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. 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. Reported Earnings • Aug 18
Second quarter 2025 earnings released: US$0.14 loss per share (vs US$0.36 loss in 2Q 2024) Second quarter 2025 results: US$0.14 loss per share (improved from US$0.36 loss in 2Q 2024). Net loss: US$27.7m (loss narrowed 52% from 2Q 2024). Revenue is forecast to grow 80% 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 21% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings. Board Change • Aug 18
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. No highly experienced directors. was the last director to join the board, commencing their role in . The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. 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 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 50% 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. Over the last 3 years on average, earnings per share has increased by 52% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings. 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 (15% 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. Annonce • May 24
Atai Life Sciences N.V. Announces Board and Supervisory Board Changes atai Life Sciences N.V. announced the appointment of Scott Braunstein, M.D., and Laurent Fischer, M.D., as independent directors of atai’s supervisory board subject to applicable legal requirements. Scott Braunstein, M.D., is the Chief Executive Officer and Chairman of Marinus Pharmaceuticals Inc. He is an operating partner at Aisling Capital and serves on the Board of Directors at both Caribou Biosciences Inc. and Trevena Inc. Previously, Dr. Braunstein was Chief Operating Officer at Pacira Pharmaceuticals Inc. and portfolio manager of the JP Morgan Global Healthcare Fund. Dr. Braunstein began his career as a practicing physician at the Summit Medical Group, earning his medical degree from the Albert Einstein College of Medicine and his undergraduate degree from Cornell University. Laurent Fischer, M.D., is the CEO and President of Adverum Biotechnologies and serves on the Board of Directors at Mirum Pharmaceuticals Inc., Lycia Therapeutics and Teal. Previously, Dr. Fischer was Chairman of CTI Biopharma, CEO of Tobira Therapeutics (subsequently Allergan), and held leadership roles at Jennerex, RXCentric, MedVantx, Dupont Pharmaceuticals, Dupont-Merck, and F. Hoffmann-La Roche. Dr. Fischer earned an undergraduate degree from the University of Geneva and his medical degree from the Geneva Medical School, Switzerland. Further, the Company announced that after four years of service, Jason Camm has stepped down from the Board. Recent Insider Transactions • May 21
Co-Founder recently sold €267k worth of stock On the 16th of May, Florian Brand sold around 151k shares on-market at roughly €1.77 per share. This transaction amounted to 31% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Florian has been a net seller over the last 12 months, reducing personal holdings by €192k. Reported Earnings • May 17
First quarter 2024 earnings released: US$0.17 loss per share (vs US$0.21 loss in 1Q 2023) First quarter 2024 results: US$0.17 loss per share (improved from US$0.21 loss in 1Q 2023). Net loss: US$26.7m (loss narrowed 19% from 1Q 2023). Revenue is forecast to grow 74% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany. Annonce • May 16
Atai Life Sciences N.V. Announces CEO Changes Atai Life Sciences N.V. announced a transition in its leadership. Florian Brand (“Mr. Brand”), Co-Founder and current CEO, will step down as CEO by the end of this year. Co-Founder Srinivas Rao, M.D., Ph.D. (“Dr. Rao”), currently the Chief Scientific Officer, will be promoted to Co-CEO effective June 1, 2024 and intends to assume the role of CEO by the end of the year subject to appointment as required by local law. Dr. Rao brings over 24 years of knowledge and experience from diverse biotechnology and pharmaceutical roles, having held the titles of Chief Scientific, Medical, or Executive Officer at companies ranging from venture-backed startups to vertically integrated, publicly traded pharmaceutical companies. Florian successfully led the company from its early days through numerous R&D, business development and financing milestones, including an IPO in 2021. Florian's leadership and execution focus have been foundational to the success of atai. Annonce • Apr 25
atai Life Sciences Announces Dosing of First Patient in Part 2 of Beckley Psytech’s Phase 2a Study Exploring BPL-003 Adjunctive to SSRIs in Patients with Treatment Resistant Depression atai Life Sciences announced that the first patient has been dosed in Part 2 of Beckley Psytech’s Phase 2a study, evaluating BPL-003 (intranasal 5-MeO-DMT) in patients living with Treatment Resistant Depression (TRD). In Part 2 of this open-label Phase 2a study (NCT05660642), patients with moderate-to-severe TRD who are on a stable course of certain oral selective serotonin reuptake inhibitor (SSRI) antidepressants will receive a single dose of BPL-003 alongside psychological support to explore the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BPL-003 as an adjunctive therapy to SSRIs. Patients will be followed for 12 weeks post-dosing. Initial results are expected in first half of 2025. Part 1 of the Phase 2a study investigating BPL-003 for TRD assessed a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants. Initial data showed that a single dose of BPL-003 induced a rapid antidepressant response in 55% of patients on the day after dosing. The antidepressant effect was durable, with a 55% response rate maintained at week 4, which continued to week 12. There were 55% of patients in remission at week 4 and 45% in remission at week 12. BPL-003 was also shown to require a short time in clinic with acute effects resolving on average in less than two hours, highlighting the potential of BPL-003 to deliver a scalable single dose treatment model that could fit within the existing Spravato two-hour treatment paradigm. The BPL-003 Phase 2b study is currently underway, evaluating the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in TRD patients (NCT05870540). Initial results from that study are expected in second half of 2024. Beckley Psytech is a private clinical-stage biopharmaceutical company developing BPL-003, which is a novel, patent-protected, synthetic benzoate salt formulation of 5-MeO-DMT which is delivered intranasally. It is a short-duration psychedelic compound that binds to a variety of serotonergic receptors. Epidemiological surveys and observational studies have reported that 5-MeO-DMT is associated with improvements in mood, anxiety, reduced stress, increased life satisfaction and mindfulness. 5-MeO-DMT has been reported to produce mystical experiences with comparative intensity as seen with high doses of psilocybin but has a significantly shorter duration of effect. In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a 35.5% 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 • Apr 23
