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| 8-K - CURRENT REPORT - VistaGen Therapeutics, Inc. | vtgn8k_nov092017.htm |
Exhibit 99.1
VistaGen Therapeutics Reports Second Fiscal Quarter 2018 Financial
Results and Provides Business Update
SOUTH SAN FRANCISCO, CA -- (Marketwired – November 9, 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 second fiscal quarter ended September 30,
2017.
The Company also provided an update on its corporate progress and
recently achieved milestone for AV-101, its oral CNS drug candidate
in Phase 2 development, initially as a new generation adjunctive
treatment for major depressive disorder (MDD).
“The FDA’s recent authorization to proceed under our
AV-101 IND application is a significant milestone in our Phase 2
program focused on MDD,” commented Shawn Singh, Chief Executive Officer of
VistaGen. “With that
authorization, we are now one step closer towards our goal of
commencing our 180-patient, multi-center, double-blind,
placebo-controlled Phase 2 adjunctive treatment study in the first
quarter of 2018.”
Milestones achieved during the quarter:
In October 2017, the U.S. Food and Drug Administration (FDA)
authorized the Company to proceed
under its Investigational New Drug (IND) application
with its planned 180-patient,
multi-center, double-blind, placebo-controlled Phase 2 study to
assess the safety, tolerability and efficacy of AV-101 as an orally
administered adjunctive treatment for adult MDD patients with an
inadequate response to standard, FDA-approved antidepressants. Dr.
Maurizio Fava of Harvard Medical School will be the Principal
Investigator of this study, expected to begin in the first quarter
of 2018 with completion expected at the end of
2018.
Recent Operational Highlights:
Intellectual Property Accomplishments
●
The European Patent
Office granted a European
Patent for AV-101 relating to the
treatment of depression, Parkinson's disease levodopa-induced
dyskinesia (PD LID) and use of multiple dosage forms to treat these
CNS disorders. The 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.
●
The Company received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S.
Patent Application No. 14/775,287 related
to certain methods of production for AV-101.
●
The corresponding patent application
related to
methods of production for AV-101 was also granted in
China.
Bolstered Clinical Team with Industry Expert
●
The Company appointed David Rotella, Ph.D. to the Scientific
Advisory Board of VistaStem Therapeutics, the Company's wholly owned subsidiary focused on
utilizing the Company’s stem cell technology, to assist in
advancing VistaStem's small molecule drug rescue objectives and in
evaluating other CNS-focused programs intended to expand
VistaGen’s drug development pipeline. Dr. Rotella has
extensive academic research and pharmaceutical industry experience
in both medicinal chemistry and drug discovery, including key
leadership roles on teams at Wyeth, Pfizer and Bristol-Meyers
focused on drug candidates to fight cancer, cardiovascular disease,
metabolic disorders, and neurodegenerative
diseases.
Financial Results for the Fiscal Quarter Ended September 30,
2017:
Net loss for the fiscal quarter ended September 30, 2017 was
approximately $5.0 million, including non-cash expenses of
approximately $2.1 million, compared to $3.1 million for the fiscal
quarter ended September 30, 2016, which included non-cash expenses
of approximately $0.7 million.
Research and development expense totaled approximately $2.4 million
for the fiscal quarter ended September 30, 2017, compared with
approximately $1.6 million for the fiscal quarter ended September
30, 2016. The increase in year-over-year research and development
expense was attributable to the Company’s increased focus on
the continuing nonclinical and clinical development of AV-101 and
ongoing preparations to launch its AV-101 MDD Phase 2 adjunctive
treatment study.
General and administrative expense was approximately $2.6 million
in the fiscal quarter ended September 30, 2017, compared to
approximately $1.5 million in the fiscal quarter ended September
30, 2016, reflecting increased professional services expenses and
noncash expense attributable to the grant of common stock for
services, noncash warrant modification expense and, to a lesser
extent, salary and benefits and noncash stock compensation
expenses.
At September 30, 2017, the Company had cash of approximately $1.76
million, compared to approximately $1.63 million as of June 30,
2017. In September 2017, the Company completed an underwritten
public offering of shares of its common stock and warrants. The
gross proceeds from this offering were approximately $2.4 million,
resulting in net proceeds of $2.0 million, after deducting the
underwriting discount and offering expenses.
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 drug candidate for MDD.
AV-101's mechanism of action is fundamentally different 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 NIMH in
a small 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 an
inadequate response to standard, FDA-approved antidepressants, with
Dr. Maurizio Fava of Harvard University as Principal Investigator.
