-----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, UzdrIUVRvvdLkotDOffapdMI5HYfnklERnQzHT2QODXc42SfT6KN0dPYSV5UL/dw x+TC3x/88kYEdM1OJogC+Q== 0001157523-08-003538.txt : 20080501 0001157523-08-003538.hdr.sgml : 20080501 20080501073835 ACCESSION NUMBER: 0001157523-08-003538 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080501 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080501 DATE AS OF CHANGE: 20080501 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: 08791951 BUSINESS ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2100 CITY: NEW YORK STATE: NY ZIP: 10111 BUSINESS PHONE: 212-994-8200 MAIL ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2100 CITY: NEW YORK STATE: NY ZIP: 10111 8-K 1 a5673550.htm 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 1, 2008
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

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

162 Fifth Avenue, Suite 900

New York, NY

10010

(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 1, 2008, Antigenics Inc. announced its financial results for the first quarter ended March 31, 2008. 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.
 
(d) Exhibits
The following exhibit is furnished herewith:
 
99.1 Press Release dated May 1, 2008



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 1, 2008 By:

/s/ Garo H. Armen

Garo H. Armen

Chairman and CEO


EXHIBIT INDEX

Exhibit No.

Description of Exhibit

99.1

Press Release dated May 1, 2008

EX-99.1 2 a5673550ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

Antigenics Reports First Quarter 2008 Financial Results

Conference Call to Follow

NEW YORK--(BUSINESS WIRE)--Antigenics Inc. (NASDAQ: AGEN) reported results today for the quarter ended March 31, 2008. The company incurred a net loss attributable to common stockholders of $11.3 million, or $0.20 per share, basic and diluted, for the first quarter of 2008, compared with a net loss attributable to common stockholders in the first quarter of 2007 of $8.9 million, or $0.19 per share, basic and diluted. The company’s net cash burn (cash used in operating activities plus capital expenditures and dividend payments) for the three months ended March 31, 2008 and 2007 was $9.4 million and $9.3 million, respectively. The 2008 results reflect, among other things, the company’s efforts to obtain registration and conduct pre-commercial launch activities for Oncophage in Russia and the timing of milestone achievements by Antigenics’ licensees of its QS-21 adjuvant. Cash, cash equivalents and short-term investments amounted to $35.4 million as of March 31, 2008, and, as adjusted for fundraising activities subsequent to the end of the quarter, amounted to $55.9 million on a pro forma basis.

“With the achievement of our regulatory approval in Russia, we have made great strides in bringing our cancer vaccine Oncophage to patients” said Garo H. Armen, PhD, chairman and CEO of Antigenics. “Russia has become the fastest growing pharmaceutical market amongst major countries and offers an exciting opportunity for launching Oncophage. In addition, we remain on track to submit a marketing authorization application to the European regulatory authorities by year-end.”

Corporate Update

  • In April, the Russian Ministry of Public Health issued a registration certificate for Oncophage® (vitespen) as an adjuvant treatment of kidney cancer patients at intermediate risk for disease recurrence. This is the first ever formal regulatory approval of a patient-specific therapeutic cancer vaccine worldwide and the first ever cancer vaccine to be approved in a major market. Oncophage is also the first post-surgical treatment option available for patients in Russia with nonmetastatic kidney cancer.
  • Russian approval was based on results from the Phase 3 clinical study that showed that patients receiving Oncophage in the intermediate-risk population (stages I/II high-grade, III T1/2/3a low-grade) who were without disease at baseline (n = 362) demonstrated a clinically significant improvement in recurrence-free survival of approximately 45 percent over patients in the observation arm (P < 0.01; hazard ratio = 0.55). Of the total 604 eligible patients in the study, 172 patients (28 percent) were enrolled at the eight sites in Russia.

