Media and Investor Contact:
Jonae R. Barnes
Vice President
Investor Relations and Corporate Communications jonae.barnes@agenusbio.com
617-818-2985
Agenus Reports Fourth Quarter and Year End 2011 Financial
Results and
Corporate Updates
• In the first quarter 2012, Agenus increased its cash position by approximately
$18 million
• Agenus to host conference call beginning at 11 am ET today
Lexington, MA - March 5, 2012 - Agenus Inc. (NASDAQ: AGEN)
reported today its results for the fourth quarter and year
ended December 31, 2011. The company reported a net loss
attributable to common stockholders of $6.2 million, or $0.29
per share, basic and diluted, for the fourth quarter of 2011,
compared with a net loss attributable to common stockholders
in the fourth quarter of 2010 of $2.6 million, or $0.16 per
share, basic and diluted. Our 2010 net loss attributable to
common stockholders included non- cash, non-recurring gains
totaling $4.7 million.
For the year ended December 31, 2011, the company incurred a
net loss attributable to common stockholders of $24.1
million, or $1.21 per share, basic and diluted, compared with
a net loss attributable to common stockholders of $22.7
million, or $1.41 per share, basic and diluted, for the
comparable period in 2010.
The company's net cash burn (cash used in operating
activities plus capital expenditures and dividend payments)
for the year ended December 31, 2011 was $17.1 million
compared to $15.7 million for the same period in 2010. The
2011 net cash burn figure reflects primarily the company's
efforts to support the Prophage Series vaccines. Our 2010
cash burn figure is net of non-recurring business development
payments and tax credits totaling $2.7 million. Cash and cash
equivalents were $10.7 million as of December 31,
2011. Subsequent to the end of the year, the company raised
$9.0 million through an expanded agreement with
GlaxoSmithKline (GSK), $6.25 million through a license of
non- core technologies and $2.8 million in equity issuances.
Collectively, these activities have increased the company's
cash position by approximately $18 million from the
year-end
2011 cash position of $10.7 million.
"In the past year we have seen an acceleration of advances in
the field of immunology and cancer vaccines and both of our
technology platforms are poised to benefit from this very
exciting new trend" stated Garo Armen, Ph.D., chairman and
CEO of Agenus. "This year will be transforming with
significant clinical milestones as our partners expect
pivotal data from at least four key clinical programs that
incorporate QS-21 during the next year or so."
Business Highlights for 2011
• In June 2011, positive Phase 2 Prophage Series
G-200 data for recurrent glioma were presented in a poster
presentation at the 47th Annual Meeting of the
American Society of Clinical Oncology (ASCO). Results from
this trial showed that 93% of the patients were alive at 26
weeks after surgery with a median overall survival of 11
months (47.6 weeks).
• In September 2011, positive results from a randomized, four-arm placebo-controlled Phase
1 study of HerpV, a recombinant (off-the-shelf) therapeutic
vaccine for the treatment of genital herpes, which contains
QS-21, were published in the peer-reviewed journal Vaccine.
This study is the first to demonstrate that heat shock
proteins complexed to viral antigens induce an
antigen-specific T cell response in humans.
• In October 2011, the New England Journal of
Medicine published positive results of a Phase 3 trial of GSK
Biologicals' RTS,S malaria vaccine candidate containing the
Company's QS-21 Stimulon®
adjuvant*. QS-21 is a component of AS01B, which
is GSK Biologicals' proprietary adjuvant system used in
RTS,S.
• In December 2011, Agenus and NewVac LLC (a
subsidiary of ChemRar), announced a license, development and
manufacturing technology transfer agreement for Agenus'
Oncophage® (HSPPC-96; vitespen) vaccine.
Oncophage is approved in Russia for the treatment of adjuvant
renal cell carcinoma (kidney cancer) in patients at
intermediate risk of recurrence. Under the agreement, Agenus
has granted NewVac an exclusive license to
manufacture, market and sell Oncophage as well as pursue a
development program of Oncophage in combination with NewVac's
co-adjuvant technology in the Russian Federation and CIS
countries. Agenus is entitled to receive payment for supply
of Oncophage and/or royalties upon Oncophage product sales,
and potential milestone payments.
Between Agenus and its partners, 18 programs are in clinical
development, including many programs that contain QS-21
Stimulon® adjuvant*. QS-21 is being
studied in clinical trials for 15 vaccine programs. They
include:
• Phase 3: GSK's RTS,S for malaria**
• Phase 3: GSK's MAGE-A3 CI for selected patients with resected melanoma**
• Phase 3: GSK's MAGE-A3 CI for selected patients with resected non-small cell lung cancer**
• Phase 3: GSK's Herpes Zoster for shingles**
• 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-Ready: HerpV (contains QS-21) for genital herpes
Saponin Platform: QS-21 Stimulon® Adjuvant
QS-21 Stimulon adjuvant is designed to strengthen the
body's immune response to a vaccine's antigen, thus
making it more effective. QS-21 has become a critical
component in the development of investigational preventive
vaccine formulations across a wide variety of infectious
diseases, and appears to be essential for several
investigational therapeutic vaccines intended to treat cancer
and degenerative disorders. Licensees of
QS-21 include GSK, Janssen Alzheimer Immunotherapy, and
Integrated Biotherapeutics. Agenus is generally entitled to
receive milestone payments as QS-21-containing
programs advance, as well as royalties for 10 years after
commercial launch.
