AVAN Avant Immunotherapeutics (MM)

AVANT Immunotherapeutics, Inc. (NASDAQ: AVAN) today reported financial results for the second quarter and six-month period ended June 30, 2008. AVANT reported a net loss of $10.3 million, or $0.67 per share, for the second quarter of 2008 compared to a net loss of $2.8 million, or $0.33 per share, for the second quarter of 2007. For the six months ended June 30, 2008, AVANT reported a net loss of $32.4 million, or $2.56 per share, compared to a net loss of $6.8 million, or $0.82 per share, for the six months ended June 30, 2007. The 2007 financial results reflect the activities of 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 six-month periods was primarily due to non-cash charge of $17.2 million, or $1.35 per share, relating to purchased in-process research and development of $14.8 million and stock-based compensation expense of $2.4 million. At June 30, 2008, AVANT reported cash and cash equivalents of $52.4 million. This amount includes upfront payments totaling $50 million from AVANT�s license and development agreement with Pfizer for CDX-110, including a $10 million equity investment by Pfizer. AVANT anticipates receiving a $10 million milestone payment from Paul Royalty Fund upon GlaxoSmithKline�s U.S. launch of Rotarix�, which we expect to receive in the second half of 2008. �During the quarter, AVANT completed one of the largest partnership agreements in cancer immunotherapy when we entered into an agreement with Pfizer for our novel therapeutic vaccine candidate�CDX-110,� said Anthony S. Marucci, AVANT�s interim President and Chief Executive Officer. �We continued to add to the rich data package for CDX-110 with the presentation of positive Phase 2 survival data in patients with glioblastoma multiforme at ASCO. In addition, we augmented our vaccine platform, entering into a collaboration with 3M to access key toll-like receptor (TLR) agonists for clinical study with our proprietary Antigen Presenting Cell Targeting Technology�. We are now able to implement a comprehensive immunotherapy strategy which we believe will open new doors to treatments for cancer and infectious disease.� Key 2008 events recently announced: Entered into an exclusive worldwide licensing agreement with Pfizer for our therapeutic cancer vaccine candidate, CDX-110, which is in Phase 2/3 development for the treatment of glioblastoma multiforme (GBM). This agreement also gives Pfizer exclusive rights to the development of EGFRvIII vaccines in other potential indications. Under the licensing and development agreement, Pfizer made an upfront payment to AVANT of $40 million and made a $10 million equity investment in AVANT, and thereafter Pfizer will fund all development costs for these programs. AVANT is also eligible to receive milestone payments exceeding $390 million for the successful development and commercialization of CDX-110 and additional EGFRvIII vaccine products, as well as double-digit royalties on any product sales. Presented updated data from the Phase 2 ACTIVATE trial (n=21) and the continuation study, ACT II (n=23) of CDX-110 in patients with newly diagnosed EGFRvIII-positive glioblastoma multiforme (GBM) at ASCO. CDX-110 was generally well-tolerated with primary toxicity reported as local injection site reactions. In the ACTIVATE study, median survival time was 26 months (95% CI: 21.6, infinity) and median time-to-progression (TTP) was 14.2 months. No significant adverse events were seen in this study. Median survival in a historical matched cohort was 15.2 months (17/17) (95% CI: 13.9, 20.5) (p=0.0001) with median time to progression of 7.13 months (p=0.0001).1 Preliminary results from the ACT II study currently estimate median overall survival to be 33.1 months, although the median has not yet been reached. The survival of a matched historical control group was 14.3 months (95% CI: 13.0, 16.2) and a subgroup treated with temozolomide (TMZ) of 15.2 months (95% CI: 13.9, 20.5 p=0.0078). Overall TTP was 16.6 months (95% CI: 10.8, infinity) compared with 6.4 months for the historical control group (95% CI: 5.0, 14.1). Announced multi-year clinical research collaborations with 3M to access their proprietary Immune Response Modifier Resiquimod� (and additional Toll-Like Receptor 7/8 agonists (TLR)) for clinical study with the Company�s proprietary Antigen Presenting Cell (APC) Targeting Technology�, for use as vaccine adjuvants. Announced that the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), has initiated a Phase 1 safety study of AVANT�s investigational single-dose, oral vaccine designed to offer combined protection against both enterotoxigenic Escherichia coli (ETEC) and cholera. ETEC infection is a major cause of travelers� diarrhea. Reported results that the double-blind, placebo-controlled multi-center Phase 2 clinical trial of Ty800 met all primary endpoints. Importantly, immunogenic response was dose-dependent. Positive immune response or seroconversion (prospectively defined as a 4-fold increase in anti-LPS titers over pre-dose level) rates were 65% (36/55) and 80% (44/55) in the low and high dose groups, respectively, and was significantly (p