Corporate Update Conference Call at 11 am ET
Today
Agenus to Host R&D Day in New York, NY on
May 14
Agenus Inc. (NASDAQ:AGEN), an immunotherapy company developing
immune-oncology checkpoint modulators (CPMs) and heat shock protein
peptide-based vaccines as well as immune adjuvants, today
announced its financial results for the first quarter ended March
31, 2015.
“We began the year by establishing a strategic alliance with
Incyte, focused on the development of novel cancer treatments
targeting immune checkpoints. During the quarter, we also advanced
our internal and partnered antibody programs,” said Garo H. Armen,
Ph.D., Chairman and CEO of Agenus. “Our recent acquisition of
Celexion’s SECANT® yeast display antibody platform and related
assets expands our antibody discovery platform and, together with
our mammalian Retrocyte Display™ platform, provides a uniquely
powerful means to maximize speed and flexibility in antibody
generation and optimization. Finally, we look forward to filing
INDs on two CPMs by the end of this year, and to progressing our
immune-oncology alliance with Merck, while also exploring other
potential corporate alliances.”
First Quarter 2015 Financial Results
The Company’s cash burn (cash provided by operating activities
excluding up-front fees received and contingent purchase price
payments) for the first quarter of 2015 was $10.7 million compared
to $10.1 million for the same period in 2014. For the first quarter
ended March 31, 2015, Agenus reported a net loss attributable to
common stockholders of $18.7 million, or $0.28 per share, basic and
diluted, compared with a net loss attributable to common
stockholders for the first quarter of 2014 of $409,000, or $0.01
per share, basic and diluted.
The increase in net loss attributable to common stockholders for
the quarter ended March 31, 2015, compared to the net loss
attributable to common stockholders for the same period in 2014,
was primarily due to non-cash, fair value adjustments of our
contingent liabilities in 2015 and non-cash, non-operating income
during the quarter ended March 31, 2014 .
Cash and cash equivalents were $79.3 million as of March 31,
2015.
First Quarter 2015 and Recent Corporate Highlights
- In January, Agenus Inc. and Incyte
Corporation formed a global alliance focused on novel
immuno-therapeutics using Agenus’ proprietary Retrocyte Display™
antibody discovery platform. Agenus received $60 million upfront,
comprised of $25 million in license and program access fees plus a
$35 million equity investment in Agenus. Agenus is eligible to
receive up to $350 million in development, regulatory and
commercial milestones across the four lead programs. The
collaboration is initially focused on the development of checkpoint
modulator antibodies directed against GITR, OX40, LAG-3 and TIM-3.
The partnership leverages Incyte’s track record of success in the
discovery and development of important new cancer therapies and
Agenus’ therapeutic antibody expertise to optimize and develop
novel checkpoint modulators in oncology, while allowing Agenus the
ability to independently advance other antibody therapies and its
heat shock protein-based vaccines. Incyte and Agenus will share
equally in costs and profits for GITR and OX40. For royalty-bearing
products, Agenus is eligible to receive tiered royalties on global
net sales ranging from 6-12%. In April, Agenus acquired key
antibody assets from Celexion, LLC, including the SECANT® yeast
display platform for the rapid generation of novel, full-length
human monoclonal antibodies. The Celexion yeast antibody display
platform and Agenus’ mammalian antibody display platform have
complementary strengths and together bolster Agenus' antibody
capabilities. The acquired assets also include Celexion’s novel
approaches to identify and characterize antibodies against membrane
bound protein targets such as GPCRs and ion channels in a highly
efficient manner.
Target Milestones for 2015
- Submission to a peer review journal of
Phase 2 data for Prophage in newly diagnosed GBM by our academic
collaborators.
- Advancement of Prophage to a Phase 3
trial for newly diagnosed GBM.
- Potential presentation of Phase 3 data
for partner GlaxoSmithKline’s HZ/su shingles vaccine at a
scientific conference. The vaccine contains Agenus’ proprietary
QS-21 Stimulon® adjuvant. Agenus is eligible to receive low
single-digit royalties on potential commercial sales of GSK’s
shingles vaccine.
