Veru (VERU) presented interim data from its enobosarm-plus-semaglutide program at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 9, 2026, painting a picture of a muscle-preserving approach to obesity treatment aimed at patients over 60.
The QUALITY trial (Phase IIb) enrolled 239 patients over 60 beginning semaglutide for the first time. Participants received either 3-milligram or 6-milligram enobosarm alongside semaglutide, with placebo groups also receiving semaglutide alone. After a 16-week active weight-loss period followed by a 12-week off-semaglutide phase, 44% of patients on semaglutide alone showed a greater than 10% decline in stair climb power—a metric CEO Mitch described as roughly equivalent to seven to eight years of natural age-related decline. Adding 3-milligram enobosarm cut that incidence by up to 60%, he said.
"Stair climb has been used in muscular dystrophy in the past. Stair climb has been used in frailty. The literature is filled with information showing the benefits of stair climb as a measurement of anabolic activity and how a patient ages," Mitch told attendees. "The FDA is not interested in making a cosmetic statement that you held onto lean. You have to show what does that mean to the patient."
Safety signals were favorable: no additive gastrointestinal side effects were observed, and enobosarm appeared to improve GI tolerability. In the 3-milligram group, one patient experienced a three-fold ALT increase that resolved while staying on treatment. The 6-milligram dose saw more liver enzyme elevations, which also resolved. No bilirubin elevations or Hy's law cases were recorded.
The fully enrolled PLATEAU trial—also Phase IIb, comprising 239 patients over 65 with a BMI above 35—is designed to run 68 weeks. An interim analysis is scheduled for the first quarter of 2027 at the 32-week mark. About 90% of patients with a BMI above 35 remain technically obese after one year on therapy, Veru noted.
Mitch pointed to competitor data to argue the muscle-preservation thesis. Eli Lilly's bimagrumab study showed 6.4% incremental weight loss at 72 weeks, and Regeneron's trevogrumab program similarly produced weight loss rather than weight gain. "If you look at the competitors… not a single patient gained more weight. They lost weight. That's proof. You hold onto muscle, you're going to burn more fat," he said. A Phase III program is expected to enroll roughly 4,500 patients.
Veru also disclosed a clinical supply agreement with Novo Nordisk covering drug supply, information sharing, direct access to trial data, and a first right of negotiation for any licensing deal involving a Novo product combined with enobosarm, with a 90-day decision window. U.S. patents were issued on September 1, 2026: a composition-of-matter patent expiring in 2035, a combination patent through 2044, and a new formulation patent through 2046.
On the financial side, Veru held approximately $24 million in cash as of June 30, 2026, sufficient to fund operations into mid-2027. The company reported a current ratio of 4.42 and levered free cash flow of negative $26 million over the trailing twelve months. Shares traded at $2.48, down 3.88%, with after-hours trading at $2.588; analysts' bullish price targets range from $24 to $25. Market capitalization stood at roughly $42 million.
