Persistent Cash BurnOngoing negative operating and free cash flow indicates the business remains funding‑dependent. Continued cash burn constrains strategic flexibility, increases dilution or financing risk, and requires sustained capital access to support commercial expansion and multi‑year clinical programs.
Rising Leverage & Thin Equity CushionMaterial increase in leverage and compressed equity reduce financial resilience. Higher debt amplifies interest and refinancing risk, narrows the margin for operational setbacks, and makes the company more vulnerable to adverse reimbursement or uptake pacing changes over the medium term.
High Opex & Long Clinical TimelineElevated operating expense guidance relative to current revenue and a multi‑year pivotal trial mean substantial near‑term spending without immediate TAM expansion. This combination prolongs the time before scale benefits offset SG&A/R&D, pressuring margins and extending dependence on external funding.