Kelonia's lead program, KLN-1010, is a potentially first-in-class lentiviral in vivo CAR-T therapy currently in Phase 1 for relapsed/refractory multiple myeloma with clinical data recently highlighted in the 2025 ASH Annual Meeting plenary session

Acquisition expands Lilly's genetic medicine capabilities with a novel in vivo gene delivery and integration technology that has potential for broad applicability

Eli Lilly and Company (NYSE: LLY) and Kelonia Therapeutics, Inc. ("Kelonia"), a clinical-stage biotechnology company pioneering in vivo gene delivery, announced a definitive agreement for Lilly to acquire Kelonia.

Kelonia has developed a proprietary in vivo gene placement system (iGPS^® ) that uses specially engineered lentiviral-based particles designed to efficiently and selectively enter T-cells inside the body, allowing the patient's own body to generate chimeric antigen receptor T-cell (CAR-T) therapies that can treat underlying disease. Kelonia's lead program, KLN-1010, is an investigational, one-time intravenous gene therapy that generates anti-B-cell maturation antigen (BCMA) CAR-T cells, targeting the BCMA protein expressed on the surface of multiple myeloma cells. Encouraging early clinical results were presented in the plenary session of the 2025 American Society of Hematology Annual Meeting, providing initial clinical validation and demonstrated promising tolerability. KLN-1010 could represent a transformative advance in the treatment of multiple myeloma by eliminating the complexities of ex vivo patient-specific cell therapy manufacturing, and pre-administration chemotherapy.

"Autologous CAR-T therapies have meaningfully improved outcomes for patients with various cancers, but significant manufacturing, safety, and access barriers mean that only a fraction of eligible patients actually receive them. Kelonia's in vivo platform has the potential to change that by delivering rapid, durable responses in a far simpler, off-the-shelf format," said Jacob Van Naarden, executive vice president and president of Lilly Oncology and head of corporate business development. "The early clinical data for KLN-1010 are highly encouraging, both as a potential step forward for patients with multiple myeloma and as proof of concept for Kelonia's platform.  We look forward to working together with the Kelonia team to rapidly advance KLN-1010 to address patient need and recognize the full potential of their platform in other conditions where patients may benefit."

"Kelonia's leadership in advancing the immense promise of in vivo cell therapy is unmatched, extending its reach and impact beyond the traditional boundaries of personalized medicine," said Kevin Friedman, Ph.D., chief executive officer of Kelonia. "We have demonstrated the ability to achieve deep multiple myeloma remissions with significantly reduced complexity and cost relative to ex vivoCAR T-cell approaches. In combination with Lilly's strengths, our in vivo iGPS platform is positioned to broaden the reach of cell therapy beyond the current CAR-T landscape in hematologic malignancies and to transform treatment across a far wider range of cancers and other serious diseases. It's been a privilege continuing the journey started by Michael Birnbaum and the Venrock team. I am deeply grateful to our employees, partners, and investigators, and most importantly, the patients who make this progress possible."

Under the terms of the agreement, Lilly will acquire Kelonia, and Kelonia shareholders will receive up to $7.00 billion in cash, inclusive of an upfront payment of $3.25 billion, and subsequent payments upon achievement of certain clinical, regulatory and commercial milestones.

The transaction is subject to customary closing conditions, including customary regulatory approvals, and is expected to close in the second half of 2026. 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.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For Kelonia, Jefferies LLC is acting as financial advisor, and Goodwin Procter LLP is acting as legal counsel.