Atai Life Sciences N.V., Annual General Meeting, May 17, 2024 Atai Life Sciences N.V., Annual General Meeting, May 17, 2024, at 18:00 Central European Standard Time. Agenda: To consider discussion of the Dutch statutory report over fiscal year 2023; to consider adoption of the Dutch statutory annual accounts over fiscal year 2023; to consider explanation of the dividend and reservation policy; to consider appointment of Deloitte & Touche LLP and Deloitte Accountants B.V. as external auditors for fiscal year 2024; to release of each member of board of supervisory directors and board of managing directors from liability for the exercise of their duties during fiscal year 2023; to consider re-appointment of directors; and to consider other matters. Annonce • Apr 17
atai Life Sciences Announces the Publication of Beckley Psytech’s Phase 1 Study of BPL-003 in the Journal of Psychopharmacology atai Life Sciences announced the publication of the Phase 1 results of BPL-003, Beckley Psytech’s novel, synthetic, intranasal benzoate salt formulation of 5-MeO-DMT, in The Journal of Psychopharmacology. The double-blind, placebo-controlled, single ascending dose Phase 1 study explored the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BPL-003 in combination with psychological support in 44 psychedelic-naïve healthy volunteers. Participants across seven cohorts were given either a single dose of BPL-003 between 1 mg to 12 mg or a placebo. The paper shows that BPL-003 was safe and well-tolerated with no serious or severe adverse events reported. BPL-003 was rapidly absorbed and eliminated, with 5-MeO-DMT systemic exposure increasing approximately dose-proportionally. There was a reliable onset of subjective psychedelic effects within minutes, which resolved in less than two hours. If confirmed in larger studies, these findings could support a scalable single dose treatment model fitting within the existing interventional treatment paradigm. The intensity of the subjective psychedelic experience was shown to correlate with exposure to the compound. The PD endpoint scores of the Mystical Experience Questionnaire (MEQ-30) and Ego Dissolution Inventory (EDI) increased with an increase in the BPL-003 dose. 60% of participants had a ‘complete mystical experience,’ which is defined as reaching or exceeding a score of three on all four subdomains of the MEQ-30 scale, at 10 mg and 12 mg doses of BPL-003. Notably, 87% of participants who received BPL-003 said they would accept the same or higher dose again, with 100% of participants who received the higher (12 mg) dose stating they would accept the same or higher dose again. BPL-003 is currently under investigation in Phase 2a studies as a potential treatment for Alcohol Use Disorder (NCT05674929) and Treatment Resistant Depression (TRD) (NCT05660642). It is also being explored in a multi-site Phase 2b study (NCT05870540) for TRD. The trial is evaluating the effects of a single, medium, or high dose of BPL-003 against a sub-perceptual dose in TRD patients not taking concomitant antidepressants. Initial results from that study are expected in H2 2024. Recent Insider Transactions • Apr 05
Co-Founder & Chief Scientific Officer recently sold €106k worth of stock On the 2nd of April, Srinivas Rao sold around 62k shares on-market at roughly €1.72 per share. This transaction amounted to 35% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Srinivas' only on-market trade for the last 12 months. Reported Earnings • Mar 29
Full year 2023 earnings released: US$0.25 loss per share (vs US$0.98 loss in FY 2022) Full year 2023 results: US$0.25 loss per share (improved from US$0.98 loss in FY 2022). Net loss: US$40.2m (loss narrowed 74% from FY 2022). Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Annonce • Mar 27
atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression atai Life Sciences announced positive initial results from Beckley Psytech's Phase 2a open label study of BPL-003 in Treatment Resistant Depression (TRD), a condition that affects approximately 100 million people worldwide. BPL-003 is a novel, synthetic, patent-protected benzoate salt formulation of 5-MeO-DMT (mebufotenin) administered intranasally. Initial results demonstrated that a single 10mg dose of BPL-003 was well-tolerated and resulted in a rapid onset and durable antidepressant effect in patients living with TRD. Acute effects resolved on average in less than two hours. These data suggest that BPL-003 could offer a shorter in-clinic treatment time when compared to other psychedelic treatments currently in development. A Part 2 extension of this Phase 2a open label study is now enrolling patients with TRD who are on stable doses of oral antidepressants to assess the safety and efficacy of BPL-003 co-administration (NCT05660642). A randomized, quadruple-masked, controlled Phase 2b study of BPL-003 is currently underway (NCT05870540). The study is investigating the effects of a single 12mg or 8mg dose of BPL-003 against a sub-perceptual dose of 0.3mg in 225 patients with TRD. Efficacy will be assessed by masked raters using the MADRS scale at several time points with the primary endpoint at week 4 and final assessment at week 8. Top-line results are expected in H2 2024. Annonce • Mar 05
atai Life Sciences Announces First Participant Dosed in Phase 1b Trial of VLS-01 atai Life Sciences announced that the first healthy participant has been dosed in the Phase 1b trial of VLS-01, an oral transmucosal film (OTF) formulation of N,N-dimethyltryptamine (DMT). The Phase 1b study is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT. This single center, open label study is anticipated to enroll a total of 16 healthy participants. Participants will initially receive a single dose of IV DMT followed by 3 different doses of VLS-01, with a 28-day washout window between administrations. Top-line results for the Phase 1b study are expected in the second half of this year. Results from the previous Phase 1 single ascending dose trial were the basis for further formulation optimization, which included the incorporation of taste masking, the addition of a backing layer, and enhancements to further increase permeability. The optimized formulation currently being tested is designed to improve PK and the patient experience ahead of moving into an anticipated Phase 2 trial with VLS-01 in TRD. VLS-01 is a proprietary OTF formulation of DMT 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 IV DMT results in rapid-acting and durable antidepressant effects in patients with major depressive disorder. The company’s proprietary OTF 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 2 hour in-clinic patient visit. Annonce • Feb 07
atai Life Sciences Announces Management Changes atai Life Sciences announced that Anne Johnson, the Company’s interim Chief Financial Officer since October 2023 and Chief Accounting Officer since August 2022, has been named Chief Financial Officer (CFO). Anne succeeds Stephen Bardin as the Company’s CFO while Stephen will continue in an advisory role until March 31, 2024 to support the transition. Anne brings almost 20 years of biotechnology and pharmaceutical experience. She previously served in senior leadership roles at Aruvant Sciences, Inc., a Roivant company; Chimerix Inc.; PPD; and Xanodyne Pharmaceuticals. Anne received her Bachelor of Science in Accounting from the University of North Carolina Wilmington and is a Certified Public Accountant and Chartered Global Management Accountant. Annonce • Jan 02
