(Source: Business Wire)
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the second quarter and six-month period ended June 30, 2009. Celldex reported a net loss of $8.7 million, or $0.55 per share, for the second quarter of 2009 compared to a net loss of $10.3 million, or $0.67 per share, for the second quarter of 2008. For the six months ended June 30, 2009, Celldex reported a net loss of $16.4 million, or $1.04 per share, compared to a net loss of $32.4 million, or $2.56 per share, for the six months ended June 30, 2008. At June 30, 2009, Celldex reported cash and cash equivalents of $31.6 million.
On May 29, 2009, Celldex Therapeutics announced that the Company has entered into a definitive agreement to acquire CuraGen Corporation (NASDAQ: CRGN). The transaction, subject to shareholder approval, is expected to close in the third quarter of 2009.
"Celldex launched a major strategic initiative one year ago to acquire a series of selected assets to fuel our Precision Targeted Immunotherapy Platform for future growth," said Anthony S. Marucci, Celldex's President and Chief Executive Officer. "The proposed acquisition of CuraGen - the fourth and most significant transaction of the last twelve months - fulfills this initiative and adds a portfolio of oncology-focused antibodies to our platform and substantial cash resources.
The second quarter also brought considerable progress in our current clinical development programs as we presented data on multiple studies at the American Society of Clinical Oncology Annual Meeting including poster presentations on updated results from Phase 2 studies of our lead candidate, CDX-110 in glioblastoma multiforme, and an oral presentation on CDX-1307, the first antibody-based dendritic cell targeted vaccine resulting from our platform. As we transition to the second half of 2009, we believe we are very well positioned with a pipeline of immunotherapy-based product candidates, multiple upcoming value-driving milestones and a strong balance sheet, made stronger by the CuraGen merger," concluded Marucci.
Second quarter and recent highlights:
Delivered an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida on data from the CDX-1307 Phase 1 studies in combination with multiple immune modulators from Celldex's proprietary platform, including recently in-licensed assets that demonstrated a favorable safety profile and strong immune responses.
Presented mature data at ASCO from the Phase 2 ACTIVATE trial (n=21) and updated data from the continuation study, ACT II (n=23), of CDX-110 in patients with newly diagnosed EGFRvIII-positive glioblastoma multiforme (GBM). In both studies, CDX-110 was generally well-tolerated with local injection site reactions being the most commonly reported toxicity.
In the single-arm Phase 2 ACTIVATE study, median overall survival (OS) was 26 months and median time to progression (TTP) was 14.2 months. Additionally, three patients remain without relapse more than four years from surgery and continue to receive the vaccine within the clinical trial.
In the single-arm Phase 2 ACT II study, median TTP is 15.2 months and three patients continue without relapse after more than two years. Results to date from this ongoing study estimate median OS to be 23.6 months. In addition, and in line with preclinical data that suggested the combination of CDX-110 with temozolomide could augment immune responses, patients demonstrate clear serological evidence of an immune response against EGFRvIII.
Enhanced our Precision Targeted Immunotherapy Platform by:
Acquiring exclusive rights to the immune-stimulatory molecules FMS-like tyrosine kinase 3 ligand (Flt3L) and CD40 ligand (CD40L) from Amgen.
Announcing the definitive agreement to acquire CuraGen Corporation in a stock-for-stock transaction, which values CuraGen at approximately $93.5 million to $94 million, subject to certain adjustments described within the definitive agreement. In addition to its pipeline of oncology-focused antibodies, CuraGen is expected to have a cash balance of approximately $53.5 million to $54 million net of certain acquisition-related costs and CuraGen convertible debt at the transaction's close.
Further Financial Highlights
The net loss of $8.7 million for the second quarter of 2009 represents a decrease of $1.6 million when compared to the net loss for the same period in 2008 and is primarily due to an increase in revenue and a decrease in operating expense. R&D expense in the second quarter of 2009 increased by $0.2 million compared to R&D expense in 2008 due primarily to increased personnel-related expenses, laboratory materials and services and clinical trials costs for CDX-110 and CDX-1307. G&A expenses in the second quarter of 2009 decreased by $1.1 million to $3.5 million as compared to $4.6 million in 2008, primarily due to a decrease in personnel-related expenses in 2009. G&A expenses for this quarter included approximately $1 million, or $0.06 per share, of transaction expenses recorded in connection with the CuraGen acquisition.
The net loss of $16.4 million for the first six months of 2009 represents an improvement of $16.0 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.
