NOTE 16 – SUBSEQUENT EVENTS

Subsequent to September 30, 2026, the Company sold 0.3 million shares of common stock under the 2025 Sales Agreement, for net proceeds of approximately $1.5 million.

On October 1, 2026, the Company 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, which are listed in the Orange Book for TONMYA, are invalid, unenforceable and/or will not be infringed by its proposed product. The Company intends to commence patent infringement litigation against DRL within 45 days after receipt of the notice to enforce its patent rights and obtain a 30-month stay of FDA approval of DRL’s application, subject to applicable statutory exceptions and court orders. The Company cannot predict the outcome of this matter.

On October 30, 2026, the Company appointed George Lederman, PhD, as Executive Vice President, Strategy and Transformation. Dr. Lederman is the son of Seth Lederman, MD, the Company’s President and Chief Executive Officer. His appointment was reviewed and approved by the independent members of the Company’s Board of Directors and Audit Committee in accordance with the Company’s related party transactions policy, and his compensation was reviewed and approved by the independent members of the Company’s Board of Directors and Compensation Committee.