- Veru Inc. (VERU, Financial) reports a net loss of $7.9 million in fiscal Q2 2025, showing improvement from the previous year's $8.7 million loss.
- The Phase 2b QUALITY study demonstrated a 71% reduction in lean mass loss with the enobosarm and semaglutide combination.
- Veru plans to hold an End of Phase 2 meeting with FDA in Q3 2025 to discuss the Phase 3 clinical program.
Veru Inc. (VERU), a biopharmaceutical company, announced its fiscal second-quarter 2025 financial results, reporting a net loss of $7.9 million or $0.05 per share. This marks an improvement from the $8.7 million net loss in the same period last year. Research and development expenses increased to $3.9 million from $3.0 million, as the company continues to invest in its clinical programs.
The company's Phase 2b QUALITY study, which evaluates the enobosarm program, revealed positive results. The study met its primary endpoint with a 71% reduction in lean mass loss when enobosarm was combined with semaglutide, compared to the placebo. The 3mg dose of enobosarm showed an impressive >99% preservation of lean mass. Additionally, patients in the enobosarm + semaglutide group experienced a selective 90.6% fat loss versus 68% in the placebo group. A notable outcome of the study also included a 54.4% reduction in patients experiencing physical function decline.
Looking forward, Veru Inc. is preparing for an End of Phase 2 meeting with the FDA scheduled in the third quarter of 2025. This meeting aims to discuss the design and requirements for the upcoming Phase 3 clinical program. Furthermore, the company expects to release unblinded safety data from the Phase 2b study in the second quarter of calendar year 2025, alongside results from an extension study that addresses weight regain upon discontinuation of GLP-1 therapy.
