Slide 1: Transforming Mental Health Care
Transforming Mental Health Care JANUARY 2023
Slide 2: Cautionary Note Regarding Forward-Looking Statements
2 | © COMPASS Pathways plc 2023 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 suc
Slide 3: We're a mental health care company
3 | © COMPASS Pathways plc 2023 We're a mental health care company. We’re committed to developing innovative, evidence-based therapies that help patients and their families, and ease the burden on our overstretched healthcare systems.
Slide 4: COMP360 psilocybin therapy elements
4 | © COMPASS Pathways plc 2023 Our synthetic, high-purity polymorphic crystalline formulation of psilocybin, a psychoactive compound. COMP360 psilocybin therapy includes three elements COMP360 psilocybin Psychological support from registered and trained mental health professionals. . Psychological
Slide 5: TRD treatment pathway: significant unmet need for 100 million patients
PLEASE DO NOT DISTRIBUTE 5 | © COMPASS Pathways plc 2023 TRD treatment pathway: significant unmet need for 100 million patients Treatment pathway stage New onset depression Major depressive disorder (MDD) Persistent depression Major depressive disorder (MDD) Treatment-resistant depression (TRD) Line
Slide 6: Phase 2b trial: rapid, sustained response in TRD
6 | © COMPASS Pathways plc 2023 In a randomized, controlled, double- blind trial, three groups of participants were given a single dose (either 1mg, 10mg or 25 mg) of COMP360 psilocybin alongside psychological support. Results were measured as a change on the MADRS* depression scale from baseline (a
Slide 7: Phase 2b trial: sustained responders and improvement beyond depression symptoms
7 | © COMPASS Pathways plc 2023 Sustained responders are participants who responded (≥50% change in MADRS total score from baseline) at weeks 3 and 12, and at least one visit out of week 6 and 9, and who did not start new treatments for depression. Sustained non-responders are participants who did n
Slide 8: Phase 2b safety: no concerns with vital signs, ECG or labs
8 | © COMPASS Pathways plc 2023 There were no concerns with vital signs, ECG or clinical laboratory data in any of the treatment groups TEAEs involving hallucinations (which only occurred in the 25mg and 10mg groups) and illusions (all groups) started and resolved on the day of administration. TEAEs
Slide 9: Phase 3 program: overview of pivotal trial designs
9 | © COMPASS Pathways plc 2023 Pivotal trial 1 Single dose monotherapy (COMP 005) COMP360 25 mg Placebo Pivotal trial 2 Fixed repeat dose monotherapy (COMP 006) COMP360 25 mg COMP 360 1 mg COMP360 25 mg COMP360 1 mg COMP360 10 mg COMP360 10 mg Randomisation = 2:1:1 n = 568 (284:142:142) Week 6 Prim
Slide 10: Our initial launch model
10 | © COMPASS Pathways plc 2023 Our offering We will deliver COMP360 (medicine) to treatment centers through speciality pharmacy channels. We will offer training, site activation services and digital solutions to treatment centers. Our revenue streams When reimbursed by payers, we will sell COMP360
Slide 11: Our integrated technology platform
11 | © COMPASS Pathways plc 2023 Therapist COMPanion Web-based portal supporting therapists through all phases of patient care Chanterelle AI & analytics infrastructure for continuous optimization myPathfinder Patient-facing app providing guidance throughout COMP360 psilocybin therapy Our digital to
Slide 12: A balanced and differentiated pipeline
12 | © COMPASS Pathways plc 2023 Discovery Preclinical Phase 1 Phase 2 Phase 3 Approved COMP360 for TRD COMP360 for anorexia nervosa COMP360 for PTSD Prodrug development Discovery Center (NCE development) Beyond COMP360 psilocybin: We’re investigating prodrugs and novel psychedelic and non- psychede
Slide 13: Investigator-initiated studies with COMP360 psilocybin
13 | © COMPASS Pathways plc 2023 Listed here are signal-generating studies looking at indications in areas of serious unmet need with COMP360 psilocybin. These studies may provide signals for new potential indications for COMP360 psilocybin that we can explore further and bring into our development
Slide 14: Team of experts and leaders
PLEASE DO NOT DISTRIBUTE 14 | © COMPASS Pathways plc 2023 1. Kabir Nath Chief Executive Officer 2. Dr Guy Goodwin Chief Medical Officer 3. Trevor Mill Chief Development Officer 4. Anne Benedict Chief People Officer 5. Mike Falvey Chief Financial Officer 6. Marco Mohwinckel Chief Commercial Officer 7
Slide 15: COMPASS Financial Overview
15 | © COMPASS Pathways plc 2023 Cash and cash equivalents $173.1 million Issued shares 42.5 million Covering analysts – Berenberg, Caroline Palomeque – BTIG, Robert (Bert) Hazlett – Canaccord Genuity, Sumant Kulkarni – Cantor Fitzgerald, Charles Duncan – CITI, Neena Bitritto-Garg – Cowen, Ritu Bara
