Full Press Release Details
Reports Fourth Quarter and Fiscal 2009 Financial Results
Management to Host Conference Call to Discuss Results and Provide 2010
Outlook Today, Thursday, March 4, at 9:00 a.m. Eastern Time -
NEEDHAM, Mass.--(BUSINESS WIRE)--March 4, 2010--Celldex Therapeutics,
Inc. (NASDAQ: CLDX) today reported financial results for the fourth
quarter and year ended December 31, 2009. Celldex reported a net loss of
$13.5 million, or $0.43 per share, for the fourth quarter of 2009
compared to a net loss of $7.5 million, or $0.47 per share, for the
fourth quarter of 2008. The net loss for the fourth quarter of 2009
included one-time expenses of $4.8 million, or $0.15 per share, incurred
in connection with the acquisition of CuraGen Corporation ("CuraGen").
For the twelve months ended December 31, 2009, Celldex reported a net
loss of $37.1 million, or $1.87 per share, compared to a net loss of
$47.5 million, or $3.34 per share, for the twelve months ended December
31, 2008. The net loss for 2009 included one-time expenses of $7.1
million, or $0.36 per share, sustained as a result of the CuraGen
acquisition. At December 31, 2009, Celldex reported cash, cash
equivalents and marketable securities of $82.5 million, which the
Company believes will be sufficient to meet estimated working capital
requirements and fund operations into 2012.
"In 2009, Celldex leveraged the power of our Precision Targeted
Immunotherapy Platform to expand and advance a promising pipeline of
clinical-stage therapeutic programs, and it is gratifying to see this
effort yield meaningful progress in the development of novel treatments
for patients. In addition, we enhanced our cash position and thereby,
strengthened the capital structure of the Company," said Anthony S.
Marucci, President and Chief Executive Officer. "We begin 2010 with four
product candidates in clinical development and a fifth positioned to
enter clinical studies later this year. These programs will drive a
number of potential value enhancing key events over the course of the
year and we look forward to updating shareholders on our continued
progress and overall strategic initiatives."
Fourth Quarter and Recent Highlights
Completed the acquisition of CuraGen, which enhanced our pipeline of
oncology-focused antibodies and increased our cash balance by
approximately $70.3 million ($57.8 million net of CuraGen's
convertible debt of $12.5 million).
Announced positive results from a Phase 1/2 study of CDX-011(formerly
CR011-vcMMAE), in patients with heavily pre-treated, locally advanced
or metastatic breast cancers. As presented at the 32nd Annual
CTRC-AACR San Antonio Breast Cancer Symposium in December 2009, the
primary efficacy endpoint for the study was met with significant
antitumor activity in patients whose tumors express the target GPNMB.
In addition, encouraging results were seen in patients with
"triple-negative disease" where treatment options are relatively
limited due to lack of hormone receptor or HER2-neu expression.
CDX-011 utilizes fully human monoclonal antibodies to deliver the
potent cellular toxin, MMAE, directly to tumor cells by targeting
GPNMB. GPNMB is a glycoprotein associated with cancer progression and
Received a sublicense income payment of $3 million in February 2010
from TopoTarget A/S (NASDAQ-OMX: TOPO.CO) as a result of the recent
co-development and commercialization agreement between TopoTarget and
Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) for Belinostat, a novel
histone deacetylase (HDAC) inhibitor for the treatment of cancer.
Continued to advance, in partnership with Pfizer, the development of
lead candidate CDX-110 in Phase 2 studies in glioblastoma multiforme.
CDX-110 is an immunotherapy that targets the tumor specific molecule
called EGFRvIII, a functional variant of the epidermal growth factor
In 2010, we plan to:
Report final Phase 1/2 data from a clinical study of CDX-011 in
patients with advanced melanoma at the American Society of Clinical
Oncology (ASCO) conference in June.
Report additional results from the Phase 1 clinical study of CDX-1307
in patients with advanced epithelial cancers, including breast, colon
and pancreatic cancer at the ASCO conference in June.
Report preliminary data from the Phase 1/2 clinical study of CDX-1401
in patients with malignant solid tumors that express NY-ESO-1.
Initiate a randomized Phase 2b clinical study of CDX-1307 in
combination with immune modulators in patients with muscle-invasive
bladder cancer expressing hCG-beta.
Initiate an expanded Phase 2b clinical study of CDX-011 in patients
with GPNMB-expressing breast cancer including triple negative disease.
Further Financial Highlights
The net loss of $13.5 million for the fourth quarter of 2009 represents
an increase of $6.0 million when compared to the net loss for the same
period in 2008 and is primarily due to an increase in operating expense
as a result of the CuraGen acquisition, an increase in interest expense
and a decrease in investment income, partially offset by an increase in
revenue. R&D expense in the fourth quarter of 2009 increased by $2.0
million compared to R&D expense in 2008 due primarily to increased
personnel-related expenses and laboratory materials and services. G&A
expenses in the fourth quarter of 2009 increased by $3.5 million to $6.4
million as compared to $2.9 million in 2008, primarily due to an
increase in personnel-related expenses and professional services fees in
2009. G&A expenses for this quarter included approximately $3.8 million,
or $0.12 per share, of transaction, severance and integration expenses
recorded in connection with the CuraGen acquisition. The increase in
cash, cash equivalents and marketable securities of $56.5 million from
September 30, 2009 includes approximately $70.3 million received in
connection with the CuraGen acquisition, partially offset by fourth
quarter net loss of $13.5 million.
The net loss of $37.1 million for 2009 represents an improvement of
$10.4 million when compared to the net loss for the same period in 2008,
primarily due to the non-cash charge of $14.8 million for purchased
in-process R&D recorded in 2008. R&D expense in 2009 increased by $3.5
million compared to R&D expense in 2008. This was primarily a result of
combining operations of AVANT and Celldex for the full 2009 year and
CuraGen related R&D expense of $2.3 million in the fourth quarter 2009,
including severance expense of $0.9 million. R&D expenses included
increased personnel-related expenses, clinical trials costs related to