Execution And Regulatory DependencyAdvancement of additional indications requires completing enabling studies and securing regulatory alignment, introducing execution risk that could delay development timelines.
Financing And Cash RunwaySignificant cash burn and a limited cash runway create a material need for additional financing, which could dilute existing shareholders and increase share price volatility.
Market Expectation RiskIf pivotal data show only modest benefit relative to investor expectations, market reaction may be muted even if regulatory approval remains possible.