Antigenics Reports Fourth Quarter and Year-End 2008 Financial Results and Highlights.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Antigenics Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : AGEN) reported results today for the three months and year ended December 31, 2008. For the three months ended December 31, 2008, the company reported net income attributable to common stockholders of $5.1 million, or $0.08 per share, basic and diluted, compared with a net loss attributable to common stockholders of $7.7 million, or $0.16 per share, basic and diluted, for the same period in 2007. For the year ended December 31, 2008, Antigenics incurred a net loss attributable to common stockholders of $29.5 million, or $0.47 per share, basic and diluted, compared with a net loss attributable to common stockholders of $37.6 million, or $0.81 per share, basic and diluted, for the year ended December 31, 2007. During the quarter ended December 31, 2008, the company paid $2.9 million to repurchase $11.8 million of its convertible notes, resulting in a gain of $8.6 million. This will reduce annual interest expense by $0.6 million. In addition, the company sold certain patent technology resulting in a gain of $4.6 million. Cash, cash equivalents and short-term investments amounted to $34.5 million as of December 31, 2008. The company's net cash burn (cash used in operating activities plus capital expenditures, debt repayments and dividend payments) for the year ended December 31, 2008 was $32.8 million, which represented an increase from the net cash burn of $27.5 million for the year ended December 31, 2007. The increase in cash burn is primarily due to registration and commercialization efforts for Oncophage in Russia and the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community coupled with reduced QS-21 revenues. Corporate Update Oncophage([R]) (vitespen) * In November 2008, final results from a Phase 1 investigator-sponsored trial of Oncophage[R] (vitespen) in recurrent, high-grade glioma glioma /gli·o·ma/ (gli-o´mah) a tumor composed of neuroglia in any of its states of development; sometimes extended to include all intrinsic neoplasms of the brain and spinal cord, as astrocytomas, ependymomas, etc. were presented at the Society for Neuro-Oncology's 13th Annual Scientific Meeting. All patients enrolled in the trial had at least one recurrence of brain cancer prior to enrollment and more than half of the patients had more than one recurrence. The Oncophage vaccination following brain tumor Brain Tumor Definition A brain tumor is an abnormal growth of tissue in the brain. Unlike other tumors, brain tumors spread by local extension and rarely metastasize (spread) outside the brain. resection resulted in overall median survival of approximately 10.5 months, with four patients surviving up to and beyond 12 months with one patient surviving almost 2.5 years. This is compared to a historical median survival of only 6.5 months post surgery. A tumor-specific response was detected after vaccination in all 12 patients. * The study also observed a correlation between immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. and overall survival as a result of treatment with Oncophage (n=12; P < .001). The responses were validated by using three separate immune techniques and showed that Oncophage evoked a tumor-specific immune response by producing activated T-cells and natural killer cells natural killer cells, n.pl lymphocytes that are part of innate immunity that kill foreign substances and abnormal tissues. Decreased number or activi-ty has been linked to a number of diseases, including AIDS, cancer, chronic fatigue syndrome, that can potentially destroy tumor cells. * The Phase 2 portion of the investigator-sponsored study of Oncophage in glioma continues to enroll patients. This study is being supported by the NIH's Brain Tumor Specialized Programs of Research Excellence (SPORE) program. * The European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. continues to review the marketing application for Oncophage as an adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. treatment in early-stage renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. (RCC RCC - An extensible language. ; the most common type of kidney cancer Kidney Cancer Definition Kidney cancer is a disease in which the cells in certain tissues of the kidney start to grow uncontrollably and form tumors. ). * The company continues to make progress toward the commercial launch of Oncophage in Russia. The current key focus of activities in Russia pertains to obtaining government reimbursement for Oncophage in 2009. QS-21 Stimulon([R]) Adjuvant * The company's licensees, including GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) and Elan, continue to advance clinical development of over 15 vaccines that contain the company's QS-21 vaccine adjuvant. * In December 2008, GSK published two studies in The New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. detailing results from its Phase 2 clinical trials testing their QS-21-containing malaria vaccine candidate in African infants and