Atai Life Sciences Announces Positive Topline Results from Single Ascending Dose Phase 1 Study with EMP-01 (R-MDMA) atai Life Sciences announced positive results from its Phase 1 study evaluating orally administered EMP-01, the R-enantiomer of MDMA (3,4-methylenedioxy-methamphetamine). The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01. The four-cohort, single-ascending dose, randomized, double-blind, placebo-controlled study enrolled 32 healthy participants who received 75mg, 125mg, 175mg or 225mg of EMP-01 or placebo in a 6+2 design. EMP-01 was well-tolerated, and treatment-related adverse events (AEs) were all expected and generally dose dependent. There were no study discontinuations, and no serious or severe AEs were observed in the study. Non-clinically significant increases in blood pressure and heart rate were observed, though such changes showed limited dose dependency. Further, the peak body temperatures observed fell within the normal range. Finally, bruxism was observed in only 1 of 24 subjects that received EMP-01. The PK profile of EMP-01 was dose-proportional. The PD measures included both subjective reports and blood-based biomarkers. Significant, consistent and dose-dependent changes were seen on several of these exploratory PD measures. EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA on standard psychedelic experience questionnaires. Further, dose dependent changes on measures of emotional breakthrough, a phenomenon thought to be a key mediator of the long-term psychological changes associated with psychedelics, were noted in this healthy volunteer population. Detailed clinical data from the Phase 1 study of EMP-01 are expected to be presented at a future medical meeting. Reported Earnings • Nov 15
Third quarter 2023 earnings released: EPS: US$0.28 (vs US$0.22 loss in 3Q 2022) Third quarter 2023 results: EPS: US$0.28 (up from US$0.22 loss in 3Q 2022). Net income: US$44.2m (up US$78.1m from 3Q 2022). Revenue is forecast to grow 80% p.a. on average during the next 3 years, compared to a 3.6% growth forecast for the Pharmaceuticals industry in Germany. Annonce • Nov 15
Atai Life Sciences N.V. (NasdaqGM:ATAI) acquired remaining stake of DemeRx IB, Inc. Atai Life Sciences N.V. (NasdaqGM:ATAI) acquired remaining stake of DemeRx IB, Inc in November 2023.Atai Life Sciences N.V. (NasdaqGM:ATAI) completed the acquisition of remaining stake of DemeRx IB, Inc in November 2023. Annonce • Oct 14
Atai Life Sciences N.V. Announces Executive Changes On October 10, 2023, Mr. Stephen Bardin, the Chief Financial Officer (principal financial officer) of atai Life Sciences N.V. (the “Company”) went on parental leave. On October 13, 2023, the Supervisory Board of Directors (the “Board”) of the Company temporarily appointed Ms. Anne Johnson, the Company’s Chief Accounting Officer (principal accounting officer), to act as the Company’s Interim Chief Financial Officer (principal financial officer) while Mr. Stephen Bardin is on parental leave. Upon Mr. Bardin’s return from parental leave, Mr. Bardin will return to his role as Chief Financial Officer (principal financial officer) and Ms. Johnson will continue her role as Chief Accounting Officer (principal accounting officer). The Board appointed Ms. Johnson due to, among other things, her financial expertise and existing leadership role with the Company. Annonce • Oct 05
Atai Life Sciences N.V. Announces Completion of Phase 1 Study of VLS-01 in Healthy Participants Atai Life Sciences N.V. announced the completion of the Phase 1 study of VLS-01 in healthy participants. The Phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VLS-01 applied to the sublingual and buccal surfaces compared to intravenous (IV) DMT. The study enrolled a total of 74 healthy participants across three parts. The third part of the study evaluated VLS-01 administered and dosed as follows: sublingual 80mg (n=8), buccal 80mg with backing layer (n=10), and buccal 160mg with backing layer (n=8). VLS-01 was well-tolerated with a favorable safety profile, and dose-dependent increases in exposure were observed. VLS-01 administration also resulted in subjective effects in most participants across doses. The company observed that participants that received 160mg of VLS-01 with a backing layer via buccal administration experienced the most robust and consistent increases in exposure and subjective effects compared to the other OTF cohorts, with results comparable to those seen in the IV cohort of DMT. The company now plans to progress VLS-01 into a Phase 1b study in healthy participants. The study is expected to explore doses up to 160 mg with an optimized OTF formulation that incorporates taste masking, an intrinsic backing layer, and enhancements designed to increase permeability, with goals of further improving the participant experience and pharmacokinetics. The company has submitted a protocol to regulatory authorities and expects to enroll the first participant in a Phase 1b study in first half of 2024. Recent Insider Transactions • Sep 15
Co-Founder & CEO recently bought €54k worth of stock On the 13th of September, Florian Brand bought around 40k shares on-market at roughly €1.35 per share. This transaction amounted to 55% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Florian has been a buyer over the last 12 months, purchasing a net total of €150k worth in shares. Annonce • Aug 09
atai Life Sciences Announces Results from the Phase 1 Iv-To-Subcutaneous Bridging Study of Pcn-101 (R-Ketamine) atai Life Sciences announced results from Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine). The Phase 1 open-label, 4-period crossover study assessed the safety, tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously (“SQ”) as compared to 60mg of PCN-101 delivered intravenously. The study enrolled 16 healthy volunteers, each into one of four sequences of administration. The study was designed to inform dosing regimens of the new subcutaneous formulation that may optimize the therapeutic index—the balance of safety, tolerability, and efficacy—of PCN-101 in future studies, thereby supporting further exploration of the potential of R-ketamine as a rapid acting anti-depressant for at-home use. Pharmacokinetic (PK) analysis indicates that 120mg of PCN-101 delivered SQ resulted in an approximate doubling of drug exposure (AUC) while maintaining approximately the same maximum concentration (Cmax) as the 60mg IV dose. Further, PCN-101 was generally well-tolerated with no serious adverse events reported. At the 60mg IV dose, rates of sedation and dissociation were consistent with prior studies of PCN-101 at this dose-level. Encouragingly, at the higher SQ dose of 120mg, rates of sedation (defined as MOAA/S score <5) and dissociation (defined as CADSS total score >4 and change from baseline >0) were each 14%. While recognizing the limitations of this small bridging study and cross-trial comparisons, this safety and tolerability profile compares favorably to that of Spravato, for which rates of sedation and dissociation have been reported to be in the ranges of 50%-61% and 61%-69%, respectively, in prior studies. In addition, rates of sedation and dissociation were similar to those seen in the placebo arms of both the prior Phase 2 study of PCN-101 and the Spravato clinical trials in depression. Collectively, they believe these data support the concept of at-home use of PCN-101 in future studies. atai continues to work with Perception Neuroscience to explore strategic partnership options. Recent Insider Transactions • Mar 31
