Veru to Report Fiscal 2024 Third Quarter Financial Results on August 8, 2024

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle during weight loss, oncology, and viral-induced acute respiratory distress syndrome [8] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [8] Enobosarm Clinical Trials - Enobosarm is being evaluated in a Phase 2b clinical trial to preserve muscle and augment fat loss in approximately 150 patients with sarcopenic obesity or overweight elderly patients receiving semaglutide [3] - The primary endpoint of the trial is total lean body mass, with key secondary endpoints including total body fat mass and physical function measured by stair climb test at 16 weeks [3] - Topline clinical results from the Phase 2b trial are expected by the end of calendar year 2024, followed by a Phase 2b extension trial to assess muscle maintenance after discontinuation of GLP-1 RA [4] Sarcopenic Obesity Context - In the U.S., 41.5% of older adults have obesity, with up to 34.4% of these patients over 60 years old suffering from sarcopenic obesity [5] - Sarcopenic obesity patients are at risk of muscle loss when taking GLP-1 RA medications, which can lead to frailty and increased mortality [5] Enobosarm's Mechanism and Safety - Enobosarm is a selective androgen receptor modulator (SARM) that has shown dose-dependent increases in muscle mass and reductions in fat mass in previous studies involving older patients [6][7] - The safety database for enobosarm includes 27 clinical trials with 1581 participants, indicating it is generally well tolerated with no significant gastrointestinal side effects [7] Future Development Plans - The company plans to conduct a Phase 3 ENABLAR-2 clinical trial of enobosarm in combination with abemaciclib for treating AR+ and ER+ metastatic breast cancer, subject to funding availability [9] - Sabizabulin is being developed for hospitalized patients with viral-induced ARDS, with further development contingent on securing external funding [10]