Orna’s Approach & Strategy
We’re reshaping RNA therapeutics to open an entirely new world of possibilities in the treatment of disease. Our field-defining engineered circular RNA (oRNA®) has unmatched advantages compared to linear RNA, and our groundbreaking LNP delivery to sites other than the liver has led the world in unlocking the treatment of a far greater span of diseases than previously addressable.
Limitless Potential
Our vision is to deliver first-in-class innovative RNA drugs wherever they’re needed in the body. Initially focusing on oncology and autoimmune diseases (with our panCAR™ in vivo CAR technology) and infectious disease (with our Merck collaboration), our delivery solutions also open up the possibility of treating certain genetic diseases, such as sickle-cell disease and beta-thalassemia, directly in the bone marrow.
Our technology will allow an immediate, off-the-shelf treatment option that will not require harsh preconditioning regimens, offering a significant advancement over traditional cell engineering therapies.
About Us
Creating a new class of therapeutics requires thinking outside the lines. Comprising a team of skilled scientists, molecular engineers, and industry veterans in addition to a world-class Board of Directors and Scientific Advisors, we are well-suited for to bring the promise of our unique oRNA® and LNP delivery method to patients.
News & Events
Lilly to acquire Orna Therapeutics to advance cell therapies
Orna Therapeutics Presents New Data Supporting its in vivo CAR Programs for Autoimmune Diseases and Oncology at the 67th American Society of Hematology Annual Meeting
Orna Therapeutics Announces Multiple Presentations Supporting its in vivo CAR Programs for Autoimmune Diseases at the 67th American Society of Hematology Annual Meeting
Orna’s in vivo CAR-T pipeline includes potential best-in-class programs to reset the immune system and address B cell-driven autoimmune diseases
Acquisition provides a broad platform for long-term innovation in genetic medicine and in vivo cell engineering
INDIANAPOLIS and WATERTOWN, Mass., Feb. 9, 2026 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Orna Therapeutics, Inc., a biotechnology company dedicated to engineering immune cells in vivo, today announced entry into a definitive agreement for Lilly to acquire Orna.
Orna is advancing a new class of therapeutics utilizing engineered circular RNA paired with novel lipid nanoparticles to allow the patient’s own body to generate cell therapies that can treat underlying disease. Orna’s lead program is ORN-252, a clinical trial-ready, CD19 targeting in vivo Chimeric Antigen Receptor T-cell (CAR-T) therapy designed to treat B cell-driven autoimmune diseases. Experiments to date suggest that Orna’s circular RNA platform may deliver more durable expression of therapeutic proteins and therefore unlock treatments that are not feasible with current RNA or cell therapy platforms.
“Early autologous CAR-T studies have shown the promise of cell therapy for patients with autoimmune diseases, but the complexity, cost, and logistics of ex vivo approaches make it challenging to deliver these breakthroughs to the broader population of patients who need them,” said Francisco Ramírez-Valle M.D., Ph.D., Senior Vice President, Head of Immunology Research and Early Clinical Development. “We look forward to working with Orna colleagues to potentially unlock an entirely new class of genetic medicines and cell therapies for patients who today have limited or no treatment options.”
“At Orna, we believe our circular RNA technology paired with our best-in-class LNP delivery platform have the potential to unlock in vivo CAR-T therapies for patients across a wide range of B cell-driven autoimmune diseases. We are excited to join forces with Lilly, an industry leader in the development of patient-centric therapeutics to realize the full potential of these technologies,” said Joe Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics.”
Under the terms of the agreement, Lilly will acquire Orna, and Orna shareholders could receive up to $2.4 billion in cash, inclusive of an upfront payment and subsequent payments upon achievement of certain clinical development milestones.
Lilly will determine the accounting treatment of this transaction in accordance with Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly’s financial results and financial guidance.
