LOS ANGELES, Nov. 10, 2016 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced financial results for the third quarter of 2016 and
provided an update on its research and development
activities.
Andrew Gengos, ImmunoCellular's
Chief Executive Officer, commented: "During the third quarter and
year to date, we continued to implement our ICT-107 registration
trial in patients with newly diagnosed glioblastoma, and conduct
our phase 1 trial of ICT-121 in patients with recurrent
glioblastoma. Today, in our ICT-107 phase 3 trial, about 225
patients have been screened, 11 have been randomized, and clinical
site activation is continuing, with a total of 66 sites activated
to date. We have determined that the number of patients who
complete screening and then proceed to randomization,
post-chemoradiation, is lower than expected, and thus the rate of
randomization is slower than we would like. To address this
challenge, we are implementing a protocol amendment for the ICT-107
trial that will modify some elements of how patients qualify for
the trial, which is designed to accelerate the pace and efficiency
of randomization. We also anticipate increasing the target number
of randomized patients, which would extend the timeline to trial
completion. We are continuing to screen and randomize patients, and
anticipate completing the amendment process in the first quarter of
2017."
Continued Mr. Gengos: "The phase 1 open-label trial of ICT-121
being conducted at six sites in the U.S. completed enrollment of 20
patients in the third quarter. The preliminary results thus far are
encouraging, showing a current median survival of 13.8 months as of
October 31st, seven
patients who are alive beyond 18 months, and four patients who are
alive at the two-year mark. We are continuing to monitor outcomes,
with the goal of having preliminary data by mid-2017, potentially
in time for the ASCO 2017 meeting. We are grateful for the
continued support of the medical and scientific cancer community
for our clinical programs, and the confidence placed in our company
by our collaborators."
Achievements, Upcoming Goals and Milestones:
- ICT-107:
- Continue to bring U.S., Canadian and European clinical sites
online. A total of 75 site initiation visits have been completed,
and 66 sites have been activated to date.
- A protocol amendment is underway, which will modify some
elements of how patients qualify for the trial, raise the target
number of randomized patients from 414 to at least 500 and result
in a potential 12 to 18 month extension to complete the trial. We
now anticipate randomization of all patients to be completed by the
first half of 2019, and an additional 2-3 years from then to
achieve the number of required events.
- Plan to conduct a futility interim analysis at 30% of events,
or at about the time of full randomization, and an efficacy interim
analysis at 67% of events, about six months later.
- Present updated immune monitoring data from the ICT-107 phase 2
trial and updated long-term survival data from the phase 1 trial at
the 2016 Society for NeuroOncology annual scientific meeting, being
held in Scottsdale, AZ in two oral
presentations.
- Friday, November 18, 4:35 pm MT, Adult Clinical Trials – Immunological
(ATIM-19) "Categorizing immune responders with fusion metrics and
simulation for association to survival and progression-free
survival with immune response in HLA-A2+ patients with GBM from a
phase 2 trial of dendritic cell (DC) immunotherapy (ICT-107),"
presented by Steven J. Swanson, PhD,
ImmunoCellular Therapeutics, Ltd, Calabasas, CA.
- Friday, November 18, 4:40 pm, MT, Adult Clinical Trials –
Immunological (ATIM-25): "Ten-year follow up with long term
remission in patients with newly diagnosed glioblastoma (GBM)
treated with ICT-107 vaccine (phase 1)," presented by Surasak Phuphanich, MD, Neuro-Oncology Program,
Department of Neurosurgery & Neurology, Cedars-Sinai Medical
Center, Los Angeles, CA
- ICT-121:
- Continuing to monitor patients, with data expected around
mid-2017.
- Research:
- Anticipate having one or more T cell receptors identified for a
Stem-to-T-cell clinical candidate or candidates by year-end
2016.
- Initial attempt to package a T cell receptor DNA sequence in
the lentivirus/gene therapy construct by year-end 2016.
- Continued progress in collaboration with University of Maryland on projects that have
application to existing dendritic cell immunotherapy and
Stem-to-T-cell technology platforms.
Third Quarter 2016 Financial Results
For the quarter ended September 30,
2016, ImmunoCellular incurred a net loss of $4.8 million, or $0.04 per basic and diluted share, compared to a
net loss of $3.4 million, or
$0.04 per basic and diluted share,
for the quarter ended September 30,
2015.
During the third quarter 2016, ImmunoCellular incurred
$4.6 million of research and
development expenses compared to $2.7
million in the prior year quarter, while general and
administrative expenses decreased to $908,000 compared to $1.1
million in the prior year. The $1.9
million increase in research and development expenses
primarily reflects the additional expenses associated with the
phase 3 trial of ICT-107. The decrease in general and
administrative expenses reflects lower professional fees in the
current quarter.
The loss for the current quarter was partially offset by a
$1.1 million credit to other income
to reflect a reduction in the valuation of the Company's warrant
derivative liabilities. In the same quarter of the prior
year, the Company recorded a corresponding credit of $339,000.
