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Iovance Biotherapeutics (IOVA) investor relations material
Iovance Biotherapeutics Corporate presentation summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Strategic positioning and product portfolio
Leading innovator in tumor infiltrating lymphocyte (TIL) therapy for solid tumors, with two approved products: Amtagvi (lifileucel) and Proleukin (aldesleukin).
Amtagvi is the first FDA-approved one-time, individualized T cell therapy for solid tumor cancer, targeting advanced melanoma and expanding into new indications and geographies.
Over 1,000 patients have been treated with commercial and clinical TIL products, with a network of more than 85 treatment centers as of December 2025.
Broad market access with payer coverage for over 250 million patient lives and rapid financial clearance for most patients.
Modular manufacturing facility in Philadelphia supports up to 5,000 patients per year, ensuring global supply and logistics.
Clinical performance and pipeline development
Amtagvi demonstrates deep and durable responses in advanced melanoma, with a 31.4% ORR and median duration of response of 36.5 months at five-year follow-up.
Real-world data show a ~50% response rate, with higher efficacy in patients treated earlier in their disease course.
Ongoing label expansion includes frontline advanced melanoma (lifileucel + pembrolizumab), advanced NSCLC, and endometrial cancer, with multiple phase 2 and 3 trials underway.
Next-generation TIL therapies in development include PD-1 inactivated TIL (IOV-4001), IL-2 analog (IOV-3001), and IL-12 tethered TIL (IOV-5001), targeting improved efficacy and safety.
TILVANCE-301, a global phase 3 trial, is enrolling for frontline melanoma, while IOV-LUN-202 targets post-anti-PD-1 NSCLC with promising interim results.
Market opportunity and financial outlook
Solid tumors represent 91% of all cancer cases, with significant unmet needs in melanoma, NSCLC, and endometrial cancer.
The global NSCLC commercial opportunity is estimated at seven times the current melanoma market.
FY25 revenue guidance is $250M–$300M, with $307M in cash as of September 30, 2025, and a gross margin of 43% in Q3 2025.
Cash runway is projected into Q2 2027, supported by anticipated revenue growth, margin improvement, and cost control from strategic restructuring.
Organization streamlined to support improved margins, leveraging economies of scale in manufacturing and a global commercial infrastructure.
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