Atai Life Sciences B.V. Stock Price, News & Analysis

atai Life Sciences (NASDAQ: ATAI) has secured a significant $50 million private placement financing through the sale of 18,264,840 ordinary shares and pre-funded warrants for 4,566,210 additional shares. The financing round was co-led by Ferring Ventures S.A. and Apeiron Investment Group, with participation from healthcare-focused investors including Ally Bridge Group and ADAR1.

The company plans to use the proceeds for general corporate purposes, working capital, and advancement of its clinical development programs. The private placement, expected to close in Q3 2025, is subject to certain conditions, including HSR Act waiting period expiration.

This strategic investment positions atai to transition from a clinical-stage biotech into a commercial entity, with plans for FDA discussions and Phase 3 planning in early 2026. TD Cowen, Leerink Partners, Guggenheim Securities, and Berenberg are serving as joint-lead placement agents for this transaction.

atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech announced positive topline results from their Phase 2b study of BPL-003 (intranasal mebufotenin) in treatment-resistant depression (TRD). The study, involving 193 patients across 38 sites in six countries, met its primary and all key secondary endpoints.

Both 8mg and 12mg single doses showed statistically significant improvements in depression symptoms compared to the 0.3mg control group. At Day 29, the 12mg dose showed a mean MADRS score reduction of 11.1 points versus 5.8 points in the control group (p=0.0038), while the 8mg dose achieved a 12.1-point reduction (p=0.0025). Effects were observed as early as Day 2 and maintained through Week 8.

The treatment demonstrated favorable safety with 99% of adverse events being mild or moderate, no drug-related serious adverse events, and no suicide-related safety signals. Most patients were ready for discharge within 90 minutes post-dose, suggesting compatibility with existing clinical treatment paradigms. Based on the results, the 8mg dose has been selected for Phase 3 development, pending regulatory consultation.

atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech announced a strategic merger to form atai Beckley, creating a global leader in psychedelic mental health treatments. The all-share transaction values Beckley at approximately $390 million, with Beckley shareholders receiving about 105 million new shares, representing 31% of the combined company. The deal includes a concurrent $30 million private placement from Ferring Ventures and Adage Capital Partners. The combined company will focus on rapid-acting psychedelic compounds, with key near-term catalyst being BPL-003's Phase 2b topline data in treatment-resistant depression expected in mid-2025. The merger, expected to close in H2 2025, aims to create a market-leading pipeline with compounds differentiated by convenient administration and short clinic time, supported by patents through 2043.

atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health treatments, has announced its participation in two upcoming investor conferences in June 2025. The company will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5 at 9:55 A.M. EDT in New York. Additionally, atai will present at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference through a pre-recorded fireside chat on June 17 at 7:00 A.M. EDT in a virtual format. Both presentations will be available via webcast on the company's investor relations website, with replays available after the events.

atai Life Sciences (NASDAQ: ATAI) announced positive topline results from Part 2 of Beckley Psytech's Phase 2a study of BPL-003 for Treatment-Resistant Depression (TRD). The study evaluated a single dose of BPL-003 in combination with SSRIs in 12 patients with moderate-to-severe depression. Key findings include:

- Mean MADRS reduction of 18 points from baseline one day after dosing - Sustained efficacy with 19-point reduction at one month and 18-point reduction at three months - Average discharge time of less than two hours post-dosing - Well-tolerated with only mild to moderate adverse events

The company is currently conducting a larger Phase 2b study with 196 patients, the largest controlled clinical study of mebufotenin in the US, with results expected in mid-2025. These findings will support end-of-Phase 2 regulatory meetings and Phase 3 planning.

atai Life Sciences (NASDAQ: ATAI) reported its Q1 2025 financial results and corporate updates, highlighting progress in its psychedelic mental health treatment pipeline. The company's key developments include: anticipated topline data from BPL-003's Phase 2b trial in treatment-resistant depression (TRD) expected midyear, first patient dosed in EMP-01's Phase 2 study for social anxiety with results expected Q1'26, and ongoing enrollment in VLS-01's Phase 2 study for TRD. Financially, atai reported a net loss of $26.4M, with R&D expenses at $11.3M and G&A expenses at $10.6M. The company's cash position strengthened to $108.2M, up from $72.3M in December 2024, following $59.1M in net proceeds from equity financings. Operations are funded into 2027.

atai Life Sciences (NASDAQ: ATAI) has initiated dosing in its Phase 2 study of EMP-01 (oral R-MDMA) for treating social anxiety disorder (SAD). The exploratory, randomized, double-blind, placebo-controlled trial will evaluate approximately 60 adult patients, who will receive two administrations of either EMP-01 or placebo, four weeks apart.

The study aims to assess safety, tolerability, and efficacy, with symptom monitoring for six weeks after the first dose. In previous Phase 1 studies, EMP-01 showed a unique, dose-dependent profile more similar to classical psychedelics than racemic MDMA. Topline data is expected in Q1 2026.

atai Life Sciences (NASDAQ: ATAI) reported its Q4 and full year 2024 financial results, highlighting significant clinical progress and a strengthened financial position. The company completed an equity offering raising $59.2 million, extending its operational runway into 2027.

Key clinical developments include: dosing the first patient in Phase 2 Elumina trial of VLS-01 for treatment-resistant depression; initiating Phase 2 trial of EMP-01 for social anxiety disorder; and Beckley Psytech completing enrollment in Phase 2b study of BPL-003. Topline data for VLS-01 and EMP-01 are expected in Q1'26, while BPL-003 results are anticipated in mid-2025.

Financial highlights: Cash position of $72.3 million as of December 31, 2024, down from $154.2 million year-over-year. R&D expenses were $55.5 million for 2024, decreased from $62.2 million in 2023. G&A expenses reduced to $47.5 million from $63.6 million. Net loss increased to $149.3 million in 2024 compared to $40.2 million in 2023.

atai Life Sciences (NASDAQ: ATAI) has initiated the Phase 2 Elumina clinical trial for VLS-01, announcing the first patient dosing. VLS-01, a proprietary oral transmucosal film formulation of DMT, is being developed to treat treatment-resistant depression (TRD) affecting approximately 100 million people globally.

The Elumina trial is a multicenter, double-blind, randomized, placebo-controlled study involving about 142 patients. The trial structure includes two treatment periods: First period participants will be randomized 1:1 to receive either 120mg VLS-01 or placebo on Day 1 and Week 2. The primary endpoint measures changes in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 4, with final assessments at Week 14. The second period begins at Week 14, testing two different dose levels (60mg vs 120mg) of VLS-01.

The company expects to report topline results in Q1 2026. VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm, aiming to provide rapid, robust, and durable antidepressant effects.