COMPASS Pathways Plc · NASDAQ:CMPS

COMPASS Pathways — Q2 2026 Earnings Presentation

49 slides from COMPASS Pathways's earnings presentation, Aug 5, 2026

  1. Slide 1: Every journey needs a Compass

    Every journey needs a Compass Investor Presentation Q2 2026

  2. 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

  3. Slide 3: Preparing for the World's First Approval and Launch of a Classic Psychedelic

    Preparing for the World's First Approval and Launch of a Classic Psychedelic “We are convinced COMP360 will lead to a profound shift in Compass is leading the way in developing a new mental health care – moving clinical standard for mental health care beyond daily or frequent administration – toward

  4. Slide 4: Positioned to Establish the Field of Psychedelic Treatments

    Positioned to Establish the Field of Psychedelic Treatments Compelling Accelerated Path Blockbuster Clinical Profile to Market Opportunity1 Consistent results across two Rolling NDA submission and review Target indications address large highly statistically significant underway with final submission

  5. Slide 5: Potential for COMP360 to Revolutionize how Mental Health is Treated

    Potential for COMP360 to Revolutionize how Mental Health is Treated​ Remarkable Consistency Durability with Infrequent Dosing* Largest Clinically meaningful efficacy in Remarkable durability sustained through Late-stage a patient population with limited treatment options at least 6 months with only

  6. Slide 6: Unmet Need in Treatment-Resistant Depression (TRD)

    Unmet Need in Treatment-Resistant Depression (TRD) 6 | © Compass Pathways

  7. Slide 7: TRD Patients Urgently in Need of New Treatment Options

    TRD Patients Urgently in Need of New Treatment Options 23M Americans experience major depressive disorder (MDD) each year1 WHY TREATMENT RESISTANCE MATTERS 55+ Antidepressants approved for MDD2 12M MDD patients drug-treated in the past year1 Only 1 FDA-approved medicine for TRD (Spravato®) ~1 in 3 4

  8. Slide 8: TRD Places Higher Burden on Patients, Communities and Healthcare Systems Compared to MDD

    TRD Places Higher Burden on Patients, Communities and Healthcare Systems Compared to MDD Prolonged TRD depressive episodes average 571 days and are 2X longer than MDD Disease Course1 Increased relapse rate and decreased remission rate after at least 2 antidepressants Increased Higher comorbidities w

  9. Slide 9: COMP360 Phase 3 Data in TRD

    COMP360 Phase 3 Data in TRD 9 | © Compass Pathways

  10. Slide 10: Rigorously Designed Phase 3 Program

    Rigorously Designed Phase 3 Program Part A (blinded) 9 weeks Part B (blinded) 17 weeks Part C (open label) 26 weeks Week 3 COMP360 Week 6 25mg COMP360 Primary endpoint N=296 25mg achieved1 P<0.001 COMP006 (2 doses in Part A) COMP360 COMP360 25mg treatment COMP360 Option for retreatment* N=581 10mg 1

  11. Slide 11: Positive Primary Endpoints Achieved for COMP005 & COMP006 in Highly Chronic TRD Population

    Positive Primary Endpoints Achieved for COMP005 & COMP006 in Highly Chronic* TRD Population Consistent improvement in 2 Least square mean (± 95% CIs) change from magnitude of MADRS total score 0 between two Phase 3 studies -2 3.6 -4 Baseline -6 3.8 2nd administration at Week 3 shows potential for a

  12. Slide 12: Remarkable Durability Through 6 Months Across Ph3 Trials

    Remarkable Durability Through 6 Months* Across Ph3 Trials Consistent separation between Change from baseline (Least square mean in Part 2 25mg and control arms A, Observed mean in Part B) +95% CIs maintained over 26 weeks in 0 both studies -2 -4 Confirms validity, consistency -6 and durability of ef

  13. Slide 13: COMP006: Rapid and Durable Response – Unique in TRD

    COMP006: Rapid and Durable Response– Unique in TRD 0 Mean (± 95% CIs) change from Baseline 39% of participants in 25mg -4 arm achieved clinically meaningful reduction in -8 >25% reduction in MADRS MADRS* at Week 6 and on -12 average maintained response at least through Week 26 -16 -20 -24 28% of tho

