Ataibeckley Inc. · NASDAQ:ATAI
Ataibeckley — ATAI Life Sciences — Merger or Acquisition (July 2025)
29 slides from Ataibeckley's merger presentation, Jul 1, 2025
Slide 1: atai Life Sciences and Beckley Psytech Announce Positive Topline Data from Phase 2b Study of BPL-003
July 1, 2025 atai Life Sciences and Beckley Psytech Announce Positive Topline Data from Phase 2b Study of BPL-003 for Treatment-Resistant Depression
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: Additional Information and Where to Find It
Additional Information and Where to Find It This presentation is being made in respect of the proposed transaction between the Company and Beckley Psytech (the “Acquisition”). In connection with the proposed transaction, a registration statement on Form S-4 will be filed (the “Registration Statement
Slide 4: BPL-003 Phase 2b study met its primary and secondary endpoints
The BPL-003 Phase 2b study met its primary & secondary endpoints demonstrating rapid, robust, and durable antidepressant effects 4 atai Life Sciences and Beckley Psytech have successfully completed a first-of-its-kind study to evaluate the efficacy and safety of BPL-003 (mebufotenin benzoate) in pat
Slide 5: Study Overview
Study Overview A Oatai 2378,
Slide 6: Depression is a debilitating condition with limited treatment options
Depression is a debilitating and life-changing condition affecting millions across the globe but with limited treatment options 6 Global Burden of Disease 2021: mental health messages, The Lancet Psychiatry, Volume 11, Issue 8, 573 GlobalData Greenberg PE, Fournier AA, Sisitsky T, Simes M, Berman R,
Slide 7: First-of-its-kind study of mebufotenin in patients with TRD
First-of-its-kind study to evaluate the efficacy and safety of mebufotenin in patients with TRD 7 Largest ever controlled clinical study to investigate mebufotenin First and only blinded Phase 2 study of mebufotenin to include the United States Designed based on FDA feedback to facilitate progressio
Slide 8: Randomized, quadruple-masked Phase 2b clinical trial design
Randomized, quadruple-masked, monotherapy Phase 2b clinical trial of BPL-003 in patients with moderate to severe TRD Phase 2b Clinical Trial Design Key Inclusion Criteria: Patients with moderate to severe TRD Hamilton Depression Scale (HAM-D) >= 19 Willing and able to discontinue current antidepress
Slide 9: Core Study designed based on FDA feedback
Core Study designed based on FDA feedback and to specifically avoid potential unblinding and expectancy effects Phase 2b Clinical Trial Design 9 TRIAL STATUS Randomization (n=193) 2 29 57 Wk-8 Washout 12 mg1 Core Study (8 weeks) Primary Analysis 29 57 Open Label Extension (8 weeks) 1st Dose 2nd Dose
Slide 10: Topline Findings From Core Study
Topline Findings From Core Study
Slide 11: Demographics and baseline characteristics well-balanced across groups
Demographics & baseline characteristics were well-balanced across groups 11 BPL-003 0.3 mg(N=74) BPL-003 8 mg(N=46) BPL-003 12 mg(N=73) Overall(N=193) Patient Disposition Age, years, mean (SD) 41.0 (11.2) 40.6 (12.1) 41.2 (10.6) 41.0 (11.1) Female, n (%) 44 (60%) 27 (59%) 43 (59%) 114 (59%) Race, Wh
Slide 12: Single dose met primary endpoint of MADRS reduction at Week 4
Single-dose of BPL-003 met primary endpoint of a statistically significant MADRS reduction at Week 4 vs. 0.3 mg, with effects sustained out to Week 8 CHANGE FROM BASELINE IN MADRS TOTAL SCORE - 12MG & 8MG VS. 0.3MG -10 -5 0 Baseline -8.8* -8.9* Day 2 -11.1* Day 8 -5.8 -12.1* -11.1* Day 29 -10.8* -10
Slide 13: Rapid and lasting clinical response; responder and remission rates
KEY: BPL-003 produced rapid & lasting clinical response in >30% of patients, with 26% remaining in remission out to Week 8 after a single 8mg dose RESPONDER & REMISSION RATES FOR SINGLE DOSE BPL-003 Subjects meeting response criteria (%) Day 2 Day 8 Day 29 Day 57 28% 0.3mg 8mg 12mg Day 2 Day 8 Day 2
Slide 14: BPL-003 generally well-tolerated, no drug related serious adverse events
BPL-003 was generally well-tolerated, adverse events were transient, with no drug related serious adverse events recorded during the Core Study TREATMENT EMERGENT ADVERSE EVENTS (TEAEs) 1. Includes the preferred terms: Blood pressure increased, Blood pressure diastolic increased, and Blood pressure
Slide 15: No suicide-related safety signal
No suicide-related safety signal SUICIDALITY TEAEs Low rates of treatment emergent suicidal ideation Suicidal ideation was not dose dependent, highest rate at 0.3 mg potentially reflective of background disease state No drug related events of suicidal intent or behaviours in active treatment arms 0.
