Veru to Showcase Two Abstracts at ObesityWeek 2025
Presentation at ObesityWeek 2025: Veru Inc. will present two abstracts at ObesityWeek 2025, including a poster on enobosarm's effects on body weight and fat regain after discontinuing semaglutide, and an oral presentation on enobosarm's selective fat loss properties when combined with GLP-1RA.
Enobosarm's Clinical Studies: The Phase 2b QUALITY clinical study showed that enobosarm, when used with semaglutide, helps preserve lean mass while promoting fat loss in older patients, leading to plans for a Phase 2b PLATEAU study to further evaluate its effects on weight and physical function in patients starting GLP-1 RA treatment.
Future Development Plans: The planned Phase 2b PLATEAU study aims to assess enobosarm's ability to enhance weight loss and preserve muscle mass over 72 weeks, with an interim analysis at 36 weeks to evaluate changes in body composition.
Forward-Looking Statements: The press release includes forward-looking statements regarding the development and regulatory pathways for enobosarm, highlighting potential risks and uncertainties that could affect the company's future results and operations.
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Veru details 72-week Phase IIb PLATEAU study aimed at obesity plateau group in accordance with FDA recommendations.
Management Transition: Veru Inc. has shifted to focus solely on drug development in cardiometabolic and inflammatory diseases, highlighted by the introduction of enobosarm and sabizabulin, following the sale of its FC2 Female Condom business.
Clinical Trial Updates: The completion of the Phase IIb QUALITY trial showed promising results for enobosarm in preserving lean mass and enhancing fat loss when combined with GLP-1 receptor agonists, leading to the launch of a new 72-week Phase IIb PLATEAU trial targeting obesity in older patients.
Financial Performance: Veru reported a net loss of $15.7 million for fiscal 2025, with increased R&D expenses, but also completed a public offering that bolstered its cash position to support upcoming trials.
Regulatory and Strategic Outlook: Management expressed confidence in navigating regulatory pathways for enobosarm, emphasizing the importance of clinical results and financial readiness, while acknowledging the need for additional capital to sustain operations beyond the interim analysis of the PLATEAU study.
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Key Earnings Dates: Major companies reporting include Navan, Ark Restaurants, and Champions Oncology on Monday; Organigram and Duluth Holdings on Tuesday; and a heavy slate on Wednesday with Jabil, General Mills, and Micron.
Investor Focus: Investors are particularly interested in Micron's performance, with expectations of strong earnings driven by high bandwidth memory sales for AI chips.
End of Week Reports: The week will conclude with Carnival Corp and other companies like Paychex and Conagra Brands reporting before Friday's market open.
