Core Viewpoint - Veru Inc. has initiated the Phase 2b PLATEAU clinical trial for enobosarm, aimed at enhancing weight loss quality and quantity in older patients with obesity when combined with semaglutide [1][2] Group 1: Clinical Trial Details - The Phase 2b PLATEAU trial is a double-blind, placebo-controlled study involving approximately 200 older patients (age ≥ 65 years) with obesity (BMI ≥ 35) starting semaglutide treatment [3] - The primary efficacy endpoint is the percent change from baseline in total body weight at 68 weeks, with an interim analysis at 34 weeks to assess changes in lean body mass and fat mass [3][6] - Key secondary endpoints include total fat mass, total lean mass, physical function, bone mineral density, and patient-reported outcomes [3] Group 2: Drug Development Strategy - Enobosarm is an oral selective androgen receptor modulator (SARM) being developed to work in conjunction with GLP-1 receptor agonists like semaglutide to maximize fat loss while preserving lean mass and physical function [2][4] - The combination therapy aims to address the weight loss plateau experienced by many patients on current therapies, particularly those with clinical obesity [2][4] - The Phase 2b PLATEAU study builds on previous positive results from the Phase 2 QUALITY clinical study, which demonstrated the efficacy of enobosarm in combination with semaglutide [4][8] Group 3: Expected Outcomes and Timeline - An interim analysis for the PLATEAU trial is expected in the first quarter of 2027, with final topline clinical data anticipated in the fourth quarter of 2027 [1][6] - The trial aims to provide critical clinical information that will inform the design of future Phase 3 studies for combination therapies [2][3]

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.

Core Viewpoint - Veru Inc. is advancing its clinical programs for innovative treatments targeting cardiometabolic and inflammatory diseases, with a focus on the upcoming presentation at the Oppenheimer 36th Annual Healthcare Life Sciences Conference [1] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company dedicated to developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development pipeline includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Obesity Program - Enobosarm is being developed as a next-generation drug to enhance weight reduction when combined with GLP-1 RA drugs, aiming for more selective fat loss while preserving lean mass [4] - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when used with semaglutide, led to greater fat loss while preserving lean mass and physical function in older patients [4] - The study involved 168 older patients (≥60 years) and showed that while weight loss was similar across treatment groups, the preservation of lean mass is expected to lead to increased energy expenditure and further weight reduction in longer studies [4] Planned Phase 2b PLATEAU Clinical Study - The upcoming Phase 2b PLATEAU clinical trial will evaluate the effects of enobosarm 3 mg on various health metrics in approximately 200 older patients (age ≥ 65) with obesity [5] - The primary efficacy endpoint is the percent change in total body weight at 68 weeks, with an interim analysis planned at 34 weeks [5] - The study aims to assess the ability of enobosarm to overcome weight loss plateaus in patients receiving GLP-1 RA treatment, with a focus on preserving muscle mass and physical function [6]

Financial Data and Key Metrics Changes - For the three months ended December 31, 2025, the net loss was $5.3 million or 26 cents per diluted common share, compared to a net loss of $8.9 million or 61 cents per diluted common share in the prior year's quarter [19] - Research and development costs decreased to $1.3 million from $5.7 million in the same period last year, primarily due to the completion of the Phase 2b 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] - Cash, cash equivalents, and restricted cash balance was $33 million as of December 31, 2025, compared to $15.8 million as of September 30, 2025 [19] Business Line Data and Key Metrics Changes - The company is focused on two main drug development programs: enobosarm and sabizabulin, targeting obesity and cardiovascular diseases respectively [3][4] - Enobosarm has shown potential in a Phase 2b clinical trial for obesity, demonstrating selective fat loss while preserving lean mass [6][7] Market Data and Key Metrics Changes - The FDA has provided regulatory clarity for enobosarm in combination with GLP-1 receptor agonists, indicating at least two possible pathways for approval based on weight loss metrics [8][9] Company Strategy and Development Direction - The company aims to develop enobosarm as a next-generation obesity treatment that preserves lean mass and physical function, addressing the limitations of current GLP-1 receptor agonists [4][5] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effects on weight loss and physical function 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 to fund operations through the interim analysis of the Phase 2b PLATEAU study [20] - The company is not currently profitable and has experienced negative cash flow from operations, but the recent public offering has bolstered its financial position [19][22] Other Important Information - The company completed a public offering of 1.4 million shares, generating approximately $23.4 million in net proceeds [16] - The company recorded a gain on the sale of the FC2 Female Condom business in the prior year, which is now classified under discontinued operations [17][18] Q&A Session Summary Question: Why not use the oral semaglutide in this study? - Management explained that the injectable form of semaglutide is preferred to minimize differences in outcomes compared to previous studies [24] Question: Did you discuss the stair climb test with the FDA? - Management confirmed discussions with the FDA regarding the stair climb test as a sensitive measure for assessing physical function in the study [26] Question: Are there any pre-specified decision rules for the interim analysis? - It was clarified that there are no futility analysis or sample size re-estimation associated with the interim analysis [32] Question: What degree of weight loss needs to be seen for functional benefit assessment? - Management indicated that greater than 5% weight loss is a clear criterion, but less than 5% could still be acceptable if accompanied by significant functional benefits [34]

