Ataibeckley Inc. · NASDAQ:ATAI
Ataibeckley — Investor Day (March 2026)
56 slides from Ataibeckley's investor day presentation, Mar 6, 2026
Slide 1: Creating breakthroughs in mental health Investor Day
Creating breakthroughs in mental health Investor Day March 6, 2026
Slide 2: Disclaimer and forward-looking statements
The following disclaimer applies to this Presentation of AtaiBeckley (the “Company”). For the purposes of this disclaimer, “Presentation” means this document, its contents or any part of it, any oral presentation, any question or answer session and any written or oral material discussed or distribut
Slide 3: Investor Day Agenda
Investor Day Agenda 3 Abbreviations: KOL = Key Opinion Leader. Agenda Item Time Speaker Strategy and Pipeline 9:00am-9:15am Srinivas Rao BPL-003 Clinical Overview 9:15am-9:45am Kevin Craig Intellectual Property 9:45am-9:55am Ryan Barrett BPL-003 Commercial Framework 9:55am-10:30am Kavita Panke Break
Slide 4: AtaiBeckley Strategy and Pipeline Overview
AtaiBeckley Strategy and Pipeline Overview Srinivas Rao, M.D., Ph.D. Co-Founder and CEO
Slide 5: AtaiBeckley is a global leader in transformative mental health therapies
AtaiBeckley is a global leader in transformative mental health therapies 5 Abbreviations: TRD = Treatment-Resistant Depression; SAD = Social Anxiety Disorder. Rapid and durable clinical impact Built for commercial scalability from Day 1 Comprehensive IP across the pipeline Major indications with hig
Slide 6: Pipeline of novel psychedelic-based neuroplastogens
AtaiBeckley’s pipeline of novel psychedelic-based neuroplastogens is designed to address urgent unmet needs in mental health 6 1. All timing provided is estimated; 2. Trial initiation defined as central regulatory and ethics approval. Abbreviations: DMT = Dimethyltryptamine; FDA = Food and Drug Admi
Slide 7: Two key markets: depression and anxiety
We are positioned in two key markets, depression and anxiety, representing the two most common mental disorders in the US and a high disease burden 7 1. Research & Markets, “United States Anxiety Disorders and Depression Treatment Market Research Report 2025-2033”, (2025); 2. SAMHSA, “Key Substance
Slide 8: Next-generation therapies needed to address gaps in mental health care
Next‑generation therapies are needed to address gaps in mental health care 8 1. Tew et al., “Impact of prior treatment exposure on response to antidepressant treatment in late life,” Am J Geriatr Psychiatry. (2006); 2. Kajumba et al., “Treatment‑resistant depression: molecular mechanisms and managem
Slide 9: Psychedelics engage distinct biological pathways
Psychedelics engage distinct biological pathways that connect subjective experience and neuroplastic changes into lasting therapeutic effect 9 Neurogenesis Synaptic Growth Network Connectivity DMN Disruption & Reset Altered State ofConsciousness Perceptual Shift Cognitive Reappraisal Emotional Relea
Slide 10: Interventional psychiatry evolving toward short-session psychedelics
Interventional psychiatry is evolving toward short-session, low-burden psychedelics that provide lasting therapeutic effects 10 First-Generation Long-Time-in-Clinic Psychedelics Second-Generation Short-Time-in-Clinic Psychedelics Emergence of Interventional Psychiatry Decreasing Burden of Treatment
Slide 11: Commercial vision in TRD: intermittently dosed, rapid-acting, durable treatment
Our commercial vision in TRD is to develop an intermittently dosed, rapid-acting, durable treatment that fits into the established 2-hour in-clinic model 11 1. Subject to further validation through future clinical studies and real-world evidence. Note: No head-to-head studies have been conducted eva
Slide 12: Why psychedelics, why AtaiBeckley, why now
It’s our time to lead as psychedelics, our purpose-built pipeline, and the interventional psychiatry market converge 12 WHY PSYCHEDELICS? WHY ATAIBECKLEY? WHY NOW? Fast circuit reset Durable benefit with intermittent dosing Address neurobiological vulnerability Execution-focused team with deep exper
Slide 13: Entering 2026 with multiple anticipated clinical milestones
