Company Description
AtaiBeckley Inc. (NASDAQ: ATAI) is a clinical-stage biopharmaceutical and biotechnology company focused on developing mental health treatments. The company describes its mission as transforming patient outcomes by developing effective, rapid-acting and convenient mental health therapies. AtaiBeckley’s work centers on investigational treatments for conditions such as treatment-resistant depression, social anxiety disorder and opioid use disorder.
The company was formed through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025. Following this combination, the parent entity completed a redomiciliation from the Netherlands to the United States via Luxembourg, with all issued and outstanding ordinary shares of Atai Beckley N.V. exchanged on a one-for-one basis for newly issued shares of common stock of AtaiBeckley Inc., a Delaware corporation. The common stock continues to trade on Nasdaq under the symbol “ATAI.” AtaiBeckley has also announced that its common stock was added to the Nasdaq Biotechnology Index (NBI), reflecting its classification in the biotechnology and pharmaceutical space.
Core focus on mental health therapeutics
AtaiBeckley characterizes itself as a clinical-stage company, meaning its product candidates are in human clinical trials and have not yet received marketing approval. Its stated aim is to create new possibilities in mental health by providing interventional psychiatry therapies that are effective, commercially scalable and convenient, and that can integrate into existing healthcare systems. The company emphasizes rapid-acting treatments and short therapeutic or psychedelic experiences as important attributes for fitting into established in-clinic treatment paradigms.
The company’s disclosed pipeline of novel investigational therapies includes:
- BPL-003, a mebufotenin (5-MeO-DMT) benzoate nasal spray, being developed for treatment-resistant depression (TRD) and alcohol use disorder (AUD). BPL-003 is described as a patent-protected, proprietary intranasal formulation administered via a nasal spray device used in a previously approved drug product. It is designed to deliver rapid and durable antidepressant effects from a single dose with a short psychedelic duration. BPL-003 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for adult patients with TRD, following positive Phase 2b clinical data.
- VLS-01, a dimethyltryptamine (DMT) buccal film for TRD, which is in a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial known as Elumina. This trial evaluates repeated doses of VLS-01 in patients with treatment-resistant depression.
- EMP-01, an oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD). EMP-01 is described as an oral formulation of R-MDMA that showed a unique, dose-dependent subjective effect profile in a Phase 1 trial, reported as more similar to classical psychedelics than to racemic MDMA. AtaiBeckley has highlighted an exploratory Phase 2a study of EMP-01 in adults with social anxiety disorder.
All three of these programs are described as being in Phase 2 clinical development. AtaiBeckley also reports that it is advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2A or 5-HT2A/2C receptor agonists for opioid use disorder and treatment-resistant depression. The company has disclosed that novel 5-HT2A receptor agonists with non-hallucinogenic potential have been discovered and are being further optimized and tested in animal models to assess therapeutic potential.
Key clinical programs and regulatory designations
BPL-003 is a central program for AtaiBeckley. The company has reported positive topline results from an eight-week, quadruple-masked, dose-finding Phase 2b core study in TRD, where single 8 mg and 12 mg doses of BPL-003 demonstrated statistically significant and clinically meaningful reductions in depressive symptoms compared to a 0.3 mg low-dose active control, with effects observed out to Week 8. An open-label extension (OLE) study of the same Phase 2b trial evaluated a second 12 mg dose administered eight weeks after the initial dose, regardless of the initial dose level. According to AtaiBeckley, the second dose was generally well-tolerated and produced additional clinically meaningful antidepressant effects that were sustained for up to two months.
The company has also described positive open-label Phase 2a data for BPL-003 in TRD, including improved antidepressant effects with a two-dose induction regimen. Safety findings across studies have been reported as generally consistent with prior BPL-003 studies and with other psychedelic-class therapies, with most adverse events occurring on the day of dosing and classified as mild or moderate and transient. AtaiBeckley has indicated that average time to readiness-for-discharge criteria in the Phase 2b program was within a short time window after dosing, which the company views as supportive of integration into existing interventional psychiatry treatment paradigms.
