Veru (NASDAQ:VERU) executives used the company’s fiscal first-quarter 2026 earnings call to outline the next steps for its obesity program and to review quarterly financial results following a recent public offering. Management described Veru as a late clinical-stage biopharmaceutical company developing two small-molecule drug candidates: enobosarm and sabizabulin.
Focus on enobosarm as a “next-generation” obesity combination therapy
Chairman, CEO and President Mitchell Steiner said Veru’s lead near-term focus is enobosarm, an oral selective androgen receptor modulator (SARM), being developed for use in combination with GLP-1 receptor agonists. Steiner argued that while GLP-1 drugs can drive significant weight loss, that loss is “tissue non-selective,” with “up to 50%” of total weight loss attributable to lean mass. He framed the company’s strategy as enabling patients to lose fat while preserving lean mass, physical function, and bone mineral density.
FDA feedback and potential approval pathways
Steiner reiterated that Veru held a successful FDA meeting in September 2025, which he said provided “regulatory clarity” for developing enobosarm with a GLP-1 receptor agonist in obesity.
According to Steiner, FDA feedback indicated at least two possible pathways based on incremental weight loss at 52 weeks of maintenance treatment:
- Pathway 1: A primary endpoint of incremental weight loss of at least a 5% placebo-corrected difference for enobosarm plus GLP-1 therapy versus GLP-1 therapy alone.
- Pathway 2: If incremental weight loss is less than 5% (including potentially similar weight loss between arms), approval could still be supported if the enobosarm group demonstrates a “clinically significant positive benefit,” such as a statistically significant and clinically meaningful benefit in preservation of physical function.
Steiner added that FDA confirmed enobosarm 3 mg as an acceptable dose for future development.
Bone mineral density discussed as a potential additional endpoint
Steiner pointed to a December 19, 2025 FDA announcement that total hip bone mineral density (BMD) assessed by DEXA scan qualifies as a validated surrogate endpoint in postmenopausal women with osteoporosis at risk for fracture, rather than requiring fracture endpoints. He connected this update to the obesity program, noting published reports that GLP-1 therapy reduces BMD.
He also said the semaglutide (Wegovy) FDA label has been updated to include an increased risk of hip and pelvic fractures based on the SELECT cardiovascular outcomes trial sponsored by Novo Nordisk in more than 17,000 subjects, stating that “four to 5x more” hip and pelvis fractures were reported on Wegovy than placebo in female patients and in patients aged 75 and older.
Steiner said preclinical rat models of postmenopausal osteoporosis have shown enobosarm has both anabolic and anti-resorptive activity that increases BMD. Based on that, he suggested improving BMD in postmenopausal women with obesity receiving a GLP-1 receptor agonist who also have osteoporosis “could be another primary endpoint going forward” for enobosarm.
PLATEAU Phase IIb study design and timing
Management detailed plans for the Phase IIb PLATEAU trial, which will evaluate whether enobosarm can help address the “weight loss plateau” seen with GLP-1 therapies. Steiner cited data from Eli Lilly’s SURMOUNT-1 study indicating that 88% of patients hit a plateau after one year on a GLP-1 drug, and that 62.6% of those patients still have clinical obesity at that point. He suggested muscle loss could stimulate appetite and contribute to the plateau.
The planned PLATEAU study is described as a double-blind, placebo-controlled trial in approximately 200 older patients (≥65 years) with obesity (BMI ≥35) initiating semaglutide. Key elements discussed on the call included:
- Primary endpoint: Percent change from baseline in total body weight at 68 weeks.
- Interim analysis: At 34 weeks to assess changes in lean body mass and fat mass measured by DEXA.
- Key secondary endpoints: Fat mass, lean mass, stair climb test, BMD, patient-reported outcomes for physical function, and metabolic measures including HbA1c and insulin resistance.
- Principal investigator: Steven Heymsfield, MD, of the Pennington Biomedical Research Center.
Steiner said the study is expected to begin “this quarter,” and that the 34-week interim analysis is anticipated in the first quarter of calendar 2027.
In the question-and-answer session, Steiner said the company chose injectable semaglutide to minimize differences versus the prior QUALITY study and noted that injectable semaglutide is “a little bit better” than the oral form. He added that because semaglutide is the active ingredient in both formulations, bridging should be possible, particularly for safety.
Steiner also said Veru discussed the stair climb test with FDA and described requested study conduct details, including duplicate stair climb runs and performing both “loaded” and “unloaded” tests to help normalize weight and challenge muscle performance.
Chief Scientific Officer Gary Barnette said the interim analysis will not include futility rules or sample-size re-estimation. He said the interim focuses on lean mass and fat mass rather than weight loss to avoid statistical penalties associated with alpha spending.
Quarterly financial results and financing update
Chief Financial Officer and Chief Administrative Officer Michele Greco reviewed results for the three months ended December 31, 2025 and the impact of recent transactions.
Greco said Veru completed an underwritten public offering on October 31, 2025 consisting of 1.4 million shares, pre-funded warrants for up to 7.0 million shares, and Series A and Series B warrants for up to 8.4 million shares each, priced at $3.00 per share (and accompanying warrants). Net proceeds were approximately $23.4 million after underwriting costs and discounts.
Greco also noted that Veru sold the FC2 Female Condom business on December 30, 2024, and that related revenues and expenses are reflected as discontinued operations.
For the quarter ended December 31, 2025:
- R&D expense: $1.3 million, down from $5.7 million, primarily due to the wind-down of the completed Phase IIb QUALITY study.
- G&A expense: $4.1 million, down from $5.2 million, primarily due to lower share-based compensation.
- Net loss: $5.3 million, or $0.26 per diluted share, compared with a net loss of $8.9 million, or $0.61 per diluted share, in the prior-year quarter (which included a $7.1 million loss from discontinued operations).
On the balance sheet, cash, cash equivalents and restricted cash were $33.0 million at December 31, 2025, compared with $15.8 million at September 30, 2025, with restricted cash of $0.1 million related to the FC2 sale in both periods. Net working capital was $29.7 million at December 31, 2025, up from $11.1 million at September 30, 2025.
Greco said the company is not profitable and has negative operating cash flow, but based on its current operating plan, cash as of the issuance date of the financial statements is expected to fund operations through the PLATEAU interim analysis. Operating cash used was $6.2 million in the quarter versus $11.3 million in the prior-year period, while financing cash provided was $23.4 million from the public offering.
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.
