COMPASS Pathways(US:CMPS)2025-11-04 14:30COMP360 Clinical Development - The company is accelerating commercialization launch readiness plans by 9-12 months[5] - COMP360 psilocybin treatment has the potential to deliver rapid, durable, and meaningful improvements[5] - Phase 2b results demonstrated significant, rapid, and durable antidepressant effects[5] - Phase 3 COMP005 trial achieved its primary endpoint with high statistical significance, showing a clinically-meaningful mean treatment difference of -3.6 points on the MADRS scale (p<0.001)[16, 20] - Long-term data from COMP004 shows average efficacy of a single dose of 25mg COMP360 at 92 days[28] Market and Financial Position - Approximately 3 million U S patients suffer from Treatment-Resistant Depression (TRD), representing a large unmet need in psychiatry[5] - An estimated 13 million adults in the U S are affected by PTSD each year, with limited effective treatment options[5] - The company had $185.9 million in cash as of September 30, 2025, providing sufficient runway into 2027[5] Commercialization Strategy - The company's early commercial planning efforts are focused on ensuring appropriate TRD patients can access COMP360, if approved[32] - Potential launch of COMP360 will leverage a well-established infrastructure of interventional psychiatry treatment centers, including approximately 6,000 Spravato treatment centers in the U S[33] TRD Market - Approximately 21 million U S adults experience major depression each year[7] - Approximately 9 million MDD patients have failed by ≥2 antidepressants and are considered TRD[7] - Spravato® (J&J) is guided to become a $3 - $3.5B product by 2028, many TRD patients remain unresponsive or intolerant to current therapies[5]