Clinical And Competitive RiskNegative clinical results, development delays, or stronger competing checkpoint inhibitors could significantly diminish expected commercial prospects and investor confidence.
Financing And Dilution RiskPlanned financings and reliance on at‑the‑market offerings may increase dilution risk and put downward pressure on the stock despite providing near‑term capital for execution.
Regulatory UncertaintyOrphan Drug Designation that does not match the Phase 3 trial indication introduces ambiguity around regulatory strategy and could limit the practical benefit of the designation.