Co-founder & CEO recently bought €96k worth of stock On the 29th of March, Florian Brand bought around 70k shares on-market at roughly €1.37 per share. This transaction increased Florian's direct individual holding by 30x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Florian's only on-market trade for the last 12 months. Reported Earnings • Mar 25
Full year 2022 earnings released: US$0.98 loss per share (vs US$1.21 loss in FY 2021) Full year 2022 results: US$0.98 loss per share (improved from US$1.21 loss in FY 2021). Net loss: US$152.4m (loss narrowed 9.2% from FY 2021). Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Annonce • Jan 10
Atai Life Sciences Company GABA Therapeutics Announces Positive Final Results from Phase 1 Single and Multiple Ascending Dose Trial of Grx-917 atai Life Sciences N.V. and its subsidiary GABA Therapeutics, announced final positive results from a Phase 1 clinical trial of GRX-917 that were previously announced as preliminary results during atai’s R&D day. The randomized, double-blind, placebo-controlled trial was designed to evaluate the safety, tolerability, and pharmacokinetic profile of single and multiple ascending doses of orally administered GRX-917. Overall, compared to placebo, GRX-917 was well-tolerated and neither dose-related nor dose-limiting adverse events were observed. There were no serious adverse events reported nor discontinuations due to drug administration. Furthermore, in contrast to current first-line anxiety disorder treatments such as benzodiazepines, sedation was found to be comparable to placebo. Dose-dependent increases in qEEG beta power, a biomarker for GABA receptor activation, was demonstrated in subjects who received GRX-917 but not with those who received a placebo, providing evidence of target engagement consistent with GRX-917’s putative mechanism of action. GRX-917 is a deuterated version of etifoxine, which is an anxiolytic approved in France, with rapid onset and efficacy comparable to leading benzodiazepines like alprazolam and lorazepam that are currently considered the standard of care but is non-addictive with minimal side effects. Etifoxine is thought to achieve its anxiolytic activity by increasing endogenous production of brain neurosteroids like allopregnanolone. Dysregulation of neurosteroidogenesis has been implicated in a broad range of neuropsychiatric diseases including generalized anxiety disorder (GAD), anxious depression, social anxiety disorder (SAD), panic disorder, and postpartum depression. In the single-ascending dose (SAD) portion of the trial, adverse events were observed in 53% (17/32) of GRX-917 treated subjects, comparable to 50% (5/10) observed in placebo-treated subjects. Adverse events related to GRX-917 specifically occurred in 25% (8/32) of subjects and were all mild in severity. In the multiple-ascending dose (MAD) portion of the trial, adverse events were observed in 60.5% (26/43) of GRX-917 treated subjects, also comparable to 60% (9/15) observed in placebo-treated subjects. Adverse events related to GRX-917 specifically occurred in 32.6% (14/43) of subjects and were all mild in severity. The results of these two trial phases indicate that there were no dose-limiting adverse events in trial subjects at higher dosages and no benzodiazepine-like side effects, including sedation were observed. Dose- and exposure-dependent increases in beta power were observed by quantitative electroencephalogram (qEEG) in healthy volunteers receiving single doses of GRX-917 but not in those who received a placebo. These results show that GRX-917 has measurable effects on the central nervous system and provide evidence of GABA receptor target engagement and mechanism of action. Annonce • Jan 07
Atai Life Sciences Announces Results from Phase 2A Trial of PCN-101 (R-Ketamine) for Treatment-Resistant Depression atai Life Sciences announced that, while PCN-101 (R-ketamine) demonstrated signals of efficacy across all timepoints out to two weeks, Perception Neuroscience's Phase 2a clinical trial did not meet its primary endpoint of a statistically significant change from baseline in participants' MADRS (Montgomery-A sberg Depression Rating Scale) score at 24 hours compared to placebo. The Phase 2a proof-of-concept trial was a two-week, randomized, double-blind, placebo-controlled multi-center study assessing the safety, tolerability and efficacy of a single IV administration of PCN-101. 102 TRD patients were enrolled across three arms 30mg, 60mg and placebo. On the primary endpoint of MADRS at 24 hours, the mean change from baseline was -15.3 for PCN-101 60mg compared to- 13.7 for placebo (-1.6 pbo-adj; p-value 0.5). However, the single 60mg dose of PCN-101 showed an efficacy signal at each timepoint over the 2-week timeframe of the study. Key secondary endpoints included a proportion of patients defined as responders, meaning patients who experienced 50% improvement from baseline in MADRS, and a proportion of patients in remission, defined as a total MADRS score of less than 10. Despite seeing greater response and remission rates in the 60mg arm, the trial did not meet statistical significance at any timepoint on these secondary measures. PCN-101 was generally well-tolerated with rates of sedation and dissociation comparable to placebo. PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all timepoints despite not achieving statistical significance on the primary endpoint. atai will further evaluate the PCN-101 data in more detail over the next weeks and will work with its subsidiary Perception Neuroscience to explore next steps, including but not limited to seeking strategic partnership options. PCN-101 Phase 2a Study Design The Phase 2a proof-of-concept trial was a randomized, double-blind, placebo-controlled multi-center study assessing the safety, tolerability and efficacy of IV PCN-101 (R-ketamine) in 102 patients with TRD across three arms. These patients -- all of whom had previously failed at least two rounds of antidepressants -- received a single IV dose of either placebo, 30 mg, or 60 mg of PCN-101 adjunctively to their existing treatment regimen. Patients were assessed for a change in depressive symptomatology using the Montgomery-A sberg Depression Rating Scale (MADRS) at intervals over 14 days, with the primary endpoint at 24 hours post-dose. Dissociation and sedation were measured using the Clinician-Administered Dissociative States Scale (CADSS) and the Modified Observer's Alertness/Sedation Scale (MOAA/S), respectively. About Perception Neuroscience Inc. Perception Neuroscience is a New York City-based clinical-stage biopharmaceutical company committed to the mission of providing more effective treatment solutions for serious psychiatric disorders. It is developing PCN-101 (R-ketamine) for the treatment of TRD. In March 2021, the company announced a collaboration and licensing agreement with Otsuka Pharmaceutical Co. Ltd. for rights in Japan to PCN-101. Perception Neuroscience is a majority-owned subsidiary of atai Life Sciences. Annonce • Dec 20
