Veru Reports Fiscal 2025 First Quarter Financial Results and Clinical Program Progress

Group 1: Clinical Study Results - The company reported positive topline results from the Phase 2b QUALITY study, achieving the primary endpoint of preserving lean mass while also demonstrating greater fat loss and improved physical function in older patients receiving semaglutide [1][2][3] - The enobosarm 3mg + semaglutide combination showed a >99% mean relative reduction in lean mass loss, while the enobosarm 6mg + semaglutide did not outperform the 3mg dose [3][4] - The study indicated that enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide, with a significant shift in body composition favoring fat loss [4][6] Group 2: Safety and Regulatory Updates - The Independent Data Monitoring Committee recommended continuing the Phase 2b QUALITY extension study based on unblinded safety data [1][7] - The company plans to request an end of Phase 2 meeting with the FDA to discuss the regulatory path forward for enobosarm as a body composition drug [10] - A new modified release formulation of enobosarm is under development, with plans for a Phase 1 bioavailability clinical trial in the first half of 2025 [11] Group 3: Financial Performance - The company reported a net loss from continuing operations of $1.8 million, or$0.01 per share, compared to a loss of $7.7 million, or$0.08 per share in the previous year [25][36] - Research and development expenses increased to $5.7 million from$1.7 million, while selling, general, and administrative expenses decreased to $5.2 million from$6.7 million [25] - Cash, cash equivalents, and restricted cash were $26.6 million as of December 31, 2024, compared to$24.9 million as of September 30, 2024 [25][35] Group 4: Business Developments - The company sold the FC2 Female Condom® business for $18 million, resulting in estimated net proceeds of approximately$12.3 million after adjustments [1][21] - The company is exploring the development of sabizabulin for treating inflammation in atherosclerotic coronary artery disease, addressing a significant unmet medical need [12][18] - The FDA has acknowledged the unmet medical need for sabizabulin in treating atherosclerotic disease and agreed with the proposed study design for a small Phase 2 trial [19]