Announcement • Sep 09

Compass Pathways Reports New 52-Week Topline Open-Label Data From Phase 3 COMP005 Trial Demonstrating Additional Benefit From Another COMP360 Dose In Part C Extending Durability Out To 1 Year

Compass Pathways plc announced the topline 52-week results (Part C) from its Phase 3 COMP005 trial of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD) which further support COMP360’s differentiated profile and potential for long lasting benefit. The open-label Part C data demonstrate four important findings: first, notable additional benefit was observed with an added reduction in MADRS score leading to an average 13-point reduction from baseline at Week 52 and extended out to 1 year for participants who were randomized to the 25 mg arm and received an additional dose in Part C; second, for participants in the Placebo arm who received their first dose of COMP360 25 mg in Part C, these findings further reinforce that a single dose of 25 mg has the potential to produce rapid onset, meaningful effect and durability; third, for all participants in Part C who received a 25 mg dose, strong response and remission rates were observed with 40%-45% responders and approximately 30% remitters across all timepoints in the 6 weeks post the Part C dose; and finally, the COMP360 safety profile in Part C is consistent with Parts A and B and continues to show a generally well-tolerated and safe profile with no new safety findings. The COMP005 trial was a randomized, double-blind, placebo-controlled study, that enrolled 258 participants in the United States assessing the safety and efficacy of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD. The trial was comprised of three parts: In Part A, blinded through Week 6, eligible participants were randomized (2:1) to receive a single dose of 25 mg of COMP360 or placebo; In Part B, blinded from Weeks 6 to 26, eligible participants could receive an additional dose of the same treatment to which they were originally randomized; In Part C, open-label from Week 26 to 52, eligible participants from both dosing arms could receive a single dose of 25 mg. Approximately 70% of the study participants continued beyond Week 26 and entered Part C: 25 mg Arm: Approximately 80% (n=90) who entered Part C received an additional open-label dose; this was their second or third dose depending on whether they received an additional dose in Part B; Placebo Arm: Approximately 90% (n=52) who entered Part C received an open-label 25 mg dose; this was their first dose of COMP360 25 mg given they received placebo in parts A and B. For participants who had originally been randomized to the 25 mg arm, and continued into Part C and received another dose: Notable additional benefit observed at all Part C timepoints through Week 52, with additional meaningful reduction in MADRS beyond what had been observed in Parts A and B, with an average 13-point reduction from baseline at Week 52. Given participants in 25 mg arm had one or two prior doses, these findings provide continued evidence that an additional dose of COMP360 25 mg may further deepen clinical response and extend its durability out to 1 year. For participants who had originally been randomized to the Placebo arm and continued into Part C, and were eligible to receive their first dose of COMP360 25 mg in this open-label portion of the trial: Data provides further evidence that a single dose of COMP360 25 mg has the potential to produce rapid onset, meaningful effect, and durability. Meaningful average reduction of 10 points from baseline in MADRS at end of Part C from one dose. For all participants who received a 25 mg COMP360 dose in open-label Part C, whether they originally were in the Placebo arm and this was their first dose, or they were originally in the 25 mg arm and this was their second or third dose: 40%-45% response rates (Responder: =50% decrease in total score from baseline) were observed between Day 1 and Week 6 following COMP360 25 mg Part C treatment. Approximately 30% remission rates (Remitter: =12 MADRS total score and no single item =4) were observed between Day 1 and Week 6 following COMP360 25 mg Part C treatment. COMP360 safety profile in Part C is consistent with Parts A and B. COMP360 continues to demonstrate a generally well-tolerated and safe profile, with no new safety signals observed. The COMP360 program aims to evaluate the safety and efficacy of COMP360 psilocybin, a synthetic, proprietary formulation of psilocybin under investigation for difficult-to-treat mental health conditions. There are two pivotal Phase 3 trials, COMP005 and COMP006, evaluating the efficacy of COMP360 for treatment-resistant depression (TRD). The ongoing COMP006 trial, is a randomized, double-blind study with 581 dosed participants across North America and Europe and is comparing the efficacy and safety of two fixed doses, taken three weeks apart, of 25 mg COMP360 to 10 mg COMP360 and 1 mg COMP360 (25 mg: n=296; 10 mg: n=142; 1 mg: n=143). There is a potential for a total of 4 doses of COMP360 across a 52-week period. The trial is comprised of three parts: Part A, which was blinded through 9 weeks, Part B which recently concluded and remained blinded through week 26, and Part C, which contains an open-label treatment part from week 26 to 52. The COMP005 trial was a randomized, double-blind, placebo-controlled study, which enrolled 258 participants across the United States assessing the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD (COMP360 25 mg: n=171; placebo: n=87). There was a potential for a total of 3 doses of COMP360 across a 52-week period. The trial was comprised of three parts: Part A, which was blinded through 6 weeks; Part B, which was blinded through week 26; and Part C, which had an open-label treatment part from week 26 to 52.

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