Ataibeckley Inc. · NASDAQ:ATAI
Ataibeckley — ATAI Life Sciences — Investor Presentation (November 2024)
42 slides from Ataibeckley's investor presentation, Nov 13, 2024
Slide 1: Company Overview – November 2024
Healing mental health disorders so that everyone everywhere can live a more fulfilled life. Company Overview Company Overview – November 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: Executive Summary and Key Highlights
atai Life Sciences: addressing significant unmet patient needs in mental health disorders so that everyone, everywhere can live a more fulfilled life Executive Summary and Key Highlights 03 1 Significant unmet need: mental health disorders are one of the largest global health burdens; it is estimate
Slide 4: Programs Overview
Our vision is being delivered through a robust pipeline of development programs and strategic investments across a range of compounds and psychiatric indications Programs Overview Abbreviations: DMT = N,N-Dimethyltryptamine; R-MDMA = R enantiomer of 3,4-Methylenedioxymethamphetamine; 5-MeO-DMT = 5
Slide 5: Upcoming Catalysts
We are funded through all expected milestones across our drug development programs and strategic investments for 2024 and 2025 Upcoming Catalysts Abbreviations: OL = Open-label; TRD = Treatment Resistant Depression; MDD = Major Depressive Disorder; PTSD = Post Traumatic Stress Disorder; AUD = Alcoho
Slide 6: RL-007 for Cognitive Impairment
RL-007 for Cognitive Impairment
Slide 7: SUMMARY: RL-007
Note: CIAS = Cognitive impairment associated with schizophrenia All dates provided for expected milestones are estimated SUMMARY: RL-007 RL-007 is a potential pro-cognitive neuromodulator, investigated in >500 participants and demonstrating consistent cognitive effects and good tolerability (2R, 3S)
Slide 8: Cognitive impairment is very common
World Health Organization Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016 Cloutier et al, The economic burden of schizophrenia in the Un
Slide 9: RL-007: Phase 2a Results
atai’s Phase 2a study in CIAS demonstrated RL-007’s potential to improve cognitive signals on a subset of MCCB neurocognitive endpoints RL-007: Phase 2a Results 09 Day 2 “pre-RL-007” was compared to Day 4 “post-RL-007” Abbreviations: MCCB = MATRICS™ Consensus Cognitive Battery PHASE 2A TRIAL - EFFIC
Slide 10: RL-007: Phase 2b Study Design
A randomized, placebo-controlled study of RL-007 is currently underway in ~234 patients with CIAS with topline data anticipated in mid’2025 RL-007: Phase 2b Study Design 10 Abbreviations: MCCB = MATRICS™ Consensus Cognitive Battery, TID = 3x/day dosing, Trial status: First patient dosed in 1Q’23, To
Slide 11: VLS-01 (DMT) for TRD
VLS-01 (DMT) for TRD
Slide 12: SUMMARY: VLS-01
SUMMARY: VLS-01 Abbreviations: DMT = N,N-Dimethyltryptamine; TRD= Treatment Resistant Depression; GAD = Generalized Anxiety Disorder; AUD = Alcohol Use Disorder; PK/PD = Pharmacokinetic/Pharmacodynamic; PCT = Patent Cooperation Treaty; OTF = Oral Transmucosal Film All dates provided for expected mil
Slide 13: Treatment resistant depression burden
World Health Organization (2020) World Health Organization – Disease Burden 2000-2019 (2020) Greenberg et al., “The Economic Burden of Adults with Major Depressive Disorder in the United States (2010 and 2018)” (2021) Salzer, “National Estimates of Recovery-Remission From Serious Mental Illness”, Ps
Slide 14: VLS-01: Commercial Potential