BPL-003 End-of-Phase 2 FDA meeting BPL-003 Phase 3 initiation BPL-003 two-dose Phase 2a initial data (Q4’26) We are entering 2026 with multiple anticipated clinical milestones that have the potential to drive significant value 13 Abbreviations: EOP2 = End of Phase 2; FDA = Food and Drug Administrati
Slide 14: BPL-003 Mebufotenin benzoate nasal spray for TRD
BPL-003 Mebufotenin benzoate nasal spray for TRD Kevin Craig, M.D. Chief Medical Officer
Slide 15: BPL-003 dry-powder intranasal formulation of mebufotenin
BPL-003 is a dry-powder, intranasal formulation of mebufotenin that acts as a serotonin receptor agonist (predominantly 5-HT1a and 5-HT2a) 15 Abbreviations: FDA = Food and Drug Administration. Multiple Ph1 and Ph2 trials of BPL-003 have demonstrated a favorable safety and efficacy profile; following
Slide 16: Routes of administration shape clinical experience, PK, and scalability
Different routes of administration shape clinical experience, PK, and scalability 16 HIGH TRD COSTS Intranasal (e.g., BPL-003)1 IV Infusion1 Buccal / Sublingual (e.g., VLS-01)1 Vaporization / Inhalation1 Oral1 Rapid transmucosal absorption Consistent PK Familiar workflow Rapid transmucosal absorptio
Slide 17: Phase 2b Data
4 Phase 2b Data
Slide 18: Phase 2b data supporting Phase 3 advancement
Phase 2 data demonstrated a compelling, scalable profile supporting phase 3 advancement 18 1. For patients who received an active dose of BPL-003 in the core study (either 8 mg or 12 mg). Abbreviations: MADRS = Montgomery-Åsberg Depression Rating Scale; OLE = Open-Label Extension. Phase 2b & OLE dat
Slide 19: Phase 2b trial design with open-label extension
Randomized, quadruple-masked Phase 2b clinical trial of BPL-003 in patients with moderate to severe TRD, with an open-label extension 19 1. Patients entering the open-label extension were randomized to receive either a single 12mg dose or a biphasic 4mg and 8mg dose approximately 10 minutes apart; 2
Slide 20: Core study final results: primary endpoint met
Core study final results: Single-dose of BPL-003 met primary endpoint, with effects sustained out to Week 8 20 Abbreviations: LS = Least Squares; MADRS = Montgomery–Åsberg Depression Rating Scale; SEM = Standard Error Means. BPL-003 | CHANGE FROM BASELINE IN MADRS TOTAL SCORE – 12 MG & 8 MG VS. 0.3
Slide 21: Overview of MADRS outcomes across psychedelic studies in TRD
Overview of MADRS outcomes across psychedelic clinical studies in TRD 21 1. Ionescu et al., “Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study
Slide 22: High completion and rollover rate into OLE study
High completion rate in core study and rollover rate into OLE study suggest strong levels of patient acceptability for BPL-003 22 1. Eligibility for the OLE study required completion of the core study and regulatory & ethics approval of the OLE protocol at the participants’ site. 126 out of 174 tota
Slide 23: Open-label extension study design
Open-label extension (OLE) study designed to assess the safety and efficacy of a 12 mg dose of BPL-003, given 8 weeks after initial dose 23 1. Eligibility for the OLE study required completion of the core study and regulatory & ethics approval of the OLE protocol at the participants’ site. 126 out o
Slide 24: Second dose produced additional antidepressant effects
Second dose of BPL-003 produced additional clinically meaningful antidepressant effects, sustained for a further 8 weeks 24 1. Core study efficacy analyses were conducted using a mixed model for repeated measures (MMRM); open-label extension results are based on observed data. Abbreviations: MADRS =
Slide 25: Responder rates improved following a second dose
Responder rates improved following a second dose of BPL-003 25 1. Response defined as ≥50% improvement in MADRS score. Abbreviations: OLE = Open-Label Extension. BPL-003 | RESPONDER RATES IN CORE AND OLE STUDIES - EXPLORATORY Day 2 Day 8 Day 29 Day 57 Day 2 (OLE) Day 8 (OLE) Day 29 (OLE) Day 57 (OLE
Slide 26: Remission rates continued to improve after second dose
Remission rates also continued to improve following a second dose of BPL-003 26 1. Remission defined as MADRS score of ≤10. Abbreviations: OLE = Open-Label Extension. BPL-003 | REMISSION RATES IN CORE AND OLE STUDIES - EXPLORATORY Day 2 Day 8 Day 29 Day 57 Day 2 (OLE) Day 8 (OLE) Day 29 (OLE) Day 57
Slide 27: BPL-003 generally well-tolerated
