Agenus to host conference call at 11 a.m. ET
today
Agenus Inc. (NASDAQ:AGEN), an immunology company developing
novel therapeutic approaches based on checkpoint modulators (CPMs),
heat shock protein-based vaccines, and immune adjuvants, today
announced its financial results and business highlights for the
fourth quarter and year ended December 31, 2014.
“2014 was a transformative year for Agenus on many levels,” said
Garo H. Armen, Ph.D., Chairman and CEO of Agenus. “We started the
year with the acquisition of privately held 4-Antibody AG, which
brought us into the critically important field of checkpoint
modulators. Through this acquisition, Agenus acquired our Retrocyte
DisplayTM technology, for the generation of antibody therapeutics,
as well as a broad portfolio of checkpoint programs. In April, we
announced a collaboration and license agreement with Merck around
two undisclosed checkpoint targets, with Agenus eligible to receive
up to $100 million in milestone payments as well as royalties on
product sales. In June, we reported positive data from a Phase 2
study of our heat shock protein-based synthetic vaccine (HerpV) for
the treatment of genital herpes, and shortly thereafter we
announced positive results from a Phase 2 study of our heat
shock-protein-based autologous vaccine (Prophage) in patients with
newly diagnosed glioblastoma multiforme (GBM). In addition, our
partner GlaxoSmithKline’s application for regulatory review of its
malaria vaccine candidate, RTS,S, was accepted by the European
Medicines Agency. The application was based on positive Phase 3
data for RTS,S, which contains Agenus’ proprietary QS-21 Stimulon®
adjuvant. In December, GlaxoSmithKline reported that its Phase 3
study with shingles vaccine candidate HZ/su, which also contains
Agenus’ proprietary QS-21 Stimulon® adjuvant, met its primary
endpoint and reduced the risk of shingles by an unprecedented 97.2%
in adults aged 50 years and older compared to placebo. Building on
our achievements in 2014, we started 2015 with a transformative
global oncology alliance with Incyte that includes, but is not
limited to, four of our checkpoint programs. We look forward to
executing on our alliances with Incyte and Merck, and expanding our
portfolio of antibody-based therapeutics as we pursue the
development of novel single agent and combination therapies for
cancer patients.”
“Supporting these initiatives has required a growth in the
breadth and depth of our R&D capabilities, including the
assembly of a world-class translational biology team,” said Robert
Stein, M.D., Ph.D., Chief Scientific Officer of Agenus. “We believe
our partnership with Incyte leverages their track record of success
in the discovery and development of important new cancer therapies,
with our therapeutic antibody expertise, as well as our shared
objectives in immuno-oncology. Our alliance aims to accelerate the
development of novel checkpoint modulators in oncology, as single
agent and combination therapies, while also allowing Agenus the
ability to independently advance other antibody therapies and heat
shock protein-based vaccines.”
Fourth Quarter 2014 and Full Year Financial Update
Cash, cash equivalents and short-term investments were $40.2
million as of December 31, 2014. Subsequent to year-end, the
company received an additional $60 million from its global alliance
with Incyte.
For the fourth quarter, Agenus reported a net loss attributable
to common stockholders of $26.0 million, including $14.3 million of
non-cash charges, or $0.41 per share, basic and diluted, compared
with a net loss attributable to common stockholders for the fourth
quarter of 2013 of $5.8 million, or $0.16 per share, basic and
diluted.
For the year ended December 31, 2014, the company incurred a net
loss attributable to common stockholders of $42.7 million, or $0.71
per share, basic and diluted, compared with a net loss attributable
to common stockholders of $33.2 million, or $1.12 per share, basic
and diluted, for the comparable period in 2013.
The increase in net loss attributable to common stockholders for
the year ended December 31, 2014, compared to the net loss
attributable to common stockholders for the same period in 2013,
was primarily due to our acquisition of 4-Antibody AG in February
2014. In addition to increased operating expenses, we recorded
non-cash expense of $6.7 million due to the fair value adjustment
of the contingent purchase price consideration and non-cash income
of $3.1 million related to the results of various trials of QS-21
Stimulon containing vaccines at GlaxoSmithKline.
During the same period of 2013, the company’s preferred stock
restructuring resulted in a non-cash deemed dividend of $2.9
million, and the retirement of its then outstanding $39 million
8.0% senior secured convertible notes due August 2014 resulted in a
non-cash expense of $3.3 million.
The increased net loss attributable to common stockholders for
the quarter ended December 31, 2014, compared to the net loss
attributable to common stockholders for the same period in 2013,
was as well due to increased expenses related to our acquisition of
4-Anitbody AG. We also recorded non-cash expenses for the quarter
ended December 31, 2014 of $6.6 million, due to the fair value
adjustment of the contingent purchase price consideration, and $7.7
million related to the fair value adjustment of our contingent
royalty obligation.
2014 Highlights:
- January: Agenus signed a
definitive agreement to acquire privately held 4-Antibody AG, with
its proprietary Retrocyte DisplayTM technology and a broad
preclinical portfolio of checkpoint modulators targeting GITR,
OX40, TIM-3 and LAG-3, among others. The acquisition closed in
February 2014.
- February: Agenus closed a public
offering that resulted in net proceeds of approximately $56
million.
- April: Agenus entered into a
collaboration and license agreement with Merck, involving
generation by Agenus of fully human antibodies against two
undisclosed checkpoint targets from Merck, in exchange for up to
$100 million in potential milestones, as well as royalties on
worldwide product sales.
- June: Agenus announced positive
data from a randomized double blind Phase 2 study involving its
heat shock protein-based vaccine candidate, HerpV, for the
treatment of adult genital herpes. The study showed a statistically
significant reduction in viral load in the more than half of
patients who generated a robust anti-HSV cytotoxic T-cell immune
response.
