Exhibit 99.2
Creating breakthroughs in mental health Investor Day March 6, 2026
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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 – 5 minutes KOL Roundtable 10:35am-11:20am KOLs Moderated Q&A 11:20am-11:55am AtaiBeckley Management Team & KOLs Close 11:55am-12:00pm Srinivas Rao
AtaiBeckley Strategy and Pipeline Overview Srinivas Rao, M.D., Ph.D. Co-Founder and CEO
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 high unmet need Protect every program with issued U.S. patents and layered claims across compositions and methods Advance therapies designed for fast onset and sustained benefit, moving beyond chronic daily or high frequency antidepressant regimens Design practical dosage forms and delivery models that fit into real-world clinical care pathways and support broad adoption Prioritize indications with significant patient burden and limited recent innovation (e.g., TRD, SAD) On a mission to transform patient outcomes by developing rapid-acting, durable, and convenient mental health treatments
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 Administration; R-MDMA = R-enantiomer of 3,4-methylenedioxy-methamphetamine; EOP2 = FDA End of Phase 2; TRD = Treatment-Resistant Depression. INDICATION PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 PROGRAMS Mebufotenin nasal spray Treatment-Resistant Depression (TRD) BPL-003 DMT buccal film Treatment-Resistant Depression VLS-01 R-MDMA oral formulation Social Anxiety Disorder (SAD) EMP-01 Novel 5-HT2A receptor agonists Opioid Use Disorder and TRD Discovery ANTICIPATEDMILESTONES1,2 EOP2 feedback: Q1’26 ‒ Completed Ph3 initiation: Q2’26 Ph3 topline data: Early 2029 Ph2 topline data: H2’26 Ph2a topline data: Q1’26 ‒ Completed Undisclosed FDA Breakthrough Therapy Designation
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 Use and Mental Health Indicators in the US”, (2025); 3. Ringeisen et al., “Mental and Substance Use Disorders Prevalence Study (MDPS): Findings Report”, (2023); 4. NIMH, “Social Anxiety Disorder”, (2025). *Total US population is estimated ~347 MM and total US adult population is estimated ~260 MM (75% of total). Abbreviations: CAGR = Compounded Annual Growth Rate; MDD = Major Depressive Disorder; SAD = Social Anxiety Disorder. The US depression and anxiety market is projected to grow, achieving a CAGR of 5.02% from 2025 to 20331 1 in 5 More than 1 in 5 US adults experience mental illness each year2 ~22M Annual prevalence of MDD among US adults*3 ~18M Annual prevalence of SAD among US adults*4
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 management,” Mol Med. (2024); 3. Zhdanava et al., “The Prevalence and National Burden of Treatment‑Resistant Depression and Major Depressive Disorder in the United States,” J Clin Psychiatry. (2021); 4. Unni et al., “Reasons for non‑adherence with antidepressants using the Medication Adherence Reasons Scale in five European countries and United States,” J Affect Disord. (2024); 5. Janik et al., “Esketamine Monotherapy in Adults With Treatment‑Resistant Depression: A Randomized Clinical Trial,” JAMA Psychiatry. (2025). The Unmet Needs The Solution Next-Generation Psychedelic Therapies Targeting Neuroplasticity for Lasting Benefit Faster ReliefCurrent treatments act too slowly to provide meaningful improvement when patients need it most1 Durable, Root Cause Impact Existing therapies often fail to deliver durable, lasting relief or address underlying neurobiological vulnerability2,3 Convenient, Non-Chronic Treatment Most available options require ongoing, frequent, long-term dosing that burdens patients and limits adherence4,5 1. 2. 3.
