MIAMI, FL — February 11, 2026 — Leads & Copy —
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company, announced its fiscal 2026 first-quarter financial results for the period ended Dec. 31, 2025, and provided a corporate update.
The company is focused on developing medicines for cardiometabolic and inflammatory diseases.
According to Veru Chairman, President, and CEO Mitchell Steiner, the strategy for the next generation of obesity drugs should involve combination therapy with GLP-1 receptor agonists, so patients only lose fat while preserving lean mass and physical function, and increasing bone mineral density for the highest quality weight reduction.
Steiner noted that Veru’s completed Phase 2b QUALITY clinical trial provided proof of concept that enobosarm could be that next-generation drug when combined with a GLP-1 RA. The combination may make weight loss 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.
Steiner added that an emerging challenge with GLP-1 RA monotherapy is that 88% of patients with obesity hit a weight-loss plateau after one year on the drug, based on the SURMOUNT-1 study conducted by Eli Lilly and Company. He said that, unfortunately, 62.6% of these patients still had clinical obesity when they reached the weight-loss plateau.
Loss of muscle may stimulate these patients to consume more calories and may be an important reason why patients hit the weight loss plateau. Enobosarm has been shown to directly burn fat and preserve muscle to increase physical function and burn more calories, which could help break through the weight loss plateau, leading to incremental weight reduction.
Veru’s Phase 2b PLATEAU clinical trial is designed to address this problem by testing a novel combination of enobosarm and a GLP-1 RA, especially in older patients who are also at risk for decline in physical function and loss of bone. The Phase 2b PLATEAU clinical trial is expected to begin this calendar quarter, with interim analysis results anticipated in the first quarter of calendar year 2027.
Dr. Steven Heymsfield, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana, will serve as the Principal Investigator for the Phase 2b PLATEAU enobosarm clinical trial, after serving as the Principal Investigator of the positive data Phase 2 QUALITY clinical trial.
Heymsfield stated that older patients with obesity receiving a GLP-1 RA are at risk for loss of muscle and physical function and could benefit from enobosarm to preserve muscle mass and physical function to improve the quality of weight loss.
Results from Veru’s Phase 2b QUALITY clinical trial in 168 older patients with obesity confirmed that preserving lean mass with enobosarm plus semaglutide led to greater fat loss during the active weight loss period. 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.
During Q1 FY2026, Veru had scientific presentations of two abstracts at ObesityWeek 2025 Nov. 4-7, 2025, in Atlanta, Georgia, and multiple presentations at The Society on Sarcopenia, Cachexia, and Wasting Disorders (SCWD) International Conference, and the SCWD’s Regulatory and Clinical Trials Update Regulatory Workshop, Dec. 12-13 in Rome, Italy.
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. According to FDA feedback on Veru’s clinical development program for enobosarm, FDA has guided that there are at least two possible regulatory pathways forward for the development of enobosarm in combination with a GLP-1 RA and are based on incremental weight loss.
The first pathway involves 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 as an acceptable primary endpoint to support efficacy for approval. The second pathway involves an incremental weight loss difference of less than 5% (including similar weight loss) observed at 52 weeks of maintenance treatment with a clinically significant positive benefit, such as clinically beneficial preservation in physical function.
The FDA confirmed that enobosarm 3 mg is an acceptable dosage for future Veru clinical development.
Enobosarm has been shown in published preclinical studies to have anabolic and antiresorptive activity to increase bone mineral density in rat models of postmenopausal women and male osteoporosis. On Dec. 19, 2025, the FDA announced that total hip bone mineral density (BMD) assessed by DXA qualifies as a validated surrogate endpoint for drug development in postmenopausal women with osteoporosis at risk for fracture.
It has been reported in the scientific literature that GLP-1 RA therapy reduces hip BMD, and recently, the Wegovy® FDA label has been updated to include the safety concern of increased risk of hip and pelvic fractures based on the SELECT cardiovascular trial, a completed clinical trial sponsored by Novo Nordisk A/S that evaluated semaglutide in over 17,000 subjects. In the SELECT trial, four to five times more fractures of the hip and pelvis were reported on semaglutide than on placebo in female patients and patients ages 75 and older.
Consequently, this means that distinct from incremental weight loss or muscle preservation and physical function as primary endpoints, improving BMD in postmenopausal women with obesity receiving GLP-1 RA at risk for bone fractures could be another primary endpoint with a clear regulatory pathway forward for enobosarm to improve body composition.
Veru’s planned Phase 2b PLATEAU clinical trial design is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass and physical function, bone mineral density and safety in approximately 200 older patients (age ≥ 65 yo) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 34 weeks to assess the percent change from baseline in lean body mass and fat mass, as measured by DXA scan.
The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), BMD, and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function), HbA1c, and insulin resistance.
The Phase 2b PLATEAU clinical study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving semaglutide treatment to achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function by 68 weeks. Semaglutide was selected as the GLP-1 RA for the Phase 2b PLATEAU study to build on Veru’s previous clinical experience in using enobosarm in combination with semaglutide in the Phase 2 QUALITY clinical study.
Further, there is an oral form of semaglutide which may be used in combination with oral enobosarm in future Phase 3 clinical studies making potential bridging of the future Phase 3 clinical studies data to the Phase 2b PLATEAU enobosarm plus injectable semaglutide data possible. In contrast, tirzepatide injectable does not have an oral formulation.
The Phase 2b PLATEAU clinical study is expected to begin in the first quarter of calendar 2026 and an interim analysis is planned for the first quarter of calendar 2027.
For the first quarter of fiscal 2026, research and development expenses decreased to $1.3 million from $5.7 million, and general and administrative expenses decreased to $4.1 million from $5.2 million. The operating loss from continuing operations decreased to $5.4 million from $10.2 million. Net loss decreased to $5.3 million, or $0.26 per share, compared to $8.9 million, or $0.61 per share.
Cash, cash equivalents, and restricted cash were $33.0 million as of Dec. 31, 2025, versus $15.8 million as of Sept. 30, 2025.
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 7414536, for one week.
Veru is a biopharmaceutical company focused on developing medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage new chemical entities, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease.
The Phase 2b QUALITY clinical study 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 augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for weight reduction. After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial ended at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the 16 week active weight loss period. While weight loss was similar across treatment groups in this short 16 week study, we anticipate that preservation of lean mass and function will lead to increased energy expenditure, and this effect coupled with the direct effects of enobosarm on the additional selective reduction in fat mass will result in incremental weight reduction in a longer clinical study in patients who have obesity.
Wegovy® is a registered trademark of Novo Nordisk A/S.
Source: Veru Inc.