A key differentiator for VLS-01 from other psychedelic-like compounds could be its potential to leverage the 2-hour in-clinic treatment paradigm established by Spravato® VLS-01: Commercial Potential 15 ANTICIPATED TIME TO RESOLUTION OF SUBJECTIVE EFFECTS1 (in hours) Illustrative Spravato® VLS-01 BPL
Slide 15: VLS-01: Phase 1b Clinical Trial Design
We have completed dosing in a Phase 1b trial investigating the PK, PD, safety and tolerability of an optimized buccal formulation of VLS-01 compared to DMT IV VLS-01: Phase 1b Clinical Trial Design Abbreviations: IV = Intravenous; OTF = Oral Transmucosal Film; PK / PD = Pharmacokinetic / Pharmacodyn
Slide 16: VLS-01: Phase 1b Results
Higher doses of VLS-01 demonstrated a plasma concentration (C-Max) comparable to DMT IV and robust subjective effects that resolved in ~2 hours VLS-01: Phase 1b Results 17 Pharmacokinetics (PK) C-Max was dose-proportional and comparable between the higher VLS-01 doses (120mg and 160mg) and the 30mg
Slide 17: VLS-01: Phase 1b Results (safety)
Optimized VLS-01 OTF had a favourable safety profile in Ph1b study with most adverse events classified as either mild or moderate, and most resolving on the day of dosing VLS-01: Phase 1b Results 18 1 Blood pressure and heart rate increases were transient and mostly resolved within 90 min without in
Slide 18: VLS-01: Phase 2 Study Design
We are now initiating a randomized, double-blind, placebo-controlled, Phase 2 study to assess the efficacy of repeated doses of VLS-01 in ~142 participants with TRD VLS-01: Phase 2 Study Design 19 VLS-01 PHASE 2 STUDY DESIGN (PRELIMINARY) Treatment Period 1 Dose 1: VLS-01 120mg R Randomized 1:1 Tota
Slide 19: EMP-01 (R-MDMA) for Social Anxiety Disorder
EMP-01 (R-MDMA) for Social Anxiety Disorder
Slide 20: SUMMARY: EMP-01
SUMMARY: EMP-01 EMP-01 is an oral formulation of R-MDMA, a moiety that is pharmacologically distinct from both racemic MDMA and S-MDMA Oral formulation of the R-enantiomer of MDMA (EMP-01) Monoamine releaser and reuptake inhibitor with prominent effects on serotonin (5-HT) First-in-class psychedelic
Slide 21: Anxiety in numbers
Schizophrenia SAD patients in the US Approximately 7.1% of US adults, or ~18 million individuals, suffered from Social Anxiety Disorder (SAD) in the past year4 ~18m Anxiety in numbers ~40m Suffer from anxiety disorders in the US1 ~$42bn Annual societal cost of anxiety disorders in the US3 #1 Most co
Slide 22: EMP-01: Unique Profile of R-MDMA
Our findings present the possibility that R-MDMA may offer unique pharmacological benefits to racemic MDMA, and with a lower risk for adverse effects EMP-01: Unique Profile of R-MDMA 22 Curry DW, Young MB, Tran AN, Daoud GE, Howell LL. Separating the agony from ecstasy: R(-)-3,4-methylenedioxymetham
Slide 23: EMP-01: Phase 1 Results
In a completed Phase 1 study, EMP-01 was generally well tolerated, with no severe or serious adverse events observed EMP-01: Phase 1 Results 23 1 2 5 Only 1/24 participants (4%) experienced bruxism, grinding of teeth, which is a common side effect of racemic MDMA Observed changes in both pulse and b
Slide 24: EMP-01: Phase 1 Results
In Phase 1 study, dose-dependent increases in acute emotional breakthroughs and increased measures of self-compassion observed 1 week post EMP-01 dose EMP-01: Phase 1 Results 24 1 Some measures of self-compassion also significantly increased with the 225mg dose of EMP-01 at the 1-week follow-up visi
Slide 25: EMP-01: Phase 1 Results
In Phase 1 study, EMP-01 also demonstrated a dose-dependent, psychedelic-like experience with a subjective effect profile more like classical psychedelics than MDMA EMP-01: Phase 1 Results 25 Oceanic Boundlesness Vigilance Reduction Visionary Restructuazilation Dread of Ego Dissolution Auditory Alte
