Antigenics Reports Third Quarter 2005 Financial Results and Recent 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 quarter ended September 30, 2005. The company incurred a net loss attributable to common stockholders of $17.5 million, or $0.38 per share, basic and diluted, for the third quarter of 2005, compared with a net loss attributable to common stockholders in the third quarter of 2004 of $18.7 million, or $0.41 per share, basic and diluted. Reflecting continued progress on developing its product candidate portfolio, Antigenics incurred research and development costs of $12.0 million for the quarter ended September 30, 2005, compared with $9.8 million for the quarter ended September 30, 2004. General and administrative expenses decreased to $5.2 million in the quarter ended September 30, 2005, from $6.3 million in the comparable period last year. Prior year 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. included a charge for acquired in-process research and development of $2.9 million. Cash, cash equivalents and short-term investments amounted to $77.2 million on September 30, 2005. "We are encouraged that the first set of data from a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trial testing Oncophage confirms the scientific premises that have driven our clinical strategy," said Garo Armen, 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. "We will use this valuable information from our Phase 3 metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. melanoma trial to develop Oncophage expeditiously ex·pe·di·tious adj. Acting or done with speed and efficiency. See Synonyms at fast1. ex and bring a potentially major therapeutic breakthrough to patients facing limited treatment options." Recent Highlights Oncophage (vitespen; formerly HSPPC-96) --Preliminary data from a Phase 3 trial testing Oncophage, a personalized therapeutic 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. , in metastatic melanoma showed improvement (not statistically significant) in median survival on an intent-to-treat basis of more than 50 percent in stage IV M1a patients in the Oncophage-treated arm compared with those in the physician's choice arm (20.9 months versus 12.8 months). Overall, patients in the intent-to-treat Oncophage-treated arm (M1a, b and c combined) fared similarly to those in the physician's choice arm in terms of survival. Antigenics plans to conduct a final analysis of this trial during the first quarter of 2006 and initiate a registrational melanoma trial in 2006. --The company anticipates initiating the final analysis of its randomized Phase 3 trial of 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 for nonmetastatic 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. ) in the first half of 2006. Independent radiological review of patient scans in this trial has started. --The company expects to initiate its first combination clinical study testing Oncophage with Antigenics' investigational drug ATRA-IV in the coming months. --Enrollment is complete in Antigenics' Phase 2 trial with 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. . Patients are receiving treatment and being evaluated for recurrence of disease. Aroplatin(TM) --Antigenics recently announced the launch of a Phase 1 trial of Aroplatin in solid tumors and B-cell lymphoma B-cell lymphoma is a type of non-Hodgkin lymphoma affecting B cells. Types include:
AG-707 (rh-HSP70-PC) --Antigenics recently launched a multicenter Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. of 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 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. . The trial will enroll up to 84 patients infected with herpes simplex virus Herpes simplex virus A virus that can cause fever and blistering on the skin, mucous membranes, or genitalia. Mentioned in: Conjunctivitis herpes simplex virus type 2 (HSV-2) who have a documented history of clinically active genital herpes. The study will evaluate the safety profile and 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. of patients to AG-707 with and without a proprietary adjuvant (a substance designed to improve immune response to vaccination) at three dose levels compared with placebo or adjuvant alone. Approximately one in five Americans age 12 and over are infected with HSV-2. AG-858 (HSPPC-70) --Antigenics has expanded enrollment of patients in an exploratory Phase 2 study of AG-858, a personalized therapeutic cancer vaccine, in combination with Gleevec(R) (imatinib mesylate imatinib mesylate Warning - Hazardous drug! Gleevec, Glivec (UK) Pharmacologic class: Protein-tyrosine kinase inhibitor Therapeutic class: Antineoplastic , Novartis), for the treatment of chronic myelogenous leukemia Chronic myelogenous leukemia (CML) Also called chronic myelocytic leukemia, malignant disorder that involves abnormal accumulation of white cells in the marrow and bloodstream. Mentioned in: Bone Marrow Transplantation (CML 1. CML - A query language. ["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986]. 2. CML - Concurrent ML. ) patients refractory to Gleevec. The trial will evaluate extended dosing with AG-858. New Hire --During the third quarter of 2005, the company appointed Jill M. Forrest as vice president of marketing and sales. Ms. Forrest was most recently director of global marketing at Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were Oncology, where she was involved in several key product launches. She brings to Antigenics 20 years of oncology experience. 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 1604545. 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 November 10, 2005. The replay number is 800.642.1687 (domestic) or 706.645.9291 (international), and the access code is 1604545. 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 patient-specific immunotherapeutics and revolutionary treatments for cancers, infectious diseases and autoimmune disorders Autoimmune Disorders Definition Autoimmune disorders are conditions in which a person's immune system attacks the body's own cells, causing tissue destruction. . The company's lead product candidate is Oncophage (vitespen), a late-stage, patient-specific cancer vaccine being evaluated in several indications, including renal cell carcinoma and metastatic melanoma. Antigenics' portfolio of investigational products also includes AG-858 (HSPPC-70), a patient-specific cancer vaccine in Phase 2 development; two liposomal cancer treatments, Aroplatin and ATRA-IV; and AG-707 (rh-HSP70-PC), a Phase 1 genital herpes vaccine. For more information, please visit www.antigenics.com. This press release contains forward-looking statements, including statements regarding Antigenics' potential commercialization of Oncophage, the timing of final analysis of the data from the Phase 3 trials in melanoma and RCC, plans to commence new trials, expectation that trials will support regulatory filings, and projected enrollment in those trials. 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, time timing of events in the RCC trial, the results of clinical trials, the cost of additional clinical trials, the ability to raise additional capital, and the factors described under Factors That May Impact Future Results in the Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations section of Antigenics' Form 10-Q Form 10-Q See 10-Q. as filed with the Securities and Exchange Commission on August 9, 2005. Antigenics 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.
Summary Consolidated Financial Information
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
(unaudited)
Three months ended Nine months ended
September 30, September 30,
2005 2004 2005 2004
-------- -------- -------- --------
Revenue $ 77 $ 282 $ 282 $ 579
Operating expenses:
Cost of sales - 5 - 5
Research and development 11,995 9,816 36,845 31,641
General and administrative 5,236 6,317 19,660 18,439
Acquired in-process research
and development - 2,888 - 2,888
---------- --------- --------- ---------
Operating loss (17,154) (18,744) (56,223) (52,394)
Other income (expense), net (101) 270 (163) 647
-------- -------- -------- --------
Loss from continuing
operations (17,255) (18,474) (56,386) (51,747)
Income from discontinued
operations (including gain on
disposal of $14.1 million in
2004) - - - 13,034
-------- -------- -------- --------
Net loss (17,255) (18,474) (56,386) (38,713)
Dividends on Series A
convertible preferred stock (198) (198) (593) (593)
-------- -------- -------- --------
Net loss attributable to
common stockholders $(17,453) $(18,672) $(56,979) $(39,306)
======== ======== ======== ========
Per common share data, basic and
diluted:
Loss from continuing
operations $ (0.38) $ (0.41) $ (1.25) $ (1.18)
Income from discontinued
operations $ - $ - $ - $ 0.29
Net loss attributable to
common stockholders $ (0.38) $ (0.41) $ (1.25) $ (0.89)
Weighted average number of
common shares outstanding,
basic and diluted 45,591 45,360 45,573 44,405
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
September 30, December 31,
2005 2004
------------- ------------
Cash, cash equivalents and short-term
investments $ 77,218 $ 86,921
Total assets 121,721 133,058
Total stockholders' equity 49,797 106,443
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