ATAI Life Sciences(US:ATAI) Globenewswire·2025-12-11 12:00Core Viewpoint - Atai Beckley N.V. has received a new patent for EMP-01 (oral R-MDMA), enhancing its intellectual property and exclusivity until 2043, which supports its mission to develop innovative mental health treatments [1][2][3] Group 1: Patent Details - The newly granted U.S. patent No. 12,492,178 covers the drug substance of EMP-01, which is a highly-crystalline, thermodynamically stable HCl salt form of (R)-MDMA, offering high aqueous solubility and low hygroscopicity [2] - This patent protects critical attributes of EMP-01, aiding in formulation development, drug product manufacture, and storage [2] Group 2: Company Strategy and Pipeline - The CEO of Atai Beckley emphasized the importance of EMP-01 in the company's pipeline and the patent's role in advancing the program while providing value to patients and shareholders [3] - Atai Beckley is expanding its global patent portfolio to support clinical development and potential commercialization of its therapies [3] Group 3: EMP-01 Overview - EMP-01 is an oral formulation of R-MDMA that has shown a unique, dose-dependent subjective effect profile, more similar to classical psychedelics than to racemic MDMA [4] - Social anxiety disorder (SAD) affects approximately 18 million people in the U.S., with no novel treatments approved in over two decades, highlighting the unmet medical need [4] - The company is currently enrolling patients for a Phase 2 study to evaluate the safety, tolerability, and efficacy of EMP-01 in adults with SAD, with topline data expected in Q1 2026 [4] Group 4: Company Background - Atai Beckley is a clinical-stage biopharmaceutical company formed from the merger of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025, focusing on mental health treatments [5] - The company's pipeline includes therapies for treatment-resistant depression and opioid use disorder, aiming to create effective and scalable psychiatric interventions [5]