Veru Inc. Reports Decreased Net Loss of $7.3 Million for Q2 2025

Veru Inc. reported a net loss of $7.3 million for the three months ended June 30, 2025, a decrease from a net loss of $10.3 million in the same period last year. For the nine months ended June 30, 2025, the company recorded a net loss of $24.2 million, compared to a loss of $29.3 million for the same period in 2024. The reduction in losses is attributed to a decrease in operating expenses, particularly in research and development, which fell to $3.0 million from $4.8 million year-over-year, primarily due to the completion of the Phase 2b QUALITY clinical study for enobosarm. Selling, general, and administrative expenses also decreased to $5.0 million from $5.8 million, reflecting lower corporate personnel costs and share-based compensation.

Significant operational changes include the completion of the Phase 2b QUALITY clinical trial for enobosarm, which is being developed to augment fat loss and prevent muscle loss in sarcopenic obese or overweight elderly patients. The trial met its primary endpoint, demonstrating a statistically significant preservation of lean mass compared to placebo. Additionally, Veru has initiated a Phase 2b extension maintenance trial to evaluate the long-term effects of enobosarm after discontinuation of semaglutide, a GLP-1 receptor agonist. The company is also exploring the development of sabizabulin as a treatment for inflammation in atherosclerotic cardiovascular disease, following a pre-IND meeting with the FDA.

Veru's financial position has been impacted by the sale of its FC2 business, which closed on December 30, 2024, for $18 million. The sale resulted in a loss of $4.3 million, and the company has classified all related revenues and expenses as discontinued operations. As of June 30, 2025, Veru reported cash and cash equivalents of $15.0 million, down from $24.9 million at the end of the previous fiscal year. The company has indicated that its current cash reserves are insufficient to meet operational needs for the next twelve months, raising concerns about its ability to continue as a going concern.

Looking ahead, Veru plans to propose a Phase 3 clinical program for enobosarm, building on the positive results from the Phase 2b trial. The company is also developing a novel modified release formulation of enobosarm, which is expected to be available for future clinical studies and commercialization. However, the company faces challenges in securing additional funding to support its ongoing drug development efforts, and it will need to navigate various market and operational risks as it moves forward.