LOS ANGELES, Nov. 10, 2015 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced financial results for the third quarter 2015.
Andrew Gengos, ImmunoCellular
Chief Executive Officer, commented: "With the many milestones we
achieved in the third quarter, and throughout this year, we believe
that we have changed the trajectory and reshaped the future of
ImmunoCellular, and made significant advances toward our goal of
becoming a leading cancer immunotherapy company. The highlights of
the quarter include reaching agreement with the FDA on the Special
Protocol Assessment for the ICT-107 registrational trial in
patients with newly diagnosed glioblastoma, and receiving the
almost $20 million award from the
California Institute for Regenerative Medicine (CIRM) to support
the program. We are on the cusp of achieving a major milestone with
the start of our Company's first registrational phase 3 program,
anticipated to be initiated this month. We also look forward to
presenting updated ICT-107 phase 2 trial results at the Society for
Neuro-Oncology (SNO) meeting on November
20th. We remain on track to achieve our goals
this year, underscoring our confidence that 2015 is a year of
meaningful growth, transition and value creation for our
company."
For the quarter ended September 30,
2015, the Company reported a net loss of $3.4 million, or $0.04 per basic and diluted share, compared to a
net loss of $1.9 million, or
$0.03 per basic and diluted share for
the quarter ended September 30, 2014.
During the quarter ended September 30,
2015, the Company incurred $2.6
million in research and development expenses compared to
$1.5 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 the ICT-121 phase 1
trial 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.
For the nine months ended September 30,
2015, the Company reported a net loss of $8.0 million, or $0.09 per basic and diluted share, compared to
$7.3 million, or $0.12 per basic and diluted share during the same
period in 2014. During the nine months ended September 30, 2015, the Company incurred
additional research and development expenses. Also, during
the nine months ended September 30,
2015, the Company recorded a gain of $2.3 million related to a reduction in the
valuation of its derivative warrants compared to a gain of
$400,000 in the same period of
2014.
The Company reported that cash used in operations during the
nine months ended September 30, 2015
was $13.2 million compared to
$7.8 million during the same period
of 2014. The increase in cash used in operations primarily reflects
additional research and development expenses and also reflects
$4.0 million of vendor deposits
related to the ICT-107 Phase 3 trial. These deposits will be offset
against future amounts owed to these vendors. 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.
On September 18, 2015 the Company
received an award in the amount of $19.9
million from CIRM to partially fund the Company's phase 3
trial of ICT-107. Under the terms of the CIRM award, the Company is
obligated to share future ICT-107 related revenue with CIRM.
Alternatively, the Company may convert the award to a loan.
Since the Company may be required to repay some or all of the
amounts awarded by CIRM, the Company plans to account for this
award as a liability rather than as revenue.
As of September 30, 2015, the
Company had $24.4 million in cash and
cash equivalents.
Conference Call and Webcast Today
ImmunoCellular plans to hold a conference call and webcast today
at 5:00 pm ET to discuss the third
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
65076933.
|
|
|
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 of
ICT-107, 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.
Consolidated
Condensed Balance Sheets
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|
|
|
|
|
9/30/2015
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12/31/2014
|
|
|
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(Unaudited)
|
|
|
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Cash
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$ 24,435,152
|
$ 23,222,296
|
|
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Other current
assets
|
1,328,955
|
1,219,873
|
|
|
Non current
assets
|
5,086,334
|
736,392
|
|
|
Total
assets
|
$ 30,850,441
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$ 25,178,561
|
|
|
|
|
|
|
|
Current
liabilities
|
$ 2,004,932
|
$ 1,289,199
|
|
|
Warrant
liability
|
2,555,735
|
597,719
|
|
|
Shareholders'
equity
|
26,289,774
|
23,291,643
|
|
|
|
$ 30,850,441
|
$ 25,178,561
|
|
|
|
|
|
|
|
|
|
|
|
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Consolidated
Condensed Statements of Operations (Unaudited)
|
|
|
|
|
|
|
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3 months
|
3 months
|
9 months
|
9 months
|
|
ended
|
ended
|
ended
|
ended
|
|
9/30/2015
|
9/30/2014
|
9/30/2015
|
9/30/2014
|
Revenue
|
$0
|
$0
|
$0
|
$0
|
Research and
development
|
2,592,255
|
1,486,352
|
6,827,691
|
4,646,156
|
Stock based
compensation
|
245,559
|
170,805
|
675,523
|
483,455
|
General and
administrative
|
908,075
|
786,688
|
2,731,384
|
2,490,322
|
Loss before other
expenses
|
(3,745,889)
|
(2,443,845)
|
(10,234,598)
|
(7,619,933)
|
Interest
income
|
5,498
|
4,207
|
14,408
|
10,711
|
Financing
expense
|
0
|
(9,478)
|
(88,939)
|
(34,078)
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Change in fair value
of warrant liability
|
339,136
|
559,873
|
2,328,298
|
392,940
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Net loss
|
($3,401,255)
|
($1,889,243)
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($7,980,831)
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($7,250,360)
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|
|
|
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Net loss per share,
basic and diluted:
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$
(0.04)
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$
(0.03)
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$ (0.09)
|
$
(0.12)
|
|
|
|
|
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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.