-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NVhRc6ZTKplgsMOMTldKX5IzO4Tql/zuj5phFXs+Q9NoIkOhH1iu+mNvnplBWfov qVKdnpzF0uKVJe0dztROpQ== 0001157523-05-010639.txt : 20051206 0001157523-05-010639.hdr.sgml : 20051206 20051206170306 ACCESSION NUMBER: 0001157523-05-010639 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051206 ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051206 DATE AS OF CHANGE: 20051206 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANTIGENICS INC /DE/ CENTRAL INDEX KEY: 0001098972 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061562417 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29089 FILM NUMBER: 051247634 BUSINESS ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2170 CITY: NEW YORK STATE: NY ZIP: 10111 BUSINESS PHONE: 2123324774 MAIL ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2170 CITY: NEW YORK STATE: NY ZIP: 10111 8-K 1 a5034618.txt ANTIGENICS, INC. 8K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 December 6,2005 Date of Report (Date of earliest event reported) ANTIGENICS INC - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) DELAWARE 000-29089 06-1562417 - -------------------------------------------------------------------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 630 Fifth Avenue, Suite 2100 New York, NY 10111 10111 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) 212-994-8200 (Registrant's telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): [_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [_] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [_] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [_] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 2.05 Costs Associated with Exit or Disposal Activities On December 6, 2005, Antigenics Inc. issued a press release, attached hereto as Exhibit 99.1, announcing an update to its business strategies and an outline of the timeline for the analysis of its Phase 3 Kidney cancer trial. The content of that press release is incorporated herein by reference. As part of these strategies, the Company has terminated approximately 70 employees and has estimated its costs related to these terminations and other related activities to be approximately $2 million including severance and other cash costs. Item 9.01 Financial Statements and Exhibits (c) Exhibits 99.1 Press Release dated December 6, 2005 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ANTIGENICS INC. Date: December 6, 2005 By: /s/ Garo H. Armen ------------------------------------- Garo H. Armen, Ph.D. Chairman and Chief Executive Officer EXHIBIT INDEX Exhibit No. Description of Exhibit - ----------- ---------------------- 99.1 Press Release dated December 6, 2005 EX-99.1 2 a5034618ex991.txt EXHIBIT 99.1 Exhibit 99.1 Antigenics Updates Business Strategy and Outlines Timeline for the Analysis of Its Phase 3 Kidney Cancer Trial NEW YORK--(BUSINESS WIRE)--Dec. 6, 2005--Antigenics Inc.: -- Company Presents Clinical Development and Funding Scenarios -- Interim Strategy Will Result in Significant Reduction in Burn Rate to Approximately $40 Million -- Results of Phase 3 Kidney Cancer Trial Expected in March 2006 Antigenics Inc. (NASDAQ: AGEN) today announced that the analysis of data from its kidney cancer trial of Oncophage(R) (vitespen; formerly HSPPC-96) will be completed in March 2006, and that an interim strategy designed to maximize shareholder value will be implemented. This strategy will significantly reduce burn rate and focus operations on the company's highest potential products and programs. "We have elected to take decisive and prudent actions now in order to preserve our cash and position the company to maximize the full value of our diverse portfolio," said Garo H. Armen, PhD, chairman and CEO of Antigenics. The company indicated that the blinded review by an independent panel of three radiologists and an oncologist of its Phase 3 trial in renal cell carcinoma (RCC; the most common form of kidney cancer) is expected to be completed in March 2006, with top-line data available shortly thereafter. If the data from this 728-patient trial are positive, Antigenics will pursue partnering and/or financing transactions that put the company in a position to (1) bring Oncophage to the market expeditiously; and (2) develop the company's priority programs in clinical and preclinical research, with an aim to rapidly partner these products. Alternatively, if the kidney cancer trial results are not positive, the company will continue to pursue Phase 2 trials of Oncophage in combination therapy. This effort is supported by significant activity demonstrated in preclinical studies of Oncophage combined with chemotherapeutic and biological agents. In addition, the company will continue with its other priority preclinical and clinical research programs, financed initially through the company's own cash reserves. The company also plans to submit to the US Food and Drug Administration (FDA) the results of its tests measuring the potency of Oncophage from both the kidney cancer and melanoma Phase 3 trials. These tests have been completed on all patient product samples; the results indicate that 96 percent of