Celldex Reports Second Quarter 2010 Financial Results - Management to Host Conference Call Today at 10:00 AM Eastern Time - NEEDHAM, Mass.--(BUSINESS WIRE)

Reports Second Quarter 2010 Financial Results

Management to Host Conference Call Today at 10:00 AM Eastern Time -

NEEDHAM, Mass.--(BUSINESS WIRE)--August 4, 2010--Celldex Therapeutics,

Inc. (NASDAQ: CLDX) today reported financial results for the second

quarter ended June 30, 2010. Celldex reported a net loss of $9.5

million, or $0.30 per share, for the second quarter of 2010 compared to

a net loss of $8.7 million, or $0.55 per share, for the second quarter

of 2009. For the six months ended June 30, 2010, Celldex reported a net

loss of $16.1 million, or $0.51 per share, compared to a net loss of

$16.4 million, or $1.04 per share, for the six months ended June 30,

2009. At June 30, 2010, Celldex reported cash, cash equivalents and

marketable securities of $65.8 million, a decrease of $9.5 million from

March 30, 2010. The decrease is due primarily to operational expenses,

$1.4 million in severance payments related to the CuraGen acquisition

and $0.7 million in capital expenditures made during the second quarter

of 2010. Remaining severance payments of $0.5 million and $0.7 million

will be made in 2010 and 2011, respectively. We believe that expected

cash inflows from existing collaborations, interest income on invested

funds and our current cash, cash equivalents and marketable securities

at June 30, 2010 are sufficient to meet estimated working capital

requirements and fund planned operations into 2012.

"In the second quarter of 2010, Celldex made significant progress

advancing our Precision Targeted Immunotherapy (PTI) platform and our

pipeline," said Anthony S. Marucci, Celldex's President and Chief

Executive Officer. "We initiated a Phase 2 study of CDX-1307 in bladder

cancer and presented positive data from three product candidates in four

presentations at the American Society of Clinical Oncology annual

meeting. As we look to the second half of 2010, we will continue this

momentum by expecting to initiate a Phase 2b study of CDX-011, our

antibody-drug conjugate (ADC), in breast cancer. These accomplishments

would position us at year end with four product candidates in late-stage

studies and a rich portfolio of earlier stage candidates. The depth and

diversity of our pipeline reflects the potential for Celldex's Precision

Targeted Immunotherapy Platform to treat cancer and other

difficult-to-treat diseases."

Second quarter highlights:

In May, we initiated a 60 patient randomized (1:1) Phase 2 controlled

study of CDX-1307, the Company's first antibody-based dendritic cell

targeted vaccine, in combination with multiple immune modulators. This

study, the N-ABLE Trial (Neoadjuvant and Adjuvant Bladder

Cancer Trial), evaluates the CDX-1307 regimen in both

neoadjuvant and adjuvant settings in patients with newly diagnosed

muscle-invasive bladder cancers that express hCG-beta. Preliminary

data is expected by year-end 2011.

Also in May, the U.S Food and Drug Administration (FDA) granted Fast

Track designation to Celldex's CDX-011 (glembatumumab vedotin) for the

treatment of advanced, refractory/resistant GPNMB-expressing breast

cancer. We expect to initiate a randomized (2:1) Phase 2b controlled

study for CDX-011 in 120 patients with heavily pre-treated, advanced

breast cancer during the third quarter.

The Company and its collaborators made the following four (4)

presentations at the recent American Society of Clinical Oncology

(ASCO) annual meeting in June:

Presented interim data for the first 40 patients from the ACT III

study, a trial testing rindopepimut (CDX-110 or PF-04948568) in

newly diagnosed Glioblastoma Multiforme (GBM). These results from

approximately 25 clinical sites across the U.S. were consistent

with results from earlier Phase 2 studies conducted at only 2

sites. Rindopepimut is partnered with Pfizer.

Presented final safety and immune activity data for CDX-011, an

antibody-drug conjugate, in patients with advanced melanoma.

Presented data on the correlation of GPNMB expression with

outcomes in breast cancer patients treated with CDX-011. The ADC

technology was licensed from Seattle Genetics, Inc.

Presented the clinical design for the randomized CDX-1307 Phase 2

study in muscle-invasive bladder cancer.

The Company expects to present preliminary data from the CDX-1401

Phase 1/2 study at the 25th Annual Meeting of the

International Society for Biological Therapy of Cancer to be held

October 2-4th in Washington, DC.

In Q4-2010, the Company expects to initiate a Phase 1 trial in healthy

subjects with CDX-301. CDX-301 is known as FLT3 ligand, a

hematopoietic growth factor that has had some previous experience in

human trials. Having acquired this product from Amgen last year, the

Company believes there are very specific clinical opportunities for

CDX-301. Our first priority is to develop this molecule for stem cell

transplant, where it has demonstrated improvement of immune cell

reconstitution in animal models. Other indications will then follow.

Finally in Q4-2010, the Company expects to complete the renovations of

its Fall River, MA, manufacturing facility to increase its capacity by

installing a 1000L bioreactor and make the facility EMEA compliant.

Implementing EMEA requirements along with US GMPs will allow Celldex

to distribute products to clinical sites in both the US and EU.

Further Financial Highlights

Second Quarter Results

The net loss of $9.5 million for the second quarter of 2010 represents

an increased loss of $0.8 million when compared to the net loss for the

same period in 2009, primarily due to increases in research and

development (R&D), royalty, amortization and interest expenses in the

second quarter of 2010, offset partially by decreases in general and

administrative (G&A) expenses.

Revenues for the second quarter of 2010 increased slightly when compared

to the second quarter of 2009. Product development and licensing revenue

in both 2010 and 2009 primarily reflects recognition of $1.3 million in

Pfizer deferred revenue related to rindopepimut (CDX-110) in the

three-month periods. In 2010, Celldex recognized $1.6 million in product

royalty revenue related to offsetting royalty expense payable to

Cincinnati Children's Hospital (CCH) compared to product royalty revenue

of $1.2 million payable to CCH in 2009.

R&D expenses in the second quarter of 2010 and 2009 were approximately