LOS ANGELES, Nov. 10, 2014 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced financial results for the quarter ended September 30, 2014.
For the quarter ended September 30,
2014, the Company incurred a net loss of $1.9 million or $0.03 per basic and diluted share, compared to a
net loss of $3.8 million, or
$0.07 per basic and diluted share
during the three months ended September
30, 2013. During the three months ended September 30, 2014, the Company increased its
research and development expenditures related to ICT-121 and
ICT-140. The Company continues to incur ICT-107 phase II expenses
related to patient follow-up and data analysis; these expenses are
decreasing as the study is completed. Also, during the three months
ended September 30, 2014, the Company
recognized a gain of $560,000 related
to the quarterly revaluation of its warrants, compared to a loss of
$1.4 million during the three months
ended September 30, 2013. For the
nine months ended September 30, 2014,
the Company incurred a loss of $7.3
million, or $0.12 per basic
and diluted share, compared to a net loss of $8.9 million, or $0.17 per basic and diluted share, during the
nine months ended September 30, 2013.
The increase reflects higher research and development expenditures
related to ICT-121 and ICT-140, partially offset by lower
expenditures related to ICT-107. The Company expects research
and development expenses to increase in future periods as ICT-121
and ICT-140 increase patient enrollment and as the Company prepares
for its anticipated phase III trial of ICT-107.
For the nine months ended September 30,
2014, the Company used approximately $7.8 million in cash from operations compared to
$6.1 million during the same period
in 2013.
As of September 30, 2014, the
Company had approximately $23.5
million of cash. During the nine months ended
September 30, 2014, the Company
raised $2.7 million from the issuance
of common stock pursuant to the Company's controlled equity
offering.
Andrew Gengos, ImmunoCellular
Chief Executive Officer, commented: "We believe that the progress
we made in the third quarter was significant. Our ICT-107 phase III
planning is well underway, and we anticipate being prepared to
initiate that program in mid-2015. We are looking forward to
presenting updated data from the ICT-107 phase II trial at the
Society for Neuro-oncology (SNO) meeting in Miami on November
14th. We have also made significant progress in
advancing our ICT-121 and ICT 140 programs. Additional clinical
sites are being added to the ICT-121 phase I trial, and enrollment
of patients with recurrent glioblastoma should increase shortly. We
plan to complete enrollment of 20 patients in this trial by the
second quarter of 2015. Plans are progressing well to initiate the
exploratory phase II ICT-140 trial, which is designed to enroll 56
patients with ovarian cancer and utilize historical controls as the
comparator in the trial."
Mr. Gengos added: "A highlight of the third quarter was the
important licensing agreement we established with Caltech, which
represents an opportunity to expand and diversify our immunotherapy
platform. Immune-based approaches to treating cancer continue to be
promising and we think that the Caltech technology will be highly
complementary to our current dendritic cell-based efforts. Our goal
is to utilize this technology to expand and enrich our pipeline of
immuno-oncology product candidates. This collaboration represents
progress toward our goal of building a leading cancer immunotherapy
company based on multiple approaches to immune system
stimulation."
ImmunoCellular plans to present updated data from the phase II
trial of ICT-107 in patients with newly diagnosed glioblastoma at
the 19th Annual Scientific Meeting and Education Day of the Society
for Neuro-Oncology, on Friday, November 14,
2014. At a later date, ImmunoCellular plans to host a
conference call and webcast to discuss the updated ICT-107 data to
be presented at the SNO meeting and other corporate
matters.
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. ImmunoCellular has concluded a phase II trial of its
lead product candidate, ICT-107, a dendritic cell-based vaccine
targeting multiple tumor-associated antigens for glioblastoma.
ImmunoCellular's pipeline also includes ICT-121, a dendritic cell
vaccine targeting CD133, and ICT-140, a dendritic cell vaccine
targeting ovarian cancer antigens and cancer stem 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
that are subject to a number of risks and uncertainties, including
the risk that ICT-107 can be further successfully developed or
commercialized, the timing and outcome of our meeting with the EMA
on the potential for European development and approval of ICT-107,
and whether or not we may be in a position to start a phase III
study in 2015. Additional risks and uncertainties are described in
IMUC's most recently filed quarterly report on Form 10-Q and
annual report on Form 10-K. Except as permitted by law, IMUC
undertakes no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact:
ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
Consolidated
Condensed Balance Sheets
|
|
|
|
|
|
9/30/2014
|
12/31/2013
|
|
|
|
(Unaudited)
|
|
|
|
Cash
|
$ 23,516,242
|
$ 27,646,351
|
|
|
Other current
assets
|
997,033
|
763,299
|
|
|
Non current
assets
|
862,117
|
531,027
|
|
|
Total
assets
|
$ 25,375,392
|
$ 28,940,677
|
|
|
|
|
|
|
|
Current
liabilities
|
$ 1,236,307
|
$ 1,402,273
|
|
|
Warrant
liability
|
705,948
|
1,064,810
|
|
|
Shareholders'
equity
|
23,433,137
|
26,473,594
|
|
|
|
$ 25,375,392
|
$ 28,940,677
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Condensed Statements of Operations (Unaudited)
|
|
|
|
|
|
|
|
|
3 months
|
3 months
|
9 months
|
9 months
|
|
ended
|
ended
|
ended
|
ended
|
|
9/30/2014
|
9/30/2013
|
9/30/2014
|
9/30/2013
|
Revenue
|
$0
|
$0
|
$0
|
$0
|
Research and
development
|
1,486,352
|
1,276,507
|
4,646,156
|
3,905,338
|
Stock based
compensation
|
170,805
|
156,277
|
483,455
|
500,351
|
General and
administrative
|
786,688
|
985,107
|
2,490,322
|
2,542,794
|
Loss before other
expenses
|
(2,443,845)
|
(2,417,891)
|
(7,619,933)
|
(6,948,483)
|
Interest
income
|
4,207
|
3,667
|
10,711
|
14,310
|
Financing
expense
|
(9,478)
|
0
|
(34,078)
|
0
|
Change in fair value
of warrant liabilty
|
559,873
|
(1,379,217)
|
392,940
|
(1,983,388)
|
Net loss
|
($1,889,243)
|
($3,793,441)
|
($7,250,360)
|
($8,917,561)
|
|
|
|
|
|
Net loss per share,
basic and diluted:
|
$
(0.03)
|
$
(0.07)
|
$
(0.12)
|
$
(0.17)
|
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SOURCE ImmunoCellular Therapeutics, Ltd.