Veru Completes Enrollment for Phase 2b Enobosarm Obesity Study, Reports Q3 2024 Financials

Veru Inc., a late-stage clinical biopharmaceutical company, recently shared important updates on its business and financial performance for the third quarter of fiscal 2024. The company focuses on developing novel medicines for muscle preservation, oncology, and viral-induced acute respiratory distress syndrome (ARDS). Notably, Veru has made significant progress in its Phase 2b QUALITY clinical trial for enobosarm, a selective androgen receptor modulator (SARM), combined with semaglutide (Wegovy®*), which aims to address muscle preservation during high-quality weight loss.

The Phase 2b QUALITY study has successfully exceeded its target, enrolling more than 150 patients. This multicenter, double-blind, placebo-controlled, randomized trial investigates the safety and efficacy of enobosarm in doses of 3mg and 6mg versus a placebo. The primary goal is to preserve lean body mass while the key secondary endpoints include total body fat mass and physical function, assessed through a stair climb test over a period of 16 weeks.

Dr. Mitchell Steiner, Chairman, President, and CEO of Veru Inc., expressed his satisfaction with the rapid enrollment completion, attributing the success to the efforts of clinical sites, investigators, and the Veru team. The topline data for the primary endpoint is expected by January 2025. Dr. Steiner highlighted the significant unmet medical need for a drug that can effectively preserve muscle mass while promoting fat loss, especially for patients using GLP-1 receptor agonists for weight management.

Enobosarm has demonstrated promising results in earlier clinical trials, showcasing its potential benefits in muscle preservation, physical function enhancement, and safety. The company has presented these findings at various prestigious scientific conferences, including the American Diabetes Association Meeting and the American Association of Clinical Endocrinology Annual Meeting.

The Phase 2b trial's efficacy dose-finding segment will be followed by an extension study where participants will stop GLP-1 RA treatment but continue with either a placebo or enobosarm for an additional 12 weeks. This extension aims to evaluate enobosarm’s ability to maintain muscle mass and prevent fat and weight regain after discontinuing GLP-1 RA therapy. The entire clinical study is being conducted across 14 sites in the United States. Final patient completion for the Phase 2b QUALITY study is projected for December 2024, with topline results expected in January 2025. Results from the Phase 2b extension study are anticipated in the second quarter of 2025.

On the financial front, Veru reported notable changes in its third-quarter fiscal performance compared to the previous year. Net revenues increased to $4.0 million from $3.3 million, with a gross profit rising to $1.3 million from $1.2 million. Research and development expenses were significantly reduced to $4.9 million from $8.8 million. Similarly, selling, general, and administrative expenses decreased to $7.5 million from $10.9 million, resulting in an operating loss reduction to $10.9 million compared to $13.7 million. Net losses also decreased to $11.0 million, or $0.07 per share, from $12.5 million, or $0.14 per share.

For the year-to-date figures, Veru experienced a decrease in net revenues to $10.2 million from $12.4 million. Gross profit fell to $3.2 million from $6.0 million, while research and development expenses dropped significantly to $9.5 million from $47.3 million. Selling, general, and administrative expenses also saw a decrease to $23.4 million from $41.3 million, leading to a reduction in operating loss to $28.7 million from $85.6 million. Net losses for the year-to-date were $29.3 million, or $0.22 per share, compared to $85.0 million, or $1.02 per share in the previous year.

Veru's balance sheet shows an increase in cash and cash equivalents to $29.2 million as of June 30, 2024, from $9.6 million as of September 30, 2023. Meanwhile, net accounts receivable reduced to $1.6 million from $4.5 million during the same period.

Enobosarm, also known as ostarine, has been previously studied extensively and has shown capability in increasing muscle mass and improving physical function. Veru continues to advance its drug development programs, with enobosarm targeting two primary areas: muscle preservation and weight loss in elderly patients, and a potential Phase 3 trial for treating metastatic breast cancer, subject to sufficient funding.

Overall, Veru Inc. is making substantial progress in its research and financial performance, aiming to meet critical medical needs in muscle preservation and weight loss management.