Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [1] - The company announced multiple presentations at the SCWD 18 International Conference and the Regulatory Workshop in Rome, Italy [1] Presentation Details - Mitchell Steiner, Veru Inc.'s Chairman, President & CEO, will present "The Veru Experience" on December 12, 2025, from 4:30 pm to 4:45 pm Central European Time [2] - Another presentation by Mitchell Steiner titled "Enobosarm" will take place on December 13, 2025, from 10:00 am to 10:15 am Central European Time [2] Regulatory Workshop Insights - The Regulatory Workshop will cover treatment approaches to address muscle wasting in obesity therapy, including comments from industry representatives and regulatory considerations from EMA and FDA [3] - A discussion on possible endpoints for regulatory approval of treatments addressing muscle wasting will also be held, featuring various industry approaches including Veru's [4][5] Drug Development Focus - Veru's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [6] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction while preserving lean mass during GLP-1 RA treatment [6] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [6] Clinical Study Updates - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass in older patients [7] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [8] - The primary efficacy endpoint for the PLATEAU study is the percent change from baseline in total body weight at 72 weeks, with an interim analysis at 36 weeks [8][9]

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue selective for fat loss while preserving lean mass [3] - The Phase 2b QUALITY clinical trial demonstrated a statistically significant 71% relative reduction in lean mass loss for patients receiving enobosarm combined with semaglutide compared to placebo [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass [5] - Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [6] - The median total body weight loss in the enobosarm + semaglutide group was 90.6% fat loss compared to 68% in the placebo + semaglutide group, indicating a shift towards greater fat loss [6] Physical Function and Safety - The Stair Climb Test indicated that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% mean relative reduction in this decline [8] - Safety data for the Phase 2b QUALITY study remains blinded, with no significant differences noted compared to previous studies of enobosarm [9] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, with a safety database consisting of 266 dosed patients [13] - A Phase 2 dose-finding proof of concept study is planned to assess the drug's efficacy in reducing inflammation associated with coronary artery disease [15]