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

atai Life Sciences (NASDAQ: ATAI) has secured a significant $11.4 million UG3/UH3 grant from the National Institute on Drug Abuse (NIDA) to develop novel treatments for opioid use disorder (OUD). The grant will fund the development of non-hallucinogenic 5-HT2A/2C receptor agonists, marking the first external validation of atai's AI-driven polypharmacology drug discovery approach.

The funding will support lead optimization, translational proof-of-concept studies, and preparations for an IND application. The company aims to develop compounds that maintain therapeutic efficacy while minimizing hallucinogenic effects and avoiding cardiac risks. This initiative addresses a critical global health crisis, with OUD affecting 16 million people worldwide and causing over 120,000 annual deaths, with associated costs exceeding $750 billion annually.

atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health treatments, has announced its participation in three major investor conferences this September.

The company will participate in fireside chat sessions at the Cantor Global Healthcare Conference on September 5th, the H.C. Wainwright Global Investment Conference on September 8th, and the TD Cowen Novel Mechanisms in Neuropsychiatry & Epilepsy Summit on September 17th. All presentations will be available via webcast on the company's investor relations website, with replays accessible after the events.

atai Life Sciences (NASDAQ: ATAI) reported Q2 2025 financial results and corporate updates, highlighting its planned strategic combination with Beckley Psytech. The company announced positive Phase 2b results for BPL-003 (intranasal mebufotenin benzoate) in treatment-resistant depression, meeting primary and secondary endpoints with a single dose showing effects for up to 8 weeks.

Financial position shows $95.9 million in cash and equivalents as of June 30, 2025, with funding expected into second half of 2027. Q2 2025 saw R&D expenses of $11.1 million (down from $12.6M YoY) and net loss of $27.7 million (improved from $57.3M YoY). The company raised nearly $140 million in 2025 through fundraising efforts.

Pipeline updates include delayed VLS-01 Phase 2 trial data now expected in H2 2026, ongoing EMP-01 Phase 2 study for social anxiety disorder, and development of novel 5-HT2A receptor agonists.

Recognify Life Sciences, a subsidiary of atai Life Sciences (NASDAQ:ATAI), announced that its Phase 2b clinical trial for inidascamine in treating cognitive impairment associated with schizophrenia (CIAS) did not meet its primary endpoint of statistical significance. The study, involving 242 patients across the US and Europe, showed modest numerical improvements in cognitive and functional measures.

Despite not achieving statistical significance, inidascamine demonstrated consistent improvement across multiple cognitive domains and maintained a favorable safety profile with no sedation, weight gain, or extrapyramidal symptoms. The company will continue analyzing secondary endpoints and subgroup data to identify potential responder populations and guide future development.

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.