May 13th, 2026

COMP360 produced positive data from two pivotal Phase III trials (005 and 006) with the program enrolling over 1,000 patients across late-stage studies and over 800 participants from the two pivotal Phase III trials. Trials were blinded for an unprecedented 26 weeks for psychiatry, supporting claims of clinically meaningful, rapid onset and extended durability. Reported response metrics included ~25% clinically meaningful response from a single administration (005) and ~40% with the addition of a second fixed dose (006). Safety, preclinical toxicology and CMC data cited as comprehensive and supportive for NDA.

COMPASS is aligned with the FDA on a rolling NDA submission and has begun submitting modules. The company was awarded a Commissioner's National Priority Voucher (CNPV), which management says could enable an ultra-accelerated review timeline (target ~1–2 months after final NDA submission) and is actively engaging with FDA/DEA to explore acceleration opportunities.

Company is ramping commercial organization rapidly: leadership hires include executives who have launched >50 products. The commercial team has already expanded (team has doubled in recent months) and is engaging sites and building field infrastructure in anticipation of launch readiness by year-end.

COMPASS secured psychedelic-specific CPT Category III codes designed to be billable by the hour for monitoring time, improving the reimbursement framework for multi-hour psychedelic treatments. Management reports nearly 90% of the U.S. population live in states that intend to reschedule COMP360 within ~30 days of federal rescheduling, meaning state-level access barriers are materially reduced if federal rescheduling follows approval. Buy-and-bill penetration for analogous treatments is estimated at ~35–45% and expected to increase over time.

Successful financing and warrant exercises in Q1 bolstered the balance sheet; management states cash runway extends well beyond launch and into 2028, supporting commercialization activities.

COMPASS is advancing a late-stage PTSD program (single Phase III/registration-focused trial planned) and is actively supporting VA studies and engagement. PTSD addressable population cited as ~13 million U.S. adults and the company expects VA participation and rollout planning to be a priority.

Management cites ~4 million treatment-resistant depression (TRD) patients in the U.S. and positions COMP360 as a potential blockbuster. Spravato is noted as expected to reach $3B by 2027 but treated <2% of TRD patients as of 2025, indicating a large unmet access opportunity. TRD patients have substantially higher economic burden: ~62% more mental health care costs and ~41% higher work-related costs versus MDD patients.

Management emphasizes COMP360's differentiated combination of rapid onset and durability not offered by current TRD options, and describes a generally safe and well-tolerated profile across trials — a commercial and clinical differentiator for both TRD and PTSD.