[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]

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 ...

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]

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]