Avidity to receive $100
million up front with the potential to receive up to
$2.2 billion in milestone payments
and up to low double-digit royalties
Global licensing and research collaboration to
focus on discovery, development and commercialization of up to five
cardiovascular targets leveraging Avidity's proprietary AOC
platform technology
SAN
DIEGO, Nov. 28, 2023 /PRNewswire/ -- Avidity
Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company
committed to delivering a new class of RNA therapeutics called
Antibody Oligonucleotide Conjugates (AOCs), today announced a
global licensing and research collaboration with Bristol Myers
Squibb (NYSE: BMY) focused on the discovery, development and
commercialization of multiple cardiovascular targets with potential
cumulative payments of up to $2.3
billion. AOCs are designed to combine the specificity of
monoclonal antibodies with the precision of oligonucleotide
therapies to target the root cause of diseases previously
untreatable with RNA therapeutics. This strategic collaboration
broadens the reach of AOCs through the expansion of the existing
relationship with Bristol Myers Squibb. Avidity continues to
advance its internal research and development programs in rare
cardiac indications.
Under the terms of the agreement, Avidity will receive
$100 million upfront, which includes
a $60 million cash payment as well as
the purchase of approximately $40
million of Avidity common stock at a purchase price of
$7.88 per share. Avidity is also
eligible to receive up to approximately $1.35 billion in research and development
milestone payments, up to approximately $825
million in commercial milestone payments, and tiered
royalties up to low double-digits on net sales. Bristol
Myers Squibb will fund all future
clinical development, regulatory and commercialization activities
coming from this collaboration.
"We are excited to expand our collaboration with Bristol Myers
Squibb, who are world leaders in cardiovascular drug discovery and
development. This strategic collaboration solidifies our commitment
in cardiology as we continue to advance our own research and
development programs in cardiac indications," said Sarah Boyce, president and chief executive
officer at Avidity. "We look forward to broadening the utility of
the AOC platform to address debilitating diseases previously
unreachable with existing RNA therapies."
The collaboration with Bristol Myers Squibb is separate from
Avidity's internal discovery pipeline consisting of research and
development candidates to treat rare skeletal muscle conditions and
rare cardiac muscle diseases. Avidity is currently advancing three
distinct rare disease Phase 1/2 programs in the clinic: AOC 1001
for myotonic dystrophy type 1 (DM1), AOC 1020 for the treatment of
facioscapulohumeral muscular dystrophy (FSHD) and AOC 1044 for the
treatment of Duchenne muscular dystrophy (DMD) mutations amenable
to exon 44 skipping (DMD44).
"This collaboration with Avidity represents an important part of
our continued investment in innovative therapeutic approaches that
have the potential to provide transformative outcomes to patients
living with serious cardiovascular conditions," said Francisco
Ramírez-Valle, MD, PhD, senior vice president and head of the
Immunology & Cardiovascular Thematic Research Center at Bristol
Myers Squibb. "Aligned with our focus on causal human biology and
efforts to successfully match therapeutic modalities to disease
mechanism, our R&D organization will continue to leverage
technologies like Avidity's AOC platform to identify meaningful
targets and develop new medicines for patients in need."
In 2021, Avidity announced a research collaboration with
MyoKardia, a wholly-owned subsidiary of Bristol Myers Squibb, to
demonstrate the potential utility of AOCs in cardiac tissue. This
new collaboration with Bristol Myers Squibb expands on the research
conducted in cardiovascular disease and is a testament to the broad
utility of the AOC platform technology.
About Avidity
Avidity Biosciences, Inc.'s mission is
to profoundly improve people's lives by delivering a new class of
RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™).
Avidity is revolutionizing the field of RNA with its proprietary
AOCs, which are designed to combine the specificity of monoclonal
antibodies with the precision of oligonucleotide therapies to
address targets and diseases previously unreachable with existing
RNA therapies. Utilizing its proprietary AOC platform, Avidity
demonstrated the first-ever successful targeted delivery of RNA
into muscle and is leading the field with clinical development
programs for three rare muscle diseases: myotonic dystrophy type 1
(DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral
muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs
with its advancing and expanding pipeline including programs in
cardiology and immunology through internal discovery efforts and
key partnerships. Avidity is headquartered in San Diego, CA. For more information about our
AOC platform, clinical development pipeline and people, please
visit www.aviditybiosciences.com and engage with us on LinkedIn and
X.
Forward-Looking Statements
Avidity cautions
readers that statements contained in this press release regarding
matters that are not historical facts are forward-looking
statements. These statements are based on the company's current
beliefs and expectations. Such forward-looking statements include,
but are not limited to, statements regarding: the potential
benefits of Avidity's collaboration with Bristol Myers Squibb;
Avidity's commitment in cardiology; Avidity's plans for its
internal programs in cardiac indications; the role of Avidity's AOC
platform in Bristol Myers Squibb's future plans; plans for the
progression of clinical programs for AOC 1001, AOC 1044 and AOC
1020 and the timing thereof; the potential of Avidity's product
candidates to treat rare diseases and Avidity's efforts to bring
them to people suffering from applicable diseases; the potential of
AOCs to target a range of different cells and tissues beyond the
liver, and to treat cardiac and immunological diseases; the
continued advancement of programs with collaboration partners; and
Avidity's plans to expand its AOC platform and to invest in its
pipeline programs.
The inclusion of forward-looking statements should not be
regarded as a representation by Avidity that any of these plans
will be achieved. Actual results may differ from those set forth in
this press release due to the risks and uncertainties inherent in
Avidity's business, including, without limitation: Avidity may not
realize the expected benefits of its collaborations, including with
Bristol Myers Squibb; Avidity's collaboration with Bristol Myers
Squibb could be terminated earlier than expected; Avidity could
fail to achieve any milestone payments under its collaboration with
Bristol Myers Squibb; Avidity may not be able to resolve the
partial clinical hold related to the serious adverse event which
occurred in the Phase 1/2 MARINA® trial, which may
result in delays in the clinical development of AOC 1001;
additional participant data related to AOC 1001 that continues to
become available may be inconsistent with the data produced as of
the most recent date cutoff, and further analysis of existing data
and analysis of new data may lead to conclusions different from
those established as of such date cutoff; unexpected adverse side
effects to, or inadequate efficacy of, Avidity's product candidates
that may delay or limit their development, regulatory approval
and/or commercialization, or may result in additional clinical
holds which may not be timely lifted, recalls or product liability
claims; Avidity is early in its development efforts; Avidity's
approach to the discovery and development of product candidates
based on its AOC platform is unproven, and the company does not
know whether it will be able to develop any products of commercial
value; potential delays in the commencement, enrollment, data
readouts and completion of preclinical studies or clinical trials;
the success of its preclinical studies and clinical trials for the
company's product candidates; Avidity's dependence on third parties
in connection with preclinical and clinical testing and product
manufacturing; regulatory developments in the United States and foreign countries;
Avidity could exhaust its available capital resources sooner than
it currently expects and fail to raise additional needed funds; and
other risks described in Avidity's Annual Report on Form 10-K for
the fiscal year ended December 31,
2022, filed with the Securities and Exchange Commission
(SEC) on February 28, 2023, and in
subsequent filings with the SEC. Avidity cautions readers not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and the company undertakes no
obligation to update such statements to reflect events that occur
or circumstances that arise after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
Avidity Investor Contact:
Geoffrey Grande, CFA
(619) 837-5014
investors@aviditybio.com
Avidity Media Contact:
Navjot
Rai
(619) 837-5016
media@aviditybio.com
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SOURCE Avidity Biosciences, Inc.