Slide 1: Transforming Mental Health Care
Transforming Mental Health Care April 19, 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: A team of experts and leaders with a record of delivering visionary innovation
PLEASE DO NOT DISTRIBUTE 4 | © COMPASS Pathways plc 2023 1. Kabir Nath Chief Executive Officer 2. Guy Goodwin, MD, PhD Chief Medical Officer 3. Trevor Mill Chief Development Officer 4. Anne Benedict Chief People Officer 5. Mike Falvey Chief Financial Officer 6. Matt Owens General Counsel and Chief L
Slide 5: COMP360 psilocybin therapy
5 | © 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 su
Slide 6: TRD treatment pathway: significant unmet need
6 | © 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 of therapy Estimated num
Slide 7: COMP001 phase 2b study design and primary endpoint
7 | © COMPASS Pathways plc 2023 COMP001 phase 2b study design and primary endpoint (n=233) Primary endpoint Reduction of symptoms of depression as measured by change in MADRS total score from baseline to week 3 Weekly visits (V1a, V1b, etc) for antidepressant discontinuation (if required) and prepar
Slide 8: Phase 2b trial: rapid, sustained response in TRD
8 | © 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 9: Phase 2b trial: sustained responders and improvement beyond depression symptoms
9 | © 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 10: Phase 2b safety and tolerability
10 | © 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. TEAE
Slide 11: Phase 3 program: overview of ongoing pivotal trial designs
11 | © 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 (Pa
Slide 12: Phase 3 long-term follow-up component
12 | © COMPASS Pathways plc 2023 pivotal trial 1 (005) n=255 Phase 3 program long-term follow up component Part A (blinded): Week 6 primary endpoint* Part B (blinded): to week 26 Part C (open label): week 26 to week 52 *Primary endpoint - change from baseline in MADRS total score at Week 6 COMP360 2
Slide 13: Preparing for scale at launch
13 | © COMPASS Pathways plc 2023 Preparing for scale at launch Treatment Centers COMPASS Pathways Payers/specialty pharmacy COMPASS Pathways intends to deliver COMP360 (medicine) to Treatment Centers through specialty pharmacy channels, reimbursed by Payers Our strategy for reimbursement is for Trea
Slide 14: Infrastructure to deliver COMP360 psilocybin therapy already exists
14 | © COMPASS Pathways plc 2023 The infrastructure to deliver COMP360 psilocybin therapy already exists and is growing • Specialty TRD centers, health systems, and integrated delivery networks (IDNs), some of which are clinical trial sites during phase 3, are already experienced in delivering inter
Slide 15: Our integrated technology platform
15 | © 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 16: Signal-generating studies in other indications
16 | © 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 17: A balanced and differentiated pipeline
17 | © 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 18: COMPASS Financial Overview
18 | © COMPASS Pathways plc 2023 Cash and cash equivalents $143.1 million COMPASS Financial Overview NOTE: Cash and cash equivalents at December 31, 2022. Issued shares as of March 31, 2023; guidance is provided as of February 28, 2023 only Issued shares 42.8 million Financial guidance for cash used
Slide 19: We're a mental health care company
19 | © 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 recruiting • Trial 1: top-line data expected Summer 2024 • Trial 2: top-line data exp
Slide 20: We're a mental health care company
20 | © 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