Full Press Release Details
Reports Third Quarter 2011 Financial Results
Preparing for Initiation of Rindopepimut Pivotal Phase 3 Study by
NEEDHAM, Mass.--(BUSINESS WIRE)--November 2, 2011--Celldex Therapeutics,
Inc. (NASDAQ: CLDX) today reported financial results for the third
quarter and nine months ended September 30, 2011. Celldex reported a net
loss of $11.8 million, or $0.27 per share, for the third quarter of 2011
compared to a net loss of $9.1 million, or $0.28 per share, for the
third quarter of 2010. For the nine months ended September 30, 2011,
Celldex reported a net loss of $32.1 million, or $0.85 per share,
compared to a net loss of $25.2 million, or $0.79 per share, for the
nine months ended September 30, 2010.
"After discussions with FDA and EMA, we are on track to initiate our
Phase 3 study of rindopepimut in EGFRvIII-expressing glioblastoma in
December," said Anthony S. Marucci, President and Chief Executive
Officer of Celldex. "The initiation of the pivotal rindopepimut program
will be a major accomplishment for Celldex and our shareholders, while
most importantly moving this promising candidate one step closer towards
potential registration for the patients who suffer from this fatal
disease. We will also initiate an additional Phase 2 clinical study of
rindopepimut in combination with Avastin by year end."
"Further, we will set the stage for a series of additional significant
events in other programs. First, we will complete enrollment in our
Phase 2b study of CDX-011 in breast cancer by the end of this year,
which should drive data availability in this important indication in
mid-2012. We will also begin a Phase 1 study of CDX-1127 in patients
with solid tumors and hematological cancers and a Phase 1 study of
CDX-301, an immune and stem cell growth factor, in healthy subjects,"
Recent Highlights and Upcoming Milestone Events:
Concluded study design discussions with FDA and EMA and finalized the
clinical protocol for the ACT IV Phase 3 randomized, KLH-controlled,
double-blind study of rindopepimut.
Continued brisk enrollment of the 120 patient, randomized Phase 2b
study of CDX-011 in patients with glycoprotein NMB (GPNMB)-expressing
advanced, refractory breast cancer, including triple negative disease.
This study is on track to fully accrue by year-end 2011.
Announced orphan drug designation in the European Union for
rindopepimut which provides 10 years of market exclusivity from
product launch in the EU, fee reductions, as well as access to the
central authorization procedure. The EMA's Orphan Medicinal Product
Designation is designed to promote the development of drugs that may
provide significant benefit to patients suffering from rare,
life-threatening diseases. The Company previously was awarded orphan
drug status in the U.S. which provides 7 years of market exclusivity
from product launch in the U.S. as well as Fast Track designation.
The Company expects to present final median overall survival data from
the rindopepimut Phase 2 multi-center ACT III study at the Annual
Meeting of the Society for Neuro-Oncology to be held November 17-20,
2011 in Orange County, CA.
Celldex expects to initiate four new clinical trials by year-end 2011:
Phase 3 randomized, KLH-controlled, double-blind study of
rindopepimut in patients with newly-diagnosed, gross total
resected glioblastoma (GB) that express EGFRvIII. The primary
endpoint of the study will be overall survival. The ACT IV study
is expected to enroll up to 374 patients at over 150 clinical
sites internationally.
Phase 2 randomized study of rindopepimut in combination with
Avastin in recurrent or refractory glioblastoma patients (the
ReACT study). The ReACT study is expected to enroll up to 95
patients in the U.S. and will evaluate objective response rates
(ORR), progression free survival (PFS) and overall survival (OS)
endpoints in this patient population.
Phase 1 study of CDX-1127, Celldex's first therapeutic antibody
program, in patients with solid tumors or hematologic cancers.
CDX-1127 is a fully human monoclonal antibody targeting CD27.
Phase 1 trial of CDX-301, an immune and stem cell growth factor,
in healthy subjects in collaboration with Rockefeller University.
Celldex's first priority is to develop this molecule for
hematopoietic stem cell transplant, where it has demonstrated
improvement of immune cell reconstitution in preclinical in vivo
Third Quarter and Year-to-Date Financial Highlights:
Revenues for the third quarter of 2011 were relatively consistent with
revenues for the third quarter of 2010 as increased product royalty
revenue related to Rotarix in 2011 was offset by $1.3 million in Pfizer
non-cash deferred revenue related to rindopepimut recognized in 2010.
Revenues for the first nine months of 2011 decreased by $2.2 million
when compared to the first nine months of 2010 due primarily to $3.9
million in Pfizer non-cash deferred revenue related to rindopepimut
recognized in 2010, offset in part by increased product royalty revenue
of $2.0 million recorded in 2011. Celldex's retained interests in Rotarix
net royalties, which were not sold to Paul Royalty Fund, are recorded as
product royalty revenue and a corresponding amount that is payable to
Cincinnati Children's Hospital (CCH) is recorded as royalty expense.
Total operating expenses for the third quarter were $13.8 million
compared to $11.3 million for the third quarter of 2010. For the first
nine months of 2011, total operating expenses were $37.8 million
compared to $36.6 million in the first nine months of 2010. The
increases in total operating expenses between periods were primarily
driven by increased clinical trials costs for rindopepimut and CDX-011
studies, including preparations for the initiation of the ACT IV study.
The increase was also due to higher costs related to R&D personnel,
primarily in clinical operations, higher preclinical costs associated
with CDX-1127 and CDX-301, as well as increased expenses resulting from
higher license/milestone payments to licensors and an increase of $2.0
million in Rotarix -related royalty fees payable to
Cincinnati Children's Hospital (CCH) in 2011. These increases were
partly offset by decreases in G&A expenses and for the nine-month
periods, a decrease in amortization expenses for acquired intangible
assets in 2011 compared to 2010. As a result of renovations in our Fall
River facility completed in late 2010, we have increased our capacity to
produce cGMP grade antibody products for our clinical programs.