Slide 1: COMP360 Phase 3 Program Topline Results COMP005 & COMP006
1 | © Compass Pathways COMP360 Phase 3 Program Topline Results COMP005 & COMP006 February 17, 2026
Slide 2: Cautionary Note Regarding Forward-Looking Statements
2 | © Compass Pathways Cautionary Note Regarding Forward-Looking Statements This presentation includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, you can identify forward-looking statements by terms such as “bel
Slide 3: Welcome
3 | © Compass Pathways Welcome Kabir Nath Chief Executive Officer Dr Guy Goodwin Chief Medical Officer Lori Englebert Chief Commercial Officer
Slide 4: Tremendous Unmet Need in Treatment Resistant Depression (TRD)
4 | © Compass Pathways Tremendous Unmet Need in Treatment Resistant Depression (TRD) >4M U.S. adults experiencing TRD each year1 Only 1 Medicine approved and used for TRD High Patient Burden vs. MDD • Chronic condition • Increased co-morbidities • 3x longer episodes2 • Greater worktime loss3 • >50%
Slide 5: Phase 3 Program Key Highlights
5 | © Compass Pathways Phase 3 Program Key Highlights • Two highly statistically significant positive Phase 3 trials of COMP360 in TRD at primary endpoint* at Week 6 - Over 1,000 participants across Phase 3 trials and Phase 2b trial - Both Phase 3 trials continuing to 52 weeks • Extremely rapid onse
Slide 6: Phase 3 Program Key Highlights (cont'd)
6 | © Compass Pathways Phase 3 Program Key Highlights (cont’d) • The emerging clinical profile of COMP360 is redefining rapidity and durability for TRD patients - No approved drug offers clinically meaningful efficacy with both rapid onset and sustained durability with a single treatment • The robus
Slide 7: Phase 3 Trial Design and Demographics
7 | © Compass Pathways Phase 3 Trial Design and Demographics
Slide 8: Phase 3 Program: Overview of Pivotal Trial Designs
8 | © Compass Pathways Phase 3 Program: Overview of Pivotal Trial Designs Pivotal trial 1 (COMP 005) single dose N=258 COMP360 25 mg N=171 Pivotal trial 2 (COMP 006) multiple dose N=581 COMP360 25 mg N=296 COMP360 1 mg N=143 COMP360 25 mg COMP360 1 mg COMP360 10 mg N=142 COMP360 10 mg Week 3 Week 6
Slide 9: COMP005 & COMP006 Participant Baseline Demographics
9 | © Compass Pathways Placebo (N=87) COMP360 25 mg (N=171) COMP005 47 (54.0)93 (54.4)Female, n (%) Race, n (%) 78 (89.7)149 (87.1)White 4 (4.6)11 (6.4)Asian 2 (2.3)6 (3.5)Black or African American 1 (1.1)0American Indian or Alaska Native 2 (2.3)5 (2.9)Other 45.3 (14.4)45.9 (13.4)Age, years, mean (S
Slide 10: COMP005 & COMP006 Participant Characteristics: Treatment History and Baseline MADRS
10 | © Compass Pathways MADRS = Montgomery-Åsberg Depression Rating Scale; n=number of observed participants; SD = standard deviation. Placebo (N=87) COMP360 25 mg (N=171) COMP005 Number of failed treatments in the current depressive episode, n (%) 1 (1.1)2 (1.2)1 63 (72.4)113 (66.1)2 18 (20.7)46 (2
Slide 11: COMP005 & COMP006 Participant Characteristics: Depression Diagnosis History
11 | © Compass Pathways n=number of observed participants; SD = standard deviation Placebo (N=87) COMP360 25 mg (N=171) COMP005 Length of current depressive episode 38.6 (33.0)34.6 (30.1)Mean Months (SD) 20 (23.0)30 (17.5)< 1 year 19 (21.8)52 (30.4)1-2 years 48 (55.2)89 (52.0)>2 years Number of life
Slide 12: COMP005 Efficacy Data
12 | © Compass Pathways COMP005 Efficacy Data
Slide 13: COMP005 - Primary Endpoint Achieved - Change in MADRS at Week 6