For the nine months ended September 30,
2016, ImmunoCellular incurred a net loss of $15.8 million, or $0.15 per basic and diluted share, compared to a
net loss of $8.0 million, or
$0.09 per basic and diluted share.
During the nine months ended September 30,
2016, ImmunoCellular incurred $13.7
million in research and development expenses compared to
$7.0 million in the prior
year.
ImmunoCellular also reported that cash used in operations during
the nine months ended September 30,
2016 was $16.1 million
compared to $13.2 million in the
prior year. The increase primarily reflects the additional research
and development expenditures in the current year. As of
September 30, 2016, ImmunoCellular
had $15.3 million in cash.
In August 2016, the Company
entered into an underwriting agreement with Maxim Group LLC,
pursuant to which the Company received net proceeds of
approximately $6.6 million (after
deducting the underwriting discount and offering expenses) from the
initial sale of 34.6 million shares of the Company's common stock,
base warrants to purchase 35,250,000 shares of common stock at an
exercise price of $0.1921 per share,
and pre-funded warrants to purchase 12,450,000 shares of common
stock at an exercise price of $0.01
per share. The underwriters partially exercised their option to
purchase additional shares and base warrants and purchased an
additional 1,500,000 million shares of the Company's common stock
at a price of $0.15 per share and
base warrants to purchase 4,478,625 shares. The pre-funded warrants
were substantially paid for at the time of the offering and have an
exercise price of $0.01 per share. As
of September 30, 2016, the Company
had 137,795,802 shares of common stock issued and outstanding.
Additionally, the terms of the California Institute of
Regenerative Medicine (CIRM) award were modified such that
ImmunoCellular received an additional $1.5
million in August 2016 as part
of the initial award received from CIRM. The total amount of the
award and other award conditions remain unchanged.
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 2016 financial results and business update. The call will
be hosted by Andrew Gengos,
President and Chief Executive Officer.
LIVE CALL:
|
(877) 853-5636
(toll-free); international dial-in: (631) 291-4544; conference code
7872776.
|
|
|
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, has been initiated. 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 ImmunoCellular's intentions and
current expectations concerning, among other things, timing for
enrollment and randomization of patients, the activation of
clinical sites, the receipt and announcement of clinical data; the
development and commercialization of ICT-107; the development of
our preclinical Stem-to-T-cell program and ImmunoCellular's ability
to achieve its other clinical, operational and financial goals.
Forward-looking statements are not guarantees of future performance
and are subject to a number of risks and uncertainties, including
the availability of resources to continue to develop
ImmunoCellular's product candidates, the uncertain timing of
completion and success of clinical trials, and the risk that
ICT-107 can be further successfully developed or
commercialized. Additional risks and uncertainties are
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
|
|
|
9/30/2016
|
12/31/2015
|
|
(Unaudited)
|
|
Cash
|
$
15,297,823
|
$
22,604,481
|
Other current
assets
|
1,668,516
|
1,956,057
|
Non-current
assets
|
5,262,438
|
5,521,836
|
Total
assets
|
$
22,228,777
|
$
30,082,374
|
|
|
|
Current
liabilities
|
$
1,733,437
|
$
2,269,398
|
CIRM
liability
|
6,523,051
|
4,133,905
|
Warrant
liability
|
2,340,876
|
1,958,775
|
Shareholders'
equity
|
11,631,413
|
21,720,296
|
Total liabilities and
shareholders' equity
|
$
22,228,777
|
$
30,082,374
|
|
|
|
Consolidated
Condensed Statements of Operations (Unaudited)
|
|
|
|
|
|
|
|
|
3 months
|
3 months
|
9 months
|
9 months
|
|
ended
|
ended
|
ended
|
ended
|
|
9/30/2016
|
9/30/2015
|
9/30/2016
|
9/30/2015
|
Revenue
|
$0
|
$0
|
$0
|
$0
|
Research and
development
|
4,563,896
|
2,662,373
|
13,734,693
|
7,028,242
|
General and
administrative
|
908,380
|
1,083,516
|
3,058,027
|
3,206,356
|
Loss before other
income (expenses)
|
(5,472,276)
|
(3,745,889)
|
(16,792,720)
|
(10,234,598)
|
Interest
income
|
9,920
|
5,498
|
18,831
|
14,408
|
Interest
expense
|
(342,323)
|
-
|
(889,146)
|
-
|
Financing
expense
|
(111,557)
|
-
|
(142,788)
|
(88,939)
|
Change in fair value
of warrant liability
|
1,118,411
|
339,136
|
2,045,082
|
2,328,298
|
Net loss
|
($4,797,825)
|
($3,401,255)
|
($15,760,741)
|
($7,980,831)
|
|
|
|
|
|
Net loss per share,
basic and diluted:
|
$
(0.04)
|
$
(0.04)
|
$
(0.16)
|
$
(0.09)
|
|
|
|
|
|
Contact:
ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
Logo -
http://photos.prnewswire.com/prnh/20140109/AQ43875LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/immunocellular-therapeutics-announces-third-quarter-2016-financial-results-and-provides-research-and-development-update-300360894.html
SOURCE ImmunoCellular Therapeutics, Ltd.