LOS ANGELES, May 11, 2015 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced financial results for the first quarter 2015.
"During the first quarter, we strengthened our Company's
financial standing, advanced ICT-107 toward our goal of initiating
the phase 3 registration trial in newly diagnosed glioblastoma,
continued to enroll patients in our ICT-121 phase 1 trial in
recurrent glioblastoma, and moved forward with our novel
Stem-to-T-cell program," said Andrew
Gengos, ImmunoCellular's Chief Executive Officer. "We
believe that we are on track to initiate the ICT-107 phase 3 trial
in the late third quarter or fourth quarter of this year, following
completion of the special protocol assessment process with the FDA
and finalization of agreements with cancer cooperative groups and
our contract research organization, which will manage the trial.
Our ICT-121 phase 1 program is actively enrolling patients, and we
are making good progress in starting our Stem-cell immunotherapy
program which has potential advantages compared to engineered
T-cell approaches to targeting and killing tumors. We believe that
there is significant value in ImmunoCellular, given the breadth of
our platforms and our preclinical and clinical assets, led by
ICT-107. We are committed to advancing our programs with the goal
of unlocking that value, and building a leading cancer
immunotherapy company."
For the quarter ended March 31,
2015, the Company reported a net loss of $1.4 million, or $0.02 per basic and diluted share, compared to a
net loss of $3.2 million, or
$0.05 per basic and diluted share for
the quarter ended March 31, 2014.
During the quarter ended March 31,
2015, the Company incurred $2.0
million in research and development expenses compared to
$1.7 million in the same quarter of
2014. The increase reflects costs related to the ramp up of the
phase 3 trial of ICT-107, patient enrollment in ICT-121 and ramp-up
of expenses related to the Company's Stem-to-T-cell program. These
expenses were partially offset by reductions in the ICT-107 phase 2
trial, which continued to wind down, and suspension of the
Company's ICT-140 ovarian cancer program. Additionally, for
the quarter ended March 31, 2015, the
Company recognized a credit of $1.8
million related to the change in fair value of its warrant
derivatives compared to a charge of approximately $400,000 during the same period in
2014.
The Company reported that cash used in operations during the
first quarter of 2015 was $3.0
million compared to $2.6
million during the first quarter of 2014. The increase in
cash used in operations primarily reflects additional research and
development expenses. Other expenses were consistent between
periods. The Company expects that research and development expenses
will continue to increase in future periods as it prepares for the
phase 3 trial of ICT-107 and as it expands its Stem-to-T-cell
program.
During the quarter ended March 31,
2015, the Company raised $14.5
million from the issuance of 26,650,000 shares of common
stock and warrants to purchase 18,655,000 shares. The warrants have
a term of five years and an exercise price of $0.66. As of March 31,
2015, the Company had $34.8
million in cash.
Conference Call and Webcast to be Held May 12, 2015
ImmunoCellular plans to hold a conference call and webcast on
Tuesday, March 12 at 5:00 pm ET to discuss the first quarter 2015
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
30452546.
|
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. ImmunoCellular has concluded a phase 2 trial of its
lead product candidate, ICT-107, a dendritic cell-based
immunotherapy targeting multiple tumor-associated antigens on
glioblastoma stem cells. ImmunoCellular's pipeline also includes:
ICT-121, a dendritic cell immunotherapy targeting the CD133 antigen
on stem cells in recurrent glioblastoma; ICT-140, a dendritic cell
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.
Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements,
including statements regarding the development and
commercialization of ICT-107, initiation of a phase 3 study in
ICT-107, the advancement of the ICT-121 phase 1 trial and the
development of our preclinical Stem-to-T-cell program. 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
|
|
|
|
|
|
|
|
3/31/2015
|
|
12/31/2014*
|
|
(unaudited)
|
|
|
Cash
|
$ 34,771,179
|
|
$ 23,222,296
|
Other current
assets
|
1,610,391
|
|
1,219,873
|
Non current
assets
|
596,235
|
|
736,392
|
|
$ 36,977,805
|
|
$ 25,178,561
|
|
|
|
|
|
|
|
|
Current
liabilities
|
$ 1,486,413
|
|
$ 1,289,199
|
Warrant
liabilities
|
3,122,077
|
|
597,719
|
Shareholders'
equity
|
32,369,315
|
|
23,291,643
|
|
$ 36,977,805
|
|
$ 25,178,561
|
|
|
|
|
* Derived from
audited financial statements
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations (unaudited)
|
|
|
|
|
|
Three
months
|
|
Three
months
|
|
ended
|
|
ended
|
|
3/31/2015
|
|
3/31/2014
|
Revenue
|
$
-
|
|
$
-
|
Research and
development
|
1,998,619
|
|
1,699,760
|
Stock based
compensation
|
205,829
|
|
184,102
|
General and
administrative
|
896,672
|
|
865,402
|
Loss before other
expenses
|
(3,101,120)
|
|
(2,749,264)
|
Interest
income
|
3,257
|
|
3,354
|
Financing
expense
|
(88,939)
|
|
-
|
Change in fair value
of warrant liabilities
|
1,761,956
|
|
(416,067)
|
Net loss
|
$ (1,424,846)
|
|
$ (3,161,977)
|
|
|
|
|
Net loss per share,
basic and diluted:
|
$
(0.02)
|
|
$
(0.05)
|
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.