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Formation Bio, an AI-native pharma company, and IMIDomics, a precision medicine company focused on immune-mediated inflammatory diseases today announced that Formation Bio has licensed worldwide rights to IMIDomics’ first-in-class anti-CD226 monoclonal antibody (mAb). The clinical program, which has received IND clearance, will be advanced by Formation Bio in autoimmune indications, initially ulcerative colitis.

The antibody targets CD226 (DNAM-1), a key immune checkpoint involved in regulating several key immune cells thereby affecting both innate and acquired immune responses. By blocking the interaction between CD226 and its ligands CD112 and CD155, the antibody aims to suppress immune overactivation, offering a novel approach for treating patients with autoimmune conditions. These diseases affect millions globally and are often characterized by high rates of treatment failure, loss of response, and limited options after first- and second-line therapies. A mechanistically distinct agent like anti-CD226 has the potential to reach patients underserved by current therapies.

Under the terms of the agreement, IMIDomics will receive an upfront payment, and is eligible for future development and commercial milestones, as well as royalties on potential sales. In addition IMIDomics will receive equity in Riverview Bio, a subsidiary of Formation Bio that has been formed to develop this therapy, which joins Libertas Bio and Highline Bio as part of Formation’s growing 

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"This is a high-potential program that fits squarely within Formation Bio’s model,” said David Steinberg, Chief Business Officer at Formation Bio. “It highlights how our hub-and-spoke approach—combining structured partnerships with fully integrated execution—can unlock value beyond traditional paths. We provide the capital, scale, and trial infrastructure to accelerate development, while partners retain meaningful upside through our shared-equity structure."

The development strategy for the anti-CD226 mAb program was supported by IMIDomics’ Immune Mediated Inflammatory Diseases Consortium in Spain, which was established twenty years ago in collaboration with a number of academic institutions. This deep, longitudinal dataset provided potential mechanistic validation, laying a robust and differentiated foundation for clinical advancement.

"We’re excited to collaborate with Formation Bio to combine their development capabilities with IMIDomics’ deep understanding of complex autoimmune diseases,” said Sandy Zweifach, President and Chief Business Officer at IMIDomics. “Advancing our anti-CD226 monoclonal antibody into clinical development is just one example of how our patient insights platform and scientific research—led by our co-founder Dr. Sara Marsal, MD, Ph.D—are translating into meaningful progress. The IND approval of this program, under the direction of our Chief Development Officer Dr. Daniel Perez, MD, marked the first in a pipeline of potential novel therapies targeting these debilitating diseases."

Formation Bio’s Platform for Drug Development Acceleration

Formation Bio acquires and advances high-potential therapeutic assets that biopharma companies are unable to prioritize internally. Its model combines deep therapeutic expertise, dedicated operating teams, and a proprietary AI technology 

 designed to accelerate asset sourcing, optimize program design, and streamline clinical trial execution—with the ultimate goal of improving development speed, efficiency, and probability of success.

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Learn more about how we bring together tech and drug development expertise.

The anti-CD226 mAb adds to Formation Bio’s growing pipeline which currently includes programs in immunology, dermatology, and rheumatology and reflects the company’s focus on first- and best-in-class programs with clear mechanistic rationale, data-rich foundations, and multi-indication potential.

Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients.

IMIDomics is dedicated to discovering and developing first-in-class medicines for immune-mediated inflammatory diseases (IMIDs), particularly for patients without treatment options or unresponsive to current treatments. The company’s proprietary Clinical Discovery Engine™ integrates comprehensive longitudinal clinical, epidemiological, and biomolecular data from IMID patients, enabling the identification of disease mechanisms and the development of precision medications which increase the probability of success (PoS). Partnering with the Spanish IMID Clinical Consortium and the Vall d'Hebron Institute of Research (VHIR), IMIDomics is uniquely positioned to deliver the next generation of IMID therapies.

This transaction with IMIDomics expands Formation Bio’s immunology pipeline with Phase 1 ready drug candidate. The clinical program, which has received IND clearance, will be advanced by Formation Bio in autoimmune indications, initially ulcerative colitis.

Formation Bio Licenses First in Class Anti-CD226 Autoimmune Program

, have joined Formation Bio as the company’s inaugural class of Entrepreneurs in Residence (EIRs). Working closely with our Chief Business Officer 

, they’ll play a key role in expanding our dealmaking and growth initiatives.

At Formation Bio, we acquire and in-license high-potential drug assets, work to advance them to key value inflection points (to Phase II and beyond), and then partner or out-license them for continued development. Our 

 is built to power this entire lifecycle—from identifying the best assets, to shaping development strategy, and to executing clinical trials with a goal of increased speed and probability of success.