  14. Slide 14: COMP005: Rapid and Durable Response – Unique in TRD

    COMP005: Rapid and Durable Response– Unique in TRD 0 -4 25% of participants in 25mg Mean (± 95% CIs) change from Baseline arm achieved clinically -8 meaningful reduction in >25% reduction in MADRS MADRS* at Week 6 and on -12 average maintained response -16 at least through Week 26 -20 -24 Over 40% o

  15. Slide 15: COMP360 Generally Well-Tolerated with a Safe Profile

    COMP360 Generally Well-Tolerated with a Safe Profile Safety data consistent with Majority of AEs transient, known profile of COMP360 SAEs were low overall across occurring on the day of psilocybin​ with no new safety both trials ​ administration signals identified 15 | © Compass Pathways

  16. Slide 16: Commercial Readiness

    Commercial Readiness 16 | © Compass Pathways

  17. Slide 17: On Track for COMP360 Launch in H1 2027, if FDA Approved

    On Track for COMP360 Launch in H1 2027, if FDA Approved FDA rolling review Breakthrough Anticipated Anticipated and National Therapy designation completion of rolling launch, if FDA Priority Voucher granted by the FDA NDA submission approved granted October Q4 H1 April 2026 2018 2026 2027 Advanced c

  18. Slide 18: Well-established Infrastructure of Interventional Psychiatry Treatment Centers in Place

    Well-established Infrastructure of Interventional Psychiatry Treatment Centers in Place and Preparing to Offer COMP360​ Centers 578 Established Practice Patterns Dedicated rooms/areas for treatments that require multi-hour monitoring Operational and scheduling capabilities with team-based workforce

  19. Slide 19: Prescribing, Dosing and Reimbursement Expected to Easily Integrate within Current Clinical Practice

    Prescribing, Dosing and Reimbursement Expected to Easily Integrate within Current Clinical Practice Prescribing Prescribed by an HCP licensed to prescribe medication to patients​ Dose Patient self-administers oral capsule, monitored by a licensed HCP during session ​ Administration Dosing and monito

  20. Slide 20: Launch Strategy Informed by Strategic Collaborators, Representing a Spectrum of Provider Archetypes

    Launch Strategy Informed by Strategic Collaborators, Representing a Spectrum of Provider Archetypes >1,000 Sites Represented Insights Gained Hackensack Meridian Health Patient care pathways Neuronetics (Greenbrook) Provider perspectives on Spravato implementation Mindful Health Solutions Reliant Med

  21. Slide 21: Expanding the Potential of COMP360: Post-Traumatic Stress Disorder

    Expanding the Potential of COMP360: Post-Traumatic Stress Disorder 21 | © Compass Pathways

  22. Slide 22: PTSD: High Unmet Need with Opportunity to Leverage TRD Foundation

    PTSD: High Unmet Need with Opportunity to Leverage TRD Foundation Significant unmet need Lack of innovation over the past 25+ years Existing treatment paradigm limited by adherence, access and PTSD affects efficacy challenges ~13M U.S. adults Strong strategic fit PTSD has high overlap with TRD popul

  23. Slide 23: Positive Phase 2a Results: Meaningful and Durable Improvements in PTSD

    Positive Phase 2a Results: Meaningful and Durable Improvements in PTSD 0 Summary of change from baseline in CAPS-5 score Safety Profile Consistent with TRD Studies -5 Mean (±SD) change from Baseline -10 • Generally safe and well-tolerated with no treatment emergent serious -15 -20 adverse events rep

  24. Slide 24: PTSD Phase 2b/3 Trial Design

    PTSD Phase 2b/3 Trial Design Multicenter, randomized, double-blind, controlled trial, with an open label extension, to investigate the efficacy, safety, and tolerability of COMP360 in 300 adult participants with PTSD Primary Endpoint: To determine if two administrations of COMP360 at a dose of 25mg

  25. Slide 25: Robust Patent Portfolio Supporting COMP360 Exclusivity

    Robust Patent Portfolio Supporting COMP360 Exclusivity​ Composition Patents Method Patents Drug Substance (DS) Drug Product (DP) Method of Treatment (MoT) • Crystalline drug substance • Orally administered formulation • Coverage of priority indications: TRD and • Pharmaceutical-grade purity • Target

