-----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, O6qLWqJgDf9Z8QdmynjNclbm/gwLA13tG0YkQBkHBBNyZjxEaVGsgxk5949J0NBI VLJ5qKfqJYkKRHh/q/g3Qg== 0001157523-05-009263.txt : 20051027 0001157523-05-009263.hdr.sgml : 20051027 20051027070124 ACCESSION NUMBER: 0001157523-05-009263 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051027 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051027 DATE AS OF CHANGE: 20051027 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: 051158378 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 a5005505.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 October 27, 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 October 27, 2005, Antigenics Inc. announced its financial results for the quarter ended September 30, 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 The following exhibit is furnished herewith: 99.1 Press Release dated October 27, 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: October 27, 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 October 27, 2005 EX-99.1 2 a5005505ex99-1.txt EXHIBIT 99.1 Exhibit 99.1 Antigenics Reports Third Quarter 2005 Financial Results and Recent Highlights NEW YORK--(BUSINESS WIRE)--Oct. 27, 2005--Antigenics Inc. (NASDAQ: 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 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 trial testing Oncophage confirms the scientific premises that have driven our clinical strategy," said Garo Armen, PhD, chairman and CEO of Antigenics. "We will use this valuable information from our Phase 3 metastatic melanoma trial to develop Oncophage expeditiously 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, 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 treatment for nonmetastatic renal cell carcinoma (RCC) 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. 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. The primary objectives of this multicenter study are to establish the maximum tolerated dose of Aroplatin and to determine the drug's pharmacokinetics and safety profile. The trial is expected to enroll up to 28 patients. Aroplatin is designed to reduce certain types of toxicities typically associated with other platinum agents as well as to overcome drug resistance. It has been reformulated for improved drug activation and stability. Aroplatin is similar to Eloxatin(R) (oxaliplatin, Sanofi Aventis), which had global sales of approximately $1.5 billion in 2004. AG-707 (rh-HSP70-PC) -- Antigenics recently launched a multicenter Phase 1 clinical trial of AG-707, a therapeutic vaccine for genital herpes. The trial will enroll up to 84 patients infected with 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 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, Novartis), for the treatment of chronic myelogenous leukemia (CML) 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 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. 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 of Financial Condition and Results of Operations section of Antigenics' Form 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 CONTACT: Antigenics Inc. Investor Relations: Shalini Sharp, 800-962-2436 ir@antigenics.com or Corporate Communications: Sunny Uberoi, 212-994-8206 suberoi@antigenics.com -----END PRIVACY-ENHANCED MESSAGE-----