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]

MIAMI, FL, April 16, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced that the Company will present at the 2nd Annual GLP-1-Based Therapeutics Summit, taking place April 29 - May 1, 2025, in Boston, Massachusetts. Presentation Title: Phase 2b QUALITY Clinical Study: Enobosarm Preserved Lean Mass and Physical Function in Older Patients Re ...

A recording will be accessible one day after the conclusion of the conference on the Company's website at www.verupharma.com. To attend the fireside chat or conference please email Jones Trading at mdoyle@jonestrading.com. About Veru Inc. Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabuli ...

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]

Financial Performance - The company reported net revenues from discontinued operations of $4,484,591 for the three months ended December 31, 2024, compared to $2,140,726 for the same period in 2023, representing an increase of approximately 109%[39]. - The cost of sales for the discontinued operations was $2,900,514 for the three months ended December 31, 2024, compared to $990,274 in 2023, resulting in a gross profit of $1,584,077, up from $1,150,452[39]. - The company reported a net loss from discontinued operations of $7,135,444 for the three months ended December 31, 2024, compared to a net loss of $608,598 in the same period of 2023[39]. - The company incurred a loss on the sale of the FC2 business amounting to $4,204,435, which contributed to an operating loss of $3,722,345 for the three months ended December 31, 2024[39]. - Total operating expenses for the discontinued operations were $1,101,987 in Q4 2024, a decrease from $1,641,283 in Q4 2023, indicating a reduction of approximately 33%[39]. Cash Flow and Financing - Cash, cash equivalents, and restricted cash on hand at December 31, 2024, was $26.6 million, an increase from $24.9 million at September 30, 2024, with working capital at $22.0 million[151]. - Operating activities used cash of $11.3 million in the three months ended December 31, 2024, including a net loss of $8.9 million and adjustments totaling an increase of $1.1 million[154]. - The company has substantial doubt regarding its ability to continue as a going concern for at least twelve months following the issuance date of the financial statements due to negative cash flow from operations[32]. - The company plans to finance its operations through public or private equity offerings, debt financing transactions, and/or other capital sources to address its cash needs[31]. - The Company completed a public offering of 52,708,332 shares at a price of $0.72 per share, resulting in net proceeds of approximately $35.2 million[166]. Asset Sales and Liabilities - The purchase price for the FC2 Business Sale was $18.0 million in cash, with expected net proceeds of $16.4 million after adjustments and costs[34]. - The company completed the sale of its FC2 female condom business for a purchase price of $18.0 million, with expected net proceeds of $16.4 million after costs and adjustments[136]. - The company entered into an agreement to resolve a commercial dispute with a supplier, agreeing to pay $8.3 million, with $2.3 million payable upon execution and the remainder in installments[93]. - The company recognized a gain on extinguishment of debt of $8.6 million related to the change of control payment of $4.2 million made on December 30, 2024[56]. - The company had a total residual royalty agreement liability of $9,876,629 as of December 31, 2024, which included an embedded derivative liability[58]. Research and Development - Research and development expenses increased significantly to $5.7 million for the three months ended December 31, 2024, compared to $1.7 million in the same period in 2023, primarily due to the Phase 2b QUALITY clinical trial[145]. - The Phase 2b QUALITY clinical trial for enobosarm received FDA clearance and enrolled 168 subjects, focusing on preserving muscle and reducing fat in older patients[113]. - The proposed Phase 3 clinical trial will focus on older patients (>60 years) with obesity or overweight, assessing the effect of enobosarm on physical function and body composition[120]. - The company is developing enobosarm and sabizabulin for cardiometabolic and inflammatory diseases, with enobosarm targeting muscle loss in sarcopenic obese patients[107][108]. - The anticipated expenditure for the ASCVD program, including chronic toxicology animal studies, is approximately $2 million through the first half of calendar 2026[133]. Clinical Trials and Regulatory Challenges - The company may experience delays in planned clinical trials, which could be interrupted, delayed, suspended, or terminated once commenced[194]. - Regulatory approval has not been obtained for any of the company's drug candidates to date, which may impact future commercialization efforts[196]. - The company plans to conduct a Phase 2 clinical study of sabizabulin with approximately 120 patients randomized into three treatment groups, focusing on a primary endpoint of percent change in low attenuation non-calcified plaque volume in coronary arteries[133]. - The company relies on contract research organizations (CROs) and third-party manufacturers for its research and development activities and drug candidates[181]. - Any delays or issues with CROs could significantly impact the company's ability to obtain regulatory approval and commercialize drug candidates[205]. Market and Competitive Landscape - Physicians' acceptance of drug candidates is critical for revenue generation, and factors such as safety, efficacy, and competition will influence this acceptance[219]. - Market acceptance and sales of drug candidates depend on coverage and reimbursement policies, which may be influenced by health care reform measures[218]. - Governmental pricing controls in foreign markets and potential U.S. proposals could adversely affect product launch likelihood and profitability[220]. - The company may face claims or investigations relating to business practices, which could result in substantial legal fees and divert management's attention[185]. - The company has identified two material weaknesses in its internal control over financial reporting, which were remediated, but there is a risk of identifying additional weaknesses in the future[190].