young children. The data reaffirms earlier study results and support the ongoing efforts, pending regulatory approvals, to launch a potentially pivotal Phase 3 study with the QS-21-containing adjuvant system in 2009. * GSK recently presented Phase 1 data in healthy volunteers (n=180) of a candidate HIV vaccine HIV vaccine AIDS As of mid-2005, there is no viable anti-HIV vaccine. See AIDS. formulated with or without a QS-21-containing adjuvant system. The highest frequencies of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. antigen-specific CD4+ T cells T cells A type of white blood cell produced in the thymus gland. T cells are an important part of the immune system. Infants born with an underdeveloped or absent thymus do not have a normal level of T cells in their blood. and responder rates were observed in the adjuvanted vaccine formulations. Furthermore, the vaccine showed an acceptable safety and reactogenicity profile and no vaccine related serious adverse events were reported. Corporate * In February 2009, Antigenics initiated a restructuring to reduce operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. in light of current market conditions and to focus its resources on near-term commercial opportunities. The restructuring resulted in a workforce reduction of approximately 20%. The company has taken other measures to reduce its 2009 cash burn, including the elimination of cash bonuses and its 401(k) match program. In addition, Antigenics' chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. elected to receive 30% of his base salary in stock. * As part of Antigenics' restructuring plan and decision to focus on near-term commercial opportunities, it has put on hold its Aroplatin[TM] and AG-707 development programs. The company will focus its current activities on the commercialization of Oncophage in Russia and Europe and sustaining its cash resources until the maturity of the pipeline of vaccines containing QS-21. The earlier-stage development program of Oncophage in glioma will continue and will be supported financially from outside organizations. Antigenics executives will host a conference call at 11:00 a.m. Eastern Time today. To access the live call, dial 877.762.5772 (domestic) or 706.643.6986 (international); the access code is 85080217. The call will also be webcast and will be accessible from the company's website at www.antigenics.com/webcast/. A replay will be available approximately two hours after the call through midnight Eastern Time on March 5, 2009. The replay number is 800.642.1687 (domestic) or 706.645.9291 (international), and the access code is 85080217. The replay will also be available on the company's website approximately two hours after the live call. About Antigenics Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases. The company's investigational product portfolio includes Oncophage[R] (vitespen), a patient-specific therapeutic cancer vaccine being evaluated in several indications; and QS-21 Stimulon[R], an adjuvant being evaluated by Antigenics' collaborative partners in approximately 15 clinical stage vaccines. For more information, please visit www.antigenics.com. This earnings release contains forward-looking statements, including statements regarding the development programs and clinical trial activities, funding, and timelines of Antigenics and its licensees and partners, the potential effects of the company's recent restructuring efforts, anticipated interest income expense reductions and other cost containment cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. measures, and commercialization efforts and potential reimbursement timelines for Oncophage in Russia and other territories. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, decisions by our licensees and partners, regulatory authorities, physicians and patients; the possibility that results from future treatments with Oncophage or studies with our other product candidates will not be as favorable as prior results; the inability to secure local distributors and payment mechanisms in Russia or any other jurisdiction in which Antigenics may obtain product approval; the ability to sustain cash resources and finance future development of Oncophage; the potential that we may not be able to maintain our listing on the NASDAQ Global Market or meet the requirements of the NASDAQ Capital Market Originally called the NASDAQ Small Cap Market, NASDAQ announced a name change to the NASDAQ Capital Market on September 27, 2005. [1] The NASDAQ Capital Market exists for securities of smaller, less-capitalized companies (small caps) that do not qualify for ; and the factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2008. Antigenics cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Antigenics undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Antigenics' business is subject to substantial risks and uncertainties, including those identified above. When evaluating Antigenics' business and securities, investors should give careful consideration to these risks and uncertainties. [TABLE OMITTED] |
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