Negative Operating Cash Flow / Cash BurnPersistent negative operating and free cash flow means the company consumes significant cash to run and grow, requiring continued financing until profitable. Even with improved burn versus 2024, sustained negative cash generation elevates dilution and execution risk over the next 2–6 months.
Large Ongoing Net LossesSubstantial recurring losses demonstrate the business is not yet profitable and dependent on successful product expansion or trial outcomes to shift the P&L. Continued negative earnings impair retained capital and increase the probability of future equity or debt raises.
Regulatory & Trial Outcome UncertaintyMaterial near‑term value hinges on DECLARATION and related regulatory decisions; trial event rates and FDA interpretation can alter approval timing, label scope and market access. This conditionality creates structural binary risk to the commercial roadmap and long‑term revenue trajectory.