Celldex Reports Second Quarter 2012 Financial Results - Management to Host Conference Call Today at 8:30 AM Eastern Time - NEEDHAM, Mass.--(BUSINESS WIRE)

Reports Second Quarter 2012 Financial Results

Management to Host Conference Call Today at 8:30 AM Eastern Time -

NEEDHAM, Mass.--(BUSINESS WIRE)--August 10, 2012--Celldex Therapeutics,

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

quarter ended June 30, 2012. Celldex reported a net loss of $13.8

million, or $0.23 per share, for the second quarter of 2012 compared to

a net loss of $10.2 million, or $0.27 per share, for the second quarter

of 2011. For the six months ended June 30, 2012, Celldex reported a net

loss of $27.3 million, or $0.50 per share, compared to a net loss of

$20.3 million, or $0.58 per share, for the six months ended June 30,

Anthony Marucci, President and Chief Executive Officer of Celldex

Therapeutics commented, "In the second quarter, Celldex has rapidly

opened clinical sites for the Phase 3 ACT IV study and the Phase 2 ReACT

study of rindopepimut in glioblastoma (GB). Celldex also reported

positive topline data from our Phase 2b EMERGE study of CDX-011 in

patients with metastatic breast cancer. The results were consistent with

previous studies and suggest that CDX-011 has considerable potential,

particularly in key patient populations with more difficult to treat

disease, including patients with high GPNMB expression levels and

patients with triple negative breast cancer. Together these patients

account for more than 35% of the total breast cancer population. We

believe CDX-011 could play a vital role as a much needed treatment

option for these patients and look forward to updating results from the

EMERGE study in the fourth quarter."

At June 30, 2012, Celldex reported cash, cash equivalents and marketable

securities of $78.7 million, which the Company believes will be

sufficient to meet estimated working capital requirements and fund

planned program development into 2014. The decrease of $13.5 million

from March 31, 2012 is due primarily to planned, increased operational

expenses during the quarter related to ongoing studies of rindopepimut

(CDX-110), including the pivotal ACT IV study in patients with newly

diagnosed EGFRvIII-positive GB and the Phase 2 ReACT study in patients

with recurrent EGFRvIII-positive GB.

Second Quarter and Recent Highlights

Celldex presented positive, topline results from the CDX-011 EMERGE

study on May 23, 2012. CDX-011 is a first-in-class, next generation

antibody drug conjugate that targets a Celldex proprietary target,

glycoprotein NMB (GPNMB). GPNMB is believed to promote breast cancer

metastases and its expression is generally associated with a poor

prognosis. Preliminary results from the EMERGE study suggest that

CDX-011 induces impressive response rates compared to currently

available therapies in patient subsets with advanced, refractory

breast cancers with high GPNMB expression (expression in 25% of tumor

cells) and in patients with triple negative breast cancer.

In the high GPNMB expressing patient population (n=25), treatment

with CDX-011 resulted in a 32% overall response rate (ORR;

includes confirmed and unconfirmed responses), whereas treatment

with Investigator's Choice (IC) single-agent chemotherapy (n=8)

resulted in a 13% ORR.

CDX-011 also demonstrated strong response rates in patients with

triple negative breast cancer across all levels of GPNMB

expression [CDX-011 ORR of 21% (n=24); IC ORR of 0% (n=9)], where

treatment options are extremely limited. In addition, in patients

with triple negative breast cancer who also highly express GPNMB,

greater activity was observed [CDX-011 ORR of 36% (n=11); IC ORR

In patients with high GPNMB in the CDX-011 arm, a trend of

improvement in progression-free survival (PFS) was observed.

In patients with both triple negative breast cancer and high GPNMB

expression, a statistically significant PFS benefit was observed

Study data continue to mature and patients continue to be

followed. The Company anticipates updating results in the fourth

Celldex continued a major initiative to open clinical sites to support

enrollment in the Phase 3 ACT IV study and the Phase 2 ReACT study of

rindopepimut in glioblastoma. In total, there are now more than 150

clinical sites around the world that have been selected to participate

in the ACT IV study and, to date, 78 of these sites are actively

screening patients. The ReACT study is also well positioned, with 25

study sites selected to participate and 17 actively screening to date.

Celldex was added to the NASDAQ Biotechnology Index (NBI), effective

prior to market open on Monday, May 21, 2012. The NBI includes

biotechnology or pharmaceutical companies listed exclusively on the

NASDAQ Global Select Market or on the NASDAQ Global Market that meet

predetermined eligibility requirements, including a minimum market

capitalization of $200 million and an average daily trading volume of

at least 100,000 shares, amongst other criteria.

Anticipated Milestones

Initiate a Phase 2 pilot study of CDX-1135 (formerly TP10) in dense

deposit disease (DDD), an orphan kidney disease in children and young

adults, in the second half of 2012. DDD is caused by uncontrolled

activation of the alternative pathway of complement. The complement

activation leads to progressive kidney damage and failure. CDX-1135

has been shown to inhibit the complement cascade at both the C3 and C5

levels and has shown clear biologic activity in DDD animal models and

in earlier human clinical trials. Celldex believes CDX-1135 could have

therapeutic applications in DDD and other complement mediated

diseases. The study will determine the appropriate dose and regimen

for further clinical development of CDX-1135 based on safety,

tolerability, biological and therapeutic activity.

Present results from Phase 1 study of CDX-1401 in solid tumors in the

fourth quarter of 2012.

Present updated overall survival data from the rindopepimut Phase 2

ACT III study in the fourth quarter of 2012.

Present more mature data from the EMERGE Phase 2b study in the fourth

Complete Phase 1 accrual of the CDX-301 healthy volunteer study in the

fourth quarter of 2012. Celldex plans to develop CDX-301 for

hematopoietic stem cell transplant.

Complete Phase 1 accrual of the solid tumor arm of the CDX-1127 study

in the fourth quarter of 2012.

Financial Highlights

Second Quarter Results