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Veru (VERU) investor relations material
Veru Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Aug, 2025
Executive summary
Phase 2b QUALITY study and Maintenance Extension showed enobosarm + semaglutide preserved lean mass, enhanced fat loss, and had fewer GI side effects in older adults with obesity, with a strong safety profile and no significant adverse events compared to placebo.
Novel modified-release oral enobosarm formulation selected, offering distinct pharmacokinetics and patent protection through 2046.
Company completed sale of FC2 Female Condom business for $18M, resulting in a $4.3M loss and a strategic shift to late-stage drug development for enobosarm and sabizabulin.
No commercial revenue post-FC2 sale; focus is on advancing clinical programs for obesity and atherosclerosis.
Awaiting FDA feedback to clarify regulatory pathway for enobosarm as adjunctive therapy in chronic weight loss management.
Financial highlights
Q3 2025 research and development expenses decreased to $3.0M from $4.8M; selling, general, and administrative expenses decreased to $5.0M from $5.8M.
Net loss from continuing operations for Q3 2025 was $7.3M ($0.50/share), down from $10.3M ($0.71/share) year-over-year.
Net loss from discontinued operations was $9,700, reflecting the FC2 business sale.
For the nine months ended June 30, 2025, net loss from continuing operations was $17.0M ($1.16/share), down from $26.7M ($2.04/share) prior period.
Cash, cash equivalents, and restricted cash were $15.0M as of June 30, 2025, down from $24.9M at September 30, 2024.
Outlook and guidance
Awaiting FDA End-of-Phase-II meeting for regulatory clarity on Phase III design for enobosarm + GLP-1; Phase III trial expected to enroll ~400 patients at an estimated cost of $40M over 18 months, pending FDA feedback.
Sufficient capital to reach next calendar year and FDA clarity, but additional funding needed for Phase III execution and ongoing R&D.
IND submission for sabizabulin in atherosclerotic cardiovascular disease planned for Q1 2026, subject to funding.
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Q4 202516 Dec, 2025
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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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