Singh, Chief Executive
Officer of VistaGen.
Mr.
Singh continued, “In conjunction with our focused efforts to
advance our AV-101 Phase 2 development program, we have continued
to expand our intellectual property portfolio. Earlier this year
the European Patent Office
issued a Notice of Intention to Grant our European Patent
Application regarding AV-101 for treatment of depression and
reduction of dyskinesias associated with levodopa therapy for
Parkinson's disease, a patent that will be in effect until at least
January 2034. In addition, the U.S. Patent and Trademark Office
recently allowed another important U.S. patent relating to
stem cell technology held by VistaStem Therapeutics, our subsidiary
using stem cell technology for drug rescue and regenerative
medicine. The breakthrough
technology under the allowed U.S. patent involves the stem cells
from which all blood cells and most bone marrow cells are derived,
technology with the potential to reach patients with a broad range
of life-threatening diseases, including cancer, with CAR-T cell
applications and foundational technology we believe may ultimately
provide approaches for producing bone marrow stem cells for bone
marrow transfusions. We are confident in our path forward through
strategic collaborations, such as our agreement with the U.S.
National Institute of Mental Health covering its full financial
sponsorship of the ongoing Phase 2 study of AV-101 for MDD that Dr.
Carlos Zarate Jr. and his team are conducting at the NIH’s
clinic in Bethesda, as well as our sublicense arrangement with
BlueRock Therapeutics, a company established by Bayer AG and
Versant Ventures, focused on regenerative medicine for heart
disease. As we have historically, we believe we have surrounded
ourselves with partners, supportive stockholders and corporate
development and finance experts who share our confidence in our
future and will assist us in securing key collaborations and
raising sufficient capital to achieve our objectives, most notably
the launch and completion in 2018 of our Phase 2 adjunctive
treatment study of AV-101 for MDD. We look forward to creating
value for our stakeholders in fiscal 2018 and
beyond."
Potential Near-Term Milestones:
During the second half of 2017, the Company is pursuing the
following objectives:
●
Receiving
U.S. Food and Drug Administration (FDA) approval to commence its
planned 180-patient, multi-center, double-blind, placebo controlled
efficacy and safety study evaluating AV-101 as a new generation
adjunctive treatment for MDD patients with an inadequate response
to standard, FDA-approved antidepressants, with Dr. Maurizio Fava
of Harvard Medical School as Principal Investigator;
and
●
Receiving
FDA Fast Track designation for AV-101 as an adjunctive treatment
for MDD.
Further, the Company anticipates that the U.S. National Institute
of Mental Health (NIMH) will complete the NIH-sponsored Phase 2
study of AV-101 in depression, with topline results during the
first half of 2018.
Recent Operational Highlights:
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
alternative for neuropathic pain. Safety data from both 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 at any dose between AV-101 and placebo. These recently
published studies, as well as statistically-significant positive
results in four well-established preclinical models of pain
associated with tissue inflammation and nerve injury,
AV-101’s excellent clinical safety profile, pharmacokinetic
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.
Bolstered Clinical Team with Industry Expert
●
The Company
appointed Mark Wallace, M.D., Distinguished Professor of Clinical
Anesthesiology at the University of California, San Diego, to its
Clinical Advisory Board to assist in advancing the potential
development of AV-101 as a non-opioid treatment for neuropathic
pain. Dr. Wallace is an internationally recognized leader in the
field of multi-modal pain management, with over 30 years of
professional experience, board certifications, licensures,
honors/awards, grants, articles and abstracts.
Intellectual Property Accomplishments
●
The Company
received a Notice of Allowance from the U.S. Patent and Trademark
Office for U.S. Patent Application No. 14/359,517 regarding
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.
Capital Market Highlights
●
The Company’s largest institutional stockholder, holding
common stock and 99.3% of the Company’s outstanding preferred
stock, entered into a 6-month lock-up agreement. Under the
agreement, the stockholder and its affiliates agreed not to enter
into any transaction involving the Company’s securities
during the term of the agreement, which runs through late-October
2017 and covers approximately 36% of the Company’s issued and
outstanding equity securities on an as-converted
basis.
Financial Results for the Fiscal Quarter Ended June 30,
2017:
At June
30, 2017, the Company had a cash and cash equivalents balance of
$1.6 million, compared to $2.9 million as of March 31, 2017.
Between late-March 2017 and late-June 2017, in self-placed private
placement transactions, the Company sold units consisting of
unregistered common stock and common stock warrants to accredited
investors, yielding approximately $1 million in net cash
proceeds.
Net
loss for the fiscal quarters ended June 30, 2017 and 2016 was
approximately $2.3 million and $2.0 million, respectively,
including non-cash expenses of approximately $0.5 million in each
period.
Research
and development expense totaled $1.1 million for the fiscal quarter
ended June 30, 2017, compared with $0.8 million for the fiscal
quarter ended June 30, 2016. The increase in year-over-year
research and development expense was attributable to the
Company’s increased focus on the continuing non-clinical and
clinical development of AV-101 and ongoing preparations to launch
its AV-101 Phase 2 Adjunctive Treatment Study.
General
and administrative expense increased slightly to $1.2 million in
the fiscal quarter ended June 30, 2017, from $1.1 million in the
fiscal quarter ended June 30, 2016 primarily because of increased
headcount and employee-related expenses and non-cash stock
compensation expense attributable to recent stock option grants,
partially offset by a reduction in professional services
fees.
About VistaGen
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other CNS disorders. VistaGen’s
lead CNS product candidate, AV-101, is in Phase 2 development,
initially as a new generation oral antidepressant prodrug candidate
for 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.
