-- Phase 2b PLATEAU clinical trial evaluating enobosarm in combination with semaglutide in older patients with obesity on track to initiate this quarter--
--Company to host conference call and webcast today at 8:00 a.m. ET--
MIAMI, FL, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Veru Inc. $(VERU)$, a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2026 first quarter ended December 31, 2025, and provided a corporate update.
"The strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 receptor agonists for patients to ONLY lose fat, while preserving lean mass and physical function and increasing bone mineral density for the highest quality weight reduction, " said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "Veru's 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 RA 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 based on the SURMOUNT-1 study conducted by Eli Lilly and Company. Unfortunately, 62.6% of these patients still had clinical obesity at the time 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 to 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. 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 initiate this calendar quarter with interim analysis results anticipated Q1 calendar year 2027."
"After serving as the Principal Investigator of the positive data Phase 2 QUALITY clinical trial, I am pleased to serve as the Principal Investigator for this important Phase 2b PLATEAU enobosarm clinical trial," said Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Dr. Heymsfield added: "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."
Enobosarm for chronic weight reduction program
Veru's Phase 2b QUALITY clinical trial in 168 older patients with obesity results confirmed 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. During Q1 FY2026, Veru had scientific presentations of two abstracts at ObesityWeek 2025 November 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, December 12-13 in Rome, Italy.
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. 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. 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 December 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 providing an alternative to fracture endpoints. It has been reported in the scientific literature that GLP-1 RA therapy reduces hip BMD, and recently, the Wegovy$(R)$ 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, 4-5 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.
Planned Phase 2b PLATEAU clinical study
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 Principal Investigator for the Phase 2b PLATEAU clinical trial will be Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana.
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.
First Quarter Financial Summary: Fiscal 2026 vs Fiscal 2025
-- Research and development expenses decreased to $1.3 million from $5.7
million
-- General and administrative expenses decreased to $4.1 million from $5.2
million
-- 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
Balance Sheet Information
-- Cash, cash equivalents and restricted cash were $33.0 million as of
December 31, 2025 versus $15.8 million as of September 30, 2025
Event Details
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