For VLS-01, AtaiBeckley has described ongoing Phase 2 development in TRD, including enrollment in the United States and expansion of clinical sites into Australia and the United Kingdom for the Elumina trial. For EMP-01, the company has reported completion of enrollment in an exploratory, randomized, double-blind, placebo-controlled Phase 2a study in adults with social anxiety disorder. In addition, AtaiBeckley has announced that the United States Patent and Trademark Office granted a U.S. patent (No. 12,492,178) covering EMP-01 (oral R-MDMA), including claims to a highly-crystalline, thermodynamically stable HCl salt form of (R)-MDMA with attributes described as beneficial for formulation development, manufacturing and storage. The company states that this patent is expected to provide exclusivity through 2043.
Drug discovery and external support
Beyond its clinical-stage assets, AtaiBeckley reports a discovery-stage program focused on non-hallucinogenic 5-HT2A/2C receptor agonists, sometimes referred to as neuroplastogens, for opioid use disorder and treatment-resistant depression. The company has disclosed that differentiated 5-HT2A receptor agonists with non-hallucinogenic potential have been identified based on preclinical drug discrimination studies, and that these compounds are being further optimized and evaluated in animal models.
AtaiBeckley has also announced external support for this work. The National Institute on Drug Abuse (NIDA), part of the U.S. National Institutes of Health (NIH), awarded the company a multi-year, milestone-driven grant to fund optimization and early-stage development of novel 5-HT2A/2C receptor agonists with non-hallucinogenic potential for opioid use disorder. The company presents this grant as supporting expansion of its innovation efforts in mental health therapeutics.
Corporate evolution and capital markets
AtaiBeckley’s current structure and name reflect a series of corporate steps. The company previously operated as ATAI Life Sciences N.V., a Dutch public company with limited liability. In connection with the acquisition of the entire issued share capital of Beckley Psytech Limited not already owned by atai, the company changed its name to Atai Beckley N.V. and later completed a redomiciliation process that resulted in AtaiBeckley Inc., a Delaware corporation, becoming the parent company. SEC filings describe the acquisition of Beckley Psytech as a share purchase transaction in which ordinary shares of atai were issued as consideration, and the redomiciliation as involving a merger step through Luxembourg and the exchange of ordinary shares for common stock of AtaiBeckley Inc.
AtaiBeckley has used public equity offerings and registration statements to support its operations and pipeline development. The company has filed shelf registration statements and prospectus supplements, completed underwritten public offerings of common shares, and registered shares for resale in connection with the Beckley Psytech acquisition and related registration rights. It has disclosed that proceeds from these offerings, together with existing cash and liquid assets, are intended to fund clinical development of BPL-003, VLS-01 and EMP-01, as well as its discovery programs and general corporate purposes.
Regulatory and exchange status
According to its SEC filings, AtaiBeckley’s common equity is listed on The Nasdaq Stock Market under the symbol ATAI. The company has reported that its stock was added to the Nasdaq Biotechnology Index, which includes securities classified as biotechnology or pharmaceutical under the Industry Classification Benchmark. There is no indication in the provided filings of delisting proceedings, deregistration filings such as Form 15-12G, or completed bankruptcy proceedings.
Business model and sector positioning
AtaiBeckley operates within the pharmaceutical preparation manufacturing and biotechnology segment, with a focus on clinical development of investigational therapies for mental health conditions. As a clinical-stage company, its activities as described in public disclosures center on research, clinical trials, regulatory interactions and intellectual property development rather than commercial product sales. The company’s programs target areas such as treatment-resistant depression, social anxiety disorder and opioid use disorder, which it characterizes as having significant unmet medical need.
AtaiBeckley emphasizes interventional psychiatry approaches, including intranasal and buccal delivery routes and short-duration psychedelic or psychedelic-like experiences, as potential ways to deliver rapid and durable symptom relief while fitting into existing healthcare infrastructure. The company also highlights patent protection and regulatory designations, such as FDA Breakthrough Therapy designation for BPL-003 and U.S. patent coverage for EMP-01, as important elements of its development and intellectual property strategy.
