– Gilead to Have Early Option to Exclusively
License Drug Candidates Against up to Four Targets for Inflammatory
Diseases –
– Expanded Research Collaboration May Result
in up to $1 Billion in Option Fees and Milestone Payments by Gilead
to Arcus –
Gilead Sciences, Inc. (Nasdaq:GILD) and Arcus Biosciences, Inc.
(NYSE:RCUS) today announced that the companies have expanded the
previously announced research collaboration focused on oncology to
include therapies for the treatment of inflammatory diseases. The
expanded collaboration builds upon Gilead’s growing presence in
inflammatory disease and serves as a step towards broadening Arcus’
capabilities and portfolio beyond oncology and into
inflammation.
“We are pleased to build upon Gilead’s efforts in inflammation
with the expansion of our strategic collaboration with Arcus,” said
Flavius Martin, M.D., Executive Vice President, Research, Gilead
Sciences. “Gilead is committed to accessing innovative approaches
to address the significant unmet medical needs across a range of
inflammatory conditions, and this expanded collaboration with Arcus
underscores that commitment. Arcus is an excellent partner with
clear strengths in discovery and development, and we believe this
partnership will significantly accelerate our progress in
developing transformative new therapies for inflammatory
diseases.”
“Since its founding, Arcus has been creating and developing
therapeutic interventions that can modulate the immune system to
treat cancer. Through this expansion of our partnership with
Gilead, we can combine our research expertise in immunology and
small molecule drug discovery with Gilead’s strong clinical
experience in inflammation,” said Terry Rosen, Ph.D., Chief
Executive Officer, Arcus. “Our two companies have a strong, broad
and productive relationship and together, we aspire to advance
innovative new therapies for patients in need. The research
collaboration facilitates much earlier alignment between Gilead and
Arcus on our discovery and development activities, while enabling
Arcus to expand into inflammation in a capital-efficient
manner.”
Under the terms of the expanded collaboration, Arcus will
receive an upfront payment of $35 million and will initiate
research programs against up to four targets jointly selected by
the parties that are applicable to inflammatory diseases. Gilead
may exercise an option to license each program at two separate,
prespecified time points. If Gilead exercises its option at the
earlier time point for the first two target programs, Arcus would
be eligible to receive up to $420 million in option and milestone
payments and tiered royalties for each optioned program. For any
other option exercise by Gilead for the four target programs, the
parties would have rights to co-develop and share global
development costs and to co-commercialize and share profits in the
United States for optioned programs.
Beginning in the first quarter of 2022, consistent with recent
industry communications from the U.S. Securities and Exchange
Commission (SEC), Gilead no longer excludes acquired IPR&D
expenses from its non-GAAP financial measures. This transaction
with Arcus is expected to reduce Gilead’s GAAP and non-GAAP 2023
EPS by $0.02.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical
company developing differentiated molecules and combination
medicines for people with cancer. In partnership with industry
partners, patients and physicians around the world, Arcus is
expediting the development of first- or best-in-class medicines
against well-characterized biological targets and pathways and
studying novel, biology-driven combinations that have the potential
to help people with cancer live longer. Founded in 2015, the
company has advanced multiple investigational medicines into
clinical studies, including new combination approaches that target
TIGIT, PD-1, the adenosine axis (CD73 and A2a/A2b receptors) and
HIF-2a. For more information about Arcus Biosciences’ clinical and
preclinical programs, please visit www.arcusbio.com.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer. Gilead operates in more than 35
countries worldwide, with headquarters in Foster City,
California.
Arcus Forward-Looking
Statements
This press release contains forward-looking statements. All
statements regarding events or results to occur in the future
contained herein are forward-looking statements reflecting the
current beliefs and expectations of management made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including, but not limited to, statements regarding:
the development of current and future programs, including programs
with targets applicable to inflammatory diseases; future option
fees, milestone and royalty payments under the expanded
partnership; and Arcus’ election to equally share global
development costs and U.S. profits for any program optioned by
Gilead. All forward-looking statements involve known and unknown
risks and uncertainties and other important factors that may cause
our actual results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to: dependence on
the collaboration with Gilead for the successful development and
commercialization of Arcus’ investigational products; difficulties
associated with the management of the collaboration activities or
expanded clinical programs; Arcus’ ability to scale its operations
to successfully develop inflammation programs; the inherent
uncertainty associated with pharmaceutical product development and
clinical trials; delays in Arcus’ clinical trials due to
difficulties or delays in the regulatory process, enrolling
subjects or manufacturing or supplying product for such clinical
trials; and changes in the competitive landscape for Arcus’
programs. Risks and uncertainties facing Arcus are described more
fully in its quarterly report on Form 10-K for the year ended
December 31, 2022, filed with the SEC on February 28, 2023. You are
cautioned not to place undue reliance on the forward-looking
statements, which speak only as of the date of this press release.
Arcus disclaims any obligation or undertaking to update, supplement
or revise any forward-looking statements contained in this press
release.
Gilead Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties, and other factors,
including the risk that Gilead may not realize the potential
benefits of this expanded research collaboration with Arcus,
including advancing new therapies for inflammatory diseases;
difficulties or unanticipated expenses in connection with the
collaboration and the potential effects on Gilead’s revenues and
earnings; the ability of the parties to initiate, progress or
complete clinical trials within currently anticipated timelines or
at all, and the possibility of unfavorable results from ongoing or
additional trials; uncertainties relating to regulatory
applications and related filing and approval timelines, including
the risk that regulatory authorities may not approve such
applications in the anticipated timelines or at all; the
possibility that the parties may make a strategic decision to
terminate the collaboration, including the research programs in
inflammatory diseases, at any time; and any assumptions underlying
any of the foregoing. These and other risks, uncertainties and
other factors are described in detail in Gilead’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2023, as filed with
the U.S. Securities and Exchange Commission. These risks,
uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements. The
reader is cautioned that any such forward-looking statements are
not guarantees of future performance and involve risks and
uncertainties and is cautioned not to place undue reliance on these
forward-looking statements. All forward-looking statements are
based on information currently available to Gilead, and Gilead
assumes no obligation and disclaims any intent to update any such
forward-looking statements.
The Arcus name and logo are trademarks of Arcus
Biosciences, Inc., and Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20230515005249/en/
Gilead Contacts: Jacquie Ross, Investors
investor_relations@gilead.com
Meaghan Smith, Media Public_affairs@gilead.com
Arcus Contacts: Pia Banerjee, Investors
pbanerjee@arcusbio.com, (617) 459-2006
Holli Kolkey, Media hkolkey@arcusbio.com, (650) 922-1269
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