Veru reports fiscal 2025 results, plans obesity drug trial

Veru Inc. (NASDAQ: VERU) reported fiscal year 2025 financial results and announced plans to initiate a Phase 2b clinical trial for its obesity treatment program in the first quarter of 2026.

The biopharmaceutical company reported a net loss of $22.7 million, or $1.55 per share, for fiscal 2025 compared to $37.8 million, or $2.80 per share, in the prior year. Operating loss from continuing operations decreased to $24.8 million from $36.2 million.

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. Cash and cash equivalents totaled $15.8 million as of September 30, 2025, down from $24.9 million the previous year.

Following the fiscal year end, Veru completed a public offering that generated net proceeds of approximately $23.4 million.

The company announced positive results from its Phase 2b QUALITY study of enobosarm, a selective androgen receptor modulator being developed in combination with GLP-1 receptor agonists for weight management. The 168-patient study in older adults showed that enobosarm preserved lean muscle mass while patients lost weight on semaglutide treatment.

Veru received regulatory guidance from the FDA indicating that incremental weight loss is an acceptable primary endpoint for approval, with a requirement of at least 5% placebo-corrected weight loss difference at 52 weeks of maintenance treatment.

The planned Phase 2b PLATEAU study will evaluate enobosarm 3 mg in approximately 200 patients aged 65 and older with a BMI of 35 or higher who are beginning GLP-1 treatment. The primary endpoint will measure percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks.

"The FDA defines obesity as a disease of excess body fat, and as such, the medical objective to treat obesity should be to reduce excess body fat, not to reduce lean mass," said Mitchell Steiner, the company's chairman, president and CEO.

Veru is developing two late-stage compounds: enobosarm for obesity treatment and sabizabulin for cardiovascular inflammation.

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