Celldex Reports Third Quarter and Nine Month Financial Results

Business Wire, Nov 5, 2008

- Conference Call Wednesday, November 5, at 9:00 a.m. Eastern Time -

NEEDHAM, Mass. -- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the third quarter and nine-month period ended September 30, 2008. Celldex reported a net loss of $7.7 million, or $0.50 per share, for the third quarter of 2008 compared to a net loss of $4.1 million, or $0.49 per share, for the third quarter of 2007. For the nine months ended September 30, 2008, Celldex reported a net loss of $40.0 million, or $3.16 per share, compared to a net loss of $10.8 million, or $1.31 per share, for the nine months ended September 30, 2007. Effective October 1, 2008, the Company changed its name from AVANT Immunotherapeutics, Inc. to Celldex Therapeutics, Inc.

The 2007 financial results reflect the activities of pre-merger, privately-held Celldex only. As discussed in further detail later in this release, the increase in net loss between the three-month periods was primarily due to increased operating expenses as a result of the merger of AVANT and Celldex, offset partially by increased revenues and investment and other income. The increase in net loss between the nine-month periods was primarily due to increased operating expenses for the combined companies and non-cash charges of $19.1 million, or $1.50 per share, relating to $14.8 million of purchased in-process research and development and $4.3 million of stock-based compensation expense. At September 30, 2008, Celldex reported cash and cash equivalents of $42.7 million. This amount does not include a $10 million milestone payment from Paul Capital Healthcare upon GlaxoSmithKline's U.S. launch of Rotarix[R], which was received on October 1, 2008. The decrease in cash and cash equivalents of $9.7 million from June 30, 2008 includes one-time cash payments to licensors of $3.5 million for sublicense fees and approximately $0.7 million in equipment purchases required to convert our Fall River facility to cell culture manufacturing. The Company believes that its current cash and cash equivalents together with the payment received from Paul Capital Healthcare will be sufficient to meet estimated working capital requirements and fund operations into the second half of 2010.

"Celldex continues to make significant progress in its ongoing clinical trials," said Anthony S. Marucci, Celldex's President and Chief Executive Officer. "We have established a positive relationship with our partner Pfizer and together are developing the clinical pathway to commercialization for CDX-110 in glioblastoma multiforme. We are actively enrolling patients in two parallel Phase 1 dose-escalation studies of CDX-1307 in metastatic or locally advanced breast, colorectal, pancreatic, ovarian and bladder cancers. The ten million dollar milestone payment for the launch of Rotarix([R]) further adds to an already strong cash position and will support our plans to advance additional candidates from our Precision Targeted Immunotherapy Pipeline into clinical trials in 2009."

Key 2008 events this quarter include:

* Appointed Anthony S. Marucci as President and Chief Executive Officer of the Company. Mr. Marucci had served as interim President and Chief Executive Officer since May 2008.

* Changed the Company's name to Celldex Therapeutics to more accurately reflect the Company's expertise and focus on developing therapeutic vaccines and antibodies, including Celldex's proprietary Precision Targeted Immunotherapy Platform of monoclonal antibodies, antibody-targeted vaccines and immunomodulators to create novel disease-specific drug candidates.

* Received a $10 million milestone payment from Paul Capital Healthcare on October 1, 2008, triggered by Glaxo's market launch of Rotarix[R].

* Presented at the 28th Annual Canaccord Adams Global Growth Conference in August and the UBS 2008 Global Life Sciences Conference in September.

Further Financial Highlights

The net loss for the third quarter of 2008 showed an increase of $3.6 million compared to the net loss for the same period in 2007. The increase in net loss reflected an increase in operating expenses which includes the combined operations of AVANT and Celldex post-merger, offset in part by an increase in revenues. The increase in net loss also reflected an increase in investment and other income. Research and development (R&D) expenses in the third quarter of 2008 increased $3.5 million compared to R&D expenses in 2007 due primarily to sublicense fees payable and increased clinical trials costs for CDX-110 and CD-1307. General and administrative (G&A) expenses increased $2.9 million due primarily to stock-based compensation expense of $1.4 million and increased professional services expenses.

The nine-month results for 2008 reflect an increase in net loss compared to the same period in 2007. The increase in net loss reflected an increase in operating expenses due primarily to the combined operating expenses of the two companies from March 8 to September 30, 2008, including a non-cash charge of $14.8 million for purchased in-process R&D and non-cash charges of $1.4 million and $2.9 million for stock-based compensation expense in R&D expense and G&A expense, respectively. The increase in operating expenses also resulted from higher general and administrative expenses, which is primarily due to increases in personnel-related expenses and professional services costs for the combined companies. The increase in net loss also reflected an increase in investment and other income.