598 Initiates Phase 2B Proof-Of-Concept Trial of Rl-007 for Cognitive Impairment Associated with Schizophrenia atai Life Sciences N.V. announced the initiation of its Phase 2b proof-of-concept clinical trial for RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS), a condition for which there are currently no FDA-approved treatments. The Phase 2b trial is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 2 doses of RL-007 and a placebo among 234 patients. The trial includes a 6-week treatment period with the MATRICS Consensus Cognitive Battery (MCCB) as the primary endpoint. The MCCB has been supported by the FDA as an approvable endpoint for CIAS. The trial will be conducted in the US, and patient screening is currently underway. RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in ten clinical studies, including one in the CIAS indication, with over 500 unique participants dosed to-date. In December 2021, atai announced positive biomarker data from a Phase 2a proof-of-mechanism study designed to evaluate the effects of RL-007 on safety, tolerability, electroencephalogram-based biomarkers, and cognition. RL-007 was well tolerated and demonstrated a clinically meaningful pro-cognitive profile consistent with previous Phase 1 and Phase 2 trials of this compound. These results supported the progression of an RL-007 Phase 2b proof-of-concept trial with the goal of demonstrating the pro-cognitive effect of RL-007 in CIAS. Schizophrenia affects approximately 24 million people worldwide. The disease is frequently associated with significant distress and impairment in personal, family, social, educational, occupational, and other important areas of life. For example, cross-sectionally, only 10% of patients with schizophrenia are employed in a competitive role2. Furthermore, they are 2 to 3 times more likely to die early compared to the general population3. 80% of people with schizophrenia suffer from cognitive impairments, which include poor learning and retention of verbal information, as well as the most consistent findings of executive functioning deficits and an impaired ability to encode and retain verbally presented information. Annonce • Nov 30
Atai Life Sciences Appoints Sahil V. Kirpekar as Chief Business Officer atai Life Sciences N.V. announced its appointment of Dr. Kirpekar to serve as the Company’s Chief Business Officer, effective today. In this newly created role, Dr. Kirpekar will be responsible for atai’s pipeline strategy, building out its commercial and market access functions and leading its global business development efforts, including in- and out-licensing, M&A, and strategic investments. Dr. Kirpekar joins atai after more than eight years at Otsuka Pharmaceutical Co. Ltd., most recently as the Head of Business Development and Co-chair of the Global Business Development Committee. During his tenure, Dr. Kirpekar helped build a successful pipeline of assets in CNS and beyond and was responsible for closing transactions with a total value of more than USD 2.7 billion. Notable accomplishments during his time at Otsuka also include the successful commercial launch of two drugs Abilify Maintena (Aripiprazole) and Jinarc (Tolvaptan) and contributing to the organization’s digital strategy and leading their evolving thinking in precision psychiatry. He also collaborated closely with atai on certain strategic investments during this time. Prior to Otsuka, Dr. Kirpekar built and executed on commercial and market access strategies for biopharmaceutical companies globally as a strategy consultant at Double Helix Consulting. He also served as a market analyst for the World Health Organization and has co-founded a company building a drug delivery device focused on adherence. Dr. Kirpekar is a trained physician and holds an MPhil from the University of Cambridge (where he is subsequently an honorary lecturer). Annonce • Nov 18
Atai Life Sciences N.V. and Massachusetts General Hospital Announce Initiation of Clinical Study Investigating Neuroplasticity Biomarkers in Treatment-Resistant Depression Patients Undergoing Ketamine Treatment atai Life Sciences N.V. announced it has initiated a clinical study with Massachusetts General Hospital (MGH). The study will utilize a neuroimaging method to identify neuroplasticity biomarkers in patients with treatment-resistant depression (TRD) undergoing intravenous (IV) ketamine treatment. The main objective of this study will be to develop a novel method to detect neuroplasticity through magnetic resonance imaging (MRI) scans, electroencephalogram (EEG) collection and clinical assessments. The study will identify changes in the brain at baseline, 24-48 hours post-treatment, and 2 weeks after ketamine administration. The availability of a validated protocol to measure structural plasticity at the neuronal level in the human brain would be a great advancement to the field of neuroplasticity research and may represent a potential tool for drug developers, researchers, and providers as an early biomarker of treatment response and efficacy. Nearly half of the $350 billion spent every year in the U.S. on mental healthcare is attributable to treatment-resistant patients: those who do not experience relief from their symptoms despite multiple treatments. Treatment resistance reflects both the limitations of its currently available treatments, as well as the likelihood that these patients’ brains are less capable of change in ways that improve mental health. Annonce • Nov 09
Alexis De Rosnay Resigns as a Member of the Supervisory Board of Directors of Atai Life Sciences N.V On November 2, 2022, Mr. Alexis de Rosnay resigned as a member of the supervisory board of directors (the “Supervisory Board”) of atai Life Sciences N.V. (the “Company”). Mr. de Rosnay’s resignation was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies and practices. Annonce • Nov 02
Atai Life Sciences N.V. to Report Q3, 2022 Results on Nov 10, 2022 Atai Life Sciences N.V. announced that they will report Q3, 2022 results on Nov 10, 2022 Annonce • Oct 26
