earnings
confidence high
sentiment positive
materiality 0.75
Iovance reports Q3 net loss of $113.8M; BLA for lifileucel on track with PDUFA Feb 24, 2024
IOVANCE BIOTHERAPEUTICS, INC.
2023-Q3 EPS reported
-$1.44
revenue$707,000
- Net loss of $113.8M ($0.46/share) vs $99.6M ($0.63/share) in Q3 2022; revenue of $0.5M from Proleukin acquisition.
- FDA Priority Review of lifileucel BLA on track; PDUFA date Feb 24, 2024; pre-approval inspections completed.
- Onboarding completed at ~30 ATCs for potential U.S. commercial launch of lifileucel as first approved TIL therapy.
- Cash position of $427.8M at Sept 30, 2023; raised ~$203.2M in Q3 from offerings; cash expected to fund operations into 2025.
- Regulatory submissions for lifileucel in Europe and Canada planned for 2024; IOV-LUN-202 NSCLC trial enrollment on track for completion H2 2024.