Iovance Biotherapeutics announced plans to reduce its workforce by less than 20% as part of a strategic restructuring following the challenging commercial launch of Amtagvi, the first tumor-infiltrating lymphocyte (TIL) cell therapy to reach market. The layoffs affect both full-time employees and contractors, though the company will maintain more than 1,000 staff members following the cuts.
The restructuring comes after Iovance significantly revised its revenue projections earlier this year. In May, the company slashed its 2024 product revenue forecast by 40%, from an initial range of $450-475 million to $250-300 million, citing "recent launch dynamics" that altered management's outlook for Amtagvi's commercial performance.
Breakthrough Therapy Faces Market Headwinds
Amtagvi represents a significant scientific milestone as the first marketed cellular medicine engineered from tumor-infiltrating lymphocytes. The therapy originated from research conducted at the National Institutes of Health in the 1980s and required decades of development and multiple regulatory delays before reaching market approval in February 2024.
The treatment is indicated for patients with advanced melanoma that has progressed after treatment with commonly used immunotherapy or targeted cancer medications. Amtagvi is derived from a patient's tumor tissue through a complex, weeks-long manufacturing process that has contributed to adoption challenges.
At approximately $515,000, Amtagvi carries the highest list price of any cell-based cancer medicine in the United States at the time of its approval. Analysts and investors expressed skepticism about the therapy's sales potential from launch, citing concerns about demand and the complex logistics required for administration.
Revised Projections Based on Real-World Data
According to Mizuho Securities analyst Salim Syed, Iovance's initial revenue projections were modeled on launches of other marketed cancer cell therapies, specifically CAR-T treatments. However, the company's updated forecasts now rely on "real data" from medical centers actively administering Amtagvi, providing a more accurate assessment of market dynamics.
The revenue projections include contributions from both Amtagvi and Proleukin, a different immunotherapy in Iovance's portfolio.
Strategic Focus on Long-Term Goals
"After careful evaluation of our long-term goals, operational needs, and resources, we have implemented a strategic restructuring that includes a selective reduction in force to support our mission to innovate, develop and deliver TIL cell therapy to patients in need," an Iovance spokesperson stated. "This restructuring will extend our cash runway, and we remain on track to deliver on our financial goals."
The company indicated it would provide additional details during its second quarter earnings report.
Pipeline and International Expansion
Despite the commercial challenges, Iovance continues to advance Amtagvi's development program. The therapy could receive approval in Europe, the United Kingdom, and Canada within the current year. Additionally, the company is conducting late-stage clinical testing of Amtagvi for non-small cell lung cancer, potentially expanding its therapeutic applications.
The market response to these developments has been significant, with Iovance shares losing nearly two-thirds of their value over the past 12 months, reflecting investor concerns about the therapy's commercial trajectory and the broader challenges facing novel cell therapy launches.