All four EIRs bring decades of experience sourcing and executing high-value biopharma transactions. Their addition marks an expansion of our business development expertise as we continue to grow our 

 through asset acquisitions, licensing opportunities, and strategic partnerships.

“Biotech is at a rare inflection point—breakthrough science and high-potential assets abound, but funding and development resources are scarce. Too many promising programs are stuck—not for lack of merit, but for lack of the right partner. Formation Bio can fill that gap, with the capital, drug development capabilities, model, and platform to accelerate development and unlock value. That’s why we’re thrilled to welcome our Entrepreneurs in Residence: a unique opportunity for seasoned dealmakers to go deep on science they believe in, deploy capital, and advance transformative medicines through an innovative model.”

— David Steinberg, Chief Business Officer, Formation Bio

Combining proprietary technology with deep domain expertise, our teams uncover overlooked or underdeveloped promising programs to transact on and develop, and the EIRs will be instrumental in this work, bringing decades of dealmaking experience, deep industry connectivity, and the ability to move quickly on high-conviction opportunities across a broad range of therapeutic areas.

The group’s diverse focus areas strengthen our ability to identify and unlock high-value opportunities across a wide range of modalities and markets.

 – Immunology & Inflammation (I&I), including bispecifics

Their arrival also reflects our growing presence in key industry hubs like Boston and North Carolina, where we’re deepening ties with leading talent, companies, and partners across the biotech and pharma ecosystem.
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Kia is a seasoned business development executive with a global network and a proven deal track record. He has led corporate development, licensing, and investor relations at Madrigal Pharmaceuticals, Akcea Therapeutics, Merck KGaA, Dyax, and Genfit, completing over 100 transactions across licensing, M&A, financing, and strategic partnerships. Before joining Formation Bio, he led BD and IR at Madrigal Pharmaceuticals, where he raised over $1B in financing, supported the FDA approval of Rezdiffra®—the first approved treatment for NASH/MASH—and helped drive a market cap increase from $800M to over $7B. Earlier in his career, he partnered with the management teams at Genfit and Dyax to reposition Genfit’s lead program from atherosclerosis to NASH, contributing to a market cap increase from $110M to over $1.2B, and helped drive the development of Takhzyro®, Dyax’s next-generation HAE therapy, leading to its $6.5B acquisition by Shire, up from an initial market cap of $120M. He also advises biopharma companies on BD, licensing, and strategy through his firm, BTeK Consulting

Kia holds a Ph.D. in Organic Chemistry from UCLA and a B.A. in Chemistry from Colorado College, and completed his NIH postdoctoral fellowship at The Scripps Research Institute. His experience spans cardiometabolic, immunology, neurology, oncology, cardiovascular, rare diseases, and more.

Minji is a biotech executive and dealmaker with more than 20 years of experience across corporate and business development, strategy, operations, and cross-border company building. She has held leadership roles at Curis, Jounce Therapeutics, Mineralys Therapeutics, and AffaMed Therapeutics—where she led high-impact transactions and built global operations across the U.S., Europe, and Asia. Her transaction experience spans over a few billion dollars in total value across licensing, equity investment, M&A, joint venture and clinical collaborations. Highlights include securing a $170M upfront cash package through partnerships with Gilead and Celgene at Jounce, transforming Curis and tripling the company value through a multi-asset strategic collaboration with Aurigene, and rapidly building AffaMed’s pipeline and global footprint through five major transactions in under a year.

Minji brings deep experience in oncology, immunology, ophthalmology, CNS, cardiovascular, and digital therapeutics, and has led both in- and out-licensing from early discovery to late-stage clinical assets. She is the Founder of Cross Border Partners and currently serves on the Board of SK Biopharmaceuticals. Minji holds a Ph.D. in Molecular and Cell Biology from Seoul National University and an MBA in Finance and Strategy from Yale School of Management. Prior to starting her industry career at Roche, she was an instructor of Neurology at Harvard Medical School.

