Antigenics Reports Second Quarter 2005 Financial Results and Recent Highlights and Pipeline Update.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 June 30, 2005. The Company incurred a loss from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the of $21.1 million, or $0.47 per share, basic and diluted, for the second quarter of 2005, compared to a loss from continuing operations in the second quarter of 2004 of $17.0 million, or $0.38 per share, basic and diluted. Research and development costs were $13.5 million in the second quarter of 2005, compared with $10.9 million for the same period in 2004. The increased loss from continuing operations in the quarter ended June 30, 2005 reflects, among other factors, the continued progress of the Company's clinical product candidates, including Oncophage(R) (HSPPC-96), Antigenics' lead product candidate, costs associated with start-up activities related to Part 2 of the Company's Phase 3 trial in 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. ), pre-commercialization activities and severance costs. For the quarter ended June 30, 2005, the Company incurred a net loss attributable to common stockholders of $21.3 million or $0.47 per share, basic and diluted, compared to a net loss attributable to common stockholders in the second quarter of 2004 of $3.3 million, or $0.07 per share, basic and diluted. The increased net loss attributable to common stockholders in the quarter ended June 30, 2005 is primarily due to the gain of $14.1 million from the sale of the Company's manufacturing rights for the feline leukemia virus feline leukemia virus n. A retrovirus that primarily affects cats, is transmitted through saliva, and causes suppression of the immune system and anemia, leading to opportunistic infections and diseases such as leukemia and lymphoma. vaccine during the quarter ended June 30, 2004. Cash, cash equivalents and short-term investments equaled $96.6 million on June 30, 2005. "Our primary focus is on completing the Phase 3 studies with Oncophage in 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. and melanoma," 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. "In addition, we are especially pleased with the recent progress Antigenics has made in the clinical development of our pipeline products that we believe will demonstrate the broader applicability of our core technologies and products across multiple indications." Pipeline and Recent Highlights Update The following table outlines Antigenics' current broad clinical development pipeline:
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Product/Trial Phase Indication Status Approximate
Patient
Numbers
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Oncophage
----------------------------------------------------------------------
C-100-12, Phase 3 Adjuvant RCC Fully enrolled 800
Part 1
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C-100-12, Phase 3 Adjuvant RCC Open to 600
Part 2 enrollment
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C-100-21 Phase 3 Metastatic Melanoma Fully enrolled 300
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C-100-23 Phase 2 Metastatic RCC Open to 40+
enrollment
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C-100-26 Phase 2 Adjuvant NSCLC Open to 10
enrollment
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AG-858
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C-300-01 Phase 2 Chronic Phase CML Open to 40+
(relapsed/failed enrollment
Gleevec(R)*)
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AG-707
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C-400-01 Phase 1 Genital Herpes Q4, 2005 trial 84
start date
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Aroplatin(TM)
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C-726-05 Phase 1 Solid Tumors Q4, 2005 trial 30
start date
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* imatinib mesylate, Novartis
Oncophage --Antigenics anticipates beginning the analysis of clinical data from Part 1 of the Company's Phase 3 trial evaluating Oncophage in 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. (non-metastatic) RCC when the number of events required for this analysis is achieved. The rate of events in this trial has continued to slow. Based on current trends, Antigenics anticipates that the final analysis will begin in the first half of 2006. Once the independent radiological review is underway later this year, Antigenics anticipates providing further guidance regarding the timing of the analysis. The Company believes this trial represents the largest single 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 to date in this patient population. Patients are being followed for recurrence-free survival and overall survival. --During the quarter, 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. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) granted Oncophage orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status for the treatment of RCC. This may, among other benefits, provide 10 years of market exclusivity if the product is approved for marketing 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 . This is another key step in the Company's continuing progress towards global regulatory filings for marketing approval assuming positive trial results. --Following validation of the Oncophage potency assays, Antigenics performed retrospective potency testing of the Oncophage lots used in the Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. for adjuvant RCC (Part 1) and 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 manufactured prior to the introduction of the potency assays in December 2003. The test results are currently being assessed. This data will be submitted to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. at or before such time that Antigenics files a Biologics License Application (BLA BLA abbr. Bachelor of Liberal Arts ) for Oncophage. --Antigenics commenced enrollment activities related to Part 2 of its Phase 3 trial in adjuvant RCC. Sites are actively screening patients for inclusion in the trial and vaccine manufacture has commenced. --Initial findings from Antigenics' Phase 3 trial with Oncophage for the treatment of metastatic melanoma should be available by year-end. --Antigenics believes that the combination of two or more therapeutic agents may provide synergistic treatment benefits in the metastatic disease setting. The Company plans to launch small clinical trials of combination therapies with Oncophage, providing an opportunity to quickly learn of possible signals of efficacy while evaluating safety in multiple late-stage cancers. The Company hopes to initiate the first combination study with Oncophage and Antigenics' investigational drug ATRA-IV later this year. --The Company will expand to additional sites, during 2005, its ongoing Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. in metastatic renal cell carcinoma currently at MD Anderson Cancer