Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company is advancing its lead program, Enobosarm, which is in the Phase 2b QUALITY study, aimed at improving body composition and physical function in obesity treatment [2][3] - The Virtual Investor KOL segment features discussions on obesity treatment, GLP-1s, and the unmet needs in the current treatment landscape [2] 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) designed to enhance weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss while preserving lean mass [3] - Sabizabulin is being developed as a microtubule disruptor for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Development - The Phase 2b QUALITY study of Enobosarm aims to provide topline clinical data that could inform future Phase 3 studies [2][4] - Discussions in the Virtual Investor segment highlight the potential of Enobosarm to help prevent fat regain and improve outcomes for obesity patients [2][4] - The company is also exploring the development of a modified-release formulation of Enobosarm, with plans for a Phase 1 study [4][5]

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]

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 focusing on its obesity program, specifically the drug candidates enobosarb and sebisibulin, with a significant emphasis on the Phase 2b quality clinical study for enobosarb [5][16] - The Phase 2b clinical trial demonstrated a 71% preservation of total lean body mass in patients receiving enobosarb plus semaglutide versus placebo plus semaglutide [10] - Enobosarb treatment resulted in a 46% greater relative loss of fat mass compared to placebo plus semaglutide, indicating a shift towards more selective fat loss [11] Market Data and Key Metrics Changes - The prevalence of obesity 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 in the United States [22] - Sarcopenic obesity, characterized by obesity and low muscle mass, poses a significant risk for older patients, highlighting the market potential for the company's drug candidates [22] 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 [16][30] - The company aims to propose a Phase 3 clinical program that is similar to the positive Phase 2b quality trial, targeting older patients with obesity or overweight [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in having sufficient cash to last into the fourth quarter of the calendar year, allowing time to navigate upcoming clinical data releases and regulatory meetings [34] - The company is in active discussions for potential partnerships to secure non-dilutive funding for the Phase 3 program, emphasizing the unique value proposition of its drug candidates [37] - Management highlighted the importance of demonstrating the ability to maintain muscle mass while promoting fat loss, which is a key differentiator in the obesity treatment landscape [38] Other Important Information - The company recognized a gain on the sale of NTAPI assets of $974,000, contributing positively to its financial results [24] - The cash generated from the sale of the FC2 business was approximately $16.3 million, which will support ongoing operations and drug development efforts [30] Q&A Session Summary Question: Could you talk about your cash balance and runway options for funding the Phase 3? - Management indicated that there is enough cash to last into the fourth quarter and is exploring non-dilutive funding options, including partnerships with large pharmaceutical companies [34][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 after stopping GLP-1 treatment [46][50] Question: What is the expected size of the Phase 3 study and concerns regarding tariffs? - The Phase 3 study is expected to involve approximately 400 patients, and management does not foresee significant tariff-related issues affecting the cost of goods for enobosarb [58][59]

