Iovance discloses FDA clinical hold on NSCLC TIL trial; BLA for lifileucel in melanoma under review

IOVANCE BIOTHERAPEUTICS, INC.

FDA placed clinical hold on IOV-LUN-202 trial (NSCLC) on Dec 22, 2023; new enrollment paused.
BLA for lifileucel in advanced melanoma under FDA review with final label discussions ongoing.
Presentation reports $428M cash as of 9/30/23 and 90%+ manufacturing success rate.
Proleukin acquisition closed May 18, 2023 for £167.7M upfront; completed.
Melanoma data: ORR 31.4% (pooled cohorts 2&4) with median DOR not reached at 36.5 months.

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