Summary of Veru's Presentation at Oppenheimer's 36th Annual Healthcare Life Sciences Conference Company Overview - **Company**: Veru Inc. - **Ticker**: V - **Focus**: Development of enobosarm, a selective androgen receptor modulator, in combination with GLP-1 for obesity treatment Key Points and Arguments Drug Development and Clinical Trials - Veru has pivoted to combine enobosarm with GLP-1, aiming to address muscle loss associated with GLP-1 treatments [2][3] - The Phase 2b QUALITY study showed positive results, and a new Phase 2b PLATEAU study is set to start this quarter [2][6] - Enobosarm has undergone 27 clinical trials, with 6 focusing on muscle endpoints, demonstrating its potential to improve muscle mass and physical function [3][4] Addressing Muscle Loss in Older Patients - GLP-1 treatments can lead to a 40%-50% loss of lean mass, which is particularly detrimental for patients over 60 [3] - Enobosarm is designed to preserve muscle while promoting fat loss, which is crucial for older patients to avoid functional limitations and increased mortality [3][4][9] - The combination of enobosarm and GLP-1 aims to mitigate the adverse effects of GLP-1 on muscle mass while enhancing cardiovascular benefits [4][10] Study Design and Expected Outcomes - The PLATEAU study will focus on patients with a BMI greater than 35, aged over 65, and will last for 68 weeks [16][17] - Primary endpoint: total body weight; secondary endpoints include physical function, mobility, and bone mineral density (BMD) [18][24] - An interim analysis will occur at 34 weeks, assessing lean body mass and fat mass [17] Regulatory Considerations - The FDA has indicated that incremental weight loss of at least 5% could serve as a primary endpoint for approval [10] - If weight loss is less than 5%, preservation of physical function could be a clinically significant endpoint for approval [25] - The FDA now considers total hip BMD as a surrogate endpoint for osteoporosis drug development, which could benefit enobosarm's approval pathway [11][26] Market Potential - Approximately 44 million Americans over 65 are on Medicare Part D, with half potentially benefiting from weight loss drugs [17] - The combination of enobosarm with GLP-1 could address unmet needs in the obesity treatment market, particularly for older patients [15] Competitive Landscape - Enobosarm is positioned as a unique agent that not only aids in weight loss but also preserves muscle and improves bone health, distinguishing it from other GLP-1 treatments [42][44] - Competitors like Scholar Rock, Regeneron, and Lilly have presented data on myostatin inhibitors, but enobosarm's oral formulation may offer advantages [21][22] Financial and Development Timeline - Veru reported $33 million in cash as of December 31, 2025, and is on track for the PLATEAU study to start in Q1 2026 [26][27] - Enrollment is expected to be completed by Q3 2026, with top-line data anticipated in Q4 2027 [27][51] Additional Important Information - Enobosarm is protected as a new chemical entity, with multiple layers of patent protection extending to 2046 [49][50] - The focus on muscle preservation and functional improvement in older patients is critical for addressing the safety issues associated with current obesity treatments [46][48] This summary encapsulates the key points from Veru's presentation, highlighting the company's strategic focus on addressing muscle loss in older patients through innovative drug development and regulatory strategies.

Financial Data and Key Metrics Changes - Research and development costs increased to $3.9 million from $3.0 million in the prior quarter, attributed to expenses related to the Innovus Arm Phase 2b quality clinical study [23] - Selling, general and administrative expenses decreased to $5.2 million from $5.9 million in the prior quarter, primarily due to a decrease in share-based compensation [24] - The net loss for continuing operations was $7.9 million or $0.05 per diluted common share, compared to a net loss of $8.7 million or $0.06 per diluted common share in the prior year's quarter [24] - Cash, cash equivalents, and restricted cash balance was $20 million as of March 31, 2025, down from $24.9 million as of September 30, 2024 [29] - The company reported a net loss from discontinued operations of $49,000 or $0.00 per diluted common share, compared to a net loss of $1.3 million or $0.01 per diluted common share in the prior quarter [25] Business Line Data and Key Metrics Changes - The company is focused on two clinical stage drug candidates: enobosarb and sebisibulin, with a particular emphasis on the obesity program [5][6] - The Phase 2b quality clinical study demonstrated a 71% preservation of total lean body mass in patients receiving enovasarm plus semaglutide versus placebo plus semaglutide [11] - Enovasarm treatment resulted in a dose-dependent greater loss of fat mass compared to placebo, with the six-milligram dose showing a 46% greater relative loss of fat mass [12] Market Data and Key Metrics Changes - Obesity prevalence is reported at 41.5% among 47.4 million patients enrolled in Medicare Part D plans, with 34.4% of patients over the age of 60 having obesity [22] - The company aims to target older patients who are at higher risk for muscle weakness and falls due to age-related loss of muscle [21] Company Strategy and Development Direction - The company plans to focus exclusively on drug development following the sale of the FC2 female condom business, allowing for a more concentrated effort on its clinical programs [28] - Upcoming catalysts include the unblinded safety data for the Phase 2b quality study and regulatory clarity from the FDA regarding the Phase 3 program [30][18] - The company is exploring non-dilutive funding options, including partnerships with larger pharmaceutical companies [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in having sufficient cash to last into the fourth quarter of 2025, allowing time to navigate upcoming clinical data releases [35] - The management highlighted the importance of demonstrating the ability of enovasarm to preserve lean mass while promoting fat loss, which is seen as a potential game changer in the obesity treatment landscape [38] - The company is actively discussing partnerships with large pharmaceutical companies to secure funding for the Phase 3 program [37] Other Important Information - The company recognized a gain on the sale of NTAPI assets of $974,000, which was not present in the prior quarter [24] - The company is developing a novel modified release oral formulation of enovasarm, expected to enter Phase 1 bioavailability clinical trials in the first half of 2025 [21] Q&A Session Summary Question: Could you talk about your cash balance and runway options for funding the Phase 3? - Management confirmed that there is enough cash to last into the fourth quarter and is exploring non-dilutive funding options, including partnerships with large pharmaceutical companies [35][37] Question: What outcomes would be considered a success for the Phase 2b extension maintenance study? - Success would be defined by the ability to blunt fat regain and potentially cause additional fat loss while maintaining muscle mass [51] Question: What is the expected size of the Phase 3 study and concerns regarding tariffs? - The expectation is to have approximately 400 patients randomized for the Phase 3 study, with one dose being selected for the trial [60] - Concerns regarding tariffs are minimal as the cost of goods for enovasarm is relatively low [61]