Veru Inc. (VERU) Advances Muscle Preservation Research with Enobosarm and Strengthens Financial Position

PRISM Emerging Weight Loss Index mover Veru Inc. (NASDAQ: VERU), is actively advancing its research and development efforts, particularly in its Phase 2b QUALITY clinical study for enobosarm—a drug designed to preserve muscle during weight loss. The company is focused on addressing the emerging concern of muscle loss associated with significant weight reduction, especially in older adults with sarcopenic obesity. This study, which has successfully exceeded its enrollment target of over 150 patients, aims to evaluate enobosarm’s effectiveness in maintaining lean body mass when combined with semaglutide (Wegovy®). Topline data for this study is anticipated in January 2025.

Veru has also showcased the potential of enobosarm at various prestigious scientific conferences, including the American Diabetes Association Meeting and the American Association of Clinical Endocrinology Annual Meeting, where the drug’s benefits in muscle preservation and high-quality weight loss were highlighted.

In its fiscal third quarter of 2024, Veru reported a quarterly net revenue increase to $4.0 million and a reduced operating loss of $10.9 million. The company’s financial position strengthened with cash and cash equivalents rising to $29.2 million as of June 30, 2024, compared to $9.6 million as of September 30, 2023.

Mitchell Steiner, M.D., Chairman, President, and CEO of Veru, has expressed satisfaction with the progress of the enobosarm clinical trial, noting the achievement of full enrollment as a critical milestone. The company remains focused on delivering topline data by January 2025, which could significantly impact the field of muscle preservation during weight loss.

About Veru Inc. 
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.

The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.