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)

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Anti-BCMA panCAR^TM 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 67^th 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 panCAR^TM 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 panCAR^TM 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

The post 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 appeared first on Orna Therapeutics.

“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

The post Orna Therapeutics Announces Multiple Presentations Supporting its in vivo CAR Programs for Autoimmune Diseases at the 67th American Society of Hematology Annual Meeting appeared first on Orna Therapeutics.

Presentation Details (encore):

Title: In Vivo panCAR Therapy Utilizing Circular RNA for the Treatment of Autoimmune Diseases 
Speaker: Isin Dalkilic-Liddle, Ph.D., Vice President, Head of Discovery Sciences, Orna Therapeutics
Date/Time: Monday, October 27, 2025, 10:30 AM – 12:30 PM CDT
Session Name: (0934-0954) Systemic Lupus Erythematosus – Animal Models Poster
Location: Hall F1

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

The post Orna Therapeutics Announces Encore Presentation at the American College of Rheumatology Annual Meeting Supporting its in vivo CAR Therapy Approach in Autoimmune Diseases appeared first on Orna Therapeutics.

“The preclinical data presented today at ASGCT highlight our potential to deliver on the promise of in vivo CAR T therapy,” said Joseph Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics. “Our CD19 panCAR program has demonstrated not only successful delivery of our lead panCAR LNP to disease-relevant immune cell types, but also robust and sustained B cell depletion at low doses in both peripheral blood and lymphoid tissues in non-human primates (NHPs). These compelling results continue to reinforce our commitment to translating our promising science into meaningful therapies for patients and we look forward to advancing our CD19 panCAR program towards the clinic in 2026.”

Presentation Details:

Title: In Vivo panCAR Therapy Using Circular RNA for the Treatment of Autoimmune Disease 

Speaker: Megan Hoban, Ph.D., panCAR Program Lead, Orna Therapeutics

Date/Time: Thursday, May 15, 2025, 8:00 AM – 9:45 AM CDT

Session Name: Cellular and Gene Therapies for Autoimmune Disease

Location: Room 388-390

In today’s presentation, Orna will showcase preclinical data demonstrating the potential of its in vivo panCAR therapy, enabled by its proprietary circular (oRNA®) technology and best-in-class lipid nanoparticle (LNP) delivery system to achieve robust and sustained B cell depletion in both humanized mouse models and non-human primates across multiple doses.

Key findings from the study include:

• Validated extra-hepatic delivery to disease-relevant immune cell types, including T cells, in mice and NHPs without requiring targeting ligands.
• Lead panCAR LNP achieved over 60% delivery to peripheral blood and splenic T cells in NHPs.
• CD19 panCAR doses as low as 0.03mpk led robust B cell depletion, with multi-dosing achieving increased B cell depletion in humanized mice.
• In a humanized lupus mouse model, CD19 panCAR showed strong B cell depletion and a meaningful and differentiated reduction in dsDNA titers compared to rituximab.
• CD19 panCAR induced full depletion of B cells across peripheral blood, spleen, lymph nodes, and bone marrow in NHPs, with peripheral B cells beginning to reconstitute after three weeks.

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, comprehensive editing programs and validating large pharma partnerships 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

The post Orna Therapeutics Presents New Preclinical Data Supporting its in vivo CAR Therapy Approach in Autoimmune Diseases at the American Society of Gene and Cell Therapy Annual Meeting appeared first on Orna Therapeutics.

“We are excited to present new data at the upcoming ASGCT annual meeting as we advance our panCAR programs towards the clinic,” said Joseph Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics. “Our platform, which pairs our circular (oRNA®) technology and best-in-class lipid nanoparticle (LNP) delivery has the potential to deliver a pipeline in a product and treat multiple diseases and therapeutic areas. The data to be presented will highlight the ability of our platform to enable sustained pharmacodynamic effects at low doses, durable protein expression, and repeat dosing. We look forward to advancing our CD19 autoimmune panCAR program into the clinic in 2026, followed by our BCMA panCAR program in oncology.”

Presentation details are as follows:

Title: In Vivo panCAR Therapy Using Circular RNA for the Treatment of Autoimmune Disease 

Speaker: Megan Hoban, Ph.D., panCAR Program Lead, Orna Therapeutics

Date/Time: Thursday, May 15, 2025, 8:00 AM – 9:45 AM CDT

Session Name: Cellular and Gene Therapies for Autoimmune Disease

Location: Room 388-390

By leveraging its leading oRNA technology and potentially best-in-class LNP delivery, Orna’s in vivo CD19 panCAR platform holds the potential to benefit patients across multiple B cell driven autoimmune diseases. New data to be presented at ASGCT will highlight the ability of Orna’s CD19 panCAR platform to generate deep and sustained B cell depletion in non-human primates across multiple doses.

