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8-K primary document
ATAI · Current Report (Form 8-K) · Filed February 26, 2026

Ataibeckley Inc8-K exhibit

ef20066456_ex99-2.htm

Exhibit 99.2

 February 26, 2026  EMP-01 (R-MDMA)Phase 2a Top Line Results in Social Anxiety Disorder (SAD) 
 

 The following disclaimer applies to this Presentation. 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 distributed during the Presentation meeting. The purpose of this Presentation is to provide an overview of AtaiBeckley (the “Company”).   Forward-Looking Statements  This Presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; our runway; the potential, success and timing of development and progress of trials and related milestones of our product candidates set forth in the Presentation; expectations regarding our intellectual property portfolio, including our newly granted patent and plans for expansion of our patent portfolio; and the plans and objectives of management for future operations, research and development and capital expenditures; progress and results of our EMP-01 trials; the timing of further data on EMP-01, the therapeutic potential of EMP-01; and the potential benefits of EMP-01 for patients with SAD. Additionally, topline results AtaiBeckley reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial.  Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in Atai Beckley N.V.'s most recent Annual Report on Form 10-K or Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in AtaiBeckley’s other filings with the SEC. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements contained in this Presentation, other than to the extent required by applicable law.  The information in this Presentation is not intended to form the basis of any contract. This Presentation does not constitute an offer or invitation for the sale, issuance or purchase of securities or any businesses or assets described in it, nor does it give or purport to give legal, tax or financial advice. Nothing herein shall be taken as constituting the giving of investment advice or an inducement to enter into investment activity in any jurisdiction and this Presentation is not intended to provide, and must not be taken as, the basis of any decision and should not be considered as an invitation, inducement, solicitation or recommendation to purchase, underwrite, subscribe for or otherwise acquire any securities of the Company. The recipient must make its own independent assessment and such investigations as it deems necessary. Save as set out below, the Presentation has been prepared on the basis of information held by the Company and also from publicly available information. This information, which does not purport to be comprehensive, has not been independently verified by or on behalf of the Company. The Presentation does not constitute an audit or due diligence review and should not be construed as such   The Company nor any of such its respective directors, officers, employees, affiliates, advisers or agents (the  “Associates”) accepts any responsibility, obligation or liability whatsoever for, or makes any representation or  warranty, express or implied, as to, and no reliance should be placed on, the fairness, truth, fullness, accuracy,  completeness or correctness of, the information in this Presentation or whether any information has been omitted  from the Presentation or as to any other information relating to the Company, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from  any use of this Presentation, its contents or otherwise arising in connection therewith. Except where otherwise  indicated in the Presentation, the information provided therein is based on matters as they exist at the date of  preparation of the Presentation and not as of any future date and will be subject to updating, revision, verification  and amendment without notice and such information may change materially. Neither the Company nor any of its Associates is under an obligation to update, revise or keep current the information contained in this Presentation to  which it relates or to provide the recipient of this Presentation with access to any additional information that may  arise in connection with it and any opinions expressed in this Presentation are subject to change without notice.   Nothing contained in this Presentation is or should be relied upon as a promise or representation as to the future.  Disclaimer  2 
 

 3  12%  Lifetime prevalence in the US2 (affects 5-6x more people than TRD)  0  Novel molecules for SAD in 20+ years  Sources: 1. NIMH, “Social Anxiety Disorder.” (2025). *Total US population is estimated ~347 MM and total US adult population is estimated ~260 MM (75% of total). 2. Harvard Medical School, National Comorbidity Survey (2007). 3. Canton et al., Optimal treatment of social phobia: systemic review and meta-analysis. (2012). 4. Keller, Social anxiety disorder clinical course and outcome: review of Harvard/Brown Anxiety Research Project (HARP) findings. (2006). Abbreviations: SAD = Social Anxiety Disorder; TRD = Treatment-Resistant Depression  60-70%  Remain symptomatic despite treatment4  30-40%  Achieve remission with medication4  Less than half of patients receive any type of treatment for SAD, with limited relief as current treatments provide only moderate efficacy and slow-onset improvement with most patients failing to achieve full remission  untreated  treated3  Social anxiety disorder (SAD) is one of the most common psychiatric disorders, affecting an estimated ~32M adults in the US1 
 

