Summary
AtaiBeckley advances clinical pipeline, strengthens balance sheet in Q3
AtaiBeckley NV (NASDAQ:ATAI, ETR:9VC) reported continued clinical and operational progress during the third quarter of 2025, advancing multiple programs targeting treatment-resistant depression (TRD) and other mental health conditions. During the quarter, the company's lead candidate BPL-003, a mebufotenin (5-MeO-DMT) benzoate nasal spray, was granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) for TRD.
Atai Beckley N.V. (ATAI) Discusses BPL-003 Phase IIb Open-Label Extension Study Results in Treatment Resistant Depression Transcript
Atai Beckley N.V. ( ATAI ) Discusses BPL-003 Phase IIb Open-Label Extension Study Results in Treatment Resistant Depression November 10, 2025 8:00 AM EST Company Participants Ashleigh Barreto Srinivas Rao - Co-Founder, CEO & Executive Director Kevin Craig - Chief Medical Officer Robert Conley - Chief Research & Development Officer Conference Call Participants Lin Tsai - Jefferies LLC, Research Division Ritu Baral - TD Cowen, Research Division Pete Stavropoulos - Cantor Fitzgerald & Co., Research Division Harry Gillis - Joh.
AtaiBeckley reports positive data supporting repeated dosing of BPL-003 in treatment-resistant depression patients
AtaiBeckley NV (NASDAQ:ATAI, ETR:9VC) has unveiled positive topline results from the open-label extension (OLE) study of its Phase 2b clinical trial evaluating BPL-003 in patients with treatment-resistant depression (TRD). The company said that a 12 mg dose of BPL-003 (mebufotenin benzoate nasal spray) administered eight weeks after an initial 0.3 mg, 8 mg, or 12 mg dose produced additional rapid and clinically meaningful antidepressant effects that were sustained for up to eight weeks.
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Atai Life Sciences N.V. Profile
| Pharmaceuticals Industry | Healthcare Sector | Srinivas G. Rao CEO | NASDAQ (NMS) Exchange | N0731H103 CUSIP |
| NL Country | 54 Employees | - Last Dividend | - Last Split | - IPO Date |
Overview
Atai Life Sciences N.V. is a pioneering clinical-stage biopharmaceutical company aimed at revolutionizing the treatment of mental health disorders including depression, anxiety, addiction, and more. Established in 2018, with its roots in Berlin, Germany, and with additional offices in New York and London, Atai Life Sciences is pushing the boundaries of traditional mental health treatment modalities by investing in and developing a wide array of therapeutics. Their mission extends towards addressing the unmet needs in mental health care through a strongly differentiated and diversified portfolio of treatments, embarking on a journey to mitigate the global mental health crisis.
Products and Services
- COMP360 (Psilocybin)
- BPL-003 (Intranasal Formulation)
- TRD
- VLS-01
- ELE-101
- IBX-210
- DMX-1002
- EMP-01
- EGX-A and EGX-B
- RL-007
- GRX-917
- PCN-101 (R-Ketamine)
- KUR-101 (Deuterated Mitragynine)
- RLS-01
A proprietary formulation of psilocybin, currently in a Phase 3 clinical program, focusing on its potential therapeutic effects for mental health disorders.
An innovative intranasal formulation of betahistine in active Phase 2a and 2b clinical studies aimed at treating vertigo with lesser side effects and improved patient outcomes.
A therapeutic under development, details unspecified, targeting treatment-resistant depression.
A transmucosal film in Phase 1b clinical studies targeted at delivering therapeutic agents effectively for mental health conditions.
A serotonergic psychedelic in Phase 1/2a study aimed at treating treatment-resistant depression, showcasing the potential of psychedelics in mental health therapy.
An intravenous formulation of ibogaine under development for treating opioid use disorder, addressing the critical need for effective addiction therapies.
An oral formulation of ibogaine indicated for the treatment of opioid use disorder, exploring a different administration route for ibogaine's therapeutic effects.
An oral formulation of an R-MDMA derivative being developed for post-traumatic stress disorder, expanding the therapeutic options for PTSD.
Psychotropic substances with novel, non-tryptamine structures offering differentiated 5-HT receptor pharmacology, aiming at unique mental health treatment pathways.
An orally bioavailable compound acting as a pro-cognitive neuromodulator, under investigation for the cognitive impairment associated with schizophrenia.
A deuterated version of etifoxine designed for the treatment of generalized anxiety disorder, highlighting an approach to minimize anxiety with potentially reduced side effects.
A subcutaneous formulation of R-ketamine focused on psychiatric indications initially targeting treatment-resistant depression, demonstrating the therapeutic versatility of ketamine.
A formulation of deuterated mitragynine under development for the treatment of opioid use disorder, reflecting on the need for innovative addiction treatments.
Indicated for treatment-resistant depression, RLS-01 represents Atai's dedication to finding solutions for those who haven't responded to existing treatments.
Contact Information
