Compass Pathways is a clinical-stage biotech developing COMP360, a proprietary pharmaceutical-grade psilocybin formulation, for serious mental health conditions. The company has no approved products and generates no revenue. Its primary target indication is treatment-resistant depression (TRD) — depression that has not responded to at least two antidepressants — which Compass estimates affects roughly 4 million U.S. adults. COMP360 is administered in a single six-to-eight-hour supervised session in a clinical setting, with preparation and follow-up sessions around it. Compass has achieved positive primary endpoints in two Phase 3 pivotal trials in TRD and is targeting an NDA submission to the FDA in Q4 2026. The company holds FDA Breakthrough Therapy designation for COMP360 in TRD. Beyond TRD, Compass is initiating a Phase 2b/3 trial in PTSD following encouraging Phase 2 open-label data. If approved, COMP360 would require DEA rescheduling before commercialization, as psilocybin remains Schedule I. The commercial model resembles esketamine (Spravato) delivery — supervised sessions at clinic networks rather than a standard pharmacy prescription — and Compass is building delivery infrastructure by partnering with interventional psychiatry networks and hospital systems ahead of potential approval. Compass funds operations entirely through equity capital and plans to use its own U.S. sales force at launch.