Business
atai Life Sciences Reports Second Quarter 2024 Financial Results and Provides Corporate Updates
• 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 •
About this update from Ataibeckley Inc.
[{"type":"text","content":"• 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 BERLIN, Aug. 13, 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 second quarter 2024 financial results and provided corporate updates. “Over the past quarter, we've made significant strides to advance our pipeline, with key updates from our VLS-01 and EMP-01 programs,” stated Dr. Srinivas Rao, Co-Chief Executive Officer and Co-founder of atai. “Our positive Phase 1b results for VLS-01 underscore its potential as a best-in-class oral treatment for patients suffering from treatment-resistant depression, and we look forward to initiating the Phase 2 study around year-end. Clinical development plans for EMP-01 are advancing with a Phase 2 study in Social Anxiety Disorder (SAD) set to begin around year-end. This follows encouraging Phase 1 results, where EMP-01 demonstrated a unique subjective profile compared to racemic MDMA and classical psychedelics. With no novel molecules approved for SAD in over 20 years, it remains an area of critical unmet need. Looking ahead, our team is focused on several important readouts and study initiations in the second half of the year. As such, we continue to establish our position as a leader in mental health innovation, with a robust set of high potential programs aimed at addressing the areas of most significant unmet need.” Recent Clinical HighlightsVLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD) VLS-01 is a proprietary oral transmucosal film formulation of DMT applied to the buccal surface designed to fit within a two-hour in-clinic treatment paradigm.Recently, atai announced positive topline data from the Phase 1b trial of VLS-01 buccal film in 17 healthy participants. Peak plasma concentration of VLS-01 occurred within 30-45 minutes. VLS-01 was shown to induce a short psychedelic experienc...