Veru to Participate in the BTIG Virtual Biotechnology Conference

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle, weight loss, oncology, and viral-induced acute respiratory distress syndrome (ARDS) [4][8] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [8] Enobosarm Clinical Trials - A Phase 2b clinical trial is underway to evaluate the safety and efficacy of enobosarm at doses of 3mg and 6mg, or placebo, in approximately 150 patients with sarcopenic obesity or overweight elderly patients receiving semaglutide (Wegovy®) [1][17] - 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 [1] - Following the initial trial, participants will enter a Phase 2b extension trial to assess whether enobosarm can maintain muscle and prevent fat and weight gain after discontinuing GLP-1 RA [5] Market Context - According to the CDC, 41.5% of older adults in the U.S. have obesity, with 34.4% of these patients over 60 years old suffering from sarcopenic obesity [6] - This demographic is at risk for muscle loss when taking GLP-1 RA medications, which may lead to frailty and increased mortality [6] Enobosarm's Mechanism and Previous Studies - 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 adults and cancer patients [7][16] - The expectation is that enobosarm, in combination with GLP-1 RA, could enhance fat reduction and total weight loss while preserving muscle mass [7] Safety Profile - Enobosarm has a large safety database from 27 clinical trials involving 1581 participants, indicating it is generally well tolerated with no significant gastrointestinal side effects [16]