Clinical Trial Results - Company reported positive topline results from the Phase 2b QUALITY study, achieving a 71% relative reduction in lean mass loss at 16 weeks (p=0.002) for enobosarm + semaglutide compared to placebo + semaglutide[6]. - Enobosarm 3mg + semaglutide demonstrated a >99% mean relative reduction in loss of lean mass (p <0.001) and a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks (p=0.014)[6][7]. - The median percentage of total body weight loss due to lean mass in the placebo + semaglutide group was 32%, while in the enobosarm + semaglutide group, it was only 9.4%[7]. - The Independent Data Monitoring Committee recommended continuing the QUALITY extension study as designed, based on the unblinded safety data evaluation[10]. - The Phase 2b extension study results are expected in the second quarter of calendar 2025, focusing on fat regain prevention after discontinuation of GLP-1 RA[11]. Future Development Plans - Company plans to request an end of Phase 2 meeting with the FDA based on the successful Phase 2b QUALITY trial, with a Phase 3 study duration expected to be 52 weeks[13]. - Veru is developing a novel modified release formulation for enobosarm, anticipated to enter Phase 1 bioavailability clinical trials in the first half of calendar 2025[14]. - Company is exploring the clinical development of sabizabulin for treating inflammation in atherosclerotic coronary artery disease, addressing a significant unmet medical need[15][20]. - The FDA has agreed on the general design of a small Phase 2 study for sabizabulin, with a new IND submission planned for the first half of calendar 2026[21]. Financial Performance - Company sold the FC2 Female Condom® business for $18 million, indicating a strategic shift in focus[2]. - Research and development expenses increased to $5.7 million from $1.7 million, while selling, general and administrative expenses decreased to $5.2 million from $6.7 million[27]. - Operating loss from continuing operations increased to $10.2 million from $7.4 million, but net loss from continuing operations decreased to $1.8 million, or $0.01 per share, compared to $7.7 million, or $0.08 per share[27]. - Cash, cash equivalents, and restricted cash were $26.6 million as of December 31, 2024, compared to $24.9 million as of September 30, 2024[27]. - Liabilities associated with the Residual Royalty Agreement, totaling $9.9 million as of September 30, 2024, were extinguished due to the sale of the FC2 business[27]. Market Potential - Enobosarm is being developed as a next-generation drug to improve body composition and physical function, targeting a large market of older adults with obesity[28]. - The clinical condition of sarcopenic obesity affects up to 34% of obese patients over the age of 60, indicating a significant potential market for weight loss medications[29]. - Enobosarm has a large safety database from 27 clinical trials involving 1,581 participants, demonstrating it was generally well tolerated[32]. - The Company anticipates that enobosarm in combination with GLP-1 RA drugs could enhance fat reduction while preserving muscle mass[31]. Financial Summary - Net loss for the three months ended December 31, 2024, was $8,945,347, compared to a net loss of $8,275,981 for the same period in 2023, representing an increase in loss of approximately 8.1%[39]. - Total operating expenses increased to $10,943,943 in Q4 2024 from $8,310,198 in Q4 2023, marking a rise of about 31.5%[39]. - Research and development expenses surged to $5,716,830 in Q4 2024, up from $1,658,574 in Q4 2023, reflecting a significant increase of approximately 244%[39]. - The company reported a net cash used in operating activities of $11,332,987 for Q4 2024, compared to $6,020,389 in Q4 2023, indicating a 88.5% increase in cash outflow[41]. - Cash, cash equivalents, and restricted cash at the end of the period were $26,607,002, down from $40,579,059 at the end of Q4 2023, a decrease of approximately 34.4%[41]. - The company recorded a gain on extinguishment of debt amounting to $8,624,778 in Q4 2024, which was not present in Q4 2023[39]. - The basic and diluted net loss per common share from continuing operations improved to $(0.01) in Q4 2024 from $(0.08) in Q4 2023[39]. - Total non-operating income for Q4 2024 was $8,438,824, compared to a non-operating expense of $(275,557) in Q4 2023, indicating a significant turnaround[39]. - The company experienced a net loss from discontinued operations of $7,135,444 in Q4 2024, compared to $608,598 in Q4 2023, reflecting a substantial increase in loss[39]. - The weighted average common shares outstanding increased to 146,383,920 in Q4 2024 from 100,601,946 in Q4 2023, representing a growth of approximately 45.5%[39]. Risks and Challenges - Forward-looking statements indicate potential risks related to product development, regulatory approvals, and market competition[33].

