Full Press Release Details
Reports Fourth Quarter and Full Year 2015 Financial and Operational
Results and Recent Highlights
to host conference call at 11am ET today
LEXINGTON, Mass.--(BUSINESS WIRE)--March 3, 2016--Agenus Inc.
(NASDAQ:AGEN), an immuno-oncology company developing checkpoint
modulator antibodies and cancer vaccines, today provided a corporate
update and reported financial results for the fourth quarter and year
ended December 31, 2015.
"During the course of 2015, we broadened our capabilities and advanced
our portfolio of checkpoint antibodies and diversified vaccine
platforms," commented Garo H. Armen, Ph.D., Chairman and CEO of Agenus.
"We made a series of strategic acquisitions, in our efforts to speed
discovery and development, as well as to improve the quality of our
leads and programs. We also validated our portfolio and discovery
capabilities through our strategic alliances with Incyte and Merck. Our
greatest asset, however, is our team of scientists with their breadth of
We believe a multidisciplinary approach is critical because the future
of cancer therapy will be based on the ability to identify
subpopulations of patients that are likely to best respond to specific
immuno-oncology (I/O) agents or combinations. This will require tailored
combinations of I/O modalities, including antibodies, vaccines and
adjuvants, and cell therapies. At Agenus, we believe that we are
uniquely positioned in the I/O landscape by having assembled the
critical parts of what could be the future I/O ecosystem.
To support all these endeavors, last year we strengthened our cash
position through partnerships, a stock offering and a non-dilutive
royalty financing, all affording the company a financial runway through
the first half of 2017."
2015 HIGHLIGHTS AND CURRENT UPDATES
January: Leveraged in-house resources through a global license,
development and commercialization agreement with Incyte Corporation.
The alliance initially focused on the development of four CPM
antibodies targeting GITR, OX40, LAG-3 and TIM-3, and was expanded in
November 2015 to include three additional undisclosed targets. Agenus
and Incyte share costs and profits equally for the GITR and OX40
programs, as well as two of the undisclosed programs. Agenus received
a $60 million upfront payment, which included a $35 million equity
investment. Agenus is also eligible to receive up to $350 million in
development, regulatory and commercial milestones across the initial
April / November: Optimized our discovery of antibodies through
acquisition of the Celexion, LLC, SECANT yeast display platform and
an agreement with IONTAS for an exclusive license to a proprietary
phage display library.
May: Raised approximately $75 million through a public offering of
June: Strengthened management team with the appointment of C.
Evan Ballantyne as the Company's Chief Financial Officer.
July: Acquired rights to antibodies targeting Carcinoembryonic
Antigen Cell Adhesion Molecule 1 (CEACAM1), a glycoprotein
expressed on T-cell and NK-cell lymphocytes from Diatheva s.r.l., an
Italian biotech company.
September: Raised net proceeds of approximately $78 million in a
non-dilutive royalty transaction pursuant to a Note Purchase
Agreement with an investor group led by Oberland Capital Management,
LLC. The investors received our rights to worldwide royalties on
future sales of GlaxoSmithKline's (GSK) shingles (HZ/su) and malaria
(RTS,S) prophylactic vaccine products that contain Agenus' QS-21
adjuvant to repay principal and interest. At its option, Agenus has
the right to buy back the loan at any time under pre-specified terms.
Agenus also has the right to receive an additional $15 million in cash
from the investors after approval of HZ/su by the FDA, provided such
approval occurs by June 30, 2018. This financing also allows Agenus to
retain any upside from vaccine royalties remaining after the loan
terms are satisfied.
December: Secured our own antibody manufacturing capability through
the acquisition of XOMA Corporation's antibody manufacturing pilot
plant and an agreement granting Agenus access to Selexis' cell line
development technologies.
December: Expanded our cancer vaccine program by acquiring
privately-held PhosImmune Inc., a company with a portfolio of
cancer neoantigens based on aberrant phosphorylation of proteins. The
acquisition provides Agenus the ability to potentially accelerate the
development of novel off-the-shelf and personalized cancer vaccines
and is synergistic with Agenus' AutoSynVax (ASV) vaccine program for
targeting patient-specific tumor neoantigens.
December: Advanced first two checkpoint modulator antibodies
toward the clinic by submitting Investigational New Drug (IND)
applications to the U.S. Food and Drug Administration (FDA) for
AGEN1884 (a CPM antibody that binds to CTLA-4) and INCAGN01876 (a CPM
antibody that targets GITR and is partnered with Incyte). In January
2016, the FDA cleared both IND applications.
Upcoming 2016 Program Milestones and Events:
Initiation of Phase 1 clinical trials for anti-CTLA-4 antibody
candidate (AGEN1884; wholly owned by Agenus), and for anti-GITR
antibody candidate (INCAGN01876, partnered with Incyte) in the first
Initiation of Phase 1 clinical trials for one or more additional CPM
antibody candidates in the second half of 2016.
Initiation of a well-controlled randomized Prophage clinical vaccine
trial in newly diagnosed glioblastoma patients in the second half of
Initiation of Phase 1 clinical trial with our first ASV vaccine
product candidate in the second half of 2016. Agenus' ASV program
targets cancer neoantigens with an autologous synthetic vaccine
Partner (GSK) filing for regulatory approval of its shingles vaccine
candidate containing Agenus' proprietary QS-21 Stimulon adjuvant in
the second half of 2016.
Initiation of combination trials with Agenus vaccines and CPM antibody
candidates in the second half of 2016.
Continually evaluate additional strategic alliances and partnerships.
Fourth Quarter and 2015 Financial Results
Cash, cash equivalents and short-term investments were $171.7 million as
of December 31, 2015.