Eli Lilly to Acquire Orna Therapeutics in RNA-Based Cell Therapy Deal

Eli Lilly and Company 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.