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Veru Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary17 Dec, 2025
Executive summary
Positive Phase 2b QUALITY trial for enobosarm combined with GLP-1 RA showed 100% lean mass preservation and enhanced fat loss in older obese patients, with regulatory clarity from the FDA for further development.
Focused on late-stage development of enobosarm and sabizabulin for cardiometabolic and inflammatory diseases, emphasizing obesity and muscle preservation in combination with GLP-1 receptor agonists.
Planned initiation of Phase 2b PLATEAU clinical study in Q1 2026, targeting older patients (age ≥65, BMI ≥35) to address weight loss plateau seen with GLP-1 RA monotherapy.
Divested legacy FC2 Female Condom business to focus exclusively on drug development.
Completed public offering post-fiscal year end, raising $23.4 million in net proceeds.
Financial highlights
Fiscal 2025 net loss from continuing operations was $15.7 million ($1.07 per diluted share), improved from $35.3 million loss in prior year.
Research and development expenses increased to $15.6 million, driven by obesity clinical study expenses.
General and administrative expenses decreased to $19.9 million from $24.6 million year-over-year.
Cash, cash equivalents, and restricted cash were $15.8 million as of September 30, 2025, with an additional $23.4 million raised in a public offering in October 2025.
Net loss from discontinued operations (FC2 business) was $7 million, including a $4.1 million loss on sale.
Outlook and guidance
Phase 2b PLATEAU clinical trial to begin in Q1 2026, targeting obese patients (BMI ≥35, age ≥65) initiating GLP-1 therapy, with interim analysis at 36 weeks (Q1 2027) to assess changes in lean and fat mass; primary endpoint is % change in total body weight at 72 weeks.
FDA guidance supports incremental weight loss as an approvable primary endpoint, with preservation of physical function and body composition as key secondary endpoints.
Current cash position expected to fund operations through the interim analysis of the PLATEAU study.
How will PLATEAU results guide Phase III endpoint selection?
Rationale for PLATEAU's older patient focus?
Cash runway through PLATEAU interim analysis?
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Q1 202612 Feb, 2026
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Frequently asked questions
Veru, Inc., an oncology biopharmaceutical company, focuses on developing medicines for the management of cancers. The company's lead product is currently in Phase III clinical trials, and it has also initiated Phase II trials with additional compounds targeting other therapeutic areas. Veru's clinical development pipeline includes two compounds formulated with cationic polymers, one of which was designed to improve the delivery of a select class of cancer therapeutics. Veru Inc. was incorporated in 1971 and is headquartered in Miami, Florida.
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