BPL-003 was generally well-tolerated, with majority of adverse events characterised as mild or moderate and transient in nature 27 1. Includes the preferred terms Blood pressure increased, Blood Pressure diastolic increased and Blood pressure systolic increased; 2. One serious drug-related adverse e
Slide 28: Key takeaways
Key takeaways 28 Abbreviations: TRD = Treatment-Resistant Depression. This Phase 2b clinical study – the largest study of mebufotenin to date – met its primary and key secondary endpoints 8mg and 12mg BPL-003 resulted in rapid and durable antidepressant effects compared with the 0.3mg dose Both acti
Slide 29: BPL-003 Pivotal Program
4 BPL-003 Pivotal Program
Slide 30: BPL-003 pivotal program overview for TRD
BPL-003 pivotal program overview for TRD 30 Abbreviations: EOP2 = End of Phase 2; FDA = Food and Drug Administration; OLE = Open-Label Extension; TRD = Treatment-Resistant Depression. Designed to maximize probability of clinical, regulatory, and commercial success BPL-003 Global Pivotal Program Two
Slide 31: Why ReConnection? TRD experienced as disconnection
Why "ReConnection"?Unmet need: Treatment-Resistant Depression Is Experienced as Disconnection 31 Our research showed the top unaided burdens of TRD: Disconnection from Life Loss of participation in meaningful activities Disconnection from Loved Ones Breakdown of intimate relationships Disconnection
Slide 32: Aligned with FDA on Phase 3 program with two pivotal trials
Aligned with FDA on a Phase 3 program with two pivotal trials that aim to demonstrate robust efficacy and long-term safety and allow for flexible dosing 32 Abbreviations: FDA = Food and Drug Administration; TRD = Treatment-Resistant Depression. Reflects Regulatory Guidance and Real-World Patient, Pr
Slide 33: Randomized, double-blind, placebo-controlled Phase 3 program
Randomized, double-blind, placebo-controlled phase 3 program in adults with treatment-resistant depression 33 Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale. Objective To evaluate whether BPL‑003 delivers rapid, clinically meaningful antidepressant effects with a short in‑clinic se
Slide 34: ReConnection-1 study design: single-dose
BPL‑003 Phase 3 ReConnection-1 study design in TRDSingle-Dose 34 Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale; OLE = Open-Label Extension; TRD = Treatment-Resistant Depression. 85 8mg Double-blind Core Day 1 – Week 12 (12 weeks) 4mg Placebo OLE Retreatment Week 12-64 (52 weeks) D
Slide 35: ReConnection-2 study design: two-dose induction
BPL‑003 Phase 3 ReConnection-2 study design in TRDTwo-Dose Induction Regimen 35 Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale; OLE = Open-Label Extension; TRD = Treatment-Resistant Depression. Monotherapy & Adjunctive TRD 8mg + 8mg 8mg Aim to maintain remission ReConnection-2 N=~3
Slide 36: Phase 3 BPL-003 development program aiming for broad label
Our robust phase 3 BPL-003 development program is aiming for a broad label 36 Abbreviations: DB = Double Blinded; MADRS = Montgomery–Åsberg Depression Rating Scale; RCT = Randomized Controlled Trial. ReConnection-1: Single‑Dose, Three‑Arm Trial ReConnection-2: Two-Dose Induction Trial Trial Size Ran
Slide 37: Next steps for BPL-003
37 2026 2028-2029 2027 FDA Feedback February-March Phase 3 Initiation Q2 2026 Phase 2a Part 4 Initial Data Q4 2026 Topline Readout Early 2029 Abbreviations: FDA = Food and Drug Administration. ReConnection-1 & ReConnection-2 Next steps for BPL-003
Slide 38: IP Overview
IP Overview Ryan Barrett Chief Legal and Business Officer
Slide 39: IP strategy integrates composition and method claims
Our IP strategy integrates both composition and method claims to align with the TPP 39 Abbreviations: API = Active Pharmaceutical Ingredient; FDA = Food and Drug Administration; IP = Intellectual Property; TPP = Target Product Profile. Composition claims Drug substance (DS) API / active ingredient S
Slide 40: Strong U.S. patent protection for BPL-003
We maintain strong U.S patent protection for BPL-003 40 1. Currently all in active prosecution as of 31st December 2025. Abbreviations: IP = Intellectual Property; TRD = Treatment-Resistant Depression. Drug Substance Drug Product Methods of Use Other Issued Pending ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ U.S IP1 Mebufoteni
