Agenus to host conference call beginning at 11
a.m. ET today
Agenus Inc. (NASDAQ: AGEN), a biopharmaceutical company
developing a portfolio of immuno-oncology candidates, including
checkpoint modulators (CPMs), heat shock protein vaccines and
adjuvants, today announced its financial results and business
highlights for the fourth quarter and year ended December 31,
2013.
“We began 2014 with the acquisition of an exciting new platform
of fully-human checkpoint antibodies. This platform has generated
six lead discovery programs in immuno-oncology,” said Garo H.
Armen, PhD, chairman and CEO of Agenus. “This transformative
acquisition along with our strengthened balance sheet from our
recent financing enables us to rigorously pursue our cancer
immuno-oncology strategy with a broad portfolio of innovative
products. I look forward to reporting progress from all of our
platforms this year, which include QS-21 Stimulon adjuvant, heat
shock protein vaccines and checkpoint modulators.”
On February 12, 2014, Agenus completed the acquisition of
4-Antibody AG, a private European-based biopharmaceutical company.
The 4-Antibody assets include the Retrocyte Display® technology
platform which is designed to enable rapid discovery and
optimization of fully human antibodies against a wide array of
molecular targets. 4-Antibody has applied Retrocyte Display to
create therapeutic antibodies to six checkpoint targets that
regulate immune response to cancers and other diseases. 4-Antibody
has multiple preclinical immune CPM programs in development
including GITR and OX40 agonists and antagonists of TIM-3, LAG-3,
PD-1 and CTLA-4. These programs are being pursued through a
strategic collaboration with the Ludwig Cancer Research.
Fourth Quarter 2013 and Full Year Financial Update
For the fourth quarter, Agenus reported a net loss attributable
to common stockholders of $5.8 million, or $0.16 per share, basic
and diluted, compared with a net loss attributable to common
stockholders for the fourth quarter of 2012 of $5.6 million, or
$0.23 per share, basic and diluted.
For the year ended December 31, 2013, the company incurred a net
loss attributable to common stockholders of $33.2 million, or $1.12
per share, basic and diluted, compared with a net loss attributable
to common stockholders of $12.1 million, or $0.51 per share, basic
and diluted, for the comparable period in 2012.
Cash and cash equivalents were $27.4 million as of December 31,
2013. Subsequent to year end, the company’s cash position includes
net proceeds of approximately $56 million from a registered public
offering completed in the first quarter of 2014.
The increase in net loss attributable to common stockholders for
the year ended December 31, 2013 compared to the net loss
attributable to common stockholders for the same period in 2012,
was primarily due to $6.2 million of non-recurring non-cash charges
incurred during 2013 and one-time payments of $13.4 million
received during 2012. In the first quarter of 2013, the Company’s
preferred stock restructuring, which reduced the dividend
requirements for its Series A-1 preferred securities, resulted in a
non-cash charge of $2.9 million. In the second quarter of 2013, the
Company retired its outstanding 8.0% senior secured convertible
notes due August 2014 in the principal amount of $39 million
resulting in a non-cash loss of $3.3 million. In 2012, revenue of
$13.4 million was generated primarily due to one-time payments
received through an expanded agreement with GlaxoSmithKline (GSK)
and through a license of non-core technologies.
Recent and Fourth Quarter 2013 Highlights:
- Identified three CPM lead candidates
that will advance into IND-enabling development. These include two
GITR agonists and a CTLA-4 antagonist, which are the result of
research collaboration with Ludwig Cancer Research.
- Completed an underwritten registered
public offering resulting in net proceeds of approximately $56
million.
- Announced initiation of a randomized
Phase 2 trial with Prophage and Yervoy® (ipilimumab) for the
treatment of Stage III and IV metastatic melanoma. The combination
has the potential to trigger a more effective immune response
against the tumor than Yervoy alone.
- Appointed Robert B. Stein, MD, PhD, to
the newly-created position of Chief Scientific Officer (CSO).
- Phase 2 data published in
Neuro-Oncology demonstrated that over 90% of patients with
recurrent glioblastoma multiforme (GBM) treated with Prophage were
alive at six months after surgery and 30% were alive at twelve
months.
- An independent editorial by John
Sampson, MD, PhD, The Dr. Robert H. Wilkins and Gloria Wilkins
Professor of Neurosurgery and Professor of Immunology and Pathology
at Duke University Medical Center called the results ‘impressive’
and said they represent a potentially ‘very promising therapy’ in
patients in desperate need of new treatments.
- Prophage for the treatment of brain
cancer was selected as a 2013 Top Project to Watch in oncology.
This selection was made through Elsevier Business Intelligence's
panel of independent experts who screen hundreds of programs and
weigh their potential as future products.
- Reported statistically significant
top-line results from its Phase 2 randomized, double-blind,
multi-center study for HerpV, a recombinant therapeutic vaccine
candidate for the treatment of patients with herpes simplex virus-2
(HSV-2). HerpV contains a defined mixture of peptides representing
HSV-2 antigens plus Agenus’ QS-21 Stimulon® adjuvant.
Additional milestones anticipated in 2014 include:
- Phase 3 data from GlaxoSmithKlines’s
(GSK) MAGE-A3 cancer immunotherapy trial in non-small cell lung
cancer. This vaccine is formulated with Agenus’ QS-21
Stimulon.