Group 1: Clinical Study Results - The company reported positive topline results from the Phase 2b QUALITY study, achieving the primary endpoint of preserving lean mass while also demonstrating greater fat loss and improved physical function in older patients receiving semaglutide [1][2][3] - The enobosarm 3mg + semaglutide combination showed a >99% mean relative reduction in lean mass loss, while the enobosarm 6mg + semaglutide did not outperform the 3mg dose [3][4] - The study indicated that enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide, with a significant shift in body composition favoring fat loss [4][6] Group 2: Safety and Regulatory Updates - The Independent Data Monitoring Committee recommended continuing the Phase 2b QUALITY extension study based on unblinded safety data [1][7] - The company plans to request an end of Phase 2 meeting with the FDA to discuss the regulatory path forward for enobosarm as a body composition drug [10] - A new modified release formulation of enobosarm is under development, with plans for a Phase 1 bioavailability clinical trial in the first half of 2025 [11] Group 3: Financial Performance - The company reported a net loss from continuing operations of $1.8 million, or $0.01 per share, compared to a loss of $7.7 million, or $0.08 per share in the previous year [25][36] - Research and development expenses increased to $5.7 million from $1.7 million, while selling, general, and administrative expenses decreased to $5.2 million from $6.7 million [25] - Cash, cash equivalents, and restricted cash were $26.6 million as of December 31, 2024, compared to $24.9 million as of September 30, 2024 [25][35] Group 4: Business Developments - The company sold the FC2 Female Condom® business for $18 million, resulting in estimated net proceeds of approximately $12.3 million after adjustments [1][21] - The company is exploring the development of sabizabulin for treating inflammation in atherosclerotic coronary artery disease, addressing a significant unmet medical need [12][18] - The FDA has acknowledged the unmet medical need for sabizabulin in treating atherosclerotic disease and agreed with the proposed study design for a small Phase 2 trial [19]

Core Viewpoint - Veru Inc. is advancing its clinical development of enobosarm, a selective androgen receptor modulator, aimed at preserving muscle mass and enhancing fat loss in elderly patients with sarcopenic obesity, particularly those receiving GLP-1 receptor agonists for weight loss [4][10][12]. Company Updates - Veru Inc. will host a conference call on February 13, 2025, to discuss its fiscal 2025 first quarter financial results and provide a business update [1]. - The company plans to request an end of Phase 2 meeting with the FDA following positive topline results from the Phase 2b QUALITY clinical trial [9]. Clinical Trial Insights - The Phase 2b QUALITY clinical trial involved 168 patients and evaluated the efficacy of enobosarm in preserving lean body mass and promoting fat loss [3]. - The trial met its primary endpoint, showing a 71% relative reduction in lean mass loss for patients receiving enobosarm with semaglutide compared to placebo [4]. - Enobosarm 3mg combined with semaglutide demonstrated a >99% mean relative reduction in lean mass loss, while the 6mg dose did not show additional benefits [4]. Secondary Endpoint Results - Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo at the 6mg dose [5]. - The composition of weight loss shifted significantly, with enobosarm + semaglutide leading to 90.6% fat loss compared to 68% in the placebo group [5]. Physical Function Assessment - The Stair Climb Test indicated that 54.4% of patients on enobosarm + semaglutide experienced a significant reduction in the decline of physical function compared to those on placebo [6]. Safety and Future Studies - Safety data from the ongoing extension study remains blinded, with no significant differences noted compared to previous studies of enobosarm [8]. - The complete safety data will be available after the Phase 2b extension study concludes in April 2025 [8]. Market Potential - The market for sarcopenic obesity is substantial, with 22% of the US population over 60 years old and 42% of older adults classified as obese [10]. - Up to 34% of obese patients over 60 may have sarcopenic obesity, highlighting the need for effective treatments [10].

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle during weight loss, oncology, and viral-induced acute respiratory distress syndrome [13] - The company's drug development program includes enobosarm and sabizabulin, with enobosarm being a selective androgen receptor modulator (SARM) [14][15] Clinical Trials and Results - The Phase 2b QUALITY clinical trial evaluated enobosarm in combination with semaglutide for preserving muscle and enhancing fat loss in 168 patients aged over 60 with sarcopenic obesity [3] - The trial met its primary endpoint, showing a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide at 16 weeks (p=0.002) [4] - Enobosarm 3mg + semaglutide demonstrated a >99% mean relative reduction in lean mass loss (p <0.001), while the 6mg dose did not show superior results [4] - Secondary endpoints indicated that enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks (p=0.014) [5] - The treatment improved body composition, with 90.6% of weight loss in the enobosarm + semaglutide group attributed to fat loss compared to 68% in the placebo group [5] Physical Function and Safety - The Stair Climb Test showed that 54.4% of patients in the enobosarm + semaglutide group had a significant reduction in the proportion of subjects losing at least 10% stair climb power compared to the placebo group (p=0.004) [6] - Safety data remains blinded, but no significant differences have been observed compared to previous studies of enobosarm [7] - An Independent Data Monitoring Committee recommended continuing the study based on unblinded safety data [8] Market Potential - The market for sarcopenic obesity is substantial, with 22% of the US population over 60 years old and 42% of older adults classified as obese [9] - Up to 34% of obese patients over 60 may have sarcopenic obesity, which poses risks when using GLP-1 drugs for weight reduction [9][10] Future Plans - Following positive topline results, the company plans to request an end of Phase 2 meeting with the FDA [8]