[Q2 2025 Financial Results and Clinical Update](index=1&type=section&id=Veru%20Reports%20Fiscal%202025%20Second%20Quarter%20Financial%20Results%20and%20Clinical%20Program%20Progress) Veru reported Q2 FY2025 financial results and clinical program updates, with key enobosarm data and FDA meeting expected in Q2/Q3 2025 [Overview and Upcoming Catalysts](index=1&type=section&id=Veru%20Reports%20Fiscal%202025%20Second%20Quarter%20Financial%20Results%20and%20Clinical%20Program%20Progress) Veru reported Q2 FY2025 results and clinical updates, with key enobosarm data and FDA meeting expected in Q2/Q3 2025 - Unblinded safety data from the Phase 2b QUALITY study is expected in **Q2 2025**[1](index=1&type=chunk) - Topline efficacy and safety data for the Phase 2b extension maintenance study, evaluating enobosarm's effect post-GLP-1 treatment, is also expected in **Q2 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) - Veru plans an End of Phase 2 meeting with the FDA in **Q3 2025** to discuss the Phase 3 program for enobosarm[2](index=2&type=chunk) [Clinical Program Progress](index=1&type=section&id=Clinical%20Program%20Progress) Veru advanced its enobosarm program with positive Phase 2b results and initiated a Phase 3 path, while exploring sabizabulin for atherosclerosis with a planned H1 2026 IND submission [Enobosarm Program (Cardiometabolic)](index=1&type=section&id=Enobosarm%20Program) The enobosarm Phase 2b QUALITY study met its primary endpoint, preserving lean muscle and augmenting fat loss, with a Phase 3 program and new formulation underway [Phase 2b QUALITY Study Results](index=1&type=section&id=Positive%20Phase%202b%20QUALITY%20clinical%20study) The Phase 2b QUALITY study met its primary endpoint, showing enobosarm significantly reduced lean mass loss by **71%** and improved fat-selective weight loss - The trial met its primary endpoint with a **71% relative reduction** in lean mass loss for enobosarm + semaglutide versus placebo + semaglutide (p=0.002)[4](index=4&type=chunk) - The **3mg enobosarm dose** achieved a **>99% mean relative reduction** in lean mass loss (p <0.001)[4](index=4&type=chunk) - Enobosarm shifted weight loss composition to be more fat-selective, with the 3mg group showing **99.1% fat** and **0.9% lean mass** loss versus 68% fat and 32% lean mass in placebo[5](index=5&type=chunk) - Enobosarm treatment led to a **54.4% relative reduction** in patients experiencing a clinically significant decline in stair climb power (p=0.0049), preserving physical function[6](index=6&type=chunk) [Safety, Extension Study, and Regulatory Path](index=3&type=section&id=Phase%202b%20QUALITY%20Clinical%20Trial%20Safety) Unblinded safety data for the Phase 2b QUALITY study and extension study results are expected this quarter, with an FDA End of Phase 2 meeting planned - Unblinded safety data for the Phase 2b QUALITY study will be available in **Q2 2025**[8](index=8&type=chunk) - A Phase 2b extension study evaluating enobosarm's ability to maintain muscle and prevent fat regain post-semaglutide is expected to report topline results this quarter[9](index=9&type=chunk) - The company plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 program[10](index=10&type=chunk) [Phase 3 Program and Formulation Development](index=3&type=section&id=Regulatory%20Next%20Steps) The proposed Phase 3 trial will assess physical function in GLP-1 RA patients, while a new enobosarm formulation with patent protection until **2045** is under development - The proposed Phase 3 trial's primary objective is assessing physical function via the Stair Climb Test at **24 weeks**[11](index=11&type=chunk) - The Phase 3 study plans to include patients treated with WEGOVY (semaglutide) and/or Zepbound® (tirzepatide)[11](index=11&type=chunk) - A new modified-release oral formulation of enobosarm is under development, with an expected patent expiry of **2045**, and is anticipated for Phase 3 studies[13](index=13&type=chunk) [Atherosclerosis Inflammation Program (Sabizabulin)](index=4&type=section&id=Atherosclerosis%20Inflammation%20Program) Veru is exploring sabizabulin for atherosclerotic cardiovascular disease, positioning it as a safer alternative to colchicine, with a Phase 2 IND submission planned by **H1 2026** - Veru is exploring sabizabulin for treating inflammation in atherosclerotic cardiovascular disease, addressing residual inflammatory risk not managed by cholesterol-lowering therapies[15](index=15&type=chunk)[16](index=16&type=chunk) - Sabizabulin has a similar mechanism to colchicine but may be safer due to lower potential for drug-drug interactions with cardiovascular drugs like statins[18](index=18&type=chunk) - The FDA agreed with the general design of a proposed small Phase 2 study using coronary CT angiography imaging as the primary endpoint during a pre-IND meeting[21](index=21&type=chunk) - Veru plans to submit a new IND for this indication by **H1 2026**, following completion of chronic