Ataibeckley Inc. · NASDAQ:ATAI
Ataibeckley — ATAI Life Sciences — Investor Presentation (January 2024)
34 slides from Ataibeckley's investor presentation, Jan 4, 2024
Slide 1: Company Overview – January 2024
Healingmental health disorders so that everyone everywhere can live a more fulfilled life. Company Overview Company Overview – January 2024
Slide 2: Forward-looking statements
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: Healing mental health disorders
1 Mental health disorders are one of the largest global health burdens; in 2019, 1 in every 8 people, or 970 million people, around the world were living with a mental disorder1 3 Eight clinical-stage drug development programs and strategic investments, each with a robust package of prior clinical e
Slide 4: Robust portfolio of psychedelic and non-psychedelic drug development programs
Our strategy will be delivered through a robust portfolio of psychedelic and non-psychedelic drug development programs and strategic investments 04 PSYCHEDELIC PROGRAMS & STRATEGIC INVESTMENTS Preclin Phase 1 Phase 2 Phase 3 Programs / Investments RL-007 / Pro-cognitive neuromodulator3 GRX-917 / Deu
Slide 5: Expected R&D milestones over next 18 months
We expect to deliver several meaningful R&D milestones across our key programs over next 18 months3 05 atai Life Sciences: Operational Focus & Program Guidance Initial Phase 1 results in 3Q ’23 Submit FDA meeting request in 1H’24 Initial Ph 1 results in 2Q‘23 Additional Ph 1 data in 3Q’23 Ph 1b firs
Slide 6: BPL-003 (5-MeO-DMT) for TRD & Alcohol Use Disorder
BPL-003 (5-MeO-DMT) for TRD & Alcohol Use Disorder 06
Slide 7: BPL-003 Phase 1 Pharmacokinetic Profile
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 Key Findings Safety All adverse events (AEs) were mild (89.5%) or moderate (10.5%); no Serious AEs occurred Most common
Slide 8: BPL-003 Phase 2a open-label monotherapy study in TRD
BPL-003 Phase 2a is an open-label monotherapy study in TRD patients BPL-003 Phase 2a Clinical Trial Design Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale; CGI-S = Clinical Global Impressions-Severity; PGIC = Patient's Global Impression of Change; EQ-5D = EuroQol-5D 8 Screening 10mg
Slide 9: BPL-003 Phase 2b randomized, double-blind study in TRD
BPL-003 Phase 2b is a randomized, double-blind, single-dose monotherapy study in 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 biphasic 4mg and 8mg dose approximately 10
Slide 10: VLS-01 (DMT) for TRD
VLS-01 (DMT) for TRD 10
Slide 11: Product Overview: VLS-01 for Depression
World Health Organization Salzer, “National Estimates of Recovery-Remission From Serious Mental Illness”, Psychiatry Online (2018) Health Volunteer Study Designed for a potential rapid, sustained reduction in depressive symptoms from a single dose Product Overview: VLS-01 for Depression Lead indicat
Slide 12: Efficacy in Randomized Control Trial of DMT in TRD
12 Double-blind, randomized placebo-controlled trial with DMT in 29 patients with treatment-resistant-depression Clinical Evidence: Efficacy in Randomized Control Trial of DMT in TRD PRIOR CLINICAL EVIDENCE (THIRD PARTY STUDY1) Double-blind, randomized placebo-controlled trial of Ayahuasca (DMT is m
Slide 13: VLS-01 Phase 1: Clinical Trial Design & Results
13 VLS-01 Phase 1: Clinical Trial Design & Results VLS-01 was well-tolerated with a favorable safety profile, with dose-dependent increases in exposure confirmed Note: IV = Intravenous; OTF = Oral Transmucosal Film; PK / PD = Pharmacokinetic / Pharmacodynamic; DMT = N,N-Dimethyltryptamine Program st
Slide 14: COMP (psilocybin) for TRD, PTSD and Anorexia
COMP 360 (psilocybin) for TRD, PTSD and Anorexia 14