the Oncophage vaccines used in these trials met potency specifications, as measured by two different assays. Independent of the outcome of the kidney cancer trial, Antigenics is working to bring to the clinic Oncophage made through an improved manufacturing process. Product made with this process has shown significantly higher activity than that made with the current process. The company's strategy also calls for the continued use of company funds for clinical development of Aroplatin in cancer and AG-707 in genital herpes. Preclinical research will focus on autoimmune diseases with the goal of bringing a lead compound to the clinic in the first half of 2007. All other clinical and preclinical or research programs have been either postponed or decelerated. The company today has also taken steps to reduce its headcount from 251 at the end of the third quarter to approximately 170 employees. The company estimates that severance and other costs will be approximately $2 million, the majority of which will be incurred by December 31, 2005. Antigenics anticipates that these cost-cutting measures will result in significant cost savings, starting immediately, and that the company's net cash burn rate (cash used in operating activities plus cash from investing activities and debt repayments), exclusive of any program sponsorship from third party sources, will be reduced for the near term to approximately $40 million per year by the second quarter of 2006. "We are streamlining our operations and narrowing our focus to those compounds that can generate meaningful and measurable milestones within the next 24 months," said Dr. Armen. "We believe our updated business strategies give us a realistic and attainable approach for the various contingencies that may arise in the coming period." Top priorities for clinical and preclinical research programs are: -- Phase 3 analysis evaluating Oncophage in kidney cancer is expected in late March 2006. -- Phase 3 final Oncophage data in melanoma are expected in March 2006. -- Combination therapies with Oncophage and other agents in small clinical trials will evaluate tumor response in patients with stage IV disease. The first investigational new drug (IND) application will be filled by year-end, with additional INDs to be filed in 2006. Data should be available within 12 to 18 months of first patient enrollment. -- Phase 1 dose-escalating trial of the reformulated Aroplatin in solid malignancies and B-cell lymphoma is ongoing. This trial will also measure tumor response in stage IV patients, with data expected within 12 to 18 months of trial commencement. -- Phase 1 trial with AG-707, a therapeutic vaccine directed at the virus that causes genital herpes, is ongoing. This trial measures immunological responses and recurrence of herpes. Data are expected in early to mid 2007, with the goal of partnering this program upon positive outcomes. -- Preclinical studies of higher-activity Oncophage made through an improved process are to be completed by the third quarter of 2006. Antigenics plans to initiate clinical trials with this product in stage IV cancer patients in the first half of 2007. -- Clinical trials of AU-801 for the treatment of autoimmune diseases are slated for the first half of 2007. About Antigenics Antigenics is working to develop patient-specific immunotherapeutics and revolutionary treatments for cancers, infectious diseases and autoimmune disorders. The company's lead product candidate is Oncophage(R) (vitespen; formerly HSPPC-96), 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(TM) and ATRA-IV; and AG-707, a Phase 1 genital herpes vaccine. This press release contains forward-looking statements, including statements regarding Antigenics' potential commercialization of Oncophage if the Phase 3 RCC trial results are positive, the timing of final analysis of the data from the Phase 3 trials in melanoma and RCC, plans to commence and timing of new clinical trials, expectation that trials will support regulatory filings, timing of regulatory submissions, projected enrollment in trials, the magnitude of cost reductions, and that the steps described in this press release will maximize the value of the product portfolio and shareholder value. It also contains forward-looking statements regarding preclinical and manufacturing process development as well as partnering and financing opportunities. All of 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, the timing of events in the RCC trial, the results of clinical trials, decisions by regulatory agencies, the cost of additional clinical trials, the outcome of process and preclinical development activities, the ability to raise additional capital, and the factors described under Factors That May Impact Future Results in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of Antigenics' Form 10-Q as filed with the Securities and Exchange Commission on November 4, 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. CONTACT: Antigenics Inc. Corporate Communications: Sunny Uberoi, 212-994-8206 suberoi@antigenics.com or Investor Relations: Shalini Sharp, 800-962-2436 ir@antigenics.com -----END PRIVACY-ENHANCED MESSAGE-----