The United States Food and Drug Administration cleared the investigational new drug application for VLS-01 (buccal film DMT); atai expects to initiate a Phase 2 study in treatment-resistant depression patients around YE’24 Remain on track to initiate a Phase 2 study of EMP-01 (oral R-MDMA) in social anxiety disorder patients around YE’24 Cash, marketable securities, and committed term loan funding expected to fund operations... Read More

NEW YORK and BERLIN, Oct. 15, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that Srinivas Rao, M.D., Ph.D., the Company’s Co-founder and Co-CEO, is scheduled to participate in the 2024 Maxim Healthcare Virtual Summit taking place from October 15 – 17, 2024. Details of... Read More

NEW YORK and BERLIN, Sept. 04, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that the Company’s management team is scheduled to participate in the H.C. Wainwright 26 th Annual Global Investment Conference in New York, NY from September 9-11, 2024. Details of the... Read More

Reported positive Phase 1b results of VLS-01 (buccal film DMT); expect to initiate a Phase 2 study in treatment-resistant depression patients around YE’24 Announced clinical development plans for EMP-01 (oral R-MDMA); expect to initiate a Phase 2 study of EMP-01 in social anxiety disorder patients around YE’24 Cash, marketable securities, and committed term loan funding expected to fund operations into 2026 NEW YORK and... Read More

VLS-01 is designed to induce a short psychedelic experience, allowing for a total in-clinic treatment of 2-hours, consistent with an established commercial paradigm in interventional psychiatry VLS-01 reached peak plasma concentration within 30-45 minutes and was shown to induce a short psychedelic experience, with subjective effects generally resolving within 90-120 minutes VLS-01 demonstrated a favorable safety profile and... Read More

NEW YORK and BERLIN, Aug. 07, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that the Company’s management team is scheduled to participate in the Canaccord Genuity 44th Annual Growth Conference taking place in Boston, MA from August 13-15, 2024. Details of the company’s... Read More

NEW YORK and BERLIN, June 26, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that the Company’s management team will participate in the H.C. Wainwright 5th Annual Neuro Perspectives Conference taking place on June 27, 2024. Details of the company’s participation: Format:... Read More

ELE-101 is a patent-protected, synthetic formulation of psilocin, designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours. The Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single intravenous (IV) dose of ELE-101 in 6-12 participants with Major Depressive Disorder (MDD).... Read More

NEW YORK and BERLIN, May 31, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that the Company’s management team will participate in the Jefferies Global Healthcare Conference being held from June 4-6, 2024. Details of the company’s participation: Format: Fireside Chat Date... Read More

NEW YORK and BERLIN, May 23, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the appointment of Scott Braunstein, M.D., and Laurent Fischer, M.D., as independent directors of atai’s supervisory board (“Board”) subject to applicable legal requirements. Scott Braunstein,... Read More

First participant dosed in Phase 1b trial of VLS-01 with data expected in 2H’24; Phase 2 study in TRD patients anticipated to initiate around YE’24 Beckley Psytech’s Phase 2a study of BPL-003 in TRD patients showed rapid and durable antidepressant effects; Phase 2b topline data expected in 2H’24 Compass Pathways’ Phase 2 study of COMP360 in PTSD patients demonstrated durable improvement in symptoms; Phase 3 data of COMP360... Read More

The BPL-003 Phase 2a trial is an open-label study investigating BPL-003 as both monotherapy and adjunctive to SSRIs in patients with Treatment Resistant Depression. Initial results from the recently completed monotherapy Part 1 of the study were shared in March 2024, and showed that a single dose of BPL-003 was safe and well-tolerated, with a rapid and durable antidepressant effect lasting up to 12-weeks post-dose. Part 2 of... Read More

BPL-003 is Beckley Psytech’s novel patent-protected benzoate salt formulation of 5-MeO-DMT that is administered intranasally. BPL-003 was shown to be safe and well-tolerated with a predictable pharmacokinetic profile and a reliable induction of subjective psychedelic effects with single doses of up to 12 mg in healthy participants. Subjective psychedelic effects correlated with 5-MeO-DMT exposure and had a rapid onset and... Read More