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 Release Biological Modification & Durable Symptom Improvement 1. Agnorelli et al., “Neuroplasticity and psychedelics: A comprehensive examination of classic and non-classic compounds in pre and clinical models”, Neurosci Behav Rev. (2025); 2. Kishon & Cycowicz, “Psychedelic therapy: bridging neuroplasticity, phenomenology, and clinical outcomes”, Front Psychiatry. (2025); 3. Gattuso, et al., ”Default mode network modulation by psychedelics: a systematic review”, Int J Neuropsychopharmacol. (2023); 4. Calder & Hasler, “Towards an understanding of psychedelic-induced neuroplasticity”, Neuropsychopharmacol. (2023). Abbreviations: DMN = Default Mode Network. Mechanistic Neuroplasticity Acute Subjective Experience
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 Improving Treatments for TRD 1. Yale Medicine, “What is Interventional Psychiatry?”, (2025); 2. Ramaekers et al., "Benefits and challenges of ultra-fast, short-acting psychedelics in the treatment of depression“, Am J Psychiatry. (2025); 3. Askariyan, et al., “An overview of psilocybin, LSD, MDMA, and ketamine in revitalizing psychedelic-assisted therapy: Insights, limitations and future directions”, Prog Neuropsychopharmacol Biol Psychiatry. (2025). Abbreviations: TMS = Transcranial Magnetic Stimulation; TRD = Treatment-Resistant Depression. Bretisilocin Mebufotenin Psilocybin LSD Esketamine Dimethyltryptamine (DMT) TMS
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 evaluating BPL-003 to esketamine. As per the FDA label, Spravato® is administered twice a week during weeks 1-4 in the induction phase, followed by maintenance treatment once weekly during weeks 5-8 and then every 2 weeks or once weekly from weeks 9 and after. Abbreviations: LSD = Lysergic Acid Diethylamide; TRD = Treatment-Resistant Depression. Spravato® BPL-003 VLS-01 Psilocybin LSD Average Workday (8 hours) ~2 ~2 ~2 ~6 to 8 ~8 to 12 Anticipated Hours to Discharge Post-Dose (illustrative)1 Short (~2 hr) time to discharge Single-dose BPL-003 showed durable benefit through Week 8 Lower burden from reduced frequency of clinic visits may expand patient access Concentrated prescriber base and fits within existing infrastructure Anticipated treatment sessions per year1 Up to 56 4 - 6 Key Differentiators Driving Commercial Opportunity
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 expertise Purpose‑built pipeline commercially scalable and differentiated therapies Clinic‑fit design with strong IP Clinical signal is maturing Commercial model is developing Regulatory pathways are clearer Abbreviations: IP = Intellectual Property.
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 Administration; OLE = Open-Label Extension. Cash runway through the planned early-2029 topline readouts from both Phase 3 pivotal studies 2025 Milestones Q1 2026 H2 2026 Q2 2026 BPL‑003 positive Ph2b topline and OLE data EMP-01 positive Ph2a topline VLS‑01 Phase 2 topline data BPL-003 FDA Breakthrough Designation Strategic combination of AtaiBeckley Key U.S. patents granted across the pipeline Added to the NASDAQ Biotechnology Index >$250 million gross proceeds from financings: BPL is our lead asset and focus for today U.S. redomiciliation completed
BPL-003 Mebufotenin benzoate nasal spray for TRD Kevin Craig, M.D. Chief Medical Officer
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 a successful End‑of‑Phase‑2 meeting, the program has FDA feedback on the Phase 3 development pathway with initiation expected in Q2’26 Granted FDA Breakthrough Therapy Designation following positive Ph2b results (n=193) that demonstrated rapid and durable antidepressant effects after a single dose BPL-003 is designed to be administered in-clinic and targets a short (~2-hour) post-dose time to discharge, supporting fit within established sites of care and treatment workflows
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 absorption Controlled PK without device dependency Very rapid onset Exposure depends on inhalation technique Pulmonary safety considerations Precise but invasive administration Limited scalability in psychiatric clinics Slower, more variable onset First-pass metabolism may limit exposure Intranasal and buccal / sublingual routes of administration align most closely to real-world treatment requirements: Predictable PK1 Fits existing psychiatric workflows2 No specialized equipment2 Rapid Onset1 Enable ~2-hour in-clinic session 1. Kim & De Jesus, “Medication Routes of Administration”, (2023); 2. Spravato® Website, “Treatment-Resistant Depression (TRD) Dosing and Administration Overview”, https://www.spravatohcp.com/dosing-spravato-trd/. Abbreviations: IV = Intravenous; PK = Pharmacokinetics.
