Reported Earnings • May 14
First quarter 2026 earnings released: US$0.083 loss per share (vs US$0.15 loss in 1Q 2025) First quarter 2026 results: US$0.083 loss per share. Net loss: US$29.8m (loss widened 13% from 1Q 2025). Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany. Annonce • Apr 24
AtaiBeckley Inc. Announces Additional Phase 2A Results for EMP-01 Oral R-M Showing Large and Consistent Improvements in Social Anxiety Disorder AtaiBeckley Inc. announced expanded Phase 2a results for EMP-01 (oral R-MDMA) in adults with Social Anxiety Disorder (SAD) (n=70), demonstrating clinically meaningful and consistent improvements across clinician-rated symptoms, patient-reported experience, and real-world behavioral outcomes. At Day 43, EMP-01 achieved a 38% reduction vs 15% on placebo (Hedges’ g=0.84) on the patient-reported Social Phobia Inventory (SPIN), a 32% reduction vs 14% on placebo on the Subtle Avoidance Frequency Examination (SAFE), and a previously reported -11.9-point LS mean difference (LSMD) on the Liebowitz Social Anxiety Scale (LSAS) versus placebo (g=0.45), with 49% responder rates on both Clinical Global Impression-Improvement (CGI-I) (previously reported) and Patient Global Impressions of Change (PGI-C). EMP-01 was well tolerated, with no severe or serious adverse events. EMP-01 produced consistent and clinically meaningful improvements across all major symptom domains of SAD: LSAS: EMP-01 demonstrated a clinically meaningful LSMD of -11.9-points vs placebo (g=0.45) at Day 43 (previously reported), with both total and subscale improvements. Improvements were observed across both fear and avoidance subscales on the clinician-rated 24-item Liebowitz Social Anxiety Scale, indicating that patients experienced fewer social situations as distressing and were more able to engage in them. This degree of change is considered clinically meaningful and reflects broad symptom improvement across core features of social anxiety disorder including fear and anxiety of social situations. SPIN: EMP-01 produced a large, clinically meaningful patient-reported improvement of -18.3-points (38% reduction vs 15% on placebo), which corresponded to a large between-group standardized effect size (g=0.84), in self-reported SAD symptoms from baseline to Day 43. Additional model-based analyses further supported treatment benefits at Day 43, showing statistically significant improvements with a placebo-adjusted LSMD of -11.5 points (95% CI: -18.5, -4.6; p=0.002) at Day 43. Patients treated with EMP-01 moved from severe baseline symptom severity to substantially lower symptom burden by Day 43. These results on the 17-item SPIN are equivalent to being able to initiate conversations, attend social events, and perform at work with substantially less fear and avoidance. SAFE: EMP-01 demonstrated a large, clinically meaningful improvement of -25.9-points (32% reduction vs 14% on placebo) in real-world behavioral avoidance at Day 43. Additional model-based analyses further supported treatment benefits at Day 43, showing statistically significant improvements with a placebo-adjusted LSMD of -15.6 points at Day 43 (95% CI: -26.0, -5.2; p=0.004). These results on the Subtle Avoidance Frequency Examination, a 32-item questionnaire that measures safety behaviors, suggest that participants were more willing to participate in everyday activities such as social interactions without engaging in avoidant coping behaviors. Clinical impression: 49% CGI-I responders (NNT=2.95) at Day 43 compared to 15% on placebo (previously reported). This measure reflects clinicians’ overall judgment of meaningful improvement in a patient’s condition, considering symptom severity, functioning, and overall clinical presentation. Patient perception: 49% PGI-C responders (NNT=2.72) at Day 43 compared to 12% on placebo. This result indicates that patients themselves perceived the treatment-associated improvements as noticeable and meaningful in their daily lives, reinforcing the clinical and functional outcomes observed on other measures. Safety & Tolerability: EMP-01 was generally safe and well tolerated: No SAEs and no severe TEAEs in any participant; 97% retention, with 0% study dropouts attributed to TEAEs; TEAEs were expected and consistent with the class, transient, and predominantly mild-to-moderate. The multi-center study enrolled 71 adults with moderate-to-severe SAD across 7 clinical sites in the UK. Participants were randomized to receive two in-clinic administrations of EMP-01 (225 mg) or placebo, given 28 days apart, with no adjunctive psychotherapy. 70 participants received at least one dose of study drug, and 69 completed the Day 43 efficacy assessments, indicating high patient acceptability and retention. All clinician-rated assessments were conducted by blinded central raters. Annonce • Apr 23
AtaiBeckley Inc., Annual General Meeting, Jun 04, 2026 AtaiBeckley Inc., Annual General Meeting, Jun 04, 2026. Annonce • Apr 08
