Tonix Pharmaceuticals Holding Corp.

On October 1, 2026, we received a paragraph IV certification notice from Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “DRL”) regarding an abbreviated new drug application seeking FDA approval of a generic version of TONMYA (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg. DRL alleges that U.S. Patent Nos. 9,636,408, 9,956,188, 10,117,936 and 10,864,175 (the “TONMYA Patents”), which are listed in the Orange Book for TONMYA, are invalid, unenforceable and/or will not be infringed by its proposed product. We intend to commence patent infringement litigation against DRL within 45 days after receipt of the notice to enforce our patent rights and obtain a 30-month stay of FDA approval of DRL’s application, subject to applicable statutory exceptions and court orders. We cannot predict the outcome of this matter. See Part II, Item 1A, “Risk Factors,” for the risks associated with DRL’s patent challenge and potential generic competition.