Financial PerformanceManagement is making early progress extending the cash runway with ~$850MM currently in hand, but there is potential for ~$400MM in annual burn, which is well above management targets.
Market RisksThere are numerous concerns about the outlook, including assay performance, health economics, regulatory clarity, reimbursement pathway, competitive disruption, cash burn, and the business model.
Regulatory ChallengesBroad reimbursement and adoption hinge on the NHS-Galleri readout and subsequent FDA approval, which are several years away.