Veru Q4 Earnings Call Highlights

Veru (NASDAQ:VERU) used its fiscal year 2025 earnings call to spotlight results from its Phase 2b obesity program for enobosarm and to outline a next clinical study aimed at older patients with obesity who may struggle to continue losing weight on GLP-1 therapy. Management also reviewed the company’s financial results following the sale of its FC2 Female Condom business and a subsequent equity financing.

Company focus and pipeline overview

Chairman, CEO and President Dr. Mitchell Steiner described Veru as a late clinical-stage biopharmaceutical company developing medicines for cardiometabolic and inflammatory diseases. The company’s current development program includes two small-molecule candidates: enobosarm, an oral selective androgen receptor modulator (SARM), and sabizabulin, a microtubule disruptor being developed as an anti-inflammatory agent for vascular plaque inflammation in atherosclerotic cardiovascular disease.

The call concentrated on the obesity program for enobosarm, which Veru is studying as an add-on to GLP-1 receptor agonists to make weight loss more “tissue-selective”—targeting fat loss while preserving lean mass and physical function, particularly in older patients with obesity.

Phase 2b QUALITY: lean-mass preservation, fat loss and function measures

Steiner framed the program around FDA guidance that defines obesity as a disease of excess body fat and noted that GLP-1 receptor agonists can drive substantial weight loss but may also lead to significant lean mass loss. Veru’s completed Phase 2b QUALITY study evaluated enobosarm with semaglutide and highlighted results focusing on the 3 mg dose selected for future development.

• Primary endpoint met: At 16 weeks, enobosarm 3 mg plus semaglutide showed a statistically significant 100% average preservation of total lean mass versus placebo plus semaglutide.
• Fat loss: Veru reported dose-dependent greater fat loss versus placebo plus semaglutide, with the 3 mg group showing 12% greater fat loss at 16 weeks.
• Body weight change: Despite preserving lean mass, the enobosarm 3 mg plus semaglutide arm had a similar mean body-weight loss to semaglutide alone at 16 weeks. Steiner noted a subset analysis in participants with baseline BMI ≥35 where incremental weight loss was observed (4.7% for semaglutide versus -5.58% for enobosarm 3 mg plus semaglutide) and a higher proportion achieving at least 5% weight loss (47.4% versus 65.4%).
• Tissue composition: Management said average weight loss was 34% lean/66% fat for placebo plus semaglutide versus 0% lean/100% fat for enobosarm 3 mg plus semaglutide.

Veru also emphasized physical function data using the Stair Climb Test. In a pre-specified responder analysis using a >10% decline in stair climb power at 16 weeks as a cutoff, semaglutide alone was associated with functional decline in 44.8% of patients, while enobosarm 3 mg reduced that proportion to 17.6%, which Steiner characterized as a 59.8% relative reduction.

Maintenance period results and safety observations

During a 12-week maintenance extension—when semaglutide was discontinued and participants continued on placebo or enobosarm 3 mg monotherapy—Veru reported less weight regain in the enobosarm arm. The placebo monotherapy group regained 43% of previously lost body weight (mean change 2.57%, about five pounds), compared with 1.41% (about 2.73 pounds) for enobosarm 3 mg. Steiner said this represented a 46% reduction in weight regain after stopping semaglutide.

Management also highlighted tissue composition of regained weight: enobosarm 3 mg was associated with regain described as 100% lean mass, while the placebo group’s regain was described as 28% fat and 72% lean mass. By the end of the 28-week study, Steiner said the enobosarm regimen preserved 100% lean mass and resulted in 58% more fat loss than placebo plus semaglutide followed by placebo.

On safety, the company reported a “positive safety profile” for enobosarm plus semaglutide at 16 weeks and stated enobosarm did not add gastrointestinal adverse events compared to semaglutide alone. During the maintenance phase, management said there were essentially no gastrointestinal side effects after semaglutide discontinuation and reported no evidence of drug-induced liver injury, no increases in obstructive sleep apnea versus placebo, no adverse events related to masculinization in women, and no adverse events related to increases in prostate-specific antigen (PSA) in men.

Next step: Phase 2b PLATEAU and evolving FDA pathways

Steiner said the regulatory landscape for “muscle-preservation drugs” remains evolving, and described FDA feedback outlining two potential pathways for enobosarm in combination with GLP-1 therapy based on incremental weight loss: (1) at least a 5% placebo-corrected incremental weight loss difference at 52 weeks compared with GLP-1 alone as an acceptable primary endpoint to support approval; or (2) if incremental weight loss is less than 5% (including similar weight loss), approval could still be supported if there is a clinically significant benefit such as preservation of physical function.

Veru’s planned Phase 2b PLATEAU trial will target older patients with more severe obesity who are initiating GLP-1 therapy, with the goal of addressing the weight-loss plateau observed in GLP-1 maintenance treatment. Steiner cited Lilly’s SURMOUNT-1 study as showing 88% of patients on tirzepatide reached a weight-loss plateau by 60–72 weeks, with many remaining clinically obese.

PLATEAU is planned to enroll approximately 200 patients with BMI ≥35 and age ≥65. The primary endpoint will be percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks assessing lean and fat mass by DEXA. Key secondary endpoints include physical function measures (including stair climb), mobility and disability status, and patient-reported outcomes such as SF-36, PF-10, and IWQOL-Lite-CT, along with body composition and bone mineral density.

In Q&A, Steiner said the trial will use one GLP-1 agent rather than allowing multiple, to reduce variability. The company was “in the process of chatting and trying to secure one or the other,” with tirzepatide currently used as a placeholder but semaglutide also possible.

Financial results: FC2 divestiture, offering proceeds and year-end figures

CFO and CAO Michele Greco reviewed financial highlights for the fiscal year ended September 30, 2025. She noted Veru sold its FC2 Female Condom business to Clear Future Inc. on December 30, 2024 for $18 million in cash (subject to adjustments). Net proceeds were approximately $16.5 million after selling costs and adjustments, before a $4.2 million change-of-control payment to SWK Holdings tied to a residual royalty agreement. Veru recorded an approximately $4.1 million loss on the FC2 sale, and the sale was treated as discontinued operations.

Greco also detailed an October 31, 2025 underwritten public offering consisting of 1.4 million common shares, pre-funded warrants to purchase up to 7.0 million shares, and accompanying Series A and Series B warrants (each up to 8.4 million shares) at a public offering price of $3 per common share (and accompanying warrants). Net proceeds were approximately $23.4 million.

• R&D expense: $15.6 million in fiscal 2025 versus $12.8 million in fiscal 2024, driven primarily by Phase 2b obesity study costs.
• SG&A expense: $19.9 million versus $24.6 million, primarily due to lower share-based compensation expense.
• Continuing operations: Net loss of $15.7 million, or $1.07 per diluted share, versus a net loss of $35.3 million, or $2.61 per diluted share, in the prior year.
• Discontinued operations: Net loss of $7.0 million, or $0.48 per diluted share, including the FC2 sale loss, versus $2.5 million, or $0.19 per diluted share, in the prior period.

Veru reported cash, cash equivalents and restricted cash of $15.8 million at September 30, 2025, compared with $24.9 million at September 30, 2024, and said cash on hand as of the issuance date of the financial statements was sufficient to fund operations through the PLATEAU interim analysis. The company used $30.0 million in cash for operating activities in fiscal 2025, compared with $21.7 million in the prior year.

Management said the PLATEAU study is expected to begin in the first quarter of calendar year 2026, with the 36-week interim analysis anticipated in the first quarter of calendar year 2027.

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.