Celldex Reports First Quarter 2013 Financial Results
NEEDHAM, Mass., May 2, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc.
(Nasdaq:CLDX) today reported financial results for the first quarter ended
March 31, 2013. Celldex reported a net loss of $17.3 million, or $0.23 per
share, for the first quarter of 2013 compared to a net loss of $13.5 million,
or $0.27 per share, for the first quarter of 2012. At March 31, 2013, Celldex
reported cash, cash equivalents and marketable securities of $182.4 million,
which the Company believes will be sufficient to meet estimated working
capital requirements and fund planned program development through 2015.
"This year will be significant for Celldex as we continue to advance multiple
clinical programs, including registration studies in both brain and breast
cancer," said Anthony S. Marucci, President and Chief Executive Officer of
Celldex Therapeutics. "We are well on track to initiate the accelerated
approval study of CDX-011 in triple negative breast cancers that over-express
GPNMB later this year and remain pleased with the pace of enrollment in both
our Phase 3 study in frontline glioblastoma and our Phase 2 study in
refractory glioblastoma. In addition, by year-end we expect data from three
clinical studies—our Phase 2 study of rindopepimut in refractory glioblastoma,
our pilot study of CDX-1135 in dense deposit disease and our ongoing Phase 1
study of CDX-1127 in both solid tumors and hematologic malignancies.
Importantly, these programs and others in our pipeline are well-financed given
the successful completion of our $114.1 million capital raise in the first
First Quarter and Recent Pipeline Highlights:
*Continued to open clinical sites to support enrollment in the Phase 3 ACT
IV study and the Phase 2 ReACT study of rindopepimut in glioblastoma.
*Advanced plans for the initiation of a randomized, accelerated approval
study of CDX-011 in patients with triple negative breast cancers that
*Continued to enroll patients in the dose-escalation portion of the
lymphoma and leukemia arm of the Phase 1 portion of the CDX-1127. The
Company is currently planning the initiation of expansion studies in the
solid tumor arm.
*Presented results from an in vitro study of CDX-1127 that further
confirmed the mechanism of action for CDX-1127 and provided additional
support for continued clinical development of the candidate in a poster
session at the AACR Annual Meeting in April.
*Presented final results from a Phase 1 multi-dose study of CDX-301
(rhuFlt3L) in healthy volunteers that demonstrated that CDX-301 was
well-tolerated and effectively mobilized hematopoietic cell populations in
an oral presentation at the 2013 BMT Tandem Meetings in February.
*Raised net proceeds of $114.1 million in the first quarter of 2013 to
support operations and clinical development activities through 2015.
Key 2013 Objectives
*Complete global recruitment in the ACT IV registration study of
rindopepimut in front line glioblastoma and in the ReACT study of
rindopepimut in combination with Avastin in patients with
recurrent/refractory EGFRvIII-positive glioblastoma. Announce results from
the ReACT study by year-end.
*Initiate a randomized, accelerated approval study of CDX-011 in patients
with triple negative breast cancers that over-express GPNMB in the second
half of 2013.
*Complete enrollment of the Phase 1 dose-escalation and expansion studies
of CDX-1127 in patients with selected malignant solid tumors or
hematologic cancers and determine next steps for this program. Report data
from this study in the second half of 2013.
*Initiate a pilot study of CDX-1135 in dense deposit disease, an orphan
renal disease in children and young adults, with data expected in the
second half of 2013.
*Initiate a pilot clinical study of CDX-301 in hematopoietic stem cell
transplant in the second half of 2013.
*Initiate a Phase 2 study of CDX-1401 in combination with CDX-301 sponsored
by the Cancer Immunotherapy Trials Network of the National Cancer
Further Financial Highlights
The net loss of $17.3 million for the first quarter of 2013 represents an
increased loss of approximately $3.8 million when compared to the net loss for
the same period in 2012 and is primarily due to higher research and
development (R&D) and general and administrative (G&A) expenses in 2013
related to the rindopepimut program.
Revenues for the first quarter of 2013 were consistent with revenues recorded
in the first quarter of 2012.
In the first quarter of 2013, R&D expense increased by $3.3 million compared
to 2012 and was primarily a result of increased clinical trial costs of $2.3
million and contract manufacturing costs of $0.5 million primarily due to our
late-stage rindopepimut program.
