Atai Life Sciences N : Company Presentation - March 2025

Published: 2025-03-03 14:30:04 ET ATAI

Healing mental health disorders so that everyone everywhere can live a more fulfilled life

Corporate Presentation - March 2025

atai's objective is to enable patients to achieve clinically meaningful improvements by developing innovative therapeutics with a focus on interventional treatments

Significant unmet need: mental health disorders are one of the largest global health burdens; it is estimated that one out of every two people in the world will develop a mental health disorder in their lifetime1

5 clinical-stageprograms: four psychedelic programs and one non-psychedelic program; our psychedelic programs focus on leveraging the "2-hour treatment window" pioneered by Spravato®

Multiple Phase 2 readouts expected over the next 12 months: several anticipated clinical trial readouts across our

drug development programs and strategic investments

Runway into 2027: cash and cash equivalents, marketable securities, and committed term loan funding expected to provide funding into 20272

Our vision is being delivered through a robust pipeline of clinical-stage programs across a range of compounds and psychiatric indications

Clinical Programs

Primary Indication

Preclin

Phase 1

Phase 2

Phase 3

Psychedelic Programs

VLS-01

Treatment Resistant Depression (TRD)

DMT

EMP-01

Social Anxiety Disorder (SAD)

R-MDMA

Beckley Psytech Strategic Investment

BPL-003

TRD

Mebufotenin benzoate

ELE-101

Major Depressive Disorder (MDD)

Psilocin

Non-psychedelic Program

RL-0071

Cognitive Impairment Associated with Schizophrenia (CIAS)

Pro-cognitive neuromodulator

Abbreviations: DMT = N,N-Dimethyltryptamine; R-MDMA = R enantiomer of 3,4-Methylenedioxymethamphetamine; -5MeO-DMT = 5-methoxy-N,N-dimethyltryptamine 1. Majority ownership stake in Recognify Life Sciences

Fully funded through multiple near-term milestones

ACHIEVED AND ANTICIPATED UPCOMING MILESTONES1,2

Q4'24

Q1'25

Q2'25

Q3'25

Q4'25

Q1'26

BPL-003

✓ Ph 2a (AUD)

Ph 2b (TRD)

Mebufotenin

benzoate

topline OL data

topline data

Ph 2a (TRD)

topline SSRI OL data

VLS-01

Ph 2 (TRD)

✓ trial initiation

topline data

DMT

EMP-01

Ph 2a (SAD)

R-MDMA

✓ trial initiation

topline data

RL-0073

Ph 2b (CIAS)

Pro-cognitive

topline data

neuromodulator

Abbreviations: OL = Open-label; TRD = Treatment Resistant Depression; SAD = Social Anxiety Disorder;; AUD = Alcohol Use Disorder; CIAS = Cognitive Impairment in Schizophrenia 1. All dates provided are as estimated

2. Trial initiation defined as central regulatory and ethics approval

3. Majority ownership stake in Recognify Life Sciences

Short duration psychedelics

BPL-003 and VLS-01 are novel, short-duration psychedelic candidates developed to optimize patient access for TRD

BPL-003

VLS-01

(Mebufotenin benzoate)

(N,N-dimethyltryptamine)

TARGET POSITION

First-in-class short-duration

Best-in-class route of administration and

psychedelic

tolerability for DMT

PHARMACOLOGY

5-HT1A/5-HT2A receptor agonist

5-HT2A receptor agonist

( 5-HT2A : 5 -HT1A binding affinit y 1 )

(1 : 0.009)

(1 : 3.4)

FORMULATION

Nasal spray

Buccal film

(transmucosal)

TREATMENT DURATION

~2 hours

DEVELOPMENT STAGE

Phase 2b; topline data anticipated mid '25

Phase 2; topline data anticipated Q1 '26

IND approved

INTELLECTUAL PROPERTY

COM and Methods;

additional pending

Abbreviations: TRD = Treatment Resistant Depression; IND = Investigational New Drug Application; COM = Composition of Matter

1. Dourron HM, Nichols CD, Simonsson O, Bradley M, Carhart-Harris R, Hendricks PS. 5-MeO-DMT: An atypical psychedelic with unique pharmacology, phenomenology & risk? Psychopharmacology (Berl). 2023 Dec

BPL-003, and VLS-01, have the potential to leverage Spravato® 2-hour in-clinic treatment paradigm in depression

ANTICIPATED TIME TO RESOLUTION OF SUBJECTIVE EFFECTS1

(in hours) Illustrative

Key Takeaways

~8 to 12

Average

workday

(8 hours)

~2 to 6*

Spravato®

BPL-003

VLS-01

Multi-dose

Psilocybin +

MDMA

LSD

5-MeO- analogs

DMT

Predictable 2-hour treatment: the potential to fit into the 2-hour in-clinictreatment paradigm established by Spravato

Established infrastructure and reimbursement: potential to

immediately leverage Spravato's reimbursement pathways and >4,500 certified clinics2

Extended durability reduces patient burden: 1-2doses of a psychedelic

therapy provides a sustained effect, simplifying the dosing schedule compared to esketamine's once-weekly regimen

Significantly improves use of infrastructure: lower dosing frequency compared to esketamine will lower provider burden, and improve payer receptivity

* If multi-dose required

VLS-01

(Buccal Film DMT) for

TRD

SUMMARY:VLS-01 (buccalVLS-01film DMT) is a patent-protected formulation, designed to fit into established ~2-hourinterventional psychiatry treatment paradigm for TRD

Optimized transmucosal buccal film formulation: Phase 1 study demonstrated favorable safety & tolerability and an IV-like PK profile, which may support a more scalable patient / provider experience

Short duration psychedelic effect: Phase 1 data suggests subjective effects experienced for ~2 hours, potentially enabling VLS-01 to fit into interventional psychiatry paradigm established by Spravato®

Potential for rapid onset and durable efficacy: Prior clinical evidence with DMT has generated sustained, clinically meaningful improvement on depressive symptoms1

Patent protected formulation: Issued patents and pending applications covering compositions and methods of use (expiry anticipated 20422)

Abbreviations: DMT = N,N-Dimethyltryptamine; TRD= Treatment Resistant Depression; PK = Pharmacokinetic;

1. Palhano-Fontes F et al, Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial. Psychol Med. 2019

2. Exclusive of possible patent term adjustments or extensions or other forms of exclusivity. For additional detail please see the most recent 10-K filing

VLS-01: Phase 1b clinical trial design

Phase 1b trial investigating the PK, PD, safety and tolerability of optimized buccal film formulation compared to DMT IV

VLS-01 PHASE 1B STUDY DESIGN

SCREENING

Treatment Period 1: Single

dose DMT IV

Cohort 1 (n=8)

Dose 1:

57-min 30mg IV

infusion

Cohort 2 (n=9)

Dose 1:

57-min 30mg IV

infusion

Day 1

Treatment Period 2:

Repeated dosing VLS-01

Dose 1:

Dose

Dose 3:

160mg BF

60mg

120mg BF

Dose 1:

Dose 2:

Dose 3:

60 or 20mg

160mg BF

120mg BF

Day 29

Day 57

Day 85

END OF STUDY

Day 99

Study Design:

Primary Endpoint:

Key Secondary Endpoints:

Abbreviations: IV = Intravenous; BF = Buccal film; PK / PD = Pharmacokinetic / pharmacodynamic

Disclaimer

ATAI Life Sciences NV published this content on March 03, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 03, 2025 at 19:29:07.274.