Slide 1: COMP360 Phase 3 Program Topline Results COMP005 & COMP006
CONFIDENTIAL COMP360 Phase 3 Program Topline Results COMP005 & COMP006 February 17, 2026 1 | © Compass Pathways
Slide 2: Disclaimer
Disclaimer 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 “believe,” “cont
Slide 3: Welcome
Welcome Kabir Nath Chief Executive Officer Dr Guy Goodwin Chief Medical Officer Lori Englebert Chief Commercial Officer 3 | © Compass Pathways
Slide 4: Tremendous Unmet Need in Treatment Resistant Depression (TRD)
Tremendous Unmet Need in Treatment Resistant Depression (TRD) Only 1 High Patient Burden vs. MDD >4M • Chronic condition • Increased co-morbidities • 3x longer episodes2 • Greater worktime loss3 • >50% increased risk of suicide4 U.S. adults experiencing Medicine approved • Poorer quality of life TRD
Slide 5: Phase 3 Program Key Highlights
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 onset with statistical sign
Slide 6: Phase 3 Program Key Highlights (cont'd)
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 robust benefit/risk profile
Slide 7: Phase 3 Trial Design and Demographics
Phase 3 Trial Design and Demographics 7 | © Compass Pathways
Slide 8: Phase 3 Program: Overview of Pivotal Trial Designs
Phase 3 Program: Overview of Pivotal Trial Designs Part A (blinded) 6 weeks Part B (blinded) 20 weeks Part C (open label) 26 weeks Week 6 COMP360 Primary Pivotal trial 1 25 mg endpoint option for COMP360 25mg treatment N=171 (COMP 005) achieved1 retreatment* based on (one dose only after relapse or
Slide 9: COMP005 & COMP006 – Participant Baseline Demographics In Line with Known TRD Epidemiology
COMP005 & COMP006 – Participant Baseline Demographics In Line with Known TRD Epidemiology COMP005 COMP360 Placebo COMP006 COMP360 COMP360 COMP360 1 25 mg 25 mg 10 mg (N=87) mg (N=143) (N=171) (N=296) (N=142) Female, n (%) 160 (54.1) 68 (47.9) 69 (48.3) Female, n (%) 93 (54.4) 47 (54.0) Race, n (%) R
Slide 10: COMP005 & COMP006 – Participant Characteristics: Treatment History and Baseline MADRS
COMP005 & COMP006 – Participant Characteristics Treatment History and Baseline MADRS COMP005 COMP360 COMP006 COMP360 COMP360 COMP360 Placebo 25 mg (N=87) 25 mg 10 mg 1 mg (N=171) (N=296) (N=142) (N=143) Number of failed treatments in the current Number of failed treatments in current depressive epis
Slide 11: COMP005 & COMP006 – Participant Characteristics: Depression Diagnosis History
COMP005 & COMP006 – Participant Characteristics Depression Diagnosis History COMP005 COMP360 Placebo COMP006 COMP360 COMP360 COMP360 25 mg 25 mg 10 mg 1 mg (N=87) (N=171) (N=296) (N=142) (N=143) Length of current depressive episode Length of current depressive episode Mean Months (SD) 34.6 (30.1) 38
Slide 12: COMP005 Efficacy Data
COMP005 Efficacy Data 12 | © Compass Pathways
Slide 13: COMP005 - Primary Endpoint Achieved – Change in MADRS at Week 6
COMP005 - Primary Endpoint Achieved – Change in MADRS at Week 6 • Highly statistically significant difference of -3.6 MADRS between 25mg vs placebo at Week 6 (p<0.001) • Statistical significance at all timepoints beginning the day after administration (Day 2) demonstrates rapid onset of action Basel
Slide 14: COMP005 – Sustained Durability to Week 26
COMP005 – Sustained Durability to Week 26 • Consistent separation from placebo through randomized and blinded part B up to Week 26 • Option for 2nd administration* of COMP360 after Week 6 during blinded long-term follow-up (Part B) • 70% of patients in 25mg arm and 53% in placebo arm received a 2nd
Slide 15: COMP005 – Durability Through Week 26 by Response Status
COMP005 – Durability Through Week 26 by Response Status • 25% of participants in 25mg arm achieved clinically meaningful reduction in MADRS * at Week 6 and maintained response at least through Week 26 • Magnitude of MADRS improvement among responders demonstrates consistent, durable and clinically m
Slide 16: COMP006 Efficacy Data
COMP006 Efficacy Data 16 | © Compass Pathways
Slide 17: COMP006 – Primary Endpoint Met – Change in MADRS at Week 6 from Baseline
COMP006 – Primary Endpoint Met – Change in MADRS at Week 6 • Statistically significant difference of -3.8 MADRS between 25mg vs 1mg at Week 6 (p<0.001) • Statistically significant treatment differences in 25mg vs 1mg and 10mg vs 1 mg found at all timepoints post administration • Rapid onset of actio
Slide 18: COMP006 – Key Secondary Met – Change in MADRS at Week 9 from Baseline
