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Jun 30
Veru Q3 2025 Earnings Report
Veru reported its fiscal 2025 third quarter financial results and provided updates on its clinical program progress, highlighting positive efficacy and safety data from its Phase 2b QUALITY and Maintenance Extension studies for enobosarm.
Key Takeaways
Veru Inc. reported a significant decrease in net loss and operating loss for the fiscal third quarter of 2025 compared to the same period last year, driven by reduced research and development and selling, general, and administrative expenses. The company also announced positive clinical trial results for enobosarm, its lead drug candidate for chronic weight loss management.
Net loss from continuing operations decreased to $7.3 million, or $0.50 per share, in Q3 2025, down from $10.3 million, or $0.71 per share, in Q3 2024.
Operating loss from continuing operations decreased to $7.5 million in Q3 2025 from $10.5 million in Q3 2024.
Research and development expenses decreased to $3.0 million in Q3 2025 from $4.8 million in Q3 2024.
The company reported positive efficacy and safety data from its Phase 2b QUALITY and Maintenance Extension studies for enobosarm, showing muscle preservation, greater fat loss, and reduced weight regain.
Veru
Veru
Forward Guidance
Veru anticipates FDA feedback to clarify the regulatory pathway for enobosarm to preserve lean mass during chronic weight loss management and plans to make a novel modified release oral enobosarm formulation available for further clinical studies and commercialization.
Positive Outlook
- Anticipates FDA feedback to clarify regulatory pathway for enobosarm.
- Selection of a novel modified release oral enobosarm formulation confirmed in a clinical pharmacokinetic study.
- New enobosarm formulation planned for further clinical studies and commercialization.
- Novel enobosarm oral formulation's unique manufacturing process protected by issued global patents through 2037.
- New patents on the novel modified release oral enobosarm formulation filed, with expiry expected to be 2046 if issued.
Challenges Ahead
- Uncertainty regarding whether the full data set from Phase 2b QUALITY and Maintenance Extension studies will align with disclosed topline results.
- Potential for delays in the timing and results from clinical trials and studies.
- Ability to fund planned clinical development and other operations is a risk.
- Uncertainty if FDA will require more than one Phase 3 study for enobosarm as a body composition drug.
- Risk that enobosarm, if approved, may not be commercially successful or meet unmet needs for obesity patients.