Compass Pathways believes it is significantly ahead of competitors and could be the first company to market with an FDA-approved psilocybin therapy.

Treatment-resistant depression affects approximately 4 million people in the United States.

Compass Pathways is confident it can secure insurance coverage for COMP360 from both commercial and government payers after receiving FDA approval.

In a second late-stage study by Compass Pathways, 40% of patients experienced a meaningful reduction in depression symptoms.

Compass Pathways is also studying its synthetic psilocybin, COMP360, for the treatment of Post-Traumatic Stress Disorder (PTSD).

Compass Pathways is developing a synthetic, proprietary form of psilocybin, named COMP360, for the treatment of treatment-resistant depression (TRD).

Compass Pathways plans to potentially complete its regulatory submission to the FDA for COMP360 later this year.

Kabir Nath is confident that Compass Pathways will have a more successful regulatory outcome with the FDA than Lycos Therapeutics due to superior data and trial design.

Compass Pathways' clinical data indicates that the therapeutic effects from one or two administrations of its psilocybin treatment can last for up to six months.

Compass Pathways' clinical trial protocol provides its psilocybin medicine with psychological support, but does not include formal psychotherapy as part of the treatment.

A recent executive order is intended to accelerate the DEA's process for reclassifying certain psychedelic medicines following potential FDA approval.

The two late-stage clinical studies for COMP360 by Compass Pathways included a total of over 800 patients.

In one of Compass Pathways' late-stage studies, 25% of patients experienced a meaningful reduction in depression symptoms from a single administration of COMP360.