John is a biotech entrepreneur and operator with a track record of building and leading clinical-stage companies across rare diseases and specialty pharma. He has served as Co-Founder and CEO of Spyryx Biosciences and Aceragen, led corporate and business development at Synageva Biopharma and Javelin Pharmaceuticals and helped launch the Entrepreneur in Residence program at the North Carolina Biotechnology Center. Over his career, John has executed more than $1 billion in transactions—including regional partnerships at Javelin Pharmaceuticals, strategic development agreements with Mitsubishi Tanabe Pharma for Synageva Biopharma, the $225M acquisition of ACG-801 from Enzyvant, multiple agreements with the Cystic Fibrosis Foundation, a $45M clinical development contract with the U.S. Defense Threat Reduction Agency, and a public listing via reverse merger at Aceragen. He has raised nearly $150 million in venture, private equity, and strategic funding, and brings hands-on expertise in dealmaking, portfolio strategy, and clinical development across biologics, peptides, small molecules, and drug delivery platforms.

John holds a B.S. in Biological Sciences from Clemson University and an M.S. in Technology Management from the University of Pennsylvania Wharton School of Business.

Anthony is a biotech investor and operator who has spent over a decade at well known biotech investment firms including RA Capital, Mission BioCapital, and Lyfe Capital. He led or co-led investments in Tidal Therapeutics (acquired by Sanofi for $160M upfront + $310M in milestones) and Vedere Bio (acquired by Novartis for $150M upfront + $130M in milestones), and backed companies such as QurAlis, ShapeTx, Mediar Therapeutics, Dren Bio, and Tune Therapeutics—advancing programs in neurodegeneration, RNA editing, and oncology.

Anthony holds a B.A. in Biochemistry from Trinity College Dublin and a D.Phil in Biophysics from Oxford University, where his research focused on the biological applications of DNA cages for targeted macromolecule delivery.

Business Development Inquiries: bd@formation.bio

Four Veteran Dealmakers Join Formation Bio to Drive Pipeline Growth and Partnerships

Welcoming Our First Class of Entrepreneurs in Residence

Formation Bio, an AI-driven pharmaceutical company revolutionizing drug development, today announced that Mikael Dolsten, MD, PhD, former Chief Scientific Officer and President, Pfizer Research & Development, has joined the company as a strategic advisor. In his role, Dolsten will serve as Chair of the Drug Picking Committee, Co-Chair of the Investment Advisory Committee, and Chair of Science, Technology, and Product Planning Committee.

Dolsten brings decades of experience in drug development and investment, having played a key role in Pfizer’s industry-leading R&D efforts, including the rapid development of the COVID-19 vaccine, the oral anti-viral drug Paxlovid, and many blockbuster therapies across a range of therapeutic areas. He concluded his tenure at Pfizer on March 1, 2025, after more than 15 years of leading the company’s R&D strategy, during which he oversaw the development and approval of more than 35 medicines and vaccines and moved over 100 drug candidates through clinical development, shaping global drug innovation at an unprecedented scale.

At Formation Bio, he will focus on leading asset selection and drug development strategy, leveraging his extensive global network to identify high-potential assets. More broadly, he will also provide strategic guidance on the company’s AI initiatives, advising on the development of its AI platform for asset search, evaluation, and deep research on drug targets to enhance decision-making and accelerate pipeline growth.

“The pharmaceutical industry is at an inflection point, where AI is shifting from an experimental tool to a core driver of efficiency and innovation in drug development,” said Mikael Dolsten. “I have seen firsthand how AI has transformed drug discovery, yet development remains a critical bottleneck. Formation Bio is leading the charge in applying AI to streamline and accelerate this process, creating a new paradigm for pharma. Their ability to integrate AI at every stage—from asset selection to clinical execution—positions them to fundamentally reshape the industry. I am excited to work alongside this exceptional team to help bring more innovative therapies to patients faster and more efficiently than ever before.”

Formation Bio seamlessly integrates AI across many facets of the drug development lifecycle—from asset sourcing and evaluation to clinical trial execution—aiming to enhance efficiency, reduce costs, and improve success rates. Currently, Formation Bio's pipeline includes four majority-owned assets, with a goal to expand to 10-15 assets over the next 3-5 years.

“Mikael is one of the most respected minds in pharmaceutical R&D, with a track record of shaping some of the most important drug advancements of our time,” said Ben Liu, Co-Founder & CEO of Formation Bio. “His scientific leadership, strategic vision, and ability to bridge cutting-edge research with real-world applications have made a lasting impact on the industry. His involvement with Formation Bio reflects his belief in the transformative power of AI in drug development, and we are incredibly fortunate to have his expertise on board.”

Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients. For more information, please visit www.formation.bio.

This press release contains forward-looking statements about Formation Bio's business prospects, pipeline development, and asset expansion plans. These statements are based on current expectations and beliefs but are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Formation Bio undertakes no obligation to update these forward-looking statements as a result of new information or future events.

