IOVANCE BIOTHERAPEUTICS, INC.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) is a commercial-stage biopharmaceutical company pioneering tumor infiltrating lymphocyte (TIL) cell therapies for treating solid tumor cancers. The company's mission centers on becoming the global leader in innovating, developing, and delivering individualized TIL cell therapies that harness each patient's immune system to recognize and destroy cancer cells unique to their tumor.

The company operates through two primary commercial products. Amtagvi (lifileucel) represents the first FDA-approved one-time individualized T cell therapy for solid tumors, specifically indicated for treating adult patients with previously treated advanced melanoma. Amtagvi is administered as part of a treatment regimen that includes lymphodepletion and a short course of Proleukin. Proleukin (aldesleukin), an interleukin-2 product acquired from Clinigen in May 2023, serves multiple channels including use in the Amtagvi treatment regimen, manufacturing processes for cell therapies, and clinical research settings.

Iovance's development pipeline includes multiple registrational trials investigating lifileucel in frontline advanced melanoma combined with pembrolizumab, previously treated advanced non-small cell lung cancer, and soft tissue sarcomas including undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. The company is also advancing next-generation programs including IOV-3001, a modified interleukin-2 analog; IOV-4001, a genetically edited TIL therapy utilizing TALEN technology to inactivate PD-1; and IOV-5001, engineered to induce IL-12 expression.

Manufacturing operations center on the Iovance Cell Therapy Center (iCTC) in Philadelphia, Pennsylvania, the first FDA-approved facility for commercial TIL manufacturing. The company has transitioned all Amtagvi and lifileucel manufacturing to this internal facility, which has capacity to supply therapies for more than 5,000 patients annually. To date, more than 1,500 patients have received treatment with commercial and investigational TIL therapies manufactured using Iovance processes.

The company maintains a robust intellectual property portfolio comprising more than 330 granted or allowed U.S. and international patents and patent applications, with Amtagvi expected to maintain exclusivity into 2042. Iovance collaborates with the National Cancer Institute through a Cooperative Research and Development Agreement and maintains licensing agreements with Cellectis for gene-editing technology and Novartis for IOV-3001 development rights.