Ataibeckley Inc. · NASDAQ:ATAI
Ataibeckley — ATAI Life Sciences — Investor Presentation (June 2024)
37 slides from Ataibeckley's investor presentation, Jun 5, 2024
Slide 1: Company Overview – June 2024
Healingmental health disorders so that everyone everywhere can live a more fulfilled life. Company Overview Company Overview – June 2024
Slide 2: Forward-looking statements disclaimer
All references in this presentation to “we”, “us”, “our”, “atai”, or the “Company” refer to ATAI Life Sciences N.V. and its consolidated subsidiaries, unless the context otherwise requires. This presentation contains forward-looking statements within the meaning of the private Securities Litigation
Slide 3: atai Life Sciences Highlights
atai Life Sciences: Healing mental health disorders so that everyone everywhere can live a more fulfilled life Highlights 03 1 Mental health disorders are one of the largest global health burdens; in 2019, 1 in every 8 people, or approx. 1 billion people around the world, were living with a mental d
Slide 4: Robust portfolio of psychedelic and non-psychedelic drug development programs and strategic investments
Our strategy to be delivered through a robust portfolio of psychedelic and non-psychedelic drug development programs and strategic investments Drug Development Programs and Strategic Investments PSYCHEDELIC PROGRAMS & STRATEGIC INVESTMENTS Preclin Phase 1 Phase 2 Phase 3 Programs / Investments RL-00
Slide 5: Upcoming Catalysts
We expect to deliver several meaningful R&D milestones anticipated across our key programs and strategic investments through 2024 and 20251 Upcoming Catalysts All dates provided are as estimated 05 Achieved and expected milestones1(2024-25) BPL-003Ph 2a OL (TRD) Part 1 data 2025 H2’24 H1’24 VLS-01Ph
Slide 6: Programs in Depression
Programs in Depression BPL-003, VLS-01, COMP360, ELE-101 06
Slide 7: atai's Depression Portfolio Comparison
A diverse portfolio of differentiated psychedelic assets to address the heterogeneity of patients who suffer from depression atai’s Depression Portfolio Comparison Associated Program Compound Primary Indication Route of Administration Receptor binding affinity (5-HT2A : 5-HT1A )1 Rapid Onset of Trea
Slide 8: Commercial Positioning: 2-hour interventional psychiatry paradigm
atai’s focus is on psychedelics with the potential to leverage the 2-hour interventional psychiatry treatment paradigm successfully established by Spravato® Commercial Positioning Anticipated in-clinic time based on duration of subjective effects1 (in hours) Illustrative Spravato® BPL-003 / VLS-01 /
Slide 9: BPL-003 (5-MeO-DMT) for TRD & AUD
BPL-003 (5-MeO-DMT) for TRD & AUD 09 Strategic Investment into Beckley Psytech
Slide 10: BPL-003: Phase 1 Results
Beckley Psytech’s BPL-003 had a favorable safety profile and was well tolerated in the Phase 1 SAD study, with no observed serious or severe adverse events BPL-003: Phase 1 Results 1 n = number of subjects reporting at least one TEAE in that category, % - rounded proportion of cohort total 10 Placeb
Slide 11: BPL-003: Phase 1 Results
12mg (n=5) 10mg (n=5) 8mg (n=5) 6mg (n=4) 4mg (n=4) 2.5mg (n=4) 1mg (n=4) Mean plasma concentration levels (ng/ml) Time post-dose (minutes) BPL-003 Phase 1 Pharmacokinetic Profile Pharmacokinetics (PK) Exposure was dose-proportional Rapid onset with mean Tmax of 6-17 min Mean half life of 15-30 min
Slide 12: BPL-003: Phase 2a Clinical Trial Design
Completed Part 1 of an open-label Phase 2a study investigating 10mg of BPL-003 as a monotherapy for TRD patients BPL-003: Phase 2a Clinical Trial Design Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale Screening Part 1: Monotherapy Open label Day 2 85 Completed Q1 2024 Phase 2a study