Mikael Dolsten, MD, PhD, former Chief Scientific Officer and President, Pfizer Research & Development will serve as Formation Bio's Chair of the Drug Picking Committee, Co-Chair of the Investment Advisory Committee, and Chair of Science, Technology, and Product Planning Committee

Former Pfizer R&D Chief Mikael Dolsten Joins Formation Bio

 - Today, Formation Bio, together with OpenAI and Sanofi, introduced Muse, an advanced AI-powered tool developed to accelerate and improve drug development by optimizing patient recruitment for clinical trials. Muse is the first outcome of the collaboration between the three companies, which aims to combine their pharma expertise and AI models to accelerate drug development and ultimately speed up breakthrough therapies to patients.

Patient recruitment is a critical yet often slow and costly aspect of clinical development. It is estimated that less than 10% of patients participate in clinical trials for different reasons, including the fact that they are never invited or informed about the opportunity. This low participation rate causes delays that directly impact how quickly new medicine can reach patients. Muse, the first AI application of its kind in the pharmaceutical industry, aims to shorten patient recruitment timelines by accelerating recruitment strategy and content creation from a typical timeline of months to just minutes.

to analyze extensive scientific literature, real world evidence and unique insights on diseases and patient populations, delivering comprehensive research, strategic opportunities, and faster preparation of patient recruitment strategies - accomplishing what typically requires large teams of experts and multiple layers of manual review with a single AI tool. First, it compiles in-depth research on diseases, patient demographics, and the competitive landscape. It then identifies optimal patient profiles and recruitment strategies to include diverse populations across therapeutic areas. Finally, Muse auto-generates high-quality recruitment materials and pre-screening questionnaires, tailored to specific patient subgroups and adaptable for various channels, languages, and styles.

Ben Liu, Co-Founder & CEO, Formation Bio:

 "AI presents a tremendous opportunity to transform drug development, ultimately enhancing both efficiency and outcomes. At scale, this AI-driven development approach can accelerate the delivery of new medicines and reshape healthcare worldwide. Muse is just the start—one of the many AI innovations we’re building for drug development.”

Developed jointly by the three companies leveraging multiple OpenAI models, Muse

is designed for use across a wide range of therapeutic areas. Both Sanofi and Formation Bio plan to implement Muse in upcoming clinical trials, with Sanofi leading the initial deployment in Phase 3 studies for multiple sclerosis (MS). For this rollout, Sanofi will provide data and expertise on MS, leveraging its deep experience in delivering innovative treatments to support patients affected by this debilitating condition.

Emmanuel Frenehard, Chief Digital Officer, Sanofi: 

“By leveraging advanced AI capabilities, we can not only enhance recruitment efficiency but also potentially bring new treatments to patients faster. The development of Muse, a result of our ongoing collaboration with OpenAI and Formation Bio, represents another proof point in Sanofi’s journey to becoming the first pharma company powered by AI at scale.”

Muse develops tailored strategies and materials designed for diverse patient populations, including historically underrepresented groups, in order to enhance inclusiveness and representation in clinical trials. This approach can expand participation and ultimately capture broader trial data, contributing to more reliable, generalizable insights that better reflect the needs of all patients.

Additionally, Muse includes an LLM agent that incorporates Institutional Review Board (IRB) and regulatory guidelines, aiming to automatically generate high-quality materials that keep compliance best practices in mind. This feature, when combined with human experts in the loop, reduces the risk of regulatory setbacks, promoting smoother, more efficient trial progression.

AI safety and data privacy are embedded throughout Muse’s development and deployment, reflecting all three companies' commitment to the responsible use of AI. Muse relies on research publications and other public and proprietary data sources, none of which contain personally identifiable information (PII).

"We believe AI can accelerate drug development, bringing new treatments to patients more quickly. This first product from our collaboration with Sanofi and Formation Bio is just the beginning, and we can't wait to see the impact it will have."

Formation Bio is a tech-driven, AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients.

OpenAI is an AI research and deployment company. Its mission is to ensure that artificial general intelligence benefits all of humanity. Last month, OpenAI announced it would be opening an office in France, so it can better support French developers, businesses and civic organizations so they can benefit from this transformative technology.

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Formation Bio collaborates with Sanofi and OpenAI to Introduce Muse, a first of its kind AI tool to accelerate patient recruitment in drug development.

Pressroom

Formation Bio Licenses First in Class Anti-CD226 Autoimmune Program

Welcoming Our First Class of Entrepreneurs in Residence

Former Pfizer R&D Chief Mikael Dolsten Joins Formation Bio

Introducing Muse