Veru (NASDAQ:VERU) said its second quarter fiscal 2026 update centered on the clinical development of enobosarm, the company’s oral selective androgen receptor modulator being studied in combination with GLP-1 receptor agonists for older patients with obesity.
Chairman, CEO and President Dr. Mitchell Steiner described Veru as a late clinical-stage biopharmaceutical company focused on cardiometabolic and inflammatory disease. Its pipeline includes enobosarm and sabizabulin, a microtubule disruptor being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation in atherosclerotic cardiovascular disease.
Enobosarm program focuses on older patients with obesity
Veru’s clinical focus is on older patients with obesity, particularly those with sarcopenic obesity, a condition involving obesity and low muscle mass. Steiner said these patients may be at greater risk of physical function decline when treated with currently approved GLP-1 receptor agonists.
The company completed its Phase 2b QUALITY clinical trial, a multicenter, double-blind, placebo-controlled, randomized dose-finding study evaluating enobosarm 3 mg, enobosarm 6 mg or placebo in combination with semaglutide. The 16-week active weight-loss portion assessed enobosarm’s ability to augment fat loss and prevent muscle loss.
Steiner highlighted the study’s use of the stair climb test to evaluate physical function. He said the QUALITY study was the first human study to show that weight reduction in older patients with obesity receiving a GLP-1 receptor agonist put them at higher risk for accelerated lean mass loss with physical function decline.
According to Steiner, 44.3% of patients in the placebo plus semaglutide group had at least a 10% decline in stair climb power at 16 weeks. He said the enobosarm 3 mg plus semaglutide group had a statistically significant and clinically meaningful 59.8% relative reduction in the proportion of patients who lost at least 10% stair climb power compared with placebo plus semaglutide, with a p-value of 0.0006. The enobosarm 6 mg plus semaglutide group had a 44.1% relative reduction.
Plateau study underway, interim data expected in 2027
Veru is now conducting its Phase 2b PLATEAU clinical study, designed to evaluate enobosarm 3 mg in approximately 200 patients aged 65 or older with obesity and a body mass index of at least 35 who are initiating semaglutide Wegovy treatment for weight reduction.
The study’s primary efficacy endpoint is percent change from baseline in total body weight at 68 weeks. An interim analysis is planned at 36 weeks to assess percent change from baseline in lean body mass and total fat mass as measured by DEXA scan. Key secondary endpoints include total fat, total lean mass, stair climb physical function, mobility disability assessment, bone mineral density, patient-reported physical function outcomes, HbA1c and insulin resistance.
Steiner said the PLATEAU trial is intended to evaluate whether enobosarm can help patients break through the weight-loss plateau often observed with GLP-1 treatment while preserving muscle mass and physical function. He cited data from Eli Lilly’s SURMOUNT-1 study, saying 62.6% of patients still had clinical obesity when they reached a weight-loss plateau after one year.
Veru announced enrollment of the first patients in the PLATEAU study on March 9, 2026. Steiner said he was “very pleased with the current enrollment rate” and that the company remains on track for results from the 36-week interim analysis in the first quarter of calendar 2027.
Quarterly loss narrows as operating expenses decline
CFO and Chief Administrative Officer Michele Greco said research and development costs for the three months ended March 31, 2026, declined to $3.1 million from $3.9 million in the prior-year quarter, primarily due to the wind-down of the Phase 2b QUALITY study. Personnel costs also declined, driven mainly by reduced share-based compensation expense.
Selling, general and administrative expenses were $4.1 million, compared with $5.2 million in the prior-year quarter, also primarily due to lower share-based compensation expense.
Veru reported a net loss from continuing operations of $3.1 million, or $0.13 per diluted common share, compared with a net loss of $7.9 million, or $0.54 per diluted common share, in the prior-year quarter. Overall net loss was $2.7 million, or $0.12 per diluted common share, compared with a net loss of $7.9 million, or $0.54 per diluted common share, in the prior-year quarter.
For the six months ended March 31, 2026, R&D costs decreased to $4.5 million from $9.6 million in the prior-year period, while SG&A expenses declined to $8.2 million from $10.4 million. Net loss from continuing operations was $8.4 million, or $0.39 per diluted common share, compared with $9.6 million, or $0.66 per diluted common share, in the prior-year period. Overall net loss was $8.1 million, or $0.38 per diluted common share, compared with $16.8 million, or $1.15 per diluted common share.
Cash position rises after public offering
As of March 31, 2026, Veru had cash, cash equivalents and restricted cash of $27.6 million, compared with $15.8 million as of Sept. 30, 2025. Net working capital was $28 million, up from $11.1 million.
Greco said Veru completed an underwritten public offering on Oct. 31, 2025, generating approximately $23.4 million in net proceeds after underwriting discounts, commissions and costs. The offering included common stock, pre-funded warrants and Series A and Series B warrants.
Greco said the company is not profitable and has negative cash flows from operations. Based on its current operating plan, Veru expects its cash to fund operations beyond the interim analysis in the Phase 2b PLATEAU study.
Regulatory path discussed during Q&A
During the question-and-answer session, Oppenheimer analyst Leland Gershell asked whether a successful PLATEAU study could support a pivotal program and whether future studies would need to be specific to individual GLP-1 agents.
Steiner said the FDA had told the company that incremental weight loss greater than 5% would be an efficacy “anchor.” If incremental weight loss is less than 5%, he said the company could consider physical function as a primary endpoint or potentially bone mineral density, noting that the FDA has said bone mineral density alone can be a surrogate endpoint in place of fractures.
On labeling, Steiner said his understanding is that initial claims would likely be based on the specific GLP-1 receptor agonist studied. He said Veru is focusing initially on semaglutide, though the company discussed the possibility that future Phase 3 work could include one or two incretin-based therapies.
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.
