Full Press Release Details
Reports First Quarter 2011 Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--May 4, 2011--Celldex Therapeutics, Inc.
(NASDAQ: CLDX) today reported financial results for the first quarter
ended March 31, 2011. Celldex reported a net loss of $10.1 million, or
$0.31 per share, for the first quarter of 2011 compared to a net loss of
$6.6 million, or $0.21 per share, for the first quarter of 2010. At
March 31, 2011, Celldex reported cash, cash equivalents and marketable
securities of $44.3 million, which the Company believes will be
sufficient to meet estimated working capital requirements and fund
planned program development into 2012, including initiation of a Phase 3
pivotal study for rindopepimut (CDX-110).
"In the first quarter of 2011, Celldex continued building what we
believe is one of the leading cancer immunotherapy pipelines in the
industry-progressing two of our late stage clinical programs and
preparing CDX-1127 for entry into a clinical study," said Anthony S.
Marucci, President and Chief Executive Officer of Celldex Therapeutics.
"We are finalizing plans for an international study of rindopepimut in
glioblastoma and remain on track to initiate this important study in the
second half of the year. Considerable progress has been made in
enrolling patients into the Phase 2b study of CDX-011 in refractory
breast cancer and we anticipate achieving our recruitment goal, as
planned, by year-end. We anticipate building on this momentum over the
course of the year and will continue to keep shareholders apprised of
First quarter and recent highlights:
Continued preparations for the initiation of a Phase 3 randomized,
placebo-controlled study of rindopepimut, including ongoing
discussions with both the U.S. Food and Drug Administration and the
European Medicines Agency. The study is expected to enroll
approximately 300 patients with newly diagnosed GBM that express
EGFRvIII at over 100 clinical sites internationally and is planned to
begin in the second half of 2011.
Continued enrollment of the 120-patient randomized Phase 2b controlled
study of CDX-011, which is on track to fully accrue by year-end 2011.
CDX-011 is Celldex's antibody-drug conjugate for the treatment of
patients with glycoprotein NMB (GPNMB)-expressing advanced, refractory
breast cancer including triple negative disease.
Retired the approximately $12.8 million of outstanding principal and
accrued interest owed to holders of the Company's 4% convertible
subordinated debt in February; and increased our term debt facility by
an additional $5 million with General Electric Capital Corporation in
Presented new preclinical data for CDX-1127, a therapeutic
antibody candidate for oncology indications, at the 2011 American
Association for Cancer Research (AACR) 102nd Annual Meeting in April.
CDX-1127 is a fully human monoclonal antibody targeting CD27. Key
findings discussed in the poster presentation included:
The agonistic function of CDX-1127 in combination with T cell
receptor activation;
The potent therapeutic effects of CDX-1127 in an aggressive tumor
The observed tolerability and lack of cytokine release in
"Consistent with our strategic imperative to align our resources to
support the advancement of our latest-stage assets, we have successfully
reorganized several of our clinical programs to reduce their costs while
maintaining the integrity needed to provide the necessary data for
future development," said Avery (Chip) Catlin, Senior Vice President and
Chief Financial Officer of Celldex Therapeutics. "Our Phase 2b study of
CDX-011 in breast cancer has been enrolling well, allowing us to limit
the number of study sites while remaining on track to achieve our
recruitment goal by year-end. We have reduced the overall number of
patients and expanded eligibility in the Phase 2 study of CDX-1307 in
bladder cancer by amending the trial design to a single-arm study, which
should accelerate completion of enrollment. These changes are consistent
with our goal of maintaining Celldex's solid financial position while
supporting our late-stage clinical candidates and simultaneously
advancing our earlier stage candidates toward proof-of-concept."
Further Financial Highlights
The net loss of $10.1 million for the first quarter of 2011 represents
an increased loss of $3.5 million when compared to the net loss for the
same period in 2010, primarily due to a decrease in revenue in 2011 of
$1.2 million, the receipt of a sublicense income payment of $3 million
from TopoTarget A/S in 2010, partially offset by a decrease in
amortization of acquired intangible assets in 2011 of $1.0 million.
Revenues for the first quarter of 2011 decreased when compared to
revenues in 2010, primarily because $1.3 million of deferred product
development and licensing revenues related to the Pfizer license
agreement were recognized in the first quarter of 2010.
Research and development (R&D) expense in the first quarter of 2011
increased by approximately $0.4 million from 2010. Changes in R&D
expense between 2011 and 2010 primarily reflect increased
personnel-related expenses related to higher headcount, consulting
expenses, clinical trial costs and contracted research expenses,
partially offset by lower facility-related expenses.
General and administrative (G&A) expense decreased by $0.4 million to
$2.4 million in 2011 as compared to G&A expense of $2.8 million in 2010
and was primarily due to lower personnel-related expenses and
professional services fees during the first quarter of 2011.
The $3.2 million decrease in investment, other income and interest
expense, net in 2011 is primarily due to other income of $3.0 million
recorded for the TopoTarget sublicense income payment received in 2010.
During the quarter ended March 31, 2011, cash, cash equivalents and
marketable securities decreased by approximately $16.8 million from
December 31, 2010, primarily due to operating expenses incurred during
the quarter, payment of outstanding principal and accrued interest owed
to holders of the Company's 4% convertible subordinated debt, offset
partially by additional term debt financing.
As of March 31, 2011, Celldex had approximately 32.1 million shares
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination
immunotherapy company. Celldex has a pipeline of drug candidates in
development for the treatment of cancer and other difficult-to-treat
diseases based on its antibody focused Precision Targeted Immunotherapy