Pre-revenue With Large Cash BurnThe company remains pre-revenue with deep, persistent negative operating and free cash flow, implying ongoing dependence on external financing. Sustained cash burn elevates dilution and funding risk, and constrains flexibility if commercial or regulatory timelines slip before revenue generation.
Reimbursement/CPT Valuation UncertaintyCategory III CPT status provides only provisional billing; progression to Category I and assignment of durable RVUs is a slow committee-driven process. Delays or low RVU outcomes would weaken provider economics, limit site adoption and constrain revenue even after regulatory approval.
Regulatory & Operational Timing RisksThe final 26-week dataset is required to complete the filing and key procedural questions (AdCom, DEA rescheduling sequencing, REMS specifics) remain open. These structural timing and operational uncertainties can delay launch, complicate training/REMS rollout, and increase execution risk for commercial uptake.