AtaiBeckley Inc. Shows Rapid And Durable Antidepressant Response With BPL-003 In Treatment-Resistant Depression Patients AtaiBeckley Inc. announced peer-reviewed Phase 2a results (NCT05660642) in CNS Drugs demonstrating that a single intranasal dose of BPL-003 (mebufotenin benzoate), which holds FDA Breakthrough Therapy Designation, achieved rapid and sustained reductions in MADRS scores from baseline in participants with treatment-resistant depression (TRD) who remained on stable SSRI therapy throughout the study (n=12). A 66.7% antidepressant response rate (=50% reduction from baseline MADRS score) was observed at Day 2 in both the 10 mg (n=6) and 12 mg (n=6) cohorts, with 83% (5/6) of participants in the 10 mg cohort and 66.7% (4/6) of participants in the 12 mg cohort maintaining a response at Week 12. BPL-003 was generally well tolerated with no serious adverse events reported, and participants achieved a mean discharge approximately 100 minutes post-dose. Phase 3 studies are on track to initiate in Second Quarter 2026 following recent FDA End-of-Phase 2 (EOP2) alignment. BPL-003 (mebufotenin benzoate intranasal spray) is a 5-HT1A and 5-HT2A agonist associated with rapid onset and treatment experience of approximately 2 hours. The indication is treatment-resistant depression (TRD); failure to respond to =2 prior antidepressants at adequate dose and duration. U.S. FDA Breakthrough Therapy Designation was granted October 2025. NCT05660642 is a four-part Phase 2a open-label study. Part 2 (SSRI-concomitant, n=12) reported here; Part 1 (monotherapy, single dose, n=12) published in Journal of Psychopharmacology in March 2026. Part 3 (8 mg + 12 mg, monotherapy, n = 12) topline announced September 2025. Part 4 (8 mg + 8 mg, adjunctive) ongoing; initial data expected Fourth Quarter 2026. Endpoint is safety and tolerability; exploratory Montgomery-Asberg Depression Rating Scale (MADRS) total score change from baseline. 66.7% of participants achieved =50% MADRS reduction from a single dose at Day 2. 83% responders (10 mg cohort); 66.7% (12 mg cohort) at Day 85. MADRS-6 Core Symptoms: 19.2 ? 6.2 (10 mg); 21.0 ? 9.3 (12 mg); =10 = remission. No serious adverse events; majority of drug-related AEs transient and resolved on same day. Mean discharge readiness approximately 100 minutes post-dose. End-of-Phase 2 meeting with U.S. FDA completed; Phase 3 initiation on track for Second Quarter 2026. The 12-week, open-label, single-center, ascending-dose trial enrolled 12 adults aged 18 to 75 years with moderate-to-severe major depressive disorder (baseline MADRS =24) and TRD. All participants had failed at least two prior antidepressants and remained on a stable dose of one of four SSRIs - citalopram, escitalopram, sertraline or fluoxetine - throughout the study. Six participants received a single intranasal 10 mg dose of BPL-003 and six received a single intranasal 12 mg dose of BPL-003, with psychological support before, during and after dosing. Participants were followed for 12 weeks. This publication represents Part 2 of the four-part Phase 2a open-label study. Data from Part 1 (BPL-003 monotherapy, 10 mg single dose, n=12) was published in the Journal of Psychopharmacology in March 2026, reporting a mean 12.6-point MADRS reduction by Day 2, sustained through 12 weeks. Topline data from Part 3 (8 mg + 12 mg, BPL-003 monotherapy, n=12) were announced in September 2025, showing that a second dose of BPL-003 at Week 2 has the potential to induce additional reductions in MADRS scores without impact on the safety and tolerability profile of the treatment. Part 4 of the program - evaluating a two-dose induction regimen of BPL-003 (8 mg + 8 mg) in participants with TRD who are also receiving defined antidepressants – is ongoing. Initial data from that cohort is expected in Fourth Quarter 2026. Annonce • Mar 17
AtaiBeckley Inc Demonstrates Rapid And Durable Antidepressant Effects In Treatment-Resistant Depression AtaiBeckley Inc. announced the peer-reviewed publication of results from its ongoing four-part Phase 2a study evaluating BPL-003 (mebufotenin benzoate nasal spray) in patients with treatment-resistant depression (TRD). Newly reported data come from Cohort 1 – a 12 week, open-label trial of a single 10 mg intranasal dose of BPL-003 in 12 patients with moderate-to-severe TRD who were not taking concomitant antidepressants. BPL-003 produced a mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score reduction of 12.6 points by Day 2 (from a baseline mean of 27.5 to 14.8), which was sustained over 12 weeks to a mean MADRS score of 14.5 at Day 85. A response rate (=50% MADRS reduction) of 54.5% was observed from the day after dosing through Day 85, and 63.6% of patients achieved remission (MADRS =10) at one or more timepoints. Mean Snaith-Hamilton Pleasure Scale (SHAPS) scores also improved from 8.4 at baseline to 1.5 at Day 85, indicating an absence of anhedonia. BPL-003 was well tolerated with no serious adverse events and no treatment withdrawals due to adverse events. Most adverse events were transient and mild-to-moderate in severity. Following a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration announced in March 2026, the Phase 3 program for BPL-003 in TRD remains on track for initiation in Second Quarter 2026. The Phase 2a trial comprises four cohorts. Results from Parts 1, 2 and 3 have been previously announced. The first patient has been dosed in the Part 4 cohort, evaluating a two-dose induction regimen (8 mg + 8 mg) of BPL-003 in TRD patients receiving defined antidepressants, with initial data expected in Fourth Quarter 2026. BPL-003 is a patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable effects from a single dose, with a short psychedelic duration, and is being investigated as a potential therapy for treatment-resistant depression (TRD) and alcohol use disorder (AUD). BPL-003 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration and is covered by granted US, UK and European composition-of-matter patents, with multiple further claims pending in various jurisdictions. Annonce • Mar 03
