Agenus Reports Fourth Quarter and Year End 2012 Financial Results

Agenus Reports Fourth Quarter and Year End 2012 Financial Results

Agenus to Host Conference Call Beginning at 11 a.m. ET Today

LEXINGTON, Mass., Feb. 28, 2013 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN),
a biotechnology company working to develop novel immunology based treatments
for cancers and infectious diseases, today announced its financial results and
business highlights for the fourth quarter and year ended December 31, 2012.

The company reported a net loss attributable to common stockholders of $5.6
million, or $0.23 per share, basic and diluted, for the fourth quarter of
2012, compared with a net loss attributable to common stockholders in the
fourth quarter of 2011 of $6.2 million, or $0.29 per share, basic and diluted.

For the year ended December 31, 2012, the company incurred a net loss
attributable to common stockholders of $12.1 million, or $0.51 per share,
basic and diluted, compared with a net loss attributable to common
stockholders of $24.1 million, or $1.21 per share, basic and diluted, for the
comparable period in 2011. The decreased net loss for the twelve months ended
December 31, 2012, compared to the same period in 2011, is directly related to
the revenue generated of $13.4 million during the first quarter of 2012
primarily due to the one-time payments received through an expanded agreement
with GlaxoSmithKline (GSK), and through a license of non-core technologies.

Cash provided by operating activities for the year ended December 31, 2012 was
$1.0 million compared to cash used in operating activities of $16.2 million
for the same period in 2011. Cash and cash equivalents were $21.5 million as
of December 31, 2012.

"Last year we saw significant progress in both our core technology areas,
which is expected to lead to the announcement of significant milestones this
year. These include GSK's Phase 3 data readouts of the MAGE-A3 cancer
immunotherapeutic vaccine candidates for melanoma and non-small cell lung
cancer and our Phase 2 data readout for HerpV, a therapeutic vaccine candidate
to treat genital herpes," said Garo H. Armen, Ph.D., chairman and CEO of
Agenus. "We believe that successful outcomes, particularly for the Phase 3
programs, could lead to a paradigm shift in the way patients are treated in
the future and make therapeutic vaccines a larger focus for the pharmaceutical
and biotech industries."

Highlights for 2012

  *In November, the second complete set of results from the Phase 3 trial of
    GSK's RTS,S malaria vaccine candidate (also known as Mosquirix^™), which
    contains Agenus' QS-21 Stimulon adjuvant^®1 (QS-21 Stimulon), were
    published online in the New England Journal of Medicine. In this trial,
    infants (aged 6-12 weeks at first vaccination) receiving the RTS,S vaccine
    candidate experienced one-third fewer episodes of both clinical and severe
    malaria and experienced similar reactions to the injection when compared
    to those who received the control meningococcal C conjugate vaccine. Both
    co-primary endpoints in the large ongoing efficacy trial were met.
  *In October, the company began a Phase 2 randomized, double-blind,
    multicenter study for HerpV, a recombinant "off-the-shelf" therapeutic
    vaccine candidate for the treatment of genital herpes in herpes simplex
    virus 2 (HSV-2) positive subjects.HerpV contains QS-21 Stimulon. The
    study designated as protocol C-400-02 has recently completed enrollment
    and data results are expected during the fourth quarter of 2013. The
    primary aim of the study is to test the biological efficacy of the HerpV
    vaccine as measured by effect on genital HSV-2 viral shedding.
  *In August, data from the Phase 1 trial for Prophage Series G-200
    (HSPPC-96; vitespen) were published by Clinical Cancer Research in an
    article titled, "Individual patient-specific immunity against high-grade
    glioma after vaccination with autologous tumor derived peptides bound to
    the 96 KD chaperone protein." This data showed that a tumor specific
    immune response to peptides bound to gp96 can be generated with autologous
    HSPPC-96 derived from glioblastoma (GBM) patients undergoing surgical
    resection and the observations provide evidence for a general mechanism to
    elicit individual patient-specific immune responses that appear to
    correlate with clinical outcome.
  *In July, GSK's herpes zoster vaccine candidate (HZ/su), which contains
    QS-21 Stimulon as a component of GSK's adjuvant system, commenced a
    global, randomized, placebo-controlled Phase 3 clinical trial for the
    prevention of shingles (herpes zoster) in immunocompromised patients. This
    study will include approximately 200 clinical sites and enroll more than
    1,400 patients 18 years of age or older undergoing hematopoietic stem cell
    transplantation (HCT). The immunocompromised study represents the
    continuation of a Phase 3 clinical program that began in August 2010,
    which includes over 30,000 adult patients.
  *In June, Agenus met the qualifications to join the broad-market Russell
    3000^®Index, Russell 2000^® Index, Russell Global Index, and Russell
    Microcap^® Index.
  *In March, GSK and Agenus amended the QS-21 Stimulon license and
    manufacturing agreement to include additional rights for the use of
    Agenus' proprietary QS-21 Stimulon in GSK adjuvant systems. In addition,
    Agenus agreed to grant GSK the first right to negotiate for the purchase
    of Agenus or certain of its assets. Under the terms of the agreement, GSK
    paid Agenus a non-refundable payment of $9 million, of which $2.5 million
    is creditable against future manufacturing technology transfer royalty
    payments. The agreement also included royalty payments for an undisclosed
    indication upon commercialization of a vaccine product.