Phase 2b Data
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 data underscore BPL‑003’s rapid, durable, and scalable clinical profile Rapid-Acting Significant improvement by Day 2, with Day 29 MADRS change of -6.2 (8 mg) compared to 0.3 mg (p < 0.01) Well-Tolerated Favorable safety profile and generally well‑tolerated across doses Durable Mean reduction in MADRS score of 19.0 points at Week 16 for patients who received two active doses across the core and OLE studies1 High Clinical Response 81% response and 67% remission at Week 16 after two doses in patients who initially received an 8 mg dose in the core study Convenient Administration ~2‑hour time to discharge post-dose supports scalable delivery
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. Patients were washed out as applicable. Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale; TRD = Treatment-Resistant Depression. KEY INCLUSION CRITERIA Patients with moderate to severe TRD Hamilton Depression Scale (HAM-D ≥19) Willing and able to discontinue current antidepressants2 KEY DETAILS PRIMARY ENDPOINT: MADRS change from baseline at Week 4 (Day 29), 12 mg vs. 0.3 mg OTHER SECONDARY ENDPOINTS: MADRS change from baseline at Day 2, Week 1 & Week 8 MADRS change from baseline for 8mg vs. 0.3 mg at Week 4 Responder and remission rates Randomization (n=193) Day 0 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 8 1 1 2 0.3 mg (n=74) 8 mg (n=46) 12 mg (n=73) BPL-003 | PHASE 2B CLINICAL TRIAL DESIGN R
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 MG Primary endpoint: Statistically significant MADRS difference observed at Day 29 (Week 4) following a single 8 mg or 12 mg dose vs. 0.3 mg: Efficacy was statistically significant as early as Day 2, with durable response through Week 8 (Day 57) for 8 mg and 12 mg dose vs. 0.3 mg 8 mg dose demonstrated comparable efficacy to 12 mg, suggesting it may be sufficient to achieve maximal therapeutic benefit KEY TAKEAWAYS Treatment Arm MADRS change (Day 29) P-value From baseline Compared to 0.3mg 8mg -12.0 -6.2 <0.01 12mg -11.2 -5.3 <0.01 Baseline -8.6* -8.9* Day 2 -11.0* -10.9* Day 8 -5.8 -12.0* -11.2* Day 29 -10.7* -10.3* Day 57 0.3mg (n=74) 8mg (n=46) 12mg (n=73) Primary Endpoint LS Mean (±SEM) Change from Baseline in MADRS Total Score * P ≤ 0.01 at all timepoints 0.3 mg (n=74) 8 mg (n=46) 12 mg (n=73)
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 (ASPIRE II)”, Int J Neuropsychopharmacol. (2021); 2. “Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression”, https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-Second-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx; 3. Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (ClinicalTrials.gov). No head-to-head trial has been conducted. Data from studies of these clinical candidates may not be directly comparable due to differences in molecule composition, trial protocols, dosing regimens, and patient populations and characteristics. Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale. Mean Change vs. Placebo / Active Control in MADRS Total Score Day 2 Day 8 Day 15 Day 22 Day 24 Week 4 Week 6 Week 8 Week 9 COMP360 25mg vs. placebo (n=171) Single Dose (COMP005) BPL-003 8mg vs. 0.3mg (n=46) Single Dose Spravato® 84mg mono vs. placebo (n=89) Twice Weekly COMP360 25mg vs. 1mg (n=79) Single Dose (COMP001) *FOR ILLUSTRATIVE PURPOSES ONLY - no head-to-head study has been conducted comparing BLP-003 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.