AtaiBeckley Inc Announces Successful End-Of-Phase 2 Meeting For BPL-003 In Treatment-Resistant Depression AtaiBeckley Inc. had a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of BPL-003, the Company’s proprietary intranasal formulation of mebufotenin benzoate, for treatment-resistant depression (TRD). Minutes from the meeting show that the FDA indicated support for AtaiBeckley’s proposed BPL-003 pivotal program and the compound’s advancement into Phase 3 studies in adults with TRD. The FDA also provided constructive feedback on the overall design and key components of the proposed program, including the overall size of the safety database for this chronic indication. BPL-003 was previously granted Breakthrough Therapy designation by the FDA for treatment-resistant depression. The Phase 3 program is designed to include two pivotal studies, ReConnection 1 and ReConnection 2, conducted in parallel. Both will include a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension (OLE) in which participants may receive individualized retreatment with BPL-003, subject to pre-specified eligibility criteria. ReConnection 1: The core study will enroll approximately 350 participants and will evaluate a single-dose of BPL-003 across three treatment arms - 8 mg, 4 mg, and placebo (randomized 2:1:2). This trial is designed to replicate and extend the treatment response observed in the Phase 2b study and to further characterize the dose–response relationship for BPL-003. ReConnection 2: The core study will enroll approximately 300 participants and will evaluate BPL-003 administered on Day 1 and Day 15 across two arms - 8 mg BPL-003 and placebo (randomized 1:1). This trial is designed to investigate a two-dose induction model of BPL-003 as a potential treatment option to increase magnitude and durability of initial response. The primary endpoint in both pivotal trials will be the change from baseline in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score at Week 4 (Day 29) of the response in the 8 mg BPL-003 treatment arm compared to placebo. In the OLE, participants may receive 8 mg BPL-003 at 8- or 12-week intervals, subject to certain conditions for re-treatment eligibility, with the goal of maintaining remission and assessing long-term safety, durability of effects, and treatment patterns. BPL-003 is a patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short psychedelic duration and is being investigated as a potential therapy for treatment-resistant depression (TRD). BPL-003 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration and is covered by granted US, UK and European composition-of-matter patents, with multiple further claims pending in various jurisdictions. BPL-003 is an investigational product and has not been approved by the FDA. Annonce • Feb 26
AtaiBeckley Inc. Announces Positive Topline Results from an Exploratory Phase 2a Trial of EMP-01 (oral R-MDMA) in Social Anxiety Disorder AtaiBeckley Inc. announced topline results from its exploratory, double-blind, placebo-controlled, first-in-patient Phase 2a study (NCT06693609) evaluating EMP-01 (oral R-MDMA) in adults with Social Anxiety Disorder (SAD). The study met its primary safety objective and generated encouraging secondary and exploratory efficacy signals in a highly severe, difficult-to-treat population. Participants were randomized to receive two in-clinic administrations of EMP-01 (225 mg) or placebo, given 28 days apart, with no adjunctive psychotherapy. 70 participants received at least one dose of study drug, and 69 completed the Day 43 efficacy assessments, indicating high patient acceptability and retention. All clinician-rated assessments were conducted by blinded central raters. Because avoidance behaviors typically change gradually and often require prolonged real-world exposure, the early, parallel improvements in both Fear and Avoidance - after two dosing sessions and without psychotherapy - suggest that EMP-01 could influence both the emotional and behavioral dimensions of social anxiety disorder. Dr. David Feifel, Professor Emeritus of Psychiatry at the University of California, San Diego, Founder and President of the Kadima Neuropsychiatry Institute, and consultant to AtaiBeckley, said, " Several findings from this preliminary study are highly encouraging, particularly that LSAS improvements became apparent after dosing was completed and the drug was no longer present, suggesting a sustained biological therapeutic effect. If confirmed in larger trials, this would represent a meaningful departure from current first-line pharmacotherapies like SSRIs, which require continuous daily dosing and frequently produce tolerability concerns. An intervention delivering durable symptom improvement with intermittent drug exposure would be a potentially transformative development for patients with this disorder". Annonce • Jan 01
AtaiBeckley Completes Redomiciliation to the United States AtaiBeckley Inc. announced the completion of the redomiciliation of the parent company of the AtaiBeckley group from a Netherlands company to a U.S. entity incorporated in Delaware. The redomiciliation was approved by approximately 99% of the votes cast at the Company’s extraordinary general meeting of shareholders on November 4, 2025. The redomiciliation was completed following the close of trading on the Nasdaq Global Market on December 30, 2025. At completion, all issued and outstanding ordinary shares of Atai Beckley N.V. were exchanged on a one-for-one basis for newly issued shares of common stock of the Delaware company, AtaiBeckley Inc. The former shareholders of Atai Beckley N.V. are now the stockholders of the Delaware company. AtaiBeckley Inc’s common stock will continue to trade on NASDAQ under the trading symbol “ATAI”. The Company expects the redomiciliation to save costs, create alignment with its U.S. listing and shareholder base, simplify its corporate structure and streamline reporting requirements, in addition to reducing the associated administrative burden for the Company and investors. Annonce • Dec 31
