Corporate presentation
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Iovance Biotherapeutics (IOVA) Corporate presentation summary

Event summary combining transcript, slides, and related documents.

Logotype for Iovance Biotherapeutics Inc

Corporate presentation summary

29 Oct, 2026

Commercial and financial outlook

  • Amtagvi is the first and only approved treatment for 2L+ advanced melanoma; commercial markets include the U.S., Canada and Australia, while Proleukin is marketed globally.

  • ~2,000 patients treated with commercial and clinical TIL products; ~100 authorized treatment centers, with >95% of addressable patients within 200 miles and >250M covered lives.

  • FY26 revenue guidance is $410M–$420M; midpoint rose $55M, or ~15%, from prior guidance. 2Q26 revenue was ~$99M, >10% above guidance and up ~66% YoY.

  • 2Q26 gross margin was 56% of cost of sales, excluding D&A; cash was ~$304M as of June 30, 2026, with runway into 2H28.

Clinical evidence and registrational programs

  • At 5-year follow-up in pooled, heavily pretreated melanoma patients, lifileucel showed 31.4% ORR, 36.5-month mDOR and 19.7% 5-year OS; median follow-up was 57.8 months.

  • Real-world melanoma data showed 44% ORR and 73% DCR; ORR was 52% with ≤2 prior lines versus 33% with ≥3 prior lines.

  • Frontline melanoma lifileucel plus pembrolizumab data showed 65.2% ORR, 30.4% CR and 64.7% PFS at 6 and 12 months; median PFS and DOR were not reached at 21.7-month median follow-up.

  • Phase 3 TILVANCE-301 is testing lifileucel plus pembrolizumab versus pembrolizumab alone in 670 patients; dual primary endpoints are ORR and PFS, with enrollment on track.

  • In post-treatment nonsquamous mNSCLC, interim lifileucel data showed 25.6% ORR and mDOR not reached at 25.4-month median follow-up; the program has FDA Fast Track Designation.

Platform and pipeline expansion

  • Centralized Philadelphia manufacturing uses a scaled, FDA-approved commercial TIL process; turnaround is ~31 days and annual capacity exceeds 5,000 patients.

  • Phase 2 SARATOGA began in 2Q26 for advanced UPS and DDLPS; earlier evaluable data showed 50% ORR, and the registrational study targets patients with 1–3 prior systemic treatments.

  • In endometrial cancer, the first five evaluable patients had 40% confirmed ORR and 100% DCR; all had pMMR disease and prior chemotherapy and checkpoint inhibitor therapy.

  • Next-generation programs include PD-1-inactivated TIL IOV-4001, IL-2 supportive therapy IOV-3001 and IL-12-tethered TIL IOV-5001, with clinical studies across solid tumors.

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