Shares of Veru Inc. (VERU) are up 17.17% today, following financial results for its fiscal 2026 third quarter ended June 30, 2026, and an update on the progress of its clinical development programs.
The company's lead drug candidate is enobosarm, which is being developed as a potential important combination therapy with GLP-1 receptor agonists for higher quality weight reduction in older patients with obesity.
Business & Clinical Updates:
Veru's Phase 2b PLATEAU clinical trial evaluating enobosarm in combination with semaglutide for higher-quality weight loss has fully enrolled 239 patients, exceeding its original target of 200 patients.
The company expects the interim analysis and results from the PLATEAU trial in Q1 2027, with final topline clinical data expected in Q4 2027.
Veru also entered into a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU trial, supporting the continued development of the enobosarm and semaglutide combination.
The company received a USPTO Notice of Allowance for a key U.S. patent covering enobosarm in combination with weight-loss drugs. If issued, the patent is expected to provide protection through at least October 2044.
Veru's earlier Phase 2b QUALITY study showed that enobosarm combined with semaglutide preserved lean mass and physical function while increasing fat loss during weight reduction.
Q3 Fiscal 2026 Performance:
Veru reported a net loss of $7.0 million, or $0.30 per share, for the fiscal third quarter ended June 30, 2026, compared with a net loss of $7.3 million, or $0.50 per share, in the same period last year.
Research and development expenses increased to $4.4 million from $3.0 million, while general and administrative expenses declined to $3.4 million from $5.0 million.
Operating loss from continuing operations was $7.7 million, compared with $7.5 million in the prior-year quarter.
The Road Ahead:
The key near-term catalyst is the PLATEAU Phase 2b interim analysis expected in Q1 2027, which will assess lean and fat mass after patients complete 32 weeks of treatment.
The company expects final topline data from the study in Q4 2027. Veru is evaluating enobosarm as a potential combination therapy with GLP-1 receptor agonists to support fat loss while preserving lean mass, physical function and bone mineral density.
Cash Position:
Veru ended the fiscal third quarter with $23.9 million in cash, cash equivalents and restricted cash, compared with $15.8 million as of September 30, 2025.
VERU is currently trading at $2.73, up 17.25%
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