––Partnership combines Gilead’s proven track
record and mission to develop transformative therapeutics targeting
serious viral diseases, with Assembly Bio’s expertise and focus on
antiviral R&D to advance differentiated treatments for
herpesviruses, HBV, HDV and beyond—
—Collaboration includes Assembly Bio’s current
and future pipeline candidates and incorporates two Gilead
herpesvirus programs—
—Assembly Bio to receive $100 million upfront
payment, including equity investment, plus potential for future
regulatory, commercial, opt-in and collaboration extension
payments—
—Assembly Bio management to host webcast today
at 8:30 a.m. ET/5:30 a.m. PT—
Gilead Sciences, Inc. (Nasdaq: GILD) and Assembly Biosciences,
Inc. (Nasdaq: ASMB), a biotechnology company developing innovative
antiviral therapeutics targeting serious viral diseases, today
announced that the companies have entered into a 12-year
partnership to advance the research and development of novel
antiviral therapies, with an initial focus in Assembly Bio’s
established areas of herpesviruses, hepatitis B virus (HBV) and
hepatitis D virus (HDV).
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the full release here:
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Assembly Bio’s current portfolio of small molecule antiviral
therapeutics includes both clinical and preclinical programs,
including next-generation core inhibitor ABI-4334 for the treatment
of HBV, long-acting helicase-primase inhibitor ABI-5366 for herpes
simplex virus (HSV), an orally bioavailable HDV entry inhibitor
ABI-6250, and a pan-herpes polymerase inhibitor program.
“Advancing the next wave of innovation in virology remains a
core focus for Gilead as we seek to address the unmet needs of
people affected by serious viral infections around the world,” said
Tomas Cihlar, Senior Vice President of Virology Research, Gilead.
“Collaborations and partnerships are key in the pursuit of the next
wave of transformative innovations. We are excited to announce this
partnership with Assembly Bio to synergize our efforts on advancing
and accelerating the discovery and development of novel antiviral
therapeutics.”
“We are thrilled to partner with Gilead to address significant
unmet medical needs in herpesviruses, viral hepatitis and beyond,”
said Jason Okazaki, chief executive officer and president of
Assembly Bio. “With Gilead’s established success in developing and
commercializing antiviral medicines and Assembly Bio’s advanced
virology research capabilities, we believe the shared expertise and
promising investigational therapies that both organizations
contribute to this collaboration have the potential to deliver
significant advances to patients. This transaction represents a
critical step in Assembly Bio’s path to becoming a fully-integrated
biotechnology company and we are eager to begin working with our
new partner.”
Terms of the Partnership
Under the terms of the agreement, Assembly Bio will receive $100
million, consisting of an $84.8 million upfront payment and a $15.2
million equity investment from Gilead. Gilead’s initial equity
investment at a premium represents 19.9 percent of the outstanding
voting stock of Assembly Bio as of the date of closing. In
addition, subject to certain conditions, Gilead has agreed to
purchase up to 29.9 percent of Assembly Bio’s outstanding voting
stock at a premium.
Gilead may opt-in to obtain exclusive rights for each of
Assembly Bio’s current and future programs, including two
preclinical programs targeting HSV and transplant-associated
herpesviruses that Gilead is licensing to Assembly Bio, upon
payment of an opt-in fee of at least $45 million per program after
clinical proof-of-concept is achieved. If Gilead opts-in to any
current or future program under the collaboration, Assembly Bio is
eligible to receive up to $330 million per program in potential
regulatory and commercial milestones, in addition to royalties
ranging from the high single digits to high teens. During the term
of the collaboration, Assembly Bio will also be eligible to receive
three separate $75 million collaboration extension payments at
prespecified timepoints during the collaboration term to help fund
future research and development.
Following Gilead’s exercise of its option for an Assembly Bio
program, Assembly Bio will have the right to opt-in to share
profits and costs in the United States. For future new programs,
Assembly Bio will also have an option to co-promote those products
in the United States.
Assembly Bio will be primarily responsible for the research and
development efforts on the collaboration programs, including the
two contributed Gilead programs, prior to Gilead’s potential
opt-in. Following Gilead’s opt-in, Gilead will control discovery,
research, development and commercialization on the optioned
program(s).
Gilead has the right to appoint two individuals to Assembly
Bio’s Board of Directors.
