– Gilead to Acquire 49.9% Equity Interest in
Tizona –
– Gilead Will Have Right to Acquire
Remainder of Tizona for up to $1.25 Billion in Potential Option
Fees and Future Milestone Payments –
– Gilead Research and Development Funding to
Accelerate Tizona’s First-in-Class Pipeline –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it
will invest $300 million to acquire a 49.9 percent equity interest
in Tizona Therapeutics, Inc., a privately held company developing
first-in-class cancer immunotherapies. Gilead will also receive an
exclusive option to acquire the remainder of Tizona for up to an
additional $1.25 billion, including an option exercise fee and
potential future milestone payments.
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Gilead can exercise its option to acquire the remainder of
Tizona following the readout of a Phase 1b study of Tizona’s
investigational antibody, TTX-080, or earlier if Gilead decides to
do so. TTX-080, discovered by Tizona, is a potential first-in-class
medicine that targets HLA-G, a novel and emerging immune checkpoint
expressed across multiple tumor types. The expression pattern of
HLA-G often appears distinct from that of PD-(L)1, suggesting
potential utility to address tumors that do not respond to current
anti-PD-(L)1 treatments and to deepen responses in tumors that are
sensitive to anti-PD-(L)1 therapies.
The U.S. Food and Drug Administration has cleared Tizona’s
Investigational New Drug (IND) application for TTX-080, and in the
third quarter of this year, Tizona plans to initiate a Phase 1
clinical trial evaluating TTX-080 both as a monotherapy and in
combination with other agents in patients with advanced
cancers.
“Tizona is pursuing first-in-class cancer immunotherapies that
could make an important difference in oncology by helping patients
who don’t respond to current checkpoint inhibitors,” said Daniel
O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “This
agreement with Tizona adds to the significant progress we’ve made
in the first half of this year in building out a strong and diverse
immuno-oncology pipeline. We now have multiple opportunities to
develop novel therapies that will improve the treatment of
cancer.”
“Gilead’s support will enable Tizona to accelerate and broaden
our TTX-080 clinical program while also enabling us to rapidly
advance our rich, first-in-class preclinical portfolio and target
validation efforts,” said Scott Clarke, Chief Executive Officer,
Tizona. “Our mission is dedicated to translating novel scientific
insights into first-in-class immunotherapies and Gilead is a
partner that shares our passion for science and delivering
breakthrough innovation to people with cancer.”
Terms of the Agreement
Under the terms of the agreement, Tizona equity holders will
receive $300 million upon closing. Gilead will obtain a 49.9
percent equity stake and an exclusive option to purchase the
remaining equity exercisable following the completion of Phase 1b
studies for TTX-080, or earlier if Gilead chooses. Tizona equity
holders will be eligible to receive up to $1.25 billion in an
option exercise fee and potential future milestone payments. Gilead
will also provide funding to support Tizona’s ongoing research and
development to advance its novel pipeline.
The transaction is expected to close in the third quarter of
this year and is subject to antitrust clearance under the
Hart-Scott-Rodino Antitrust Improvements Act and other customary
closing conditions.
Gilead will have the right to appoint two individuals to
Tizona’s Board of Directors upon closing of the transaction.
Tizona will spin off TTX-030, the company’s investigational,
first-in-class anti-CD39 antibody partnered with AbbVie, into a
separate entity prior to closing of this transaction. TTX-030 is
not subject to this agreement.
TTX-080 is investigational and not approved anywhere globally.
Its efficacy and safety have not been established.
Cowen is acting as financial advisor and Ropes & Gray is
acting as legal counsel to Gilead. Latham & Watkins is acting
as legal counsel and Squire Patton Boggs is acting as IP counsel to
Tizona.
About Tizona
Therapeutics
Tizona is a privately held, clinical-stage immunotherapy company
that develops first-in-class medicines to deliver transformational
benefits for people with cancer. Tizona translates scientific
breakthroughs into therapeutics that stimulate the immune system
and counter immune suppression. Its novel pipeline includes the
clinical-stage TTX-080, an anti-HLA-G antibody, and rich
preclinical portfolio. Tizona investors include MPM, Canaan,
Abingworth, Interwest Partners, Lightstone Ventures, Amgen
Ventures, Astellas Venture Management, and AbbVie Ventures.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
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 ability of the parties to close this transaction in a
timely manner or at all, the ability of the parties to initiate and
complete clinical trials involving TTX-080 in the currently
anticipated timelines or at all, the possibility of unfavorable
results from one or more of such trials involving TTX-080, the
ability of the parties to meet potential milestones in the
estimated timelines or at all and the risk that the parties may not
realize the expected benefits of this collaboration. All statements
other than statements of historical fact are statements that could
be deemed forward-looking statements. These risks, uncertainties
and other factors could cause actual results to differ materially
from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking
statements. These and other risks are described in detail in
Gilead’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2020, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.
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Gilead Contacts:
Douglas Maffei, PhD, Investors (650) 522-2739
Marni Kottle, Media (650) 522-5388
Tizona Contacts:
Shari Annes, Investors (650) 888-0902
Janet Graesser, Media (917) 685-8799
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