nonclinical toxicology studies requested by the FDA[21](index=21&type=chunk) [Financial Results](index=5&type=section&id=Financial%20Results) Veru reported a Q2 FY2025 net loss of **$7.9 million**, an improvement year-over-year, with total assets at **$32.7 million** and cash at **$20.0 million** as of March 31, 2025 [Financial Highlights](index=5&type=section&id=Second%20Quarter%20Financial%20Summary%3A%20Fiscal%202025%20vs%20Fiscal%202024) Veru reported a Q2 FY2025 net loss of **$7.9 million**, an improvement from prior year, with cash and equivalents at **$20.0 million** as of March 31, 2025 - Cash, cash equivalents, and restricted cash totaled **$20.0 million** as of March 31, 2025, down from **$24.9 million** as of September 30, 2024[24](index=24&type=chunk) Q2 FY2025 vs Q2 FY2024 Financial Summary | Metric | Q2 FY2025 ($M) | Q2 FY2024 ($M) | | :--- | :--- | :--- | | R&D Expenses | $3.9 | $3.0 | | SG&A Expenses | $5.2 | $5.9 | | Operating Loss from Cont. Ops | $8.1 | $8.9 | | Net Loss from Cont. Ops | $7.9 | $8.7 | | Net Loss | $7.9 | $10.0 | YTD FY2025 vs YTD FY2024 Financial Summary | Metric | YTD FY2025 ($M) | YTD FY2024 ($M) | | :--- | :--- | :--- | | R&D Expenses | $9.6 | $4.6 | | SG&A Expenses | $10.4 | $12.6 | | Operating Loss from Cont. Ops | $18.4 | $16.3 | | Net Loss from Cont. Ops | $9.7 | $16.4 | | Net Loss | $16.8 | $18.3 | [Condensed Consolidated Financial Statements](index=8&type=section&id=FINANCIAL%20SCHEDULES%20FOLLOW) The condensed financial statements show total assets of **$32.7 million** and stockholders' equity of **$21.0 million** as of March 31, 2025, with a **$16.8 million** net loss for the six months Condensed Balance Sheet | Balance Sheet (Condensed) | March 31, 2025 ($M) | September 30, 2024 ($M) | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $20.0 | $24.9 | | Total current assets | $21.4 | $35.2 | | Total assets | $32.7 | $60.4 | | Total current liabilities | $5.6 | $11.9 | | Total liabilities | $11.6 | $28.1 | | Total stockholders' equity | $21.0 | $32.3 | Condensed Statement of Operations | Statement of Operations (Condensed) | Six Months Ended Mar 31, 2025 ($M) | Six Months Ended Mar 31, 2024 ($M) | | :--- | :--- | :--- | | Total operating expenses | $20.0 | $17.2 | | Operating loss | $(18.4) | $(16.3) | | Net loss from continuing operations | $(9.7) | $(16.4) | | Net loss | $(16.8) | $(18.3) | | Net loss per share ($) | $(0.12) | $(0.15) | Condensed Statement of Cash Flows | Statement of Cash Flows (Condensed) | Six Months Ended Mar 31, 2025 ($M) | Six Months Ended Mar 31, 2024 ($M) | | :--- | :--- | :--- | | Net cash used in operating activities | $(19.1) | $(11.7) | | Net cash provided by (used in) investing activities | $18.4 | $(0.04) | | Net cash (used in) provided by financing activities | $(4.2) | $36.8 | | Net decrease in cash | $(4.9) | $25.1 | | Cash at end of period | $20.0 | $34.7 |

Core Insights - Veru Inc. announced positive topline efficacy data from the Phase 2b QUALITY study, which demonstrated that enobosarm in combination with GLP-1 receptor agonists can lead to selective fat loss while preserving lean mass [3][4][8] - The company plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program, expected to provide regulatory clarity [2][11] - Financial results for the second quarter of fiscal 2025 showed a decrease in net loss compared to the previous year, indicating improved financial performance [27][34] Clinical Development - The Phase 2b QUALITY study showed a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide [4] - The enobosarm 3mg + semaglutide combination resulted in a >99% mean relative reduction in lean mass loss, outperforming the 6mg dose [4] - The ongoing Phase 2b extension maintenance study aims to evaluate the effects of stopping GLP-1 receptor agonist treatment while continuing enobosarm [10] Safety and Efficacy - Unblinded safety data from the Phase 2b QUALITY study is expected to be released soon, with no significant safety concerns reported so far [9] - The treatment with enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [5] - Enobosarm treatment preserved lean mass, leading to a shift in body composition towards greater fat loss [5][8] Financial Performance - For the second quarter of fiscal 2025, research and development expenses increased to $3.9 million from $3.0 million, while selling, general, and administrative expenses decreased to $5.2 