Slide 16: High completion and rollover rates into open-label extension
High completion rate of Core Study, rollover rate into the open-label extension (OLE) study suggest strong levels of patient acceptability 16 90% of participants in Core Study completed the study 85% of eligible participants in Core Study rolled over onto OLE study screening Note: Eligibility for th
Slide 17: Key achievements and upcoming catalysts for BPL-003
Key achievements and upcoming catalysts for BPL-003 What BPL-003 has demonstrated so far: Rapid, robust, and durable therapeutic benefit for at least 2 months Favorable safety & tolerability profile POC data in adjunctive patients show similar tolerability and efficacy results 2-hour in-clinic treat
Slide 18: BPL-003 Opportunity & Competitor Landscape
BPL-003 Opportunity & Competitor Landscape
Slide 19: Spravato achieved blockbuster status with 2-hour treatment paradigm
Spravato® (esketamine) achieved blockbuster status with 2-hour interventional psychiatry treatment paradigm 19 2-hour dosing protocol with established infrastructure Patients monitored for at least 2 hours at each treatment session Delivered intranasally under the supervision of a healthcare provide
Slide 20: BPL-003 designed to leverage Spravato 2-hour in-clinic paradigm
BPL-003 is uniquely designed to leverage Spravato® 2-hour in-clinic treatment paradigm 20 ANTICIPATED TIME TO DISCHARGE FROM CLINIC POST-DOSE 1 (in hours) Illustrative SPRAVATO® BPL-003 Multi-dose 5-MeO-DMT Psilocybin + analogs MDMA LSD Average workday(8 hours) ~2 ~2 ~2 ~1 to 3* ~6 ~8 ~8 to 12 VLS-0
Slide 21: Change in MADRS: single dose BPL-003 vs twice weekly Spravato
KEY: CHANGE IN MADRS FOLLOWING SINGLE DOSE OF BPL-003 VS TWICE WEEKLY DOSING SPRAVATO® MONOTHERAPY1 21 Single-dose of BPL-003 demonstrated comparable MADRS response to published results from a twice-weekly Spravato® monotherapy dosing regimen RESPONDER & REMISSION RATES FOLLOWING SINGLE DOSE OF BPL-
Slide 22: BPL-003 potential advantages over Spravato
BPL-003 offers potential advantages over Spravato® with longer duration of effect and reduced patient burden driven by fewer required dosing sessions Established Medical Device Delivered in Interventional Psychiatry Setting Pre-Dose Education & Counselling 2-Hour Treatment Time to Discharge 1 or 2 D
Slide 23: Next Steps
Next Steps 3 ¥ Beckley fe) atal SPs
Slide 24: Stronger together, atai and Beckley Psytech unlock value
24 Stronger together, atai life sciences and Beckley Psytech unlock value for patients and shareholders Experienced management team Fully owned pipeline with first-in-class potential Multiple near-term milestones Commercially scalable psychedelic therapies Strong IP portfolio Long-term financial syn
Slide 25: atai-Beckley Business Combination Highlights
Lock-up holders may not sell or transfer shares before the later of (a) 60 days following the public announcement of the Phase 2b study or (b) transaction closing (the “Lock-Up Period”). Upon the expiry of the Lock-Up Period lock-up holders shall cease to be restricted at a rate of 1/12th of each lo
Slide 26: Pipeline of fully-owned psychedelic development programs
Combined vision is being delivered through a pipeline of fully-owned psychedelic development programs for mental health indications Abbreviations: DMT = Dimethyltryptamine; R-MDMA = R enantiomer of 3,4-Methylenedioxymethamphetamine ELE-101 Psilocin Programs Primary Indication Preclin Phase 1 Phase
Slide 27: BPL-003 Phase 2b study met its primary and secondary endpoints
The BPL-003 Phase 2b study met its primary & secondary endpoints demonstrating rapid, robust, and durable antidepressant effects 27 BPL-003 was generally well-tolerated at all doses, with 99% of treatment-emergent adverse events being mild or moderate, no drug-related serious adverse events or suici
Slide 28: Q&A
Q&A yy ¥ Beckley Oatai OPsytech
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