Atai Life Sciences and Perception Neuroscience Completes Enrollment for Phase 2A Clinical Trial of PCN-101 (R-Ketamine) for Treatment-Resistant Depression Atai Life Sciences and its subsidiary, Perception Neuroscience announced the completion of enrollment of its Phase 2a clinical trial to evaluate the safety and efficacy of a single intravenous infusion (IV) dose of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of ketamine being developed for treatment-resistant depression (TRD). TRD patients are partially or entirely unresponsive to antidepressants and face issues of misdiagnosis, prolonged depressive periods, co-occurring mental and physical disorders, and longer periods with a lower quality of life than patients suffering from less severe depression. The Phase 2a proof-of-concept trial is a randomized, double-blind, placebo-controlled study with an enrollment target of 93 TRD patients across three arms. The last patient is expected to be dosed this week, with the total number of patients expected to be around 100. These patients – all of whom had previously failed at least two rounds of antidepressants – received either a single dose of placebo, 30 mg, or 60 mg of PCN-101 via IV in addition to their existing treatment regimen. Patients were assessed for a change in depressive symptomatology using the Montgomery-Asberg Depression Rating Scale (MADRS) at intervals over 14 days, with the primary endpoint at 24 hours post-dose. Dissociation and sedation were measured using the Clinician-Administered Dissociative States Scale (CADSS) and the Modified Observer’s Alertness/Sedation Scale (MOAA/S), respectively. Annonce • Oct 19
Atai Life Sciences N.V. Announces Initiation of Phase 1 Proof-Of-Concept Clinical Trial for Its Sol-Gel Based Direct-To-Brain Drug Delivery Technology Atai Life Sciences N.V. announced the initiation of the Phase 1 proof-of-concept (PoC) clinical trial of intranasal INB-01, a sol-gel based, excipient (drug-delivery) technology. This is a Phase 1 two-stage, open-label, randomized study of the safety, tolerability, and effective brain delivery of INB-01. INB-01 or placebo will be administered to subjects using the Aptar Nasal Drug Delivery Device. Topline results are expected in H1 2023. Traditional oral or intravenous drug delivery methods can be problematic in the treatment of central nervous system (CNS) disorders. When drugs are delivered via these peripheral methods, the blood--brain barrier restricts the entry of therapeutic agents to the CNS, thereby decreasing drug efficacy. A potential solution is direct-to-brain delivery through the nose. This method has the potential to be a non-invasive administration route and may offer additional advantages such as ease of administration, increased patient compliance, lower dose requirements, rapid onset of action, and minimized systemic exposure, which may reduce the risk of peripheral toxicity. The company's INB-01 technology is designed to deliver pharmaceutical compounds as a liquid at room temperature, which becomes a gel instantaneously in the nasal cavity. The novel technology has been successfully utilized with both water-soluble and insoluble compounds and extracts. Prior to launching this PoC trial in humans, dosing of INB-01 has shown positive results in animals when measuring levels of INB-01 in the brain as well as MRI imaging of the brain. These results are a promising predictor for the use of INB-01 in human subjects for intranasal direct-to-brain drug delivery. Annonce • Oct 16
Atai Life Sciences N.V. Appoints Stephen Bardin as Managing Director Atai Life Sciences N.V. appointed Stephen Bardin as Managing Director at the AGM held on October 13, 2022. Annonce • Oct 13
Atai Life Sciences Announces Positive Initial Results for Phase 1 Trial of KUR-101, an Oral Formulation of Mitragynine for OUD Atai Life Sciences N.V. announced positive initial results for their Phase 1 clinical trial of KUR-101. KUR-101 is an oral formulation of deuterated mitragynine, the major active alkaloid of the kratom plant, under development for the treatment of opioid use disorder (OUD). Initial results indicate that KUR-101 is safe and generally well-tolerated. Results also showed a dose-proportional pharmacokinetic (PK) profile that was unaffected by food. In the single ascending oral dose portion of the trial, no severe or serious adverse events were reported, with most treatment-related adverse events being mild. Changes in respiratory rate following treatment with KUR-101 were comparable to that of placebo-treated patients for the doses tested and comparable across doses. The pharmacological therapies currently approved for OUD, buprenorphine, methadone, and naltrexone, carry several challenges, including limited efficacy for many patients, inconvenient treatment regimens, and access barriers due to inherent risks of abuse. Compared with current options, KUR-101 is an atypical opioid receptor modulator with unique pharmacology that may make it safer for chronic use. The deuteration of mitragynine improves the PK and overall safety profile of KUR-101 while dosing requirements. Topline results, including Part 2 of the trial comparing a single dose of KUR-101 to a single dose of oxycodone or placebo, are expected by the end of 2022. Annonce • Oct 06
Atai Life Sciences Announces First Subject Dosed in Phase 1 Trial of Buccal and Iv Vls-01, A Synthetic Form of Dmt atai Life Sciences N.V. announced the dosing of the first subject in their Phase 1 SAD trial of VLS-01. The trial is a randomized, double-blind, placebo-controlled study designed to evaluate the relative bioavailability of buccal versus IV formulations, the safety, and tolerability of VLS-01 administered by both routes, as well as pharmacodynamics of DMT using qEEG and other measures. Buccal VLS-01 is formulated to provide a psychedelic experience lasting 30 to 45 minutes, thus potentially allowing for a shorter clinic visit compared to many other psychedelic compounds that may require a patient to be monitored for four or more hours. The trial includes the companion use of atai’s IDEA-1 digital therapeutic app to provide contextual “(mind)set-and-setting” prior to dosing, as well as behavioral activation therapy, group therapy, and patient monitoring post-dosing. These behavioral assessments, in conjunction with the pharmacokinetic and safety readouts, are expected to inform the design of and doses tested in future Phase 2 clinical trials of VLS-01. An estimated 100 million people live with TRD globally – or a third of people with depression – who are undertreated or unresponsive to available treatment options. In addition to its impact on patients, families, and caregivers, TRD significantly burdens healthcare systems and payers. Direct medical costs for TRD patients are estimated to be two times higher than for non-TRD major depressive disorder (MDD) patients, with an average of twice the number of inpatient visits and hospital stays that are over one-third longer. Annonce • Sep 28