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

The post Orna Therapeutics Announces Presentation at the American Society of Gene and Cell Therapy Annual Meeting Supporting its in vivo CAR Therapy Approach in Autoimmune Diseases appeared first on Orna Therapeutics.

Orna expects to initiate clinical studies in 2026 for its two wholly owned, potentially best-in-class in vivo panCAR assets, including its CD19 program for B cell-driven autoimmune diseases and a BCMA program for multiple myeloma. In addition to its wholly owned pipeline, Orna has secured two major, potentially multi-billion-dollar pharma partnerships with Merck for the development of vaccines and therapeutics in infectious disease and oncology and with Vertex for next generation approaches to sickle cell disease and transfusion-dependent beta thalassemia.

“At its core, Orna is a science driven organization that has greatly benefited from Joe’s breadth and depth of drug development expertise,” said Ansbert Gadicke, M.D., Chairman of Orna and Managing Partner of MPM BioImpact. “This is the perfect time for Joe to take the helm as Orna advances both its proprietary programs in autoimmune and oncology to the clinic. Joe’s scientific expertise and organizational leadership capabilities, in conjunction with the Company’s strong cash position, will enable us to achieve key milestones across our wholly owned and partnered programs.”

Dr. Gadicke continued, “Amit leaves Orna in a strong position and we would like to express our deep appreciation for his commitment and contributions.”

Dr. Bolen joined Orna through its acquisition of ReNAgade Therapeutics and has served as CSO since November 2024, concurrent to his role as an Entrepreneur Partner at MPM BioImpact. Prior to Orna, Dr. Bolen served in leadership roles at ReNAgade Therapeutics. Previously, he oversaw all aspects of R&D for Moderna Therapeutics as CSO and President of Research and Development. Before Moderna, Dr. Bolen was CSO at Millennium Pharmaceuticals and Global Head of Oncology Research at Takeda Pharmaceutical Company. Earlier in his career, he held senior R&D positions at Hoechst Marion Roussel, Schering-Plough (DNAX) and Bristol Myers Squibb. Dr. Bolen began his career at the National Institutes of Health (NIH). He earned a Ph.D. in Immunology and conducted his postdoctoral training in molecular virology at Kansas State University Cancer Center. He graduated from the University of Nebraska with a B.S. in Microbiology and Chemistry.

“I am excited to lead our world-class team, as we advance some of the most transformative science I’ve seen in my 35-year career in this industry. Our leading circular RNA paired with our potentially best-in-class delivery technologies hold the potential to overcome the limitations of existing ex-vivo technologies and deliver large-scale impact to patients across a range of diseases,” said Dr. Bolen. “With robust data in hand demonstrating our ability to deliver and engineer immune cells in vivo, our focus is now on advancing our first two panCAR programs into the clinic in 2026 and continuing to progress our pharma partnerships. I look forward to leading our team through this next exciting chapter of the Company’s growth as we unlock the potential of RNA medicines.”

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 circular RNA 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

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Under the agreement, Simnova will pursue the research and development and commercialization of in vivo panCar cell therapies targeting BCMA in greater China and Orna will retain all rights for development and commercialization in the rest of the world. Each party will have the right to receive an upfront payment within their respective licensed territories and is eligible for clinical development, regulatory, and commercialization milestones as well as royalties on any approved products derived from the collaboration.

In January 2023, Simnova and Orna announced a collaboration agreement granting Simnova exclusive rights to develop and commercialize Orna’s in vivo cell therapy products in the Greater China region. This includes Orna’s lead isCAR project targeting CD19, “ORN-101.”

“We are excited to deepen our partnership with Simnova to bring an in vivo BCMA panCAR therapy to patients with multiple Myeloma,” said Ansbert Gadicke, M.D., Chairman of Orna and Managing Partner of MPM BioImpact. “Orna’s panCAR approach holds the potential to introduce a novel class of in vivo CAR therapies that overcomes the limitations of current ex vivo cell therapies. The exciting pre-clinical and non-human primate data that Orna has generated continues to reinforce our commitment in this area. We look forward to advancing our programs towards the clinic.”

Dr. Zhuoxiao CAO, CEO of Simnova, added, “Our shared commitment to advancing immunotherapies and oncology treatments opens new opportunities to address unmet medical needs through the development of BCMA-targeted therapeutics.”

About Orna
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 circular RNA 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.

