LOS ANGELES, May 12, 2016 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced financial results for the first quarter of
2016.
Andrew Gengos, ImmunoCellular
Chief Executive Officer, commented: "We continue to make progress
in all aspects of implementing our ICT-107 registration trial in
patients with newly diagnosed glioblastoma. Over half of the
targeted clinical sites in the US have been activated and are
screening patients. We anticipate that all sites in the US can be
activated by the middle of 2016. In Europe, the process of gaining regulatory
approval for the trial and bringing clinical trial sites online is
going very well. Clinical trial applications have been approved by
the regulatory authorities in the
Netherlands and the UK, and we are involved in interactions
with the six other country authorities where the trial will be
conducted. We also have received regulatory approval to start the
trial in Canada. We expect to
manufacture clinical supplies for the first qualifying patients in
Canada and Europe in the third quarter. As the
competitive landscape in newly diagnosed glioblastoma evolves, we
continue to think that our phase 3 registration program, with the
strong foundational support of placebo-controlled phase 2 data, is
the best designed program underway in this indication. We are
pleased with the progress we made in the first quarter, and believe
that 2016 will be a year of accomplishment and value creation for
our company."
For the quarter ended March 31,
2016, ImmunoCellular incurred a net loss of $5.6 million, or $0.06 per basic and diluted share, compared to a
net loss of $1.4 million, or
$0.02 per basic and diluted share,
for the quarter ended March 31,
2015.
During the first quarter 2016, the Company incurred $4.7 million of research and development expenses
compared to $2.1 million in the prior
year quarter while general and administrative expenses remained
relatively constant between periods. The $2.6 million increase in research and development
expenses primarily reflects the additional expenses associated with
the phase 3 trial of ICT-107. During the first quarter of 2016, the
Company recorded a credit to other income of $500,000 related to reflect a write-down of the
Company's warrant liability, compared to a credit to other income
of $1.8 million during the same
period in 2015.
The Company also reported that cash used in operations in the
first quarter of 2016 was $5.4
million compared to $3.0
million in the prior year quarter. The increase
primarily reflects that additional research and development
expenditures in the current year. As of March 31, 2016, the Company had $17.5 million in cash.
Conference Call and Webcast Today
ImmunoCellular plans to hold a conference call and webcast today
at 5:00 pm ET to discuss the first
quarter 2016 financial results and business update. The call will
be hosted by Andrew Gengos,
President and CEO.
LIVE CALL:
|
(877) 853-5636
(toll-free); international dial-in: (631) 291-4544; conference code
5791130.
|
|
|
WEBCAST:
|
Interested parties
who wish to listen to the webcast should visit the Investor
Relations section of ImmunoCellular's website at www.imuc.com,
under the Events and Presentations tab. A replay of the webcast
will be available one hour after the conclusion of the
event.
|
The conference call will contain forward-looking statements. The
information provided on the teleconference is accurate only at the
time of the conference call, and ImmunoCellular will take no
responsibility for providing updated information except as required
by law.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that
is developing immune-based therapies for the treatment of brain and
other cancers. The phase 3 registrational trial of lead product
candidate, ICT-107, a patient-specific, dendritic cell-based
immunotherapy targeting multiple tumor-associated antigens on
glioblastoma stem cells, is open for patient screening.
ImmunoCellular's pipeline also includes: ICT-121, a
patient-specific, dendritic cell-based immunotherapy targeting the
CD133 antigen on stem cells in recurrent glioblastoma; ICT-140, a
patient-specific, dendritic cell-based immunotherapy targeting
antigens on ovarian cancer stem cells; and the Stem-to-T-cell
research program which engineers the patient's hematopoietic stem
cells to generate antigen-specific cancer-killing T cells. To learn
more about ImmunoCellular, please visit www.imuc.com.
Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements,
including statements regarding the development and
commercialization of ICT-107 and design of our clinical trial,
initiation of a phase 3 study of ICT-107, progress with European
regulators and the potential for enrollment at clinical sites,
whether or not the SEC will approve as final the settlement terms
agreed upon with the enforcement division, the advancement of the
ICT-121 phase 1 trial, the development of our preclinical
Stem-to-T-cell program and our ability to achieve our other
clinical, operational and financial goals. These statements are
based on ImmunoCellular's current expectations and involve
significant risks and uncertainties, including those described
under the heading "Risk Factors" in ImmunoCellular's most recently
filed quarterly report on Form 10-Q and annual report on Form 10-K.
Except as required by law, ImmunoCellular undertakes no obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
3/31/2016
|
12/31/2015
|
|
(Unaudited)
|
|
Cash
|
$
17,514,213
|
$
22,604,481
|
Other current
assets
|
1,933,977
|
1,956,057
|
Non current
assets
|
5,244,905
|
5,521,836
|
Total
assets
|
$
24,693,095
|
$
30,082,374
|
|
|
|
Current
liabilities
|
$
2,271,886
|
$
2,269,398
|
CIRM
liability
|
4,398,732
|
4,133,905
|
Warrant
liability
|
1,492,400
|
1,958,775
|
Total
liabilities
|
8,163,018
|
8,362,078
|
Shareholders'
equity
|
16,530,077
|
21,720,296
|
Total liabilities and
shareholders' equity
|
$
24,693,095
|
$
30,082,374
|
Condensed
Consolidated Statements of Operations
|
|
(Unaudited)
|
|
|
|
For the
Three
|
For the
Three
|
|
Months
Ended
|
Months
Ended
|
|
March 31,
2016
|
March 31,
2015
|
Revenue
|
$
-
|
$
-
|
Research and
development
|
4,737,575
|
2,065,225
|
General and
administrative
|
1,099,832
|
1,035,895
|
Loss before other
expenses
|
5,837,407
|
3,101,120
|
Interest
income
|
2,514
|
3,257
|
Interest
expense
|
(264,827)
|
-
|
Financing
expense
|
(14,636)
|
(88,939)
|
Change in fair value
of warrant liability
|
481,011
|
1,761,956
|
Net loss
|
$
(5,633,345)
|
$
(1,424,846)
|
|
|
|
Net loss per share,
basic and diluted:
|
$
(0.06)
|
$
(0.02)
|
Contact:
ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
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SOURCE ImmunoCellular Therapeutics, Ltd.