atai Life Sciences N.V. Announces Initiation of Phase 1 Trial for Its MDMA Derivative, EMP-01 atai Life Sciences N.V. announced its Phase 1 study has received regulatory and ethics approvals required from Medsafe and HDEC, respectively, to initiate participant enrollment. The Phase 1 randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of single-ascending doses of EMP-01 in healthy adult participants, as well as assess the usability and acceptability of the IDEA-1 app in delivering "set and setting" content to participants in preparation for their EMP-01 administration. This study also includes a range of behavioral assessments that, in conjunction with the PK and safety readouts, are expected to inform the design of and doses tested in future Phase 2 clinical trials of EMP-01. In the U.S. alone, an estimated 9.3 million people meet the criteria for a PTSD diagnosis according to the National Institute of Health. At present, the only FDA-approved treatments for PTSD are two selective serotonin reuptake inhibitors (SSRIs), paroxetine and sertraline. Evidence shows that two-thirds of patients either do not respond or have only a partial response to these medications. MDMA itself is an amphetamine derivative that possesses complex pharmacology and is believed to act by increasing the release of monoamines like serotonin, norepinephrine, and dopamine in the brain, as well as stimulating neurohormonalactivity. Studies show that this activity may result in the anxiolytic, prosocial, and empathic responses commonly associated with the approximately six-hour experience. As a result, MDMA is often classified as an entactogen ratherthan a typical psychedelic. EmpathBio is focused on developing MDMA derivatives with different pharmacological profiles than MDMA. These modifications are designed to separate the entactogenic effects of MDMA from some of the known side effects, specifically its stimulant-associated effects. This may result in an improved safety profile compared to MDMA in the treatment of PTSD populations with comorbidities including hypertension, history of stroke, and cardiovascular disease. If successful, such an approach could help minimize some of the transient physiological changes caused by MDMA and potentially expand the PTSD patient pool medically eligible for the therapy. Reported Earnings • Aug 17
Second quarter 2022 earnings released: US$0.24 loss per share (vs US$0.37 loss in 2Q 2021) Second quarter 2022 results: US$0.24 loss per share (up from US$0.37 loss in 2Q 2021). Net loss: US$36.6m (loss narrowed 24% from 2Q 2021). Over the next year, revenue is expected to shrink by 87% compared to a 6.5% growth forecast for the Pharmaceuticals industry in Germany. Annonce • Aug 02
Atai Life Sciences N.V. to Report Q2, 2022 Results on Aug 15, 2022 Atai Life Sciences N.V. announced that they will report Q2, 2022 results on Aug 15, 2022 Annonce • Jun 18
Atai Life Sciences N.V. Announces Executive Changes On June 15, 2022, Greg Weaver, Chief Financial Officer of ATAI Life Sciences N.V. and ATAI Life Sciences US Inc., entered into a Transition and Separation Agreement with the Company and ATAI US pursuant to which Mr. Weaver will resign from his current positions and support in the transition of duties to his successor as further described below. Mr. Weaver will continue serving as the Company’s Chief Financial Officer during the Transition Term. During the Transition Term Stephen Bardin will serve as the Company’s Deputy CFO and CFO Designate and will subsequently be appointed as the Company’s Chief Financial Officer effective during the third quarter of 2022, but in any event no later than September 30, 2022, as determined by the Supervisory Board. Mr. Bardin, age 32, is expected to commence his employment with the Company as Deputy CFO and CFO Designate effective June 27, 2022. Prior to joining the Company, Mr. Bardin served in various capacities at BridgeBio Pharma Inc. (“BridgeBio”), a commercial-stage biopharmaceutical company, most recently as its Senior Vice President, Finance and Operations, from October 2019 until June 2022. Prior to that, Mr. Bardin served as Director, Corporate Development and Associate Director, Corporate Development at Myovant Sciences Ltd., a biopharmaceutical company, from July 2017 – October 2019. Prior to that, Mr. Bardin served as a Consultant at The Boston Consulting Group from August 2011 - May 2014 and September 2016 – July 2017. Mr. Bardin received his Master of Business Administration from Stanford Graduate School of Business and his Bachelor of Science in Engineering in biomedical engineering from Duke University. Annonce • May 07
Atai Life Sciences N.V. to Report Q1, 2022 Results on May 16, 2022 Atai Life Sciences N.V. announced that they will report Q1, 2022 results on May 16, 2022 Annonce • May 02
Atai Life Sciences N.V., Annual General Meeting, May 25, 2022 Atai Life Sciences N.V., Annual General Meeting, May 25, 2022, at 18:00 Central European Standard Time. Agenda: To Explanation of the dividend and reservation policy ;to Appointment of the external auditor for fiscal year 2022 for purposes of Dutch law ;to Articles Amendment A Approval of amendment of Articles of Association to provide for a quorum of, at least, 33-1/3% of common shares at any general meeting of shareholders and authorization to implement such amendment and to consider other matters. Annonce • Jan 28
atai Life Sciences N.V. Launches Invyxis to Accelerate Discovery of Next-Generation Mental Health Treatments atai Life Sciences N.V. launched Invyxis, a new, wholly owned platform company committed to developing new chemical entities and to further pioneering next-generation mental health treatments. Invyxis will bring proven medicinal chemistry tools and comprehensive biological screening approaches to atai’s growing enterprise of drug discovery and design. The launch of Invyxis is a further step-up in atai’s growth and commitment to innovation in the treatment of mental health disorders. The new atai platform company has entered into a strategic collaboration with Dalriada Drug Discovery, specialists in the discovery of small molecule therapeutics. Invyxis will harness a broad array of methods including structure-based design, synthetic chemistry, high-throughput screening, and in vivo characterization. Invyxis’ goal will be to discover new agents with potential in treating mental health disorders, generating NCEs to progress into atai’s research & development pipeline of psychedelic and non-psychedelic compounds. The platform company will initially focus on agonists at the 5-HT2A receptor, recognizing the importance of this key serotonin receptor system in treating a range of mental health disorders. Expanding intellectual property has been essential to atai’s strategy since inception, with key investments made to unlock NCEs. In 2019, atai launched EntheogeniX to pursue novel compounds using machine learning-based drug discovery, and the recent launch of TryptageniX added biosynthetic capabilities to atai’s discovery efforts.1,2 atai has already made substantial progress in its drug discovery efforts to date, synthesizing and screening approximately 300 compounds and identifying novel scaffolds that display potential in targeting mental health disorders. Mental health disorders impact over 1 billion people around the world, representing a growing global crisis, but medical innovation has failed to offer recent novel solutions.3 Only 7 treatments have been approved by the FDA for psychiatry disorders since 2015; a time in which approximately 100 have been advanced in oncology.4atai Life Sciences is proud to be a driving force in mental health innovation and to make Invyxis the latest addition to its diversified platform, to develop new therapeutic options in key areas of patient unmet need. Annonce • Jan 13