Atai Beckley N.V. Files Form 15 Atai Beckley N.V. (NasdaqGM:ATAI) has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock, par value €0.10 per share under the Securities Exchange Act of 1934, as amended. New Risk • Dec 02
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 116% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (116% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$138m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Revenue is less than US$5m (US$3.0m revenue). Reported Earnings • Nov 13
Third quarter 2025 earnings released: US$0.28 loss per share (vs US$0.16 loss in 3Q 2024) Third quarter 2025 results: US$0.28 loss per share (further deteriorated from US$0.16 loss in 3Q 2024). Net loss: US$61.1m (loss widened 132% from 3Q 2024). Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 2.8% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 11% per year whereas the company’s share price has increased by 9% per year. Annonce • Nov 11
Atai Beckley N.V. Announces Positive Topline Data from the Phase 2b Open-Label Extension Study of BPL-003 Atai Beckley N.V. announced positive topline results from the open-label extension (OLE) study of its Phase 2b clinical trial (NCT05870540) of BPL-003 in patients with treatment-resistant depression (TRD). The Phase 2b clinical trial of BPL-003 was conducted in two parts: an eight-week, quadruple-masked, dose-finding core study designed to evaluate the efficacy and safety of a single 0.3 mg, 8 mg, or 12 mg dose of B PL-003 in patients with TRD, followed by an eight-week OLE study to assess the safety and efficacy of a second 12 mg dose, given eight weeks after the initial dose, regardless of the patient's Montgomery-Asberg Depression Rating Scale (MADRS) score. Of the 126 patients who completed the blinded core study and were eligible to enroll, 107 continued into the extension study. Patients who initially received an 8 mg dose of BPL-003 in the core study of the Phase 2b trial (n=23): Mean reduction in MADRS score of 22.3 points at Day 57 in the OLE (Week 16 of the Phase 2b clinical trial) compared to their baseline at the start of the core study. Pooled population of patients who received an active dose (either 8 mg or 12mg) of BPL-003 In the core study of the Phase2b trial (n=60): Mean reduction in MADRS scores of 19.0 points at Day 57 in theOLE (Week 16 of the phase 2b clinical trial) compared To their baseline at the start of The core study. Next Steps: The topline results from the OLE study are in line with the previously announced topline results from the eight-week, blinded core study, which demonstrated that both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms when compared to a 0.3 mg low-dose active control for up to eight weeks. Safety and efficacy data from the core and OLE studies of the Phase 2b clinical study support the selection of the 8 mg dose to advance into Phase 3 clinical development and also support the potential for continued and increased antidepressant effects with repeat dosing. Atai Beckley is scheduled to meet with the FDA at an End-of-Phase 2 meeting to align on clinical trial designs and other aspects of the Phase 3 development program. The Company anticipates providing guidance on the Phase 3 clinical program in the first quarter of 2026. Annonce • Nov 06
AtaiBeckleyAnnounces Board Changes The shareholders of atai Life Sciences voted to approve the strategic combination with Beckley Psytech Limited and the corporate redomiciliation at the Extraordinary General Meeting of Shareholders on November 4, 2025. Their Strategic Combination to Create AtaiBeckley. Dr. Srinivas Rao, CEO and Co-Founder of atai, to lead experienced team of executives from atai and Beckley
Psytech; Cosmo Feilding Mellen, CEO and Co-Founder of Beckley Psytech, to serve on the Board of Directors. Board of Directors to be led by Founder and Chairman of atai, Christian Angermayer, and newly appointed Vice Chairman, Scott Braunstein, M.D. All members of the atai Board will remain on the AtaiBeckley Board and, in addition to Cosmo Feilding Mellen, will be joined by Beckley Psytech Board Member Robert Hershberg, M.D., Ph.D. Experienced Leadership Team AtaiBeckley will be led by CEO and Co-Founder Dr. Rao. He will be joined by an executive team with deep expertise in neuroscience, psychiatry, and drug development including: Anne Johnson, CPA as Chief Financial Officer, Rob Conley, M.D. as Chief Research & Development Officer, Gerd Kochendoerfer,
Ph.D. as Chief Operating Officer, Kevin Craig, M.D. as Chief Medical Officer, Glenn Short, Ph.D. as Chief Scientific Officer and Ryan Barrett as Chief Legal and Business Officer. Annonce • Sep 23