COMP006 – Key Secondary Met – Change in MADRS at Week 9 • Statistical significance maintained through Week 9 0 -2.7; Least square mean (± 95% CIs) change -2 -3.7; (-4.4, -1.0) 25mg vs 1 mg 10mg vs 1 mg (-5.4, -2.1) LS Mean LS Mean Visit Difference Difference -4 -5.3; (95% CI) (95% CI) -6.3; (-7.0, -
Slide 19: COMP005 & COMP006 Primary Endpoint Comparison
COMP005 & COMP006 Primary Endpoint Comparison* • Consistent magnitude of MADRS total score improvement between two Phase 3 studies • 2nd administration at Week 3 shows potential for a deeper treatment effect than a single administration 2 Least square mean (± 95% CIs) change from 0 -2 3.6 -4 Basel
Slide 20: Safety Data COMP005 and COMP006
Safety Data COMP005 and COMP006 20 | © Compass Pathways
Slide 21: Safety Summary
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 trials, the rate for SAE
Slide 22: COMP005 & COMP006 Treatment-Emergent Adverse Events (TEAEs) for Part A
COMP005 & COMP006 Treatment-Emergent Adverse Events (TEAEs) for Part A COMP360 COMP360 COMP360 COMP360 Placebo 25 mg 25 mg 10 mg 1 mg COMP005 COMP006 N=171 N=87 N=296 N=142 N=143 n (%) n (%) n (%) n (%) n (%) Any TEAE up to Week 6 120 (70.2) 34 (39.1) Any TEAE up to Week 9 274 (92.6) 125 (88.0) 116
Slide 23: COMP005 & COMP006 TEAE Incidence for Part A
COMP005 & COMP006 Treatment-Emergent Adverse Events (TEAE) Incidence for Part A COMP005 COMP360 25 mg Placebo COMP006 COMP360 25 mg COMP360 10 mg COMP360 1 mg (>5% Incidence) (>10% Incidence) N=171 N=87 N=296 N=142 N=143 MedDRA TEAE MedDRA TEAE Preferred Term n (%) n (%) n (%) n (%) n (%) Preferred
Slide 24: COMP005 & COMP006 Treatment-Emergent Serious Adverse Events (SAEs) for Part A
COMP005 & COMP006 Treatment-Emergent Serious Adverse Events (SAEs) for Part A COMP360 COMP360 COMP360 COMP360 Placebo 25 mg 25 mg 10 mg 1 mg COMP005 COMP006 N=171 N=87 N=296 N=142 N=143 n (%) n (%) n (%) n (%) n (%) Any SAE 4 (2.3) 1 (1.1) Any SAE 6 (2.0) 1 (0.7) 5 (3.5) Suicidal ideation 2 (1.2) 0
Slide 25: COMP005 – Safety Data Through Week 26
COMP005 – Safety Data Through Week 26 TEAEs SAEs COMP360 COMP360 Placebo Placebo 25 mg 25 mg MedDRA TEAE Preferred MedDRA TEAE Term N=171 N=87 N=171 N=87 Preferred Term n (%) n (%) n (%) n (%) Any TEAE 111 (64.9) 23 (26.4) Any TESAE 8 (4.7) 2 (2.3) Headache 61 (35.7) 15 (17.2) Nausea 42 (24.6) 4 (4.
Slide 26: Commercial update
Commercial update Lori Englebert, Chief Commercial Officer 26 | © Compass Pathways
Slide 27: Treatment-Resistant Depression (TRD) Affects Millions in the U.S.
Treatment-Resistant Depression (TRD) Affects Millions in the U.S. ~23M Prevalence of U.S. adults experiencing major depression each year1 ~12M Adult patients who are Over 55 medicines drug treated for MDD in approved for MDD the past year2 ~4M MDD patients failed by ≥2 antidepressants and Only 2 med
Slide 28: TRD has a significantly greater impact on individuals' lives compared to MDD
TRD has a significantly greater impact on individuals’ lives compared to MDD Patients with TRD have Compared to patients with non-TRD longer depressive episodes1 MDD, those with TRD experience: lighter color = MDD darker color = TRD 1st MDD episode 200 1st TRD episode 571 70% 17-30% 51% greater incr
Slide 29: TRD Disproportionately Impacts the Annual Economic Burden of MDD
TRD Disproportionately Impacts the Annual Economic Burden of MDD 1/3rd ~$93B of MDD patients are failed by ≥2 Annual Economic Burden of drug-treated MDD 1 antidepressants and considered treatment resistant1 TRD 47% Non-TRD MDD 53% TRD is associated with disproportionate health care costs and unemplo
Slide 30: Potentially Highly Differentiated and Compelling COMP360 Clinical Profile
Potentially Highly Differentiated and Compelling COMP360 Clinical Profile for TRD Patients and their Providers COMP3601 Spravato® Traditional Antidepressants Yes Yes Efficacy in TRD patient population 2 No (Positive trials: 2 ph3 trials; 1 ph2b) (FDA approved) Change from baseline in Change from bas
Slide 31: We are Planning To Be Launch Ready by the End of the Year
We are Planning To Be Launch Ready by the End of the Year Educate & Learn Launch Readiness Enable Patient Access Enable Awareness & Access Clinical care teams Commercial team build-out DEA rescheduling (Federal & State) KOLs/HCPs Product positioning Product distribution Federal and State policy make
Slide 32: Summary
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 sustained durability with
Slide 33: Thank you… Q&A
Thank you… Q&A For more information: Stephen Schultz SVP, Investor Relations stephen.schultz@compasspathways.com +1 401-290-7324 33 | © Compass Pathways