Veru Reports Fiscal 2024 First Quarter Financial Highlights

—Company receives FDA IND clearance for the development of enobosarm in combination with GLP-1 drugs for potentially higher quality weight loss than has been shown with GLP-1 drug alone—

—Company to initiate Phase 2b obesity study by April 2024—

—Company completed public offering for net proceeds of $35.2 million, bringing total cash to $40.6 million at December 31, 2023—

—Company to host conference call and webcast today at 8:00 a.m. ET—

MIAMI, FL, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for potentially higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced financial highlights for its fiscal 2024 first quarter and provided a business update.

“FDA’s clearance of the Investigational New Drug application (IND) for the planned enobosarm clinical trial to further increase fat loss and weight loss while preventing the significant muscle loss that occurs with weight-loss drugs, is a significant milestone for Veru,” said Mitchell Steiner, M.D., Chairman, President, and CEO of Veru Inc. “There's a critical unmet medical need for orally administered therapeutics today that produce higher quality weight loss for patients by preserving muscle and augmenting fat loss with minimal to no additional side effects. Based on the promising results of past enobosarm clinical muscle studies, we think that enobosarm could effectively meet this critical unmet medical need. We plan to commence the Phase 2b clinical study in April 2024 and expect top line data by the end of the calendar year.”

Dr. Steiner added: "Supported by the solid institutional investment of our recent financing, including many highly regarded biotech institutional investors who were excited about the potential of enobosarm for the avoidance of muscle loss - weight loss indication, we believe our current funds are sufficient to complete and report topline results for the Phase 2b enobosarm study for potentially higher quality weight loss as well as the Phase 2b open label extension study.”

Metabolic Disease Program Update:

The Company’s metabolic disease drug pipeline is focused on the clinical development of enobosarm, a novel oral selective androgen receptor modulator, to preserve muscle while augmenting fat loss in patients receiving a GLP-1 RA for weight loss.

Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss or wasting of both muscle and fat mass similar to what is observed with GLP-1 RA treatment. The totality of the clinical data from these five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while avoiding muscle loss.