atai Life Sciences and Beckley Psytech Limited Report Positive Phase 2a Data Demonstrating Improved Outcomes with A Two-Dose Induction Regimen of BPL-003 in Patients with Treatment-Resistant Depression atai Life Sciences and Beckley Psytech Limited announced positive data from a proof-of-concept study investigating a two-dose induction regimen of BPL-003 (intranasal mebufotenin biozoate), in patients with treatment-resistant depression (TRD). The open-label Phase 2a study (NCT05660642) enrolled 13 patients with TRD who were not on concurrent drugs, and 12 met the criteria for per-protocol analysis. These findings suggest that a second dose of BPL-003 may further enhance the clinical response beyond what is achieved with a single administration. Together with the results from the Phase 2b program, these data provide a strong foundation of evidence to design Phase 3 program, and the company are grateful to the patients, investigators and sites who have made this progress possible. The results from this study add to the growing body of evidence from the BPL-003 clinical program demonstrating that BPL-003 has the potential to be a rapid-acting, durable and convenient treatment option for patients with TRD. Dosing and follow-up in the open-label extension (OLE) of the Phase 2b study, which is evaluating the effects of a 12 mg dose of BPL-003 administered eight weeks after the initial dose in the core study, is complete and data are expected in October. atai and Beckley Psytech are finalizing plans to engage with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to discuss the design of the Phase 3 clinical trial for BPL-003 in patients with TRD. Pending FDA feedback, initiation of Phase 3 trials are expected in the first half of 2026. Annonce • Sep 20
atai Life Sciences Awards Grant from the National Institutes of Health atai Life Sciences announced that it has been awarded a multi-year, milestone-driven grant worth up to $11.4 million by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). The UG3/UH3 grant will fund the optimization and early-stage development of atai’s novel 5-HT2A/2C receptor agonists with non-hallucinogenic potential for opioid use disorder (OUD). The grant provides non-dilutive funding to advance atai’s 5-HT2A/2C agonist program, focused on developing novel compounds that modulate serotonin receptors implicated in addiction. The funding will support lead optimization, translational proof-of-concept studies, and the toxicology and manufacturing work needed to file an Investigational New Drug (IND) application. The goal is to identify clinical candidates that maintain therapeutic activity against opioid use disorder while minimizing hallucinogenic effects and avoiding 5-HT2B activity, which has been linked to cardiac valvulopathy. If early-stage development milestones are met, atai plans to progress the program into a first-in-human Phase 1 study. OUD affects 16 million people globally, costing >$750 billion annually. More than 120,000 opioid-related deaths occur annually worldwide. atai’s novel 5-HT2A/2C receptor agonists with non-hallucinogenic potential could support lasting abstinence while reducing the daily treatment burden seen with current OUD therapies. Annonce • May 21
atai Life Sciences Announces Positive Topline Data from Part 2 of Beckley Psytech's Phase 2a Study of BPL-003 in Combination with SSRIs for Treatment-Resistant Depression atai Life Sciences announced positive topline data from Part 2 of Beckley Psytech's Phase 2a study (NCT05660642) of BPL-003 (mebufotenin benzoate), for treatment-resistant depression (TRD). The findings show that a single dose of BPL-003, when given to patients who were also taking defined selective serotonin reuptake inhibitors (SSRIs), was well-tolerated, with rapid and durable antidepressive effects of up to three months with an average in-clinic treatment time of less than two hours following dosing. These findings demonstrate the potential of BPL-003 to deliver a commercially scalable single dose treatment model, if approved, that fits within the current interventional psychiatric care model established by Spravato®?. The results are also consistent with initial results from Part 1 of the study, which investigated BPL-003 as a monotherapy. Data from that study showed that a single dose of B PL-003 was well-tolerated and produced a rapid and lasting antidepressant effect for up to three months after dosing. Beckley Psytech is expecting results from the core, randomized, quadruple-masked stage of its Phase 2b study of BPL-003 for TRD in mid-2025. In January 2024, atai made a strategic investment in Beckley Psytech, resulting in an approximate one third ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization. Annonce • May 15
atai Life Sciences Announces First Patient Dosed in Phase 2 Study of EMP-01 for the Treatment of Social Anxiety Disorder atai Life Sciences announced that the first patient has been dosed in the exploratory Phase 2 study of EMP-01 (R-3,4-methylenedioxy-methamphetamine (R-MDMA)) for the treatment of social anxiety disorder (SAD). The Phase 2 study is an exploratory, randomized, double-blind, placebo-controlled trial (NCT06693609) to assess the safety, tolerability and efficacy of EMP-01 in approximately 60 adults with SAD. Patients will be randomized 1:1 to receive two double-blind administrations of either EMP-01 or placebo, spaced four weeks apart. EMP-01 is an oral formulation of R-3,4-methylensioxy-methamphetamine ("R-MDMA") that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA. anxiety disorders are the most common mental health disorders worldwide, affecting how one experiences worry, fear and anxiety in everyday situations. Social anxiety disorders (SAD) is an area of high unmet medical need with approximately 18 million people currently diagnosed in the United States and no novel molecules approved in over two decades. atai is currently enrolling patients into an exploratory, randomized, single-blind, placebo-controlled Phase 2 study to assess the safety, tolerable and efficacy of EMP-01 In adults with SAD. Topline data from the Phase 2 study is anticipated in the first quarter of 2026. Annonce • Apr 14
Atai Life Sciences N.V., Annual General Meeting, May 15, 2025 Atai Life Sciences N.V., Annual General Meeting, May 15, 2025. Location: nautadutilh n.v., beethovenstraat 400, 1082 pr, amsterdam Netherlands Recent Insider Transactions • Mar 26
