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Mar 31
Veru Q2 2025 Earnings Report
Veru reported its fiscal 2025 second quarter financial results and provided an update on its clinical program progress, highlighting positive Phase 2b QUALITY study results for enobosarm and plans for an End of Phase 2 meeting with the FDA.
Key Takeaways
Veru Inc. reported a net loss of $7.9 million for the fiscal second quarter of 2025, an improvement from the $10.0 million net loss in the same period last year. The company saw a decrease in operating loss from continuing operations and an increase in research and development expenses, while selling, general, and administrative expenses decreased.
Unblinded safety data from the Phase 2b QUALITY study is expected in Q2 2025.
Topline efficacy and safety data for the Phase 2b extension maintenance study is expected in Q2 2025.
Veru plans for an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program for enobosarm.
The Phase 2b QUALITY study showed enobosarm in combination with GLP-1 RA drugs made weight reduction more tissue selective for fat loss while preserving lean mass and physical function.
Veru
Veru
Forward Guidance
Veru anticipates significant progress in its clinical programs, including regulatory clarity for Phase 3 enobosarm studies and the development of a novel modified-release formulation, while also exploring a new indication for sabizabulin in atherosclerotic cardiovascular disease.
Positive Outlook
- Unblinded safety data from Phase 2b QUALITY study expected in Q2 2025.
- Topline efficacy and safety data for Phase 2b extension maintenance study expected in Q2 2025.
- End of Phase 2 meeting with FDA for enobosarm Phase 3 clinical program anticipated in Q3 2025.
- Novel modified release oral enobosarm formulation expected to be available for Phase 3 clinical studies and commercialization.
- Sabizabulin's potential clinical development for atherosclerotic cardiovascular disease, with FDA agreement on Phase 2 study design.
Challenges Ahead
- The company assumes no obligation to update forward-looking statements.
- Actual results could differ materially due to known and unknown risks and uncertainties.
- Potential delays in the timing and results from clinical trials and studies.
- Ability to fund planned clinical development and other operations is a factor.
- Uncertainty regarding FDA approval and commercial success of products.