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Sep 30, 2025
Veru Q4 2025 Earnings Report
Veru reported its fiscal year 2025 financial results, highlighting progress in its obesity program with positive Phase 2b QUALITY study results and FDA regulatory clarity for enobosarm in combination with GLP-1 RA.
Key Takeaways
Veru Inc. announced its fiscal year 2025 financial results, with a net loss of $22.7 million, or $1.55 per share. The company reported positive efficacy and safety results from its Phase 2b QUALITY study for enobosarm in combination with GLP-1 RA, receiving FDA regulatory clarity. Veru plans to initiate the Phase 2b PLATEAU clinical study in Q1 calendar year 2026.
Veru received FDA regulatory clarity for enobosarm in combination with GLP-1 RA following positive Phase 2b QUALITY study results.
The company plans to initiate the Phase 2b PLATEAU clinical study in Q1 calendar year 2026, with interim analysis results anticipated in Q1 calendar year 2027.
Fiscal year 2025 saw a net loss of $22.7 million, or $1.55 per share, compared to a net loss of $37.8 million, or $2.80 per share, in fiscal year 2024.
Research and development expenses increased to $15.6 million in fiscal year 2025 from $12.8 million in fiscal year 2024.
Forward Guidance
Veru plans to initiate the Phase 2b PLATEAU clinical study in Q1 calendar year 2026 to assess enobosarm's ability to break through the weight loss plateau in older patients with obesity, aiming for clinically meaningful incremental weight reduction and preservation of muscle mass and physical function.
Positive Outlook
- FDA regulatory clarity for enobosarm in combination with GLP-1 RA for greater weight loss in obesity.
- Incremental weight loss with at least a 5% placebo-corrected difference at 52 weeks is an acceptable primary endpoint for approval.
- FDA confirmed enobosarm 3 mg as an acceptable dosage for future clinical development.
- Phase 2b PLATEAU study designed to assess enobosarm's ability to break through weight loss plateau in older patients with obesity.
- Anticipated interim analysis results for Phase 2b PLATEAU study in Q1 calendar year 2027.
Challenges Ahead
- Potential for FDA to disagree that clinical trials support approval.
- Uncertainty regarding agreement with FDA on study design requirements for future Phase 3 studies.
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