- July: Agenus announced positive
data from a single arm Phase 2 study involving its heat shock
protein-based autologous vaccine, Prophage, in the setting of GBM.
The data showed patients treated with Prophage achieved a median
overall survival of 23.8 months, compared with the historical
expectation of about 16 months median survival with the standard of
care. Subsequently, an end of Phase 2 meeting was held with the
FDA.
- July: The EMA accepted
GlaxoSmithKline’s application for regulatory review of its malaria
vaccine candidate, RTS,S, based on positive data from a large Phase
3 study involving over 16,000 children. The vaccine contains
Agenus’ proprietary QS-21 Stimulon® adjuvant, and Agenus is
eligible to receive low single digit royalties on any future
product sales.
- December: Agenus announced
positive data from our partner GlaxoSmithKline’s ZOE-50 Phase 3
trial involving its HZ/su vaccine candidate for the prevention of
shingles in adults aged 50 and over. The study showed an
unprecedented 97.2% efficacy rate in the prevention of shingles
compared to placebo. Full study results will be submitted for
publication this year and presented at a forthcoming medical
conference. The vaccine candidate contains Agenus’ proprietary
QS-21 Stimulon® adjuvant, and Agenus is eligible to receive low
single digit royalties on any future product sales.
Target Milestones for 2015 include:
- Publication of the Phase 2 data for
Prophage in newly diagnosed GBM in a peer reviewed journal. Explore
options for the advancement of Prophage for newly diagnosed GBM to
a Phase 3 trial.
- Full Phase 3 data for partner
GlaxoSmithKline’s HZ/su shingles vaccine are expected to be
presented at a scientific conference and submitted for publication
in a peer-reviewed journal. The vaccine contains Agenus’
proprietary QS-21 Stimulon® adjuvant.
- EMA regulatory decision on
GlaxoSmithKline’s malaria vaccine candidate RTS,S, which
contains Agenus’s QS-21 Stimulon® adjuvant.
- File Investigational New Drug (IND)
applications for two checkpoint modulator antibody programs as part
of our global oncology alliance with Incyte.
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 866-233-4585
(U.S.) or 416-640-5946 (international). The live and archived
webcast of the presentation will be accessible from the Company’s
website at www.agenusbio.com/webcast. Please log in approximately
5-10 minutes before the call to ensure a timely connection. The
archived replay will be available on the Agenus website for 60
days. The replay number is 866-245-6755 (U.S.) or 416-915-1035
(international), and the access code is 55109. The replay will also
be available on the Company’s website approximately two hours after
the live call.
About Agenus
Agenus is an immunology company developing a series of
immuno-oncology CPMs, heat shock protein peptide-based vaccines and
immune adjuvants. These programs are supported by three separate
technology platforms. Agenus’ checkpoint modulator programs target
GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The Company’s
proprietary discovery engine Retrocyte DisplayTM is used to
generate fully human and humanized therapeutic antibody drug
candidates. The Retrocyte DisplayTM platform uses a high-throughput
approach incorporating IgG format human antibody libraries
expressed in mammalian B-lineage cells. Agenus’ heat shock protein
vaccines have completed Phase 2 studies in newly diagnosed
glioblastoma multiforme, and in the treatment of herpes simplex
viral infection; the heat shock protein platform can generate
personalized as well as off the shelf products. The Company’s QS-21
Stimulon® adjuvant platform is extensively partnered with
GlaxoSmithKline and Janssen Sciences Ireland UC and includes
several candidates in Phase 2, as well as shingles and malaria
vaccines which have successfully completed Phase 3 clinical trials.
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 that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding the Company’s
research and development and clinical trial activities, potential
revenue streams, potential regulatory approvals, the potential
application of the Company’s technologies and product candidates in
the prevention and treatment of diseases, plans to execute on the
Company’s alliances with Incyte and Merck, the expected timing for
filing IND applications for CPM antibody candidates, the submission
and publication of data in peer-reviewed journals and presentations
of data at scientific conferences. 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 most recent Quarterly Report on Form 10-Q or annual
report on Form 10-K 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 press
release, and Agenus undertakes no obligation to update or revise
the statements, other than to the extent required by law. All
forward-looking statements are expressly qualified in their
entirety by this cautionary statement.
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,
2014 2013 2014
2013 Revenue $ 1,619 $
393 $ 6,977 $ 3,045 Operating expenses: Cost of revenue - 7
- 536 Research and development 7,369 3,241 22,349 13,005 General
and administrative 5,374 3,372 21,250 14,484 Non-cash contingent
consideration fair value adjustment 6,535 -
6,699 - Operating loss
(17,659 ) (6,227 ) (43,321 ) (24,980 ) Other income
(expense), net (8,319 ) 450 835
(5,093 ) Net loss (25,978 ) (5,777 ) (42,486 )
(30,073 ) Dividends on Series A convertible preferred stock
(51 ) (50 ) (204 ) (3,159 ) Net
loss attributable to common stockholders $ (26,029 ) $ (5,827 ) $
(42,690 ) $ (33,232 ) Per common share data, basic and
diluted: Net loss attributable to common stockholders $ (0.41 ) $
(0.16 ) $ (0.71 ) $ (1.12 ) Weighted average number of common
shares outstanding, basic and diluted 62,849 35,676 59,754 29,766
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(Unaudited)
December 31,2014
December31, 2013
Cash, cash equivalents and short-term investments $ 40,224 $
27,352 Total assets 74,527 34,835 Total stockholders' equity
(deficit) 23,018 (4,481 )
Agenus Inc.Media:BMC CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.comorInvestors:Argot
PartnersAndrea Rabney/ Jamie
Maarten212-600-1902andrea@argotpartners.comjamie@argotpartners.com
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