Slide 1: COMP360 psilocybin therapy for treatment-resistant depression: Phase IIb topline data
~COMP360 psilocybin therapy | for treatment-resistant depression Phase IIb topline data 09 November 2021 ©) COMPASS Navigating Mental Health Pathways aes a
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by COMPASS Pathways ple (“we,” “us,” “our,” “Compass” “a “Company’) and is made for informational purposes only and does not Snselihe ) offer to sell solicitation of an offer to buy securities, nor shall there be any sale of any securities in any state
Slide 3: Our COMP360 psilocybin therapy
Our COMP360 psilocybin therapy COMP360 Investigational synthetic, high-purity, polymorphic crystalline formulation of psilocybin | Oral capsules | Designated Breakthrough Therapy for TRD (in 2018) Psychological support | COMP360 is combined with psychological support from specially trained therapist
Slide 4: COMP study design and endpoints
COMP 001 study design and endpoints : D1: COMP360 : ‘Screening D-1: Baseline psilocybin : : Week 12 (v1) (v2) administration (v4) (V5) (v6) (v7) : + | (EOs*, vio) (v3) : : + ° ° ° ° ° ° ° 41mg COMP360 10mg COMP360 25mg COMP360 Primary endpoint (to determine appropriate phase III dose) Reduction of s
Slide 5: Participant disposition and demographics
Participant disposition and demographics Randomised (n=233) | | [ comesso 25mg 79) [ compsso 10mg (n-75) [ COMP360 1mg (n=79) | Follow-up Completed (n=74) Completed (n=66) Completed (n=69) Discontinued (n=5) Discontinued (n=9) Discontinued (n=10) + Withdrawal by participant (n=2) + Withdrawal by par
Slide 6: LS mean change from baseline in MADRS total score
LS mean change from baseline in MADRS total score Primary endpoint - change from baseline in MADRS total score Statistically significant primary endpoint (p<0.001) at week 3 (25mg vs 1mg). There was a rapid onset of action and durable effects with treatment differences between the 25mg vs 1mg group
Slide 7: % responders
% responders Key secondary endpoint - MADRS responders 25mg group demonstrated rapid response, with treatment differences from day 2 to week 3 compared with the 1mg group 60 | Responder: 250% decrease in MADRS total score from baseline ] 50 36.7% a0 (29/79) 32.9% (26/79) 30 20 0) Day 2 Week 1 Week 3
Slide 8: % remitters
% remitters Key secondary endpoint - MADRS remitters 25mg group demonstrated rapid remission, with treatment differences from day 2 to week 3 compared with the 1mg group [ Remitter: MADRS total score < 10 35 29.1% 30 (23/79) 26.6% (21/79) 25 20 15 ; ; 0 Day 2 Week 1 Week 3 Week 6 Week 9 Week 12 mCOM
Slide 9: MADRS sustained responders at week 12
MADRS sustained responders at week 12 Higher proportion of ained responders found in the 25mg vs 1mg arm 30 24.1% 19/79 A 25 ( ) Sustained responder* - patients meeting the MADRS response criteria at week 3 and at week 12, and at least at one visit out of ie 20 week 6 and week 9, and who did not sta
Slide 10: Safety - treatment emergent adverse events (TEAEs) overview
Safety - treatment emergent adverse events (TEAEs) overview The vast majority of TEAEs (over 90%) were of mild or moderate severity The proportion of patients reporting a serious TEAE was comparable between the 25mg and 10mg groups: - 5 (6.3%) patients in the 25mg COMP360 arm - 6(8.0%) patients in t
Slide 11: Most frequent TEAEs ordered by the 25mg arm
Most frequent TEAEs ordered by the 25mg arm (at least 5% in any treatment group) TEAE incidence is higher in the 25mg group overall COMP360 compP360 COMP360 Overall 25mg 10mg n(%) Headache 27 (34.2) 16 (21.3) 0 (25. (27.0) Nausea 18 (22.8) 7(9.3) 4(5.1) 29 (12.4) Key mood-related Fatigue 12 (15.2) 5
Slide 12: Treatment emergent serious adverse events (TESAEs) ordered by 25mg arm
Treatment emergent serious adverse events (TESAEs) ordered by 25mg arm COMP360 COMP360 COMP360 Overall 25mg 10mg 1mg 19 TESAEs were reported in total, MedDRA preferred term Nee ge Bead by 12 Number of patients per category (% patients Patients with a TESAE 5 (6.3) 6 (8.0) 4 (1.3) 42 (5.2) (note: two
Slide 13: Largest, randomised, controlled double-blind psilocybin therapy trial
Largest, randomised, controlled double-blind psilocybin therapy trial shows rapid and sustained response for COMP360 psilocybin therapy Largest, randomised, controlled, double-blind psilocybin therapy study ever completed shows rapid and sustained response for patients receiving a single 25mg dose o
Slide 14: COMP360 psilocybin therapy development moving forward
COMP360 psilocybin therapy development moving forward Complete final analysis of all data and endpoints to further inform path forward Hold an end-of-phase II meeting with FDA to discuss topline data and continue discussions around development path and phase Ill design - Meeting anticipated Q1 2022
Slide 15: Thank you
Thank you for your time Any questions? : ©) COMPA SS Pathways