Celldex Reports Third Quarter 2013 Financial Results
"As we approach year-end, Celldex is well positioned to achieve a number of milestones that will play an important role in advancing our pipeline into 2014 and beyond," said
Rindopepimut in EGFRvIII(v3)—Positive Glioblastoma (GBM):
Celldex continues to actively enroll newly diagnosed patients with GBM in the Phase 3 ACT IV registration study.
In August, the Company announced that it had completed enrollment of Group 2 (Avastin® refractory patients) in the ReACT study and that, based on early evidence of anti-tumor activity, an expansion cohort of up to 75 patients would be added to better characterize the potential activity of rindopepimut in this refractory patient population. Enrollment is ongoing in this expansion cohort and in Group 1 (Avastin naive patients). Celldex will report data from the ReACT study in an oral presentation at the
Society for Neuro-Oncology(SNO) Annual Meeting on Sunday, November 24, 2013.
Celldex will host a conference call on
Monday, November 25, 2013at 8:30 am ETto provide a program update and discuss the data presented at SNO.
Glembatumumab vedotin ("glemba"; CDX-011) in Breast Cancers that Over-express GPNMB
Celldex continues to advance plans for the METRIC study, a randomized, accelerated approval study of glemba in patients with triple negative breast cancers that over-express GPNMB. The study is expected to initiate by year-end 2013 and will be conducted in approximately 100 sites, primarily in
the United Stateswith additional sites in Canadaand Australia.
CDX-1127 Targeting CD27 in Solid Tumors and Hematologic Malignancies
Enrollment continues in the Phase 1 dose-escalation study of CDX-1127. Celldex will present data from this study in poster sessions at the
Society for Immunotherapy of Cancer Meeting(SITC) on Saturday, November 9, 2013. The Company will also present preclinical data on combination studies of CDX-1127, including chemotherapies and checkpoint inhibitors, in a poster session at SITC on Friday, November 8, 2013.
Celldex hosted a conference call on
Thursday, November 7, 2013to provide a program update and discuss the data to be presented at SITC. The results from the Phase 1 dose-escalation study suggest an excellent safety profile and demonstrate clear biologic activity and promising signs of clinical activity in an advanced, refractory patient population. Based on the data, after completing the dose-escalation study and its corresponding expansion cohorts, the Company intends to initiate additional studies of CDX-1127.
CDX-1135 in Dense Deposit Disease (DDD)
The Company's pilot study of CDX-1135 (a soluble form of human complement receptor type 1) in DDD is ongoing. DDD is an ultra-rare, progressive kidney disease that ultimately results in kidney failure in the majority of affected individuals. The Company anticipates presenting a program update on our year-end conference call in
Celldex continues to advance plans to initiate a pilot clinical study of CDX-301 (Flt3L) in hematopoietic stem cell transplant (HSTC) that will build upon ongoing work with Mozobil (plerixafor) and anticipates this study will begin in early 2014.
The Company is planning a collaborative Phase 2 study of CDX-1401 in combination with CDX-301 in malignant melanoma. This study will be conducted under a cooperative research and development agreement (CRADA) with the Cancer Immunotherapy Trials Network (CITN) and the Cancer Therapy Evaluation Program (CTEP) of the
National Cancer Institute.
Further Financial Highlights
Third Quarter and First Nine Months 2013 Results
Total revenue in the third quarter of 2013 was
Research and development (R&D) expenses in the third quarter of 2013 were
General and administrative (G&A) expenses in the third quarter of 2013 were
Avastin is a registered trademark of
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 www.celldex.com.
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), Glembatumumab vedotin ("glemba"; 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, glemba 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 TechnologyTM 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.
|(In thousands, except per share amounts)|
|CONSOLIDATED STATEMENTS||Quarter||Nine Months|
|OF OPERATIONS DATA||
|Product Development and|
|Licensing Agreements||$ 40||$ 28||$ 117||$ 103|
|Contracts and Grants||940||79||1,040||228|
|Research and Development||20,417||11,769||49,597||33,650|
|General and Administrative||3,578||2,835||10,128||7,372|
|Amortization of Acquired Intangible Assets||254||254||760||836|
|Total Operating Expense||24,249||17,864||62,819||49,082|
|Investment and Other Income, Net||142||105||682||436|
|Net Loss||$ (23,140)||$ (15,027)||$ (59,488)||$ (42,316)|
|Basic and Diluted Net Loss per Common Share||$ (0.29)||$ (0.25)||$ (0.76)||$ (0.75)|
|Weighted Average Common Shares Outstanding||81,015||59,467||78,676||56,090|
|Cash, Cash Equivalents and Marketable Securities||$ 136,588||$ 83,962|
|Other Current Assets||3,358||1,152|
|Property and Equipment, net||8,814||7,205|
|Intangible and Other Assets, net||32,195||33,222|
|Total Assets||$ 180,955||$ 125,541|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current Liabilities||$ 16,795||$ 17,685|
|Total Liabilities and Stockholders' Equity||$ 180,955||$ 125,541|
Sarah CavanaughVice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc.(781) 433-3161 firstname.lastname@example.org
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