Antigenics Inc. (NASDAQ: AGEN) reported today its results for the quarter and year ended December 31, 2009. The company reported net income attributable to common stockholders of $1.7 million, or $0.02 per share, basic and diluted, for the fourth quarter of 2009, compared with net income attributable to common stockholders in the fourth quarter of 2008 of $3.9 million, or $0.06 per share, basic and diluted. For the year ended December 31, 2009, the company incurred a net loss attributable to common stockholders of $31.1 million, or $0.39 per share, basic and diluted, compared with a net loss attributable to common stockholders of $31.6 million, or $0.50 per share, basic and diluted, for the year ended December 31, 2008. The company’s net cash burn (cash used in operating activities plus capital expenditures and dividend payments) for the years ended December 31, 2009 and 2008 was $25.2 million and $29.9 million, respectively. The 2009 net cash burn primarily reflects the company’s efforts to support Oncophage® (vitespen), the company’s novel patient-specific cancer vaccine, in Russia, Europe, and other territories, while also executing cost containment efforts. Cash, cash equivalents and short-term investments amounted to $30.1 million as of December 31, 2009.
- Under the direction of Andrew Parsa, MD, PhD, the Brain Tumor Research Center at the University of California, San Francisco (UCSF), continues to conduct two Phase 2 clinical trials testing Oncophage in recurrent and newly-diagnosed glioma patients. The investigator-sponsored studies will evaluate median overall survival, progression-free survival and immunologic response. This trial is sponsored by the National Institutes of Health (NIH) and patient advocacy groups. Glioma is a difficult-to-treat type of brain tumor for which there are currently no curative treatment options.
- The first 20 Phase 2 recurrent glioma patients treated with Oncophage showed a median survival of 10.1 months, with at least six patients (30 percent) surviving 12 months or longer. These early clinical data appear to compare favorably with the long-established historical median survival of 6.5 months, and with the recently reported median survival of 9.2 months with Avastin® (bevacizumab) in patients with recurrent high-grade glioma. Further data updates are anticipated in the first half of 2010.
- Antigenics continues to explore government reimbursement and local partnerships for Oncophage in the treatment of intermediate-risk renal cell carcinoma (RCC), or kidney cancer, in Russia. Antigenics is also exploring the possibility of making Oncophage available to patients in various territories through named patient and similar programs.
- Last fall, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion on the marketing authorization application for Oncophage in early-stage, localized RCC. Antigenics continues to evaluate its options to determine its strategy for Oncophage in Europe.
- Approximately 15 vaccines containing Antigenics’ QS-21 investigational adjuvant are in clinical-stage development by partners such as GlaxoSmithKline. Phase 3 programs include vaccines for malaria, melanoma and non-small cell lung cancer. Antigenics is entitled to receive milestone payments as these vaccine programs advance in development as well as royalties for at least 10 years after commercial launch. The cost of developing and marketing these vaccines will be assumed entirely by the company’s licensees.
- Antigenics continues to make efforts to contain costs and currently anticipates that its net cash burn in 2010 will be in the $16-18 million range. At the company’s current net cash burn rate, it has sufficient funds to sustain operations at least into the second half of 2011.