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 total completers were at sites with OLE protocol approval and were eligible to enter the OLE portion of the study and 107 (85%) received a BPL-003 dose. 90% of participants completed the core study 85% of eligible participants in the core study received a 2nd dose as part of the OLE study1
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 of 174 total completers were at sites with OLE protocol approval and were eligible to enter the OLE portion of the study and 107 received a BPL-003 dose; 2. Patients entering the open-label extension are randomized to receive either a single 12mg dose or a biphasic 4mg and 8mg dose approximately 10 minutes apart. Abbreviations: OLE = Open-Label Extension. KEY DETAILS Primarily designed to assess safety of a second dose of BPL-003 Efficacy assessed at multiple time points by centralized, blinded raters 8-week long observation period to demonstrate durability of effect Participants were provided psychological support, but not active psychotherapy BPL-003 | PHASE 2B OPEN-LABEL EXTENSION CLINICAL TRIAL DESIGN N=193 Randomization Day 0 2 29 57 Wk -8 Washout 12 mg2 N=107 Core Study (8 weeks) Primary Analysis 29 57 Open-Label Extension (8 weeks) 1st Dose 2nd Dose 8 1 1 2 0.3 mg N=74 8 mg N=46 12 mg N=73 N=174 (90%) N=126 Eligible participants at OLE- approved sites 1
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 = Montgomery–Åsberg Depression Rating Scale; OLE = Open-Label Extension; SEM = Standard Error of the Mean. Change from Baseline in MADRS Total Score – Exploratory1 Day 2 Day 8 Day 29 Day 57 Day 2 Day 8 Day 29 Day 57 Core study (N=193) Open-label extension (n=107) 12mg dose administered 0.3mg + 12mg (n=47) 8mg + 12mg (n=23) 12mg + 12mg (n=37) 0.3 mg (n=74) 8 mg (n=46) 12 mg (n=73) All patients who entered the OLE study received a 12 mg dose of BPL-003, regardless of MADRS score Patients who received 0.3 mg in the core study showed MADRS reductions in line with the antidepressant effects seen in patients who received an active dose in the core study Patients who received an active dose in the core study (either 8 mg or 12 mg) showed mean reduction in MADRS score of 19.0 points at Day 57 in the OLE compared to baseline at the start of the Phase 2b clinical trial 8 mg dose selected for Phase 3 studies KEY TAKEAWAYS
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) 35% 76% Subjects Meeting Response1 Criteria (%) Core study Open-label extension 12mg dose administered
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 (OLE) 57% 18% 15% 15% 36% 37% Core study Open-label extension 12mg dose administered Subjects Meeting Response1 Criteria (%)
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 event was reported where a participant who had received 0.3 mg in the core study experienced dissociation and suicidal ideation requiring inpatient monitoring and support after receiving 12 mg of BPL-003 in the OLE study. The symptoms were considered resolved the next day. Abbreviations: AE = Adverse Event; TEAEs = Treatment Emergent Adverse Events; OLE = Open-Label Extension. Core Study Open-label Extension (OLE) 0.3 mg(N=74) 8 mg(N=46) 12 mg(N=73) Overall(N=193) 2nd 12 mg dose (N=107) TEAEs N participants (%) Any TEAE 54 (73%) 35 (76%) 62 (85%) 151 (78%) 92 (86%) Any Drug Related TEAE 25 (34%) 32 (70%) 60 (82%) 117 (61%) 85 (79%) Any Drug Related Serious TEAE 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (1%) Most Reported Drug Related TEAEs (≥10% of subjects) Nausea 1 (1%) 13 (28%) 27 (37%) 41 (21%) 30 (28%) Headache 7 (10%) 9 (20%) 20 (27%) 36 (19%) 24 (22%) Administration Site Pain 5 (7%) 8 (17%) 16 (22%) 29 (15%) 18 (17%) Blood Pressure Increased1 1 (1%) 6 (13%) 15 (21%) 22 (11%) 14 (13%) Administration Site Discomfort 2 (3%) 5 (11%) 12 (16%) 19 (10%) 17 (16%) Anxiety 2 (3%) 2 (4%) 10 (14%) 14 (7%) 14 (13%) Vomiting 0 (0%) 6 (13%) 9 (12%) 15 (8%) 11 (10%) Psychomotor Hyperactivity 0 (0%) 0 (0%) 4 (6%) 4 (2%) 11 (10%) Majority of TEAEs occurred on day of dosing and were classified as mild or moderate in severity and transient in nature Most commonly reported side effects included nausea, headache, administration site pain, administration site discomfort, blood pressure increases and anxiety Blood pressure and heart rate increases were transient with mean levels returning to baseline within ~1 hour One serious drug-related AE was reported in the OLE part of the study which resolved with additional in-patient monitoring and support2 Average time to meet readiness-for-discharge criteria was within 2 hours of dosing 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 active doses resulted in a short psychedelic experience allowing subjects to meet readiness to discharge criteria in less than 2 hours 8 mg showed a better safety and tolerability profile vs. 12 mg with comparable efficacy and was selected as the Phase 3 dose Intranasal BPL-003 has shown potential benefits in the treatment of TRD, supporting progression into Phase 3 studies
BPL-003 Pivotal Program
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 randomized, double-blind, placebo-controlled Phase 3 studies: ReConnection-1 & ReConnection-2 12-week core study + 52-week OLE Use of remote, independent, blinded raters No psychotherapy Single and two-dose induction study designs Individualized retreatment every 8-12 weeks in OLE BPL-003 Phase 3 FDA Feedback after EOP2 Global Phase 3 Program with Long-Term OLE Potential for 4-6 Treatments per Year if Approved Short ~2-Hour In-Clinic Session Robust Phase 2b Efficacy Results & Day 2 Onset Breakthrough Therapy Designation
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 from Self Loss of identity and purpose Withdrawal and Self Isolation Patients describe pulling away from social engagement ReConnection Abbreviations: SSRI = Selective Serotonin Reuptake Inhibitor; TRD = Treatment-Resistant Depression.
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, Provider, and Payer Preferences Designed to build the large, long‑term safety database required for a chronic TRD indication and to provide confidence to key stakeholders Designed based on Positive Phase 2b Evaluates 8 mg efficacy and safety across two independent, well‑controlled trials; evaluates dose‑response and induction strategies (8 mg, 4 mg, placebo) Supports Flexibility and Optionality Designed to inform responder patterns and individualized retreatment timing, as well as to broaden evidence across diverse patients and treatment settings
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 session and supports durable remission through flexible, individualized retreatment. Trial Design ReConnection-1 Three-arm randomized, double-blind trial (8 mg, 4 mg, placebo) Single-dose treatment 8 mg chosen as optimal dose; 4 mg included to characterize dose‑response vs. placebo and to support blinding Designed to replicate Phase 2b efficacy and safety ReConnection-2 Two-arm randomized, double-blind trial (8 mg, placebo) Two-dose induction (Day 1 + Day 15) Endpoint Primary Endpoint: Change from baseline in MADRS total score at Week 4 (Day 29) for 8 mg vs. placebo
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) Day 1 92 8mg Randomization 2:1:2 Aim to maintain remission Wk 4 (MADRS Primary endpoint) 29 Wk 8 Wk 12 447 Wk 64 Study Population Adults with TRD Dosing Schema Randomized 2:1:2 with single intranasal administration on Day 1 OLE Retreatment Individualized 8 mg retreatment every 8-12 weeks Designed to replicate Phase 2b results and define the dose–response relationship for BPL‑003 Key Design Elements ReConnection-1 N=~350