Slide 13: BPL-003: Phase 2a Results
BPL-003 produced meaningful clinical response and durable remission rates after just a single dose, and was generally well tolerated with no serious adverse events BPL-003: Phase 2a Results Source: internal Beckley Psytech data Response rate defined as ≥50% reduction in MADRS score and Remission rat
Slide 14: BPL-003: Phase 2b Clinical Trial Design
BPL-003 is actively recruiting for its ongoing Phase 2b study, a randomized, quadruple-masked, monotherapy study in 225 moderate to severe TRD patients BPL-003: Phase 2b Clinical Trial Design 1 Patients entering the open-label extension are randomized 1:1 to receive either a single 12mg dose or a bi
Slide 15: VLS-01 (DMT) for TRD
VLS-01 (DMT) for TRD 15
Slide 16: VLS-01: Product Overview
Potential for rapid onset, durable efficacy, and designed to fit within 2-hour in-clinic treatment paradigm VLS-01: Product Overview World Health Organization Salzer, “National Estimates of Recovery-Remission From Serious Mental Illness”, Psychiatry Online (2018) Abbreviations: OTF = Oral transmucos
Slide 17: VLS-01: Efficacy in Randomized Control Trial of DMT in TRD
Double-blind, randomized placebo-controlled trial with DMT in 29 patients with TRD demonstrated rapid & statistically significant changes on HAM-D & MADRS VLS-01: Efficacy in Randomized Control Trial of DMT in TRD PRIOR CLINICAL EVIDENCE (THIRD PARTY STUDY1) Double-blind, randomized placebo-controll
Slide 18: VLS-01: Phase 1 Clinical Trial Design & Results
Phase 1 results of VLS-01 showed it was safe and well-tolerated with dose-dependent increases in exposure VLS-01: Phase 1 Clinical Trial Design & Results Note: IV = Intravenous; OTF = Oral Transmucosal Film; PK / PD = Pharmacokinetic / Pharmacodynamic; DMT = N,N-Dimethyltryptamine; IV = Intravenous
Slide 19: COMP (Psilocybin) for TRD, PTSD and Anorexia
COMP 360 (Psilocybin) for TRD, PTSD and Anorexia 19 Strategic Investment into Compass Pathways
Slide 20: COMP360 Phase 2b trial showed rapid, sustained reduction in depressive symptoms
COMP360 Phase 2b trial showed a rapid, sustained reduction in depressive symptoms PRODUCT PHARMA-COLOGY PRODUCT FEATURES INDICATIONS CURRENT STATUS INTELLECTUAL PROPERTY Oral Psilocybin (COMP360) 5-HT2A-R agonist Rapid onset, potential for sustained efficacy after single dose Primary: Treatment Resi
Slide 21: COMP360: Phase 3 Trial Designs
COMPASS Pathways is currently conducting a Phase 3 pivotal program, with topline data expected in 4Q 2024 and mid 2025 COMP360: Phase 3 Trial Designs Source: Compass Pathways Capital Markets Day presentation as of May 11th, 2023 Primary endpoint = Change from baseline in MADRS total score at week 6
Slide 22: COMP360: Phase 2 PTSD Results
Open-label phase 2 study of COMP360 in post-traumatic stress disorder demonstrated an early onset and sustained improvement in PTSD symptoms at week 4 and week 12 COMP360: Phase 2 PTSD Results 22 Source: Compass Pathways NCT05312151 Response rate defined as a reduction of ≥ 15 points in CAPS-5 score
Slide 23: ELE-101 (Psilocin) for MDD
ELE-101 (Psilocin) for MDD 23 Strategic Investment into Beckley Psytech
Slide 24: ELE-01: IV Psilocin
Potential benefits of psilocybin’s active moiety in an optimized delivery and treatment model ELE-01: IV Psilocin 1 Psilocin simulations based on primary data from Brown et al. 2017, Madsen et al . 2019, Hasler et al. 1997, and Carhart-Harris et al. 2011. 2 Holze F. et al (2023). Pharmacokinetics an
Slide 25: ELE-101: Phase 1/2a Clinical Trial Design