ABI-4334, ABI-5366 and ABI-6250 are investigational and not
approved anywhere globally. Their efficacy and safety have not been
established. More information about clinical trials with ABI-4334
is available at www.clinicaltrials.gov.
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 Assembly Bio is expected to reduce Gilead’s GAAP and non-GAAP
2023 EPS by approximately $0.05 - $0.07.
BofA Securities, Inc. and Mizuho Securities USA LLC are acting
as financial advisors to Assembly Bio. Wilson Sonsini is serving as
legal counsel to Assembly Bio.
Assembly Bio Webcast
Management from Assembly Bio will be hosting an investor webcast
today at 8:30 a.m. ET/5:30 a.m. PT to discuss the Gilead
partnership. The live webcast will be available on the Events &
Presentations page in the Investors section of Assembly Bio’s
website and a replay will be accessible following the event. An
accompanying slide presentation will also be available. To register
for the live webcast and replay, please visit:
https://investor.assemblybio.com/events-presentations.
About Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the
development of innovative small molecule antiviral therapeutics
designed to change the path of serious viral diseases and improve
the lives of patients worldwide. Led by an accomplished team of
leaders in virologic drug development, Assembly Bio is committed to
improving outcomes for patients struggling with the serious,
chronic impacts of herpesvirus, hepatitis B virus (HBV) and
hepatitis delta virus (HDV) infections. For more information, visit
Assemblybio.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, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
California.
Assembly Biosciences Forward-Looking Statements
The information in this press release contains forward-looking
statements that are subject to certain risks and uncertainties that
could cause actual results to materially differ. These risks and
uncertainties include: Assembly Bio’s ability to realize the
potential benefits of its collaboration with Gilead, including all
financial aspects of the collaboration and equity investments;
Assembly Bio’s ability to initiate and complete clinical studies
involving its therapeutic product candidates, including studies
contemplated by Assembly Bio’s collaboration with Gilead, in the
currently anticipated timeframes or at all; the occurrence of any
event, change or other circumstance that could give rise to the
termination of Assembly Bio’s collaboration with Gilead; safety and
efficacy data from clinical or nonclinical studies may not warrant
further development of Assembly Bio’s product candidates; clinical
and nonclinical data presented at conferences may not differentiate
Assembly Bio’s product candidates from other companies’ candidates;
results of nonclinical studies may not be representative of disease
behavior in a clinical setting and may not be predictive of the
outcomes of clinical studies; and other risks identified from time
to time in Assembly Bio’s reports filed with the U.S. Securities
and Exchange Commission (the SEC). You are urged to consider
statements that include the words may, will, would, could, should,
might, believes, hopes, estimates, projects, potential, expects,
plans, anticipates, intends, continues, forecast, designed, goal or
the negative of those words or other comparable words to be
uncertain and forward-looking. Assembly Bio intends such
forward-looking statements to be covered by the safe harbor
provisions contained in Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. More information about Assembly Bio’s risks and
uncertainties are more fully detailed under the heading “Risk
Factors” in Assembly Bio’s filings with the SEC, including its most
recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K. Except as required by law,
Assembly Bio assumes no obligation to update 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 Gilead’s ability to realize the anticipated benefits from
the collaboration with Assembly; difficulties or unanticipated
expenses in connection with the collaboration, including Gilead’s
equity investment in Assembly, and the potential effects on Gilead
s 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 trials,
including those involving ABI-4334, ABI-5366, ABI-6250 and
additional programs that may become subject of the collaboration;
the possibility that the parties may make a strategic decision to
terminate the collaboration or discontinue development of any of
the investigational agents under the collaboration, and therefore
these investigational agents 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 Quarterly Report on Form 10-Q
for the quarter ended June 30, 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 Assembly Bio
name and logo are trademarks of Assembly Biosciences, Inc.
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/20231017843279/en/
Assembly Bio
Investors and Corporate: Shannon Ryan SVP, Investor Relations,
Corporate Affairs and Alliance Management (415) 738-2992
Media: Sam Brown Inc. Hannah Hurdle (805) 338-4752
Gilead
Investors: Jacquie Ross investor_relations@gilead.com
Media: Meaghan Smith public_affairs@gilead.com
Assembly Biosciences (NASDAQ:ASMB)
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