Business Description

NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY General Organization and Business Iovance Biotherapeutics, Inc. (the “Company”) is a commercial-stage biopharmaceutical company pioneering a transformational approach to treating cancer. The Company’s mission is to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (“TIL”) cell therapies for patients with solid tumor cancers. TIL cell therapies harness the individual immune system’s ability to recognize and destroy cancer cells that are unique to each patient. These individualized therapies are manufactured using centralized, scalable, and proprietary manufacturing processes which rejuvenate and multiply each patient’s polyclonal T cells into the billions. The Company was founded to build upon the promise of TIL cell therapy initially developed at academic research centers, including the National Cancer Institute (“NCI”). The Company’s multi-center trials, scalable manufacturing, regulatory approvals, and commercial infrastructure have transformed TIL cell therapy from a research product available to only a small number of patients, into a commercially viable treatment that is accessible for thousands of cancer patients. The Company’s two commercial products include Amtagvi ® (lifileucel), and Proleukin ® (aldesleukin), an interleukin-2 (“IL-2”) product used in the Amtagvi ® treatment regimen and in other applications. Amtagvi ® is the first one-time, individualized T cell therapy for a solid tumor cancer and for the treatment of adult patients with previously treated advanced, or unresectable or metastatic melanoma. Amtagvi ® is administered as part of a treatment regimen that includes lymphodepletion and a short course of Proleukin ® . Globally, Amtagvi ® has the potential to address tens of thousands of previously treated advanced melanoma patients annually. Amtagvi ® is approved in the U.S. and Canada, and the Company plans to launch Amtagvi ® into additional markets with a high prevalence of advanced melanoma. Potential approvals are pending in the United Kingdom (“UK”) and Australia in the first half of 2026, and Switzerland in 2027. In the European Union (“EU”), the Company withdrew its initial marketing authorization application (“MAA”) in July 2025. The Company is working with the European Medicines Agency (“EMA”) to resubmit a centralized MAA in 2026. The Company’s development pipeline consists of TIL cell therapies and next generation approaches in additional solid tumor cancers, including one-time TIL monotherapies for previously treated patients and TIL cell therapy combined with standard of care in earlier treatment settings. The Company is conducting two ongoing registrational trials in frontline advanced melanoma and previously treated advanced non-small cell lung cancer (“NSCLC”). The Company plans to commence a registrational trial in previously treated advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma in the second quarter of 2026 and engage with the Food and Drug Administration on a path to expedited approval. Liquidity As of December 31, 2025, the Company had $303.0 million in cash, cash equivalents, short-term investments, and restricted cash ($163.1 million of cash and cash equivalents, $133.9 million in short-term investments, and $6.0 million in restricted cash). The Company has launched its first internally developed commercial product and continues to be engaged in the development of therapeutics to fight cancer, specifically solid tumors. With the approval of the Biologics License Application (“BLA”), the Company began to generate revenue from the sale of its product Amtagvi ® in the second quarter of 2024. Furthermore, following the acquisition of the worldwide rights to Proleukin ® (as discussed below in Note 4 - Proleukin ® Acquisition) in the second quarter of 2023, the Company began to generate revenue from the sales of Proleukin ® . However, such revenues for Amtagvi ® and Proleukin ® may not be material enough to generate positive operational cash flows during the 12 months from the date the consolidated financial statements are issued, and this Form 10-K is filed.…