Antigenics Reports Second Quarter 2008 Financial Results
* Reuters is not responsible for the content in this press release.
Conference Call Scheduled for Today at 11:00 a.m. ET
NEW YORK--(Business Wire)--
Antigenics Inc. (NASDAQ: AGEN) reported results today for the
quarter ended June 30, 2008. The company incurred a net loss
attributable to common stockholders of $12.2 million, or $0.19 per
share, basic and diluted, for the second quarter of 2008, compared
with a net loss attributable to common stockholders in the second
quarter of 2007 of $10.1 million, or $0.22 per share, basic and
diluted. For the six months ended June 30, 2008, Antigenics incurred a
net loss attributable to common stockholders of $23.4 million, or
$0.39 per share, basic and diluted, compared with a net loss
attributable to common stockholders of $18.9 million, or $0.41 per
share, basic and diluted, for the comparable period in 2007.
The company's net cash burn (defined as cash used in operating
activities plus capital expenditures and dividend payments) for the
three months ended June 30, 2008 and 2007 was $6.9 million and $6.8
million, respectively. The company's net cash burn for the six months
ended June 30, 2008 and 2007 was $16.3 million and $16.2 million,
respectively. The 2008 results reflect, among other things, the
company's efforts to obtain registration and conduct pre-commercial
launch activities for Oncophage(R) (vitespen) in Russia, while the
2007 results reflect non-recurring milestone payments received from
the company's QS-21 Stimulon(R) adjuvant licensees of $1.0 million for
the second quarter of 2007 and $3.0 million for the six months ended
June 30, 2007. Cash, cash equivalents and short-term investments
amounted to $49.0 million as of June 30, 2008.
"We continue to focus on our top priorities, which include the
launch of Oncophage in Russia and the submission of our marketing
authorization application for Oncophage in Europe, both of which we
expect to happen by year-end," said Garo H. Armen, Ph.D., chairman and
chief executive officer of Antigenics. "As the groundswell of support
for treating patients with Oncophage intensifies among key opinion
leaders in Russia and Europe, we are working quickly to bring
Oncophage to market for kidney cancer patients with very limited
treatment options."
Second Quarter 2008 Corporate Highlights
-- In April, Oncophage became the first cancer vaccine to be
approved in a major pharmaceutical market. The Russian
Ministry of Public Health issued a registration certificate
for Oncophage(R) (vitespen) as an adjuvant treatment for renal
cell carcinoma (RCC; or kidney cancer) patients at
intermediate-risk for disease recurrence. Presently, there are
no approved products anywhere in the world for this stage of
RCC patients.
-- Russian approval was based on a 45 percent reduction in
recurrences for patients with intermediate-risk kidney cancer
who were treated with Oncophage in the company's Phase 3
clinical study. These intermediate-risk patients (stages I/II
high-grade, III T1/2/3a low-grade) demonstrated an improvement
in recurrence-free survival of approximately 45 percent over
patients in the observation arm (P less than 0.01; hazard
ratio = 0.55).
-- The Lancet recently fast-tracked and published Oncophage data
from the Phase 3 kidney cancer study.
-- By year end 2008 Antigenics expects to file for conditional
authorization in Europe for Oncophage as an adjuvant treatment
for kidney cancer patients. In this regard, several
discussions and meetings were held with the European Medicines
Agency (EMEA) during the first half of 2008, including
meetings with authorities from the lead countries that have
been assigned the responsibility for reviewing the Oncophage
marketing authorization application.
-- Data from QS-21 Stimulon(R) containing products were presented
at the Annual Meeting of the American Society of Clinical
Oncology (ASCO) in June. GlaxoSmithKline (GSK) presented data
from a Phase 2 study of its MAGE-A3 Antigen-Specific Cancer
Immunotherapeutic in melanoma. The study concluded that
antibody titers and CD4+ T cell responses were higher in the
arm containing the adjuvant system comprised of QS-21, MPL and
CpG.
