Veru (NASDAQ:VERU) used its presentation at Oppenheimer’s 36th Annual Healthcare Life Sciences Conference to outline a strategic shift centered on pairing its selective androgen receptor modulator (SARM) enobosarm with GLP-1 weight loss therapy, with a particular focus on older adults who may be vulnerable to loss of muscle and physical function during pharmacologic weight reduction.
Rationale: addressing muscle loss and function with GLP-1s
Company leadership said it is targeting what it described as a key limitation of GLP-1 therapies: substantial lean mass loss that can occur alongside fat loss. Veru stated that GLP-1s can be associated with losing “between 40% and 50% of lean mass,” which it characterized as potentially detrimental for patients over age 60 due to risks such as poor balance, reduced gait, functional limitations, falls and fractures, higher hospitalization rates, and increased mortality.
Phase 2b “QUALITY” study results discussed
Veru briefly reviewed results from what it referred to as a positive Phase 2b “QUALITY” study designed to explore how an anabolic agent like enobosarm performs when combined with a GLP-1 and to emphasize functional endpoints, consistent with FDA feedback the company said it received.
According to the presentation, the 16-week study evaluated semaglutide with placebo versus semaglutide with enobosarm at 3 mg or 6 mg. After 16 weeks, the study stopped the GLP-1 to examine rapid weight regain and whether enobosarm could mitigate it. Veru said the study showed:
- Lean mass preservation and increased fat loss, with similar overall body weight change despite retaining lean mass.
- The weight lost being “100% adiposity” (fat), which the company framed as a desirable outcome for a weight loss regimen.
- In a subgroup with BMI greater than 35, incremental weight loss and a higher proportion of patients achieving at least 5% weight loss with enobosarm 3 mg, alongside 84% lean mass preservation.
Management also emphasized functional findings in older patients. Using a cutoff of greater than 10% physical decline on a stair-climb measure, Veru said about 44% of patients on semaglutide plus placebo experienced this level of decline over 16 weeks, while enobosarm prevented that decline in the study.
Regulatory feedback and additional endpoint opportunities
Veru said it discussed next steps with the FDA and characterized the agency as open to multiple potential approval pathways. The company said FDA feedback indicated that incremental weight loss of at least 5% for a combination versus GLP-1 alone could serve as a primary endpoint for efficacy. Alternatively, if incremental weight loss is less than 5%, Veru said a clinically meaningful benefit in preservation of physical function with the combination could still be approvable.
The company also pointed to a December FDA statement it described as recognizing total hip bone mineral density (BMD), as measured by DEXA at 24 months, as a surrogate endpoint for osteoporosis drug development in certain settings, potentially reducing the need for fracture endpoint studies. Veru tied this to concerns it raised about bone loss reported with semaglutide and tirzepatide, and it cited the Wegovy label’s discussion of fracture findings from the SELECT trial, including higher hip and pelvic fracture rates in women and in patients over 75.
The upcoming Phase 2b “Plateau” study: design and timing
Most of the presentation focused on Veru’s planned Phase 2b “Plateau” study, which the company said is expected to initiate in the first quarter of 2026. Veru framed the trial around another perceived limitation of GLP-1 therapy: weight loss “plateau,” where patients stop losing additional weight after about a year.
Veru said the Plateau study is designed to “match a Phase 3 program” and inform a path forward. Key design elements described included:
- Population: Non-diabetic patients with BMI ≥35 and age >65.
- Arms: Semaglutide alone versus semaglutide plus enobosarm 3 mg.
- Duration: 68 weeks total (16-week titration to maintenance dose and 52 weeks at maintenance dose).
- Interim analysis: At 34 weeks, focusing on lean body mass and fat mass.
- Primary endpoint: Total body weight.
- Other assessments emphasized: Stair-climb tests, patient-reported physical function, mobility and disability assessments, body composition, and bone mineral density.
Veru said it selected semaglutide in part because it now has an oral form, and management said learnings from the injectable semaglutide study could “bridge easily” to an oral semaglutide Phase 3 setting. The company added that Dr. Steven Himmelfarb, the principal investigator for the QUALITY study, will serve as PI for the Plateau study.
On timing, management said it expects enrollment to be completed by the third quarter of 2026, with an interim look in the first quarter of 2027 and top-line data anticipated in the fourth quarter of 2027.
Funding and intellectual property commentary
Veru said it had $33 million in cash as of December 31, 2025. On intellectual property, the company said enobosarm has not been approved previously and would be eligible for five years of market exclusivity upon approval. Management said composition-of-matter protection runs out in 2029, and with potential patent-term extension could extend to 2034. Veru also described multiple method-of-use patents related to combining enobosarm with GLP-1s that it said could extend protection to 2044, as well as a “novel 3D-printed formulation” for Phase 3 and commercialization that it said could have potential protection to 2046.
In a question-and-answer session, Veru reiterated its view that preserving muscle could support incremental weight loss, potentially affect weight regain after GLP-1 discontinuation, and help differentiate future combination regimens through secondary outcomes such as physical function and bone endpoints.
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.
