Iovance Biotherapeutics Highlights Business Achievements, Pipeline Milestones, and Third Quarter 2025 Results

Core Insights - Iovance Biotherapeutics reported a 13% increase in total product revenue to approximately $68 million for the third quarter of 2025, driven by strong demand for Amtagvi and operational efficiencies [1][3] - The gross margin improved to 43%, reflecting better execution and initial benefits from cost optimization efforts [1][3] - The clinical profile of Lifileucel in previously treated advanced non-small cell lung cancer (NSCLC) is considered best-in-class, with a median duration of response not reached after over 25 months of follow-up [1][9] Financial Performance - Total product revenue for Q3 2025 was approximately $68 million, with U.S. Amtagvi revenue at around $58 million and global Proleukin revenue at approximately $10 million [3] - Gross margin was reported at 43%, with cost of sales amounting to approximately $39 million [3] - Cash and cash equivalents, investments, and restricted cash totaled approximately $307 million as of September 30, 2025, expected to fund operations into Q2 2027 [3] Business Developments - The company is expanding its community treatment centers to enhance patient access and improve treatment outcomes [2][3] - More than 80 U.S. authorized treatment centers have been activated, providing access to approximately 95% of Amtagvi patients within a two-hour drive [3] - Health Canada granted the first Amtagvi approval outside the U.S. for patients with previously treated advanced melanoma, with potential approvals anticipated in the UK, Australia, and Switzerland in the coming years [3] Pipeline Progress - Lifileucel is undergoing clinical trials for various solid tumors, with significant milestones expected in 2026 [4][9] - The IOV-LUN-202 trial for Lifileucel in advanced nonsquamous NSCLC is expected to complete enrollment in 2026, supporting a supplemental Biologics License Application with a potential launch in 2027 [9] - Initial results from the IOV-END-201 trial for advanced endometrial cancer are on track for early 2026 [9]