-- Clinical development continues by Antigenics' collaborative
partners for approximately 15 additional QS-21-containing
vaccines for other types of cancer, infectious diseases and
Alzheimer's disease. These trials include GSK's MAGE-A3
Antigen-Specific Cancer Immunotherapeutic, which is currently
in a Phase 3 clinical trial for the treatment of non-small
cell lung cancer.
-- Analysis of immune responses from the Phase 1 study of AG-707
in genital herpes is ongoing. Antigenics has elected to
conduct additional immunology analysis, and results are now
expected around year-end. The company will provide a report on
the results of the analysis once complete information is
available.
-- Antigenics reached the maximum tolerated dose of Aroplatin(TM)
in a Phase 1 study in advanced solid malignancies and B cell
lymphoma. The company plans to review the results from this
trial with its medical advisors and discuss future development
options for this compound.
Antigenics' Key Upcoming Milestones
-- Launch Oncophage in Russia by the end of 2008. Antigenics is
currently working with the FDA to obtain an export license for
Oncophage. The required documentation has been submitted to
the agency, and the review is ongoing.
-- File for conditional approval of Oncophage as an adjuvant
treatment for RCC with the EMEA in Europe.
Conference Call Information
Antigenics executives will host a conference call at 11:00 a.m. ET
today. To access the live call, dial 877.762.5772 (domestic) or
706.643.6986 (international); the access code is 55836270. 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
14, 2008. The replay number is 800.642.1687 (domestic) or 706.645.9291
(international), and the access code is 55836270. 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(R) (vitespen), a
patient-specific therapeutic cancer vaccine being evaluated in several
indications; Aroplatin(TM) (L-NDDP), a liposomal, third-generation
platinum chemotherapeutic; AG-707, a therapeutic vaccine for the
treatment of genital herpes; and QS-21 Stimulon(R), an adjuvant being
evaluated by Antigenics' collaborative partners in approximately 15
clinical stage vaccines. For more information, please visit
www.antigenics.com.
This earnings release contains forward-looking statements,
including statements regarding activities and potential timelines
relating to commercial launch of Oncophage in Russia; potential
strategies and timing for pursuing marketing registration for
Oncophage in other territories including Europe; the availability,
review and presentation of data; and present and future clinical
trials and product candidate developments by the company and its
licensees, including Antigenics' QS-21 licensees. 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 or studies with our other
product candidates will not be as favorable as prior results; the
inability to secure local distributors and payment 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
Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission for the period ended March 31, 2008. 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 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.
-0-
*T
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,
2008 2007 2008 2007
--------- --------- --------- ---------
Revenue $ 595 $ 1,444 $ 1,445 $ 3,796
Operating expenses:
Research and development 5,839 6,051 11,570 12,013
General and administrative 5,737 4,397 11,009 8,731
--------- --------- --------- ---------
Operating loss (10,981) (9,004) (21,134) (16,948)
Other expense, net (973) (848) (1,891) (1,601)
--------- --------- --------- ---------
Net loss (11,954) (9,852) (23,025) (18,549)
Dividends on Series A
convertible preferred stock (198) (198) (395) (395)
--------- --------- --------- ---------
Net loss attributable to
common stockholders $(12,152) $(10,050) $(23,420) $(18,944)
========= ========= ========= =========
Per common share data, basic
and diluted:
Net loss attributable to
common stockholders $ (0.19) $ (0.22) $ (0.39) $ (0.41)
Weighted average number
of common shares
outstanding, basic and
diluted 64,586 45,982 60,166 45,972
*T
-0-
*T
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
June 30, 2008 December 31, 2007
------------------- ---------------------
Cash, cash equivalents, and
short-term investments $ 49,050 $ 18,679
Total assets 72,140 44,537
Total stockholders' deficit (19,929) (47,060)
*T
Antigenics Inc.
Investor Relations
Robert Anstey, 800-962-2436
ir@antigenics.com
or
Corporate Communications
Sunny Uberoi, 212-994-8206
suberoi@antigenics.com
Copyright Business Wire 2008
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.



Follow Reuters