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
peptide-based vaccines, and adjuvants, today announced its
financial results and business highlights for the second quarter
ended June 30, 2014.
The company’s net loss attributable to common stockholders for
the second quarter of 2014 was $7.7 million, or $0.12 per share,
basic and diluted, compared to a net loss attributable to common
stockholders of $11.2 million, or $0.40 per share, basic and
diluted, for the second quarter of 2013.
For the six months ended June 30, 2014, the company reported a
net loss attributable to common stockholders of $8.4 million, or
$0.15 per share, basic and diluted, compared with a net loss
attributable to common stockholders of $20.0 million, or $0.76 per
share, basic and diluted, for the six months ended June 30,
2013.
The net loss for the six months ended June 30, 2014, and the
same period of 2013, was impacted by various corporate
transactions. During the first six months of 2014, the company
recorded other non-cash income of $11.0 million related to the
impact of, among other things, the termination of GlaxoSmithKline’s
Phase 3 MAGE-A3 trial in non-small cell lung cancer. 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.
In the second quarter of 2013, the company retired its outstanding
$39 million 8.0% senior secured convertible notes due August 2014
resulting in a non-cash loss on extinguishment of debt of $3.3
million. Cash, cash equivalents and short-term investments were
$62.8 million as of June 30, 2014.
“Our focus is to advance our six checkpoint modulator programs
in our efforts to broaden our immuno-oncology portfolio beyond
cancer vaccines and adjuvants. We consummated an agreement with
Merck this quarter and expect additional corporate partnerships,
particularly with our checkpoint programs and platform,” said Garo
H. Armen, Ph.D., chairman and CEO of Agenus. “Following positive
data readouts during the second quarter for both our Prophage
cancer vaccine candidate in glioma and HerpV candidate in genital
herpes, we are also exploring partnerships to advance these
programs.”
Second Quarter and Recent 2014 Highlights
- Announced a collaboration and license
agreement with Merck to discover and optimize fully human
antibodies for cancer against two undisclosed Merck checkpoint
targets using the 4-Antibody Retrocyte Display® platform. Agenus is
eligible to receive approximately $100 million in potential
payments associated with the completion of certain clinical,
regulatory and commercial milestones. In addition, Agenus is
eligible to receive royalty payments on worldwide product sales.
This collaboration is now underway, and we are making good progress
on this novel checkpoint modulator program.
- Reported final results from a
single-arm, multi-institutional, open-label, Phase 2 study showing
that patients with newly diagnosed glioblastoma multiforme (GBM)
who received Agenus’ Prophage autologous cancer vaccine added to
the standard of care treatment, lived nearly twice as long as
expected. Study results showed that 50% of the patients lived for
two years, an encouraging result for a cancer that often kills
patients within one year. Prophage patients demonstrated a median
overall survival of approximately 24 months and 33% of patients
remain alive at 2 years and continue to be followed for
survival.
- Reported positive results from a
randomized, Phase 2 study for HerpV, a synthetic vaccine candidate
for the treatment of patients with genital Herpes Simplex Virus-2
(HSV-2). The majority of patients showed an immune response to the
HSV antigens after a series of vaccinations and a booster dose at
six months. More than half of those vaccinated developed a robust
anti-HSV cytotoxic T-cell immune response, and in those patients
there was a statistically significant 75% reduction in viral load
(P<0.001; CI: 46.2 – 88.6%). We believe this is the first
demonstration of a correlation between immune responders and a
statistically significant reduction in viral load. A reduction in
viral load is thought to be very relevant in reduction of
transmission and symptoms.
- Agenus was selected for inclusion in
the broad-market Russell 3000 Index and Russell Global Index when
Russell Investments reconstituted its comprehensive set of U.S. and
global equity indexes on June 27, 2014. Annual reconstitution of
Russell’s U.S. indexes captures the 4,000 largest U.S. stocks as of
the end of May, ranking them by total market capitalization.
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. Agenus’ checkpoint modulator programs target GITR, OX40,
CTLA-4, LAG-3, TIM-3 and PD-1.
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
several investigational vaccines across a wide variety of
infectious diseases and 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-based (HSP) Vaccine
Platform; Prophage Cancer Vaccines
Derived from each individual’s tumor, Prophage 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 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 vaccines are currently being
studied in both newly diagnosed and recurrent glioblastoma.
Heat Shock Protein-based (HSP) Vaccine
Platform: 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, reported 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 719-325-2362. 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 24, 2014. The replay number is 416-915-1035, and
the access code is 49971. 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 peptide 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. 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-Q filed with the Securities and Exchange
Commission for the quarter ended March 31, 2014. 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.
Agenus includes its affiliates for purposes of this press
release. 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 June
30, Six months ended June 30, 2014 2013 2014
2013 Revenue $ 3,074 $ 807 $ 3,795 $ 1,917
Operating expenses: Cost of sales - 177 - 449 Research and
development 5,223 3,317 9,695 5,871 General and administrative
5,847 4,642 11,290 7,534 Non-cash contingent consideration fair
value adjustment 224 - 1,133 -
Operating loss income (8,220) (7,329) (18,323) (11,937)
Other income (expense), net 458 (3,813) 9,924 (5,040)
Net loss (7,762) (11,142) (8,399) (16,977)
Dividends on Series A-1 convertible preferred stock (51) (51) (102)
(3,058) Net loss attributable to common
stockholders $ (7,813) $ (11,193) $ (8,501) $ (20,035) Per
common share data, basic and diluted: Net loss attributable to
common stockholders $ (0.12) $ (0.40) $ (0.15) $ (0.76) Weighted
average number of common shares outstanding, basic and diluted
62,608 27,846 56,616 26,466
Condensed Consolidated Balance Sheet
Data
(in thousands)
(unaudited) June 30, 2014
December 31, 2013
Cash, cash equivalents and short-term investments $ 62,815 $
27,352 Total assets 100,188 34,835 Total stockholders' equity
(deficit) 57,633 (4,481)
Media and Investor:Jonae R. Barnes, 617-818-2985Vice
PresidentInvestor Relations and Corporate
Communicationsjonae.barnes@agenusbio.com
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