Core Findings - Atai Life Sciences and Beckley Psytech Limited announced successful topline results from the Phase 2b trial of BPL-003, achieving primary and key secondary endpoints in patients with treatment-resistant depression [1][3][4] Efficacy Results - A single 12 mg dose of BPL-003 resulted in a statistically significant mean reduction of 11.1 points in depressive symptoms on the MADRS scale at Day 29, compared to a 5.8 point reduction in the 0.3 mg comparator group (p = 0.0038) [3][4] - The 8 mg dose also showed significant improvement with a mean MADRS score reduction of 12.1 points at Day 29 (p = 0.0025) [4] - Both 8 mg and 12 mg doses demonstrated significant efficacy as early as Day 2, with mean reductions of 8.8 points and 8.9 points, respectively, compared to a 3.9 point reduction in the 0.3 mg group [6] - Durable effects were observed, with the 8 mg group showing a mean reduction of 10.8 points at Day 57 [7] Safety Findings - More than 99% of treatment-emergent adverse events were mild or moderate, with no serious adverse events reported [8] - The 8 mg dose was better tolerated than the 12 mg dose, with dose-related increases in discomfort and other mild side effects [8] - No instances of treatment-emergent suicidal intent or behavior were observed in the 8 mg or 12 mg groups [9] Future Developments - The study includes an ongoing eight-week open-label extension to evaluate the safety and efficacy of a second 12 mg dose, with data expected in Q3 2025 [9][10] - Atai Life Sciences announced a private placement of 18.3 million shares, raising approximately $50 million in gross proceeds [10] Transaction Update - The companies plan to combine in an all-share transaction, contingent on the success of the Phase 2b trial, expected to close in the second half of 2025 [2] Market Reaction - Following the announcement, ATAI stock rose by 28.3% to $2.81 in premarket trading [10]