Veru(US:VERU)2026-02-11 14:02Financial Data and Key Metrics Changes - For the three months ended December 31, 2025, the net loss was $5.3 million or $0.26 per diluted common share, compared to a net loss of $8.9 million or $0.61 per diluted common share in the prior year's quarter [20] - Research and development costs decreased to $1.3 million from $5.7 million in the same period last year, primarily due to the wind-down of the phase II-B QUALITY clinical study [17] - General administrative expenses were $4.1 million compared to $5.2 million in the prior quarter, mainly due to a decrease in share-based compensation [17] Business Line Data and Key Metrics Changes - The company is focused on two main drug development programs: enobosarm and sabizabulin, with enobosarm being developed for obesity treatment in combination with GLP-1 receptor agonists [3][4] - The completed phase II-B QUALITY clinical trial demonstrated that enobosarm could lead to greater fat loss while preserving lean mass compared to GLP-1 receptor agonist treatment alone [6][7] Market Data and Key Metrics Changes - The FDA has provided regulatory clarity for the development of enobosarm in combination with GLP-1 receptor agonists, indicating at least two possible regulatory pathways for approval based on weight loss outcomes [8][9] - The company noted that GLP-1 receptor agonist therapy can lead to significant weight loss but often results in the loss of lean mass, which enobosarm aims to address [5][10] Company Strategy and Development Direction - The company is strategically focusing on developing combination therapies that enhance weight loss while preserving lean mass and physical function, particularly for older patients with obesity [4][6] - The planned phase II-B PLATEAU clinical study aims to evaluate the effect of enobosarm on various health metrics in older patients initiating semaglutide treatment [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's cash position, stating that current funds are expected to support operations through the interim analysis of the phase II-B PLATEAU clinical study [21] - The management highlighted the importance of demonstrating functional benefits, such as physical function preservation, as a potential pathway for regulatory approval [26][36] Other Important Information - The company completed a public offering of 1.4 million shares, generating approximately $23.4 million in net proceeds [16] - The cash balance as of December 31, 2025, was $33 million, an increase from $15.8 million as of September 30, 2025 [20] Q&A Session Summary Question: Why not use oral semaglutide in the PLATEAU study? - Management explained that the injectable form of semaglutide is preferred to minimize differences in outcomes compared to the phase II-B QUALITY study [25] Question: Did the FDA discuss the stair climb test for functional endpoints? - Management confirmed discussions with the FDA regarding the stair climb test, emphasizing its sensitivity in measuring patient function [27][29] Question: Are there pre-specified decision rules for the interim analysis? - The Chief Scientific Officer clarified that there are no futility analyses or sample size re-estimations associated with the interim analysis [34] Question: What degree of weight loss is needed for functional benefit assessment? - Management indicated that greater than 5% weight loss is a clear threshold, but less than 5% could still support approval if functional benefits are demonstrated [36]