  26. Slide 26: Multidisciplinary Executive Team with Deep Experience Bringing Innovative CNS Therapies to Patients

    Multidisciplinary Executive Team with Deep Experience Bringing Innovative CNS Therapies to Patients Kabir Nath Dr Guy Goodwin, Lori Englebert, Chief Dr Michael Gold, Dr Steve Levine, Chief Teri Loxam, Chief Executive Officer Chief Medical Officer Commercial Officer Chief R&D Officer Patient Officer

  27. Slide 27: For More Information

    For More Information: Stephen Schultz, SVP Investor Relations +1 401 290 7324 | Stephen.Schultz@compasspathways.com | IR@compasspathways.com

  28. Slide 28: Appendix

    Appendix 28 | © Compass Pathways

  29. Slide 29: Phase 3 Program in TRD

    Phase 3 Program in TRD 29 | © Compass Pathways

  30. Slide 30: Phase 3 Program in TRD: Trial Designs

    Phase 3 Program in TRD: Trial Designs Part A (blinded) 9 weeks Part B (blinded) 17 weeks Part C (open label) 26 weeks Week 3 COMP360 Week 6 25mg COMP360 Primary endpoint N=296 25mg achieved1 P<0.001 COMP006 (2 doses in Part A) COMP360 COMP360 25mg treatment COMP360 Option for retreatment* N=581 10mg

  31. Slide 31: COMP005 & COMP006 – Participant Baseline Demographics In Line with Known TRD Epidemiology

    COMP005 & COMP006 – Participant Baseline Demographics In Line with Known TRD Epidemiology COMP360 COMP360 COMP360 1 COMP005 COMP360 25 Placebo COMP006 25 mg 10 mg mg (N=143) mg (N=171) (N=87) (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

  32. Slide 32: COMP005 & COMP006 – Participant Characteristics Treatment History and Baseline MADRS

    COMP005 & COMP006 – Participant Characteristics Treatment History and Baseline MADRS COMP360 COMP360 COMP360 COMP360 Placebo COMP005 25 mg (N=87) COMP006 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 depr

  33. Slide 33: COMP005 & COMP006 – Participant Characteristics Depression Diagnosis History

    COMP005 & COMP006 – Participant Characteristics Depression Diagnosis History COMP360 COMP360 25 Placebo COMP360 25 COMP360 1 COMP005 mg (N=171) (N=87) COMP006 mg (N=296) 10 mg mg (N=143) (N=142) Length of current depressive episode Length of current depressive episode Mean Months (SD) 34.1 (29.1) 38

  34. Slide 34: Duration of Current Episode Strongest Predictor of Non-Response in TRD

    Duration of Current Episode Strongest Predictor of Non- Response in TRD Source: European Neuropsychopharmacology. Volume 98, September 2025, Pages 26-34 (https://www.sciencedirect.com/science/article/pii/S0924977X25001294) 34 | © Compass Pathways

  35. Slide 35: COMP006 – Phase 3 Data

    COMP006 – Phase 3 Data 35 | © Compass Pathways

  36. Slide 36: COMP006 - Primary Endpoint Met – Change in MADRS at Week 6

    COMP006 - Primary Endpoint Met – Change in MADRS at Week 6 Statistically significant treatment Rapid onset of action with the Statistically significant difference 39% of participants in 25mg arm differences in 25mg vs 1mg and effect occurring the day after the of -3.8 MADRS between 25mg achieved a c

  37. Slide 37: COMP006 – Rapid Onset and Sustained Durability to Week 26

    COMP006 – Rapid Onset and Sustained Durability to Week 26 Rapid effect from 25mg evident from day after administration: 2 Change from baseline (Least square mean in Part A, apparent after both first and 0 second fixed doses in Part A Observed mean in Part B) +95% CIs -2 -4 -6 Persistent treatment ef

  38. Slide 38: COMP006 - COMP360 Response Can Be Rapid and Durable – Unique in TRD

    COMP006 - COMP360 Response Can Be Rapid and Durable – Unique in TRD 0 Mean (± 95% CIs) change from Baseline 39% of participants in 25mg -4 arm achieved clinically meaningful reduction in -8 >25% reduction in MADRS MADRS* at Week 6 and on -12 average maintained response at least through Week 26 -16 -