Strategic investment in Beckley Psytech to accelerate the development of psychedelic-based therapies that fit within the two hour in-clinic treatment paradigm established by Spravato® Initial BPL-003 (intranasal 5-MeO-DMT) Phase 2a open-label results demonstrated a rapid and durable antidepressant effect through three months in TRD patients; top-line results from a controlled Phase 2b TRD study anticipated in 2H 2024 Dosing... Read More

A single dose of BPL-003 demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12 55% of patients achieved a clinical response on the day after dosing and this rate of response was maintained at week 4 and week 12 BPL-003 showed a good safety profile and was well-tolerated with no serious adverse events reported Acute effects resolved on average in less... Read More

The Phase 1b trial of VLS-01 investigates the pharmacokinetics, pharmacodynamics, safety and tolerability of atai’s proprietary, optimized oral transmucosal formulation of DMT VLS-01 is being developed as a rapid-acting and durable antidepressant for treatment resistant depression, which affects approximately 100 million people globally VLS-01 is designed to induce a short psychedelic experience, allowing for a total... Read More

NEW YORK and BERLIN, Feb. 28, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that management will participate in a panel discussion at the TD Cowen conference in Boston, MA, at 12:50pm ET on March 4, 2024. A live audio webcast of the panel discussion will be available on the Investors... Read More

NEW YORK and BERLIN, Feb. 06, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”) today 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... Read More

Strategic investment in Beckley Psytech reinforces atai’s position as the biopharmaceutical company with the largest and most diverse portfolio of clinical-stage psychedelic candidates Two 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... Read More

EMP-01 (R-MDMA) was generally well-tolerated and treatment-related adverse events (AEs) were as expected The PK profile of EMP-01 was dose-proportional, and a range of exploratory pharmacodynamic (PD) measures, including subjective reports and blood-based biomarkers, showed dose-dependent changes EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA, a result that is likely to have... Read More

Phase 2b study of RL-007 in CIAS patients continues to be on track to report data in 2H 2024 and data from the EMP-01 (MDMA derivative) Phase 1 study is anticipated to report out later this year. Phase 1 data of VLS-01 (a proprietary oral transmucosal film formulation of DMT) demonstrated that 160mg of VLS-01 reached exposure levels comparable to 30mg of IV DMT. Acceptance of three non-clinical poster presentations at... Read More

TORONTO , Oct. 10, 2023 /CNW/ - This press release is being issued pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues (" NI 62-103 "), in connection with certain transactions completed by atai Life Sciences AG (Nasdaq: ATAI) (" atai ") and IntelGenx Technologies Corp. (the " IntelGenx "), that were previously described in a press release issued by... Read More

NEW YORK and BERLIN, Oct. 06, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in the Jefferies Inaugural Biotech CNS/Neuro Summit being held from October 11-12, 2023. Details of the company’s participation is as follows: Jefferies Inaugural Biotech CNS/Neuro Summit Format: Fireside... Read More

VLS-01, a proprietary oral transmucosal film (OTF) formulation of DMT, was well-tolerated with a favorable safety profile Pharmacokinetic and pharmacodynamic data confirmed systemic delivery of DMT via the oral, transmucosal route at levels comparable to those achieved with IV administration Company plans to further optimize VLS-01 in preparation for a Phase 2 study in treatment-resistant depression (TRD) NEW YORK and... Read More

NEW YORK and BERLIN, Sept. 14, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in the 2023 Cantor Fitzgerald Global Healthcare Conference. Details of the company’s participation is as follows: 2023 Cantor Fitzgerald Global Healthcare Conference Format: Fireside Chat Date and Time:... Read More

NEW YORK and BERLIN, Sept. 06, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in upcoming September Investor Conferences. Details of the company’s participation are as follows: Citi's 18th Annual BioPharma Conference Format: 1x1 Only Date: Thursday, September 7 th Location: Boston,... Read More

Advanced multiple clinical stage assets in development, including the on-going Phase 2b study of RL-007 in patients with Cognitive Impairment Associated with Schizophrenia DMX-1002 (Ibogaine) Phase 1 results enable discussions with regulatory authorities to assess progressing into proof-of-concept study in patients with Opioid Use Disorder The Company’s $227M cash position and committed term loan funding is expected to fund... Read More

NEW YORK and BERLIN, Aug. 08, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, 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... Read More

