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

SOURCE Avidity Biosciences, Inc.