Veru Announces Q2 Fiscal 2024 Results and Enobosarm Weight Loss Program Progress

Veru Inc., a biopharmaceutical company at an advanced clinical stage, has announced its financial results for the second quarter of fiscal 2024 and provided updates on its business activities. The company, which focuses on developing innovative treatments for muscle preservation in quality weight loss, oncology, and acute respiratory distress syndrome induced by viral infections, is currently enrolling patients in a Phase 2b clinical trial of enobosarm combined with semaglutide (Wegovy®) aimed at achieving high-quality weight loss.

CEO Mitchell Steiner, M.D., highlighted the critical need for a medication that can preserve muscle and enhance fat loss in patients using GLP-1 drugs for weight management. Enobosarm, a novel oral selective androgen receptor modulator, is the focus of this high-quality weight loss program. The company has also established a Scientific Advisory Board comprising five experts with significant expertise in obesity and muscle-related medical fields, who are expected to provide valuable guidance for the enobosarm development program.

The Phase 2b clinical trial for enobosarm is designed as a multicenter, double-blind, placebo-controlled, and randomized study to assess the safety and efficacy of enobosarm in doses of 3mg and 6mg compared to a placebo. It aims to evaluate muscle preservation and fat loss in approximately 90 patients with sarcopenic obesity or overweight elderly patients taking semaglutide. The trial's primary endpoint is the difference in total lean body mass measured by DEXA scans, while secondary endpoints include changes in total body fat mass and physical function as measured by a stair climb test at 16 weeks. The trial is being conducted at up to 15 clinical sites in the United States, with topline results expected by the end of 2024.

Following the initial Phase 2b trial, patients will enter an extension study for an additional 12 weeks, during which they will stop receiving GLP-1 RA medication but continue taking either a placebo, enobosarm 3mg, or enobosarm 6mg. This extension aims to determine if enobosarm can maintain muscle mass and prevent the typical weight gain that occurs after discontinuing GLP-1 RA drugs. The results of this extension study are anticipated in the second quarter of 2025.

Financially, Veru Inc. reported a decrease in net revenues to $4.1 million from $6.6 million in the same period the previous fiscal year. Gross profit also fell to $0.7 million from $4.1 million. Research and development expenses decreased significantly to $3.0 million from $17.9 million, while selling, general, and administrative expenses dropped to $7.6 million from $12.8 million. Consequently, the operating loss was reduced to $9.9 million from $34.4 million, and net loss was $10.0 million, or $0.07 per share, compared to $33.8 million, or $0.42 per share, as restated.

For the year-to-date financial summary, net revenues fell to $6.3 million from $9.1 million, with gross profit decreasing to $1.8 million from $4.8 million. Research and development expenses went down to $4.6 million from $38.5 million, and selling, general, and administrative expenses were reduced to $15.9 million from $30.4 million. The operating loss was $17.8 million, compared to $71.9 million, and the net loss was $18.3 million, or $0.15 per share, compared to $72.5 million, or $0.90 per share.

As of March 31, 2024, Veru Inc. held $34.7 million in cash and cash equivalents, compared to $9.6 million as of September 30, 2023. The company's net accounts receivable stood at $2.8 million, down from $4.5 million.

The ongoing development of enobosarm and its potential to preserve muscle mass while promoting fat loss in patients using semaglutide could address a significant need in the treatment of obesity and muscle wasting conditions. The company continues to advance its clinical programs and looks forward to sharing further results from its ongoing studies.