AtaiBeckley Reports New U.S. Patent Granted for EMP-01, Strengthening Intellectual Property Position

NEW YORK and AMSTERDAM, Dec. 11, 2025 — Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biopharmaceutical company dedicated to transforming patient outcomes through the development of effective, rapid-acting, and accessible mental health treatments, today announced that the United States Patent and Trademark Office has granted a new patent covering EMP-01 (oral R-MDMA). This milestone further bolsters the company’s intellectual property portfolio and enhances long-term exclusivity for the program.

The newly issued U.S. patent, No. 12,492,178, includes claims related to the drug substance of EMP-01 and is anticipated to provide exclusivity through 2043. It identifies a highly crystalline, thermodynamically stable HCl salt form of (R)-MDMA characterized by high aqueous solubility and low hygroscopicity—form-specific properties that are advantageous during formulation development, drug product manufacturing, and the storage of both the drug substance and final product. This patent protects critical attributes of EMP-01’s drug substance and supports the company’s strategy to advance innovative, differentiated therapies targeting significant unmet mental health needs.

“Receiving this patent underscores the strength of our scientific foundation and our long-term commitment to building sustainable, defensible innovation,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of AtaiBeckley. “EMP-01 is a key asset in our pipeline, and securing this U.S. patent further strengthens our ability to advance the program while delivering meaningful value to patients and shareholders. We look forward to sharing 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 it pursues its mission to drive 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, in a Phase 1 trial, exhibited a unique, dose-dependent subjective effect profile generally found to be more akin to classical psychedelics than to racemic MDMA. Anxiety disorders are the most prevalent mental health conditions globally, influencing how individuals experience worry, fear, and anxiety in daily life. Social anxiety disorder (SAD) represents a significant unmet medical need, with approximately 18 million diagnosed cases in the United States and no new approved molecules in over two decades. Atai is currently enrolling patients in an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, and efficacy of EMP-01 in adults with SAD. Topline data from this exploratory Phase 2a study is expected in the first quarter of 2026.

About AtaiBeckley N.V.

AtaiBeckley is a clinical-stage biopharmaceutical company focused on transforming patient outcomes by developing effective, rapid-acting, and accessible mental health treatments. 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, all of which are in Phase 2 clinical development. The company 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 mental health solutions by delivering effective, commercially scalable, and accessible interventional psychiatry therapies that can integrate smoothly into healthcare systems.

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Forward-Looking Statements

This press release includes forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995, as amended. We intend these forward-looking statements to be covered by the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these terms. Forward-looking statements include, among others, statements regarding: our business strategy and plans; the potential, success, and timing of development, trial progress, and related milestones for product candidates like EMP-01; expectations for our intellectual property portfolio, including the newly granted patent and plans to expand it; and management’s plans and objectives for future operations, research and development, and capital expenditures.

Forward-looking statements are not guarantees of performance and involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected. These include, without limitation, the factors detailed in the “Risk Factors” section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), which may be updated in AtaiBeckley’s subsequent filings with the SEC. AtaiBeckley disclaims any obligation to update or revise the forward-looking statements in this press release, except as required by applicable law.

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