Business
atai Life Sciences Reports Third Quarter 2022 Financial Results and Business Update
Last patient dosed in the Phase 2a proof-of-concept trial of PCN-101 (R-ketamine) for treatment-resistant depression (TRD), with topline results expected
About this update from Ataibeckley Inc.
[{"type":"text","content":"Last patient dosed in the Phase 2a proof-of-concept trial of PCN-101 (R-ketamine) for treatment-resistant depression (TRD), with topline results expected around year-end 2022.Announced positive preliminary pharmacokinetics and pharmacodynamics results in a Phase 1 study of GRX-917 (deuterated etifoxine) being developed for generalized anxiety disorder (GAD), demonstrating target engagement based on qEEG. Announced positive preliminary results of the single ascending dose (SAD) portion of the Phase 1 study of KUR-101 (deuterated mitragynine) being developed for opioid use disorder (OUD), demonstrating dose-dependent pain relief with effects on respiration comparable to that of placebo. Announced the first patient dosed in the Phase 1 SAD trial of VLS-01 (DMT) being developed for TRD, initiation of the Phase 1 trial of EMP-01 (MDMA derivative) being developed for post-traumatic stress disorder (PTSD), and initiation of proof-of-concept Phase 1 clinical trial of a sol-gel based direct-to-brain drug delivery technology.Ended quarter with $304M in cash, which combined with the non-dilutive funding facility from Hercules provides anticipated runway into 2025. Video interview with Management to be posted today at 8:30 a.m. EST NEW YORK and BERLIN, Nov. 10, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (Nasdaq: ATAI) (“atai” or “the Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today reported financial results for the quarter ended September 30, 2022 and provided a business update. “In addition to multiple study initiations this quarter, we have announced two positive clinical trial results, with more on the way,” said Florian Brand, Co-Founder and Chief Executive Officer of atai. “We’re excited about the upcoming Phase 2a topline results of PCN-101 that could represent a meaningful shift in the current treatment paradigm for patients.” “The third quarter of 2022 demonstrated our strong capability to execute. Not only did we have first patient dosed of a Phase 1 trial of VLS-01 and initiation of a Phase 1 trial of EMP-01, we also began collecting data on our digital therapeutic app supporting ‘(mind)set-and-setting’ prior to dosing,” said Srinivas Rao, Co-Founder and Chief Scientific Officer. “Moreover, positive safety, tolerability, and pharmacodynamic results fro...