Veru's Q3 2025 Earnings Call: Unpacking Key Contradictions in Phase III Trial Costs and Enobosarm's Safety Profile

Phase III trial cost estimation, Enobosarm's safety profile - liver tests, Phase III trial design and endpoints, safety data blinding and disclosure, and modified release formulation and partnership discussions are the key contradictions discussed in Veru Inc.'s latest 2025Q3 earnings call.



Revenue and Financial Performance:
- Veru Inc. reported a net loss of $17 million or $1.16 per diluted common share for the 9 months ended June 30, 2025, compared to a net loss of $26.7 million or $2.04 per diluted common share in the prior period.
- The decrease in net loss was attributed to a gain on the sale of ENTADFI assets and the FC2 Female Condom business, despite a decrease in research and development costs.

Research and Development Focus:
- Research and development costs decreased to $3 million from $4.8 million in the prior quarter, primarily due to the wind down of the Phase IIb QUALITY clinical study.
- The focus shifted towards the enobosarm drug, which showed promising results in preserving lean mass and improving physical function in patients receiving semaglutide.

New Formulation and Intellectual Property:
- Veru announced the selection of a novel modified release oral formulation for chronic weight management, demonstrating distinct pharmacokinetic profiles compared to the immediate-release formulation.
- This new formulation is protected by issued global patents, which are expected to provide patent protection through 2037 and 2046, respectively, enhancing the company's IP portfolio.

Regulatory and Clinical Trial Progress:
- The company is awaiting an end of Phase II FDA meeting, which is expected to provide clarity on the regulatory path for the enobosarm and GLP-1 receptor agonist combination Phase III program.
- The proposed indication is for enobosarm as an adjunct to GLP-1 receptor agonists for older adult patients with obesity, aiming to preserve lean mass and physical function.