VERU INC.

Veru Inc. (Nasdaq: VERU) is a late-stage biopharmaceutical company focused on developing novel medicines for cardiometabolic and inflammatory diseases. The company operates through two primary drug development programs targeting significant unmet medical needs in obesity and atherosclerotic cardiovascular disease.

The company's lead candidate, enobosarm, is an oral selective androgen receptor modulator being developed to preserve muscle mass and physical function while augmenting fat loss in patients receiving glucagon-like peptide-1 receptor agonist therapy for weight reduction. Clinical trial data demonstrates that enobosarm significantly reduces lean mass loss during GLP-1 RA treatment, with the Phase 2b QUALITY study showing a 100 percent relative reduction in lean mass loss compared to placebo. The company plans to advance enobosarm into a Phase 2b PLATEAU clinical trial evaluating approximately 200 patients with obesity receiving tirzepatide for weight reduction, with the study expected to begin in the first quarter of 2026.

The company's second major program involves sabizabulin, an oral microtubule disruptor being explored as a broad anti-inflammatory agent to reduce inflammation in atherosclerotic cardiovascular disease. Sabizabulin targets the same mechanism as colchicine, which received FDA approval in 2023 for reducing cardiovascular events, but with a potentially improved safety profile and fewer drug-drug interactions. The company plans to conduct a Phase 2 proof-of-concept study measuring high-sensitivity C-reactive protein levels in patients with stable coronary artery disease.

Veru has a notable corporate history dating to 1971 as The Wisconsin Pharmacal Company. The company transitioned to a biopharmaceutical focus following its 2016 acquisition of Aspen Park Pharmaceuticals and subsequently divested its FC2 Female Condom business in December 2024, marking a strategic shift toward pure-play drug development. The company maintains a robust intellectual property position, including pending patent applications for a novel modified-release enobosarm formulation expected to expire in 2046. Veru operates as a smaller reporting company and is classified as a non-accelerated filer with the Securities and Exchange Commission.