On December 17, 2025 Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, reported financial results for its fiscal year 2025 ended September 30, 2025 and provided an update on the clinical progress of its obesity program.
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"The current FDA regulatory guidance for muscle preservation drugs in combination with GLP-1 RA drugs in the treatment of obesity seems particularly well aligned for enobosarm," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "The FDA defines obesity as a disease of excess body fat, and as such, the medical objective to treat obesity should be to reduce excess body fat, NOT to reduce lean mass. Although GLP-1 RAs have demonstrated profound weight loss results, the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 RAs for patients to ONLY lose fat, while preserving lean mass and physical function for a quality weight reduction. The completed positive Phase 2b QUALITY clinical trial provided the proof of concept that enobosarm could be that next generation drug in combination with a GLP-1 receptor agonist to make the weight loss journey more selective for only fat while preserving lean mass and physical function in older patients who have obesity lessening the potential risk of loss of balance, and fractures."
Dr. Steiner added: "An emerging, common, and serious clinical and therapeutic challenge with GLP-1 RA monotherapy is that 88% of patients with obesity after one year on drug hit a weight loss plateau where they stop losing additional weight while on a GLP-1 RA. Unfortunately, 62.6% of these patients still had clinical obesity at the time they reached the weight loss plateau based on the SURMOUNT-1 study. Loss of muscle may stimulate these patients to consume more calories and may be an important reason why patients hit the weight loss plateau. The Phase 2b PLATEAU clinical trial is designed to address this problem, especially in older patients, by testing a novel combination of enobosarm and a GLP-1 RA. Enobosarm has been shown to directly burn fat and preserve muscle to increase physical function and burn more calories which could help to break through the weight loss plateau leading to incremental weight reduction. With our public offering now completed, the Phase 2b PLATEAU clinical trial is expected to start Q1 calendar year 2026 with interim analysis results anticipated Q1 calendar year 2027."
Enobosarm for chronic weight reduction program
Phase 2b QUALITY study: Enobosarm is a next generation drug that makes GLP-1 RA weight loss more selective for fat loss while preserving lean mass and physical function
In January 2025, the Company announced positive topline efficacy results from the Phase 2b QUALITY clinical study, which was a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to increase fat loss and to prevent the loss of muscle in 168 older patients (≥60 years of age) receiving a GLP-1 RA (semaglutide) for chronic weight loss.
Highlights from the Phase 2b QUALITY clinical trial focusing on 3 mg enobosarm dose that has been selected by the Company and agreed upon by FDA for the PLATEAU clinical trial
Efficacy
The results for the 16 week active weight loss period of treatment with enobosarm 3 mg or placebo in combination with semaglutide:
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The enobosarm 3 mg + semaglutide group met the primary endpoint of study, preservation of total lean mass, with a statistically significant 100% average preservation of total lean mass compared to placebo + semaglutide at 16 weeks.
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Enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide with the enobosarm 3 mg group having a 12% greater fat loss at 16 weeks.
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Even with having preserved lean mass, enobosarm 3 mg + semaglutide treatment resulted in a similar mean body weight loss as semaglutide alone at 16 weeks. However, it should be noted, in a subset analysis of the subjects receiving enobosarm 3 mg and had a baseline BMI ≥ 35, incremental weight loss was observed at 16 weeks:
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There was weight loss of -4.7% for semaglutide versus -5.58% for enobosarm 3 mg + semaglutide treatment group.
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Proportion of patients that lost at least 5% of body weight at 16 weeks was 47.4% for semaglutide vs 65.4% for enobosarm 3 mg + semaglutide treatment group.
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This weight loss occurred even with 84% preservation of lean mass in this subset of patients receiving semaglutide on enobosarm 3 mg.
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The tissue composition of the total body weight lost on average was 34% lean mass and 66% fat mass in the placebo and semaglutide group, whereas for the enobosarm 3 mg + semaglutide group, the weight loss was 0% lean mass and 100% fat mass.
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Physical function was measured by the Stair Climb Test. A prespecified responder analysis was conducted using a greater than 10% decline in stair climb power as the cut off at 16 weeks which is a decline that represents an approximate 7 to 8 years of loss of stair climb power function that naturally occurs with aging, but it occurred in 16 weeks.
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Semaglutide alone resulted in a loss of physical function as 44.8% of the placebo + semaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks. The Phase 2b QUALITY study is the first to confirm that older patients with obesity receiving a GLP-1 RA had a significant and relevant physical function decline as early as 16 weeks on treatment.
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In contrast, enobosarm 3 mg treatment reduced the proportion of patients receiving semaglutide to 17.6% who experienced ≥10% decline in stair climb power. This represents a 59.8% relative reduction in proportion of patients receiving enobosarm who experienced ≥10% decline in stair climb power.
Results for the Maintenance Extension portion of the study, where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg as monotherapy for 12 weeks:
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The placebo monotherapy group regained 43% of body weight that was previously lost during the Phase 2b QUALITY study for a mean percent change of 2.57% (5.06 lbs) in body weight, compared to 1.41% (2.73 lbs) for the 3 mg enobosarm group. This means that the 3 mg enobosarm monotherapy significantly reduced the body weight regained by 46% after discontinuation of semaglutide.
