21.02.2007 12:00:00
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Antigenics Reports Fourth Quarter and Year-End 2006 Financial Results
Antigenics Inc. (NASDAQ: AGEN) reported results today for the quarter
and year ended December 31, 2006. For the three months ended December
31, 2006, the company incurred a net loss attributable to common
stockholders of $11.7 million, or $0.26 per share, basic and diluted,
compared with a net loss attributable to common stockholders of $17.9
million, or $0.39 per share, basic and diluted, for the same period in
2005. For the year ended December 31, 2006, Antigenics incurred a net
loss attributable to common stockholders of $52.7 million, or $1.15 per
share, basic and diluted, compared with a net loss attributable to
common stockholders of $74.9 million, or $1.64 per share, basic and
diluted, for the same period in 2005. The decreased loss reflects, among
other factors, the company’s restructuring
efforts in 2006, the completion of most activity related to its Phase 3
clinical trials, and its general ongoing commitment to reducing cash
burn. Research and development costs decreased to $28.6 million for the
year ended December 31, 2006, compared with $47.1 million for the year
ended December 31, 2005. General and administrative expenses decreased
to $21.3 million for the year ended December 31, 2006, compared with
$25.9 million in the same period in 2005. As a result of the adoption of
Statement of Financial Accounting Standards No. 123R effective January
1, 2006, Antigenics incurred a non-cash charge related to the expensing
of stock-based compensation of $3.3 million, or $0.07 per share, basic
and diluted, for the year ended 2006, and $1.2 million, or $0.03 per
share, basic and diluted, for the quarter ended December 31, 2006. Cash,
cash equivalents and short-term investments amounted to $40.1 million on
December 31, 2006. Subsequent to the end of the quarter, Antigenics
received net proceeds of approximately $1.5 million from the sale of its
stake in the Applied Genomic Technology Capital Fund, L.P.
"2006 was a year of both challenges and
opportunities for Antigenics. Although the results of our kidney cancer
trial did not put us on a path for rapid commercialization in the US, we
are pursuing several paths to bring Oncophage to patients in other major
markets based on the significant benefit observed in a significant
proportion of well defined, intermediate-risk kidney cancer patients,”
said Garo H. Armen, PhD, chairman and CEO of Antigenics. "Last
year we also solidified our position in one of the industry’s
rapidly emerging and fastest growth segments by extending our QS-21
vaccine adjuvant collaborations with GlaxoSmithKline, Acambis and others
in the vaccine space.” Corporate Update QS-21 Stimulon®
Adjuvant
Subsequent to the end of the year, Antigenics completed the sharing of
manufacturing technologies and related know-how with GlaxoSmithKline
(GSK), triggering a $2 million milestone payment to Antigenics.
In a recent review of the malaria vaccine landscape published in Vaccine
(Girard et al. Vaccine 2007;25), it was noted that
protective immune response was induced with the use of the RTS,S
antigen and GSK’s proprietary AS02 adjuvant
formulation, which contains QS-21.
Oncophage®
(vitespen)
The lead US investigator from the Phase 3 study of Oncophage in kidney
cancer will present data from the trial at the American Urological
Association’s annual meeting in May.
Antigenics plans to continue to follow patients from this study for
recurrence-free survival and overall survival through March of 2007,
and anticipates announcing data from an updated analysis in mid-2007.
The company will discuss the updated data with regulatory agencies to
define a pathway by which Oncophage may be made available to kidney
cancer patients in the United States and other territories.
In November 2006, the company announced preliminary data from an
investigator-sponsored Phase 1/2 study of Oncophage in recurrent
glioma. In the first cohort of six patients, all patients exceeded the
overall survival historical benchmark of 14.6 months from time of
diagnosis. Enrollment is near completion in the second cohort of six
patients, which will be followed by initiation of enrollment in the
Phase 2 portion of the study. Experience gained from this study will
guide the design of a potential follow-on study. Updated data will be
presented at the annual meeting of the American Association of
Neurological Surgeons in April.
Final data from Antigenics’ Phase 3
metastatic melanoma study are expected to be published in a
peer-reviewed journal by the end of the year.
In mid- to late-2007, Antigenics expects to launch one or more small
clinical trials of Oncophage in combination with other agents to
evaluate tumor response in patients with stage IV disease. Data should
be available within 12 to 18 months of first patient enrollment.
Aroplatin™ (L-NDDP)
Treatment continues in Antigenics’ Phase 1
study in advanced solid tumors and B cell lymphomas. Data generated
thus far indicate a safety profile consistent with past studies of
Aroplatin, including no significant reports of neurotoxicity. The
maximum tolerated dose is expected to be reached in the first quarter,
after which Antigenics anticipates initiating a trial in pancreatic
cancer.
AG-707
More than one third of the required patients have been enrolled in the
ongoing Phase 1 trial in genital herpes. Antigenics anticipates
completing enrollment by the end of 2007, at which time the
immunological testing component of the trial will begin.
Corporate
With the closing of the $25 million convertible note in October,
Antigenics expects cash reserves to be sufficient to fund operations
into 2008. The company is reviewing additional financing strategies
that would further strengthen its balance sheet while minimizing
dilution to existing shareholders. Meanwhile, efforts to further
reduce the company’s cash burn are ongoing.
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 8810929. 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 March 7, 2007. The replay number is 800.642.1687
(domestic) or 706.645.9291 (international), and the access code is
8810929. 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’
corporate partners in several late-stage clinical trials. For more
information, please visit www.antigenics.com.
This press release contains forward-looking statements, including
statements regarding the company’s ongoing
commitment to reduce cash burn; the company’s
anticipated sufficiency of funds and ability to bolster its cash
position; the potential market for, and the growth in development of
products containing QS-21 by the company’s
collaborative partners and licensees; the current and future preclinical
and clinical development and commercialization activities and timelines
for Oncophage; and the company’s Phase 1
clinical programs involving Aroplatin and AG-707 and their potential
development paths. These risks and uncertainties include, among others,
the risk of the inability of the company to operate within its targeted
burn rate and identify additional means of cost savings; unfavorable
data resulting from the analysis of the Oncophage Phase 3 Part 1 kidney
cancer trial data; retention of key employees; clinical trial
enrollment; decisions by collaborative partners and licensees; decisions
by regulatory agencies; timing and results of clinical and preclinical
studies; timely and successful development of QS-21 manufacturing
capabilities 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 9, 2006. Antigenics
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 release, 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 endedDecember 31,
Year endedDecember 31,
2006
2005
2006
2005
Revenue
$
320
$
348
$
692
$
630
Operating expenses:
Research and development
6,015
10,689
28,643
47,080
General and administrative
5,265
6,360
21,288
25,868
Restructuring costs
-
990
1,374
1,596
Operating loss
(10,960)
(17,691)
(50,613)
(73,914)
Other expense, net
(577)
(27)
(1,268)
(190)
Net loss
(11,537)
(17,718)
(51,881)
(74,104)
Dividends on Series A convertible preferred stock
(197)
(197)
(790)
(790)
Net loss attributable to common stockholders
$
(11,734)
$
(17,915)
$
(52,671)
$
(74,894)
Per common share data, basic and diluted:
Net loss attributable to common stockholders
$
(0.26)
$
(0.39)
$
(1.15)
$
(1.64)
Weighted average number of common shares outstanding, basic and
diluted
45,868
45,591
45,809
45,577
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
December 31, 2006
December 31, 2005
Cash, cash equivalents and short-term investments
$
40,095
$
61,748
Total assets
72,952
104,151
Total stockholders' (deficit) equity
(17,393)
31,899
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