LOS ANGELES, Aug. 22, 2016 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced financial results for the second quarter of
2016.
Andrew Gengos, ImmunoCellular
Chief Executive Officer, commented: "We are pleased with the
progress we made in the first half of this year, and believe that
2016 will be a year of accomplishment for our company. The first
patient in the ICT-107 phase 3 trial was treated in June – a major
achievement for our company. Today, more than 140 patients have
been screened and clinical site activation is accelerating. We
currently have activated 60 clinical sites in the US, two in
Canada, and one in the UK, with
more expected to come in the third quarter. With ICT-107,
ImmunoCellular is one of a small number of companies in the cancer
immunotherapy arena that we believe to be in the final stage of
clinical development. In light of these achievements, our
confidence remains high for the value and quality of our phase 3
program, and the therapeutic and commercial potential of ICT-107.
The phase 1 open-label trial of ICT-121 in patients with recurrent
glioblastoma has completed enrollment, reaching the target of 20
patients. The trial is being conducted at six sites in the US and
preliminary results are expected in about 9 months. We are grateful
for the continued support of the medical and scientific cancer
community, and the confidence placed in our company by our
collaborators."
Upcoming Goals and Milestones:
- ICT-107:
- Continue to bring US, Canadian and European clinical sites
online, with the goal of having all sites in all 10 countries
activated by the end of 2016.
- Anticipate randomization of all patients by the end of 2017,
and an additional 2-3 years from then to achieve the at least 274
required events.
- Plan to conduct a futility interim analysis at 30% of events,
or at about the 2-year mark, and an efficacy interim analysis at
67% of events, or at about the 2½ -year mark.
- 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 Society for NeuroOncology annual scientific meeting in
November 2016 in two oral
presentations.
- ICT-121:
- Continuing to monitor patients, with data expected in about 9
months.
- 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.
Second Quarter 2016 Financial Results
For the quarter ended June 30,
2016, ImmunoCellular incurred a net loss of $5.3 million, or $0.06 per basic and diluted share, compared to a
net loss of $3.2 million, or
$0.03 per basic and diluted share,
for the quarter ended June 30,
2015.
During the second quarter 2016, ImmunoCellular incurred
$4.4 million of research and
development expenses compared to $2.3
million in the prior year quarter while general and
administrative expenses remained relatively constant between
periods. The $2.1 million increase in
research and development expenses primarily reflects the additional
expenses associated with the phase 3 trial of ICT-107.
For the six months ended June 30,
2016, ImmunoCellular incurred a net loss of $11.0 million, or $0.12 per basic and diluted share, compared to a
net loss of $4.6 million, or
$0.05 per basic and diluted share,
During the six months ended June 30,
2016, ImmunoCellular incurred $9.2
million in research and development expenses compared to
$4.4 million in the prior
year.
ImmunoCellular also reported that cash used in operations during
the six months ended June 30, 2016
was $11.2 million compared to
$6.9 million in the prior year. The
increase primarily reflects that additional research and
development expenditures in the current year. As of
June 30, 2016, ImmunoCellular had
$11.9 million in cash.
Subsequent to June 30, 2016, ImmunoCellular entered into an
underwriting agreement with Maxim Group LLC, pursuant to which it
sold 34,550,000 shares of common stock, pre-funded warrants to
purchase 12,450,000 shares of ImmunoCellular's common stock and
base warrants to purchase 35,250,000 shares of its common
stock. The common stock and base warrants were sold at a
combined public offering price of $0.16, and the base warrants were approved for
listing on the NYSE MKT under the symbol "IMUC.WS." The
pre-funded warrants were sold to certain investors in lieu of
common stock less the $0.01 per share
exercise price for each pre-funded warrant. The base warrants have
an exercise price of $0.1921 per
share. Additionally, ImmunoCellular granted the underwriters a 45
day option to purchase up to an additional 7,050,000 shares of
common stock and/or base warrants to purchase 5,287,000 shares of
its common stock. On August 12, 2016, the underwriters
exercised the option to purchase 4,478,625 of additional base
warrants at a price of $0.01266 per
base warrant. The gross proceeds from the offering are
approximately $7.5 million.
Additionally, the terms of the California Institute of
Regenerative Medicine (CIRM) award were modified such that
ImmunoCellular received an additional $1.5
million in July 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 second
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
67085549.
|
|
|
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, 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.
Contact:
ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
|
6/30/2016
|
|
12/31/2015
|
|
(Unaudited)
|
|
|
Cash
|
$
11,948,858
|
|
$
22,604,481
|
Other current
assets
|
2,428,678
|
|
1,956,057
|
Non current
assets
|
4,888,814
|
|
5,521,836
|
Total
assets
|
$
19,266,350
|
|
$
30,082,374
|
|
|
|
|
Current
liabilities
|
$
1,641,750
|
|
$
2,269,398
|
Warrant
liability
|
1,063,335
|
|
1,958,775
|
CIRM
liability
|
4,680,728
|
|
4,133,905
|
Shareholders'
equity
|
11,880,537
|
|
21,720,296
|
|
$
19,266,350
|
|
$
30,082,374
|
Condensed
Consolidated Statement of Operations (Unaudited)
|
|
|
|
|
|
|
|
|
|
3 months
|
|
3 months
|
|
6 months
|
|
6 months
|
|
ended
|
|
ended
|
|
ended
|
|
ended
|
|
6/30/2016
|
|
6/30/2015
|
|
6/30/2016
|
|
6/30/2015
|
Revenue
|
$0
|
|
$0
|
|
$0
|
|
$0
|
Research and
development
|
4,433,222
|
|
2,299,903
|
|
9,170,797
|
|
4,365,862
|
General and
administrative
|
1,049,815
|
|
1,087,686
|
|
2,149,647
|
|
2,122,847
|
Loss before other
income (expenses)
|
(5,483,037)
|
|
(3,387,589)
|
|
(11,320,444)
|
|
(6,488,709)
|
Interest
income
|
6,397
|
|
5,653
|
|
8,911
|
|
8,910
|
Interest
expense
|
(281,996)
|
|
0
|
|
(546,823)
|
|
0
|
Financing
expense
|
(16,595)
|
|
0
|
|
(31,231)
|
|
(88,939)
|
Change in fair value
of warrant liability
|
445,660
|
|
227,206
|
|
926,671
|
|
1,989,162
|
Net loss
|
($5,329,571)
|
|
($3,154,730)
|
|
($10,962,916)
|
|
($4,579,576)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted:
|
$
(0.06)
|
|
$
(0.03)
|
|
$
(0.12)
|
|
$
(0.05)
|
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-second-quarter-2016-financial-results-300316440.html
SOURCE ImmunoCellular Therapeutics, Ltd.