ATAI - Earnings announcements

EMP-01 met its primary objective on safety and tolerability, demonstrating a generally favorable and manageable safety and tolerability profileEMP-01 demonstrated a clinically meaningful placebo-adjusted least squares mean reduction of 11.85 points on the Liebowitz Social Anxiety Scale (LSAS) at Day 43 (Hedges' g = 0.45; p-value = 0.036, one-tailed)EMP-01 demonstrated a robust separation from placebo on the Clinician Global Impression–Improvement (CGI-I) assessment: 49% responders vs. 15% for placebo, corresponding to a Number Needed to Treat (NNT) of 2.95EMP-01 demonstrated improvements across both Fear and Avoidance sub-domains of the LSAS, including improvement in social avoidance behavio

A 12 mg dose of BPL-003 (mebufotenin benzoate nasal spray) administered eight weeks after an initial 12 mg, 8 mg or 0.3 mg dose in the core study of the Phase 2b clinical trial produced additional rapid, clinically meaningful antidepressant effects that were sustained for up to eight weeksPatients who received an active dose of BPL-003 in the core study of the Phase 2b clinical trial (either 8 mg or 12 mg) met response and remission criteria for depression at increased rates after receiving a 12 mg dose in the OLE study, with 63% in response and 48% in remission at Week 8 in the OLE study (Week 16 of the Phase 2b clinical trial)An End-of-Phase 2 meeting has been scheduled with the U.S. Food

Study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single doseBoth 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8BPL-003 was generally well-tolerated at all doses, with 99% of treatment-emergent adverse events being mild or moderate, and no drug-related serious adverse events or suicide-related safety signalsMajority of patients deemed ready for discharge at the 90 minutes post-dose assessment, which suggests BPL-003 could fit within t

Strategic combination establishes a market-leading mental health company with a pipeline that includes potentially transformative, rapid-acting psychedelic assets differentiated by their convenient route of administration and short time-in-clinicCombined company will operate under the name atai Beckley with a joint leadership team and Board that leverage the deep psychedelic, drug development and CNS expertise within both organizationsTopline data from the Phase 2b study of BPL-003 in patients with treatment-resistant depression (TRD) is expected in mid-2025 - the largest controlled trial of mebufotenin (5-MeO-DMT) and the first and only controlled trial to investigate mebufotenin in the U.S

Strategic investment in Beckley Psytech reinforces atai's position as the biopharmaceutical company with the largest and most diverse portfolio of clinical-stage psychedelic candidatesTwo patent-protected, clinical-stage programs BPL-003 (intranasal 5-MeO-DMT) and ELE-101 (intravenous psilocin) complement atai's existing drug development programs Multiple clinical readouts anticipated from this investment in Beckley Psytech within next 12 months, including a Phase 2b readout of BPL-003 in Treatment Resistant Depression in 2H24 BPL-003 has the potential to become a first-in-class short-duration psychedelic treatment with rapid acting and durable antidepressant effects Anticipated synergies th

–   Highlights included positive Phase 2b data with COMP360 from a ground-breaking treatment resistant depression (TRD) trial, highly encouraging Phase 2a proof-of-mechanism data with RL-007 in cognitive impairment associated with schizophrenia (CIAS), clinical trial initiations with PCN-101, GRX-917 and DMX-1002, and successful completion of 2 cohorts in the Introspect Digital Therapeutics ketamine trials –   Eight new programs added to platform since January 2021 bringing total, as of today, to 13 discovery and drug development programs and four enabling technologies –   Ended 2021 very well capitalized with $362 million to execute our strategy to achieve clinically meaningful and sustai

NEW YORK and BERLIN, March 23, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it plans to host a webcast on Wednesday, March 30, 2022 at 8:30 a.m. ET to discuss its financial results for the fourth quarter 2021 and provide a business update. To access the webcast, please log in at https://wsw.com/webcast/cc/atai/1358298. The live and archived webcast of this call will be available in the "Events" section of the atai Life Sciences website at ir.atai.life. About atai Life Sciences atai was founded in 2018 as a response to the significant

-Positive topline results from COMP360's Phase 2b study- -RL-007 Phase 2a topline data in cognitive impairment associated with schizophrenia expected end of Q4- -Continued progress across 11 therapeutic programs, including initiation of Perception's Phase 2a and DemeRx's Phase 1/2 trials as well as interim Phase 2a RL-007 readout of first cohort- -Launch of atai Impact, a philanthropic program to harness the power of innovative mental health approaches for social change- -Company to host a webcast and conference call today at 08:30am EST- BERLIN and NEW YORK, Nov. 15, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company ai

NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it plans to host a conference call on Monday, November 15, 2021 at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2021 and provide a business update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13724750. The live and archived webcast of this call will be available in the "Events" section of the atai Life Sciences website at ir.atai.life.

BERLIN, Aug. 09, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (NASDAQ:ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it plans to host a conference call on Monday, August 16, 2021 at 8:30 a.m. ET to discuss its financial results for the quarter ended June 30, 2021 and provide a business update. To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13721888. The live and archived webcast of this call will be available in the "Events" section of the atai Life Sciences website at ir.atai.life. Abou