INVESTIGATOR’S AGREEMENTInvestigator Agreement • March 25th, 2025
Name of Sponsor/Company:Tonix Pharmaceuticals, Inc. Name of Investigational Product:TNX-601 ER (tianeptine hemioxalate extended-release tablets) Name of Active Ingredient:Tianeptine hemioxalate Title of Study:A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-601 ER Monotherapy versus Placebo in Patients with Major Depressive Disorder (MDD) Study center(s): Approximately 30 sites in the United States Study Population: Male and female patients aged 18 to 65 years (inclusive) with a diagnosis of MDD as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, currently suffering from a major depressive episode (MDE). Objectives:Primary:To evaluate the efficacy of TNX-601 ER (tianeptine hemioxalate extended-release tablets) monotherapy in the treatment of major depressive disorder (MDD)Secondary:To evaluate the safety and tolerability of TNX-601 ER (tianeptine hemio