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Celldex Reports Third Quarter 2013 Financial Results

PHILLIPSBURG, N.J., Nov. 8, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported financial results for the third quarter ended September 30, 2013. Celldex reported a net loss of $23.1 million, or $0.29 per share, for the third quarter of 2013 compared to a net loss of $15.0 million, or $0.25 per share, for the third quarter of 2012. For the nine months ended September 30, 2013, Celldex reported a net loss of $59.5 million, or $0.76 per share, compared to a net loss of $42.3 million, or $0.75 per share, for the nine months ended September 30, 2012. At September 30, 2013, Celldex reported $136.6 million in cash, cash equivalents and marketable securities.

"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 Anthony Marucci, President and Chief Executive Officer. "We remain on track to initiate our accelerated approval study of CDX-011 in triple negative breast cancer and we continue to make excellent progress advancing our Phase 3 study of rindopepimut in frontline glioblastoma. We also recently announced the initiation of an expansion cohort for our ReACT study in refractory glioblastoma and will present data from ReACT in an oral session at the Society for Neuro-Oncology meeting in late November. In addition, we are presenting data from the Phase 1 CDX-1127 study at the Society for Immunotherapy of Cancer Meeting this weekend."

Program Updates:

Rindopepimut in EGFR v III(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, 2013 at 8:30 am ET to 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 States with additional sites in Canada and 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, 2013 to 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 February 2014.

Other programs

  • 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 $1.0 million, compared to $3.1 million in the third quarter of 2012. Total revenue for the nine months ended September 30, 2013 was $3.5 million, compared to $7.6 million for the nine months ended September 30, 2012. The decrease in revenue was primarily due to the decrease in Rotarix ® royalty revenue with a corresponding reduction in royalty expense. Our agreement with GlaxoSmithKline terminated upon the anticipated expiration of the last relevant patent right covered by the GlaxoSmithKline agreement. We do not expect additional royalty revenue or royalty expense related to Rotarix ®. Included in revenue for the third quarter of 2013 was $0.9 million recognized from a new services contract with Rockefeller University for the development and manufacture of two anti-HIV antibodies.

Research and development (R&D) expenses in the third quarter of 2013 were $20.4 million, compared to $11.8 million in the second quarter of 2012. R&D expenses for the nine months ended September 30, 2013 were $49.6 million, compared to $33.7 million for the nine months ended September 30, 2012. The increase in Celldex's R&D investment was primarily due to the continued progression of our late-stage rindopepimut clinical development program, including ACT IV and ReACT, as well as planning for the METRIC study and the expansion of the CDX-1127 study. Clinical trial expenses in 2013 increased by $3.1 million and $7.1 million when compared to 2012 for the three- and nine-month periods, respectively. In addition, during 2013, we have substantially expanded our manufacturing activities with our commercial suppliers to support our pivotal studies in rindopepimut and glemba. External contract manufacturing expenses increased by $3.3 million and $5.0 million for the three- and nine-month periods, respectively, in 2013 versus 2012.

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