Between Agenus and its partners, a total of 19 vaccine programs are in
clinical development of which 17 contain QS-21 Stimulon. They include, but are
not limited to:

  *Phase 3: GSK's RTS,S for malaria^2
  *Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with
    resected melanoma^2
  *Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with
    resected non-small cell lung cancer^2
  *Phase 3: GSK's HZ/su for shingles^2
  *Phase 2:Janssen's ACC-001 for Alzheimer's disease

Agenus' pipeline programs include:

  *Phase 2: HerpV (contains QS-21 Stimulon) for genital herpes
  *Phase 2: Prophage Series G-100 for newly diagnosed glioma
  *Phase 2: Prophage Series G-200 for recurrent glioma

Saponin Platform: QS-21 Stimulon^®Adjuvant

Agenus' QS-21 Stimulon adjuvant is one of the most widely tested vaccine
adjuvants under development. QS-21 Stimulon is designed to strengthen the
body's immune response to a vaccine's antigen, thus making it more effective.
QS-21 Stimulon is a key component in the development of investigational
preventive vaccine formulations across a wide variety of infectious diseases,
and appears to play an important role for several investigational therapeutic
vaccines intended to treat cancer and degenerative disorders. Licensees of
QS-21 Stimulon include GSK and Janssen Alzheimer Immunotherapy. Agenus is
generally entitled to receive milestone payments as QS-21 Stimulon-containing
programs advance, as well as royalties for 10 years after commercial launch,
with some exceptions.

Heat Shock Protein Platform (HSP): Recombinant Series
HerpV

HerpV is a recombinant therapeutic vaccine candidate for the treatment of
genital herpes, which is caused by the herpes simplex virus-2 (HSV-2). HerpV
is the most clinically advanced HSV-2 therapeutic vaccine and is currently in
a Phase 2 randomized, double-blind, multicenter study. The vaccine is based
on Agenus' HSP platform technology, and contains Agenus' proprietary QS-21
Stimulon adjuvant. 

HerpV consists of recombinant human heat shock protein-70 complexed with 32
distinct 35-mer synthetic peptides from the HSV-2 proteome. This broad
spectrum of herpes antigens is intended to allow for more accurate immune
targeting and surveillance, reducing the likelihood of immune escape. Further,
the diversity of antigens in HerpV increases the chance of providing efficacy
for a wide segment of the patient population.

In a four-arm, Phase 1 study, 35 HSV-2 seropositive patients received HerpV
(designated in the study as AG-707 plus QS-21), AG-707, QS-21 alone, or
placebo. Patients received three treatments at two-week intervals. The vaccine
was generally well tolerated, with injection site pain as the most common
reported adverse event. All patients who received HerpV and were evaluable for
immune response showed a statistically significant CD4+ T cell response (100%;
7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those
patients demonstrated a CD8+ T cell response (75%; 6/8). This study was
published in the scientific journal Vaccine.

Heat Shock Protein Platform( HSP): Prophage Series Cancer Vaccines

Derived from each individual's tumor, Prophage Series vaccines contain the
'antigenic fingerprint' of the patient's particular cancer and are designed to
reprogram the body's immune system to target only cancer cells bearing this
fingerprint. Prophage Series vaccines, based on our HSP platform technology,
are intended to leave healthy tissue unaffected and limit the debilitating
side effects typically associated with traditional cancer treatments such as
chemotherapy and radiation therapy.The Prophage G Series vaccines are
currently being studied in two different settings of glioma: newly diagnosed
and recurrent disease.

The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute
(NCI) approved a study of the Prophage Series G-200 vaccine in a large,
randomized Phase 2 trial in combination with Avastin^® (bevacizumab;
Genentech/Roche) in patients with surgically resectable recurrent GBM.The
study will be sponsored by the Alliance for Clinical Trials in Oncology, an
NCI cooperative group. This trial will investigate the combination of G-200
and Avastin in a three-arm randomized study of approximately 220 patients with
surgically resectable recurrent GBM.The study will compare efficacy of G-200
given with Avastin either concomitantly or at progression, versus Avastin
alone, in the therapy of surgically resectable recurrent GBM. This study is
anticipated to begin enrolling patients during the first half of 2013.

