High Cash Burn / Runway RiskSizable negative operating and free cash flows, coupled with cash running to Q4‑2027, create a persistent financing overhang. Continued burn forces reliance on capital markets or dilution to fund commercialization and trials, elevating long‑term funding and execution risk if revenue or cost improvements disappoint.
Persistent Large LossesVery large negative margins and returns reflect a cost structure far ahead of current revenues. Although margins are improving, sustained heavy losses constrain reinvestment flexibility, increase dilution risk, and delay company‑level profitability, making long‑term value creation dependent on successful scale and margin realization.
Manufacturing & Market Access Execution RiskPlanned capacity increases and third‑party manufacturing transfers are critical to meeting volume and cost targets. Unproven tech transfer and ongoing European access discussions create durable execution risk: failures or delays would impair unit economics, slow international revenue diversification, and keep commercial costs elevated.