Celldex Therapeutics Reports Revenue Of $2.4m In Q3 2011
Announced Date : Nov 02 2011
Celldex Therapeutics, Inc. (Celldex) reported a total revenue of $2.36m in the third quarter of 2011 compared to $2.41m in the same period of 2010. Net loss was $11.77m, or $0.27 per share, in the third quarter of 2011, compared to a net loss of $9.1m, or $0.28 per share, in the same period of 2010.
R&D expenses were $8.6m in the third quarter of 2011 compared to $7.22m in the same period of 2010. General and administrative expenses were $2.27m in the third quarter of 2011 compared to $2.42m in the same period of 2010. Total operating expenses were $13.84m in the third quarter of 2011 compared to $11.3m in the same period of 2010.
The company reported a total revenue of $6.83m for the nine months ended September 30, 2011 compared to $9.07m for the same period of 2010. Net loss was $32.07m, or $0.85 per share, for the nine months ended September 30, 2011, compared to a net loss of $25.19m, or $0.79 per share, for the same period of 2010.
R&D expenses were $22.62m for the nine months ended September 30, 2011 compared to $20.91m for the same period of 2010. General and administrative expenses were $6.9m for the nine months ended September 30, 2011 compared to $7.85m for the same period of 2010. Total operating expenses were $37.85m for the nine months ended September 30, 2011 compared to $36.64m for the same period of 2010.
Anthony S Marucci, president and CEO of Celldex, said, "After discussions with FDA and EMA, we are on track to initiate our Phase 3 study of rindopepimut in EGFRvIII-expressing glioblastoma in December. The initiation of the pivotal rindopepimut program will be a major accomplishment for Celldex and our shareholders, while most importantly moving this promising candidate one step closer towards potential registration for the patients who suffer from this fatal disease. We will also initiate an additional Phase 2 clinical study of rindopepimut in combination with Avastin® by year end."
Recent highlights and upcoming milestone events:
• Concluded study design discussions with FDA and EMA and finalized the clinical protocol for the ACT IV Phase III randomized, KLH-controlled, double-blind study of rindopepimut.
• Continued brisk enrollment of the 120 patient, randomized Phase IIb 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.
• Announced orphan drug designation in the EU for rindopepimut which provides 10 years of market exclusivity from product launch in the EU, fee reductions, as well as access to the central authorization procedure. The EMA's orphan medicinal product designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. The company previously was awarded orphan drug status in the US which provides seven years of market exclusivity from product launch in the US as well as fast track designation.
• The company expects to present final median overall survival data from the rindopepimut Phase II multi-center ACT III study at the annual meeting of the society for neuro-oncology to be held November 17-20, 2011 in Orange County, California.
Celldex expects to initiate four new clinical trials by year-end 2011:
• Phase III randomized, KLH-controlled, double-blind study of rindopepimut in patients with newly-diagnosed, gross total resected glioblastoma (GB) that express EGFRvIII. The primary endpoint of the study will be overall survival. The ACT IV study is expected to enroll up to 374 patients at over 150 clinical sites internationally.
• Phase II randomized study of rindopepimut in combination with Avastin in recurrent or refractory glioblastoma patients (the ReACT study). The ReACT study is expected to enroll up to 95 patients in the US and will evaluate objective response rates (ORR), progression free survival (PFS) and overall survival (OS) endpoints in this patient population.
• Phase I 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 I trial of CDX-301, an immune and stem cell growth factor, in healthy subjects in collaboration with Rockefeller University. 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 models.