Bristol Myers Squibb Strengthens and Diversifies Cell Therapy Portfolio with Acquisition of Orbital Therapeutics

Acquisition includes OTX-201, an investigational next-generation CAR T-cell therapy designed to reprogram cells in vivo with potential best-in-class profile for autoimmune diseases

Transaction further strengthens BMS's industry-leading cell therapy portfolio, expanding CAR T-cell access to more patients in the future

Bristol Myers Squibb (NYSE:BMY, "BMS")) and Orbital Therapeutics ("Orbital") today announced a definitive agreement under which BMS will acquire Orbital, a privately held biotechnology company pioneering a new generation of RNA medicines that reprogram the immune system in vivo, enabling treatments that provide the precision, control, and flexibility needed to address the underlying biology and unique complexities of each disease.

"In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases," said Robert Plenge, MD, PhD, executive vice president, Chief Research Officer, BMS. "This acquisition enhances our robust cell therapy research platform and provides an opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system. We are excited by the promise this holds for patients with autoimmune diseases who are waiting for better options."

The acquisition includes Orbital's lead RNA immunotherapy preclinical candidate currently in IND-enabling studies, OTX-201, which comprises an optimized circular RNA encoding a CD19-targeted CAR for in vivo expression delivered via targeted lipid nanoparticles (LNPs). This in vivo approach, in which the patient's own body serves as the manufacturer of CAR T-cells, has the potential to offer a reduced treatment burden and improved accessibility compared to ex vivo CAR T-cell therapies. Additionally, BMS will acquire Orbital's proprietary RNA platform, which integrates circular and linear RNA engineering, advanced LNP delivery, and AI-driven design to enable durable, programmable RNA therapies tailored to the distinct biology of a broad spectrum of diseases.

"With the acquisition of Orbital Therapeutics and its next-generation RNA platform, we have an incredible opportunity to make CAR T-cell therapy more efficient and accessible to more patients," said Lynelle B. Hoch, president, Cell Therapy Organization, BMS. "As a leader in cell therapy, we are uniquely positioned to evaluate multiple different platform approaches to induce immune reset in autoimmune diseases and continue to optimize in vivo technology in clinical development."

"This agreement with Bristol Myers Squibb, a recognized leader in global medicine, marks a transformational moment for Orbital and the advancement of RNA medicine," said Ron Philip, Chief Executive Officer, Orbital Therapeutics. "Since inception, Orbital has made significant strides developing a differentiated RNA platform designed to enable a new generation of RNA medicines that reach more tissues, address more diseases, and benefit more patients. The promising early data from our lead program, OTX-201, underscore the strength of this approach and the potential of our integrated RNA technologies. Together, we aim to deliver RNA medicines that provide patients with treatments that are simpler, safer, and more accessible compared to today's complex therapies."

Under the terms of the agreement, BMS will pay $1.5 billion in cash at closing to acquire Orbital, which is subject to the satisfaction of customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and until then, BMS and Orbital will continue to operate as separate and independent companies. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction.

Advisors

Covington & Burling LLP is serving as legal counsel to Bristol Myers Squibb. Centerview Partners LLC is serving as exclusive financial advisor to Orbital Therapeutics, and Goodwin Proctor LLP is serving as legal counsel.

About Bristol Myers Squibb: Transforming Patients' Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what's possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy

A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease.

Bristol Myers Squibb is currently the only company with two approved CAR T-cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy's transformational potential.

The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the proposed transaction with Orbital Therapeutics. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the parties' ability to satisfy certain closing conditions, any delay or inability of Bristol Myers Squibb to realize the expected benefits of the proposed transaction, that the therapeutic potential of OTX-201 may change and that the proposed transaction may not close on the terms or within the time frame described in this press release. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

About Orbital Therapeutics

Orbital Therapeutics is advancing a new generation of RNA medicines designed to reprogram cells in vivo, treating diseases at their source. This approach offers patients a simpler, safer, and more accessible alternative to today's complex treatments. Built from day one with a fully integrated platform spanning circular and linear RNA, targeted delivery, and AI-guided design, Orbital is working to develop durable, programmable therapies tailored to the distinct biology of each disease. The company's lead program, OTX-201, targets autoimmune disease through B cell depletion to reset the immune system. Orbital's platform is built for expansion into broader autoimmune indications, oncology, next-generation vaccines, and protein therapeutics. Led by a team with deep expertise in RNA science, clinical development, and commercialization, Orbital is united by a shared commitment to reach more patients, in more places, with fewer barriers. Learn more at www.orbitaltx.com.

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Bristol Myers Squibb

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Orbital Therapeutics

Investors: Monique Allaire, THRUST

[email protected]

Media: Dan Budwick, 1AB

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