Compass Pathways Achieves Second Positive Phase 3 Trial for Psilocybin Depression Treatment

Compass Pathways plc (Nasdaq: CMPS) announced the successful achievement of the primary endpoint in the ongoing Phase 3 COMP006 trial, the second of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). Two fixed doses – administered 3 weeks apart – of COMP360 25 mg versus 1 mg demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.8 points in change at the primary endpoint.

The primary endpoint was the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the 25 mg and 1 mg groups at Week 6. Two highly statistically significant positive Phase 3 trials confirm highly differentiated profile for COMP360, demonstrating a level of clinical effect that has historically been extremely difficult to achieve in TRD.

COMP360 is the first classic psychedelic to consistently achieve a highly statistically significant result and clinically meaningful effect, with a generally well-tolerated and safe profile. Clinically meaningful reduction in MADRS (≥ 25%) was observed in a significant number of participants in the 25mg arm of both trials with 25% in COMP005 and 39% in COMP006.

Statistically significant rapid onset from the day following administration was maintained at all measured timepoints through Week 6 in both clinical trials in the 25 mg arm. In COMP005, participants who achieved a clinically meaningful reduction in MADRS at Week 6 with COMP360 25 mg maintained durability of effect at least through Week 26 after just one or two doses.

Across COMP005 and COMP006 to date, COMP360 is demonstrating a generally well-tolerated and safe profile, with treatment-emergent adverse events (TEAEs) being mild or moderate in severity, and the vast majority resolving within 24 hours. Retreatment with a second dose was well-tolerated, with a consistent safety profile.

In COMP005, the primary endpoint of Part A showed a single dose of COMP360 25 mg versus placebo with a mean treatment difference of -3.6 points, 95% CI [-5.7, -1.5]; p<0.001 at Week 6. For participants who had a clinically meaningful reduction in MADRS (≥ 25%), a statistically significant rapid onset from the day following administration was maintained at all measured timepoints through Week 6 in the 25 mg arm. Over 40% of those who achieved a clinically meaningful reduction in MADRS but had not remitted by 6 weeks went into remission after the second dose in Part B.

The Chair of the independent Data Safety Monitoring Board (DSMB) provided a statement: "Based on the latest review of this data for the 005 and 006 TRD studies, safety findings are consistent with previous studies of COMP360 and there are no new, unexpected or concerning safety findings. Safety findings are consistent with the known profile of the study drug (a classical psychedelic) and the treatment-resistant depression patient population. From this review of the data, there is no evidence of a clinically meaningful imbalance between treatment arms in suicidality in either study."

The 26-week data (Part B) from COMP006 is expected in early Q3 2026. Across three robust, well-designed and well-executed clinical trials involving more than 1,000 participants, the company has now demonstrated consistent, highly statistically significant results at the primary endpoint and a clinically meaningful effect.

Compass has submitted a request for a meeting with the U.S. Food and Drug Administration (FDA) to discuss a rolling submission and review and expects to complete an NDA submission in Q4. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

The company announced the pricing of its public offering of 17,500,000 American Depositary Shares ("ADSs") at a public offering price of $8.00 per ADS, each representing one ordinary share, and in lieu of ADSs, to certain institutional investors, pre-funded warrants to purchase up to 1,250,000 ADSs at a public offering price of $7.9999 per pre-funded warrant. In addition, Compass Pathways has granted the underwriters a 30-day option to purchase up to an additional 2,812,500 ADSs at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about February 20, 2026, subject to the satisfaction of customary closing conditions.

The gross proceeds to Compass Pathways from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be $150.0 million. Compass Pathways currently intends to use the net proceeds from this offering, together with its existing cash and cash equivalents, to fund ongoing COMP005 and COMP006 Phase 3 trials, its Phase 2b/3 trial of COMP360 in PTSD, acceleration of its commercial readiness activities, and for working capital and general corporate purposes.

Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Compass is headquartered in London, UK, with offices in New York in the US.