Celldex Reports First Quarter 2009 Financial Results

Business Wire, May 05, 2009

- Conference Call Tuesday, May 5, at 9:00 a.m. Eastern Time -

NEEDHAM, Mass. -- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the first quarter ended March 31, 2009. Celldex reported a net loss of $7.7 million, or $0.49 per share, for the first quarter of 2009 compared to a net loss of $22.1 million, or $2.19 per share, for the first quarter of 2008. On March 7, 2008, privately-held Celldex Therapeutics, Inc. completed its merger with a wholly-owned subsidiary of AVANT Immunotherapeutics, Inc. and, effective October 1, 2008, AVANT changed its name to Celldex Therapeutics, Inc.

As discussed in further detail later in this release, the decrease in net loss between the three-month periods was primarily due to increased revenues, gain on sale of assets in 2009 as well as a non-cash charge in 2008 of $14.8 million related to purchased in-process research and development (R&D) recorded in connection with the merger, offset by increased R&D expenses in 2009 as a result of the combined operations of AVANT and Celldex. At March 31, 2009, Celldex reported cash and cash equivalents of $39.4 million.

“In the first quarter of 2009, Celldex continued to add value to our Precision Targeted Immunotherapy Platform by in-licensing two additional molecules for development in cancer, inflammatory and infectious diseases,” said Anthony S. Marucci, Celldex’s President and Chief Executive Officer. “This license marks the third strategic transaction we’ve closed in the past year to obtain rights to technologies and product candidates whose therapeutic potential we believe can be fully realized through integration with our Precision Targeted Immunotherapy Platform. We look forward to exploring these molecules and advancing other candidates from the Platform into clinical trials in the coming months.”

First quarter and recent highlights:

• Enhanced our Precision Targeted Immunotherapy Platform—acquired exclusive rights to the immune-stimulatory molecules FMS-like tyrosine kinase 3 ligand (Flt3L) and CD40 ligand (CD40L) from Amgen.
• Divested non-core assets—entered into a worldwide fee- and royalty-bearing exclusive license and development agreement with Vaccine Technologies, Inc. (VTI) to develop and commercialize Celldex's CholeraGarde(R) and ETEC vaccine programs and sold our poultry vaccines assets to Lohmann Animal Health International.

The Company will be making an oral presentation on June 1st of safety and immune activity data from its first antibody-based dendritic cell targeted vaccine, CDX-1307, in combination with multiple immune modulators at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. Mature data from the ACT II study, a trial testing CDX-110 in newly diagnosed Glioblastoma Multiforme, will also be presented at ASCO.

Further Financial Highlights

The net loss of $7.7 million for the first quarter of 2009 represents an improvement of $14.4 million when compared to the net loss for the same period in 2008, primarily due to the non-cash charge of $14.8 million for purchased in-process R&D recorded in 2008. R&D expense in the first quarter of 2009 increased by $4.2 million compared to R&D expense in 2008 due primarily to the combined operations of AVANT and Celldex for the full quarter, including increased personnel-related expenses, royalty and license fee expenses, clinical trials costs for CDX-110 and CDX-1307 and facility-related costs. General and administrative (G&A) expenses increased by $0.3 million to $3.3 million in 2009 as compared to G&A expense of $3.0 million in the first quarter of 2008.

Revenues for 2009 increased by $3.6 million compared with revenues for 2008. The increase in product development and licensing revenue in 2009 primarily reflects recognition of $1.3 million in Pfizer deferred revenue related to CDX-110 in 2009. The increase in contracts and grants revenue in 2009 compared to 2008 primarily reflects increased levels of vaccine development work billable to Rockefeller University between the two three-month periods. In 2009, Celldex also recognized $2.1 million in product royalty revenue related to offsetting royalty expense payable to Cincinnati Children’s Hospital. There was no product royalty revenue in 2008.

As of March 31, 2009, the Company had approximately 15.8 million shares outstanding.

Important Information Related to Celldex’s Financial Results

On March 7, 2008, the Company completed the merger of its wholly-owned subsidiary with privately-held Celldex Therapeutics, Inc. In connection with the merger, the Company implemented a 1-for-12 reverse stock split of its common stock on March 7, 2008.