Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [2] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [2] Enobosarm Obesity Program - Enobosarm is being developed as a next-generation drug to enhance fat loss while preserving lean mass, particularly in older patients receiving semaglutide for chronic weight management [3][4] - The Phase 2b QUALITY clinical study showed positive topline and safety results, with participants losing an average of 11.88 lbs during the active weight loss period [4] - After discontinuation of semaglutide, the placebo group regained 43% of lost body weight, while the enobosarm 3mg and 6mg groups regained only 1.41% (2.73 lbs) and 2.87% (5.29 lbs) respectively, demonstrating a significant reduction in weight regain [4][5] - Enobosarm monotherapy preserved more than 100% of lean mass compared to the placebo group, which experienced a loss of lean mass [5][6] Sabizabulin Atherosclerosis Inflammation Program - Sabizabulin is being explored for the treatment of inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [8][9] - The drug has shown broad anti-inflammatory activity in previous clinical studies, with a safety database consisting of 266 dosed patients [8][9] - The company believes that combining sabizabulin with statin therapy could effectively reduce inflammation and slow the progression of atherosclerotic cardiovascular disease [8][9] Upcoming Events - Veru Inc. will participate in one-on-one meetings and a fireside chat presentation with investors at the 2025 BTIG Virtual Biotech Conference on July 29-30, 2025 [1]

Core Insights - The Phase 2b QUALITY clinical study demonstrated that the combination of enobosarm and semaglutide has a positive safety profile, with fewer gastrointestinal side effects compared to semaglutide alone [1][3][4] - Enobosarm 3mg has been selected as the proposed oral dose for the upcoming Phase 3 clinical program based on the efficacy and safety data from the Phase 2b trial [1][8] - The combination treatment resulted in a highly selective loss of fat mass, with 99% of total weight lost attributed to fat, while preserving lean mass [1][14] Safety Profile - The Phase 2b QUALITY clinical trial showed no increases in gastrointestinal side effects or drug-induced liver injury compared to placebo [3][4] - Adverse events related to gastrointestinal issues were lower in the enobosarm + semaglutide group compared to the placebo + semaglutide group [4][6] - No serious adverse events related to treatment were observed, and all reported adverse events were mild and returned to baseline levels [3][4][6] Efficacy Results - The trial met its primary endpoint with a statistically significant reduction in lean mass loss, showing a 71% relative reduction in lean mass loss for enobosarm + semaglutide compared to placebo + semaglutide [9][14] - Enobosarm 3mg + semaglutide showed a 99.1% mean relative reduction in lean mass loss, while the 6mg dose did not provide additional benefits [9][11] - The treatment also demonstrated a significant reduction in the percentage of patients experiencing a decline in stair climb power, indicating improved physical function [17] Regulatory Steps - Following the positive results from the Phase 2b study, the company has requested an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program [1][16] - The proposed Phase 3 study will be a double-blind, placebo-controlled trial focusing on older patients with obesity or overweight, assessing the effects of enobosarm on physical function and body composition [19][20] Future Developments - The company is developing a novel modified release oral formulation of enobosarm, expected to enter Phase 1 bioavailability clinical trials in early 2025 [21] - The new formulation aims to be available for Phase 3 clinical studies and commercialization, with patent protection anticipated until 2045 [21]

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 Program - 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 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide at 16 weeks (p=0.002) [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass (p <0.001) [5] - Enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks (p=0.014) [6] - The median total body weight loss in the placebo + semaglutide group was 32% lean mass and 68% fat loss, while in the enobosarm + semaglutide group, it was 9.4% lean mass and 90.6% fat loss, indicating a 33.2% greater fat loss [6] - The study also found 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 (p=0.0049) [8] Sabizabulin Program - Sabizabulin is being explored for the treatment of inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, including Phase 2 and 3 pulmonary inflammation COVID-19 clinical studies [13] - The company plans to submit a new IND for sabizabulin in atherosclerotic coronary artery disease by the first half of calendar 2026 [14]