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By the way, the mean tissue composition of body weight regained was 100% lean mass, not fat for the enobosarm 3 mg compared to 28% fat and 72% lean mass in the placebo group.
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In fact, by end of the 28 week study, enobosarm 3 mg plus semaglutide followed by enobosarm 3 mg monotherapy regimen was more effective in preserving 100% lean mass and in losing 58% more fat compared to placebo plus semaglutide followed by placebo monotherapy.
Safety
At the end of the 16 week active weight loss period, enobosarm and semaglutide combination had a positive safety profile and enobosarm did not have any added gastrointestinal (GI) adverse events compared to semaglutide alone. For the Maintenance Extension clinical trial, where semaglutide was stopped for 12 weeks, enobosarm monotherapy also had a positive safety profile. After discontinuation of semaglutide, there were essentially no GI side effects, no evidence of drug induced liver injury, and no increases in obstructive sleep apnea observed at any dose of enobosarm compared to placebo monotherapy. There were no AEs related to masculinization in women. There were no AEs of increases in prostate specific antigen in men.
Summary
The Phase 2b QUALITY clinical trial confirms that preserving lean mass with enobosarm plus semaglutide led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, enobosarm monotherapy significantly prevented the regain of both weight and fat mass such that by the end of the 28 week study there was greater loss of fat mass while preserving lean mass for a higher quality weight reduction compared to the placebo group.
FDA Regulatory Feedback
In September 2025, the Company announced a successful FDA meeting providing regulatory clarity for enobosarm in combination with GLP-1 RA for greater weight loss in the treatment of obesity
Highlights from September 2025 FDA meeting
Incremental weight loss: According to FDA feedback on Veru’s clinical development program for enobosarm, FDA has guided us that there are at least 2 possible regulatory pathways forward for the development of enobosarm in combination with a GLP-1 RA and are based on incremental weight loss. First, incremental weight loss with at least a 5% placebo-corrected weight loss difference at 52 weeks of maintenance treatment with enobosarm in combination with a GLP-1 RA treatment compared to the GLP-1 RA treatment alone is an acceptable primary endpoint to support efficacy for approval. Second, if incremental weight loss difference of <5% (including similar weight loss) is observed at 52 weeks of maintenance treatment with a clinically significant positive benefit, such as clinically beneficial preservation in physical function, enobosarm in combination with GLP-1 RA may also be acceptable to support efficacy for approval.
Enobosarm dose – FDA confirmed that enobosarm 3 mg is an acceptable dosage for future Veru clinical development.
Planned Phase 2b PLATEAU clinical study
The planned Phase 2b PLATEAU clinical trial will measure incremental weight loss in this enriched patient population that has more weight to lose (BMI ≥ 35) and more at risk for physical decline and functional limitations (age ≥ 65) to better inform the design of the Phase 3 development program. For the planned Phase 2b PLATEAU clinical trial, we will evaluate the effect of enobosarm 3 mg on total body weight, physical function, and safety in approximately 200 patients who have obesity (BMI ≥ 35) and are older (age ≥ 65) and are initiating GLP-1 RA treatment for weight reduction. The primary efficacy endpoint of the study will be the percent change from baseline in total body weight at 72 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass and fat mass, as measured by DEXA scan. Since we want to continue to evaluate enobosarm as a muscle preserving and body composition drug, the key secondary endpoints will be function endpoints, physical function (stair climb test), mobility disability status (functional limitations), and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function) as well as body composition endpoints, total fat mass, total lean mass, and bone mineral density.
Building on the Phase 2 QUALITY study and with greater FDA regulatory clarity, we have designed the Phase 2b PLATEAU clinical study to assess the ability of enobosarm treatment to break through the weight loss plateau in older patients (age ≥ 65) with obesity (BMI ≥ 35) receiving GLP-1 RA treatment with the expectation that patients will achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function at 52 weeks of GLP-1 weight reduction maintenance dose.
Full Year Financial Summary: Fiscal 2025 vs Fiscal 2024
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Research and development expenses increased to $15.6 million from $12.8 million
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General and administrative expenses decreased to $19.9 million from $24.6 million
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Operating loss from continuing operations decreased to $24.8 million from $36.2 million
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Net loss from continuing operations decreased to $15.7 million, or $1.07 per share, compared to $35.3 million, or $2.61 per share
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Net loss decreased to $22.7 million, or $1.55 per share, compared to $37.8 million, or $2.80 per share
Balance Sheet Information
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Cash, cash equivalents and restricted cash were $15.8 million as of September 30, 2025 versus $24.9 million as of September 30, 2024
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Post fiscal 2025 year end, company completed public offering for additional net cash proceeds of approximately $23.4 million
Event Details
The audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2225332, for one week.
(Press release, Veru, DEC 17, 2025, View Source [SID1234661507])