13 | © Compass Pathways COMP005 - Primary Endpoint Achieved – Change in MADRS at Week 6 CI = Confidence Interval; LSM = Least Squares Mean; MADRS = Montgomery–Åsberg Depression Rating Scale; SD=standard deviation. LS Mean Difference (95% CI) P-value Visit -4.7 (-7.0, -2.3), p<0.001 Day 2 -7.2 (-9.6,
Slide 14: COMP005 - Sustained Durability to Week 26
14 | © Compass Pathways COMP005 – Sustained Durability to Week 26 Source: Post Hoc (Include Number) Note: : CI = Confidence Interval; LSM = Least Squares Mean; MADRS = Montgomery–Åsberg Depression Rating Scale. • Consistent separation from placebo through randomized and blinded part B up to Week 26
Slide 15: COMP005 Response and Remission Durability
15 | © Compass Pathways Definitions (n at Week 6): Remitters (n=11) = MADRS ≤12 and no single item ≥4 Responders and Partial Responders (n=31) = % CFB in MADRS ≥ 25% and do not meet remission criterion Non-Responder (n=115) = % CFB in MADRS ≤ 25% Total n at 6 weeks = 157 (8% dropout) *Clinically mea
Slide 16: COMP006 Efficacy Data
16 | © Compass Pathways COMP006 Efficacy Data
Slide 17: COMP006 - Primary Endpoint Achieved - Change in MADRS at Week 6
17 | © Compass Pathways -14 -12 -10 -8 -6 -4 -2 0 COMP360 25 mg (N=296) COMP360 10 mg (N=142) COMP360 1 mg (N=143) 10mg vs 1 mg LS Mean Difference (95% CI) P-value 25mg vs 1 mg LS Mean Difference (95% CI) P-value Visit -3.0 (-5.0, -1.0) 0.002 -2.9 (-4.6, -1.2) <0.001 Day 2 -3.6 (-5.9, -1.2) 0.001 -5
Slide 18: COMP006 - Key Secondary Met - Change in MADRS at Week 9
18 | © Compass Pathways CI = Confidence Interval; LSM = Least Squares Mean; MADRS = Montgomery–Åsberg Depression Rating Scale. 10mg vs 1 mg LS Mean Difference (95% CI) P-value 25mg vs 1 mg LS Mean Difference (95% CI) P-value Visit -2.5 (-4.9, -0.2) 0.016 -3.8 (-5.8, -1.8) <0.001 Week 6 (Primary) -2.
Slide 19: COMP005 & COMP006 Primary Endpoint Comparison
19 | © Compass Pathways COMP005 & COMP006 Primary Endpoint Comparison* *Cross-trial comparisons should be interpreted with caution. Differences between these trials, including but not limited to study designs, protocols, timing of assessments, number or timing of doses and participant populations ca
Slide 20: Safety Data COMP005 and COMP006
20 | © Compass Pathways Safety Data COMP005 and COMP006
Slide 21: Safety Summary
21 | © Compass Pathways Safety Summary • COMP360 is generally well-tolerated, with a safe profile, with the majority of AEs resolving on day of treatment • Safety data is consistent with known safety profile of COMP360 – no new safety signals identified • For the data available to date across both t
Slide 22: Treatment-Emergent Adverse Events Overview
22 | © Compass Pathways N=number of participants in the treatment group in the Safety Analysis Set by administration; n = number of participants; TEAE = treatment emergent adverse event PlaceboCOMP360 25 mg COMP005 N=87N=171 n (%) n (%) 34 (39.1)120 (70.2)Any TEAE up to Week 6 1 (1.1)4 (2.3)Any Seri
Slide 23: Most Common Treatment-Emergent Adverse Events
23 | © Compass Pathways MedDRA = Medical Dictionary for Regulatory Activities; N=number of participants in the treatment group in the Safety Analysis Set by administration; n = number of participants. PlaceboCOMP360 25 mgCOMP005 (>5% Incidence) MedDRA TEAE Preferred Term N=87N=171 n (%) n (%) 12 (13
Slide 24: Treatment-Emergent Serious Adverse Events (SAEs) for Part A
