Celldex Reports Third Quarter 2010 Financial Results NEEDHAM, Mass.--(BUSINESS WIRE)

Reports Third Quarter 2010 Financial Results

NEEDHAM, Mass.--(BUSINESS WIRE)--November 2, 2010--Celldex Therapeutics,

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

quarter ended September 30, 2010. Celldex reported a net loss of $9.1

million, or $0.28 per share, for the third quarter of 2010 compared to a

net loss of $7.2 million, or $0.45 per share, for the third quarter of

2009. For the nine months ended September 30, 2010, Celldex reported a

net loss of $25.2 million, or $0.79 per share, compared to a net loss of

$23.6 million, or $1.49 per share, for the nine months ended September

30, 2009. At September 30, 2010, Celldex reported cash, cash equivalents

and marketable securities of $57.7 million, a decrease of $8.1 million

from June 30, 2010. The decrease is due primarily to operational

expenses, $0.3 million in severance payments related to the CuraGen

acquisition and $0.5 million in capital expenditures made during the

third quarter of 2010. Remaining severance payments of $0.2 million and

$0.7 million will be made in 2010 and 2011, respectively.

Celldex believes that expected cash inflows from interest income on

invested funds, an anticipated refinancing of outstanding debt, an

anticipated milestone payment, taken together with our current cash,

cash equivalents and marketable securities at September 30, 2010 are

sufficient to meet estimated working capital requirements and fund

planned operations into 2012, including clinical development costs for

rindopepimut (CDX-110) anticipated to be paid during that period.

"Importantly, effective November 1, 2010, Celldex has regained rights to

develop and commercialize rindopepimut. Rindopepimut is widely perceived

by clinicians as one of the most promising drug candidates for patients

with Glioblastoma Multiforme-a population with very limited treatment

options. We believe we can advance the program at a pace that most

appropriately reflects its considerable value proposition and market

opportunity-which should benefit patients with GBM and our

shareholders-and we are well positioned to advance rindopepimut into a

pivotal study by the second half of 2011," said Anthony S. Marucci,

Celldex's President and Chief Executive Officer. "In addition, during

the third quarter of 2010, Celldex initiated a Phase 2b study of

CDX-011, our antibody-drug conjugate, in advanced, refractory breast

cancer patients and presented promising initial clinical data from a

Phase 1/2 dose-escalating clinical trial of our CDX-1401 vaccine in

Third quarter highlights:

In September, Celldex announced that it would regain rights to develop

and commercialize rindopepimut from Pfizer, effective November 1,

2010. Rindopepimut is an experimental therapeutic cancer vaccine that

targets the tumor-specific molecule epidermal growth factor receptor

variant III (EGFRvIII) in patients with Glioblastoma Multiforme (GBM).

In September, Celldex initiated a 120 patient randomized Phase 2b

controlled study of CDX-011 (glembatumumab vedotin), the Company's

antibody drug conjugate for the treatment of patients with

glycoprotein NMB (GPNMB) expressing advanced, refractory breast

cancer. CDX-011 targets the protein GPNMB, which is over expressed in

a variety of cancers including breast cancer, melanoma and brain

tumors. Patients are being randomized (2:1) to receive either CDX-011

or single-agent "Investigator's Choice" chemotherapy. Study endpoints

include response rate, progression-free survival and overall survival.

The study is being conducted in approximately 25 academic and

community sites across the U.S and enrollment is expected to be

completed by Q4 2011.

The Company and its collaborators presented positive, preliminary data

from the CDX-1401 Phase 1/2 study at the iSBTc Annual Meeting in

October. CDX-1401 is a novel antibody-based targeted cancer vaccine

candidate being evaluated as a treatment for patients with melanoma

and other cancers known to express the tumor antigen NY-ESO-1.

CDX-1401 was well tolerated and there were no dose-limiting

toxicities. Robust anti-NY-ESO-1 immunity was induced with the

majority of the patients developing anti-NY-ESO-1 antibody responses

and 39% of the patients experiencing increases in NY-ESO-1 specific T

cell responses including both CD4 and CD8 responses. Importantly, the

T cell responses were directed against multiple regions of the

NY-ESO-1 antigen. Based on these results, the Company is conducting

ongoing cohorts of CDX-1401 in combination with additional TLR

agonists including with poly-ICLC (HiltonolTM), a potent

TLR3 agonist and stimulator of immune cells.

Fourth quarter and upcoming events:

On November 1, 2010, Celldex received notice from the IRS that it has

been awarded Qualifying Therapeutic Discovery Project (QTDP) grants

totaling approximately $1.7 million from the U.S. government related

to seven of the Company's projects, including rindopepimut, CDX-011,

CDX-1307, CDX-1401, CDX-1135, CDX-301 and CDX-1127.

At the Society of Neuro-Oncology Annual Meeting being held November

18-21, 2010 in Montreal, Celldex expects to present final data on the

5.5-month Progression Free Survival (PFS) rate from all 65 patients

enrolled in the rindopepimut ACT III study as well as an update on

Overall Survival (OS) data from this study. Final OS data from the ACT

II study will also be presented. These data will provide additional

information that will allow us to better design the future clinical

development of rindopepimut. Celldex is currently planning to initiate

a Phase 3 randomized study of rindopepimut in patients with GBM by the

second half of 2011.

In the fourth quarter of 2010, Celldex expects to complete the

renovations of its Fall River, MA, manufacturing facility, increasing

its capacity by installing a 1000L bioreactor and making the facility

EMEA compliant. Implementing EMEA requirements along with US GMPs will

allow Celldex to distribute potential products to clinical sites in

Further Financial Highlights

Third Quarter Results

The net loss of $9.1 million for the third quarter of 2010 represents an

increased loss of $1.9 million when compared to the net loss for the

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

development (R&D) as a result of the advancement and expansion of

Celldex's clinical pipeline, amortization and interest expenses in the

third quarter of 2010, offset partially by decreases in revenues,

royalty and general and administrative (G&A) expenses.