Agenus to host conference call beginning at 11
a.m. ET today
Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company developing
a portfolio of checkpoint modulators (CPMs), heat shock protein
vaccines and adjuvants, today announced its financial results and
business highlights for the first quarter ended March 31, 2014.
“I am very pleased to report that shortly following the
announcement of the 4-Antibody AG acquisition, we selected our
first checkpoint modulator antibody candidates to advance into
investigational new drug-enabling studies and raised funding to
advance our programs to important value inflection points,” said
Garo H. Armen, PhD, chairman and CEO of Agenus. “In addition, we
consummated our first major corporate collaboration in the
checkpoint antibody field with Merck, a leader in
immuno-oncology.”
First Quarter and Recent 2014 Highlights
- Completed the acquisition of 4-Antibody
AG, a private European-based biopharmaceutical company.
- Entered into a collaboration and
license agreement with Merck for the discovery of fully human
antibodies against two undisclosed Merck checkpoint targets using
the Retrocyte Display® platform. Agenus is eligible to receive
approximately $100 million in potential milestone payments as well
as worldwide royalties on product sales.
- Identified three check point modulator
(CPM) candidates to advance into investigational new drug-enabling
development. These include two GITR agonists and a CTLA-4
antagonist which are the result of a 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.
- Announced GlaxoSmithKline’s (GSK) Phase
3 MAGE-A3 cancer immunotherapeutic trial for non-small cell lung
cancer (NSCLC) did not show benefit in the overall study
population.
- Appointed Robert B. Stein, MD, PhD, to
the newly-created position of Chief Scientific Officer (CSO).
First Quarter Results
The company reported a net loss attributable to common
stockholders of $409,000, or $0.01 per share, basic and diluted,
for the first quarter of 2014, compared with a net loss
attributable to common stockholders in the first quarter of 2013 of
$8.8 million, or $0.35 per share, basic and diluted. In the first
quarter of 2014, the company recorded other non-cash income of $9.9
million related to the impact of the termination of GSK’s Phase 3
MAGE-A3 trial in NSCLC. 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 deemed dividend of $2.9 million.
Cash and cash equivalents were $73.5 million as of March 31,
2014.
Checkpoint Antibody
Platform
Through the company’s 4-Antibody subsidiary, Agenus has
developed a powerful fully-human antibody drug discovery and
optimization technology platform which it is utilizing to generate
a novel pipeline of antibody therapeutic drug candidates. The
Retrocyte Display® platform uses a high-throughput approach
incorporating IgG format human antibody libraries expressed in
mammalian B-lineage cells.
Saponin Platform: QS-21
Stimulon® Adjuvant
Agenus’ QS-21 Stimulon adjuvant is one of the most widely tested
vaccine adjuvants in clinical 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 in 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-21Stimulon-containing programs advance, as
well as royalties for 10 years after commercial launch, with some
exceptions.
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 Series
vaccines are currently being studied in both newly diagnosed and
recurrent glioblastoma.
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 consists of recombinant human heat shock
protein-70 complexed with 32 distinct 35-mer synthetic peptides
from the HSV-2 proteome. It is one of the most clinically advanced
HSV-2 therapeutic vaccines and is in a Phase 2 study. Initial Phase
2 data were reported during the fourth quarter of 2013 with
post-booster viral shedding results, along with immune response
data, anticipated in the second quarter of 2014. The vaccine is
based on Agenus' HSP platform technology, and contains Agenus’
proprietary QS-21 Stimulon adjuvant.
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 July 8, 2014. The replay number is 416-915-1035, and the
access code is 571716. The replay will also be available on the
company’s website approximately two hours after the live call.
About Agenus
Agenus is an immuno-oncology company developing a portfolio of
checkpoint modulators (CPMs), heat shock protein vaccines and
adjuvants. Agenus’ checkpoint modulator programs target GITR, OX40,
CTLA-4, LAG-3, TIM-3 and PD-1. The company’s proprietary discovery
engine Retrocyte Display® is used to generate fully human
therapeutic antibody drug candidates. The Retrocyte Display
platform uses a high-throughput approach incorporating IgG format
human antibody libraries expressed in mammalian B-lineage cells.
Agenus’ heat shock protein vaccines for cancer and infectious
disease are in Phase 2 studies. The company’s 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, 22 programs are in clinical development.
For more information, please visit www.agenusbio.com, or connect
with the company on Facebook, LinkedIn, Twitter and Google+. For
more information, please visit www.agenusbio.com.
Forward-Looking Statement
This press release contains forward-looking statements,
including statements regarding our research and development 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 Annual Report on Form 10-K
filed with the Securities and Exchange Commission for the year
ended December 31, 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 and Stimulon 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 March 31, 2014 2013 Revenue $ 721 $
1,109 Operating expenses: Cost of sales - 273 Research and
development 4,473 2,554 General and administrative 5,163 2,891
Non-cash contingent consideration fair value adjustment 909
- Operating loss (9,824 ) (4,609 )
Other income (expense), net 9,466
(1,226 ) Net loss (358 ) (5,835 ) Dividends on Series
A-1 convertible preferred stock (51 ) (3,007 )
Net loss attributable to common stockholders $ (409 ) $ (8,842 )
Per common share data, basic and diluted: Net loss
attributable to common stockholders $ (0.01 ) $ (0.35 ) Weighted
average number of common shares outstanding, basic and diluted
50,557 25,072
Condensed Consolidated Balance Sheet
Data (in thousands) (unaudited) March 31, 2014
December 31, 2013
Cash and cash equivalents $ 73,491 $ 27,352 Total assets
108,304 34,835 Total stockholders' equity (deficit) 63,285 (4,481 )
Media and Investor:AgenusJonae R. Barnes
781-674-4538 Office | 617-818-2985 CellVice President Investor
Relations and Corporate
Communicationsjonae.barnes@agenusbio.com
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