Veru (NASDAQ:VERU) said it has fully enrolled its Phase IIb PLATEAU study of enobosarm in older adults with obesity who are starting treatment with semaglutide, positioning the company to report interim data in the first quarter of calendar 2027.
Chairman, President and CEO Mitchell Steiner said the 239-patient trial is evaluating whether 3 milligrams of oral enobosarm can enhance weight loss while preserving lean mass, physical function and bone mineral density in patients age 65 and older with a body mass index of at least 35. The double-blind, placebo-controlled study’s primary endpoint is the percentage change in total body weight at 68 weeks.
Focus on lean-mass preservation
Steiner described enobosarm as an oral selective androgen receptor modulator being developed for use alongside GLP-1 receptor agonists. Veru’s strategy is aimed at older patients with obesity and low muscle mass, a condition the company characterized as sarcopenic obesity.
According to Steiner, GLP-1 treatments can produce nonselective weight loss that includes losses of both fat and lean mass. He said Veru’s previously completed Phase IIb QUALITY study in 168 patients age 60 and older found that enobosarm preserved lean mass and reduced the proportion of patients with clinically significant declines in stair-climb performance compared with semaglutide alone.
Veru is also studying whether enobosarm could help patients move beyond weight-loss plateaus during GLP-1 treatment. Steiner cited data from Eli Lilly’s SURMOUNT-1 study, saying that many patients stopped losing additional weight after one year of GLP-1 therapy and that a substantial portion remained clinically obese at that point.
“The objective of the Phase IIb PLATEAU clinical trial is to focus on the effects of longer-term GLP-1 receptor agonist treatment in older patients who have obesity,” Steiner said, adding that the company will assess whether enobosarm can deliver clinically meaningful incremental weight reduction while preserving muscle and physical function.
Novo Nordisk supply agreement and intellectual property
Veru entered a supply agreement with Novo Nordisk on June 2 under which Novo Nordisk will provide Wegovy at no charge for use in the PLATEAU study. Veru is responsible for sponsoring and conducting the trial and will provide Novo Nordisk with updates and insights related to obesity, weight management, trial design, methodology and clinical conduct.
Veru retains global development and commercialization rights for enobosarm. However, the company granted Novo Nordisk a right of first negotiation should Veru seek in the future to develop, commercialize or license enobosarm intellectual property in combination with Novo Nordisk GLP-1 products.
The company also reported receiving a notice of allowance from the U.S. Patent and Trademark Office for a patent application covering methods of using enobosarm in combination with semaglutide and other weight-loss treatment regimens. Steiner said the allowed claims cover uses related to lean mass, fat mass, physical function, bone health, insulin resistance, HbA1c and weight or body-composition rebound after semaglutide discontinuation.
If issued, Veru said the patent would expire no earlier than Oct. 3, 2044, before any potential patent-term adjustment or extension. The company also has pending applications covering other weight-loss drugs and an oral modified-release enobosarm formulation that, if granted, could provide protection until at least May 2046.
Quarterly loss narrows as trial spending rises
For the fiscal third quarter ended June 30, Veru reported a net loss of $7 million, or $0.30 per diluted share, compared with a net loss of $7.3 million, or $0.50 per diluted share, in the prior-year period.
Research and development expense increased to $4.4 million from $3 million in the prior-year quarter, primarily reflecting costs associated with the PLATEAU study and the wind-down of the completed QUALITY study. General and administrative expense declined to $3.4 million from $5 million, driven by lower share-based compensation and reduced third-party consulting costs.
For the first nine months of fiscal 2026, Veru recorded a net loss of $15.1 million, or $0.68 per diluted share, compared with a loss of $24.2 million, or $1.65 per diluted share, a year earlier. Nine-month research and development costs fell to $8.8 million from $12.7 million, while general and administrative expenses declined to $11.5 million from $15.4 million.
As of June 30, Veru had $23.9 million in cash equivalents and restricted cash, up from $15.8 million at Sept. 30, 2025. Net working capital was $21.1 million, compared with $11.1 million at the end of the prior fiscal year. Chief Financial Officer and Chief Administrative Officer Michele Greco said the company expects its cash to fund operations beyond the PLATEAU interim analysis.
About Veru (NASDAQ:VERU)
Veru Inc is a clinical-stage biopharmaceutical company headquartered in Miami, Florida. The company is dedicated to the development and commercialization of novel therapies in the fields of oncology and infectious disease. Veru’s research strategy centers on advancing small-molecule and biologic candidates through clinical trials, leveraging its in-house manufacturing and formulation capabilities as well as strategic partnerships to support late-stage development.
The company’s lead product candidate is sabizabulin (VERU-111), an oral, microtubule-disrupting agent undergoing pivotal trials for indications that include metastatic castration-resistant prostate cancer and hospitalized patients with severe COVID-19.
