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Investor Relations14 Oct 2025
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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
Reported positive Phase 2b and maintenance extension data for enobosarm (Inovasarm) plus semaglutide, showing preserved lean mass, enhanced fat loss, and improved safety in older adults with obesity; enobosarm monotherapy reduced weight regain after semaglutide discontinuation.
Selected a novel modified release oral enobosarm formulation with patent protection through 2037 and potential extension to 2046.
Completed sale of FC2 Female Condom business for $18.0M, resulting in a $4.3M loss and strategic shift to focus solely on late-stage drug development.
Awaiting FDA feedback to clarify regulatory pathway for Phase 3 program in chronic weight loss management, targeting older adults at high risk for muscle loss and falls.
No commercial revenue post-FC2 sale; company is focused on advancing clinical programs for obesity and atherosclerosis.
Financial highlights
For the quarter ended 06/30/2025: R&D expenses were $3.0M (down from $4.8M), SG&A expenses were $5.0M (down from $5.8M), and net loss from continuing operations was $7.3M ($0.50/share), improved from $10.3M ($0.71/share) year-over-year.
For the nine months ended 06/30/2025: R&D expenses rose to $12.7M (from $9.5M), SG&A dropped to $15.4M (from $18.4M), and net loss from continuing operations was $17.0M ($1.16/share), improved from $26.7M ($2.04/share) prior period.
Cash, cash equivalents, and restricted cash were $15.0M at 06/30/2025, down from $24.9M at 09/30/2024.
Net proceeds from the FC2 business sale were $16.3M, with a $4.3M loss on sale.
Gain on extinguishment of debt of $8.6M recognized after FC2 sale; $35.2M raised in a December 2023 public offering.
Outlook and guidance
Cash on hand is insufficient to fund operations for the next 12 months, but sufficient to reach FDA regulatory clarity for enobosarm.
Additional capital required for ongoing drug development; Phase 3 trial estimated to require $40M over 18 months for about 400 patients.
IND submission for sabizabulin in atherosclerotic cardiovascular disease planned for Q1 2026, subject to funding.
Actively pursuing non-dilutive funding and partnership opportunities, especially for ex-U.S. markets and fixed-dose combinations.
FDA Phase III clarity expectations?
New formulation's IP and partner appeal?
Phase III capital needs estimate?
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Next Veru earnings date
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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