Slide 16: Summary and upcoming milestones
16 | © COMPASS Pathways plc 2023 We're a mental health care company. – Lead product candidate: COMP360 psilocybin therapy – Phase 2 TRD program published in The New England Journal of Medicine – Phase 3 TRD program expected to commence by end of 2022 • Trial 1: top-line data expected end of 2024 • T
Slide 17: Appendix
17 | © COMPASS Pathways plc 2023 Appendix
Slide 18: Most frequent TEAEs by 25mg arm
PLEASE DO NOT DISTRIBUTE 18 | © COMPASS Pathways plc 2023 Most frequent TEAEs ordered by the 25mg arm (at least 5% in any treatment group) TEAE incidence is higher in the 25mg group overall Key mood-related TEAEs (euphoric mood, depression, depressed mood, suicidal ideation) do not have a higher inc
Slide 19: Modulation of cortical and limbic systems via 5-HT2A receptors
PLEASE DO NOT DISTRIBUTE 19 | © COMPASS Pathways plc 2023 Modulation of cortical and limbic systems via 5- HT2A receptors Note: understood mechanism of action based on studies of psilocybin (not COMP360); *5-HT2A = 5- hydroxytyryptamine 2A; DMN = default mode network; mPFC = medial prefrontal cortex
Slide 20: Brain network alterations and novel connectivity patterns
PLEASE DO NOT DISTRIBUTE 20 | © COMPASS Pathways plc 2023 Placebo Psilocybin Brain network alterations may indicate the emergence of novel patterns of connectivity, following downregulation of the DMN Note: Figure adapted from Petri et al, 2014; study analysed fMRI (functional magnetic resonance ima
Slide 21: MADRS sustained responders at week 12
PLEASE DO NOT DISTRIBUTE 21 | © COMPASS Pathways plc 2023 Higher proportion of sustained responders found in the 25mg vs 1mg arm. Note: MADRS = Montgomery- Åsberg Depression Rating Scale; Statistical significance cannot be claimed on secondary endpoints due to hierarchical testing being broken for t
Slide 22: Therapist training model
22 | © COMPASS Pathways plc 2023 Therapist training model Phase III delivery Value Tier I Self-paced learning Therapist COMPanion platform in a new, dynamic digital format Optimized user learning experience Analytics to ensure learning objectives are achieved Tier II Interactive clinical skills trai
Slide 23: Phase 3 investigational sites by country
23 | © COMPASS Pathways plc 2023 Phase 3 investigational sites COMP 005 COMP 006 US (33) US (43) DEU (7) UK (14) CAN (8) AUS (3) DEN (1) NOR (1) CZR (8) SWE (5) NDL (3) FRA (6) IRE (2) ESP (10) POL (6) New site clustersPhase 2b sites Number of sites per study/country
Slide 24: Targeting treatment center networks and clinical adoption
24 | © COMPASS Pathways plc 2023 • Targeting networks of commercial treatment centers with the right infrastructure, capabilities / workforce and TRD patient mix / flow (eg. Greenbrook TMS, others) • Hundreds of clinics managing tens of thousands of TRD patients • Offering TMS, IV Ketamine, SPRAVATO
Slide 25: COMP360 IP protection and regulatory exclusivity
PLEASE DO NOT DISTRIBUTE 25 | © COMPASS Pathways plc 2023 COMP360 IP protection and regulatory exclusivity IP protection COMPASS has US patents covering COMP360 (including composition of matter, formulation, methods of treatment, and methods of manufacture) that expire in 2038 (20-year term) as well
Slide 26: Treatment centers offering COMP360 alongside other interventional psychiatry services
26 | © COMPASS Pathways plc 2023 We anticipate treatment centers will offer COMP360 psilocybin therapy alongside other interventional psychiatry services References: [1] ICER, 2019; [2] Ross, 2018; [3] Petrides, 2011; [4] Thirthalli, 2020; [5] Voigt, 2017 (r)TMS 1h once /day for 30-40 days + screeni
Slide 27: Anorexia nervosa
PLEASE DO NOT DISTRIBUTE 27 | © COMPASS Pathways plc 2023 Anorexia nervosa (AN) AN is an eating disorder characterized by weight loss or difficulties maintaining a healthy body weight, usually associated with distorted body image. People with AN generally restrict their caloric intake, types of food
Slide 28: Post-traumatic stress disorder (PTSD)
PLEASE DO NOT DISTRIBUTE 28 | © COMPASS Pathways plc 2023 Where we are at… Post-traumatic stress disorder (PTSD) PTSD can occur in people who have experienced or witnessed a traumatic event (eg, natural disaster, serious accident, war, rape). Some people with PTSD experience symptoms from immediatel
Slide 29: We're a mental health care company
29 | © COMPASS Pathways plc 2023 We're a mental health care company. We’re committed to developing innovative, evidence-based therapies that help patients and their families, and ease the burden on our overstretched healthcare systems. Stephen Schultz SVP, Investor Relations stephen.schultz@compassp