In addition to the recurrent GBM study with G-200, a Phase 2 trial testing the
Prophage Series G-100 vaccine in patients with newly diagnosed glioma is
underway. In this trial, G-100 is being used with the standard of care, which
includes Temodar^® (Merck; temozolomide) and radiation. It is believed that
the efficacy of G-100 could potentially be enhanced through this combination
regimen.Preliminary findings from this study will be presented in a plenary
session of a major medical meeting in early May 2013.

For additional information please refer to www.clinicaltrials.gov or click on
the following link
(http://www.clinicaltrials.gov/ct2/show/NCT00905060?term=C-100-37&rank=1)

Conference Call and Web Cast Information

Agenus executives will host a conference call at 11:00 a.m. Eastern Time
today. To access the live call, dial 877.475.3568 (domestic) or 678.809.3092
(international); the access code is 14310694. The call will also be webcast
and will be accessible from the company's website at
www.agenusbio.com/webcast/. A replay will be available approximately two
hours after the call through midnight Eastern Time on April 25, 2013. The
replay number is 855.859.2056 (domestic) or 404.537.3406 (international), and
the access code is 14310694. The replay will also be available on the
company's website approximately two hours after the live call.

About Agenus

Agenus Inc. is a biotechnology company working to develop treatments for
cancers and infectious diseases. The company is focused on immunotherapeutic
products based on strong platform technologies with multiple product
candidates advancing through the clinic, including several product candidates
that have advanced into late-stage clinical trials through corporate partners.
For more information, please visit www.agenusbio.com.

The Agenus logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8187

Forward-Looking Statement

This earnings release contains forward-looking statements, including
statements regarding development and clinical trial activities and timelines
of the company and its licensees and collaborators; potential benefit of
product candidates in development, and potential revenue streams from our
partnering and licensing arrangements. 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, patients, and our existing and potential
licensees and collaborators; the possibility that clinical trial results will
not be favorable; the inability to secure favorable partnering arrangements;
the ability to raise capital; and the factors described under the Risk Factors
section of our Quarterly Report on Form 10-Q filed for the period ended
September 30, 2012 and other reports filed with the Securities and Exchange
Commission. Agenus 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 Agenus undertakes no
obligation to update or revise the statements. All forward-looking statements
are expressly qualified in their entirety by this cautionary statement.
Agenus' business is subject to substantial risks and uncertainties, including
those identified above. When evaluating Agenus' business and securities,
investors should give careful consideration to these risks and uncertainties.

1. QS-21 Stimulon^® adjuvant and the related agreements, and HerpV are assets
of Antigenics Inc., a wholly owned subsidiary of Agenus Inc.

2. QS-21 Stimulon is a component of certain GSK adjuvant systems.

Stimulon is a registered trademark of Agenus Inc. and its subsidiaries.


Summary Consolidated Financial Information
                                                               
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
(unaudited)
                                                               
                          Three months ended December Year ended December 31,
                           31,
                          2012          2011          2012        2011
                                                               
Revenue                    $1,090      $644        $15,961   $2,756
                                                               
Operating expenses:                                             
Cost of revenue            303          --          672        --
Research and development   2,371        2,856        10,565     11,023
General and                2,645        2,710        11,465     10,820
administrative
                                                               
Operating loss             (4,229)      (4,922)      (6,741)    (19,087)
                                                               
Other expense, net         1,211        1,098        4,584      4,190
                                                               
Net loss                   (5,440)      (6,020)      (11,325)   (23,277)
                                                               
Dividends on Series A
convertible preferred      (199)        (197)        (792)      (790)
stock
                                                               
Net loss attributable to   $(5,639)    $(6,217)    $(12,117) $(24,067)
common stockholders
                                                               
Per common share data,                                          
basic and diluted:
Net loss attributable to   $(0.23)     $(0.29)     $(0.51)   $(1.21)
common stockholders
Weighted average number of
common shares outstanding, 24,682       21,519       23,629     19,899
basic and diluted
                                                               
                                                               
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
                                                               
                          December 31,  December 31,             
                           2012          2011
                                                               
Cash and cash equivalents  $21,468     $10,748                
Total assets               29,093       19,808                  
Total stockholders'        (17,600)     (20,831)                
deficit

CONTACT: Media and Investors:
         Jonae R. Barnes
         Vice President
         Investor Relations &
         Corporate Communications
         617-818-2985

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