  • Launch activities are ongoing, and the company anticipates that it could begin generating modest revenues from Oncophage in Russia in the second half of 2008.
  • Oncophage for commercial use in Russia will be manufactured at Antigenics’ state of the art personalized protein manufacturing facility in Lexington, Massachusetts. The facility has been operational for clinical production for approximately five years and has been used to manufacture product for hundreds of patients at more than 150 treatment centers worldwide.
  • Antigenics continues to investigate additional registrational opportunities for Oncophage. The company is working towards filing a marketing authorization application in the European Union for conditional authorization of Oncophage as an adjuvant treatment for kidney cancer patients by the end of the year.
  • Antigenics expects the data from its Phase 3 study of Oncophage in kidney cancer to be submitted for publication to a peer-reviewed journal in mid-2008.
  • The company continues to consider Oncophage registrational pathways in the U.S. in kidney cancer as well as in glioma. Enrollment is ongoing in the Phase 2 portion of the investigator-sponsored glioma study at the University of California, San Francisco.
  • A poster presentation of data from the Phase 2 feasibility study of Oncophage in non-small cell lung cancer will be made at the Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held May 30 – June 3, 2008.
  • Clinical development is ongoing for approximately 15 QS-21-containing vaccines by Antigenics’ collaborative partners, including two vaccines in Phase 3 clinical studies. Antigenics anticipates that the first vaccine containing QS-21 could launch in the 2010 timeframe.
  • Analysis of immune response in serum samples of patients treated in the Phase 1 study of AG-707 in genital herpes has been initiated at Antigenics. Data is expected to be available in mid-2008.
  • In April, Antigenics raised gross proceeds of $21 million in a private placement of common stock and warrants.

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 44383079. 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 15, 2008. The replay number is 800.642.1687 (domestic) or 706.645.9291 (international), and the access code is 44383079. The replay will also be available on the company’s website approximately two hours after the live call.

About Antigenics

Antigenics (NASDAQ: AGEN) is a biotechnology company working to develop treatments for cancers and infectious diseases. The company’s investigational product portfolio includes Oncophage® (vitespen), a patient-specific therapeutic cancer vaccine being evaluated in several indications; Aroplatin™ (L-NDDP), a liposomal, third-generation platinum chemotherapeutic; AG-707, a therapeutic vaccine for the treatment of genital herpes; and QS-21 Stimulon®, an adjuvant being evaluated by Antigenics’ collaborative partners in approximately 15 clinical stage vaccines. For more information, please visit www.antigenics.com.


This press release contains forward-looking statements, including statements regarding the potential clinical benefit of Oncophage in kidney cancer based on a subgroup analysis; potential strategies and timing for pursuing marketing registration for Oncophage in Europe; the availability, presentation and publication of data; present and future clinical trials; the advancement and potential timing for commercial launch of products using QS-21 by Antigenics’ licensees; and the potential timing and scale of generating revenues. 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, decisions by regulatory authorities, physicians and patients; the possibility that results from future treatments with Oncophage will not be as favorable as the results from our subset analysis; the inability to secure local distributors and reimbursement mechanisms in Russia or any other jurisdiction in which Antigenics may obtain product approval; the ability to raise capital and finance future development of Oncophage; Antigenics’ dependence on its collaborative partners to successfully develop and commercialize products containing QS-21; and the factors described under the Risk Factors Section of our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the period ended December 31, 2007. Antigenics cautions investors that we do not expect to generate significant revenue from sales of Oncophage in Russia for several months, if ever. The amount of revenue we generate will depend on, among other things, securing reimbursement mechanisms and physician and patient assessment of the benefits and cost-effectiveness of Oncophage. Antigenics also 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,
  2008     2007  
 
 
Revenue $ 850 $ 2,353
 
Operating expenses:
Research and development 5,731 5,962
General and administrative   5,273     4,335  
 
Operating loss (10,154 ) (7,944 )
 
Other expense, net   (917 )   (752 )
 
Net loss (11,071 ) (8,696 )
 
Dividends on Series A convertible preferred stock   (198 )   (198 )
 
Net loss attributable to common stockholders $ (11,269 ) $ (8,894 )
 
Per common share data, basic and diluted:
Net loss attributable to common stockholders $ (0.20 ) $ (0.19 )
Weighted average number of common shares outstanding, basic and diluted   55,746     45,962  
 
 
 
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
 
March 31, 2008 December 31, 2007
 
Cash, cash equivalents and short-term investments $ 35,410 $ 18,679
Total assets 60,218 44,537
Total stockholders' deficit (30,538 ) (47,060 )

CONTACT:
Antigenics Inc.
Robert Anstey, 800-962-2436
Investor Relations
ir@antigenics.com
or
Sunny Uberoi, 212-994-8206
Corporate Communications
suberoi@antigenics.com

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