Antigenics Reports First Quarter 2008 Financial Results.Conference Call to Follow 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 quarter ended March 31, 2008. The company incurred a net loss attributable to common stockholders of $11.3 million, or $0.20 per share, basic and diluted, for the first quarter of 2008, compared with a net loss attributable to common stockholders in the first quarter of 2007 of $8.9 million, or $0.19 per share, basic and diluted. The company's net cash burn (cash used in operating activities plus capital expenditures and dividend payments) for the three months ended March 31, 2008 and 2007 was $9.4 million and $9.3 million, respectively. The 2008 results reflect, among other things, the company's efforts to obtain registration and conduct pre-commercial launch activities for Oncophage in Russia and the timing of milestone achievements by Antigenics' licensees of its QS-21 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. . Cash, cash equivalents and short-term investments amounted to $35.4 million as of March 31, 2008, and, as adjusted for fundraising activities subsequent to the end of the quarter, amounted to $55.9 million on a pro forma As a matter of form or for the sake of form. Used to describe accounting, financial, and other statements or conclusions based upon assumed or anticipated facts. The phrase pro forma basis. "With the achievement of our regulatory approval in Russia, we have made great strides in bringing our cancer vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. Oncophage to patients" said Garo H. Armen Garo H. Armen is chairman and chief executive officer of Antigenics Inc., the biotechnology company he cofounded with Pramod Srivastava in 1994. From mid-2002 through 2004, he was chairman of the board of directors for the biopharmaceutical company Elan Corporation plc. Dr. , PhD, 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. of Antigenics. "Russia has become the fastest growing pharmaceutical market amongst major countries and offers an exciting opportunity for launching Oncophage. In addition, we remain on track to submit a marketing authorization application to the European regulatory authorities by year-end." Corporate Update * In April, the Russian Ministry of Public Health issued a registration certificate for Oncophage([R]) (vitespen) as an adjuvant treatment 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. patients at intermediate risk for disease recurrence. This is the first ever formal regulatory approval of a patient-specific therapeutic cancer vaccine worldwide and the first ever cancer vaccine to be approved in a major market. Oncophage is also the first post-surgical treatment option available for patients in Russia with nonmetastatic kidney cancer. * Russian approval was based on results from the Phase 3 clinical study that showed that patients receiving Oncophage in the intermediate-risk population (stages I/II high-grade, III T1/2/3a low-grade) who were without disease at baseline (n = 362) demonstrated a clinically significant improvement in recurrence-free survival of approximately 45 percent over patients in the observation arm (P < 0.01; hazard ratio The hazard ratio in survival analysis is the effect of an explanatory variable on the hazard or risk of an event. For a less technical definition than is provided here, consider hazard ratio to be an estimate of relative risk and see the explanation on that page. = 0.55). Of the total 604 eligible patients in the study, 172 patients (28 percent) were enrolled at the eight sites in Russia. * Launch activities are ongoing, and the company anticipates that it could begin generating modest revenues from Oncophage in Russia in the second half of 2008. * Oncophage for commercial use in Russia will be manufactured at Antigenics' state of the art personalized protein manufacturing facility in Lexington, Massachusetts. The facility has been operational for clinical production for approximately five years and has been used to manufacture product for hundreds of patients at more than 150 treatment centers worldwide. * Antigenics continues to investigate additional registrational opportunities for Oncophage. The company is working towards filing a marketing authorization application in 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 for conditional authorization of Oncophage as an adjuvant treatment for kidney cancer patients by the end of the year. * Antigenics expects the data from its Phase 3 study of Oncophage in kidney cancer to be submitted for publication to a peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. in mid-2008. * The company continues to consider Oncophage registrational pathways in the U.S. in kidney cancer as well as in 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. . Enrollment is ongoing in the Phase 2 portion of the investigator-sponsored glioma study at the University of California, San Francisco . * A poster presentation of data from the Phase 2 feasibility study of Oncophage in non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. will be made at the Annual Meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) to be held May 30 - June 3, 2008. * Clinical development is ongoing for approximately 15 QS-21-containing vaccines by Antigenics' collaborative partners, including two vaccines in Phase 3 clinical studies. Antigenics anticipates that the first vaccine containing QS-21 could launch in the 2010 timeframe. * Analysis of 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. in serum samples of patients treated in the Phase 1 study of AG-707 in genital herpes Genital Herpes Definition Genital herpes is a sexually transmitted disease caused by a herpes virus. The disease is characterized by the formation of fluid-filled, painful blisters in the genital area. has been initiated at Antigenics. Data is expected to be available in mid-2008. * In April, Antigenics raised gross proceeds of $21 million in a private placement of common stock and warrants. Conference Call Information Antigenics executives will host a conference call at 11:00 a.m. ET today. To access the live call, dial 888.271.9082 (domestic) or 706.679.7741 (international); the access code is 44383079. 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 ET on May 15, 2008. The replay number is 800.642.1687 (domestic) or 706.645.9291 (international), and the access code is 44383079. The replay will also be available on the company's website approximately two hours after the live call. About Antigenics Antigenics (NASDAQ: AGEN) 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; Aroplatin[TM] (L-NDDP), a liposomal, third-generation platinum chemotherapeutic; AG-707, a therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. for the treatment of genital herpes; 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 press release contains forward-looking statements, including statements regarding the potential clinical benefit of Oncophage in kidney cancer based on a subgroup analysis; potential strategies and timing for pursuing marketing registration for Oncophage in Europe; the availability, presentation and publication of data; present and future clinical trials; the advancement and potential timing for commercial launch of products using QS-21 by Antigenics' licensees; and the potential timing and scale of generating revenues. 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 regulatory authorities, physicians and patients; the possibility that results from future treatments with Oncophage will not be as favorable as the results from our subset analysis; the inability to secure local distributors and reimbursement mechanisms in Russia or any other jurisdiction in which Antigenics may obtain product approval; the ability to raise capital and finance future development of Oncophage; Antigenics' dependence on its collaborative partners to successfully develop and commercialize products containing QS-21; and the factors described under the Risk Factors Section of our Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Securities and Exchange Commission for the period ended December 31, 2007. Antigenics cautions investors that we do not expect to generate significant revenue from sales of Oncophage in Russia for several months, if ever. The amount of revenue we generate will depend on, among other things, securing reimbursement mechanisms and physician and patient assessment of the benefits and cost-effectiveness of Oncophage. Antigenics also cautions investors not to place considerable reliance on the forward-looking statements contained in this press 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] |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion