Veru Reports Fiscal 2026 First Quarter Financial Results and Clinical Program Progress

Core Insights - Veru Inc. is advancing its Phase 2b PLATEAU clinical trial, which evaluates enobosarm in combination with semaglutide for older patients with obesity, set to initiate this quarter [1] - The company reported financial results for Q1 FY2026, showing a significant reduction in operating loss and net loss compared to the previous year [10][11] Clinical Development - The Phase 2b PLATEAU trial aims to address the weight loss plateau experienced by 88% of patients on GLP-1 receptor agonists, with enobosarm potentially aiding in fat loss while preserving lean mass [2][8] - Enobosarm has demonstrated the ability to burn fat and preserve muscle, which may help patients achieve incremental weight reduction beyond the plateau [2][3] - The trial will involve approximately 200 older patients (age ≥ 65) and will assess various endpoints including total body weight, fat mass, lean mass, physical function, and bone mineral density [7][8] Financial Performance - As of December 31, 2025, the company reported cash and cash equivalents of $33.0 million, a significant increase from $15.8 million at the end of September 2025 [10] - Research and development expenses decreased to $1.3 million from $5.7 million, while general and administrative expenses also saw a reduction [11] - The net loss for the first quarter was $5.3 million, or $0.26 per share, down from $8.9 million, or $0.61 per share in the same period last year [11][21] Regulatory Insights - The FDA has provided regulatory clarity for enobosarm in combination with GLP-1 RA, indicating two potential pathways for approval based on weight loss outcomes [4][5] - The FDA confirmed that enobosarm 3 mg is an acceptable dosage for future clinical development [5] Research Highlights - The Phase 2b QUALITY trial demonstrated that enobosarm combined with semaglutide led to greater fat loss while preserving lean mass, indicating a higher quality of weight reduction [3][14] - The FDA has recognized total hip bone mineral density as a validated surrogate endpoint for drug development in postmenopausal women with osteoporosis, which could be relevant for enobosarm's development [6]