Paul, Weiss, Rifkind, Wharton & Garrison LLP is acting as legal counsel to Lilly. Lazard is acting as financial advisor to Orna. Goodwin Procter LLP is acting as legal counsel to Orna.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. F-LLY
About Orna Therapeutics
Orna Therapeutics is dedicated to designing and delivering a new class of fully engineered circular RNA (oRNA®) therapeutics to unlock the potential of RNA medicine to treat diseases anywhere in the body. Orna’s oRNA transcripts have advantages over traditional mRNA approaches, including simplified production, improved formulation into lipid nanoparticles, and superior protein expression. Its industry-leading LNP-based delivery systems and comprehensive editing programs position Orna to advance novel RNA medicines with vast potential to transform patient care.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of Lilly’s acquisition of Orna and Orna’s Circular RNA therapeutics and LNP delivery platform, including its CAR-T program, and reflects Lilly’s current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in implementing the acquisition and in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the acquisition, that the acquisition will achieve the results discussed in this release or that the acquisition will yield commercially successful products. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, see Lilly’s Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
No Offer or Solicitation
This communication is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.
Refer to:
Ashley Hennessey; gentry_ashley_jo@lilly.com; 317-416-4363 (Media)
Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)
Alex Lobo; Alex.lobo@precisionaq.com (Orna Investors)
Anti-CD19 panCARTM program (ORN-252) demonstrated robust B cell depletion with significant reduction in anti-dsDNA titers in humanized lupus model
Anti-BCMA panCARTM program showed robust and durable plasma cell depletion in preclinical models
Orna expects to submit its first Clinical Trial Application for ORN-252 by the end of 2025 and anticipates initiating a first-in-human study in early 2026
WATERTOWN, Mass., Dec. 7, 2025 – Orna Therapeutics (Orna), a biotechnology company dedicated to engineering immune cells in vivo to treat autoimmune and oncology diseases, today announced new preclinical data supporting the Company’s in vivo CAR programs to target and treat a broad range of B cell-mediated autoimmune diseases and plasma cell or BCMA-related diseases at the 67th American Society of Hematology (ASH) Annual Meeting taking place in Orlando, Florida from December 6-9, 2025.
“The preclinical data presented at this year’s ASH Annual Meeting further highlights our potent, non-viral, transient, tunable, and scalable approach to in vivo CAR therapies in both autoimmune diseases and oncology,” said Joseph Bolen, Ph.D., Chief Executive Officer of Orna. “Our panCAR platform has demonstrated robust activity in B cell autoimmunity and BCMA-related diseases without the need for preconditioning lymphodepletion. Additionally, the non-human primate (NHP) data presented across both programs demonstrated specific and targeted depletion of B cells or plasma cells. As we look ahead, we anticipate submitting our first Clinical Trial Application for ORN-252, our anti-CD19 panCAR program this year and entering the clinic in early 2026.”
Oral Presentation details:
In Vivo panCAR™ Therapy Utilizing Circular RNA for Treatment of Autoimmune Diseases
In this presentation, Orna highlighted preclinical data demonstrating the potential of its proprietary circular (oRNA®) technology paired with its best-in-class lipid nanoparticle (LNP) delivery platform to enable the next generation of in vivo therapies and treat a variety of B cell-mediated autoimmune diseases.
Key findings in the study include:
- ORN-252, Orna’s anti-CD19 panCAR mediated robust B cell depletion in humanized mice in vivo at doses as low as 0.03 mg/kg.
- In a humanized mouse lupus model, ORN-252 showed robust B cell depletion with concurrent reduction in dsDNA titers in contrast to rituximab.
- Treatment with ORN-252 led to complete peripheral and splenic B cell depletion in NHP at doses as low as 0.1 mg/kg.
- CAR+ T cells upregulated cytotoxicity markers after the first dose when the majority of cell killing occurs.
- ORN-252 demonstrated durable B cell depletion with a reduction in switched memory and an increase in naïve B cell phenotype upon repopulation.
- ORN-252 showed superior binding affinity, expression, and killing of CD19 cells in human vs. NHP cells, potentially providing increased potency upon translation to humans.
Orna anticipates filing a Clinical Trial Application for this program by the end of 2025 and expects to initiate a first-in-human study in early 2026.
Poster Presentation details:
In Vivo panCARTM Therapy Utilizing Circular RNA for Treatment of Multiple Myeloma
In today’s poster presentation, Orna will showcase preclinical data demonstrating the potential of its in vivo panCARTM therapy to treat a range of plasma cell or BCMA-related diseases including multiple myeloma.
Key findings in the study include:
- High surface expression of anti-BCMA panCAR was observed in a dose-dependent manner on human and cynomolgus immune cells and was maintained at least 72 hours in vitro.
