NEW YORK and AMSTERDAM, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced that the United States Patent and Trademark Office has granted a new patent covering EMP-01 (oral R-MDMA), further strengthening the company’s intellectual property estate and long-term exclusivity for the program.
The newly granted U.S. patent, No. 12,492,178, includes claims to the drug substance of EMP-01, and is expected to provide exclusivity through 2043. This patent identifies a highly-crystalline, thermodynamically stable HCl salt form of (R)-MDMA with high aqueous solubility and low hygroscopicity, form-specific attributes that are beneficial during formulation development, drug product manufacture, as well as drug substance and drug product storage. This patent protects critical drug substance attributes of EMP-01 and supports the company's strategy to develop innovative, differentiated therapies designed to address significant unmet needs in mental health.
“This patent grant reinforces the strength of our science and our long-term commitment to building durable, defensible innovation,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of AtaiBeckley. “EMP-01 is an important asset in our pipeline, and securing this patent issuance in the U.S. further strengthens our ability to advance the program while delivering meaningful value for patients and shareholders. We look forward to reporting topline data from the exploratory Phase 2a study evaluating EMP-01 in adults with social anxiety disorder in the first quarter of 2026.”
AtaiBeckley continues to expand its global patent portfolio across its pipeline to support clinical development, potential commercialization, and strategic flexibility as the company advances its mission to create new breakthroughs in mental health.
About EMP-01 (Oral R-MDMA)
EMP-01 is an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA) that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA. Anxiety disorders are the most common mental health disorders worldwide, affecting how one experiences worry, fear and anxiety in everyday situations. Social anxiety disorder (SAD) is an area of high unmet medical need with approximately 18 million people currently diagnosed in the United States and no novel molecules approved in over two decades. atai is currently enrolling patients into an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD. Topline data from the exploratory Phase 2a study is anticipated in the first quarter of 2026.
About AtaiBeckley N.V.
AtaiBeckley is a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments. It was formed through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (buccal film DMT) for TRD and EMP-01 ((R)-MDMA HCI) for social anxiety disorder, which are in Phase 2 clinical development. It is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new possibilities in mental health by providing effective, commercially scalable and convenient interventional psychiatry therapies that can integrate seamlessly into healthcare systems.
For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; the potential, success and timing of development and progress of trials and related milestones of our product candidates such as EMP-01; expectations regarding our intellectual property portfolio, including our newly granted patent and plans for expansion of our patent portfolio; and the plans and objectives of management for future operations, research and development and capital expenditures.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in AtaiBeckley’s other filings with the SEC. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.
Contact Information
Investor Contact:
IR@ataibeckley.com
Media Contact:
PR@ataibeckley.com