million from $5.9 million [27] - The net loss from continuing operations decreased to $7.9 million, or $0.05 per share, compared to $8.7 million, or $0.06 per share in the previous year [27][34] - Cash and cash equivalents were reported at $20.0 million as of March 31, 2025, down from $24.9 million as of September 30, 2024 [24] Future Plans - The company is developing a novel modified release oral formulation of enobosarm, expected to enter Phase 1 bioavailability clinical trials in the first half of 2025 [14] - A Phase 3 clinical program is planned, focusing on older patients with obesity or overweight, assessing the effect of enobosarm on physical function and body composition [12][21] - Veru is exploring the clinical development of sabizabulin for treating inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [15][19]

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 Development - 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] - The Phase 2b QUALITY clinical trial demonstrated a statistically significant 71% relative reduction in lean mass loss for patients receiving enobosarm combined with semaglutide compared to placebo [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass [5] - Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [6] - The median total body weight loss in the enobosarm + semaglutide group was 90.6% fat loss compared to 68% in the placebo + semaglutide group, indicating a shift towards greater fat loss [6] Physical Function and Safety - The Stair Climb Test indicated that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% mean relative reduction in this decline [8] - Safety data for the Phase 2b QUALITY study remains blinded, with no significant differences noted compared to previous studies of enobosarm [9] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, with a safety database consisting of 266 dosed patients [13] - A Phase 2 dose-finding proof of concept study is planned to assess the drug's efficacy in reducing inflammation associated with coronary artery disease [15]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [2][10] - The company will present at the 2nd Annual GLP-1-Based Therapeutics Summit from April 29 to May 1, 2025, in Boston, Massachusetts [1] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by GLP-1 RA drugs, focusing on fat loss while preserving lean mass [2][3] - The Phase 2b QUALITY clinical trial demonstrated a 71% relative reduction in lean mass loss for patients receiving enobosarm with semaglutide compared to placebo [4] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in lean mass loss, indicating significant efficacy [4] Clinical Trial Results - Secondary endpoints indicated that enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide [5] - The median total body weight loss in the placebo + semaglutide group was 32% lean mass and 68% fat loss, while the enobosarm + semaglutide group had 9.4% lean mass and 90.6% fat loss, showing a shift towards greater fat loss [5] - The study found that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% reduction in this decline [6][7] Safety and Future Studies - Safety data from the Phase 2b QUALITY study remains blinded, with an unblinded complete safety set expected after the ongoing extension study [8] - The Phase 2b extension trial will evaluate enobosarm's ability to maintain muscle and prevent fat regain after discontinuing semaglutide, with topline results expected in Q2 2025 [9] Sabizabulin Development - Veru is exploring sabizabulin for treating inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [10][13] - Sabizabulin has shown broad anti-inflammatory activity in previous studies and may be combined with statin therapy for enhanced efficacy [12] - The company plans to submit a new IND for sabizabulin in the first half of 2026, with ongoing preclinical studies [14]

