-- Agreement Covers Buyout of Remaining
Financial Obligations for Anti-CCR8 Antibody in Development as a
Potential Treatment for Solid Tumors --
Gilead Sciences, Inc. (Nasdaq: GILD) and Jounce Therapeutics,
Inc. (Nasdaq: JNCE) amended their existing license agreement for
GS-1811 (formerly JTX-1811), enabling Gilead to buy out remaining
contingent payments potentially due under the license agreement
executed in August 2020. As part of the transaction, certain
operational obligations of the parties related to GS-1811, an
anti-CCR8 antibody, set forth in the license agreement have also
been terminated. Gilead will acquire certain related intellectual
property, including all outstanding rights of Jounce to GS-1811,
pursuant to the transaction agreement. GS-1811, a potentially
first-in-class immunotherapy, is designed to selectively deplete
immunosuppressive tumor-infiltrating T regulatory cells in the
tumor microenvironment and is currently in Phase 1 clinical
development as a possible treatment for patients with solid
tumors.
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“We are pleased to announce the signing of this transaction with
Gilead, who have a strong track record of developing and
successfully commercializing leading brands in biotechnology,” said
Richard Murray, Ph.D., Chief Executive Officer and President of
Jounce. “This transaction allows us to extend our runway and remain
focused on delivering meaningful and long-lasting benefits to
cancer patients. It was important for Jounce at this time to
bolster our cash resources, given challenges in capital markets for
biotech companies.”
Jounce will receive proceeds of $67 million for this
transaction, and Gilead will be solely responsible for all further
research, development and commercialization of GS-1811
globally.
“Today’s news about GS-1811 further demonstrates our commitment
to our rapidly evolving oncology franchise and mission of
pioneering next-generation medicines for people with cancer,” said
Bill Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area
Head, Gilead Oncology. “GS-1811, with its potential new pathway of
activating the immune system, gives us the opportunity to
potentially change the standard of care with a treatment that works
from inside cancerous cells to shrink solid tumors.”
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. We expect the
transaction with Jounce to reduce Gilead’s GAAP and non-GAAP 2022
EPS by approximately $0.04.
Jounce will no longer be entitled to receive the remaining
contingent payments of up to $645 million in milestones and high
single-digit to mid-teens royalties based upon worldwide sales
under the original license agreement. Additional details of the
transaction, including related agreements and matters, will be
contained in a Current Report on Form 8-K to be filed by
Jounce.
About Jounce Therapeutics
Jounce Therapeutics, Inc. is a clinical-stage immunotherapy
company dedicated to transforming the treatment of cancer by
developing therapies that enable the immune system to attack tumors
and provide long-lasting benefits to patients through a
biomarker-driven approach. Jounce currently has multiple
development-stage programs ongoing while simultaneously advancing
additional early-stage assets from its robust discovery engine
based on its Translational Science Platform. Jounce’s highest
priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist
shown to reprogram immune-suppressive tumor-associated macrophages
to an anti-tumor state in preclinical studies. JTX-8064 is being
investigated alone and in combination with pimivalimab (formerly
JTX-4014), Jounce’s internal PD-1 inhibitor, in one monotherapy and
seven indication-specific combination therapy cohorts in the Phase
1/2 INNATE trial and is currently enrolling patients with advanced
solid tumors in the Phase 2 portion of the study. Jounce’s most
advanced product candidate, vopratelimab, is a monoclonal antibody
that binds to and activates ICOS, and is currently being studied in
the SELECT Phase 2 trial. Pimivalimab is a PD-1 inhibitor intended
for combination use with Jounce’s broader pipeline. For more
information, please visit www.jouncetx.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.
Jounce Forward-Looking
Statements
Various statements in this release concerning Jounce’s future
expectations, plans and prospects, including without limitation,
Jounce’s expectations regarding its ability to extend its cash
runway may constitute forward-looking statements for the purposes
of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws and
are subject to substantial risks, uncertainties, and assumptions.
You should not place reliance on these forward-looking statements.
Although Jounce believes that the expectations reflected in the
forward-looking statements are reasonable, Jounce cannot guarantee
such outcomes. Actual results may differ materially from those
indicated by these forward-looking statements as a result of
various important factors, including, without limitation, Jounce’s
ability to manage operating expenses and capital expenditures;
Jounce’s ability to successfully demonstrate the efficacy and
safety of its product candidates and future product candidates;
Jounce’s ability to obtain, maintain and protect its intellectual
property; and those risks more fully discussed in the section
entitled “Risk Factors” in Jounce’s most recent Annual Report on
Form 10-K filed with the Securities and Exchange Commission as well
as discussions of potential risks, uncertainties, and other
important factors in Jounce’s subsequent filings with the
Securities and Exchange Commission. All such statements speak only
as of the date made, and Jounce undertakes no obligation to update
or revise publicly any forward-looking statements, whether as a
result of new information, future events or otherwise.
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 complete or implement the
transaction in a timely manner or at all; the possibility that
various closing conditions for the transaction may not be satisfied
or waived; the risk that Gilead may not realize the potential
benefits of the transaction, including the possibility of
difficulties or unanticipated expenses in connection with the
transaction and the potential effects on Gilead’s revenues and
earnings; Gilead’s ability to advance and successfully
commercialize GS-1811; Gilead’s ability 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 involving GS-1811; 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 September 30,
2022, 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.
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/20221227005077/en/
Gilead Contacts: Jacquie Ross, Investors
investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
Jounce Contact: Eric Laub, Media and Investors
elaub@jouncetx.com, (857) 259-3853
Jounce Therapeutics (NASDAQ:JNCE)
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