 4  Abbreviations: LSAS = Liebowitz Social Anxiety Scale; PBO = Placebo; PK = Pharmacokinetics; SAD = Social Anxiety Disorder  Exploratory Phase 2a, randomized, placebo-controlled study assessing safety, tolerability, and efficacy of 2 doses of EMP-01 in 70 adults with SAD  EMP-01 Phase 2a Study Design  Study Endpoints  Study Design  Phase 2a, randomized, double-blind, placebo-controlled study  Adult participants diagnosed with Social Anxiety Disorder (SAD)  Liebowitz Social Anxiety Scale (LSAS) total score ≥70 at screening  Primary Endpoint:   Safety and tolerability (baseline to Day 43)  Secondary Endpoint:  Change in LSAS total score (baseline to Day 43)   Exploratory Endpoints:  Subjective drug effects scales   Change from baseline in clinician and patient rated anxiety, depression, and health status scales and proportion of treatment responders  PK of EMP-01 and its metabolites  EMP-01 225mg  R  Randomized  1:1  Day 43  Day 1  Total N = 70 patients  Placebo  EMP-01 225mg  Placebo  Dose 1  Dose 2  Day 0  Day 29  Primary Endpoint 
 

 Baseline characteristics were well balanced across armsPopulation: ITT  5  Source: Table 14.1.1.6 Demographics and Baseline Characteristics (Intent-to-Treat Population). Abbreviations: BMI=Body Mass Index; CGI-S = Clinical Global Impression-Severity; LSAS = Liebowitz Social Anxiety Scale; SD = Standard Deviation; SNRI = Serotonin-Norepinephrine Reuptake Inhibitor; SSRI = Selective Serotonin Reuptake Inhibitor; IIT: Intent to treat population  Characteristic  Placebo (N=36)  EMP-01 225mg (N=35)  Overall (N=71)  Age mean (SD)  33.7 (9.1)  34.0 (11.2)  33.9 (10.1)  Age range  20-54  20-59  20-59  Sex   Female n (%)  16 (44.4)  18 (51.4)  34 (47.9)  Male n (%)  20 (55.6)  17 (48.6)  37 (52.1)  Ethnicity  Hispanic or Latino n (%)  2 (5.6)  0  2 (2.8)  Not Hispanic or Latino n (%)  34 (94.4)  34 (97.1)  68 (95.8)   Not Reported n (%)  0  1 (2.9)  1 (1.4)  BMI Mean (SD)  25.3 (3.6)  26.3 (3.5)  25.8 (3.5)  Baseline LSAS Total Score (0-144) Mean (SD)  108.3 (16.72)  108.4 (16.71)  108.4 (16.60)  Baseline LSAS range  77-139  72-134  72-139  Prior medications total n (%)  16 (44.4)  13 (37.1)  29 (40.8)  SSRI n (%)  13 (36.1)  8 (22.9)  21 (29.6)  SNRI n (%)  2 (5.6)  1 (2.9)  3 (4.2)  Beta Blockers n (%)  6 (16.7)  7 (20.0)  13 (18.3) 
 

