Veru (NasdaqCM:VERU) Q4 2025 Earnings Call December 17, 2025 08:00 AM ET Company ParticipantsRohan Mathur - Biopharma Equity Research AssociateMichele Greco - Chief Financial Officer and Chief Administrative OfficerMitchell Steiner - Chairman, CEO and PresidentSam Fisch - Executive Director of Investor Relations and Corporate CommunicationsConference Call ParticipantsNone - AnalystWilliam Wood - Research AnalystOperatorGood morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. ...

Core Insights - The company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA, indicating that incremental weight loss is an acceptable primary endpoint for approval [1][10] - The Phase 2b PLATEAU clinical study is planned to start in Q1 2026, focusing on older patients with obesity [1][12] - The company completed a public offering post fiscal year end, raising approximately $23.4 million [1][19] Clinical Development - The Phase 2b QUALITY study demonstrated that enobosarm, when combined with GLP-1 RA, selectively promotes fat loss while preserving lean mass and physical function in older patients [4][17] - The FDA has confirmed that enobosarm 3 mg is an acceptable dosage for future clinical development [11] - The Phase 2b PLATEAU study will evaluate the effects of enobosarm on body weight, physical function, and safety in patients aged 65 and older with a BMI of 35 or higher [12][13] Financial Performance - For fiscal year 2025, research and development expenses increased to $15.6 million from $12.8 million, while general and administrative expenses decreased to $19.9 million from $24.6 million [14] - The operating loss from continuing operations decreased to $24.8 million from $36.2 million [14] - The net loss from continuing operations decreased to $15.7 million, or $1.07 per share, compared to $35.3 million, or $2.61 per share in the previous year [19]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company will host a conference call on December 17, 2025, to discuss its fiscal year 2025 financial results and provide a business update [1] 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) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm combined with semaglutide led to greater fat loss and preservation of lean mass in older patients [4] - The upcoming Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [5] - The primary efficacy endpoint of the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5]

MIAMI, FL, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced multiple presentations at The Society on Sarcopenia, Cachexia, and Wasting Disorders (SCWD) 18th International Conference, and the SCWD’s Regulatory and Clinical Trials Update Regulatory Workshop, both in Rome, Italy. 18th International Conference of the Society on Sarc ...

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company announced the presentation of two abstracts at ObesityWeek 2025, highlighting its drug enobosarm's potential in weight management [1][2] Company Overview - Veru Inc. is developing two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making fat loss more tissue-selective while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - 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 [4] - The study involved 168 older patients (≥60 years) and showed that while weight loss was similar across treatment groups, the preservation of lean mass is expected to enhance energy expenditure [4] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients initiating GLP-1 RA treatment [5][6] - The primary efficacy endpoint for the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5][7]

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]