Slide 26: EMP-01: Phase 2 Study Design
We are initiating an exploratory Phase 2a, placebo-controlled study to assess the safety and efficacy of two 225 mg doses of EMP-01 versus placebo in adults with SAD EMP-01: Phase 2 Study Design 26 Design: Phase 2a, randomized, double-blind, placebo-controlled study Adult participants diagnosed with
Slide 27: IBX-210 (IV-Ibogaine) for Opioid Use Disorder
IBX-210 (IV-Ibogaine) for Opioid Use Disorder
Slide 28: 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 29: Clinical Evidence: oral ibogaine 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 & safety of oral ibogaine in open-label study PRIOR CLINICAL EVIDENCE (THIRD PARTY STUDY1) Note: TRD = Treatment Resistant Depression; DMT = N,N-Dimethyl
Slide 30: 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 31: BPL-003 (5-MeO-DMT) for TRD & AUD
BPL-003 (5-MeO-DMT) for TRD & AUD Strategic Investment into Beckley Psytech
Slide 32: SUMMARY: BPL-003
SUMMARY: BPL-003 Abbreviations: TRD = Treatment Resistant Depression, AUD = Alcohol Use Disorder As of January 4th 2024. Terms of the strategic investment also included a 1:1 warrant coverage on the Primary Investment. atai also holds a time-limited right of first refusal on a future sale of the com
Slide 33: BPL-003: Phase 1 Results
BPL-003 had a favorable safety profile and was well tolerated in a Phase 1 study, with no observed serious or severe adverse events BPL-003: Phase 1 Results 1 n = number of partcipants reporting at least one TEAE in that category, % - rounded proportion of cohort total Abbreviations: TEAE = Treatmen
Slide 34: 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 35: BPL-003: Phase 2a Clinical Trial Design
Completed Part 1 of an open-label Phase 2a study investigating BPL-003 as a therapy for patients with TRD 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 BPL-003 PHASE 2A STUD
Slide 36: BPL-003: Phase 2a TRD 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 TRD Results Source: internal Beckley Psytech data Response rate defined as ≥50% reduction in MADRS score and Remission
Slide 37: BPL-003: Phase 2b TRD Clinical Trial Design
BPL-003 is actively recruiting for its ongoing Phase 2b study, a randomized, quadruple-masked, monotherapy study in moderate to severe TRD patients BPL-003: Phase 2b TRD Clinical Trial Design 1 Patients entering the open-label extension are randomized to receive either a single 12mg dose or a biphas
Slide 38: ELE-101 (Psilocin) for MDD
ELE-101 (Psilocin) for MDD Strategic Investment into Beckley Psytech
Slide 39: SUMMARY: ELE-101
SUMMARY: ELE-101 Abbreviations: TRD = Treatment Resistant Depression; PTSD = Post Traumatic Stress Disorder As of January 4th Goodwin et al, 2022; Raison et al, 2023 All dates provided for expected milestones are estimated Optimized formulation: intravenous formulation enables an improved PK profile
Slide 40: ELE-01: IV Psilocin
ELE-101 is design to demonstrate 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.
Slide 41: ELE-101: Phase 1/2a Clinical Trial Design
A Phase 1/2a study is currently underway: Part A, a dose-escalation study in healthy volunteers, is complete and dosing has initiated for Part B, an open-label study in MDD ELE-101: Phase 1/2a Clinical Trial Design ELE-101 Phase 1/2a – Part A Topline data1: Well-tolerated with no serious or severe a
Slide 42: atai
atai LIFE SCtEN@ES Nasdaq: ATAI
ATAI Life Sciences — Investor Presentation (November 2024) on 6ix