Slide 15: COMP360 Phase 2b 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 16: COMPASS Pathways Phase 3 pivotal program
16 COMPASS Pathways is currently conducting a Phase 3 pivotal program, with topline data expected in summer-2024 and mid-2025 Week 6 Primary endpoint1 Week 3 Proceeded by long-term follow up Pivotal study 1 Single dose monotherapy (COMP 005) COMP360 25mg Placebo Randomization = 2:1 Target N2 = 255 T
Slide 17: ELE-101 (psilocin) for MDD
ELE-101 (psilocin) for MDD 17
Slide 18: Potential benefits of IV psilocin delivery
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 19: 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 19 ELE-101 Phase 1/2a – Part A Key Objectives: Safety and tolerability Assessment of PK & PD Target concentration of psilocin in <2 minutes Consistenc
Slide 20: DMX-1002 (ibogaine) for Substance Use Disorder
DMX-1002 (ibogaine) for Substance Use Disorder 20
Slide 21: Product Overview: DMX-1002 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) Designed to have a rapid, sustained reduction in depressive symptoms through psychedelic effects
Slide 22: Efficacy of ibogaine in Open-Label Safety and Efficacy Study
22 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 and Efficacy Study PRIOR CLINICAL EVIDENCE (THIRD PARTY STUDY1) Note: TRD = Treatment Resistant Depression; DMT = N,N
Slide 23: DMX-1002 Phase 1 Trial Design & Results Summary
Demonstrated safety level and plasma concentrations of DMX-1002 in line with previous trials Phase 1 Study: DMX-1002 Trial Design & Results Summary COMPLETED PHASE 1 TRIAL: SINGLE ASCENDING DOSE No serious adverse events reported Nearly all adverse events were mild-to-moderate (>94%), consistent wit
Slide 24: DMX-1002 potential first and best in-class treatment for OUD
DMX-1002 has the potential to become the first & best in-class treatment for OUD, minimizing risk of relapse SUMMARY DMX-1002 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 c
Slide 25: RL-007 for Cognitive Impairment
RL-007 for Cognitive Impairment 25
Slide 26: Product Overview: RL-007 for Cognitive Impairment
World Health Organization Bora et al, Cognitive Impairment in Schizophrenia and Affective Psychoses: Implications for DSM-V Criteria and Beyond GlobalData (as of 6/1/2023) 4. Schaffer et al., 2013 Demonstrated consistent pro-cognitive effects in prior clinical trials, with a favorable safety profile
Slide 27: Efficacy on Cognitive Endpoints in a Phase 2 Study
27 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
Slide 28: 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 29: Clinical Trial Design: RL-007 Phase 2b Study
29 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
Slide 30: GRX-917 for Anxiety Disorders
GRX-917 for Anxiety Disorders 30
Slide 31: 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 32: GRX-917 Phase 1 Trial Design & Results Summary
32 Note: PK / PD = Pharmacokinetic / Pharmacodynamic; qEEG = Quantitative electroencephalography; BID = Twice daily Demonstrated a rapid and dose-dependent PK/PD effect along with a favourable safety profile Phase 1 Study: GRX-917 Trial Design & Results Summary COMPLETED PHASE 1 TRIAL Part 2: Multip
Slide 33: GRX-917 Pharmacodynamic Evidence of Target Engagement
33 Phase 1 Study: GRX-917 Pharmacodynamic Evidence of Target Engagement Beta Power ∆ (µV2) ∆ Placebo (n=14) ∆ GRX-917 (200mg+300mg, n=25) p = 0.05 p = 0.03 p = 0.02 p = 0.03 p = 0.03 * * * * * Sensitivity Analysis: Line plot showing Beta power ∆ (mean±SEM) at each hour for placebo and GRX-917 (combi
Slide 34: atai Life Sciences
atai LIFE SCtEN@ES Nasdaq: ATAI
ATAI Life Sciences — Investor Presentation (January 2024) on 6ix