Atai Life Sciences Announces Fda Investigational New Drug Clearance for Pcn-101 R-Ketamine Program Atai Life Sciences N.V. announced the U.S. Food and Drug Administration has given Investigational New Drug clearance to conduct a clinical DDI study of PCN-101 (R-ketamine). atai plans to initiate the study early this year through its platform company Perception Neuroscience. The unique properties of PCN-101 could offer a differentiated profile to currently available antidepressants and address key patient needs, including the potential of rapid action and anti-suicidal effect. Rapid onset of action is particularly important in this patient population, but frontline selective serotonin reuptake inhibitors (SSRIs) can take up to 12 weeks before providing maximal benefit, while suicidality affects as much as 30% of treatment-resistant depression (TRD) patients at least once during their lifetime. In preclinical animal models of depressive behavior, R-ketamine has demonstrated the potential to offer longer durability and a potentially more favorable safety and tolerability profile than S-ketamine, which could enable the potential for at-home use. In addition, a third-party, open-label study observed a rapid, durable antidepressant response and limited dissociative side effects in patients with TRD after a single intravenous dose of another formulation of R-ketamine. An estimated 100 million people live with TRD globally, representing a third of people with depression, who are undertreated or unresponsive to available treatment options.7,8 In addition to its impact on patients, families, and caregivers, TRD severely impacts healthcare systems and payers. Direct medical costs for TRD patients are estimated to be two times higher than for non-TRD major depressive disorder (MDD) patients, with an average of twice the number of inpatient visits and hospital stays that are over one-third longer. This clinical DDI trial will advance alongside an existing Phase 2a proof-of-concept trial in TRD, recently initiated in Europe.11 Additionally, atai anticipates running a bioavailability study in 2022, which is designed to bridge the IV formulation to a subcutaneous formulation of PCN-101, supporting the potential for self-administration. The clinical study is an open-label, 2-cohort, fixed-sequence, drug-drug interaction study to evaluate the effects of CYP450 inhibition on the pharmacokinetics of PCN-101 in healthy adult subjects. atai will use the results of this study in conjunction with clinical pharmacokinetic data to advance the development of PCN-101 in TRD. Perception Neuroscience is developing PCN-101 (R-ketamine) for the treatment of TRD. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical depression model studies in rodents suggest that R-ketamine could possess more durable effects and favorable safety and tolerability profile. Further supporting the potential of R-ketamine, an open-label clinical study has demonstrated rapid, durable response and limited dissociative side effects in TRD patients after a single intravenous dose. Annonce • Dec 15
atai Life Sciences Announces Successful Outcome of Phase 2a Biomarker Trial of RL-007 in Cognitive Impairment Associated with Schizophrenia atai Life Sciences announced positive topline data from its Phase 2a study of RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS). The 32-patient, single-arm, single-blind study demonstrated a clinically meaningful pro-cognitive profile for RL-007, based on analysis of general cognition and episodic memory. Additionally, the trial showed changes in quantitative electroencephalogram (qEEG) that are consistent with previous results of a prior study of healthy volunteers. Together, the results support atai’s decision to progress RL-007 to a double-blind, placebo-controlled Phase 2 trial focused on cognition. The topline Phase 2a data showed dose-related improvements on exploratory cognitive endpoints. These included the Brief Assessment of Cognition in Schizophrenia, Symbol Coding Test (Symbol Coding) and Hopkins Verbal Learning Task (HVLT), focusing on general cognitive function and episodic memory, respectively.1,2 The dose-responsive improvement of Symbol Coding and HVLT replicated the previously observed cognitive bi-phasic dose response of RL-007. Importantly, Symbol Coding is a highly sensitive cognitive endpoint in CIAS patients, has a high correlation with patient outcome, and is a key component of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB™). In addition to the pro-cognitive effects, a dose dependent response in qEEG was observed, with the greatest increases seen in 20mg and 40mg doses of RL-007. The qEEG data demonstrated salient increases in amplitude in the alpha band (up to 17% increase in normalized, baseline adjusted band power) and in the alpha-slow wave index (up to 21% increase), both markers of alertness believed to correlate with aspects of cognition.4Notably, these findings recapitulate promising results from a previous study of RL-007 in a human model of cognitive impairment utilizing a scopolamine challenge. This previous trial observed similar qEEG responses and changes in a word recall task within the same dose range. Recognify Life Sciences, an atai Life Sciences platform company, is conducting the current and upcoming RL-007 trials in CIAS. Annonce • Dec 10
Atai Life Sciences N.V. Announces the Launch of TryptageniX atai Life Sciences N.V. announced the launch of TryptageniX. This new platform company will specialize in both the discovery of new chemical entities (NCEs) for the atai pipeline through bioprospecting and on biosynthesis of atai's naturally derived development candidates. Both approaches are expected to further strengthen atai’s already robust intellectual property (IP) portfolio spanning psychedelic and non-psychedelic compounds. Bioprospecting refers to the search for natural products from which medicines can be developed, while biosynthesis is the production of complex molecules within living organisms or cells. Both are central to TryptageniX’s approach to the development of NCEs. In addition, the development of innovative biosynthetic methods will further optimize the scalability of compound manufacturing, allowing atai to address the escalating mental health crisis in an ecologically sustainable manner. Naturally derived compounds play an important role across drug development for the central nervous system (CNS). TryptageniX will be a strong complement to atai’s existing drug discovery and development expertise, while also allowing atai to minimize its ecological footprint and ensure a sustainable supply chain for the future.