24 | © Compass Pathways n = number of participants with TESAE; TESAE = treatment emergent serious adverse event COMP360 1 mg COMP360 10 mg COMP360 25 mg COMP006 N=143N=142N=296 n (%)n (%) n (%) 5 (3.5)1 (0.7)6 (2.0)Any SAE 2 (1.4)1 (0.7)0Suicidal ideation 1 (0.7)00Suicidal behaviour 1 (0.7)01 (0.3)S
Slide 25: COMP005 - Safety Data Through Week 26
25 | © Compass Pathways COMP005 – Safety Data Through Week 26 TEAEs MedDRA = Medical Dictionary for Regulatory Activities; N=number of participants in the treatment group in the Safety Analysis Set by administration; n = number of participants. Table shows TEAEs occurring in ≥ 5% in each treatment p
Slide 26: Commercial update
26 | © Compass Pathways Commercial update Lori Englebert, Chief Commercial Officer
Slide 27: Treatment-Resistant Depression (TRD) Affects Millions in the U.S.
27 | © Compass Pathways ~23M ~4M ~12M The definition of TRD adopted by the US Food and Drug Administration (FDA) is failure to respond to two or more antidepressant regimens despite adequate dose and duration and adherence to treatment3TRD 1.. https://www.nimh.nih.gov/health/statistics/major-depress
Slide 28: TRD has a significantly greater impact on individuals' lives compared to MDD
28 | © Compass Pathways 1. Wu B, et al. PLoS One. 2019;14(8):e0220763. 2. Amos TB, et al. J Clin Psychiatry. 2018;79(2):17m11725. 3. Gustafsson TT, et al. J Affect Disord. 2025;368:136-142. TRD has a significantly greater impact on individuals’ lives compared to MDD Patients with TRD have longer dep
Slide 29: TRD Disproportionately Impacts the Annual Economic Burden of MDD
29 | © Compass Pathways TRD Disproportionately Impacts the Annual Economic Burden of MDD ~$93B Annual Economic Burden of drug-treated MDD1 1. Zhdanava, M., et. al; The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States. The Journal of
Slide 30: Potentially Highly Differentiated COMP360 Clinical Profile for TRD
30 | © Compass Pathways Potentially Highly Differentiated and Compelling COMP360 Clinical Profile for TRD Patients and their Providers Traditional AntidepressantsSpravato®COMP3601 NoYes (FDA approved) Yes (Positive trials: 2 ph3 trials; 1 ph2b)Efficacy in TRD patient population2 Various: typically c
Slide 31: We are Planning To Be Launch Ready by the End of the Year
31 | © Compass Pathways Clinical care teams KOLs/HCPs Federal and State policy makers Patient advocacy organizations Payers DEA rescheduling (Federal & State) Product distribution Pricing & Reimbursement Formulary access Patient Support Commercial team build-out Product positioning Site of care trai
Slide 32: Summary
32 | © Compass Pathways Summary • The emerging clinical profile of COMP360 is redefining rapidity and durability for TRD patients • TRD is a chronic and extremely refractory condition with very few treatment options - No approved drug offers clinically meaningful efficacy with both rapid onset and s
Slide 33: Thank you… Q&A
33 | © Compass Pathways Thank you… Q&A For more information: Stephen Schultz SVP, Investor Relations stephen.schultz@compasspathways.com +1 401-290-7324
Slide 34: Appendix
34 | © Compass Pathways Appendix
Slide 35: COMP006 - Treatment-Emergent Adverse Events (TEAE) - Incidence >5%
35 | © Compass Pathways MedDRA = Medical Dictionary for Regulatory Activities; N=number of participants in the treatment group in the Safety Analysis Set by administration; n = number of participants. Note: COMP006 safety includes 2 dose administrations and goes out to 9 weeks vs. 1 administration o