Frequently asked questions about AtaiBeckley Inc. (ATAI)
The following questions and answers summarize key points drawn from AtaiBeckley’s public disclosures.
What does AtaiBeckley Inc. do?
AtaiBeckley Inc. is a clinical-stage biopharmaceutical and biotechnology company focused on developing effective, rapid-acting and convenient mental health treatments. Its disclosed pipeline includes investigational therapies for treatment-resistant depression, social anxiety disorder and opioid use disorder, along with a discovery program for non-hallucinogenic 5-HT2A/2C receptor agonists.
How was AtaiBeckley formed?
AtaiBeckley was formed through a strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025. The combination involved atai acquiring the entire issued share capital of Beckley Psytech not already owned by atai, and the combined entity adopting the name Atai Beckley N.V. before later redomiciling to the United States as AtaiBeckley Inc.
What are AtaiBeckley’s main clinical programs?
The company’s main clinical programs are BPL-003, a mebufotenin benzoate nasal spray for treatment-resistant depression and alcohol use disorder; VLS-01, a DMT buccal film for treatment-resistant depression; and EMP-01, an oral R-MDMA formulation for social anxiety disorder. All three are described as being in Phase 2 clinical development.
What is BPL-003 and why is it significant?
BPL-003 is a proprietary intranasal formulation of mebufotenin benzoate (5-MeO-DMT) delivered via a nasal spray device used in a previously approved drug product. AtaiBeckley reports that BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short psychedelic duration. It has received FDA Breakthrough Therapy designation for adult patients with treatment-resistant depression, based on Phase 2b data showing clinically meaningful and statistically significant reductions in depressive symptoms.
What is VLS-01?
VLS-01 is a buccal film formulation of dimethyltryptamine (DMT) being evaluated for treatment-resistant depression. AtaiBeckley has described a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial called Elumina, which assesses repeated doses of VLS-01 in patients with TRD across sites in the United States and other countries.
What is EMP-01?
EMP-01 is an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA) being developed for social anxiety disorder. The company notes that EMP-01 showed a distinct, dose-dependent subjective effect profile in a Phase 1 trial and that it is being studied in an exploratory Phase 2a trial in adults with social anxiety disorder. A U.S. patent covering EMP-01’s drug substance and a specific crystalline HCl salt form is expected, according to the company, to provide exclusivity through 2043.
Does AtaiBeckley have any discovery-stage programs?
Yes. AtaiBeckley reports a drug discovery program aimed at identifying novel, non-hallucinogenic 5-HT2A or 5-HT2A/2C receptor agonists for treatment-resistant depression and opioid use disorder. The company has stated that it has discovered differentiated 5-HT2A receptor agonists with non-hallucinogenic potential and is optimizing these compounds and testing them in animal models.
What regulatory milestones has AtaiBeckley reported?
The company has disclosed that BPL-003 received FDA Breakthrough Therapy designation for treatment-resistant depression. It has also reported scheduling an End-of-Phase 2 meeting with the FDA for BPL-003 to discuss Phase 3 development plans. In addition, AtaiBeckley has highlighted the grant of a U.S. patent for EMP-01 and the award of a NIDA grant supporting its 5-HT2A/2C agonist program.
Where is AtaiBeckley listed?
AtaiBeckley’s common equity trades on The Nasdaq Stock Market under the symbol ATAI. The company has announced that its stock has been included in the Nasdaq Biotechnology Index, which tracks biotechnology and pharmaceutical companies listed on Nasdaq.
Is AtaiBeckley a commercial-stage company?
Based on its public disclosures, AtaiBeckley describes itself as a clinical-stage company. Its primary activities involve clinical trials, regulatory interactions, research and development, and intellectual property work rather than the commercial sale of approved products.