Iovance Biotherapeutics, Inc.
Health Care · Biotechnology
Structural: first-in-class commercial TIL therapy in solid tumors, addressing post-checkpoint melanoma (~20k US patients/yr) with deep, durable responses no other modality delivers. Autologous one-time treatment, ~$515k list price. iCTC manufacturing facility in Philadelphia (Navy Yard) is the throughput chokepoint - revenue scales with slot count, not demand.
(1) Amtagvi ramp accelerating - authorized treatment centers (ATCs) expanding from launch cohort toward 70+; (2) NSCLC + cervical + frontline melanoma combos extend TAM 5-10x if Ph2/3 read out; (3) cash runway extended via Feb 2026 raise; (4) Proleukin acquisition gives captive IL-2 supply, removes cost-of-goods risk; (5) only scaled TIL manufacturer - moat is regulatory + operational, not IP.
(1) launch slower than buyside hoped - ATC onboarding + lymphodepletion logistics gate uptake; (2) 22-day vein-to-vein turnaround + ICU-grade infrastructure caps real-world adoption; (3) cash burn ~$400m/yr against capacity build; (4) competitive pressure from next-gen TIL ($ADAP, Achilles) and bispecifics in melanoma 2L; (5) reimbursement friction at smaller ATCs; (6) micro-cap cell-therapy beta - funding-window risk if rate regime tightens.
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