Approval Timeline UncertaintyApproval timelines remain uncertain with synthetic control and P2b data potentially supporting accelerated approval in 2025 and full approval in 2026.
Cash ReservesThe company has $1.8M in cash and a $15M equity line, which may limit its financial flexibility despite providing runway into the first half of 2026.
Market CompetitionRecurrent osteosarcoma, the initial indication, poses a $1.5B+ market opportunity but faces no standard of care, which may complicate market penetration efforts.