Core Viewpoint - Veru Inc. has received regulatory clarity from the FDA regarding enobosarm, a selective androgen receptor modulator, as a muscle preservation drug candidate in combination with GLP-1 RA for obesity treatment, allowing incremental weight loss as an acceptable primary endpoint for approval [2][3][5]. Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases, with enobosarm and sabizabulin as key drug candidates [9]. FDA Meeting Highlights - The FDA has indicated that incremental weight loss with enobosarm added to GLP-1 RA treatment is an acceptable primary endpoint for approval [2]. - Enobosarm 3mg has been confirmed as an acceptable dosage for future clinical development [2]. - The FDA has encouraged the expansion of the enobosarm development program to include younger populations with obesity [2]. Clinical Development Program - The Phase 2b PLATEAU clinical study will evaluate the effect of enobosarm 3mg on total body weight, physical function, and safety in approximately 180 older and younger patients initiating tirzepatide treatment for weight reduction [6][8]. - The primary efficacy endpoint is the percent change from baseline in total body weight at 72 weeks, with key secondary endpoints including total fat mass, total lean mass, and physical function [7]. Phase 2b QUALITY Study Insights - The Phase 2b QUALITY study demonstrated that enobosarm treatment preserved lean mass and improved physical function while leading to greater fat loss during the 16-week active weight loss period [3][10]. - Enobosarm monotherapy was able to prevent weight regain by 46% after discontinuation of semaglutide, resulting in greater fat loss compared to the placebo group [3]. Weight Loss Plateau Context - The weight loss plateau occurs when patients on GLP-1 RA stop losing weight; approximately 88% of patients in the SURMOUNT-1 study reached this plateau by 72 weeks [4]. - Combining tirzepatide with enobosarm is expected to lead to additional fat loss by preserving muscle and physical function, particularly in older patients [4].

Core Insights - The company reported positive efficacy and safety data from the Phase 2b QUALITY study, indicating that enobosarm combined with semaglutide led to muscle preservation, increased fat loss, and fewer gastrointestinal side effects compared to semaglutide alone [1][3] - The Phase 2b Maintenance Extension study showed that enobosarm significantly reduced body weight regain and fat regain while preserving lean mass after discontinuation of semaglutide [1][7] - A novel modified release oral formulation of enobosarm has been selected for further clinical studies following a pharmacokinetic clinical study [1][9] Clinical Development - The Phase 2b QUALITY study involved 168 older patients (≥60 years) and demonstrated that the 3mg enobosarm dose preserved 100% of total lean mass compared to placebo + semaglutide at 16 weeks (p<0.001) [4][8] - Enobosarm treatment resulted in a 42% greater relative loss of fat mass with the 6mg dose compared to placebo + semaglutide at 16 weeks (p=0.017) [4][8] - The study found that 44.8% of the placebo + semaglutide group experienced at least a 10% decline in stair climb power, indicating a risk of physical function loss [5][8] Safety and Efficacy - Enobosarm plus semaglutide treatment maintained similar mean body weight loss as semaglutide alone while preserving lean mass [4][7] - The enobosarm 3mg monotherapy significantly reduced body weight regain by 46% after semaglutide discontinuation [8] - The safety profile of enobosarm was positive, with no gastrointestinal side effects or evidence of drug-induced liver injury observed [8][9] Financial Overview - As of June 30, 2025, the company reported cash, cash equivalents, and restricted cash of $15.0 million, down from $24.9 million as of September 30, 2024 [12][19] - Research and development expenses decreased to $3.0 million from $4.8 million year-over-year [15][21] - The net loss from continuing operations decreased to $7.3 million, or $0.50 per share, compared to $10.3 million, or $0.71 per share in the previous year [15][22]

Core Insights - Veru Inc. has selected a novel modified release oral formulation of enobosarm for chronic weight loss management after confirming pharmacokinetic endpoints in a clinical study [1][2] - The new formulation aims to improve the pharmacokinetic profile of enobosarm, including reduced maximum plasma concentration and delayed time to maximum plasma concentration [2][3] - The formulation is protected by a robust patent estate, with existing patents extending through 2037 and new applications potentially extending to 2046 [3] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases, with enobosarm and sabizabulin as key drug candidates [4] - Enobosarm is a selective androgen receptor modulator being developed to enhance fat loss while preserving lean mass, particularly in older patients [4][5] Clinical Development - The Phase 2b QUALITY clinical study showed positive results for enobosarm in augmenting fat loss and preventing muscle loss in older patients receiving semaglutide [5][6] - The maintenance extension study confirmed that enobosarm significantly reduced body weight regain and preserved lean mass after discontinuation of semaglutide [6][7] - The company has been granted an FDA meeting to discuss its Phase 3 program for enobosarm [8] Collaboration and Technology - The novel formulation was developed in collaboration with Laxxon Medical, utilizing proprietary SPID-Technology for advanced oral delivery profiles [3][4] - Laxxon Medical is recognized for its innovative drug delivery systems and holds a significant patent portfolio, enhancing the commercialization potential of the new formulation [9][10][12]

Core Viewpoint - Veru Inc. is implementing a 1-for-10 reverse stock split to regain compliance with Nasdaq's minimum bid price requirement of $1.00, which was approved by shareholders on July 25, 2025 [3]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 11:59 pm CT on August 8, 2025, with trading on a split-adjusted basis starting on August 11, 2025 [1]. - All outstanding stock options and equity incentive plans will be proportionally affected, with every 10 shares converting into 1 share without changing the par value of $0.01 per share [2]. - No fractional shares will be issued; shareholders will receive cash payments for any fractional shares [2]. Group 2: Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [6]. - The company's drug development includes enobosarm, a selective androgen receptor modulator aimed at improving body composition, and sabizabulin, a microtubule disruptor for treating inflammation in cardiovascular disease [6].