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, PD LID 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 funding, launch, continuation and results of the
NIMH’s Phase 2 (monotherapy) and/or the Company’s
planned Phase 2 (adjunctive treatment) clinical studies of AV-101
in MDD, and other CNS diseases and disorders, including neuropathic
pain and PD LID, protection of its intellectual property, and the
availability of substantial additional capital to support its
operations, including the AV-101 Phase 2 adjunctive treatment study
and other potential 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
Tables Follow:
|
VISTAGEN THERAPEUTICS
|
||
|
Condensed Consolidated Balance Sheets
|
||
|
Amounts in
Dollars
|
||
|
|
|
|
|
|
|
|
|
|
September 30,
|
March 31,
|
|
|
2017
|
2017
|
|
|
(Unaudited)
|
|
|
|
|
|
|
ASSETS
|
||
|
Current
assets:
|
|
|
|
Cash
and cash equivalents
|
$1,764,400
|
$2,921,300
|
|
Prepaid
expenses and other current assets
|
563,300
|
456,600
|
|
Total
current assets
|
2,327,700
|
3,377,900
|
|
Property
and equipment, net
|
242,000
|
286,500
|
|
Security
deposits and other assets
|
47,800
|
47,800
|
|
Total
assets
|
$2,617,500
|
$3,712,200
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT)
|
||
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$1,151,000
|
$867,300
|
|
Accrued
expenses
|
625,600
|
443,000
|
|
Current
notes payable
|
105,200
|
54,800
|
|
Capital
lease obligations
|
2,500
|
2,400
|
|
Total
current liabilities
|
1,884,300
|
1,367,500
|
|
|
|
|
|
Non-current
liabilities:
|
|
|
|
Accrued
dividends on Series B Preferred Stock
|
2,081,400
|
1,577,800
|
|
Deferred
rent liability
|
312,700
|
139,200
|
|
Capital
lease obligations
|
10,700
|
11,900
|
|
Total
non-current liabilities
|
2,404,800
|
1,728,900
|
|
Total
liabilities
|
4,289,100
|
3,096,400
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
Stockholders’
equity (deficit):
|
|
|
|
Preferred
stock, $0.001 par value; 10,000,000 shares authorized at September
30, 2017 and March 31, 2017:
|
|
|
|
Series
A Preferred, 500,000 shares authorized, issued and outstanding at
September 30, 2017 and March 31, 2017
|
500
|
500
|
|
Series
B Preferred; 4,000,000 shares authorized at September 30, 2017 and
March 31, 2017; 1,160,240
|
|
|
|
shares
issued and outstanding at September 30, 2017 and March 31,
2017
|
1,200
|
1,200
|
|
Series
C Preferred; 3,000,000 shares authorized at September 30, 2017 and
March 31, 2017;
|
|
|
|
2,318,012
shares issued and outstanding at September 30, 2017 and March 31,
2017
|
2,300
|
2,300
|
|
Common
stock, $0.001 par value; 100,000,000 and 30,000,000 shares
authorized at September 30, 2017 and
|
|
|
|
March
31, 2017, respectively; 11,764,639 and 8,974,386 shares issued at
September 30, 2017 and
|
|
|
|
March
31, 2017, respectively
|
11,800
|
9,000
|
|
Additional
paid-in capital
|
151,541,700
|
146,569,600
|
|
Treasury
stock, at cost, 135,665 shares of common stock held at September
30, 2017 and March 31, 2017
|
(3,968,100)
|
(3,968,100)
|
|
Accumulated
deficit
|
(149,261,000)
|
(141,998,700)
|
|
Total
stockholders’ equity (deficit)
|
(1,671,600)
|
615,800
|
|
Total
liabilities and stockholders’ equity (deficit)
|
$2,617,500
|
$3,712,200
|
|
VISTAGEN THERAPEUTICS
|
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|
STATEMENT OF OPERATIONS
|
||||
|
Amounts in
Dollars, except share amounts
|
||||
|
|
|
|
|
|
|
UNAUDITED
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
Six Months Ended
September 30,
|
||
|
|
2017
|
2016
|
2017
|
2016
|
|
Operating
expenses:
|
|
|
|
|
|
Research
and development
|
$2,426,600
|
$1,606,100
|
$3,522,800
|
$2,431,800
|
|
General
and administrative
|
2,567,100
|
1,493,600
|
3,731,400
|
2,631,200
|
|
Total
operating expenses
|
4,993,700
|
3,099,700
|
7,254,200
|
5,063,000
|
|
Loss
from operations
|
(4,993,700)
|
(3,099,700)
|
(7,254,200)
|
(5,063,000)
|
|
Other
expenses, net:
|
|
|
|
|
|
Interest
expense, net
|
(3,300)
|
(1,400)
|
(5,700)
|
(2,800)
|
|
|
|
|
|
|
|
Loss
before income taxes
|
(4,997,000)
|
(3,101,100)
|
(7,259,900)
|
(5,065,800)
|
|
Income
taxes
|
-
|
-
|
(2,400)
|
(2,400)
|
|
Net
loss and comprehensive loss
|
(4,997,000)
|
(3,101,100)
|
(7,262,300)
|
(5,068,200)
|
|
|
|
|
|
|
|
Accrued
dividend on Series B Preferred stock
|
(256,300)
|
(241,000)
|
(503,600)
|
(780,800)
|
|
Deemed
dividend on Series B Preferred Units
|
-
|
-
|
-
|
(111,100)
|
|
|
|
|
|
|
|
Net
loss attributable to common stockholders
|
$(5,253,300)
|
$(3,342,100)
|
$(7,765,900)
|
$(5,960,100)
|
|
|
|
|
|
|
|
Basic
and diluted net loss attributable to common
|
|
|
|
|
|
stockholders
per common share
|
$(0.53)
|
$(0.42)
|
$(0.82)
|
$(0.91)
|
|
|
|
|
|
|
|
Weighted
average shares used in computing basic
|
|
|
|
|
|
and
diluted net loss attributable to common
|
|
|
|
|
|
stockholders
per common share
|
9,892,016
|
8,041,619
|
9,465,459
|
6,577,769
|
###