About Simnova
Shanghai Simnova Biotech Co., Ltd. (www.simnovabio.com) is dedicated to bringing innovative cell therapy products to oncology and autoimmune patients. Simnova Biotech has a rich R&D pipeline, with technical advantages in its proprietary universal off-the-shelf CAR-NK and BiTE CAR-T programs, both of which are currently in clinical development stage.

Orna Therapeutics Investor Contact:
Alex Lobo
Precision AQ
alex.lobo@precisionaq.com

The post Simnova and Orna Expand Strategic Partnership to Include BCMA-Targeted RNA Therapeutics appeared first on Orna Therapeutics.

“We are thrilled to welcome Vikas to our Board of Directors. He brings a wealth of leadership experience spanning finance, corporate strategy and capital raising in the cell and gene therapy space,” commented Amit Munshi, Chief Executive Officer of Orna. “We look forward to leveraging his expertise as we enter our next stage of growth and advance our panCAR programs for patients with cancer and autoimmune diseases.”

Mr. Sinha brings more than 25 years of experience working in executive finance roles in the life sciences industry. He currently serves as Chief Financial Officer and co-founder of ElevateBio, a holding company focused on building cell and gene therapy companies. Mr. Sinha also serves as President, Chief Financial Officer, and Director of AlloVir, an ElevateBio portfolio company. Concurrently, he serves as a member of the board of directors of Verona Pharma. Prior to joining ElevateBio and AlloVir, he was Chief Financial Officer of Alexion Pharmaceuticals. Before that, Mr. Sinha held various positions with Bayer across the world including Chief Financial Officer, Bayer North America and Chief Financial Officer, Bayer Yakuhin, Japan.

Mr. Sinha holds an MBA from the Asian Institute of Management. He is a qualified Chartered Accountant from the Institute of Chartered Accountants of India and a Certified Public Accountant in the U.S.

“I am excited to join Orna’s Board of Directors and have been impressed by the breadth and depth of the Company’s platforms and pipeline, which hold the potential to overcome existing limitations of cell therapies to deliver outsized impact to patients living with cancer and autoimmune diseases,” said Mr. Sinha. “I look forward to working with the Orna Board and leadership to advance its lead panCAR programs towards the clinic and position the organization for future growth.”

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 circular RNA 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.

Investor Contact:
Precision AQ
Alex Lobo
alex.lobo@precisionaq.com

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— Orna to receive an upfront payment and is eligible to receive potential pre-clinical, clinical, and commercialization milestone payments and royalties —

WATERTOWN, Mass., Jan. 7, 2025 /PRNewswire/ — Orna Therapeutics (through its wholly owned subsidiary ReNAgade Therapeutics Inc.) announced a three-year strategic research collaboration with Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) to utilize Orna’s novel and proprietary LNP delivery solutions to enhance Vertex’s efforts in developing next generation gene editing therapies for patients with SCD and TDT.

“Vertex is a leader in delivering next-generation approaches to treating hemoglobinopathies, and we are excited to collaborate with them to develop in vivo therapies that leverage our proprietary technologies to achieve unprecedented delivery to HSCs,” commented Amit Munshi, Chief Executive Officer of Orna. “Today’s collaboration further validates our industry leading extra-hepatic LNP delivery chemistries and highlights the importance of delivery to enable the next wave of RNA medicines.”

Ansbert Gadicke, M.D., Chairman of Orna and Managing Partner of MPM BioImpact added, “Today’s collaboration leveraging Orna’s industry-leading non-viral HSC delivery represents our second major partnership and is testament to the breadth and potential of the Company’s platform. We look forward to partnering with Vertex to develop transformative therapies for SCD and TDT, while simultaneously advancing our lead panCAR pipeline programs in autoimmune and oncology. This deal further solidifies Orna’s leadership in next generation RNA medicines and has the potential to deliver large-scale impact to patients.”

About the Collaboration
Under the terms of the agreement, Orna will receive upfront payments of $65 million, including an investment in the form of a convertible note, and is eligible to receive up to $635 million based upon the achievement of specified pre-clinical, research, development, regulatory and commercial milestones related to SCD/TDT products. Additionally, Orna is further eligible to receive up to $365 million in additional option fees and milestones per product for up to ten additional products if Vertex options rights in additional indications. Orna will be eligible to receive tiered royalties on future net sales of any products that may result from this collaboration. Vertex is funding the three-year research collaboration and holds an option to extend the research collaboration term.

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 circular RNA 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

The post Orna Therapeutics Establishes Strategic Collaboration with Vertex Pharmaceuticals to Develop Next Generation Approaches for Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT) appeared first on Orna Therapeutics.