Center. --The Company anticipates completing enrollment in its Phase 2 trial 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. (NSCLC NSCLC non (or cancer). NSCLC Non-small cell lung cancer, see there ) shortly. Aroplatin --Aroplatin is an investigational liposomal formulation of a platinum chemotherapeutic being developed for the treatment of multiple cancer types. --Aroplatin has shown evidence of activity in several cancer indications, and data from a Phase 2 trial in colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. and a Phase 1/2 trial in advanced solid tumors using the previous formulation of Aroplatin are currently being evaluated. --During the quarter, Antigenics completed pre-clinical toxicology studies of the reformulated Aroplatin, which the Company intends to take back into the clinic later this year. --The Company will shortly submit an amendment to its Investigational New Drug Application (IND) with the FDA, and if approved by the FDA, plans to initiate a Phase 1 dose-escalating trial of Aroplatin in solid malignancies during the fourth quarter of this year. AG-858 --AG-858 (HSPPC-70) is an investigational personalized vaccine designed to treat cancer with the intent of minimizing side effects Side effects Effects of a proposed project on other parts of the firm. . AG-858 is currently being investigated as a cancer treatment primarily in the liquid tumor setting. --Antigenics is currently enrolling patients in an exploratory Phase 2 study of AG-858 in combination with Gleevec, 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. Antigenics plans on expanding enrollment in this trial during the second half of 2005. AG-707 --AG-707 is an off-the-shelf multivalent multivalent /mul·ti·va·lent/ (-val´ent) 1. having the power of combining with three or more univalent atoms. 2. active against several strains of an organism. 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. directed at the virus that causes 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. (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, or HSV-2), which currently affects approximately one in five Americans over the age of 12. --During the quarter, Antigenics submitted an IND to the FDA for AG-707 and awaits FDA acceptance of the IND. --During the fourth quarter of 2005, Antigenics expects to begin enrollment in a multi-center Phase 1 trial with AG-707. Other --From time to time as its portfolio programs progress, Antigenics reviews their prioritization. Towards the end of the quarter, the Company conducted such an assessment, resulting in some limited headcount reductions in non-critical areas and other prioritization cost savings. The Company incurred severance and related costs during the quarter of $606,000. --The Company continues to actively pursue a number of important preclinical and discovery efforts based on its core technology platform in heat shock proteins heat shock protein n. Any of a group of cellular proteins that are produced under conditions of heat stress and help to stabilize other cellular proteins exposed to high temperatures. in an effort to seed its pipeline for the future, with a particular emphasis on autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . 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 709.679.7741 (international); the access code is 7730381. 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 August 11, 2005. The replay number is 800.642.1687 (domestic) or 706.645.9291 (international), and the access code is 7730381. 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 personalized immunotherapeutics and revolutionary treatments for cancers and infectious diseases. The Company's lead product candidate is Oncophage (HSPPC-96), a late-stage, personalized 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 personalized cancer vaccine in Phase 2 development; two liposomal cancer treatments, Aroplatin and ATRA-IV; and AG-702/AG-707, a genital herpes program. This press release contains forward-looking statements, including statements regarding plans for, and expected timing of, commencement of new clinical trials, including combination studies, expansion of existing clinical trials, and completion of enrollment in ongoing trials; the timing for, and results of, analysis of data from Part 1 of the Company's Phase 3 RCC trial and the filing of a BLA for Oncophage in RCC; other potential filings with regulatory agencies, including plans to make global regulatory filings for Oncophage in RCC; potential commercialization of Oncophage; timing for analysis of data from the Company's Phase 3 melanoma trial; potential benefits of orphan drug designation in the EU; plans for and timing of the filing of an amended IND for Aroplatin; FDA acceptance of an IND for AG-707; expected further development of product candidates addressing 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 potential broad applicability of the Company's technologies and product candidates; and the potential for combination therapies. These risks and uncertainties include, among others, the results from the Company's clinical trials; the need for and extent of additional clinical trials; decisions by regulatory agencies; timing and results of preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. ; 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 May 10, 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 Six months ended
June 30, June 30,
2005 2004 2005 2004
--------- -------- --------- ---------
Revenue $ 85 $ 187 $ 205 $ 296
Operating expenses:
Research and development 13,547 10,879 24,850 21,825
General and administrative 7,623 6,576 14,423 12,121
--------- -------- --------- ---------
Operating loss (21,085) (17,268) (39,068) (33,650)
Other income (expense), net (43) 225 (63) 377
--------- -------- --------- ---------
Loss from continuing operations (21,128) (17,043) (39,131) (33,273)
Income from discontinued
operations (including gain on
disposal of $14.1 million in
2004) - 13,960 - 13,034
--------- -------- --------- ---------
Net loss (21,128) (3,083) (39,131) (20,239)
Dividends on Series A
convertible preferred stock (198) (198) (395) (395)
--------- -------- --------- ---------
Net loss attributable to common
stockholders $(21,326) $(3,281) $(39,526) $(20,634)
========= ======== ========= =========
Per common share data, basic and
diluted:
Loss from continuing
operations $ (0.47) $ (0.38) $ (0.87) $ (0.77)
Income from discontinued
operations $ - $ 0.31 $ - $ 0.30
Net loss attributable to
common stockholders $ (0.47) $ (0.07) $ (0.87) $ (0.47)
Weighted average number of
common shares outstanding,
basic and diluted 45,564 45,068 45,563 43,923
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
June 30, 2005 December 31, 2004
------------- -----------------
Cash, cash equivalents and short-term
investments $ 96,570 $ 86,921
Total assets 142,559 133,058
Total stockholders' equity 66,987 106,443
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