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MIAMI, FL - Veru Inc. (NASDAQ: VERU), a biopharmaceutical company with a market capitalization of $74.6 million, announced positive safety results from its Phase 2b QUALITY clinical study, which evaluated enobosarm, in combination with semaglutide, for fat loss and muscle preservation in older patients. According to InvestingPro data, while the company has demonstrated strong revenue growth of 134% over the last twelve months, it faces challenges with profitability. The study found that the enobosarm 3mg dose, when combined with semaglutide, showed a favorable safety profile and fewer gastrointestinal side effects compared to semaglutide alone.
The combination also resulted in selective fat loss, accounting for 99% of total weight loss, while preserving lean mass. Following these results, Veru has selected the 3mg dose of enobosarm for its upcoming Phase 3 clinical program and has requested a meeting with the FDA to discuss the next steps.
The Phase 2b QUALITY trial, a double-blind, placebo-controlled study, included participants aged 60 and above who were receiving semaglutide for chronic weight management. With analyst price targets ranging from $3 to $4, significantly above the current trading price, market experts appear optimistic about the company’s potential. InvestingPro subscribers can access additional insights, including 7 more key ProTips and comprehensive financial analysis. The primary endpoint of the trial was the preservation of lean mass, which was met with a significant reduction in lean mass loss for patients treated with enobosarm and semaglutide.
Secondary endpoints included fat mass loss, weight loss composition, and physical function measured by the Stair Climb Test. The combination treatment led to a significant shift in weight loss composition towards fat loss and improved physical function compared to the control group.
Veru anticipates presenting detailed efficacy and safety data from the QUALITY trial and its extension study, which assesses enobosarm’s ability to prevent fat and weight regain post-semaglutide treatment, in the second quarter.
The company is also developing a novel, patentable, modified release oral formulation of enobosarm, which is expected to be available for Phase 3 clinical studies and commercialization, with a patent expiry anticipated in 2045.
This update is based on a press release statement from Veru Inc. and has not been independently verified. Veru’s forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those projected. The company cautions investors not to place undue reliance on these forward-looking statements. Financial metrics from InvestingPro show the company maintains a healthy current ratio of 3.8, indicating strong short-term liquidity, though investors should note the company’s rapid cash burn rate. For deeper insights into Veru’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Veru Inc. reported its Q2 2025 earnings, showing a slight improvement over analyst expectations with an earnings per share (EPS) of -$0.05, surpassing the forecasted -$0.06. The company’s net loss decreased to $7.9 million from $8.7 million in the same quarter the previous year. Veru Inc. has shifted its strategic focus towards drug development, highlighted by the sale of its FC2 Female Condom business for $18 million. This move aligns with the company’s emphasis on developing Inovasarm, a promising drug in its pipeline. The company announced promising Phase 2b clinical trial results for Inovasarm, which aims to enhance fat loss while preserving muscle mass. Research and development costs increased to $3.9 million, reflecting Veru’s investment in its clinical study efforts. Analysts from firms like Jefferies and Raymond James have shown interest in Veru’s cash runway, which is expected to last through Q4 2025, and potential partnerships to fund further development. Veru is also planning to meet with the FDA in Q3 2025 to discuss its Phase 3 trial design, targeting around 400 patients.
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