NEW YORK and BERLIN, June 01, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in upcoming June Investor Conferences. Details of the company’s participation are as follows: Jefferies 2023 Healthcare Conference Format: Corporate Presentation Date and Time: Friday, June 9 th , 9:00 a.m.... Read More

RL-007: First patient dosed in the Phase 2b study of RL-007 in Cognitive Impairment Associated with Schizophrenia. GRX-917: Presented PD data from the completed Phase 1 study, which suggest the potential for anxiolytic effects without the significant sedative effects seen with benzodiazepines. VLS-01: Well-tolerated in Parts 1 (IV) and 2 (OTF) of the on-going Phase 1 study. Amended protocol to expand study into Part 3, which... Read More

NEW YORK and BERLIN, May 02, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in the 2023 Aegis Virtual Conference. Details of the company’s presentation is as follows: Aegis Virtual Conference Format: Corporate Presentation Date and Time: Wednesday, May 3 rd , 11:30 a.m. ET Location:... Read More

Pharmacodynamic profile of GRX-917 indicates potential for anxiolytic activity without the significant sedative side effects associated with benzodiazepines NEW YORK and BERLIN, April 28, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced that pharmacodynamic data on GRX-917, a deuterated... Read More

NEW YORK and BERLIN, April 13, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced that the first subject has been dosed in Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine). This Phase 1 open-label study is designed to assess the safety,... Read More

atai’s development candidates, such as RL-007 and GRX-917, all represent significant opportunities to address unmet medical needs of patients living with mental health conditions Continued operational progress on robust clinical pipeline, with multiple phase 1 and phase 2 proof-of-concept datasets expected in the next two years $273 million in cash, cash equivalents and short-term investments at end of 2022 and access to a... Read More

RL-007: First patient dosed in the on-going phase 2b study in cognitive impairment associated with schizophrenia GRX-917: Intention to progress GRX-917 into a phase 2 study in an anxiety disorder as the next step in clinical development COMP360: Recently announced acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program, with top line data now expected in the summer of 2024 Corporate: As a result of our... Read More

NEW YORK and BERLIN, March 01, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in the Cowen 43rd Annual Health Care Conference. Details of the company’s panel participation are as follows: Cowen 43rd Annual Health Care Conference Format: Neuropsych Corporate Panel Date and Time:... Read More

GRX-917 (deuterated etifoxine) was well-tolerated with no dose-limiting toxicities and only mild adverse effects comparable to that of placebo in both single and multiple ascending doses, as previously announced as preliminary results during atai’s R&D day. Final results demonstrate target engagement of GRX-917 via dose-related activation of quantitative electroencephalography (qEEG) frontal beta power, a biomarker for... Read More

NEW YORK and BERLIN, Jan. 06, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “the Company”), a clinical-stage biopharmaceutical company focused on mental health, 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... Read More

This two-part phase 1 trial in healthy volunteers was designed to assess the safety, pharmacokinetics, and analgesic activity of KUR-101 KUR-101 was well tolerated and demonstrated analgesic activity in two experimental pain models An assessment of the respiratory impact of KUR-101 was inconclusive as the positive control, oxycodone, failed to separate from placebo KUR-101, a deuterated derivative of mitragynine, is a... Read More

The phase 2b proof-of-concept trial will evaluate the novel compound, RL-007, for pro-cognitive effects in patients with Cognitive Impairment Associated with Schizophrenia (CIAS). The trial was initiated and has begun patient screening this month with first-patient-in anticipated by end-of-year. There are currently no FDA-approved medications for CIAS, a major cause of disability in 80% of patients with schizophrenia 1.... Read More

NEW YORK and BERLIN, Dec. 16, 2022 (GLOBE NEWSWIRE) -- atai Impact, the philanthropic arm of a tai Life Sciences N.V. (NASDAQ: ATAI) (“atai”), today announced the first cohort of the atai Fellowship Fund in Psychedelic Neuroscience (the “Fellowship Fund”) at Massachusetts General Hospital (“MGH”) Center for the Neuroscience of Psychedelics. The $2 million Fellowship Fund was announced in December 2021 to facilitate research... Read More

NEW YORK and BERLIN, Nov. 17, 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 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... Read More