-----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, RBJubshyXaNJwLN+SPCYphz5Ks40gkCsjCGqL55WxG5TXFtSSjYSCjDxV48FIK/y cNK+bcCVs0fa+jW8KV4U9g== 0001157523-05-004342.txt : 20050505 0001157523-05-004342.hdr.sgml : 20050505 20050505094206 ACCESSION NUMBER: 0001157523-05-004342 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050505 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050505 DATE AS OF CHANGE: 20050505 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: 05801535 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 a4881748.txt ANTIGENICS INC 8-K 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 May 5, 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 2.02 Results of Operations and Financial Condition On May 5, 2005, Antigenics Inc. announced its financial results for the quarter ended March 31, 2005. The full text of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this current report on Form 8-K. Item 9.01 Financial Statements and Exhibits (c) Exhibits: 99.1 Press Release dated May 5, 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: May 5, 2005 By: /s/ Garo H. Armen ----------------- Garo H. Armen, Ph.D. Chairman and Chief Executive Officer EXHIBIT INDEX The following designated exhibits are filed herewith: Exhibits: 99.1 Press Release dated May 5, 2005 EX-99.1 2 a4881748ex991.txt EXHIBIT 99.1 Exhibit 99.1 Antigenics Reports First Quarter 2005 Financial Results and Recent Highlights NEW YORK--(BUSINESS WIRE)--May 5, 2005--Antigenics Inc. (NASDAQ: AGEN) reported results today for the quarter ended March 31, 2005. The company incurred a net loss attributable to common stockholders of $18.2 million, or $0.40 per share, basic and diluted. This is compared with a net loss attributable to common stockholders in the first quarter of 2004 of $17.4 million, or $0.41 per share, basic and diluted. Research and development expenses were $11.3 million in the first quarter of 2005, compared with $10.9 million for the same period in 2004. The increased loss reflects the continued progress of the company's clinical product candidates, including Oncophage(R) (HSPPC-96), Antigenics' lead product candidate, and an increase in professional fees relating to preparations for the potential commercialization of Oncophage. Cash, cash equivalents and short-term investments amounted to $114.1 million on March 31, 2005. "As we await the data from Part 1 of our Phase 3 renal cell carcinoma trial, we are readying Antigenics for the next steps, including a potential global filing of Oncophage in RCC if the regulatory agencies in the United States, Canada and Europe concur," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "We expect that the total number of events necessary to trigger final analysis will be achieved during the third quarter of 2005. Our RCC trial is designed to demonstrate a significant clinical benefit to patients treated with Oncophage postsurgery." Recent Highlights -- Antigenics has successfully concluded discussions with the FDA regarding the analytical validations for the potency tests used to release Oncophage for clinical investigation. -- Antigenics has been preparing for global filing (eCTD) of Oncophage for renal cell carcinoma, assuming the results from the 800-patient, Phase 3 Part 1 trial are positive and that various regulatory agencies concur with the company's approval strategy. -- The company has initiated Part 2 of the Phase 3 RCC trial, which will potentially enroll 600 patients if the trial design remains unchanged after analysis of data from Part 1. -- Antigenics has completed toxicology studies with the new formulation of Aroplatin(TM). The company expects to submit an amendment to the Aroplatin IND by mid-year in order to start clinical trials with the improved new formulation shortly thereafter. -- The company has commenced retrospective potency testing of the Oncophage lots used in Part 1 of the Phase 3 clinical trial for RCC. -- Antigenics is expanding commercial development activities, including publication planning, growing the company's network of key opinion leaders, and developing a speakers bureau and reimbursement strategy. -- A new Enterprise Resource Planning system has been implemented to establish a strong framework for manufacturing and commercializing the company's personalized products. 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 5671279. 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 12, 2005. The replay number is 800.642.1687 (domestic) or 706.645.9291 (international), and the access code is 5671279. The replay will also be available on the company's website approximately two hours after the live call. About Antigenics Antigenics is 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 Phase 2 liposomal cancer treatments, Aroplatin and ATRA-IV; and AG-702/AG-707, a Phase 1 genital herpes program. This press release contains forward-looking statements, including statements regarding the timing for, and results of, final analysis of Part 1 of our Phase 3 renal cell carcinoma trial, potential filings with regulatory agencies, potential commercialization of Oncophage, the filing of an amended IND for Aroplatin, and the initiation of a new clinical study of that compound. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the results from our clinical trials; the need for and extent of additional clinical trials; decisions by regulatory agencies; timing and results of preclinical studies; and the factors described in our Form 10-K as filed with the Securities and Exchange Commission on March 31, 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 March 31, 2005 2004 ------------ -------------- Revenue $120 $110 Operating expenses: Research and development 11,304 10,946 General and administrative 6,800 5,545 ------------ -------------- Operating loss (17,984) (16,381) Other income (expense), net (19) 151 ------------ -------------- Loss from continuing operations (18,003) (16,230) Loss from discontinued operations - (925) ------------ -------------- Net loss (18,003) (17,155) Dividends on Series A convertible preferred stock (198) (198) ------------ -------------- Net loss attributable to common stockholders $(18,201) $(17,353) ============ ============== Per common share data: Loss from continuing operations, basic and diluted $(0.40) $(0.38) Net loss per share from discontinued operations, basic and diluted $- $(0.02) Net loss attributable to common stockholders, basic and diluted $(0.40) $(0.41) Weighted average number of common shares outstanding, basic and diluted 45,563 42,778 Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) March 31, December 31, 2005 2004 ------------ ---------------- Cash, cash equivalents and short-term investments $114,064 $86,921 Total assets 161,983 133,058 Total stockholders' equity 88,174 106,443 CONTACT: Antigenics Inc. Investor Relations: Jack Howarth, 212-994-8244 jhowarth@antigenics.com or Corporate Communications: Sunny Uberoi, 212-994-8206 suberoi@antigenics.com -----END PRIVACY-ENHANCED MESSAGE-----