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=~300 Double-blind Core Day 1 – Week 12 (12 weeks) OLE Retreatment Week 12-64 (52 weeks) Randomization 1:1 85 Day 1 92 Wk 4 (MADRS Primary endpoint) 29 Wk 8 Wk 12 447 Wk 64 Key Design Elements Study Population Adults with TRD Dosing Schema Randomized 1:1 (8 mg + placebo); two intranasal administrations on Day 1 and Day 15 OLE Retreatment Individualized 8 mg BPL-003 retreatment every 8-12 weeks Designed to evaluate the potential of a two‑dose induction regimen to increase responder rate and durability of initial response 15 Placebo + Placebo
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 Randomization Primary Endpoint Trial Arms Design N = ~350 N = ~300 2:1:2 Randomization 1:1 Randomization 8 mg BPL‑003 vs. 4 mg BPL‑003 vs. Placebo 8 mg BPL‑003 vs. Placebo 8‑week DB, RCT (single dose at Day 1) 52‑week Extension with individualized retreatment (every 8–12 weeks) 8‑week DB, RCT (two-dose induction at Days 1 and 15) 52‑week Extension with individualized retreatment (every 8–12 weeks) MADRS at Week 4 Aligned clinical trial designs intended to maximize operational efficiencies
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
IP Overview Ryan Barrett Chief Legal and Business Officer
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 Salts Polymorphs Indication agnostic Drug product (DP) Formulation Delivery approach Dosage form Methods of treatment (MoT) Use of composition Indications Dosing regimens Indication specific Protect what the product is Method claims Why it matters (Orange Book strategy) FDA “Orange Book” lists approved small-molecule patents and exclusivities Only DS, DP and MoT patents are listable so critical to align issued claims to the product TPP / label A generic typically must certify to listed patents, creating a defined pathway for dispute resolution prior to market entry Protect how the product is used
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 Mebufotenin compositions for transmucosal delivery including intranasal, buccal and sublingual (Exp 2041) Mebufotenin benzoate salt compositions (Exp 2041) Methods of treating depression using mebufotenin benzoate (Exp 2041) Dry powder of mebufotenin & silicon dioxide (Exp 2043) “Other” includes alternative salt forms of mebufotenin and their methods of use (Exp 2041-43) BPL-003 has IP protection out to 2043+ BPL-003: mebufotenin benzoate nasal spray for TRD Issued IP contemplates (non-exhaustive)
BPL-003 Commercial Framework Kavita Panke SVP, New Product Planning and Early Commercial Development
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 comprehensive analysis almost 5 years after first approval”, Am J Psychiatry (2025); 3. McIntyre et al., “Treatment‐resistant depression: definition, prevalence, detection, management, and investigational interventions”, World Psychiatry (2023). †Based on US TRD population size and real-world post approval data on the number of US Spravato®-treated patients. Abbreviations: FDA = Food and Drug Administration; MDD = Major Depressive Disorder; TRD = Treatment-Resistant Depression. People with MDD failed by 2+ antidepressants and are deemed treatment resistant1 1 in 3 <3% of people with TRD are on an FDA-approved treatment for TRD†2 Unmet need remains for a rapid-acting, durable treatment that is convenient3
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 - indefinitely Symptom suppression - not resolution The problem: Patients manage indefinitely, trading one burden for another TOMORROW Psychedelic-Based Interventional Psychiatry ✓ Intermittent dosing ✓ Rapid acting - effects within hours to days ✓ Durable - long-lasting effects from single dose ✓ Neuroplasticity - addresses root-cause biology Potential opportunity: Fewer doses, faster results, lasting freedom ▶ PARADIGM SHIFT
