Iovance Biotherapeutics (IOVA) investor relations material

Strategic pillars and commercial performance

• Focus on three pillars: U.S. commercial business with Amtagvi, a robust immuno-oncology pipeline, and operational excellence targeting profitability in 2026 and beyond.

• Amtagvi achieved strong commercial traction in 2025, with significant growth in community center adoption and improved manufacturing efficiency.

• Real-world evidence shows higher response rates, especially with earlier use, validating clinical trial results and encouraging earlier patient referrals.

• Deepening of response and durable outcomes from Amtagvi are driving enthusiasm and adoption among oncologists.

• Margin expansion is prioritized, with Q4 cost of sales margin reaching 50% due to manufacturing optimization and transition to in-house production.

Pipeline development and future opportunities

• Lead pipeline program in advanced non-small cell lung cancer aims for best-in-class durability, addressing a major unmet need with low current benchmarks.

• Registrational trial in lung cancer aligns with recent FDA approval models, leveraging existing ATC network and manufacturing infrastructure.

• Expansion into soft tissue sarcoma shows unprecedented early responses in highly refractory patients, with a single-arm registrational trial planned.

• Additional ISTs are underway in cutaneous squamous cell and Merkel cell carcinoma, with rapid pivot to investment if early signals are positive.

• Genetically modified TIL programs (IOV-4001, IOV-5001) are advancing, with IOV-5001 preclinical data to be presented at SITC Spring, aiming to broaden indications and improve safety.

International expansion and financial outlook

• Global opportunity for Amtagvi estimated at 30,000 patients, with approvals pending in the U.K. and Australia and reimbursement discussions ongoing.

• Ex-U.S. revenues expected to be an upside beyond 2026 due to longer approval and reimbursement timelines.

• Financial discipline and operational efficiencies are expected to drive profitability, with ongoing improvements in gross margin as in-house manufacturing scales.