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Celldex Reports Fourth Quarter and Fiscal 2008 Financial Results - Conference Call Friday, February 27, at 9:00 a.m. Eastern Time - NEEDHAM, Mass.--(BUSINESS WIRE)

Key Takeaway: Reports Fourth Quarter and Fiscal 2008 Financial Results Conference Call Friday, February 27, at 9:00 a.m. Eastern Time - NEEDHAM, Mass.--(BUSINESS WIRE)--February 27, 2009--Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the fourth quarter and

Full Press Release Details

Reports Fourth Quarter and Fiscal 2008 Financial Results
Conference Call Friday, February 27, at 9:00 a.m. Eastern Time -
NEEDHAM, Mass.--(BUSINESS WIRE)--February 27, 2009--Celldex
Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for
the fourth quarter and year ended December 31, 2008. Celldex reported a
net loss of $7.5 million, or $0.47 per share, for the fourth quarter of
2008 compared to a net loss of $4.2 million, or $0.51 per share, for the
fourth quarter of 2007. For the year ended December 31, 2008, Celldex
reported a net loss of $47.5 million, or $3.34 per share, compared to a
net loss of $15.1 million, or $1.81 per share, for the year ended
December 31, 2007. On March 7, 2008, privately-held Celldex
Therapeutics, Inc. completed its merger with a wholly-owned subsidiary
of AVANT Immunotherapeutics and, effective October 1, 2008, AVANT
changed its name to Celldex Therapeutics, Inc.
The 2007 financial results reflect the activities of pre-merger,
privately-held Celldex only. As discussed in further detail later in
this release, the change in net loss between the three-month periods was
primarily due to increased operating expenses as a result of the merger
of AVANT and Celldex, offset by increased revenues, investment and other
income. The increase in net loss between fiscal years reflects increased
operating expenses for the combined companies and non-cash charges of
$19.6 million, or $1.38 per share, relating to $14.8 million of
purchased in-process research and development and $4.8 million of
stock-based compensation expense.
At December 31, 2008, Celldex reported cash and cash equivalents of
$44.3 million. This amount includes a $10.0 million milestone payment
received during the fourth quarter from Paul Capital Healthcare upon
GlaxoSmithKline's U.S. launch of Rotarix . The Company believes that its
cash and cash equivalents and expected sources of revenue will be
sufficient to meet estimated working capital requirements and fund
operations through 2010.
"We believe our Precision Targeted Immunotherapy platform has the
ability to open a new era in immunotherapy and potentially address a
number of difficult-to-treat diseases," said Anthony S. Marucci,
Celldex's President and Chief Executive Officer. "To this end, in 2008,
we made significant progress advancing this platform and our pipeline,
including entering into a substantial partnership with Pfizer and
completing multiple strategic licensing arrangements to access
synergistic technologies to enhance our core technology. At the same
time we sold or out-licensed non-core assets to narrow our strategic
focus. In 2009, we remain focused on advancing our ongoing clinical
trials in glioblastoma multiforme (GBM) and in breast, colorectal,
pancreatic, ovarian and bladder cancers and will move additional
candidates from our Precision Targeted Immunotherapy Pipeline into
clinical trials in the third quarter. Likewise, the strength of our cash
position allows us to continue to explore in-licensing and business
development opportunities that we believe support the discovery,
development and commercialization of targeted immunotherapies."
Fourth quarter and recent highlights:
Amended the ongoing ACT III clinical trial for CDX-110 in patients
with newly diagnosed GBM to convert the study to a single-arm Phase 2
clinical trial in which all patients receive the study medication in
combination with the current standard of care, temozolomide. ACT III
will continue to enroll to approximately 60 patients. The Company's
decision to amend was based on the observation that the majority of
patients randomized to the control (temozolomide alone) arm withdrew
after learning they were not on the active arm of this open-label
Announced initial results from multi-center Phase 1 clinical trials of
its cancer vaccine candidate, CDX-1307, combined with GM-CSF in
patients with advanced breast, lung, bladder or pancreatic cancers.
Based on the safety and immunogenicity seen in these dose escalation
studies, the Company intends to initiate a Phase 2 clinical trial of
CDX-1307 in combination with selected TLR agonists in the second half
Entered into a license agreement with the University of Southampton,
U.K., to develop human antibodies towards CD27, a potentially
important target for immunotherapy of various cancers.
Received a $10.0 million milestone payment from Paul Capital
Healthcare on October 1, 2008, triggered by GlaxoSmithKline's U.S.
market launch of Rotarix .
Divested non-core assets-entered into a worldwide fee- and
royalty-bearing exclusive license and development agreement with
Vaccine Technologies, Inc. (VTI) to develop and commercialize
Celldex's CholeraGarde and ETEC vaccine programs and sold our poultry
Further Financial Highlights
The net loss of $7.5 million for the fourth quarter of 2008 increased
$3.2 million when compared to the net loss for the same period in 2007.
The 2008 net loss reflected an increase in operating expenses, which
includes the combined operations of AVANT and Celldex post-merger,
offset in part by an increase in revenues and an increase in investment
and other income when compared to 2007. Research and development (R&D)
expenses in the fourth quarter of 2008 increased by $6.0 million
compared to R&D expenses in 2007 due primarily to increased
personnel-related expenses, royalty and license fee expenses, clinical
trials costs for CDX-110 and CDX-1307 and facility-related costs.
General and administrative (G&A) expenses of $2.9 million in 2008
approximated G&A expense of $3.0 million in the fourth quarter of 2007.
The twelve-month results for 2008 reflect an increase of $32.4 million
in net loss compared to the same period in 2007. The increase in net
loss reflects an increase in operating expenses due primarily to the
combined operating expenses of the two companies from March 8 to
December 31, 2008, and includes non-cash charges of $14.8 million for
purchased in-process R&D and $1.6 million and $3.2 million for
stock-based compensation expense in R&D and G&A expense, respectively.
The increase in operating expenses also resulted from higher G&A
expenses, which is primarily due to increases in personnel-related
expenses and professional services costs for the combined companies. The
increase in net loss was offset in part by an increase in investment and
Revenues for 2008 increased by $6.0 million compared with revenues for
2007. The increase in product development and licensing revenue in 2008
primarily reflects recognition of $2.9 million in Pfizer deferred
Last updated: Feb 27, 2009