Data from Phase 3 pivotal trials of four GSK vaccine
candidates, which include MAGE- A3 Cancer immunotherapeutic
(CI) for selected patients with non-small cell lung cancer
and melanoma, RTS,S for malaria, and Herpes Zoster for
shingles, are anticipated to be released over the next year
or so.
QS-21 Stimulon® Adjuvant and RTS,S Phase 3 Data for Malaria
The GSK Phase 3 trial for RTS,S was conducted at 11 trial
sites in seven countries across sub-Saharan Africa in 6,000
children aged 5 to17 months. Results of the study
demonstrated that RTS,S provided young African children with
significant protection against clinical and severe malaria -
reducing risk by 56 percent and 47 percent, respectively, for
the 12-month period following vaccination. Malaria is
responsible for close to 800,000 deaths each year, most of
whom are children under five in sub-Saharan Africa.
The efficacy and safety results in 6 to 12 week-old infants
from the ongoing RTS,S Phase
3 trial are expected by the end of 2012. The RTS,S malaria
vaccine candidate is still under development and will be
subject to the evaluation of the benefits and risks by
regulatory authorities before being made
available. It is anticipated that the RTS,S
malaria vaccine candidate could be available as early as
2015.
HSP Platform: The Prophage Series G Cancer Vaccines
The Prophage Series G vaccines (HSPPC-96; vitespen) are being
studied in two different
settings of glioma: newly diagnosed and recurrent disease.
Glioma is the deadliest form of brain cancer with an average
survival of six to 14 months.
Data from the Phase 2 trial of Prophage Series vaccine,
G-200, in recurrent glioma was presented at the 2011 ASCO
Annual Meeting. Results from this trial showed that 93% of
the patients were alive at 26 weeks after surgery with a
median overall survival of 11 months (47.6 weeks).
Importantly, measures of immune response post-vaccination
with Prophage Series G-200 demonstrated a significant
localized tumor-specific CD8+ T cell response as
well as innate immune responses as marked by a significant
increase in levels of circulating NK cells. Overall survival
results from this trial support advancement of Prophage
Series G-200 into a randomized study using a combination
regimen.
A Phase 2 trial testing the Prophage Series vaccine, G-100,
in patients with newly diagnosed glioma is actively enrolling
with approximately 27 patients treated. In this trial,
G-100 is being used on top of 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. Please refer to
www.clinicaltrials.gov for additional details on the study,
including the status of participating centers.
The company continues to explore development and commercial
partnerships for the
Prophage Series cancer vaccines on both a global and regional
basis.
HSP Platform: Recombinant Series HerpV
HerpV is the most advanced HSV-2 vaccine currently in
clinical development for the
treatment of genital herpes. Agenus plans to initiate a Phase
2 trial of HerpV in the second half of 2012 that will measure
the effect of vaccination on viral shedding in individuals
infected with HSV-2. Experts in HSV-2 clinical research
believe that a reduction in viral shedding could translate
into the clinical benefit of a reduction in recurrent
outbreaks.
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 well
tolerated, with injection site pain as the most common
reported adverse event.
All patients who were evaluable for immune response and
received HerpV showed a statistically significant
CD4+ T cell response (100%; 7/7) to HSV-2
antigens as detected by IFN Elispot, and the
majority of those patients demonstrated a CD8+ T
cell response (75%; 6/8).
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 54303509.
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 September 5,
2012. The replay number is 855.859.2056 (domestic) or
404.537.3406 (international), and the access code is
54303509. 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.
Forward-Looking Statement
This earnings release contains forward-looking statements,
including statements
regarding clinical trial activities; data, results and
timelines of the company and its
licensees and collaborators; potential revenue streams from
its partnering and licensing arrangements, and the cash
position of the company. 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 finance future activities and maintain our
listing on the NASDAQ Capital Market; Agenus' dependence on
its collaborative partners to successfully develop and
commercialize products; the
possibility that the first right to negotiate granted to GSK
might adversely affect our ability to effect a change of
control transaction, 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 September 30, 2011. 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.
*QS-21 Stimulon adjuvant and the related agreements, and HerpV are assets of Antigenics Inc., a wholly owned subsidiary of Agenus Inc.
**QS-21 is a component of certain GSK adjuvant systems.
***Janssen Alzheimer Immunotherapy, a wholly owned subsidiary of Johnson & Johnson.
Stimulon and Oncophage are registered trademarks 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 31, Year ended December 31,
2011 2010 2011 2010
Revenue
$ 644 $
994 $
2,756 $
3,360
Operating expenses:
Cost of goods sold - - - 123
Research and development 2,856 2,796 11,023 12,878
General and administrative 2,710 3,154 10,820 12,112
Operating loss (4,922) (4,956) (19,087) (21,753) Other income (expense), net (1,098) 2,540 (4,190) (154) Net loss (6,020) (2,416) (23,277) (21,907)
Dividends on Series A convertible preferred
stock (197) (197) (790) (790)
Net loss attributable to common stockholders
$ (6,217) $
(2,613) $
(24,067) $
(22,697)
Per common share data, basic and diluted: Net loss attributable to common stockholders $ Weighted average number of common
(0.29) $
(0.16) $
(1.21) $
(1.41)
shares outstanding, basic and diluted 21,519 16,771 19,899 16,108
Condensed Consolidated Balance Sheet Data(in thousands) (unaudited)
December 31, 2011 | December 31, 2010 | ||
Cash and cash equivalents | $ 10,748 | $ 19,782 | |
Total assets | 19,808 | 30,907 | |
Total stockholders' deficit | (20,831) | (14,707) |