Core Viewpoint - Veru Inc. is preparing to discuss its fiscal 2025 third quarter financial results and provide a business update during a conference call on August 12, 2025 [1] 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 Obesity Program - Enobosarm is being developed as a next-generation drug to enhance fat loss while preserving lean mass, making weight reduction more tissue-selective when used with GLP-1 RA drugs [4] - The Phase 2b QUALITY clinical study showed positive topline and safety results, evaluating enobosarm in older patients receiving semaglutide for chronic weight management [4][5] - The study confirmed that enobosarm significantly reduced body weight regain and preserved lean mass after discontinuation of semaglutide treatment [6] Clinical Trials and FDA Interaction - The company has been granted a meeting with the FDA to discuss its Phase 3 program for enobosarm [7]

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]

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 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 [2] - Positive topline and safety results were announced from the Phase 2b QUALITY clinical study, which involved 168 older patients (≥60 years) receiving semaglutide for chronic weight management [3] - The Phase 2b extension study will evaluate whether enobosarm can prevent fat regain after stopping GLP-1 RA treatment, with topline results expected in Q2 2025 [3] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [4][5] - The drug has shown broad anti-inflammatory activity in previous clinical studies, with a safety database consisting of 266 dosed patients [4][5] - The company plans to submit a new IND for sabizabulin's proposed indication by the first half of 2026 [6] Market Opportunity - The decision to explore sabizabulin for atherosclerotic cardiovascular disease is based on the large global market opportunity and the high probability of success due to its mechanism of action being similar to colchicine [5] - The company aims to assess the progression of coronary atherosclerosis using coronary CT angiography imaging as a primary endpoint in a small Phase 2 proof of concept study [5]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company is advancing its lead program, Enobosarm, which is in the Phase 2b QUALITY study, aimed at improving body composition and physical function in obesity treatment [2][3] - The Virtual Investor KOL segment features discussions on obesity treatment, GLP-1s, and the unmet needs in the current treatment landscape [2] Company Overview - Veru's drug development program includes two late-stage novel small molecules: Enobosarm and Sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) designed to enhance weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss while preserving lean mass [3] - Sabizabulin is being developed as a microtubule disruptor for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Development - The Phase 2b QUALITY study of Enobosarm aims to provide topline clinical data that could inform future Phase 3 studies [2][4] - Discussions in the Virtual Investor segment highlight the potential of Enobosarm to help prevent fat regain and improve outcomes for obesity patients [2][4] - The company is also exploring the development of a modified-release formulation of Enobosarm, with plans for a Phase 1 study [4][5]

Core Insights - Veru Inc. announced positive topline efficacy data from the Phase 2b QUALITY study, which demonstrated that enobosarm in combination with GLP-1 receptor agonists can lead to selective fat loss while preserving lean mass [3][4][8] - The company plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program, expected to provide regulatory clarity [2][11] - Financial results for the second quarter of fiscal 2025 showed a decrease in net loss compared to the previous year, indicating improved financial performance [27][34] Clinical Development - The Phase 2b QUALITY study showed a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide [4] - The enobosarm 3mg + semaglutide combination resulted in a >99% mean relative reduction in lean mass loss, outperforming the 6mg dose [4] - The ongoing Phase 2b extension maintenance study aims to evaluate the effects of stopping GLP-1 receptor agonist treatment while continuing enobosarm [10] Safety and Efficacy - Unblinded safety data from the Phase 2b QUALITY study is expected to be released soon, with no significant safety concerns reported so far [9] - The treatment with enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [5] - Enobosarm treatment preserved lean mass, leading to a shift in body composition towards greater fat loss [5][8] Financial Performance - For the second quarter of fiscal 2025, research and development expenses increased to $3.9 million from $3.0 million, while selling, general, and administrative expenses decreased to $5.2 million from $5.9 million [27] - The net loss from continuing operations decreased to $7.9 million, or $0.05 per share, compared to $8.7 million, or $0.06 per share in the previous year [27][34] - Cash and cash equivalents were reported at $20.0 million as of March 31, 2025, down from $24.9 million as of September 30, 2024 [24] Future Plans - The company is developing a novel modified release oral formulation of enobosarm, expected to enter Phase 1 bioavailability clinical trials in the first half of 2025 [14] - A Phase 3 clinical program is planned, focusing on older patients with obesity or overweight, assessing the effect of enobosarm on physical function and body composition [12][21] - Veru is exploring the clinical development of sabizabulin for treating inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [15][19]

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]