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Celldex Reports Second Quarter and Six Month 2009 Financial Results - Conference Call Wednesday, August 5, at 9:00 a.m. Eastern Time - NEEDHAM, Mass.--(BUSINESS WIRE)

Key Takeaway: Reports Second Quarter and Six Month 2009 Financial Results Conference Call Wednesday, August 5, at 9:00 a.m. Eastern Time - NEEDHAM, Mass.--(BUSINESS WIRE)--August 5, 2009--Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the second quarter and

Full Press Release Details

Reports Second Quarter and Six Month 2009 Financial Results
Conference Call Wednesday, August 5, at 9:00 a.m. Eastern Time -
NEEDHAM, Mass.--(BUSINESS WIRE)--August 5, 2009--Celldex Therapeutics,
Inc. (NASDAQ: CLDX) today reported financial results for the second
quarter and six-month period ended June 30, 2009. Celldex reported a net
loss of $8.7 million, or $0.55 per share, for the second quarter of 2009
compared to a net loss of $10.3 million, or $0.67 per share, for the
second quarter of 2008. For the six months ended June 30, 2009, Celldex
reported a net loss of $16.4 million, or $1.04 per share, compared to a
net loss of $32.4 million, or $2.56 per share, for the six months ended
June 30, 2008. At June 30, 2009, Celldex reported cash and cash
equivalents of $31.6 million.
On May 29, 2009, Celldex Therapeutics announced that the Company has
entered into a definitive agreement to acquire CuraGen Corporation
(NASDAQ: CRGN). The transaction, subject to shareholder approval, is
expected to close in the third quarter of 2009.
"Celldex launched a major strategic initiative one year ago to acquire a
series of selected assets to fuel our Precision Targeted Immunotherapy
Platform for future growth," said Anthony S. Marucci, Celldex's
President and Chief Executive Officer. "The proposed acquisition of
CuraGen - the fourth and most significant transaction of the last twelve
months - fulfills this initiative and adds a portfolio of
oncology-focused antibodies to our platform and substantial cash
The second quarter also brought considerable progress in our current
clinical development programs as we presented data on multiple studies
at the American Society of Clinical Oncology Annual Meeting including
poster presentations on updated results from Phase 2 studies of our lead
candidate, CDX-110 in glioblastoma multiforme, and an oral presentation
on CDX-1307, the first antibody-based dendritic cell targeted vaccine
resulting from our platform. As we transition to the second half of
2009, we believe we are very well positioned with a pipeline of
immunotherapy-based product candidates, multiple upcoming value-driving
milestones and a strong balance sheet, made stronger by the CuraGen
merger," concluded Marucci.
Second quarter and recent highlights:
Delivered an oral presentation at the American Society of Clinical
Oncology (ASCO) Annual Meeting in Orlando, Florida on data from the
CDX-1307 Phase 1 studies in combination with multiple immune
modulators from Celldex's proprietary platform, including recently
in-licensed assets that demonstrated a favorable safety profile and
strong immune responses.
Presented mature data at ASCO from the Phase 2 ACTIVATE trial (n=21)
and updated data from the continuation study, ACT II (n=23), of
CDX-110 in patients with newly diagnosed EGFRvIII-positive
glioblastoma multiforme (GBM). In both studies, CDX-110 was generally
well-tolerated with local injection site reactions being the most
commonly reported toxicity.
In the single-arm Phase 2 ACTIVATE study, median overall survival
(OS) was 26 months and median time to progression (TTP) was 14.2
months. Additionally, three patients remain without relapse more
than four years from surgery and continue to receive the vaccine
within the clinical trial.
In the single-arm Phase 2 ACT II study, median TTP is 15.2 months
and three patients continue without relapse after more than two
years. Results to date from this ongoing study estimate median OS
to be 23.6 months. In addition, and in line with preclinical data
that suggested the combination of CDX-110 with temozolomide could
augment immune responses, patients demonstrate clear serological
evidence of an immune response against EGFRvIII.
Enhanced our Precision Targeted Immunotherapy Platform by:
Acquiring exclusive rights to the immune-stimulatory molecules
FMS-like tyrosine kinase 3 ligand (Flt3L) and CD40 ligand (CD40L)
Announcing the definitive agreement to acquire CuraGen Corporation
in a stock-for-stock transaction, which values CuraGen at
approximately $93.5 million to $94 million, subject to certain
adjustments described within the definitive agreement. In addition
to its pipeline of oncology-focused antibodies, CuraGen is
expected to have a cash balance of approximately $53.5 million to
$54 million net of certain acquisition-related costs and CuraGen
convertible debt at the transaction's close.
Further Financial Highlights
The net loss of $8.7 million for the second quarter of 2009 represents a
decrease of $1.6 million when compared to the net loss for the same
period in 2008 and is primarily due to an increase in revenue and a
decrease in operating expense. R&D expense in the second quarter of 2009
increased by $0.2 million compared to R&D expense in 2008 due primarily
to increased personnel-related expenses, laboratory materials and
services and clinical trials costs for CDX-110 and CDX-1307. G&A
expenses in the second quarter of 2009 decreased by $1.1 million to $3.5
million as compared to $4.6 million in 2008, primarily due to a decrease
in personnel-related expenses in 2009. G&A expenses for this quarter
included approximately $1 million, or $0.06 per share, of transaction
expenses recorded in connection with the CuraGen acquisition.
The net loss of $16.4 million for the first six months of 2009
represents an improvement of $16.0 million when compared to the net loss
for the same period in 2008, primarily due to the non-cash charge of
$14.8 million for purchased in-process R&D recorded in 2008. R&D expense
in the first six months of 2009 increased by $4.4 million compared to
R&D expense in 2008 due primarily to the combined operations of AVANT
and Celldex for the full six-month period in 2009, including increased
personnel-related expenses, royalty and license fee expenses, clinical
trials costs for CDX-110 and CDX-1307 and facility-related costs. G&A
expenses decreased by $0.8 million to $6.9 million in 2009 as compared
to G&A expense of $7.6 million in the first six months of 2008,
primarily due to reduced personnel-related expenses.
Revenues for the first six months of 2009 increased by $4.3 million
compared with revenues for 2008. The increase in product development and
licensing revenue in 2009 primarily reflects recognition of $2.1 million
in Pfizer deferred revenue related to CDX-110 in 2009. The decrease in
contracts and grants revenue in 2009 compared to 2008 primarily reflects
Last updated: Aug 5, 2009