Agenus Reports Third Quarter 2012 Financial Results

Agenus Reports Third Quarter 2012 Financial Results

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

LEXINGTON, Mass., Oct. 25, 2012 (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 third quarter ended September 30, 2012.

The company reported a net loss attributable to common stockholders of $5.9
million, or $0.24 per share, basic and diluted for the third quarter of 2012,
compared with a net loss attributable to common stockholders in the third
quarter of 2011 of $5.7 million, or $0.28 per share, basic and diluted.

For the nine months ended September 30, 2012, the company incurred a net loss
attributable to common stockholders of $6.5 million, or $0.28 per share, basic
and diluted, compared with a net loss attributable to common stockholders of
$17.8 million, or $0.92 per share, basic and diluted, for the comparable
period in 2011. The decreased net loss for the nine months ended September 30,
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 nine months ended September 30,
2012 was $4.3 million compared to cash used in operations of $12.1 million for
the comparable period in 2011. Cash and cash equivalents were $24.8 million as
of September 30, 2012.

"During the quarter, substantial progress was made with both our QS-21
Stimulon^® adjuvant and Heat Shock Protein Platforms," said Garo H. Armen,
Ph.D., chairman and CEO of Agenus. "Our internal development programs advanced
with the initiation of our HerpV Phase 2 study for the treatment of genital
herpes and a number of GSK QS-21 Stimulon adjuvant containing vaccine
candidates are nearing pivotal data readouts."

Recent Business and Clinical Highlights

  *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^®1
    adjuvant. The study designated as protocol C-400-02 will enroll 75 HSV-2
    positive subjects who have a history of frequent disease recurrences. The
    study will test the biological efficacy of the HerpV vaccine as measured
    by effect on genital viral shedding.
  *In October, Aeras and GSK announced that they will jointly advance the
    clinical development of a tuberculosis vaccine candidate that contains
    QS-21. The Phase 2b proof-of-concept trial is planned for Kenya, India and
    South Africa. Promising results from early stage clinical trials showed
    that the GSK TB vaccine candidate has an acceptable safety and
    reactogenicity profile and demonstrated an immune response.
  *In August, data from the Phase 1 trial for Prophage Series G-200
    (HSPPC-96; vitespen) were published online 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 adjuvant 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.

Between Agenus and its partners, a total of 19 vaccine programs are in
clinical development of which 17 contain QS-21. 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: Prophage Series G-100 for newly diagnosed glioma
  *Phase 2: Prophage Series G-200 for recurrent glioma
  *Phase 2: HerpV (contains QS-21) for genital herpes

Saponin Platform: QS-21 Stimulon^®Adjuvant

Agenus' QS-21 Stimulon adjuvant is one of the most widely tested vaccine
adjuvants under development. QS-21 is designed to strengthen the body's immune
response to a vaccine's antigen, thus making it more effective. QS-21 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 include GSK and
Janssen Alzheimer Immunotherapy. Agenus is generally entitled to receive
milestone payments as QS-21-containing programs advance, as well as royalties
for 10 years after commercial launch, with some exceptions.

Heat Shock Protein Platform (HSP): Recombinant Series

HerpV is a recombinant therapeutic vaccine candidate for the treatment of
genital herpes, which is caused by the herpes simplex virus-2 (HSV-2) and is
the most advanced HSV-2 vaccine currently in clinical development. The
vaccine is based on Agenus' HSP platform technology, and contains Agenus'
proprietary adjuvant 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 early 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

For additional information please refer to or click on
the following link

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 43143599. The call will also be webcast
and will be accessible from the company's website at 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 43143599. 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

The Agenus logo is available at

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 June
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 is a component of 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)
                       Three months ended         Nine months ended September
                        September 30,              30,
                       2012          2011         2012          2011
Revenue                 $869        $654       $14,871     $2,112
Operating expenses:                                           
Cost of services        217          --         369          --
Research and            2,606        2,528       8,194        8,167
General and             2,587        2,567       8,820        8,110
Operating loss          (4,541)      (4,441)     (2,512)      (14,165)
Other expense, net      1,188        1,093       3,373        3,091
Net loss                (5,729)      (5,534)     (5,885)      (17,256)
Dividends on Series A
convertible preferred   (198)        (198)       (593)        (593)
Net loss attributable   $(5,927)    $(5,732)   $(6,478)    $(17,849)
to common stockholders
Per common share data, basic and                               
Net loss attributable   $(0.24)     $(0.28)    $(0.28)     $(0.92)
to common stockholders
Weighted average number
of common shares        24,529       20,225      23,275       19,352
outstanding, basic and
Condensed Consolidated Balance Sheet Data
(in thousands)
                       September 30, December 31,              
                        2012          2011
Cash, cash equivalents,
and short-term          $24,758     $10,748                 
Total assets            32,224       19,808                   
Total stockholders'     (13,157)     (20,831)                 

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

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