  39. Slide 39: COMP006 – Adverse Events through 26 weeks

    COMP006 – Adverse Events through 26 weeks COMP360 COMP360 COMP360 COMP360 COMP360 COMP360 25 mg 10 mg 1 mg COMP006 Through 26 25 mg 10 mg 1 mg Weeks COMP006 Through 26 Weeks N=296 N=142 N=143 (>10% Incidence in 25mg) N=296 N=142 N=143 MedDRA TEAE n (%) n (%) n (%) Preferred Term n (%) n (%) n (%) An

  40. Slide 40: COMP006 – SAEs Similar in 25mg and 1mg Arms and Low in Number Overall

    COMP006 – SAEs Similar in 25mg and 1mg Arms and Low in Number Overall COMP360 COMP360 COMP360 COMP360 COMP360 COMP360 25 mg 10 mg 1 mg 25 mg 10 mg 1 mg MedDRA TEAE MedDRA TEAE Preferred Term N=296 N=142 N=143 Preferred Term N=296 N=142 N=143 n (%) n (%) n (%) n (%) n (%) n (%) Any TESAE 17 (5.7) 5 (

  41. Slide 41: COMP005 – Phase 3 Data

    COMP005 – Phase 3 Data 41 | © Compass Pathways

  42. Slide 42: 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 Statistical significance at all timepoints beginning the day after 25mg vs placebo at Week 6 (p<0.001) administration (Day 2) demonstrates rapid onset of action Baseline

  43. Slide 43: COMP005 – Sustained Durability to Week 26

    COMP005 – Sustained Durability to Week 26 Primary Endpoint 2nd administration option during blinded long- at Week 6 term follow-up through Week 26 (Part B) Consistent separation from 2 placebo through randomized and Change from baseline (Least square mean in Part A, Observed mean in Part B) +95% CIs

  44. Slide 44: COMP005 - COMP360 Response Can Be Immediate and Durable – Unique in TRD

    COMP005 - COMP360 Response Can Be Immediate and Durable – Unique in TRD 0 -4 25% of participants in 25mg Mean (± 95% CIs) change from Baseline arm achieved clinically -8 meaningful reduction in >25% reduction in MADRS MADRS* at Week 6 and on -12 average maintained response -16 at least through Week

  45. Slide 45: COMP005 – Adverse Events through 26 weeks

    COMP005 – Adverse Events through 26 weeks COMP360 COMP360 Placebo COMP005 Through 26 Weeks Placebo 25 mg 25 mg COMP005 Through 26 weeks (>10% Incidence in 25mg) N=171 N=87 MedDRA TEAE N=171 N=87 n (%) n (%) Preferred Term n (%) n (%) Any TEAE up to Week 26 145 (84.8) 52 (59.8) Any TEAE 145 (84.8) 52

  46. Slide 46: COMP005 – SAEs Through Week 26

    COMP005 – SAEs Through Week 26 COMP360 Placebo 25 mg MedDRA TEAE N=171 N=87 Preferred Term n (%) n (%) Any TESAE 8 (4.7) 2 (2.3) Suicidal ideation 4 (2.3) 0 Depression suicidal 1 (0.6) 0 Major depression 0 1 (1.1) Cellulitis 1 (0.6) 0 Diverticulitis 1 (0.6) 0 Urinary tract infection bacterial 0 1 (1

  47. Slide 47: COMP001 – Phase 2b

    COMP001 – Phase 2b 47 | © Compass Pathways

  48. Slide 48: Phase 2b Trial Results Demonstrated the Potential for a Rapid, Sustained Response in TRD

    Phase 2b Trial Results Demonstrated the Published in The NEW ENGLAND Potential for a Rapid, Sustained Response in TRD JOURNAL of MEDICINE* Secondary Efficacy Assessment Follow-up Period 3 Weeks Post Dose 6-12 Weeks Post-Dose In a randomized, controlled, double-blind trial, three groups of participan

  49. Slide 49: Thank You

    Thank You For More Information: Stephen Schultz, SVP Investor Relations +1 401 290 7324 | Stephen.Schultz@compasspathways.com | IR@compasspathways.com

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