Co-Founder & CEO recently sold €94k worth of stock On the 21st of March, Srinivas Rao sold around 75k shares on-market at roughly €1.25 per share. This transaction amounted to 26% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Srinivas has been a net seller over the last 12 months, reducing personal holdings by €200k. New Risk • Mar 20
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m (US$308k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$132m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Reported Earnings • Mar 18
Full year 2024 earnings released: US$0.93 loss per share (vs US$0.25 loss in FY 2023) Full year 2024 results: US$0.93 loss per share (further deteriorated from US$0.25 loss in FY 2023). Net loss: US$149.3m (loss widened 271% from FY 2023). Revenue is forecast to grow 67% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 35% per year but the company’s share price has fallen by 36% per year, which means it is significantly lagging earnings. Annonce • Mar 11
atai Life Sciences Announces First Patient Dosed in Elumina, the Phase 2 Clinical Trial of VLS-01 for Treatment-Resistant Depression atai Life Sciences announced that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai's proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, in people suffering from treatment-resistant depression (TRD). Elumina is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, clinical trial to assess the efficacy, safety and tolerability of repeated doses of VLS-01 (NCT06524830). The trial consists of two treatment periods. In the first treatment period, approximately 142 patients will be randomized 1:1 to receive a 120mg dose of VLS-01 or placebo on Day 1, followed by a second dose of the same intervention at Week 2. The primary endpoint is the change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 4. The last double-blind assessment visit will be at Week 14. The first treatment period will provide 12 weeks of blinded durability data following two doses of VLS-01 administered in a placebo-controlled fashion. Topline results from the first treatment period are anticipated in the first quarter of 2026. The second treatment period starts at Week 14 and will explore the response to two different dose levels of VLS-01. Patients will be randomized 1: 1 to receive a third dose of either 60mg or 120mg of VLS-01. Final safety and efficacy assessment will be conducted two weeks after administration of the third dose. VLS-01 (buccal film DMT) VLS-01 is a proprietary oral transmucosal film formulations of N,N-Dimylryptamine (DMT) application to the buccal surface. VLS-01 is a patented oral transmucosal film formulation the N,N-Dimethy Ltdryptamine (DMT) apply to the buccal surface., being developed for the treatment of people suffering from treatment-resistant Depression (TRD). Pharmacologically, VLS-01 is a partial to full agonist of the 5-HT1/2/6/7 receptors and is being developed to potentially offer rapid, robust, and durable efficacy with a favorable safety profile. VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm, positioning it for integration into existing care models. atai is enrolling patients into Elumina, the Phase 2, multi-center., double-blind, randomized, trial to assess the efficacy, Safety and tolerability of VLS-01 in people suffering from treatment- resistant depression (TRD). Topline results from the established two-hour inter conventional psychiatry treatment paradigm, positioning it For integration into existing care models. Atai is enrolling patients intoElumina, the phase 2, multi-center, multi-center, double theblind, randomized, placebo- controlled, trial to assess the efficacy. Topline results from the First treatment period of the Phase 2 Elumina study are expected in the first quarter of 2026. Annonce • Mar 06
atai Life Sciences Announces Completion of Enrollment in Phase 2B Clinical Trial Evaluating BPL-003 for Treatment-Resistant Depression atai Life Sciences announced the completion of patient enrollment in the eight-week, double-blind, core stage of the global Phase 2b clinical trial evaluating BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression (TRD). BPL-003 is Beckley Psytech’s patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable effects from a single dose, with a short time in clinic. Topline results from the core stage of the Phase 2b clinical trial are expected in mid-2025. The eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial (NCT05870540) is evaluating the efficacy and safety of a single medium (8mg) or high (12mg) dose of BPL-003 against a sub-perceptual dose. The trial enrolled 196 patients with moderate-to-severe depression that had failed to respond to at least two or more prior treatments in the current episode of depression across 38 sites in six countries. Patients are followed for eight weeks, and efficacy is assessed at various timepoints by centralized, blinded raters using the Montgomery-Asberg Depression Rating Scale (MADRS). The eight-week, open-label, extension stage of the Phase 2b clinical trial continues to enroll patients to evaluate the safety and efficacy of a second high dose of BPL-003 administered after the completion of the core stage of the trial. Data from the Phase 2b clinical trial will be used in conjunction with data from the Phase 2a study of BPL-003 in patients with TRD to support end-of-Phase 2 meetings with regulatory bodies and Phase 3 planning in the second half of 2025. Initial Phase 2a data showed that a single 10mg dose of BPL-003 can produce a rapid and lasting antidepressant effect, with 55% of patients meeting the criteria for remission (MADRS =10) at Day 29 and 45% meeting the criteria for remission at Day 85. BPL-003 only required a short time in clinic, with patients deemed dischargeable within an average time of less than two hours after dosing. Annonce • Jan 28
