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ATAI Life Sciences N.V. (NASDAQ: ATAI) is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of mental health disorders. Based in the United States and Germany, ATAI leverages a decentralized, technology- and data-driven platform to serve millions suffering from mental health challenges. The company’s mission is to develop innovative treatments that address significant unmet medical needs, leading to paradigm shifts in mental health care.
ATAI's product pipeline includes promising candidates such as COMP360/Psilocybin therapy, PCN-101/R-ketamine, RL-007/Compound, DMX-1002/Ibogaine, GRX-917/Deuterated etifoxine, VLS-01/DMT, EMP-01/MDMA derivative, RLS-01/Salvinorin A, KUR-101/Deuterated Mitragynine, and DMX-1001/Noribogaine. These candidates are designed to treat conditions such as depression, anxiety, addiction, and other mental health disorders.
Recently, ATAI announced positive results from its Phase 1 study of EMP-01, the R-enantiomer of MDMA. The study aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01. Involving 32 healthy participants, the study showed that EMP-01 was well-tolerated with no severe adverse events. The PK profile was dose-proportional, and PD measures indicated significant, consistent, and dose-dependent changes. These promising results might pave the way for EMP-01’s further clinical development.
ATAI Life Sciences is committed to efficient drug development by pooling resources, expertise, and best practices across its portfolio. This approach helps mitigate risks and accelerates the development of impactful, evidence-based treatments. The company’s vision is to heal mental health disorders, enabling everyone to live a more fulfilled life.
For more information, visit their official website at www.atai.life.
atai Life Sciences (NASDAQ: ATAI) announced positive topline results from Beckley Psytech's Phase 2a open-label study of BPL-003, a synthetic intranasal formulation of 5-MeO-DMT benzoate, in treating alcohol use disorder (AUD). The study, involving 12 patients with moderate to severe AUD, demonstrated significant improvements following a single dose combined with relapse prevention therapy:
Key results after 12 weeks include:
- Reduction in daily alcohol consumption from 9.3 to 2.2 units
- Decrease in heavy drinking days from 56% to 13%
- Increase in abstinent days from 33% to 81%
- 50% of patients maintained complete abstinence
The treatment was well-tolerated with only mild to moderate adverse events reported, and patients were typically ready for discharge within two hours. Beckley Psytech plans to evaluate future development options and share additional clinical data throughout 2025.
atai Life Sciences (NASDAQ: ATAI) has announced significant leadership changes to advance its pipeline of mental health therapeutics. Srinivas Rao, M.D., Ph.D., has become the sole Chief Executive Officer, while Kevin Craig, M.D. has been promoted to Chief Medical Officer, Glenn Short, Ph.D. to Chief Scientific Officer, and Gerd Kochendoerfer, Ph.D. has joined as Chief Operating Officer.
The company is at a important phase with VLS-01 and EMP-01 advancing into Phase 2 clinical trials. VLS-01 is currently screening patients, and the company anticipates mid-year Phase 2b data readout for Beckley Psytech's BPL-003, marking a significant step toward developing commercially scalable short-duration psychedelic therapies for treatment-resistant depression.
Each new leader brings substantial expertise: Dr. Craig has over 20 years of clinical experience, Dr. Short possesses more than 20 years of industry experience, and Dr. Kochendoerfer contributes 25+ years of pharmaceutical and biotech leadership experience.
atai Life Sciences (NASDAQ: ATAI) reported Q3 2024 financial results and pipeline updates. The FDA cleared the IND for VLS-01 (buccal film DMT) for treatment-resistant depression, with Phase 2 study initiation expected around YE'24. The company plans to initiate Phase 2 study of EMP-01 (oral R-MDMA) for social anxiety disorder around YE'24. Q3 net loss was $26.3M, with cash position at $101.0M. R&D expenses were $12.4M, down from $13.3M year-over-year, while G&A expenses decreased to $10.3M from $13.6M. The company expects current funding to support operations into 2026.
atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on transforming mental health disorder treatments, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The event is scheduled from October 15 – 17, 2024.
Key details of atai's involvement include:
- Participant: Srinivas Rao, M.D., Ph.D., Co-founder and Co-CEO
- Format: Virtual fireside chat
- Date: Wednesday, October 16, 2024
- Presentation Time: 3:30 P.M. EDT
A webcast registration link is provided, and an archived replay will be available on the Investors section of atai's website under Events for up to 30 days after the presentation.
atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health disorders, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference in New York, NY from September 9-11, 2024. The company's management team will engage in a fireside chat on Tuesday, September 10 at 4:30 P.M. EDT, along with 1x1 investor meetings.
Investors can access the fireside chat via a provided webcast link, and an archived replay will be available on the company's website for up to 90 days. This participation offers atai an opportunity to showcase its progress and strategies in transforming mental health treatment to a global investment audience.
atai Life Sciences (NASDAQ: ATAI) reported Q2 2024 financial results and corporate updates. Key highlights:
- Positive Phase 1b results for VLS-01 (buccal film DMT) in treatment-resistant depression
- Plans to initiate Phase 2 studies for VLS-01 and EMP-01 (oral R-MDMA) around year-end 2024
- Cash and securities of $103.3 million as of June 30, 2024
- Funding expected to last into 2026
- R&D expenses decreased to $12.6 million from $15.5 million year-over-year
- G&A expenses decreased to $13.4 million from $16.6 million year-over-year
- Net loss of $57.3 million, up from $33.0 million in Q2 2023
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.
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