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 Medical School 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.
About VistaStem
VistaStem
Therapeutics is VistaGen’s wholly-owned subsidiary focused on
applying human pluripotent stem cell (hPSC) technology, internally
and with third-party collaborators, to discover, rescue, develop
and commercialize (i) proprietary new chemical entities (NCEs),
including NCEs with regenerative potential, for CNS and other
diseases and (ii) cellular therapies involving stem cell-derived
blood, cartilage, heart and liver cells. VistaStem’s internal
drug rescue programs are designed to utilize CardioSafe 3D, its
customized cardiac bioassay system, to develop NCEs for
VistaGen’s pipeline. To advance potential regenerative
medicine (RM) applications of its cardiac stem cell technology, in
December 2016, VistaStem exclusively sublicensed to BlueRock
Therapeutics LP, a next generation regenerative medicine company
established in 2016 by Bayer AG and Versant Ventures, rights to
certain proprietary technologies relating to the production of
cardiac cells for the treatment of heart disease. In a manner
similar to its exclusive sublicense agreement with BlueRock
Therapeutics, VistaStem may pursue additional collaborations and
potential RM applications of its stem cell technology platform,
including using blood, cartilage, and/or liver cells derived from
hPSCs, for (i) cell-based therapy, (ii) cell repair therapy, and/or
(iii) tissue engineering.
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 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 levodopa
(L-DOPA)-induced dyskinesia associated with Parkinson’s
disease, the potential for the Company’s stem cell technology
to produce NCEs, cellular therapies, regenerative medicine or bone
marrow stem cells to treat any medical condition, including
autoimmune disorders and cancer, protection of its intellectual
property, and the availability of substantial additional capital to
support its operations, including the AV-101 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
Investor Contact:
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
Phone:
+1 (212) 896-1254/+1 (212) 896-1267
Email:
VistaGen@KCSA.com
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VISTAGEN THERAPEUTICS
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Condensed Consolidated Balance Sheets
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Amounts
in Dollars
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June 30,
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March 31,
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2017
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2017
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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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$1,628,200
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$2,921,300
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Prepaid
expenses and other current assets
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498,000
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456,600
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Total
current assets
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2,126,200
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3,377,900
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Property
and equipment, net
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262,900
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286,500
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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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$2,436,900
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$3,712,200
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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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$632,000
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$867,300
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Accrued
expenses
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204,900
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443,000
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Current
portion of notes payable and accrued interest
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165,500
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54,800
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Capital
lease obligations
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2,400
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2,400
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Total
current liabilities
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1,004,800
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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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1,825,100
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1,577,800
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Deferred
rent liability
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202,500
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139,200
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Capital
lease obligations
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11,300
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11,900
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Total
non-current liabilities
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2,038,900
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1,728,900
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Total
liabilities
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3,043,700
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3,096,400
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Commitments
and contingencies
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Stockholders’
deficit:
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Preferred
stock, $0.001 par value; 10,000,000 shares authorized at June 30,
2017 and March 31, 2017:
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Series
A Preferred, 500,000 shares authorized and outstanding at June 30,
2017 and March 31, 2017
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500
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500
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Series
B Preferred; 4,000,000 shares authorized at June 30, 2017 and March
31, 2017; 1,160,240
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shares
issued and outstanding at June 30, 2017 and March 31,
2017
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1,200
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1,200
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Series
C Preferred; 3,000,000 shares authorized at June 30, 2017 and March
31, 2017;
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2,318,012
shares issued and outstanding at June 30, 2017 and March 31,
2017
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2,300
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2,300
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Common
stock, $0.001 par value; 30,000,000 shares authorized at June 30,
2017 and March 31, 2017;
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9,437,137
and 8,974,386 shares issued at June 30, 2017 and March 31, 2017,
respectively
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9,400
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9,000
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Additional
paid-in capital
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147,611,900
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146,569,600
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Treasury
stock, at cost, 135,665 shares of common stock held at June 30,
2017 and March 31, 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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(144,264,000)
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(141,998,700)
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Total
stockholders’ equity (deficit)
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(606,800)
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615,800
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Total
liabilities and stockholders’ equity (deficit)
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$2,436,900
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$3,712,200
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VISTAGEN THERAPEUTICS
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STATEMENT OF OPERATIONS
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Amounts
in Dollars, except share amounts
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UNAUDITED
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Three Months Ended
June 30,
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2017
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2016
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Operating
expenses:
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Research
and development
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$1,096,200
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$825,700
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General
and administrative
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1,164,300
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1,137,600
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Total
operating expenses
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2,260,500
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1,963,300
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Loss
from operations
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(2,260,500)
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(1,963,300)
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Other
expenses, net:
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Interest
expense, net
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(2,400)
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(1,400)
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Loss
before income taxes
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(2,262,900)
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(1,964,700)
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Income
taxes
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(2,400)
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(2,400)
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Net
loss and comprehensive loss
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(2,265,300)
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(1,967,100)
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Accrued
dividend on Series B Preferred stock
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(247,300)
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(539,800)
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Deemed
dividend on Series B Preferred Units
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-
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(111,100)
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Net
loss attributable to common stockholders
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$(2,512,600)
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$(2,618,000)
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Basic
and diluted net loss attributable to common
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stockholders
per common share
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$(0.28)
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$(0.51)
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Weighted
average shares used in computing basic
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and
diluted net loss attributable to common
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stockholders
per common share
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9,034,213
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5,097,832
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