 Generally favorable and manageable safety and tolerability profile   6  Source: 14.3.1.1 Summary of All TEAEs with Risk Differences (Safety Population), Source: Table 14.3.1.7 Incidence of TEAEs by Maximum Severity, System Organ Class and Preferred Term (Safety Population). 1 TEAEs are defined as adverse events that occurred following the first administration of study medication. If a participant has multiple occurrences of a TEAE, the participant is presented only once in the Participant count (n) column for a given Preferred Term. ** N=3: n=2 Elevated blood pressure, n=1 Suicidal ideation. Abbreviations: TEAE = Treatment-Emergent Adverse Event; AESI = Adverse Event of Special Interest; CEQ = Challenging Experience and Questionnaire  Characteristic  Placebo (N=35)  EMP-01 225mg (N=35)  Overall (N=70)  Any TEAE n (%)   27 (77.1)  35 (100.0)   62 (88.6)  Any Serious TEAE n (%)  0  0  0  Any Drug-Related TEAE n (%)  17 (48.6)  35 (100.0)  52 (74.3)   Maximum Severity   Mild  23 (65.7)  14 (40.0)  37 (52.9)   Moderate  4 (11.4)  21 (60.0)  25 (35.7)  Severe  0  0  0  Related TEAEs Leading to Discontinuation  ≥1 related-TEAE leading to treatment discontinuation  0  3 (9%)**  3  ≥1 related-TEAE leading to study discontinuation  0  0  0  Well-tolerated safety profile   No severe or serious TEAEs  All TEAEs were mild to moderate  No suicidal intent or behavior reported during the study  Low mean CEQ scores confirm that participants did not report meaningfully challenging or unpleasant subjective experiences  Takeaways 
 

 Drug-related TEAEs were in line with expected psychedelic profile  7  Source: Safety: Table 2. Incidence of Common (≥15%) Non-Serious TEAEs by System Organ Class and Preferred Term (Population: Safety), Source: Safety: 14.3.1.8 Incidence of TEAEs by Strongest Relationship, System Organ Class and Preferred Term (Population: Safety). 1 TEAEs are defined as adverse events that occurred following the first administration of study medication. If a participant has multiple occurrences of a TEAE, the participant is presented only once in the Participant count (n) column for a given Preferred Term. Common= ≥10%incidence. Drug-related=probable and/related. Abbreviations: TEAE = Treatment-Emergent Adverse Event; AESI = Adverse Event of Special Interest  Common psychedelic drug-related AESIs (>15%):  Feeling of relaxation  Sensory disturbance  Hallucination, visual  Illusion  Euphoric mood  Anxiety  Somnolence  Disinhibition  Drug-related TEAEs excluding AESIs (>15%), n (%)  Placebo  (N=35)  EMP-01 225mg   (N=35)  Nausea   1 (2.9)   21 (60.0)   Headache   8 (22.9)   17 (48.6)   Fatigue   4 (11.4)   15 (42.9)   Dizziness   1 (2.9)   13 (37.1)   Decreased Appetite   0  10 (28.6)   Palpitations  0  9 (25.7)   Vomiting   0  8 (22.9)  Paraesthesia   0  8 (22.9)   Hyperhidrosis  0  7 (20.0)   Bruxism   0  6 (17.1)   Vision Blurred  0  6 ( 17.1)   AESIs reflected expected psychedelic-related experiences, were transient, and all mild/moderate 
 

 8  Unique opportunity for EMP-01 to support mindset shift to engage in disease modifying treatment  Repeat exposure leading to behavior change1  Treatment is difficult for SAD patients to engage with as it requires repeat exposure to social situations  SAD patient  Source: 1. Hofmann SG, Otto MW. Cognitive Behavioral Therapy for Social Anxiety Disorder: Evidence-Based and Disorder Specific Treatment Techniques. New York, Routledge (2017). Abbreviations: SAD = Social Anxiety Disorder 
 

 9  Source: Efficacy: 14.2.1.2 Mixed Model for Repeated Measures (MMRM) of Liebowitz Social Anxiety Scale Total Score Change from Baseline to Day 43 with Standardized Effect Sizes. (Population: mITT n=70 ). Abbreviations: LS = Least Square; LSAS = Liebowitz Social Anxiety Scale; LSMD = Least Squares Mean Difference; mITT = Modified Intent-to-Treat; MMRM = Mixed Models for Repeated Measures; SAD = Social Anxiety Disorder  MMRM (Baseline to Day 43)  Placebo (N=35)  EMP-01 225mg (N=35)  LS Mean (Standard Error)  -16.67 (4.54)  -28.53 (4.64)   95% CI  -25.7, -7.6  -37.8, -19.3  LS Mean Treatment Difference (LSMD)  -11.85  p-value (one-tailed)  0.036  Standardized Effect Size  -0.45  Efficacy: EMP‑01 showed clinically meaningful improvement across the LSASPopulation: mITT (n=70) 
 

