Persistent Negative Cash FlowSustained large negative operating and free cash flow implies ongoing cash burn and dependence on external financing. Over the medium term this increases dilution risk and constrains discretionary commercial investments unless revenue ramps materially after approval.
Pre‑revenue With Large Operating LossesBeing pre-revenue with persistently large operating losses means margins and profitability are theoretical until product commercialization. This structural loss profile requires sustained capital and elevates execution risk around achieving profitable scale once market access and reimbursement are secured.
Reimbursement And REMS UncertaintyCategory III CPT status, pending RUC valuation, REMS specifics and DEA sequencing create prolonged reimbursement and access uncertainty. These structural payer and operational unknowns can suppress uptake, complicate revenue forecasting and extend the time to realize the product's market potential.