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Celldex Reports Fourth Quarter And Fiscal 2012 Financial Results

NEEDHAM, Mass., March 7, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported financial results for the fourth quarter and the year ended December 31, 2012. Celldex reported a net loss of $16.8 million, or ($0.27) per share, for the fourth quarter of 2012 compared to net loss of $12.7 million, or ($0.29) per share, for the fourth quarter of 2011. For the twelve months ended December 31, 2012, Celldex reported a net loss of $59.1 million, or ($1.02) per share, compared to a net loss of $44.8 million, or ($1.13) per share, for the twelve months ended December 31, 2011. At December 31, 2012, Celldex reported cash, cash equivalents and marketable securities of $84.0 million. Following recent financings, as of February 28, 2013, Celldex had cash, cash equivalents and marketable securities of approximately $189 million.

"Celldex ended 2012 reporting positive data from four clinical programs at major medical meetings, including final results from our Phase 2b study of CDX-011 in metastatic breast cancer," said Anthony Marucci, Chief Executive Officer of Celldex Therapeutics. "Based on the CDX-011 final data package and subsequent discussions with the FDA, we look forward to initiating a randomized trial suitable for accelerated approval in patients with triple negative breast cancer that also over-express GPNMB in the second half of 2013."

Marucci continued, "Importantly, we begin 2013 well-financed with a current cash position that will support operations and clinical development through 2015. To that end, in addition to the CDX-011 accelerated approval study, we will also initiate new clinical studies and expansion studies for four other Celldex programs in 2013. We expect data from three clinical studies by year end—including from our Phase 2 study of rindopepimut with Avastin ® in refractory glioblastoma. To close what will already be a very busy year, we also look forward to completing enrollment in the rindopepimut ACT IV registration trial in frontline glioblastoma."

Fourth Quarter and Recent Highlights
  • Presented positive final results from the Phase 2b EMERGE study of CDX-011 in patients with GPNMB-expressing, advanced, heavily pretreated breast cancer at the San Antonio Breast Cancer Symposium in December. Progression free and overall survival benefits were demonstrated in the subgroup of patients with triple negative disease that also over-expressed GPNMB, and strong trends towards benefits were seen in all patients with over-expression of GPNMB.  
  • Announced impressive three-year survival data across three Phase 2 studies of rindopepimut, in EGFRvIII-positive glioblastoma at the Society for Neuro-Oncology Annual Meeting in November. In addition, Celldex announced a new contemporary historical control data set compiled from the Radiation Therapy Oncology Group (RTOG)'s Phase 3 0525 study that continues to demonstrate that patients with EGFRvIII-positive glioblastoma fare worse than the general glioblastoma patient population. Importantly, the data set provides further confidence in the ACT IV registration study design.  
  • 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. In total, there are now more than 142 clinical sites around the world that are actively screening patients to participate in the ACT IV study. The ReACT study is also well-positioned, with all 25 study sites actively screening to date.  
  • Presented positive results from the Phase 1 study of CDX-1401 in solid tumors at the Society for Immunotherapy of Cancer Annual Meeting in October 2012. The study identified a well-tolerated and immunogenic regimen.  
  • Completed enrollment in the Phase 1 portion of the CDX-1127 solid tumor arm. CDX-1127 was determined to be well-tolerated to date, including at the highest dose level. Celldex continues to enroll patients in the dose escalation portion of the lymphoma and leukemia arm.  
  • Presented final results from a Phase 1 multi-dose study of CDX-301 (rhuFlt3L) in healthy volunteers in an oral presentation at the American Society for Blood and Marrow Transplantation 2013 BMT Tandem Meetings in February 2013. The study demonstrated that CDX-301 was well-tolerated and can effectively mobilize hematopoietic cell populations in healthy volunteers.  
  • 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 pivotal, randomized, accelerated approval study of CDX-011 in patients with triple negative breast cancers that over-express GPNMB in the second half.  
  • Complete enrollment of the Phase 1 dose-escalation and expansion studies of CDX-1127 in patients with hematologic cancers and initiate expansion cohorts in both solid tumors and hematologic malignancies. Report data from this study in the second half.  
  • Initiate a pilot study of CDX-1135 in dense deposit disease, an orphan renal disease in children and young adults, with data expected by year end.  
  • Initiate a pilot clinical study of CDX-301 in hematopoietic stem cell transplant in the second half.  
  • 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.

Fourth Quarter and Year-to-Date Financial Highlights

The increase in net loss of $4.1 million between the fourth quarters of 2012 and 2011 is primarily due to higher research and development (R&D) expense as a result of higher clinical trials costs for the rindopepimut Phase 3 and Phase 2 programs. General and administrative (G&A) expense in the fourth quarter of 2012 increased by $0.3 million from $2.3 million in 2011 due primarily to higher personnel-related expenses in 2012. The increase in cash, cash equivalents and marketable securities of $6.3 million from September 30, 2012 primarily reflects the issuance of 3.5 million shares during the quarter through our Cantor ATM facility that raised net proceeds to Celldex of $20.9 million, partially offset by our fourth quarter operations-related cash burn of approximately $13.3 million and principal payments on our term loan of $1.3 million.

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