 10  Source: Table 14.2.1.1 Summary and Change from Baseline to Day 29 and Day 43 of Liebowitz Social Anxiety Scale Total and Subscale Scores (Modified Intent-to-Treat Population). Abbreviations: LSAS = Liebowitz Social Anxiety Scale; SAD = Social Anxiety Disorder; SD = Standard Deviation  LSAS Sub-Scale Scores Mean (SD) %  Placebo (N=35)  EMP-01 225mg (N=35)  Change From Baseline To Day 43  Fear Total  -8.1 (11.87)  -15.45%   -13.7 (13.63 )   -25.39%  Avoidance Total   -8.5 (12.04)   -17.1%  -15.1 (14.91)   -28.6%  Fear Social Interactions  3.8 (5.28)  -15.8%   -7.0 (6.97)  -26.9%  Avoidance Social Interactions  -4.6 (5.65)  -18.32%   -8.14 (7.23)  -31.85%  Fear Performance  -4.3 (6.85)  -15.1%   -6.69 (7.12)  -23.6%  Avoidance Performance  -3.9 (6.75)  -15.7%  -7.0 (8.18)  -24.9%  Meaningful improvements observed across both fear and avoidance domains 
 

 11  1. One patient in the placebo arm had a missing value at Day 43 on the CGI-I Responder Assessment. Abbreviations: CGI-I = Clinical Global Impression-Improvement; CI = Confidence Interval; LSAS = Liebowitz Social Anxiety Scale  CGI-I Responder  Placebo (N=351)  EMP-01 225mg (N=35)   Yes n (%)  5 (14.7)  17 (48.6)   No n (%)  29 (85.3)  18 (51.4)   Risk Difference    (95% CI)  33.87%   (13.47, 54.26)  Number Needed to   Treat (95% CI)  2.95  (1.84, 7.42)  Treatment Response (CGI-I = 1 or 2)   CGI‑I responder analysis supported LSAS findings  CGI Responders (Score ≤ 2) at Day 43  5(14.7%)  Placebo(N=35)  17(48.6%)  EMP-01(N=35) 
 

 EMP-01-201: Clinical activity benchmarking vs. approved SAD therapies  12  Sources: 1. Williams et al., Pharmacotherapy for social anxiety disorder (SAnD) (Review). (2017). 2. Davis et al., Update on the efficacy of pharmacotherapy for social anxiety disorder: a meta-analysis. (2014). 3. van der Linden et al., The efficacy of the selective serotonin reuptake inhibitors for social anxiety disorder (social phobia): A meta-analysis of randomized controlled trials. (2000). 4. Liebowitz, M. et al. (2007). Efficacy of venlafaxine XR and placebo in social anxiety disorder: Effects of gender and physical symptoms. 5. Carpenter et al., Cognitive behavioral therapy for anxiety and related disorders: A meta-analysis of randomized placebo-controlled trials. (2018). 6. de Ponti et al., The efficacy of psychotherapy for social anxiety disorder, a systematic review and meta-analysis. (2024). Abbreviations: CBT = Cognitive Behavioral Therapy; CGI-I = Clinical Global Impression-Improvement; CI = Confidence Interval; LS = Least Square; LSAS = Liebowitz Social Anxiety Scale; NNT = Number Needed to Treat; SAD = Social Anxiety Disorder; RR = Relative Risk  Drug / Trial  Baseline LSAS  LSAS LS Mean Difference vs. Placebo  CGI-I Responders (RR)  Effect Size  (Hedges’ g)  NNT  EMP-01  108.4  N=71  -11.85  (CI: -24.8, 1.1)  RR: 3.31  0.45  2.95  SSRIs for SAD  74-96  24 studies1  -10.141  RR: 1.651  0.392  3.73  SNRIs for SAD  86-89  4 studies1  -11.911  RR: 1.301  0.452  4.64  Psychotherapy/  CBT  0.485  3.86  *FOR ILLUSTRATIVE PURPOSES ONLY - no head-to-head study has been conducted comparing EMP-01 against any other candidates or products, and differences exist between study designs, patient populations and other factors. Caution should be exercised when comparing results across unrelated studies or trials.  
 