atai Life Sciences Announces Positive Topline Results from Beckley Psytech’s BPL-003 (intranasal 5-MeO-DMT benzoate) Phase 2a Open-Label Study for Alcohol Use Disorder atai Life Sciences announced positive topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe alcohol use disorder (AUD). BPL-003 is a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate designed to deliver rapid and durable treatment effects from a single dose with a short in-clinic treatment time. The results showed that a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy, induced meaningful and sustained reduction in alcohol use and heavy drinking days (HDDs) in patients with moderate to severe AUD out to 12 weeks. The 12-week Phase 2a open-label study enrolled 12 patients with moderate to severe AUD and evaluated the safety, tolerability, pharmacodynamic effects and impact on alcohol use of a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy (NCT05674929). The results demonstrated meaningful and sustained reductions in alcohol use following a single dose of BPL-003: Mean number of alcohol units consumed per day decreased from 9.3 units to 2.2 units at Week 12, Mean percentage of HDDs, defined as consuming seven or more units of alcohol per day for women and nine or more units of alcohol per day for men, declined from 56% to 13% at Week 12, Mean number of abstinent days increased from 33% to 81% at Week 12, 50% of the patients remained completely abstinent through the 12-week study .BPL-003 was shown to be well-tolerated with adverse events (AEs) being reported as mild or moderate and there were no serious or severe adverse events reported. Most patients were assessed as ready for discharge within approximately two hours. Beckley Psytech plans to evaluate future development options for BPL-003 in substance use disorders and anticipates reporting additional clinical data from this study in publications and conferences in 2025. Annonce • Jan 25
Atai Life Sciences N.V. Announces Resignation of Michael Auerbach as Member of the Supervisory Board of Directors and Supervisory Board’s Compensation Committee On January 19, 2025, Mr. Michael Auerbach resigned as a member of the supervisory board of directors of Atai Life Sciences N.V and of the Supervisory Board’s compensation committee. Mr. Auerbach’s resignation was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies and practices. The Company thanks Mr. Auerbach for his service to the Company and its shareholders. Following Mr. Auerbach’s resignation, effective January 19, 2025, the Supervisory Board decreased its size from seven to six directors. Annonce • Jan 10
Srinivas Rao Assumes the Role of Sole CEO of Atai Life Sciences N.V atai Life Sciences announced key leadership appointments to advance its goal of delivering novel mental health therapeutics. Srinivas Rao M.D., Ph.D., has assumed the role of sole Chief Executive Officer (CEO). As announced in May 2024, Co-Founder Srinivas Rao, M.D., Ph.D., was promoted to Co-CEO effective June 1, 2024, and assumed the role of CEO on January 1, 2025. Dr. Rao has over 24 years of diverse biotechnology and pharmaceutical experience, having held the titles of Chief Scientific, Medical, and Executive Officer at companies ranging from venture-backed startups to vertically integrated, publicly traded pharmaceutical companies. Reported Earnings • Nov 15
Third quarter 2024 earnings released: US$0.16 loss per share (vs US$0.28 profit in 3Q 2023) Third quarter 2024 results: US$0.16 loss per share (down from US$0.28 profit in 3Q 2023). Net loss: US$26.3m (down 159% from profit in 3Q 2023). Revenue is forecast to grow 85% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 43% per year but the company’s share price has fallen by 46% per year, which means it is significantly lagging earnings. New Risk • Nov 10
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 11% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$79m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Revenue is less than US$1m (US$378k revenue). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$88m net loss in 3 years). Reported Earnings • Aug 14
Second quarter 2024 earnings released: US$0.36 loss per share (vs US$0.21 loss in 2Q 2023) Second quarter 2024 results: US$0.36 loss per share (further deteriorated from US$0.21 loss in 2Q 2023). Net loss: US$57.3m (loss widened 74% from 2Q 2023). Revenue is forecast to grow 79% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Annonce • Aug 14
atai Life Sciences Announces Positive Preliminary Results from Phase 1b Trial of VLS-01 (Bccal Film DMT) atai Life Sciences announced positive preliminary results from the Phase 1b trial of VLS-01, its proprietary oral transmucosal film formulation of N,N-dimethyltryptamine (DMT) that is applied to the buccal surface. The Phase 1b trial was designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VLS-01 compared to intravenous (IV) DMT. The single center, open-label study enrolled a total of 17 healthy participants, each of whom received a single dose of IV DMT followed by 3 different doses of VLS-01 buccal film--20mg (N=8), 60mg (N=6), 120mg (N=14) or 160mg (N=16)--with a 28-day washout window between administration. Key takeaways: Peak plasma concentrations (Cmax) were dose-proportional and comparable between the higher VLS-01 buccal film doses (120mg and 160mg) and the 30mg IV DMT dose; peak plasma concentrations were achieved