ATAI Life Sciences N.V. Common Shares - ATAI STOCK NEWS

atai Life Sciences (NASDAQ: ATAI) has initiated a Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine), with the first subject dosed. This open-label study aims to evaluate the safety, tolerability, and pharmacokinetic profiles of varying doses (60mg, 90mg, 120mg) administered subcutaneously compared to an intravenous dose. Approximately 16 healthy volunteers will be enrolled, with completion expected mid-2023. Earlier, atai reported Phase 2a results showing PCN-101's encouraging safety profile in treatment-resistant depression, although primary endpoints were not statistically significant. The current study could inform future dosing regimens for potential at-home use of R-ketamine as an antidepressant.

atai Life Sciences (NASDAQ: ATAI) reported its financial results for Q4 and full year 2022, highlighting progress in its clinical pipeline for mental health treatments. As of December 31, 2022, the company had $273 million in cash and equivalents, with access to an additional $160 million loan facility, ensuring funding into mid-2026. Key developments include the initiation of a Phase 2 study for RL-007 in cognitive impairment associated with schizophrenia and plans for Phase 2 studies of GRX-917 for anxiety. The net loss for 2022 decreased to $152.4 million from $167.8 million in 2021, indicating improved financial management.

atai Life Sciences (NASDAQ: ATAI) announced significant updates regarding its clinical pipeline and corporate strategy. The company has initiated a phase 2b study for RL-007, targeting cognitive impairment linked to schizophrenia, with initial results expected in late 2024. Additionally, atai plans to advance GRX-917 into a phase 2 study for anxiety disorders. The company has streamlined operations by reducing its workforce by approximately 30%, aiming to focus resources on key clinical developments. Importantly, the cash runway has been extended into the first half of 2026, indicating improved financial stability.

atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health treatment, will participate in the Cowen 43rd Annual Health Care Conference on March 6, 2023, from 12:50 p.m. to 1:20 p.m. ET. The event format will be a Neuropsych Corporate Panel held in Boston, MA. A live webcast of the panel can be accessed via the atai website, with an archived replay available for 30 days post-event. Founded in 2018, atai is dedicated to innovating therapeutics for mental health disorders, aiming to enhance patient outcomes and transform lives.

atai Life Sciences (Nasdaq: ATAI) announced positive final results from the Phase 1 trial of GRX-917, a deuterated form of etifoxine, aimed at treating anxiety disorders. The trial showed GRX-917 was well-tolerated with mild side effects similar to placebo, demonstrating dose-related increases in qEEG beta power, indicative of GABA receptor activation. An efficacy study is planned for H1 2023, with results expected in 2024. The potential for GRX-917 lies in its improved pharmacokinetics, allowing less frequent dosing compared to non-deuterated etifoxine.

atai Life Sciences (NASDAQ: ATAI) announced that its Phase 2a trial of PCN-101 (R-ketamine) for treatment-resistant depression did not meet its primary endpoint of a statistically significant improvement in MADRS scores at 24 hours compared to placebo. Despite showing signals of efficacy across all timepoints, the study's primary analysis yielded p=0.5. A total of 102 patients were enrolled, with the 60mg dose group demonstrating a mean change of -15.3. While generally well-tolerated, the trial's secondary endpoints also failed to reach statistical significance.

atai Life Sciences announced outcome data from a Phase 1 trial of KUR-101, a novel analgesic treatment. The trial assessed safety and analgesic activity in healthy volunteers. KUR-101 was well tolerated and showed analgesic effects in two pain models, although less effective than oxycodone. An inconclusive assessment of respiratory impact highlighted the need for further research. KUR-101 aims to provide therapeutic benefits without significant respiratory depression, potentially offering a safer alternative for treating opioid use disorder and acute pain.

atai Life Sciences N.V. (Nasdaq: ATAI) has initiated its Phase 2b proof-of-concept trial for the novel compound RL-007, targeting Cognitive Impairment Associated with Schizophrenia (CIAS). With no FDA-approved treatments available for CIAS, this randomized, placebo-controlled study aims to evaluate the pro-cognitive effects of RL-007 among 234 patients. The trial is underway with expectations for topline results in H1 2024. RL-007 has shown positive outcomes in prior studies and could address a significant unmet need in mental health treatment.