Iovance Biotherapeutics (IOVA) investor relations material

Product portfolio and approvals

• Two approved products: Amtagvi (lifileucel) for advanced post-PD-1 melanoma and Proleukin, an IL-2 analog used in the treatment regimen.

• Amtagvi is the first FDA-approved T-cell therapy for solid tumors, with recent approvals in the U.S. and Canada.

• Planning for further approvals in the EU, UK, Australia, and Switzerland.

Clinical development and pipeline

• Expanding Amtagvi to new indications, notably non-small cell lung cancer (NSCLC) and endometrial cancer, with pivotal studies ongoing.

• Advancing to earlier lines of therapy, including frontline melanoma in combination with pembrolizumab (TIL1301 trial).

• Developing next-generation TIL therapies, such as PD-1 inactivated TIL and IL-12 tethered TIL, with clinical and preclinical progress expected this year.

Market opportunity and patient access

• U.S. market potential for Amtagvi exceeds $1 billion, with significant unmet need in melanoma, NSCLC, and endometrial cancer.

• Initial U.S. melanoma target population is about 8,000 patients annually, with global expansion targeting up to 70,000 patients.

• Over 250 million patient lives covered by insurance; more than 75% of patients have private insurance.

• 80 authorized treatment centers in the U.S., with most patients living within 200 miles of a center.