- Regulatory submission for GSK’s RTS,S
malaria vaccine formulated with Agenus’ QS-21 Stimulon
- Phase 2 booster data for HerpV, Agenus’
therapeutic vaccine for HSV-2
- Data presentations on Prophage Series
vaccine for GBM
- At least one corporate collaboration
with the 4-Antibody platform
Checkpoint Antibody
Platform
The company’s proprietary discovery engine Retrocyte Display® is
capable of rapidly generating high quality therapeutic antibody
drug candidates using a high-throughput approach incorporating
full-length IgG format human antibody libraries expressed in
mammalian B-lineage cells.
Heat Shock Protein Platform( HSP):
Prophage Anti-Cancer Vaccines
The company’s individualized cancer vaccine platform produces
therapeutic cancer vaccine candidates from each patient’s own tumor
tissue. As a result of its individualized nature, each Prophage
vaccine intends to contain the precise signals (antigenic
fingerprint) of the patient’s particular cancer which is meant to
engage the body’s immune system to target only cancer cells bearing
this specific fingerprint. Such high precision in immunological
targeting represents a distinctly different method for treating
cancer compared to conventional anti-cancer treatments such as
chemotherapy or radiation therapy without many of the side effects
seen in conventional therapy.
Prophage is currently being studied in both newly diagnosed and
recurrent GBM. Patient enrollment is underway for the large-scale,
randomized Phase 2 trial of Prophage in combination with Avastin®
in patients with surgically resectable recurrent GBM. This
three-arm study of 222 patients will compare efficacy of Prophage
given with Avastin either concomitantly or at progression, versus
Avastin alone.
For additional information please refer to
www.clinicaltrials.gov or click on the following link
http://www.clinicaltrials.gov/ct2/show/NCT01814813?term=HSPPC-96&rank=6
Heat Shock Protein Platform (HSP):
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). Positive preliminary results were reported from a
Phase 2 randomized study during the fourth quarter of 2013 and
post-booster results, along with immune response data, are
anticipated in the first half of 2014. HerpV consists of
recombinant human heat shock protein-70 complexed with 32 distinct
35-mer synthetic peptides from the HSV-2 proteome and contains
QS-21 Stimulon.
Saponin Platform: QS-21
Stimulon Adjuvant
QS-21 Stimulon adjuvant is one of the most widely tested vaccine
adjuvants in clinical development. QS-21Stimulon 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 of 21
investigational vaccines for infectious diseases, cancers and
degenerative disorders. Licensees include GSK and Janssen Alzheimer
Immunotherapy. Agenus is generally entitled to receive milestone
payments as well as royalties for 10 years after commercial
launch.
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 647-426-1845. 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 May 5, 2014. The replay number is 416-915-1035 and the
access code is 498676. The replay will also be available on the
company’s website approximately two hours after the live call.
About Agenus
Agenus is a biopharmaceutical company developing a portfolio of
immuno-oncology candidates, including checkpoint modulators (CPMs),
heat shock protein vaccines and adjuvants. The company’s
proprietary discovery engine Retrocyte Display® is designed to
rapidly generate high quality therapeutic antibody drug candidates
using a high-throughput approach incorporating full-length IgG
format human antibody libraries expressed in mammalian B-lineage
cells. A portfolio of checkpoint modulator programs is advancing in
preclinical development. The company’s heat shock protein vaccines
for cancer and infectious disease are in Phase 2 studies. Agenus’
QS-21 Stimulon adjuvant platform is extensively partnered with
GlaxoSmithKline and Janssen and includes several candidates in
Phase 3 trials. Among Agenus and its partners, 23 programs are in
clinical development. For more information, please visit
www.agenusbio.com, or connect with the company on Facebook,
LinkedIn, Twitter and Google+.
Forward-Looking Statement
This press release contains forward-looking statements,
including statements regarding the potential impact of the
4-Antibody acquisition on the company’s business, preclinical and
clinical trial activities, the publication of data, and the
potential application of the Company’s technologies and product
candidates in the prevention and treatment of diseases. 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, 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, 2013. 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.
Yervoy is a registered trademark of Bristol-Myers Squibb.
Retrocyte Display is a registered trademark of 4-Antibody AG.
Stimulon is a registered trademark of Agenus Inc. and its
subsidiaries. Avastin is a registered trademark of Genentech.
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, 2013 2012 2013 2012
Revenue $ 393 $ 1,090 $ 3,045 $ 15,961
Operating expenses: Cost of revenue 7 303 536 672 Research and
development 3,241 2,371 13,005 10,565 General and administrative
3,372 2,645 14,484
11,465 Operating loss (6,227 ) (4,229 ) (24,980 )
(6,741 ) Other expense, net (450 ) 1,211
5,093 4,584 Net loss
(5,777 ) (5,440 ) (30,073 ) (11,325 ) Dividends on Series A
convertible preferred stock (50 ) (199 )
(3,159 ) (792 ) Net loss attributable to common
stockholders $ (5,827 ) $ (5,639 ) $ (33,232 ) $ (12,117 )
Per common share data, basic and diluted: Net loss attributable to
common stockholders $ (0.16 ) $ (0.23 ) $ (1.12 ) $ (0.51 )
Weighted average number of common shares outstanding, basic and
diluted 35,676 24,682 29,766 23,629
Condensed Consolidated Balance Sheet
Data
(in thousands)
(unaudited)
December 31, 2013 December 31, 2012 Cash and cash
equivalents $ 27,352 $ 21,468 Total assets 34,835 29,093 Total
stockholders' deficit (4,481 ) (17,600 )
Agenus Inc.Media and Investors:Investor Relations &Corporate
CommunicationsJonae R. Barnes, 617-818-2985Vice President
Agenus (NASDAQ:AGEN)
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