Veru to Report Fiscal 2025 First Quarter Financial Results on February 13, 2025

Core Viewpoint - Veru Inc. is advancing its clinical development of enobosarm, a selective androgen receptor modulator, aimed at preserving muscle mass and enhancing fat loss in elderly patients with sarcopenic obesity, particularly those receiving GLP-1 receptor agonists for weight loss [4][10][12]. Company Updates - Veru Inc. will host a conference call on February 13, 2025, to discuss its fiscal 2025 first quarter financial results and provide a business update [1]. - The company plans to request an end of Phase 2 meeting with the FDA following positive topline results from the Phase 2b QUALITY clinical trial [9]. Clinical Trial Insights - The Phase 2b QUALITY clinical trial involved 168 patients and evaluated the efficacy of enobosarm in preserving lean body mass and promoting fat loss [3]. - The trial met its primary endpoint, showing a 71% relative reduction in lean mass loss for patients receiving enobosarm with semaglutide compared to placebo [4]. - Enobosarm 3mg combined with semaglutide demonstrated a >99% mean relative reduction in lean mass loss, while the 6mg dose did not show additional benefits [4]. Secondary Endpoint Results - Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo at the 6mg dose [5]. - The composition of weight loss shifted significantly, with enobosarm + semaglutide leading to 90.6% fat loss compared to 68% in the placebo group [5]. Physical Function Assessment - The Stair Climb Test indicated that 54.4% of patients on enobosarm + semaglutide experienced a significant reduction in the decline of physical function compared to those on placebo [6]. Safety and Future Studies - Safety data from the ongoing extension study remains blinded, with no significant differences noted compared to previous studies of enobosarm [8]. - The complete safety data will be available after the Phase 2b extension study concludes in April 2025 [8]. Market Potential - The market for sarcopenic obesity is substantial, with 22% of the US population over 60 years old and 42% of older adults classified as obese [10]. - Up to 34% of obese patients over 60 may have sarcopenic obesity, highlighting the need for effective treatments [10].