Veru(US:VERU)2026-02-11 12:00Financial Performance - Veru reported cash, cash equivalents, and restricted cash of $33.0 million as of December 31, 2025, compared to $15.8 million as of September 30, 2025, indicating a significant increase[11] - The operating loss from continuing operations decreased to $5.4 million from $10.2 million year-over-year, indicating improved financial performance[14] - Net loss decreased to $5.3 million, or $0.26 per share, compared to $8.9 million, or $0.61 per share, demonstrating a reduction in losses[14] - The net loss from continuing operations for the three months ended December 31, 2025, was $5,332,579, compared to a net loss of $1,809,903 for the same period in 2024[23] - The basic and diluted net loss per share for the three months ended December 31, 2025, was $0.26, compared to $0.61 for the same period in 2024[23] Expenses Management - Research and development expenses decreased to $1.3 million from $5.7 million year-over-year, reflecting a reduction in spending[14] - General and administrative expenses decreased to $4.1 million from $5.2 million year-over-year, showing cost management efforts[14] - Total operating expenses for the three months ended December 31, 2025, were $5,424,015, down from $10,943,943 in the same period of 2024, a decrease of 50.5%[23] - The company reported a net cash used in operating activities of $6,169,490 for the three months ended December 31, 2025, compared to $11,332,987 in 2024, a reduction of 45.5%[25] Clinical Trials - The Phase 2b PLATEAU clinical trial is expected to initiate in the first quarter of calendar 2026, with an interim analysis planned for the first quarter of calendar 2027[10] - The Phase 2b PLATEAU clinical trial will evaluate the effect of enobosarm 3 mg on total body weight, fat mass, lean mass, and physical function in approximately 200 older patients with obesity[7] - The primary efficacy endpoint of the Phase 2b PLATEAU study is the percent change from baseline in total body weight at 68 weeks[7] - FDA feedback indicated that a primary endpoint for enobosarm in combination with GLP-1 RA could be a placebo-corrected weight loss difference of at least 5% at 52 weeks[5] - The Phase 2b QUALITY clinical trial demonstrated that enobosarm plus semaglutide led to greater fat loss while preserving lean mass, confirming its potential as a next-generation obesity treatment[4] Assets and Liabilities - Total current assets increased to $36,806,716 as of December 31, 2025, compared to $18,915,118 on September 30, 2025, reflecting a growth of 94.6%[21] - Total liabilities decreased to $10,442,989 from $11,503,049, a reduction of 9.2%[21] - Cash, cash equivalents, and restricted cash at the end of the period increased to $32,991,417 from $15,794,562, marking a rise of 108.5%[25] Business Risks - The company has ongoing risks related to regulatory approvals and potential disruptions that could affect business operations[17]