atai Life Sciences NV $(ATAI)$ and Beckley Psytech Limited have announced positive results from a proof-of-concept study investigating a two-dose induction regimen of BPL-003 in patients with treatment-resistant depression (TRD). The open-label study evaluated an 8 mg dose of BPL-003 followed by a 12 mg dose two weeks later, demonstrating rapid, clinically meaningful, and durable antidepressant effects sustained for up to three months. The data suggests that the second dose enhances the clinical response beyond a single administration. These findings, alongside data from Beckley Psytech's Phase 2b study and an upcoming Phase 2b open-label extension study, will inform the design of Phase 3 clinical trials. atai and Beckley Psytech plan to engage with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to discuss the Phase 3 clinical program, with initiation expected in the first half of 2026, pending FDA feedback.