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

atai Life Sciences (NASDAQ: ATAI) announced positive preliminary results from its Phase 1b trial of VLS-01, a proprietary oral transmucosal film formulation of N,N-dimethyltryptamine (DMT). The trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of VLS-01 compared to intravenous DMT in healthy participants.

Key findings include:

• Dose-proportional peak plasma concentrations achieved within 30-45 minutes
• Robust subjective effects at 120mg and 160mg doses
• Favorable safety profile with mild to moderate adverse events
• Short psychedelic experience resolving within 90-120 minutes

Based on these results, atai plans to initiate a Phase 2 study in patients with treatment-resistant depression around year-end 2024, with topline data expected around year-end 2025.

atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health disorder treatments, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event will take place in Boston, MA from August 13-15, 2024.

Key details of atai's involvement include:

• A fireside chat scheduled for Wednesday, August 14 at 11:00 A.M. EDT
• One-on-one investor meetings
• A webcast link provided for remote access

An archived replay of the fireside chat will be available on the Investors section of atai's website under Events for up to 90 days following the conference.

atai Life Sciences (NASDAQ: ATAI) announced its participation in the H.C. Wainwright 5th Annual Neuro Perspectives Conference on June 27, 2024. The company, focused on revolutionizing mental health disorder treatments, will engage in a virtual fireside chat and one-on-one investor meetings. The fireside chat will be accessible on-demand starting at 07:00 A.M. ET on June 27. A replay will be available on the Investors section of the atai website for up to 90 days.

atai Life Sciences has provided an update on Beckley Psytech's Phase 1/2a trial of ELE-101 for Major Depressive Disorder (MDD). ELE-101 is a synthetic psilocin formulation designed for a consistent and shorter treatment duration of approximately two hours. The Phase 2a study will assess the safety, tolerability, and efficacy of a single IV dose in 6-12 participants, with results expected in H2 2024.

Phase 1 results indicate ELE-101 was well-tolerated with no serious adverse events and exhibited a dose-proportional pharmacokinetic profile. Initial data suggests a reliable induction of short-duration psychedelic experiences. The trial aims to demonstrate that ELE-101 could offer rapid onset and reduced treatment variability compared to oral psilocybin, potentially reducing the resource burden on healthcare systems.

Full Phase 1 data will be published later, and ELE-101, along with other candidates like BPL-003 and VLS-01, is part of atai's pipeline targeting in-clinic treatments of around two hours.

atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health disorders, announced its participation in the Jefferies Global Healthcare Conference from June 4-6, 2024. The company will engage in a fireside chat on June 6 at 10:00 A.M. ET in New York. The live webcast will be accessible on the company's investor relations page, with a replay available post-event.

atai Life Sciences (NASDAQ: ATAI) has appointed Scott Braunstein, M.D., and Laurent Fischer, M.D., as new independent directors to its supervisory board, effective May 23, 2024. Scott Braunstein is the CEO and Chairman of Marinus Pharmaceuticals and has held key positions at Pacira Pharmaceuticals and JP Morgan Global Healthcare Fund. Laurent Fischer currently serves as the CEO and President of Adverum Biotechnologies and has a robust background with roles at CTI Biopharma, Tobira Therapeutics, and others. Jason Camm steps down after four years of service. The addition of Braunstein and Fischer is expected to strengthen atai's board as the company progresses into advanced clinical trials.

atai Life Sciences (NASDAQ: ATAI) reported its Q1 2024 financial results and corporate updates. Notably, the company commenced Phase 1b trials for VLS-01 with data expected in the second half of 2024. Beckley Psytech's BPL-003 Phase 2a showed rapid antidepressant effects, and Phase 2b data is expected in 2H 2024. Compass Pathways’ COMP360 demonstrated significant symptom improvement in PTSD patients. Co-Founder Florian Brand will step down as CEO by YE 2024, succeeded by Co-Founder Srinivas Rao. Financially, atai's cash and equivalents decreased to $121.3 million from $154.2 million in Q4 2023, primarily due to R&D and investment expenditures. The company anticipates its resources to fund operations into 2026. R&D expenses fell to $11.5 million, and G&A expenses also saw a decline, leading to a lower net loss of $26.7 million compared to the previous year.