Full Press Release Details
Reports Second Quarter 2011 Financial Results and Announces Finalization
of Rindopepimut Pivotal Program Design
Management to Host Conference Call Today at 8:30 AM Eastern Time -
NEEDHAM, Mass.--(BUSINESS WIRE)--August 3, 2011--Celldex Therapeutics,
Inc. (NASDAQ: CLDX) today reported financial results for the second
quarter ended June 30, 2011. Celldex reported a net loss of $10.2
million, or $0.27 per share, for the second quarter of 2011 compared to
a net loss of $9.5 million, or $0.30 per share, for the second quarter
of 2010. For the six months ended June 30, 2011, Celldex reported a net
loss of $20.3 million, or $0.58 per share, compared to a net loss of
$16.1 million, or $0.51 per share, for the six months ended June 30,
At June 30, 2011, Celldex reported cash, cash equivalents and marketable
securities of $71.2 million, an increase of $26.9 million from March 30,
2011. The increase is due primarily to completion of an underwritten
public offering in May, which resulted in net proceeds to Celldex of
$33.7 million. The increase was partially offset by operational expenses
during the quarter. Celldex believes that interest income on invested
funds and current cash, cash equivalents and marketable securities as of
June 30, 2011 are sufficient to meet estimated working capital
requirements and fund planned operations into 2013.
"Celldex achieved critical milestones across multiple corporate
objectives," said Anthony S. Marucci, President and Chief Executive
Officer of Celldex. "Most importantly, after consultation with both US
and EU regulatory authorities, we have finalized the protocol for the
Phase 3 study of rindopepimut in glioblastoma, which will be called ACT
IV, and expect to begin enrollment by year-end 2011. In addition, we
also secured the financial means to support the initiation of ACT IV
while maintaining the forward momentum of our other pipeline programs,
netting a total of $33.7 million in an over-subscribed public offering.
The significant progress made in the first half of 2011 will support a
number of important events over the next 18 months."
Second quarter and recent highlights:
Finalized the protocol for the ACT IV Phase 3 randomized,
KLH-controlled, double-blind study of rindopepimut. KLH is a
biologically active compound that is being utilized to mimic the overt
signs of injection site reaction associated with rindopepimut. The
primary endpoint of the study will be overall survival. The study is
expected to enroll up to 374 patients with newly-diagnosed,
resected, EGFRvIII expressing glioblastoma multiforme (GBM) at over
150 clinical sites internationally. Enrollment is expected to begin in
the second half of 2011.
Continued brisk enrollment of the 120 patient, randomized Phase 2b
study of CDX-011 in patients with glycoprotein NMB (GPNMB)-expressing
advanced, refractory breast cancer, including triple negative disease.
This study is on track to fully accrue by year-end 2011.
Completed an underwritten public offering in May of 11.5 million
shares of common stock, which netted proceeds to Celldex of
approximately $33.7 million, after deducting underwriting discounts,
commissions and other estimated offering expenses payable by Celldex.
The over-allotment was fully exercised.
Hired Ronald A. Pepin, Ph.D., as Senior Vice President and Chief
Business Officer, who formerly served as Vice President at Shire and
previous as Senior Vice President, Business Development at Medarex,
where he completed more than 40 major transactions.
Based on Celldex's ongoing commitment to prioritize the allocation of
resources and to focus on its lead programs, the Company has determined
that the best path forward for CDX-1307 is to make the candidate
available for collaborative development. As such, Celldex has
discontinued the Company-sponsored Phase 2 study of CDX-1307 in newly
diagnosed muscle-invasive bladder cancer.
The Company expects to present final median overall survival data from
the rindopepimut ACT III study at the Annual Meeting of the Society
for Neuro-Oncology to be held November 17-20, 2011 in Orange County,
Celldex expects to initiate four new clinical trials by year-end 2011:
Phase 3 randomized, KLH-controlled, double-blind study of
rindopepimut in patients with newly-diagnosed, resected GBM that
express EGFRvIII. The ACT IV study is expected to enroll up to 374
patients at over 150 clinical sites internationally.
Phase 2 randomized study of rindopepimut alone or in combination
with Avastin in recurrent or refractory GBM
Phase 1 study of CDX-1127, Celldex's first therapeutic antibody
program, in patients with solid tumors or hematologic cancers.
CDX-1127 is a fully human monoclonal antibody targeting CD27.
Phase 1 trial of CDX-301, an immune and stem cell growth factor,
in healthy subjects in collaboration with a leading academic
institution. Celldex's first priority is to develop this molecule
for hematopoietic stem cell transplant, where it has demonstrated
improvement of immune cell reconstitution in preclinical in vivo
Further Financial Highlights:
Second Quarter Results
The net loss of $10.2 million for the second quarter of 2011 represents
an increase of $0.7 million when compared to the net loss for the same
period in 2010, primarily due to decreases in revenues and increases in
interest expense, partially offset by decreases in research and
development (R&D), amortization and general and administrative (G&A)
Revenues for the second quarter of 2011 decreased when compared to the
second quarter of 2010 due primarily to $1.3 million in Pfizer non-cash
deferred revenue related to rindopepimut recognized in 2010.
R&D expenses in the second quarter of 2011 and 2010 were $7.2 million
and $7.3 million, respectively. Changes in R&D expenses between 2011 and
2010 primarily reflect higher costs related to personnel, the ACT III
and ACT IV rindopepimut clinical trials (2010 costs for ACT III were
funded by Pfizer), and laboratory supplies and services in 2011, offset
by lower contracted research and contract manufacturing expenses as well
as lower license/milestone payments to licensors in 2011.
Royalty expense includes product royalty and sublicense royalty fees on
the Company's out-licensed programs. The $0.2 million increase in
royalty expenses in 2011 primarily reflects an increase in Rotarix -related
royalty fees. Retained interests in Rotarix net
royalties, which were not sold to Paul Royalty Fund, are recorded as