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Veru Completes Full Enrollment for PLATEAU Clinical Trial

"We are extremely pleased with the continued enobosarm progress during this past quarter," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. "We reached full enrollment of the Phase 2b PLATEAU clinical trial and entered into a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU clinical trial.* In addition, we received from the USPTO a notice of allowance for a key U.S. patent for enobosarm with semaglutide for high quality weight loss which when issued, will provide U.S. patent protection until at least October 2044." Dr. Steiner added: "We believe these accomplishments mark important milestones in advancing enobosarm as a potential important combination therapy with GLP-1 receptor agonists. There is a significant unmet medical need to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction especially in older patients who have low muscle reserves and obesity. I want to thank both the patients and the investigators for their enthusiasm to expeditiously reach full enrollment for this very important study. We remain on track to achieve the near-term milestone of reporting the interim analysis results from the Phase 2b PLATEAU clinical trial in the first quarter of calendar year 2027."

Veru Completes Enrollment in Phase 2b PLATEAU Clinical Study

Veru announced the completion of enrollment in the Phase 2b PLATEAU clinical study to evaluate the effect of oral enobosarm 3 mg versus placebo on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in approximately 200 older patients who have obesity and are initiating semaglutide treatment for weight reduction. The interim analysis results from the study are expected in the first quarter of calendar year 2027 with final topline clinical data expected in the fourth quarter of calendar year 2027.

Veru Enters Clinical Supply Agreement with Novo Nordisk

In a regulatory filing, Veru (VERU) announced that on June 2, the company entered into a clinical supply agreement with Novo Nordisk A/S (NVO) in conjunction with the company's Phase 2b PLATEAU clinical study. The objective of the Phase 2b PLATEAU clinical study is to evaluate the combination of enobosarm, the company's oral, first-in-class, novel small molecule, selective androgen receptor modulator, with Novo Nordisk's Wegovy, a GLP-1 RA, in older adults with obesity who are receiving Wegovy therapy for weight reduction. Under the terms of the Supply Agreement, the company is solely responsible for conducting and sponsoring the Phase 2b PLATEAU clinical study while Novo Nordisk will supply Wegovy to the company at no charge and as required for the conduct of the Phase 2b PLATEAU study. Novo Nordisk provides Wegovy solely for use within the study under a clinical supply agreement. In return, the Company will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct, including regular clinical study updates, protocol changes, and safety updates. While the company maintains full global development and commercialization rights to enobosarm, the company has granted Novo Nordisk a right of first negotiation in the Supply Agreement if the company in the future intends to develop, commercialize, or license enobosarm intellectual property in combination with any Novo Nordisk GLP-1 product, including Wegovy, for any indication.