COMPASS Pathways : investor presentation March 2025

Published: 2025-03-02 17:59:05 ET CMPS

Transforming Mental Health Care

InvestorPresentation

March2025

Compass Pathways

Dedicatedtoacceleratingpatientaccesstoevidence-based innovationinmentalhealth

3 | © CompassPathways

US TRD prevalence

~21M

~10M ~3M

Estimated prevalence of US

Adult MDD patients who are

~1/3 of MDD drug treated

adults experiencing Major

drug treated3

patients have been failed by

Depression (MDD)2

prior treatments and are

considered to have TRD4

Treatment-resistant depression (TRD) is broadly referred to as the inadequate response to at least 2 trials of

antidepressant pharmacotherapy1

4 | © CompassPathways

Current treatment progression pathway for MDD/TRD patients in US

Condition

Treatment Line of Therapy

Typical treatment progression and available treatments

Major Depressive Disorder

Treatment Resistant

Depression

(MDD)

(TRD)

1st Line

2nd Line

3rd Line+

Pharmacotherapy:

- Traditional antidepressant

Switch to different traditional

Switch to a different traditional

- Dose escalation of current

antidepressant

Add a traditional

Add a traditional antidepressant

antidepressant

Augmentation therapy

(antidepressant + mood stabilizers,

anticonvulsants, atypical

antipsychotics)

Spravato (esketamine)

- Somatic therapy (rTMS, tDCS,

ECT, DBS)*

*NOTE: rTMS = repetitive transcranial magnetic stimulation; tDCS=transcranial direct current stimulation; ECT=electroconvulsive therapy; DBS=deep brain stimulation

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Phase 3 program: Overview of pivotal trial designs

Pivotal trial 1

(COMP 005)

N=255

Pivotal trial 2

(COMP 006)

N=568

Part A (blinded) 6 weeks

Part B (blinded) 20 weeks

COMP360

25 mg

N=170

Week 6

option for

Primary

retreatment

Placebo

endpoint1

(same dose as Part A)

N=85

Part A (blinded) 9 weeks

Part B (blinded) 17 weeks

Week 3

Week 6

COMP360

Primary

COMP360

endpoint1

25 mg

N=284

COMP360

option for

10 mg

retreatment

10 mg

N=142

(same dose as Part A)

COMP360

1 mg

N=142

Part C (open label) 26 weeks

COMP360 25mg treatment

(one dose only after relapse or for

non-remitters from Part B)

Part C (open label) 26 weeks

COMP360 25mg treatment

(one dose only after relapse or for

non-remitters from Part B)

The participant population (TRD definition and core inclusion/exclusion criteria) remains unchanged compared to Phase 2b

1. Primary endpoint = change from baseline in MADRS total score at Week 6. 2. Remitters are defined as patients with MADRS total score ≤12 and no single item ≥4. Note that it can take several weeks to organise a dosing session for non-remitters from Part A or Part B so re-dosing does not necessarily happen immediately at the start of Part B or Part C, respectively.

6 | © CompassPathways

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

Published in The NEW ENGLAND JOURNAL of MEDICINE*

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 day prior to administration) over a 12-week period.

The primary endpoint of this study was the change from baseline in MADRS total score at week 3.

Secondary Efficacy Assessment

Follow-up Period

3 Weeks Post Dose

6-12 Weeks Post-Dose

25mg vs 1mg: p<0.001

10mg vs 1mg: p = 0.162

Clinical Effect: We saw a statistically significant and clinically meaningful reduction in depression symptoms

Rapid onset of action: The effect occurred the day after the administration.

Durability: We saw a sustained response at week 12 - a positive indication for high potential as a monotherapy.

NOTE: **Least square mean change from baseline in MADRS total score; MADRS = Montgomery-Åsberg Depression Rating Scale; the above analysis is from the NEJM Supplement and does not include the imputation for use of anti-depressants (see appendix for the trial protocol analysis)

7 | © CompassPathways

*N Engl J Med 2022;387:1637-48. DOI: 10.1056/NEJMoa2206443

Phase 2b most frequent TEAEs ordered by the 25mg arm

(at least 5% in any treatment group)

COMP360

Overall

25mg

10mg

1mg

MedDRA TEAE preferred term

N=79

N=75

N=79

N=233

n (%)

Headache

(34.2)

16 (21.3)

20 (25.3)

63 (27.0)

Nausea

18 (22.8)

(9.3)

4 (5.1)

29 (12.4)

Fatigue

(15.2)

(6.7)

7 (8.9)

24 (10.3)

Insomnia

8 (10.1)

11 (14.7)

(17.7)

33 (14.2)

Anxiety

(8.9)

(17.3)

3 (3.8)

23 (9.9)

Mood altered

(8.9)

3 (4.0)

(1.3)

11 (4.7)

Back pain

(7.6)

3 (3.8)

9 (3.9)

Dizziness

(7.6)

(1.3)

8 (3.4)

Suicidal ideation

(6.3)

(6.7)

4 (5.1)

14 (6.0)

Myalgia

5 (6.3)

2 (2.7)

1 (1.3)

8 (3.4)

Euphoric mood

4 (5.1)

(6.7)

4 (5.1)

13 (5.6)

Depression

4 (5.1)

6 (8.0)

5 (6.3)

15 (6.4)

Abdominal pain upper

4 (5.1)

(2.7)

(1.3)

7 (3.0)

Irritability

4 (5.1)

(2.7)

(1.3)

7 (3.0)

Panic reaction

4 (5.1)

(1.3)

6 (2.6)

Depressed mood

(3.8)

(6.7)

4 (5.1)

12 (5.2)

Paraesthesia

(3.8)

4 (5.3)

(1.3)

8 (3.4)

Thinking abnormal

4 (5.3)

4 (1.7)

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 incidence in the 25mg arm

Note: MedDRA = Medical Dictionary for Regulatory Activities; TEAE = treatment emergent adverse event; N = number of participants in the population; n = number observed

Phase 2b trial: COMP360 psilocybin treatment was generally well-tolerated

Treatment-emergent adverse events (TEAEs)

>90% of TEAEs were of mild or moderate severity.

most frequent TEAEs

5 across the 10mg and 25mg doses were headaches, nausea, fatigue, insomnia and anxiety.

of TEAEs occurring on the

>77% day of administration resolved on the same or next day; most were mild or moderate.

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.

TESAEs of suicidal ideation, suicidal behaviour and intentional self-injury were uncommon but occurred unevenly across groups in non-responders

Planning for commercial execution through an existing and well- established infrastructure of interventional psychiatry treatment centers

If approved, COMP360 is expected to be delivered to patients through an established infrastructure of interventional psychiatry treatment centers

Strategic collaborations have been established between Compass and a variety of treatment center models across the US to help inform preparation for a scalable delivery model for COMP360, if approved

Current interventional psychiatry treatments are delivered frequently#, allowing for operational experience at the treatment centers, but requiring a cumulatively high number of hours of patient and provider time

Spravato® (esketamine):

ketamine:

20-28 treatments(1)

12-15 treatments(6)

TMS:

ECT:

30-36 treatments(2)(5)

6-12+ treatments (3)(4)

If approved, COMP360 and the services/time* provided at treatment centers are expected to be reimbursed by Payers

Disclaimer

Compass Pathways plc published this content on March 02, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 02, 2025 at 22:59:05.489.