Financial RiskHigh cash burn and a limited cash runway create funding and dilution risk that could force equity raises or slow commercialization plans.
Scalability And OperationsExtended single-session monitoring requirements introduce uncertainty around clinic throughput and staffing, potentially increasing operating costs and limiting rapid scale-up.
Trial ConductDifficulty preserving blinding in PTSD studies, particularly among participants with prior psychedelic experience, could complicate trial integrity and regulatory assessment.