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NEW YORK and BERLIN - atai Life Sciences (NASDAQ:ATAI), a biopharmaceutical company focused on mental health treatments with a current market capitalization of $261 million, has announced the completion of patient enrollment for the core stage of its global Phase 2b clinical trial, assessing the efficacy and safety of BPL-003 in individuals with treatment-resistant depression (TRD). The company’s stock has shown resilience with a 27% gain over the past six months, despite recent market volatility.InvestingPro analysis reveals that atai maintains a strong liquidity position, with liquid assets exceeding short-term obligations. Subscribers can access 8 additional key insights about atai’s financial health and market position. BPL-003, an intranasal formulation of mebufotenin benzoate, is being tested for its potential to provide rapid and lasting antidepressant effects from a single dose.
The trial, which is the largest controlled study of mebufotenin to date, has enrolled 196 patients with moderate-to-severe depression across 38 sites in six countries. These participants had not responded to at least two prior treatments for their current depressive episode. The study’s core stage is a double-blind, eight-week, quadruple-masked, dose-finding phase, where the medium (8mg) or high (12mg) dose of BPL-003 is being compared against a sub-perceptual dose. The company maintains a healthy current ratio of 5.81, indicating strong ability to fund its research operations, though InvestingPro data shows the company is currently burning through cash rapidly. Efficacy is being measured using the Montgomery-Asberg Depression Rating Scale (MADRS) by centralized, blinded raters at various timepoints throughout the eight weeks.
An open-label extension stage is ongoing to evaluate the safety and efficacy of a second high dose of BPL-003 after the core stage’s completion. The data from this trial will be used alongside information from the Phase 2a study of BPL-003 to support regulatory meetings and planning for Phase 3 trials in the latter half of 2025.
Previous Phase 2a results indicated that a single 10mg dose of BPL-003 could lead to rapid antidepressant effects, with significant remission rates at Day 29 and Day 85 post-dosing. Additionally, the treatment required a short clinic time, with patients ready for discharge in less than two hours on average after administration.
Topline results from the Phase 2b trial are anticipated in mid-2025, with the next earnings report expected on March 27, 2025. This trial’s completion marks a significant milestone for atai Life Sciences, which holds a significant stake in Beckley Psytech Ltd., the developer of BPL-003, following a strategic investment in January 2024. According to InvestingPro data, analysts maintain a strong buy consensus on the stock, with price targets ranging from $5 to $11, suggesting significant potential upside from current levels. Based on InvestingPro’s Fair Value analysis, the stock appears to be trading near its fair value.
The information provided is based on a press release statement from atai Life Sciences and Beckley Psytech Ltd.
In other recent news, atai Life Sciences reported positive preliminary results from a Phase 2a study of BPL-003 for alcohol use disorder. The study involved 12 patients and showed a significant reduction in alcohol consumption when combined with cognitive behavioral therapy. Participants saw a decrease in daily alcohol units from 9.3 to 2.2, and heavy drinking days dropped from 56% to 13%. In other developments, atai Life Sciences announced a reshuffle of its executive team, with Dr. Srinivas Rao now serving as the sole CEO. Dr. Kevin Craig was appointed as Chief Medical (TASE:BLWV) Officer, Dr. Glenn Short as Chief Scientific Officer, and Dr. Gerd Kochendoerfer as Chief Operating Officer. Additionally, the company is advancing its Phase 2 trials for VLS-01 and EMP-01, with data expected in 2026. Furthermore, the company announced the resignation of Mr. Michael Auerbach from its supervisory board, reducing the board’s membership from seven to six. The company has not yet disclosed plans to fill the vacancy.
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