COMPASS Pathways Plc · NASDAQ:CMPS

COMPASS Pathways — Investor Presentation (November 2025)

19 slides from COMPASS Pathways's investor presentation, November 2025

  1. Slide 1: Transforming Mental Health Care

    Transforming Mental Health Care Investor Presentation November 2025

  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: Key Highlights

    Key Highlights • Company is accelerating commercialization launch readiness plans by 9-12 months • 9-week (Part A) data from COMP006 in Q1 2026 Near-term Catalysts • 26-week (Part B) data from COMP005 in Q1 2026 • 26-week (Part B) COMP006 data expected in early Q3 2026 • ~3M U.S. patients suffer fro

  4. Slide 4: Treatment-resistant Depression (TRD) affects millions in the U.S.

    Treatment-resistant Depression (TRD) affects millions in the U.S. ~21M Prevalence of U.S. adults experiencing major depression each year1 ~9M Adult patients who are +50 pharmacotherapies drug treated for MDD in approved for MDD the past year2 ~3M MDD patients failed by ≥2 antidepressants and Only 2

  5. Slide 5: Compass is developing COMP360 to transform the lives of patients living with TRD

    Compass is developing COMP360 to transform the lives of patients living with TRD SSRIs / SNRIs / Antipsychotics COMP360 Robust clinical profile in a TRD MDD Indicated with limited First multi-hour market with a high unmet need efficacy and safety liabilities pharmacologic for TRD in a large patient

  6. Slide 6: TRD patients are disproportionately impacted vs. non-TRD MDD patients

    TRD patients are disproportionately impacted vs. non-TRD MDD patients Patients with TRD have Compared to patients with non-TRD MDD, longer depressive episodes1 those with TRD experience: 1st MDD 200 episode 1st TRD episode 571 70% 17-30% 51% greater increased risk of increased risk of 0 100 200 300

  7. Slide 7: 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 COMP360 Pivotal trial 1 25 mg COMP360 25mg treatment Week 6 option for (one dose only after relapse or for (COMP 005) Primary retreatment non-remitters from Part B) endp

  8. Slide 8: Phase 3 COMP005 trial: Primary endpoint achieved with high statistical significance

    Phase 3 COMP005 trial: Primary endpoint achieved with high statistical significance • Clinically-meaningful mean treatment difference of -3.6 points on MADRS Part A (blinded) 6 weeks • p<0.001; CI: 95% (-5.7, -1.5) Primary endpoint 1 • Safety (statement provided by the DSMB chair June COMP360 25 23,

  9. Slide 9: Phase 2b trial: Results demonstrate the potential for a rapid, sustained response in TRD

    Phase 2b trial: Results demonstrate the potential Published in The NEW ENGLAND for a rapid, sustained response in TRD JOURNAL of MEDICINE* In a randomized, controlled, double- Secondary Efficacy Assessment Follow-up Period 3 Weeks Post Dose 6-12 Weeks Post-Dose blind trial, three groups of participa

  10. Slide 10: 2b trial: COMP360 psilocybin treatment was generally well-tolerated

    Phase 2b trial: COMP360 psilocybin treatment was generally well- tolerated Treatment-emergent adverse events (TEAEs) There were no concerns with vital signs, ECG or clinical laboratory data in any of the treatment groups >90% ofmoderate TEAEs were of mild or severity. TEAEs involving hallucinations

  11. Slide 11: COMP004: Long-term data shows average efficacy of a single dose of 25mg COMP360 at 92 days

    COMP004: Long-term data shows average efficacy of a single dose of 25mg COMP360 at 92 days Durable improvement in symptoms: 52-week observational follow-up study from Phase 2b reveals single 25 mg COMP360 psilocybin dose offers longer-term antidepressant effects compared to lower doses, with average

  12. Slide 12: Our early commercial planning efforts are focused on ensuring appropriate TRD patients can access COMP360

    Our early commercial planning efforts are focused on ensuring appropriate TRD patients can access COMP360, if approved Educate & Learn Enable Awareness & Access Prepare for Launch KOLs/HCPs Educating advocacy organizations Strategic collaborations Clinical care teams Developing a meaningful value Id

  13. Slide 13: Potential launch of COMP360 will leverage a well-established infrastructure of interventional psychiatry treatment centers

    Potential launch of COMP360 will leverage a well-established infrastructure of interventional psychiatry treatment centers ~6,000 Spravato treatment centers in US1 Established Practice Patterns • Dedicated rooms/areas for longer treatments • Operational and scheduling capabilities with team-based wo

  14. Slide 14: If approved, COMP360 prescribing, dosing, and reimbursement is expected to integrate within current clinical practice

    If approved, COMP360 prescribing, dosing, and reimbursement is expected to integrate within current clinical practice Prescribing Prescribed by an HCP licensed to prescribe medication to patients Patient self-administers and is monitored by a licensed HCP 1 during session Dose administration Dosing

  15. Slide 15: Phase 2 PTSD study safety profile (primary endpoint)

    Phase 2 PTSD study safety profile (primary endpoint) Summary of most frequent TEAES (≥10% prevalence) COMP360 was generally well tolerated with no treatment emergent serious adverse events reported No participants re- started SSRI’s or antidepressants after COMP360 administration in study There were

  16. Slide 16: Phase 2 PTSD study: meaningful and sustained symptom improvement

    Phase 2 PTSD study: meaningful and sustained symptom improvement • N=22, multi-center open-label, single administration of 25mg Summary of change from baseline in CAPS-5 score COMP360 with psychological support • Early onset and sustained change from baseline in CAPS-5 observed at week 4 and week 12

  17. Slide 17: Appendix

    Appendix 17 | © Compass Pathways

  18. Slide 18: Phase 2b most frequent TEAEs ordered by the 25mg arm

    Phase 2b most frequent TEAEs ordered by the 25mg arm (at least 5% in any treatment group) COMP360 COMP360 COMP360 TEAE incidence is higher in the Overall MedDRA TEAE 25mg 10mg 1mg 25mg group overall preferred term N=79 N=75 N=79 N=233 n (%) Key mood-related TEAEs Headache 27 (34.2) 16 (21.3) 20 (25.

  19. Slide 19: We're a biotechnology company…

    We're a biotechnology company… …dedicated to accelerating patient access to evidence-based innovation in mental health. Stephen Schultz SVP, Investor Relations stephen.schultz@compasspathways.com +1 401-290-7324 19 | © Compass Pathways

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