Veru Inc. reported a net loss of $22.7 million for the fiscal year ending September 30, 2025, a decrease from a loss of $37.8 million in the previous year. The company's total revenue for the year was $10.8 million, primarily driven by a gain on the sale of its ENTADFI assets amounting to $10.8 million. This sale, along with the termination of the Residual Royalty Agreement, contributed to a significant gain of $8.6 million. Research and development expenses increased to $15.6 million, reflecting ongoing clinical trials for its drug candidate enobosarm, while selling, general, and administrative expenses decreased to $19.9 million, down from $24.6 million in the prior year.
In a strategic shift, Veru sold its FC2 female condom business on December 30, 2024, for $18 million, resulting in a loss of $4.1 million on the sale. This divestiture has allowed the company to focus on its biopharmaceutical development, particularly enobosarm and sabizabulin, both of which are in late-stage clinical trials. The company plans to initiate a Phase 2b clinical trial for enobosarm in early 2026, targeting patients with obesity who are also receiving GLP-1 receptor agonists for weight reduction. The FDA has provided guidance that incremental weight loss with enobosarm is an acceptable primary endpoint for approval.
Veru's workforce consisted of 20 full-time employees as of December 1, 2025, all based in the U.S. The company has emphasized the importance of attracting and retaining skilled personnel to support its growth strategy. Despite the challenges, including the need for substantial capital to fund ongoing drug development, Veru is optimistic about its prospects, particularly with the evolving regulatory landscape for muscle preservation drugs in obesity treatment.
Looking ahead, Veru faces significant financial challenges, with its cash reserves of $15.8 million as of September 30, 2025, deemed insufficient to cover operational needs for the next twelve months. The company is exploring various financing options, including public and private equity offerings, to secure the necessary capital for its development programs. The ongoing uncertainty regarding funding raises substantial doubt about Veru's ability to continue as a going concern, highlighting the critical need for successful execution of its clinical trials and commercialization strategies.
About VERU INC.
Veru Inc. is a biopharmaceutical company focused on developing and commercializing medicines for metabolic diseases, oncology, and ARDS. Its core assets include late-stage drug candidates enobosarm and sabizabulin, targeting obesity, breast cancer, and viral-induced lung injury. The company also markets the FDA-approved FC2 Female Condom, serving global sexual health markets and public health sectors. Its business model combines drug development, clinical trials, and health product sales.
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