Financial 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 [18] - 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 2b QUALITY clinical study [16] - 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 [16] Business Line Data and Key Metrics Changes - The company is focused on two main drug development programs: enobosarm and sabizabulin, targeting obesity and cardiovascular diseases respectively [3][4] - The completed Phase 2b QUALITY clinical trial demonstrated that enobosarm, in combination with a GLP-1 receptor agonist, could lead to more selective fat loss while preserving lean mass [6] Market Data and Key Metrics Changes - The FDA has provided regulatory clarity for the development of enobosarm in combination with a GLP-1 receptor agonist, indicating at least two possible regulatory pathways for approval based on weight loss outcomes [7][8] Company Strategy and Development Direction - The company aims to develop enobosarm as a next-generation obesity treatment that preserves lean mass and physical function, addressing the limitations of current GLP-1 receptor agonist therapies [4][5] - The planned Phase 2b PLATEAU clinical study will evaluate the effects of enobosarm on weight loss and physical function in older patients initiating semaglutide treatment [12][13] 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 2b PLATEAU clinical study [19] - The company is not yet profitable and has experienced negative cash flow from operations, but the recent public offering has strengthened its financial position [18][20] Other Important Information - The company completed a public offering of 1.4 million shares, generating approximately $23.4 million in net proceeds [15] - The cash balance as of December 31, 2025, was $33 million, up from $15.8 million as of September 30, 2025 [18] Q&A Session Summary Question: Why not use oral semaglutide in the PLATEAU study? - The company aims to minimize differences between the Phase 2b QUALITY study and the PLATEAU study, opting for the injectable form of semaglutide for consistency [22] Question: Did the FDA discuss the stair climb test for functional endpoints? - Yes, the FDA was consulted about the stair climb test, which has been validated through extensive prior studies, and they requested specific testing protocols [24] Question: Are there pre-specified decision rules for the interim analysis? - No, there are no futility analysis or sample size re-estimation rules associated with the interim analysis [30] Question: What degree of weight loss is needed for approval if functional benefits are observed? - Greater than 5% weight loss is required for approval, but if less than 5% is observed, significant functional benefits could still support approval [32]

Core Viewpoint - Veru Inc. is set to host a conference call on February 11, 2026, to discuss its fiscal 2026 first quarter financial results and provide a business update [1] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Obesity Program - Enobosarm is being developed as a next-generation drug to enhance weight reduction when combined with GLP-1 RA drugs, aiming for more selective fat loss while preserving lean mass [4] - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass and physical function in older patients [4] - The Phase 2b PLATEAU clinical trial is planned to evaluate the effect of enobosarm on total body weight, fat mass, lean mass, and physical function in approximately 200 older patients initiating GLP-1 RA treatment [5][6] Planned Clinical Studies - The primary efficacy endpoint of the Phase 2b PLATEAU study is the percent change from baseline in total body weight at 68 weeks, with an interim analysis at 34 weeks [5] - The study aims to assess the ability of enobosarm to overcome weight loss plateaus in patients receiving GLP-1 RA treatment [6]

Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [30] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the Phase 2b obesity clinical study for enobosarm [28] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [28] Business Line Data and Key Metrics Changes - The company sold the FC2 Female Condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after adjustments, which allowed the company to focus exclusively on drug development [24][26] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [28] Market Data and Key Metrics Changes - The company reported a cash balance of $15.8 million as of September 30, 2025, down from $24.9 million as of September 30, 2024 [31] - The company generated cash from investing activities of $25.1 million for fiscal 2025, compared to $0.1 million from investing activities in the prior year [32] Company Strategy and Development Direction - The company is focusing on developing enobosarm as a muscle-preserving agent in combination with GLP-1 receptor agonists to enhance fat loss while preserving lean mass, particularly targeting older patients with obesity [5][19] - The planned Phase 2b PLATEAU clinical trial aims to assess the ability of enobosarm to break through the weight loss plateau in patients with a BMI greater than 35 and age greater than or equal to 65 [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the evolving regulatory landscape for muscle-preservation drugs and the potential for multiple pathways to approval based on clinical outcomes [17][19] - The company highlighted the importance of addressing the weight loss plateau experienced by many patients on GLP-1 receptor agonists, indicating a significant market opportunity [18][50] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million, which will support ongoing clinical studies [27][23] - The company reported a loss on the sale of the FC2 Female Condom business of approximately $4.1 million, impacting the financial results for the year [25][31] Q&A Session Summary Question: Will any GLP-1 be allowed in your Phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently as the placeholder [40] Question: How does the FDA's guidance affect the transition from Phase 2 to Phase 3? - Management clarified that the Phase 2b study is designed to mirror Phase 3 conditions, allowing for a clear understanding of incremental weight loss and functional endpoints [43] Question: What patient population is being targeted in the PLATEAU study? - Management explained that the focus is on patients over 65 with physical limitations, as this group is most in need and will provide informative data for the study [46][49]

Core Insights - The company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA, indicating that incremental weight loss is an acceptable primary endpoint for approval [1][10] - The Phase 2b PLATEAU clinical study is planned to start in Q1 2026, focusing on older patients with obesity [1][12] - The company completed a public offering post fiscal year end, raising approximately $23.4 million [1][19] Clinical Development - The Phase 2b QUALITY study demonstrated that enobosarm, when combined with GLP-1 RA, selectively promotes fat loss while preserving lean mass and physical function in older patients [4][17] - The FDA has confirmed that enobosarm 3 mg is an acceptable dosage for future clinical development [11] - The Phase 2b PLATEAU study will evaluate the effects of enobosarm on body weight, physical function, and safety in patients aged 65 and older with a BMI of 35 or higher [12][13] Financial Performance - For fiscal year 2025, research and development expenses increased to $15.6 million from $12.8 million, while general and administrative expenses decreased to $19.9 million from $24.6 million [14] - The operating loss from continuing operations decreased to $24.8 million from $36.2 million [14] - The net loss from continuing operations decreased to $15.7 million, or $1.07 per share, compared to $35.3 million, or $2.61 per share in the previous year [19]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company will host a conference call on December 17, 2025, to discuss its fiscal year 2025 financial results and provide a business update [1] Company Overview - Veru's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm combined with semaglutide led to greater fat loss and preservation of lean mass in older patients [4] - The upcoming Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [5] - The primary efficacy endpoint of the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [1] - The company announced multiple presentations at the SCWD 18 International Conference and the Regulatory Workshop in Rome, Italy [1] Presentation Details - Mitchell Steiner, Veru Inc.'s Chairman, President & CEO, will present "The Veru Experience" on December 12, 2025, from 4:30 pm to 4:45 pm Central European Time [2] - Another presentation by Mitchell Steiner titled "Enobosarm" will take place on December 13, 2025, from 10:00 am to 10:15 am Central European Time [2] Regulatory Workshop Insights - The Regulatory Workshop will cover treatment approaches to address muscle wasting in obesity therapy, including comments from industry representatives and regulatory considerations from EMA and FDA [3] - A discussion on possible endpoints for regulatory approval of treatments addressing muscle wasting will also be held, featuring various industry approaches including Veru's [4][5] Drug Development Focus - Veru's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [6] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction while preserving lean mass during GLP-1 RA treatment [6] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [6] Clinical Study Updates - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass in older patients [7] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [8] - The primary efficacy endpoint for the PLATEAU study is the percent change from baseline in total body weight at 72 weeks, with an interim analysis at 36 weeks [8][9]