- EMA regulatory decision on
GlaxoSmithKline’s malaria vaccine candidate RTS,S, which
contains Agenus’s QS-21 Stimulon® adjuvant. Agenus is eligible to
receive low single-digit royalties on potential commercial sales of
GSK’s malaria vaccine.
- Investigational New Drug (IND)
application filings for two checkpoint modulator antibody programs
by Agenus or Incyte.
- Leverage Agenus capabilities through
further corporate partnerships.
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 call will also be
webcast and will be accessible from the company’s website at
www.agenusbio.com/webcast/. A replay will be available on the
company’s website approximately two hours after the call and will
remain available for 60 days. The replay number is 866-245-6755
(U.S.) or 416-915-1035 (international), and the access code is
601129. The replay will also be available on the company’s website
approximately two hours after the live call.
Research & Development Day Information
Agenus will be hosting a Research and Development Day on May
14th in New York City at 4:30pm. The Company intends to provide the
financial community with a detailed update on our internal and
partnered R&D efforts, as well as on major advances, challenges
and opportunities around the development of immuno-oncology
therapies focused on checkpoint modulators. Guest presenters will
include Charles Drake, M.D., Ph.D., Co-Director at the Prostate
Cancer Multidisciplinary Clinic and Associate Professor of
Oncology, Urology, and Immunology at the Johns Hopkins School of
Medicine, and Orin Bloch, M.D., Khatib Professor of Neurological
Surgery at Northwestern University Feinberg School of Medicine. The
event will also be webcast live and will be accessible from the
company’s website at www.agenusbio.com/webcast/.
About Agenus
Agenus is an immunology company developing a series of
Checkpoint Modulators for the treatment of patients with cancer,
infectious diseases, and other immune disorders, heat shock protein
(HSP)-based vaccines, and immune adjuvants. These programs are
supported by three separate technology platforms. Agenus’ internal
and partnered checkpoint modulator programs target GITR, OX40,
CTLA-4, LAG-3, TIM-3, PD-1 and other undisclosed programs. The
company’s proprietary discovery engine Retrocyte DisplayTM is used
to generate fully human and humanized 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 recently acquired a
powerful yeast antibody display platform termed SECANT, developed
by Celexion. SECANT allows rapid generation of soluble, full-length
human antibodies. SECANT and Agenus’ mammalian antibody display
platform have complementary strengths and further bolster Agenus'
abilities to generate and optimize fully human monoclonal
antibodies. Agenus’ heat shock protein-based vaccines have
completed Phase 2 studies in newly diagnosed glioblastoma
multiforme, and in the treatment of herpes simplex viral infection;
the heat shock protein-based vaccine 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 with Janssen Sciences Ireland UC and includes
several candidates in Phase 2 trials, 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+; information that may be important to investors will be
routinely posted in these locations.
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 existing partners and potentially enter
into new alliances, 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 March 31, 2015 2014 Revenue $ 3,953 $ 721
Operating expenses: Research and development 9,220 4,473
General and administrative 5,487 5,163 Non-cash contingent
consideration fair value adjustment 7,538 909
Operating loss (18,292 ) (9,824 ) Other income
(expense), net (450 ) 9,467 Net loss
(18,742 ) (357 ) Dividends on Series A-1 convertible
preferred stock (51 ) (51 ) Net loss
attributable to common stockholders $ (18,793 ) $ (408 ) Per
common share data, basic and diluted: Net loss attributable to
common stockholders $ (0.28 ) $ (0.01 ) Weighted average number of
common shares outstanding, basic and diluted 66,667 50,557
Condensed Consolidated Balance Sheet Data (in
thousands) (unaudited) March 31, 2015 December 31, 2014
Cash and cash equivalents $ 79,304 $ 40,224 Total assets
117,324 74,527 Total stockholders' equity 46,259 23,018
Agenus Inc.Media:BMC CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.comorInvestors:Argot
PartnersAndrea Rabney/ Jamie Maarten,
212-600-1902andrea@argotpartners.comjamie@argotpartners.com
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