Slide 41: BPL-003 Commercial Framework
BPL-003 Commercial Framework Kavita Panke SVP, New Product Planning and Early Commercial Development
Slide 42: TRD is a large, untapped market with massive unmet need
TRD is a large, untapped market with massive unmet need 42 1. Zhdanava et al., “The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States”, J Clin Psychiatry. (2021); 2. Sanacora et al., “Real-world safety of esketamine nasal spray: a com
Slide 43: Paradigm shift in psychiatry from managing symptoms to durable change
Paradigm shift in psychiatry from managing symptoms to enabling durable changeThe goal is not to maintain patients – it's to transform them 43 DEPRESSION TREATMENT LANDSCAPE TODAY Chronic Antidepressants Slow onset - weeks to months Chronic side effects (weight gain, sexual dysfunction) Daily dosing
Slide 44: BPL-003: potential to deliver rapid, durable, convenient treatment
44 1. Based on dose of 8mg, with a second dose administered 8-weeks after the initial dose; 2. Based on Ph2b open-label extension study; second dose administered 8-weeks after the initial dose; 3. Based on Ph2a and Ph2b open-label studies. Abbreviations: HCP = Healthcare Professional; MADRS = Montgo
Slide 45: BPL-003 potential for best-in-class TRD profile
45 1. Defined as a treatment effect seen by Day 2 following drug administration; 2. Defined as blinded, controlled evidence that a single dose produces clinically meaningful efficacy sustained for at one month; 3. Subject to further validation through future clinical studies and real-world evidence;
Slide 46: Single dose of BPL-003 vs. Spravato monotherapy regimen
Single-dose of BPL-003 demonstrated comparable MADRS response across published results from 8 doses of a Spravato® monotherapy dosing regimen 46 Day 2 Day 8 Day 15 Day 22 Week 4 Week 8 BPL-003 0.3mg (n=74) BPL-003 8mg (n=46) Spravato Placebo (n=197) Spravato 84mg (n=95) Mean Change from Baseline in
Slide 47: Real-world Spravato use and annual cost
47 According to an analysis of ~5 years of real-world use of Spravato® in the US: ~70% of Spravato® patients are on a weekly maintenance treatment based on real world utilization, with an annual WAC of up to $65K Pricing Assumptions: WAC price per device (28mg): 417 USD, WAC price per 56mg: 834 USD,
Slide 48: Envisioned dosing session model without psychotherapy
48 Prior to Dosing Preparatory Session(s) In-clinic or Remote HCP-administered Dosing and Patient Support as Needed Arrival and Check In Observation and Discharge Follow-Up Visit In-Clinic or Remote DosingTime to Discharge Post-Dose ~2hr Post-Dosing We are envisioning a dosing session model that pri
Slide 49: BPL-003 could drive favorable clinic economics
49 3 Treatments / Room / Day 1 Treatment / Room / Day Drug Revenue Drug Revenue $$$ $ Observation Revenue / Day Observation Revenue / Day 6-hours 6-hours 2-hours 6+ hours BPL-003 could drive favorable clinic economics relative to long in-clinic psychedelics1 1. Subject to further validation through
Slide 50: Lean, targeted commercial model
50 We are uniquely positioned to leverage a lean, targeted commercial model Interventional psychiatry presents optimal market factors to successfully self-commercialize 50 to 100 repsto cover high value targets at launch ~ 500 to 600clinics drive 75% of prescription volume1 7,000 to 8,000 interventi
Slide 51: TRD is just the beginning
51 TRD is just the beginning BPL-003 and our pipeline of novel psychedelic-based neuroplastogens are designed to address urgent unmet needs in mental health 1. Zhdanava et al., “The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States”,
Slide 52: Break
5 Minute Break
Slide 53: KOL Roundtable
KOL Roundtable Kavita Panke SVP, New Product Planning and Early Commercial Development
Slide 54: Key Opinion Leader Roundtable Discussion
54 Key Opinion Leader Roundtable Discussion Dr. David Feifel Kadima Neuropsychiatry Institute Dr. Samuel Wilkinson Yale University Dr. Peter Hendricks UAB Medicine Kavita Panke AtaiBeckley Moderated by Kavita Panke, SVP New Product Planning & Commercial Strategy
Slide 55: Q&A
Q&A AtaiBeckley Management Dr. Peter Hendricks, Dr. David Feifel, Dr. Samuel Wilkinson
Slide 56: Thank you
Thank you