Slide 1: Compass Pathways: Transforming Mental Health Care
Compass Pathways: Transforming Mental Health Care January 7, 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 and Agenda
Welcome and Agenda Kabir Nath Chief Executive Officer Compass Pathways 3 | © Compass Pathways
Slide 4: Today's Agenda
Today’s Agenda • Unmet Need and Current Treatment Landscape for PTSD Guy Goodwin, MD, Chief Medical Officer, Compass Pathways • COMP360 in PTSD Michael Gold, MD, Chief R&D Officer Compass Pathways • Unmet need and Current Treatment Landscape for TRD Gary Small, MD, Director of Behavioral Health Brea
Slide 5: Post-traumatic Stress Disorder (PTSD) and Compass Clinical Program
Post-traumatic Stress Disorder (PTSD) and Compass Clinical Program Guy Goodwin, MD Chief Medical Officer, Compass Pathways Michael Gold, MD Chief R&D Officer, Compass Pathways 5 | © Compass Pathways
Slide 6: Post-Traumatic Stress Disorder (PTSD)
Chronic and debilitating psychiatric condition affecting ~13 million adults annually in the U.S.; lifetime prevalence ~6–8% Evidence-based psychotherapies are first line, but difficult to Post-Traumatic Stress adhere to and access is limited Disorder (PTSD) Existing treatments yield limited efficacy
Slide 7: Phase 2a PTSD Study: Meaningful and Sustained Symptom Improvement
Phase 2a 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 (mean baseline of 47.5 CAPS-5 total score, which is considered severe) Early onset and sustained change from baseline
Slide 8: PTSD Late-Stage Phase 2b/3 Trial Design
PTSD Late-Stage Phase 2b/3 Trial Design Design: Multicenter, randomized, double-blind, controlled study, with an open label extension, to investigate the efficacy, safety, and tolerability of COMP360 in 234 participants Primary Objective: To determine if two administrations of COMP360 at a dose of 2
Slide 9: Unmet Need & Treatment of TRD
Unmet Need & Treatment of TRD Gary Small, MD Director of Behavioral Health Breakthrough Therapies Professor of Psychiatry & Behavioral Health, Hackensack Meridian School of Medicine Hackensack Meridian Health Professor Emeritus of Psychiatry & Biobehavioral Sciences Founding Director, UCLA Longevity
Slide 10: Disclosures
Disclosures Advisory Boards: Cogensus, Electro Cellular Health Solutions, LLC, Handok, Herbalife, Lundbeck, Lilly, McCormick Science Institute, Merry Life Biomedical, Otsuka, Roche, TheKey, Theravalues Equity Interest: Ceremark Pharma, LLC
Slide 11: Treatment Resistant Depression (TRD)
Treatment Resistant Depression (TRD) • Definition – Inadequate response to > 2 antidepressants despite adequacy of and adherence to treatment • Approximately 1/3 of patients with major depressive disorder (MDD) develop TRD • Affects an estimated 100 million people worldwide • Accounts for more than
Slide 12: Treatments Used for MDD & TRD
Treatments Used for MDD & TRD • MDD – Limited innovation – Most based on monoaminergic (serotonin, norepinephrine, dopamine) mechanisms • TRD – Most strategies • Ineffective/inefficient (e.g., extending, combining, or switching antidepressants, psychotherapy) • Require daily, chronic use • Impose on
Slide 13: Management of TRD
Management of TRD • Extending antidepressant trial – Systematic review of available studies on response after 4 weeks: – About 20% of patients responded during weeks 5‐8 & 10% responded during weeks 9‐12 – Depressed patients prioritize rapidity of antidepressant action & reluctant to prolong trials
Slide 14: Intranasal Esketamine (Spravato)
Intranasal Esketamine (Spravato) • Widely-used, FDA-approved treatment for TRD • Labeled for 3rd-line use, but usually prescribed 5th-line or later and typically along with other antidepressants • Limited durability requires frequent repeat dosing – Typically, 25-35 or more administrations per year
Slide 15: COMP360 Differentiated Emerging Profile
COMP360 Differentiated Emerging Profile SSRIs / SNRIs / Antipsychotics COMP360 Differentiated clinical profile in MDD Indicated with limited First multi-hour medicine for a TRD market with a high efficacy and tolerability TRD unmet need in a large patient challenges population Delayed onset of effic
Slide 16: Differentiated Profile of COMP360
Differentiated Profile of COMP360 • Rapid onset, durable efficacy • Phase 3: – Effect size of 1 dose at week-6 comparable to Spravato after 8 doses • Phase 2b data showed: – Psilocybin at a single dose of 25 mg reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks Go
Slide 17: TRD Treatment Landscape
TRD Treatment Landscape Steve Levine, MD Chief Patient Officer Compass Pathways 17 | © Compass Pathways
Slide 18: Key Takeaways
Key Takeaways 1. The only marketed pharmacotherapy indicated for TRD - Spravato® - requires frequent dosing to maintain treatment effect and can be highly burdensome to both patients and their caregivers 2. There is currently no existing medicine indicated for TRD that offers both rapid onset and du
Slide 19: Fireside Chat: TRD Treatment Delivery Landscape
Fireside Chat: TRD Treatment Delivery Landscape Geoffery Grammer, MD Greenbrook, Chief Medical Officer Myriam Barthes Journey Clinical, Co-founder and CEO Dimitri Cavathas HealthPort, Chief Executive Officer 19 | © Compass Pathways
Slide 20: Commercial Launch Readiness for COMP360 in TRD
Commercial Launch Readiness for COMP360 in TRD Lori Englebert Chief Commercial Officer Compass Pathways 20 | © Compass Pathways
Slide 21: 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 22: TRD Patients are Disproportionately Impacted vs. MDD
TRD Patients are Disproportionately Impacted vs. 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 increased risk of increased
Slide 23: Our Commercial Planning Efforts are Focused on Ensuring Appropriate TRD Patients Can Access COMP360
Our Commercial Planning Efforts are Focused on Ensuring Appropriate TRD Patients Can Access COMP360, if Approved Educate & Learn Launch Readiness Enable Patient Access Enable Awareness & Access Clinical care teams Commercial team build-out DEA rescheduling (Federal & State) KOLs/HCPs Product positio
Slide 24: 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 Dose Patient self-administers oral capsule and is monitored by a licensed HCP1 during session administra
Slide 25: Investment Highlights
Investment Highlights Significant Unmet Late-stage Near-term Value Strong Cash Medical Need with Development Drivers Position Large Target Markets TRD: ~4M in the U.S. suffer with COMP360: Proprietary synthetic Part A (9-week) data from $186 million cash as of TRD with limited treatment formulation
Slide 26: Thank you… Q&A
Thank you… Q&A For more information: Stephen Schultz SVP, Investor Relations stephen.schultz@compasspathways.com +1 401-290-7324 26 | © Compass Pathways