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].

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle during weight loss, oncology, and viral-induced acute respiratory distress syndrome [13] - The company's drug development program includes enobosarm and sabizabulin, with enobosarm being a selective androgen receptor modulator (SARM) [14][15] Clinical Trials and Results - The Phase 2b QUALITY clinical trial evaluated enobosarm in combination with semaglutide for preserving muscle and enhancing fat loss in 168 patients aged over 60 with sarcopenic obesity [3] - The trial met its primary endpoint, showing a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide at 16 weeks (p=0.002) [4] - Enobosarm 3mg + semaglutide demonstrated a >99% mean relative reduction in lean mass loss (p <0.001), while the 6mg dose did not show superior results [4] - Secondary endpoints indicated that enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks (p=0.014) [5] - The treatment improved body composition, with 90.6% of weight loss in the enobosarm + semaglutide group attributed to fat loss compared to 68% in the placebo group [5] Physical Function and Safety - The Stair Climb Test showed that 54.4% of patients in the enobosarm + semaglutide group had a significant reduction in the proportion of subjects losing at least 10% stair climb power compared to the placebo group (p=0.004) [6] - Safety data remains blinded, but no significant differences have been observed compared to previous studies of enobosarm [7] - An Independent Data Monitoring Committee recommended continuing the study based on unblinded safety data [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 [9] - Up to 34% of obese patients over 60 may have sarcopenic obesity, which poses risks when using GLP-1 drugs for weight reduction [9][10] Future Plans - Following positive topline results, the company plans to request an end of Phase 2 meeting with the FDA [8]

Core Insights - The Phase 2b QUALITY clinical study demonstrated that enobosarm treatment significantly reduced lean mass loss and improved fat mass loss in older patients receiving WEGOVY [1][4][6] - Enobosarm treatment preserved muscle mass and physical function, addressing a critical need in older patients undergoing weight loss treatments [6][10] Study Design - The Phase 2b QUALITY clinical study was a multicenter, double-blind, placebo-controlled trial involving 168 older patients over 60 years of age, who are overweight or obese and receiving WEGOVY [3][14] - The primary endpoint was the change in total lean body mass from baseline to 16 weeks, with key secondary endpoints including total fat mass, total body weight, and physical function [3][14] Topline Results - Enobosarm treatment resulted in a 71% reduction in lean mass loss compared to WEGOVY alone (p=0.002) [1][4] - Patients on enobosarm lost 27% more fat mass than those receiving WEGOVY alone, although this result was not statistically significant (p=0.096) [1][4] - The study found that 54.5% fewer patients on enobosarm experienced a ≥10% decline in stair climb power compared to those on placebo [4][8] Safety and Regulatory Steps - Safety data remains blinded, but previous studies indicate enobosarm is generally well tolerated with no significant gastrointestinal side effects [7][19] - The company plans to meet with the FDA to discuss the design of the Phase 3 clinical program based on the positive topline results [10][11] Future Directions - The ongoing Phase 2b extension study will evaluate whether enobosarm can maintain muscle and prevent weight gain after discontinuing GLP-1 RA [9][14] - The anticipated Phase 3 trial will focus on older patients receiving GLP-1 RA, with stair climb power as the primary objective [11][12]

Group 1: Momentum Investing Overview - Momentum investing involves following a stock's recent trend, with the aim of buying high and selling higher, capitalizing on established price movements [1][2] - The Zacks Momentum Style Score helps investors identify stocks with strong momentum by evaluating various metrics [2][4] Group 2: Veru Inc. (VERU) Performance - Veru Inc. currently holds a Momentum Style Score of B and a Zacks Rank of 2 (Buy), indicating strong potential for outperformance [3][4] - Over the past week, VERU shares have increased by 24.76%, significantly outperforming the Zacks Medical - Products industry, which rose by only 0.59% [6] - In the last month, VERU's price change is 65.5%, compared to the industry's 1.4% [6] - Over the past quarter, VERU shares have risen by 35.81%, and over the last year, they have increased by 144.19%, while the S&P 500 has only moved 4.32% and 27.01%, respectively [7] Group 3: Trading Volume and Earnings Outlook - The average 20-day trading volume for VERU is 2,368,062 shares, indicating strong interest and potential bullish momentum [8] - In terms of earnings outlook, three earnings estimates for VERU have been revised upwards in the past two months, raising the consensus estimate from -$0.30 to -$0.26 [10] - For the next fiscal year, one estimate has moved upwards with no downward revisions, suggesting positive sentiment around future earnings [10] Group 4: Conclusion - Given the strong performance metrics and positive earnings outlook, VERU is positioned as a promising momentum pick for investors [12]

Group 1 - Veru Inc. reported a quarterly loss of $0.06 per share, better than the Zacks Consensus Estimate of a loss of $0.07, and improved from a loss of $0.16 per share a year ago, resulting in an earnings surprise of 14.29% [1] - The company posted revenues of $6.66 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 86.99%, and up from $3.86 million in the same quarter last year [2] - Over the last four quarters, Veru has surpassed consensus revenue estimates three times [2] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $3.18 million, and for the current fiscal year, it is -$0.29 on revenues of $12.78 million [8] - The Zacks Industry Rank for Medical - Products is in the top 33% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [9]

MIAMI, FL, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present at the at the 17th International Conference of the Society on Sarcopenia, Cachexia, & Wasting Disorders, taking place December 6-8, 2024, in Washington, DC. Presentation Name: The use of ...

MIAMI, FL, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced data from a meta-analysis presentation at ObesityWeek, which took place November 5, 2024, in San Antonio, Texas. Highlights from the presentation:The objective of the meta-analysis was to determine the effects of enob ...

MIAMI, FL, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present at ObesityWeek, taking place November 3-6, 2024, in San Antonio, Texas. Presentation Name: Meta-analysis of subjects from 4 randomized clinical trials supports the potential of enobosarm ...

MIAMI, FL, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present at the World Obesity and Weight Management Congress, taking place October 24-26, 2024, in Baltimore, Maryland. Keynote Presentation Name: Advancing enobosarm, an oral novel Selective Andr ...

MIAMI, FL, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will present a corporate update with a focus on the progress of Veru's Phase 2b clinical development program of enobosarm to augme ...