Pre-revenue With Widening LossesOperating without revenue and with accelerating net losses means capital is being consumed rather than compounded. Over the medium term this increases reliance on external funding, heightens dilution risk, and constrains optionality if clinical results or timelines slip.
Sustained Negative Operating Cash FlowConsistent negative operating and free cash flow requires recurring financing to sustain development. This structural cash burn limits runway sensitivity to trial timing and outcome, and pressures capital allocation decisions, potentially forcing dilution or reduced investment if milestones delay.
Commercial And Regulatory Execution RiskThe company's path to durable revenue depends on positive pivotal outcomes plus favorable FDA, coding and payer decisions. Even strong clinical data may face labeling, scheduling or reimbursement hurdles that could delay adoption, limit pricing power, or increase launch complexity.