Randomized, Phase 1 dose-escalation study in healthy volunteers followed by Phase 2a open-label study in MDD ELE-101: Phase 1/2a Clinical Trial Design ELE-101 Phase 1/2a – Part A Key Objectives: Safety and tolerability Assessment of PK & PD Target concentration of psilocin in <2 minutes Consistency
Slide 26: IBX-210 (IV-Ibogaine) for Substance Use Disorder
IBX-210 (IV-Ibogaine) for Substance Use Disorder 26
Slide 27: Product Overview: IBX-210 for Opioid Use Disorder
Post traumatic stress disorder and traumatic brain injury, respectively World Health Organization Salzer, “National Estimates of Recovery-Remission From Serious Mental Illness”, Psychiatry Online (2018) A single dose of ibogaine may support withdrawal and long-term relapse prevention in OUD patients
Slide 28: Clinical Evidence: Efficacy of ibogaine in Open-Label Study
Results from an open-label study of 8-12 mg/kg of ibogaine in patients seeking detoxification from opioids and cocaine Clinical Evidence: Efficacy of ibogaine in Open-Label Safety & Efficacy Study PRIOR CLINICAL EVIDENCE (THIRD PARTY STUDY1) Note: TRD = Treatment Resistant Depression; DMT = N,N-Dime
Slide 29: IBX-210 potential first and best in-class treatment for OUD
IBX-210 has the potential to become the first & best in-class treatment for OUD, minimizing risk of relapse SUMMARY IBX-210 could potentially become a paradigm-shifting therapy for Opioid Use Disorder (OUD) Current standard of care for OUD is medication therapy, requiring opioid substitutes that car
Slide 30: RL-007 for Cognitive Impairment
RL-007 for Cognitive Impairment 30
Slide 31: Product Overview: RL-007 for Cognitive Impairment
World Health Organization Schaffer et al., 2013 Bora et al, Cognitive Impairment in Schizophrenia and Affective Psychoses: Implications for DSM-V Criteria and Beyond GlobalData (as of 31/12/2023) Demonstrated consistent pro-cognitive effects in prior clinical trials, with a favorable safety profile
Slide 32: Clinical Evidence: Efficacy on Cognitive Endpoints in Phase 2
Third-Party Phase 2 study in DPNP showed statistically significant positive cognitive signals (exploratory endpoints) Note: * = P< 0.05 vs Placebo; N=60 patients/treatment group; dosed TID = 3x/day dosing; randomized, cross-over design Clinical Evidence: Efficacy on Cognitive Endpoints in a Phase 2
Slide 33: Efficacy Signals Reproduced in Phase 2a Study in CIAS
PHASE 2a TRIAL - EFFICACY DATA ON COMPONENTS MCCB COMPOSITE Signal of improvement n=7 n=8 n=8 n=8 Cohen’s d* (Symbol Coding): 20 mg: 0.79 40 mg: 0.56 80 mg: 0.38 *Active vs pbo T-Scores (Normalized for age, gender, and education level) atai’s Phase 2a study in CIAS demonstrated positive cognitive si
Slide 34: Clinical Trial Design: RL-007 Phase 2b Study
Clinical Trial Design: RL-007 Phase 2b Study Note: MCCB = MATRICS Consensus Cognitive Battery; BACS = Brief Assessment of Cognition in Schizophrenia; CIAS = Cognitive Impairment Associated with Schizophrenia; TID = 3x/day dosing Trial status: First patient dosed in 1Q’23, Topline data anticipated mi
Slide 35: GRX-917 for Anxiety Disorders
GRX-917 for Anxiety Disorders 35
Slide 36: Product Overview: GRX-917 for Anxiety Disorders
World Health Organization Anxiety and Depression Association of America (2021) GlobalData (as of 6/1/2023) - All recent approvals by the FDA have been reformulations of long-standing antidepressant and benzodiazepine options Designed to have rapid onset of anxiolytic activity but without the negativ
Slide 37: atai
atai LIFE SCtEN@ES Nasdaq: ATAI
ATAI Life Sciences — Investor Presentation (June 2024) on 6ix