Near-term Profitability And Execution RiskPlanned increases in research and selling expenses, combined with revenue guidance below expectations and the lag between site activation and patient starts, could pressure near-term profitability and operational performance.
Reimbursement RiskNet pricing is sensitive to hospital participation in the 340B program, which can substantially reduce reimbursement and pressure realized revenue per procedure.
Treatment Regimen LimitationsThe CHOPIN protocol's limited number of treatment cycles may constrain clinical efficacy unless clinicians adopt a higher-cycle approach, potentially limiting broader clinician uptake.