 13  1. Presented data from EMP-01 225mg (n=35) and placebo (n=35) from Ph2a study. 2. Goodwin, G. M. et al. (2025). The role of the psychedelic experience in psilocybin treatment for treatment-resistant depression. (2025). 3. Schmid Y. et al. (2020) Acute subjective effects in LSD- and MDMA-assisted psychotherapy.  Abbreviations: 5D-ASC = 5-Dimensional Altered State of Consciousness.   EMP-01 produced a robust psychedelic experience, with a distinct profile that differs from racemic MDMA, and its subjective effects fully resolved on average in <6 hours  Subjective‑effect profile reflects the unique pharmacology of the R‑enantiomer of MDMA  5D-ASC Raing Scale Total and Subscale Score (0-100) Day 1 and Day 29 Observed Score Mean1  Oceanic Boundlessness  Anxious Ego Dissolution  Visionary Destructuralization  Auditory Alterations  Reduction of Vigilance  5D-ASC Total Score  EMP-01 225mg   Placebo  5D-ASC Comparison*: EMP-011 / Psilocybin2 / Racemic MDMA3  Oceanic Boundlessness  Anxious Ego Dissolution  Visionary Destructuralization  Auditory Alterations  Reduction of Vigilance  Psilocybin 25mg  EMP-01 225mg   MDMA 125mg  *FOR ILLUSTRATIVE PURPOSES ONLY - no head-to-head study has been conducted comparing EMP-01 against any other candidates or products, and differences exist between study designs, patient populations and other factors. Caution should be exercised when comparing results across unrelated studies or trials.  
 

 14  An exploratory Phase 2a study demonstrated feasibility, generally well tolerated safety profile, and patient acceptability  Successfully evaluated EMP-01 in 70 adults with marked–severe SAD across 7 UK sites in 7 months   Strong adherence and retention through the primary endpoint  Placebo-adjusted improvement in LSAS at Day 43 (LSMD −11.85; g = 0.45, p-value = 0.036, one-tailed)  Observed marked improvement in clinician-rated global response (CGI-I Responder: EMP-01: 49% vs PBO: 15%); lower NNT vs SoC   Improved Fear and Avoidance on LSAS subdomains after two doses over six weeks, including social‑avoidance behaviors, without psychotherapy  Generally well-tolerated with favorable and manageable safety profile; comparable to racemic MDMA  No SAEs, no severe TEAEs, no suicidal intent or behaviors  225mg of EMP-01 was robustly psychedelic  Subjective effects fully resolved on average <6 hours  EFFICACY  Abbreviations: CGI-I = Clinical Global Impression – Improvement; LSAS = Liebowitz Social Anxiety Scale; LSMD = Least Squares Mean Difference; PBO = Placebo; SAD = Social Anxiety Disorder; SAE = Serious Adverse Event; TEAE = Treatment-Emergent Adverse Event  EMP‑01: Strong feasibility, favorable safety profile, and encouraging early signals of efficacy  FEASIBILITY & EXECUTION  SAFETY & TOLERABILITY  *No head-to-head study has been conducted comparing EMP-01 against any other candidates or products, and differences exist between study designs, patient populations and other factors. Caution should be exercised when comparing results across unrelated studies or trials.  
 

 Thank You 
 


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