On October 1, 2026, Tonix Pharmaceuticals Holding Corp. (the "Company") received a notice (the "Notice") from Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, "DRL") stating that DRL filed an Abbreviated New Drug Application ("ANDA") containing a Paragraph IV patent certification with the U.S. Food and Drug Administration ("FDA") for a generic version of the Company’s drug, TONMYA® (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg. The Notice states that the Paragraph IV patent certification was made with respect to U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175 listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. A Paragraph IV patent certification is a certification by a generic applicant that, in the opinion of that applicant, the patent listed in the Orange Book for a branded product is invalid, unenforceable, or will not be infringed by the manufacture, use or sale of the generic product. Under the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations, the filing of a patent infringement lawsuit within 45 days of the receipt of notice of a Paragraph IV patent certification automatically prevents the FDA from approving the ANDA until the earliest of the expiration of a 30-month period beginning on the receipt of the Notice by the patent owner, the expiration of the patents, the entry of a settlement order or consent decree stating that the patents are invalid or not infringed, a decision in the infringement case that is favorable to the ANDA applicant, or such shorter or longer period as the court may order. The Company intends to vigorously enforce its intellectual property rights relating to TONMYA against infringement, but cannot predict the outcome of this matter or guarantee the outcome of any litigation. TONMYA is protected by four patents, all of which are listed in the Orange Book.