Veru Inc. Reports Fiscal 2025 Third Quarter Financial Results and Clinical Program Progress

Veru Inc., a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, has released its financial results for the fiscal 2025 third quarter. The company also provided updates on the progress of its clinical development programs.

Financial Highlights

For the fiscal 2025 third quarter, Veru Inc. reported a net loss from continuing operations of $7.3 million, or $0.50 per share, compared to a net loss of $10.3 million, or $0.71 per share, in the same period last year. The net loss decreased to $7.3 million, or $0.50 per share, from $11.0 million, or $0.75 per share, in the previous year. Research and development expenses decreased to $3.0 million from $4.8 million, while selling, general, and administrative expenses decreased to $5.0 million from $5.8 million.

Business and Operational Highlights

Veru Inc. reported positive efficacy and safety data from its Phase 2b QUALITY study, showing that enobosarm added to semaglutide led to the preservation of muscle, greater fat loss, and fewer gastrointestinal side effects compared to semaglutide alone. Additionally, the Phase 2b QUALITY Maintenance Extension study demonstrated that enobosarm significantly reduced body weight regain, prevented fat regain, and preserved lean mass after semaglutide discontinuation.

The company has also selected a novel modified release oral enobosarm formulation following a pharmacokinetic clinical study. This new formulation is expected to be available for further clinical studies and commercialization, with patent protection through 2046.

Strategic Initiatives and Corporate Developments

Veru Inc. is anticipating feedback from the FDA to clarify the regulatory pathway for enobosarm to preserve lean mass during chronic weight loss management. The company is also planning to advance the 3mg enobosarm dose into the Phase 3 program based on its positive profile in the Phase 2b QUALITY study.

Management's Perspective

Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru, commented, "We have now reported all the positive efficacy and safety topline results from our Phase 2b QUALITY and Maintenance Extension study, and are looking forward to FDA feedback on the regulatory pathway for enobosarm to be used as an adjunctive therapy with GLP-1 RA to preserve lean mass while burning more fat for chronic weight loss management."

Future Outlook

Veru Inc. is focused on advancing its clinical development programs and is awaiting FDA feedback on the regulatory pathway for enobosarm. The company is also preparing for the commercialization of its novel modified release oral enobosarm formulation, which has shown promising results in pharmacokinetic studies.

SEC Filing: VERU INC. [ VERU ] - 8-K - Aug. 12, 2025