Celldex Reports First Quarter 2012 Financial Results NEEDHAM, Mass.--(BUSINESS WIRE)

Reports First Quarter 2012 Financial Results

NEEDHAM, Mass.--(BUSINESS WIRE)--May 3, 2012--Celldex Therapeutics, Inc.

(NASDAQ: CLDX) today reported financial results for the first quarter

ended March 31, 2012. Celldex reported a net loss of $13.5 million, or

$0.27 per share, for the first quarter of 2012 compared to a net loss of

$10.1 million, or $0.31 per share, for the first quarter of 2011. At

March 31, 2012, Celldex reported cash, cash equivalents and marketable

securities of $92.1 million, which the Company believes will be

sufficient to meet estimated working capital requirements and fund

planned program development into 2014, including enrollment of both the

pivotal ACT IV study and the ReACT Phase 2 study for rindopepimut

"In the first quarter of 2012, Celldex continued to advance multiple

late- and mid-stage product candidates," said Anthony S. Marucci,

President and Chief Executive Officer. "First, for rindopepimut, we have

made very real progress with our pivotal Phase 3 global registration

study in patients with newly diagnosed EGFRvIII-positive glioblastoma

(ACT IV) and our randomized Phase 2 study in recurrent EGFRvIII-positive

patients (ReACT). Second, in collaboration with Rockefeller University,

Celldex initiated a Phase 1 study of CDX-301 (Mobista ), a potent stem

cell mobilizer and dendritic cell growth factor, to support subsequent

trials for patients requiring hematopoietic stem cell transplantation.

On the business front, Celldex raised total net proceeds of $51.9

million which will provide continued financial support, particularly for

our later-stage product candidates."

First quarter and recent highlights:

Announced the initiation of patient screening to the ReACT study.

ReACT is a Phase 2 trial of rindopepimut in combination with Avastin

(bevacizumab) in patients with recurrent EGFRvIII-positive GB. This

study will run in parallel with Celldex's ACT IV study. The ReACT

study is expected to enroll approximately 95 patients in a first or

second relapse of GB following receipt of standard therapy and will

evaluate objective response rates (ORR), PFS and OS endpoints in this

patient population. Approximately 70 Avastin naive patients will be

randomized to receive Avastin along with either rindopepimut or a

control injection of KLH (Keyhole Limpet Hemocyanin) in a blinded

fashion. Additionally, 25 patients refractory to Avastin, having

progressed despite receiving Avastin in either the frontline or

recurrent setting, will receive rindopepimut plus Avastin in

a single treatment arm. The study will be conducted at approximately

20 sites across the United States.

Initiated a Phase 1 dose-escalation and safety study of CDX-301, or

MobistaTM, a hematopoietic growth factor, in healthy

subjects. The study is being conducted in collaboration with

Rockefeller University. CDX-301 is soluble, recombinant human FMS-like

tyrosine kinase 3 ligand (Flt3L) and previous human experience has

shown that it increases the numbers and activity of blood stem cells

and immune cells. The use of CDX-301 in hematopoietic transplantation

could lead to safer and more successful procedures and its various

effects on the immune system could also address many other indications.

Raised net proceeds of $8.5 million through the sale of 2.5 million

shares of common stock during January 2012 through a controlled equity

offering facility with Cantor Fitzgerald & Co.

Conducted a successful Research and Development Day in New York City

led by three key opinion leaders, which highlighted our oncology

pipeline. The webcast of our January R&D day presentation is available

on our website at http://www.celldextherapeutics.com.

Issued 12.1 million shares of our common stock in an over-subscribed

underwritten public offering resulting in net proceeds of

approximately $43.4 million.

The Company will disclose topline results from the EMERGE randomized

Phase 2b study of CDX-011 on May 23rd and will make preparations for

next steps in this program. Interim topline results include objective

response rate at 3 months. Mature data will be presented at an

appropriate scientific conference later this year. 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.

In the second half of 2012, Celldex expects to 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. DDD is a

rare and devastating kidney disease that 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.

Further Financial Highlights

The net loss of $13.5 million for the first quarter of 2012 represents

an increased loss of approximately $3.5 million when compared to the net

loss for the same period in 2011, primarily due to an increase in

research and development (R&D) expense in 2012.

Revenues for the first quarter of 2012 decreased when compared to

revenues in 2011, primarily because of lower product royalty revenues

In the first quarter of 2012, R&D expense increased by approximately

$3.9 million compared to the first quarter of 2011. Changes in R&D

expense between 2012 and 2011 reflect higher clinical trial costs of

$3.7 million primarily due to initiation and upfront expenses related to

the ACT IV and ReACT rindopepimut studies.

General and administrative (G&A) expense in 2012 of $2.3 million was

comparable to G&A expense in 2011 and included higher investor relations

expenses, offset in part by lower professional services fees in the

first quarter of 2012 compared to 2011.

During the quarter ended March 31, 2012, cash, cash equivalents and

marketable securities increased by approximately $38.8 million from

December 31, 2011, primarily due to our two financing transactions,