- In a humanized mouse model engrafted with BCMA-expressing tumor cells, anti-BCMA panCAR demonstrated superior tumor control, eliminating tumors for at least 30 days, functionally outperforming a clinically validated anti-BCMA binder.
- In NHPs, treatment with BCMA panCAR resulted in specific and targeted plasma cell depletion.
- Anti-BCMA panCAR is highly selective, demonstrating no significant impact on the overall B cell repertoire in NHPs.
About Orna Therapeutics
Orna Therapeutics is dedicated to designing and delivering a new class of fully engineered circular RNA (oRNA®) therapeutics to unlock the potential of RNA medicine to treat diseases anywhere in the body. Orna’s oRNA transcripts have advantages over traditional mRNA approaches, including simplified production, improved formulation into lipid nanoparticles, and superior protein expression. Its industry-leading LNP-based delivery systems and comprehensive editing programs position Orna to advance novel RNA medicines with vast potential to transform patient care. To learn more, visit www.ornatx.com and follow Orna on X and LinkedIn.
Orna Therapeutics Investor Contact:
Alex Lobo
Precision AQ
Alex.lobo@precisionaq.com
WATERTOWN, Mass., Nov. 3, 2025 – Orna Therapeutics, a biotechnology company dedicated to engineering immune cells in vivo to treat autoimmune and oncology diseases, today announced upcoming presentations at the 67th American Society of Hematology (ASH) Annual Meeting being held December 6-9, 2025, in Orlando, Florida. The oral and poster presentations will highlight data supporting Orna’s leading in vivo CAR programs to target and treat a broad range of B-cell driven autoimmune diseases and its anti-BCMA platform to selectively deplete plasma cells.
“We are excited to share new data at ASH from our NHP studies for our CD19 and BCMA panCAR programs,” said Joseph Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics. “Data to be presented continues to demonstrate the best-in-class nature of our in vivo CAR platform in NHP for both our anti-CD19 and our anti-BCMA programs. As we look ahead, we have completed our pre-clinical package for anti-CD19 and will be submitting our Clinical Trial Application this Quarter.”
Oral Presentation details:
Title: In Vivo pan CAR Therapy Utilizing Circular RNA for Treatment of Autoimmune Diseases
Speaker: Isin Dalkilic-Liddle, Ph.D., VP Discovery Sciences,, Orna Therapeutics
Date/Time: Saturday, December 6, 2025, 9:45 AM – 10:00 AM ET
Session Name: CAR-T Cell Therapies: Basic and Translational: In vivo CAR-T cell platforms and resistance mechanisms
Location: OCCC – Sunburst Room (W340)
Poster Presentation details:
Title: In Vivo pan CAR Therapy Utilizing Circular RNA for Treatment of Multiple Myeloma
Speaker: Rebecca Silver, Ph.D., Pr. Scientist, Orna Therapeutics
Date/Time: Sunday, December 7, 2025, 6:00 PM – 8:00 PM ET
Session Name: CAR-T Cell Therapies: Basic and Translational: Poster II
Location: OCCC – West Halls B3-B4
By leveraging its leading oRNA technology and best-in-class LNP delivery, Orna’s in vivo oRNA panCAR therapies hold the potential to benefit patients across multiple B cell driven autoimmune diseases. New data to be presented at ASH will highlight the ability of Orna’s oRNA panCAR platform to generate deep and sustained B cell depletion in non-human primates across multiple doses in multiple therapeutic areas.
About Orna Therapeutics
Orna Therapeutics is dedicated to designing and delivering a new class of fully engineered circular RNA (oRNA®) therapeutics to unlock the potential of RNA medicine to treat diseases anywhere in the body. Orna’s oRNA transcripts have advantages over traditional mRNA approaches, including simplified production, improved formulation into lipid nanoparticles, and superior protein expression. Its industry-leading LNP-based delivery systems and comprehensive editing programs position Orna to advance novel RNA medicines with vast potential to transform patient care. To learn more, visit www.ornatx.com and follow Orna Therapeutics on X and LinkedIn.
Orna Therapeutics Investor Contact:
Alex Lobo
Precision AQ
Alex.lobo@precisionaq.com