Atossa Therapeutics Responds to PTAB Ruling on U.S. Patent No. 11,572,334 and Announces the Issuance of U.S. Patent No. 12,201,591

Core Viewpoint - Atossa Therapeutics expresses disappointment over the Patent Trial and Appeal Board's (PTAB) decision to find all challenged claims in U.S. Patent No. 11,572,334 unpatentable, but the decision does not affect the formulations currently in clinical development [2][5] Patent Developments - Atossa will not appeal the PTAB decision due to cost and time considerations, and will instead focus on obtaining patent protection for its current formulations through a new Continuation Patent Application [2] - A new patent, U.S. Patent No. 12,201,591, was issued on January 21, 2025, covering sustained release compositions of endoxifen with 31 claims [3] - Atossa's patent estate includes several patents: U.S. Patent No. 11,261,151 (21 claims), U.S. Patent No. 11,680,036 (22 claims), U.S. Patent No. 12,071,391 (44 claims), and the newly issued U.S. Patent No. 12,201,591 (31 claims), providing a comprehensive coverage for its formulations [4] Product Development - Atossa is developing a proprietary oral formulation of (Z)-endoxifen designed to bypass stomach acidity, which can convert a significant portion of (Z)-endoxifen to an inactive form [6] - (Z)-endoxifen has shown good tolerability in Phase 1 studies and is currently being evaluated in five Phase 2 trials targeting various breast cancer conditions [6] - The company aims to provide better treatment options for breast cancer patients through its innovative (Z)-endoxifen formulations [5][7]