– Gilead Receives Exclusive Option to
License Novel Trispecific Therapeutics Resulting from the
Collaboration –
Gilead Sciences, Inc. (Nasdaq:GILD) and Merus N.V. (Nasdaq:MRUS)
today announced a research collaboration, option and license
agreement to discover novel dual tumor-associated antigens (TAA)
targeting trispecific antibodies. Gilead and Merus agreed to
collaborate on the use of Merus’ proprietary Triclonics® platform
along with Gilead’s oncology expertise to research and develop
multiple, separate preclinical research programs.
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Merus is a clinical-stage oncology company developing
innovative, full-length, multispecific antibodies (Biclonics® and
Triclonics®), referred to together as Multiclonics®, that are
generated by a proprietary common light chain technology. The
Triclonics® or trispecific platform provides the unique opportunity
to design antibodies capable of simultaneously binding to three
targets at once.
"We have seen the successful application of bispecific
antibodies as an immune-modulating modality used to treat cancer.
We are now looking ahead to the development of additional
multispecific antibodies capable of driving robust anti-tumor
immune responses with an improved efficacy and safety profile,"
said Flavius Martin, M.D., Executive Vice President, Research,
Gilead Sciences. "We are excited to explore the potential of Merus’
differentiated Triclonics® platform to discover and advance
transformative new cancer therapies as we deepen our portfolio
across oncology indications."
"We are looking forward to working with Gilead to develop novel
T-cell engager antibodies using our Triclonics® technology," said
Hui Liu, Ph.D., Executive Vice President, Chief Business Officer
& Head of Merus US. "We are grateful for our collaborations
which represent opportunities for Merus to leverage our research
capabilities to pursue innovative biology and to address
significant unmet medical needs. Importantly, this collaboration
represents the first for our proprietary Triclonics® platform."
Terms of the Agreement
Under the terms of the agreement, Merus will lead early-stage
research activities for two programs, with an option to pursue a
third. Gilead will have the right to license programs developed
under the collaboration after the completion of select research
activities. If Gilead exercises its option to license any such
program from the collaboration, Gilead will be responsible for
additional research, development and commercialization activities
for such program. Merus will receive an upfront cash payment of $56
million for initial targets as well as an equity investment by
Gilead of $25 million in Merus common shares. Across all potential
programs, Merus is also eligible to receive up to $1.5 billion
including additional near term and option payments, potential
development and commercialization milestones, as well as tiered
royalties ranging from the mid-single to low-double digits on
product sales should Gilead successfully commercialize a therapy
from the collaboration. For the third potential program, Merus may
opt-in to share 50/50 split of net profits and net losses, in lieu
of future milestone and royalty payments.
Gilead does not exclude acquired IPR&D expenses from its
non-GAAP financial measures. This transaction with Merus is
expected to reduce Gilead’s GAAP and non-GAAP 2024 EPS by
approximately $0.03 - $0.05.
About Merus
Merus is a clinical-stage oncology company developing innovative
full-length human bispecific and trispecific antibody therapeutics,
referred to as Multiclonics®. Multiclonics® are manufactured using
industry standard processes and have been observed in preclinical
and clinical studies to have several of the same features of
conventional human monoclonal antibodies, such as long half-life
and low immunogenicity. For additional information, please visit
Merus’ website, X and LinkedIn.
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, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
Calif.
Merus Forward-Looking
Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation, benefits
of a collaboration between Gilead Sciences, Inc. and Merus; whether
and when Merus will receive any future payment under the
collaboration, including milestones or royalties, and the amounts
of such payments; whether any programs under the collaboration will
be successful; the potential of Merus’ Triclonics® platform to
leverage our research capabilities to pursue innovative biology and
to address significant unmet medical needs, and to provide the
unique opportunity to design antibodies capable of simultaneously
binding to three targets at once. Importantly, this collaboration
represents the first for our proprietary Triclonics® platform.
These forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees,
but involve known and unknown risks, uncertainties and other
important factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements, including, but not limited to, the
following: our need for additional funding, which may not be
available and which may require us to restrict our operations or
require us to relinquish rights to our technologies or antibody
candidates; potential delays in regulatory approval, which would
impact our ability to commercialize our product candidates and
affect our ability to generate revenue; the lengthy and expensive
process of clinical drug development, which has an uncertain
outcome; the unpredictable nature of our early stage development
efforts for marketable drugs; potential delays in enrollment of
patients, which could affect the receipt of necessary regulatory
approvals; our reliance on third parties to conduct our clinical
trials and the potential for those third parties to not perform
satisfactorily; impacts of the COVID-19 pandemic; we may not
identify suitable Biclonics®, Triclonics® or multispecific antibody
candidates under our collaborations or our collaborators may fail
to perform adequately under our collaborations; our reliance on
third parties to manufacture our product candidates, which may
delay, prevent or impair our development and commercialization
efforts; protection of our proprietary technology; our patents may
be found invalid, unenforceable, circumvented by competitors and
our patent applications may be found not to comply with the rules
and regulations of patentability; we may fail to prevail in
potential lawsuits for infringement of third-party intellectual
property; our registered or unregistered trademarks or trade names
may be challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks.
These and other important factors discussed under the caption
“Risk Factors” in our Annual Report on Form 10-K for the period
ended December 31, 2023, filed with the Securities and Exchange
Commission, or SEC, on February 28, 2024, and our other reports
filed with the SEC, could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management’s estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if
subsequent events cause our views to change, except as required
under applicable law. These forward-looking statements should not
be relied upon as representing our views as of any date subsequent
to the date of this press release.
Multiclonics®, Biclonics® and Triclonics® are registered
trademarks of Merus N.V.
Gilead Forward-Looking
Statement
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 Gilead’s ability to realize the anticipated benefits from
the collaborations; difficulties or unanticipated expenses in
connection with the collaborations and the potential effects on
Gilead’s earnings; the risk that Gilead’s investment in Merus will
lose value for any number of reasons; 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, including those
developed pursuant to the collaborations; the ability of the
parties to file applications for regulatory approval or receive
regulatory approvals in a timely manner or at all for the
investigational therapeutics developed pursuant to the
collaborations, and the risk that any such approvals may be subject
to significant limitations on use; the possibility that the parties
may make a strategic decision to discontinue development of any of
the investigational therapeutics developed pursuant to the
collaborations, and therefore these therapeutics may never be
successfully commercialized; and any assumptions underlying any of
the foregoing. These and other risks, uncertainties and other
factors are described in detail in Gilead’s Annual Report on Form
10-K for the year ended December 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.
Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc., or its related companies. The Merus name and
logo are trademarks of Merus.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
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Merus Info
Sherri Spear VP Investor Relations and Corporate Communications
617-821-3246 s.spear@merus.nl
Kathleen Farren Investor Relations and Corporate Communications
617-230-4165
Gilead Info
Meaghan Smith, Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
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