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 Program - 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] - The Phase 2b QUALITY clinical trial demonstrated a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide at 16 weeks (p=0.002) [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass (p <0.001) [5] - Enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks (p=0.014) [6] - The median total body weight loss in the placebo + semaglutide group was 32% lean mass and 68% fat loss, while in the enobosarm + semaglutide group, it was 9.4% lean mass and 90.6% fat loss, indicating a 33.2% greater fat loss [6] - The study also found that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% mean relative reduction in this decline (p=0.0049) [8] Sabizabulin Program - Sabizabulin is being explored for the treatment of inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, including Phase 2 and 3 pulmonary inflammation COVID-19 clinical studies [13] - The company plans to submit a new IND for sabizabulin in atherosclerotic coronary artery disease by the first half of calendar 2026 [14]

Core Viewpoint - Veru Inc. (VERU) has experienced a significant downtrend with a 9.2% decline over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to analysts' positive earnings outlook [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - VERU's current RSI reading is 25.85, indicating that the heavy selling pressure may be exhausting, which could lead to a price rebound [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts regarding an increase in earnings estimates for VERU, with a 14.3% rise in the consensus EPS estimate over the last 30 days [6]. - An upward trend in earnings estimate revisions is generally associated with price appreciation in the near term, supporting the case for a potential rebound in VERU's stock price [6]. Group 3: Analyst Ratings - VERU holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [7].

Financial Data and Key Metrics Changes - The net loss for continuing operations was $1.8 million or $0.01 per diluted common share, compared to a net loss of $7.7 million or $0.08 per diluted common share in the prior year's quarter [45] - Research and development costs increased to $5.7 million from $1.7 million in the prior quarter, primarily due to expenses related to the enobosarm Phase 2b QUALITY clinical study [43] - Selling, general and administrative expenses decreased to $5.2 million from $6.7 million in the prior quarter, attributed to a decrease in share-based compensation and headcount [44] Business Line Data and Key Metrics Changes - The company sold its FDA-approved commercial product, the FC2 female condom, for $18 million, allowing it to focus exclusively on drug development [6][38] - The sale resulted in a loss of approximately $4.2 million, reflecting a change in strategy to concentrate on biopharmaceuticals [41][42] Market Data and Key Metrics Changes - The obesity program targets a significant market, with 22% of the U.S. population over 60 years old, and 41.5% of older adults classified as obese [9][10] - The Phase 2b QUALITY clinical study showed a 71% relative reduction in lean mass loss for patients receiving enobosarm plus semaglutide compared to placebo [12] Company Strategy and Development Direction - The company is advancing its drug development strategy for enobosarm and sabizabulin, focusing on cardiometabolic and inflammatory diseases [5][28] - Plans to request an end of Phase 2b meeting with the FDA and to run a similar study as a Phase III trial based on the successful Phase 2b results [25] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the top-line results from the Phase 2b QUALITY study, indicating potential for improved quality weight reduction and muscle preservation [21] - The independent data monitoring committee recommended continuing the study based on the unblinded safety data, indicating confidence in the ongoing clinical trials [23] Other Important Information - The company has sufficient cash to fund operations until the end of the calendar year, but additional capital will be needed to support drug development candidates [48][96] - The Phase 2b extension trial will evaluate whether enobosarm alone can maintain muscle and prevent fat regain after discontinuing GLP-1 receptor agonist therapy [24] Q&A Session Summary Question: What is the dropout rate for the extension trial? - The dropout rate is about 13%, primarily due to gastrointestinal side effects associated with GLP-1 receptor agonists [55] Question: What are the expectations for the extension trial data? - The focus is on whether enobosarm can minimize fat regain while maintaining muscle mass, with an emphasis on fat loss as the primary endpoint [64][66] Question: Will the full safety data be reported when the extension study results are released? - Yes, the full safety data set will be reported when the Phase 2b extension study is unblinded [114]