LOS ANGELES, March 9, 2017 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced financial results for the fourth quarter and full year
2016 and provided a corporate update.
Anthony Gringeri, PhD,
ImmunoCellular's President and Chief Executive Officer, commented:
"During 2016, 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, 376 patients have
been screened, 21 have been randomized, and clinical site
activation is continuing, with a total of 68 sites activated to
date. We are pleased to report that the protocol amendment we
submitted to the US FDA for the ICT-107 trial, designed to modify
some elements of the patient screening process and accelerate the
pace and efficiency of randomization, is currently being
implemented at US clinical sites, and amended protocol submissions
are underway in Europe and
Canada. As a result of the
protocol change, the Special Protocol Assessment (SPA) is no longer
applicable. We plan to engage in further discussions with the FDA
concerning a SPA for the amended protocol in the future. We do not
expect the change in the status of the SPA to materially impact the
execution of the phase 3 trial, and data generated from a
successful phase 3 study can still be used as primary evidence to
support a marketing application."
Continued Dr. Gringeri: "The phase 1 open-label trial of ICT-121
being conducted at six sites in the US, completed enrollment of 20
patients. We are now in the process of analyzing the results, and
have submitted an abstract to present the data at the American
Society of Clinical Oncology (ASCO) annual meeting in June. As
previously noted, the preliminary results, while unvalidated, were
encouraging. We were also pleased to announce the achievement of a
significant milestone in our Stem-to-T-cell program: the successful
sequencing of a target T cell receptor gene, which is a key step
toward identification of a potential clinical candidate. We are
excited that our stem cell program is advancing, and look forward
to working with our collaborators to develop antigen-specific
killer T cell therapies."
Achievements, Upcoming Goals and Milestones:
- ICT-107:
- Continue to bring US, Canadian and European clinical sites
online. A total of 68 sites have been activated to date.
- Implementation of the protocol amendment, which will modify
some elements of how patients qualify for the trial. We plan to
randomize a total of 542 patients, and anticipate randomization of
all patients to be completed by mid-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.
- ICT-121:
- Complete analysis of the data from the phase 1 trial. An
abstract to ASCO has been submitted, with the goal of presenting
preliminary results at the annual conference in June 2017.
- Research:
- Having achieved identification of a T cell receptor identified
for a Stem-to-T-cell clinical candidate, the next research phase
will focus on packaging the T cell receptor sequence into a
lentivirus vector, the vehicle that will be used to transfect human
hematopoietic cells.
- Continue to progress in collaboration with University of Maryland on projects that have
application to existing dendritic cell immunotherapy and
Stem-to-T-cell technology platforms.
Fourth Quarter and Full Year 2016 Financial Results
For the year ended December 31,
2016, the Company incurred a net loss of $22.1 million, or $7.89 per basic and diluted share, compared to a
net loss of $12.8 million, or
$5.87 per basic and diluted share,
for the year ended December 31, 2015.
During 2016, the Company incurred $19.1
million of research and development expenses compared to
$10.9 million in 2015. The
$8.2 million increase reflects the
additional expenses associated with the implementation of the phase
3 trial of ICT-107. During 2016, the Company accrued
$1.3 million of interest expense
related to the California Institute of Regenerative Medicine (CIRM)
award compared to $134,000 in 2015.
For the quarter ended December 31,
2016, the Company incurred a net loss of $6.3 million, or $1.36 per basic and diluted share, compared to a
net loss of $4.8 million, or
$2.13 per basic and diluted share,
for the quarter ended December 31,
2015.
The Company also reported that cash used in operations in 2016
was $19.9 million compared to
$19.0 million in 2015. During 2015,
the Company purchased $2.2 million in
supplies and incurred $3.7 million in
vendor deposits. During 2016, the Company utilized $2.2 million of vendor deposits, and the amount
of supplies on-hand remained relatively constant with the prior
year. As of December 31, 2016, the
Company had $11.4 million in cash and
cash equivalents.
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 863,750 shares of the Company's common stock, base
warrants to purchase 881,250 shares of common stock at an exercise
price of $7.68 per share, and
pre-funded warrants to purchase 311,250 shares of common stock at
an exercise price of $0.40 per share.
The aforementioned securities were sold at an offering price of
$6.40 per unit. The underwriters
partially exercised their option to purchase additional shares and
base warrants and purchased an additional 37,500 shares of the
Company's common stock at a public offering price of $6.00 per share and base warrants to purchase
111,965 shares. The pre-funded warrants were substantially paid for
at the time of the offering and have an exercise price of
$0.40 per share. As of December 31, 2016, the Company had 3,444,859
shares of common stock issued and outstanding.
Additionally, the CIRM award was 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 year-end
and fourth quarter 2016 financial results and business update. The
call will be hosted by Anthony
Gringeri, PhD, President and Chief Executive Officer.
LIVE CALL:
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(877) 853-5636
(toll-free); international dial-in: (631) 291-4544; conference code
73761073.
|
|
|
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 Company's lead product candidate, ICT-107, is a
patient-specific, dendritic cell-based immunotherapy targeting
glioblastoma and is currently being studied in an international
phase 3 trial. ImmunoCellular's pipeline also includes: ICT-121, a
patient-specific, dendritic cell-based immunotherapy targeting
CD133 found in recurrent glioblastoma; ICT-140, a patient-specific,
dendritic cell-based immunotherapy targeting ovarian cancer; and
the Stem-to-T-cell research program which engineers hematopoietic
stem cells to generate cytotoxic 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;
ImmunoCellular's ability to obtain a SPA for the amended protocol
of its phase 3 clinical trial of ICT-107; the development and
commercialization of ICT-107; the development of its 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
for the period ended September 30,
2016. 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
Consolidated
Condensed Balance Sheets
|
|
|
|
12/31/2016
|
12/31/2015
|
Cash
|
$
11,437,118
|
$
22,604,481
|
Other current
assets
|
1,977,671
|
1,956,057
|
Non current
assets
|
3,475,201
|
5,521,836
|
Total
assets
|
$
16,889,990
|
$
30,082,374
|
|
|
|
Current
liabilities
|
$
3,238,943
|
$
2,269,398
|
CIRM
liability
|
6,945,741
|
$
4,133,905
|
Warrant
liability
|
573,560
|
1,958,775
|
Shareholders'
equity
|
6,131,746
|
21,720,296
|
|
$
16,889,990
|
$
30,082,374
|
Consolidated
Condensed Statements of Operations
|
|
|
|
|
|
|
|
Year
|
Year
|
Year
|
|
ended
|
ended
|
ended
|
|
12/31/2016
|
12/31/2015
|
12/31/2014
|
Revenue
|
$0
|
$0
|
$0
|
Research and
development
|
19,105,727
|
10,896,591
|
5,969,182
|
General and
administrative
|
5,006,398
|
4,616,500
|
3,889,359
|
Loss before other
income (expenses)
|
(24,112,125)
|
(15,513,091)
|
(9,858,541)
|
Interest
income
|
24,381
|
19,863
|
13,917
|
Interest
expense
|
(1,311,836)
|
(133,905)
|
-
|
Financing
expense
|
(498,520)
|
(88,939)
|
(62,683)
|
Change in fair value
of warrant liability
|
3,812,398
|
2,925,258
|
529,774
|
Net loss
|
($22,085,702)
|
($12,790,814)
|
($9,377,533)
|
|
|
|
|
Net loss per share,
basic and diluted:
|
$
(7.89)
|
$
(5.87)
|
$
(6.26)
|
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SOURCE ImmunoCellular Therapeutics, Ltd.