G&A expense in the first quarter of 2013 increased by $0.8 million from $2.3
million in 2012 due primarily to higher personnel-related expenses and
rindopepimut-related commercial planning costs in 2013.
During the quarter ended March 31, 2013, the increase in cash, cash
equivalents and marketable securities of $98.4 million from December 31, 2012
primarily reflects the issuance of 16.2 million shares of common stock during
the quarter through our Cantor ATM facility and an underwritten public
offering that raised aggregate net proceeds to Celldex of $114.1 million,
partially offset by our first quarter operations-related cash burn of
approximately $16.1 million.
As of March 31, 2013, Celldex had approximately 80.9million shares
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline is built from a
proprietary portfolio of antibodies and immunomodulators used alone and in
strategic combinations to create novel, disease-specific therapies that
induce, enhance or suppress the body's immune response. Visit
Safe Harbor Statement Under the Private Securities Litigation Reform Act of
1995: This release contains "forward-looking statements" made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of
1995, including those related to the Company's strategic focus and the future
development and commercialization (by Celldex and others) of rindopepimut
(CDX-110), CDX-011, CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat and
other products. Forward-looking statements reflect management's current
knowledge, assumptions, judgment and expectations regarding future performance
or events. Although management believes that the expectations reflected in
such statements are reasonable, they give no assurance that such expectations
will prove to be correct and you should be aware that actual results could
differ materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and uncertainties,
including, but not limited to, our ability to successfully complete research
and further development and commercialization of rindopepimut, CDX-011 and
other drug candidates, our ability to obtain additional capital to meet our
long-term liquidity needs on acceptable terms, or at all, including the
additional capital which will be necessary to complete the clinical trials
that we have initiated or plan to initiate; our ability to adapt our APC
Targeting Technology^TM to develop new, safe and effective vaccines against
oncology and infectious disease indications; our ability to successfully
complete product research and further development of our programs; the
uncertainties inherent in clinical testing; our limited experience in bringing
programs through Phase 3 clinical trials; our ability to manage research and
development efforts for multiple products at varying stages of development;
the timing, cost and uncertainty of obtaining regulatory approvals; the
failure of the market for the Company's programs to continue to develop; our
ability to protect the Company's intellectual property; the loss of any
executive officers or key personnel or consultants; competition; changes in
the regulatory landscape or the imposition of regulations that affect the
Company's products; and other factors listed under "Risk Factors" in our
annual report on Form 10-K.
All forward-looking statements are expressly qualified in their entirety by
this cautionary notice. You are cautioned not to place undue reliance on any
forward-looking statements, which speak only as of the date of this release.
We have no obligation, and expressly disclaim any obligation, to update,
revise or correct any of the forward-looking statements, whether as a result
of new information, future events or otherwise.
CELLDEX THERAPEUTICS, INC.
(In thousands, except per share amounts)
CONSOLIDATED STATEMENT Quarter
OF OPERATIONS DATA Ended March 31,
Product Development and Licensing Agreements $30 $35
Contracts and Grants 50 54
Product Royalties 2,334 2,344
Total Revenue 2,414 2,433
Research and Development 14,090 10,769
Royalty 2,334 2,344
General and Administrative 3,138 2,317
Amortization of Acquired Intangible Assets 253 291
Total Operating Expense 19,815 15,721
Operating Loss (17,401) (13,288)
Investment and Other Income, Net 379 205
Interest Expense (310) (433)
Net Loss $(17,332) $(13,516)
Basic and Diluted Net Loss per
Common Share $(0.23) $(0.27)
Weighted Average Common
Shares Outstanding 74,027 50,145
BALANCE SHEETS DATA March 31, December 31,
Cash, Cash Equivalents and Marketable Securities $182,377 $83,962
Other Current Assets 2,076 1,152
Property and Equipment, net 7,131 7,205
Intangible and Other Assets, net 32,781 33,222
Total Assets $224,365 $125,541
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities $18,330 $17,685
Long-Term Liabilities 11,094 12,082
Stockholders' Equity 194,941 95,774
Total Liabilities and Stockholders' Equity $224,365 $125,541
CONTACT: Sarah Cavanaugh
Vice President of Investor Relations &
Celldex Therapeutics, Inc.
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