within 30-45 minutes (Tmax). Dose-dependent and robust subjective effects were seen at the 120mg and 160mg doses. In the 120mg dose cohort: 13/14 participants achieved Subjective Intensity Rating Scale (SIRS) scores greater than seven out of ten. Subjective effects, assessed with the SIRS, were fully resolved by 120 minutes. Participants reported that the experience was ‘psychologically meaningful’ with ‘increased levels of self-reflection’. Safety and tolerability: VLS-01 demonstrated a favorable safety profile and was well tolerated, with all adverse events classified as either mild or moderate, and most resolving on the day of dosing. The most common treatment-emergent adverse events (TEAEs) were headache, dissociation, euphoric mood and nausea. No TEAEs of vomiting or local irritation were noted at doses of 120mg or lower, and only 1 subject out of 14 (7%) reported nausea at the 120mg dose. There were no observed adverse events related to blood pressure, heart rate or suicidality. Based on the positive results from the Phase 1b trial, the Company plans to initiate a randomized, double-blind, placebo-controlled Phase 2 study (NCT06524830) to assess the safety, efficacy and durability of response of repeated doses of VLS-01 in patients with treatment-resistant depression (TRD). The Phase 2 trial will consist of two treatment periods. In the first treatment period, approximately 142 patients will be randomized 1:1 to receive a 120mg dose of VLS-01 buccal film or placebo on Day 1, followed by a second dose of the same intervention at Week 2. The primary endpoint is the change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 4 and the last double-blind assessment visit will be at Week 14. The first treatment period will provide 12 weeks of durability data following two doses of VLS-01 administered in a placebo-controlled fashion. The second treatment period starts at Week 14 and will explore the response to two different dose levels of VLS-01. Patients will be randomized 1:1 to receive a third dose of either 60mg or 120mg of VLS-01. Final safety and efficacy assessment will be conducted two weeks after administration of the third dose. atai expects to initiate the Phase 2 trial around year-end 2024, with topline data anticipated around year-end 2025. VLS-01 (also referred to as VLS-01-BU) is a proprietary oral transmucosal film formulation of DMT applied to the buccal surface, being developed for patients living with treatment-resistant depression. Pharmacologically, DMT is a partial agonist of the 5-HT 1A/2A/2C receptors, characterized by an intrinsically short duration of psychedelic effect. Clinical evidence suggests that a single administration of intravenous (IV) DMT results in rapid-acting and durable antidepressant effects in patients with major depressive disorder. The Company’s proprietary buccal film formulation is designed to eliminate the need for IV administration, provide improved PK compared to such route of administration, and maximize the therapeutic potential of a two-hour in-clinic patient visit. New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$86m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$86m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Revenue is less than US$1m (US$277k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$99m net loss in 3 years). Significant insider selling over the past 3 months (€482k sold). Annonce • Jun 20
Atai Life Sciences Announces Update on Beckley Psytech’S Phase 1/2A Trial of Ele-101 (Iv Psilocin) for Major Depressive Disorder, with Initial Results from Phase 1 and First Patients Dosed in Phase 2A atai Life Sciences announced an update on Beckley Psytech’s Phase 1/2a trial of ELE-101 (NCT05434156) for people living with MDD, with initial results from Phase 1 and the dosing of the first patients in the Phase 2a part of the study. ELE-101, a patent-protected IV formulation of psilocin, has been designed to provide consistent and controllable drug delivery in patients with neuropsychiatric conditions. As the active metabolite of psilocybin, psilocin has the potential to offer a rapid onset, significantly shorter treatment duration, and reduced inter-subject variability compared to oral formulations of psilocybin. This could enhance convenience and therapeutic outcomes for patients with depression while reducing the resource burden on healthcare systems. The open-label Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single IV dose of ELE-101 in 6-12 patients diagnosed with MDD. Patients will be assessed at various time points in the study for up to three months after dosing, with results expected in H2 2024. The dose was selected using preliminary PK/PD data from the Phase 1 part of the study, a randomized, double-blind, placebo-controlled, single ascending dose study of ELE-101 in healthy participants. Initial data from Phase 1 supports the differentiated profile of ELE-101, showing that ELE-101: Was well-tolerated with no serious or severe adverse events (AE) reported, and an AE profile which is consistent with other compounds in this class. Demonstrated a dose-proportional PK profile, leading to reduced inter-subject variability compared to oral psilocybin. Induced high-intensity, short-duration psychedelic experiences, suggesting a potential treatment time of approximately two hours in the clinic. If validated in further studies, these findings could support the development of a scalable treatment model similar to the established paradigm of Spravato®, an esketamine nasal spray for treatment-resistant depression. Full data from the Phase 1 study is expected to be published at a later date.