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 = Montgomery–Åsberg Depression Rating Scale. Durable: 6.2 pt MADRS reduction observed at Week 41, sustained for at least 16 weeks in most patients2 Convenient: 4-6 doses per year with 2 hr in-clinic time could allow for broader patient accessibility Rapid: Single dose produced positive efficacy results @ Day 23 BPL-003 BPL-003: Potential to deliver on the trifecta without the tradeoffs
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; 3. DataMonitor, BioMedTracker (both as of 2026); 4. Company websites. Abbreviations: LSD = Lysergic Acid Diethylamide; MDD = Major Depressive Disorder; NDMA = N-methyl-D-aspartate; SNRI = Serotonin-Norepinephrine Reuptake Inhibitor; SSRI = Selective Serotonin Reuptake Inhibitor; TCA = Tricyclic Antidepressant; TRD = Treatment-Resistant Depression. BPL-003 has the potential for a best-in-class TRD profile BPL-003(Intranasal mebufotenin) Pipeline psychedelic therapies for TRD / MDD GH001(Inhaled mebufotenin) DT120(Oral LSD) COMP360(Oral psilocybin) Spravato®(Intranasal esketamine) Mechanism of action 5-HT1a / 5-HT2a agonist 5-HT1a / 5-HT2a agonist 5-HT2a agonist 5-HT2a agonist NDMA antagonist SSRIs / SNRIs / TCAs Oral Antidepressants Company Generic and Branded Approved therapies for TRD / MDD RAPID onset of treatment action1 ✓ ✓ ✓ ✓ ✓ X ‒ DURABLE efficacy from a single dose2 ✓ ✓ ✓ X X CONVENIENT ~2 hr time to discharge post-dose3 ✓ X X X ✓ N/A Potential for:
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 MADRS Total Score BPL-003 | CHANGE IN MADRS FOLLOWING SINGLE DOSE OF BPL-003 VS. TWICE WEEKLY DOSING SPRAVATO® MONOTHERAPY1 BPL-003 SPRAVATO® 1. Janik, et al., “Esketamine monotherapy in adults with treatment-resistant depression: a randomized clinical trial”, JAMA Psychiatry (2025). Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale. *FOR ILLUSTRATIVE PURPOSES ONLY - no head-to-head study has been conducted comparing BLP-003 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.
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, WAC price per 84mg: 1,251 USD (based on GlobalData). 1. Induction dosing is twice weekly, either 56mg or 84mg; 2. Optimization dosing is weekly 84 mg, either 56mg or 84mg; 3. Maintenance is weekly or bi-weekly on 56 mg or 84 mg; 4. Sanacora et al. Am J Psychiatry. (2025); 5. Sanacora et al., ASCP Annual Meeting (2025). Abbreviations: WAC = Wholesale Acquisition Cost. Assumed Annual Cost of Spravato® (WAC Price) Patients were prescribed the 84mg dose by treatment session 64 > 80% Patients have at least one treatment per week as maintenance5 ~70% $0K $20K $40K $60K $80K Maintenance (56mg every 2wks) Maintenance (84mg every 2wks) Maintenance (84mg weekly) Maintenance (56mg weekly) $28K $38K $47K $65K Induction1 Optimization2 Maintenance The majority of Spravato® patients are maintained on the 84mg weekly dose, placing them at the high end of the price range
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 prioritizes patient safety and convenience, without the requirement for psychotherapy Abbreviations: HCP = Healthcare Professional.
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 future clinical studies and real-world evidence. BPL-003 Long In-Clinic Psychedelics
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 interventional psychiatry clinics have prescribed Spravato®1 1. Forian and Komodo Health Prescription Data (2026).
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”, J Clin Psychiatry. (2021). Abbreviations: MDD = Major Depressive Disorder; TRD = Treatment-Resistant Depression. First Program in TRD 1 in 3 MDD patients with need for rapid, durable and convenient treatment1 Adjacent Psychiatric Disorders High unmet need and severe disease burden Limited treatment options
5 Minute Break
KOL Roundtable Kavita Panke SVP, New Product Planning and Early Commercial Development
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
Q&A AtaiBeckley Management Dr. Peter Hendricks, Dr. David Feifel, Dr. Samuel Wilkinson
Thank you