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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 quarter."

First Q uarter and R ecent Pipeline H ighlights:

The Company
  • 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 over-express GPNMB.
  • 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 Institute.

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.

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