[Forward Looking Statements](index=4&type=section&id=Forward%20Looking%20Statements) This section outlines potential risks and uncertainties that could cause actual results to differ from forward-looking statements, including those related to product development, financial performance, and the company's ability to continue as a going concern - The company identifies its development and commercialization plans for enobosarm and sabizabulin as key areas subject to forward-looking risks[10](index=10&type=chunk) - Key risk factors that could cause actual results to differ from expectations include potential delays in clinical trials, failure to obtain FDA approval, and the ability to secure sufficient financing to continue as a going concern[11](index=11&type=chunk) - The company also highlights risks related to its history of losses, the fact it currently has no commercial revenue, and the potential for future material weaknesses in internal controls[14](index=14&type=chunk) PART I. FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the quarterly period ended March 31, 2025, including balance sheets, statements of operations, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining accounting policies and significant events [Unaudited Condensed Consolidated Balance Sheets](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2025, shows a significant decrease in total assets to $32.7 million from $60.4 million at September 30, 2024, primarily due to the sale of the FC2 business, which also reduced liabilities Condensed Consolidated Balance Sheet Data | Metric | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $20,018,392 | $24,916,285 | | Total Assets | $32,671,943 | $60,418,772 | | Total Liabilities | $11,624,710 | $28,102,060 | | Total Stockholders' Equity | $21,047,233 | $32,316,712 | [Unaudited Condensed Consolidated Statements of Operations](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported a net loss of $7.9 million, an improvement from $10.0 million in the prior-year period, with the six-month period showing a net loss of $16.8 million, improved by an $8.6 million gain on debt extinguishment Operating Results (Three Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $3,932,102 | $2,985,118 | | Operating loss from continuing operations | $(8,122,232) | $(8,888,791) | | Net loss | $(7,901,619) | $(10,025,948) | | Net loss per share | $(0.05) | $(0.07) | Operating Results (Six Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $9,648,932 | $4,643,693 | | Gain on extinguishment of debt | $8,624,778 | $0 | | Net loss from discontinued operations | $(7,184,670) | $(1,931,448) | | Net loss | $(16,846,966) | $(18,301,929) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended March 31, 2025, net cash used in operating activities was $19.1 million, offset by $18.4 million provided by investing activities, resulting in a net decrease in cash of $4.9 million Cash Flow Summary (Six Months Ended March 31, 2025) | Activity | Amount | | :--- | :--- | | Net cash used in operating activities | $(19,069,450) | | Net cash provided by investing activities | $18,393,168 | | Net cash used in financing activities | $(4,221,611) | | Net decrease in cash | $(4,897,893) | - The primary source of cash was **$16.3 million** from the sale of the FC2 business, while the main financing use was a **$4.2 million** payment to extinguish a residual royalty agreement[21](index=21&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies and significant events, including substantial doubt about going concern, the sale of the FC2 business, debt extinguishment, ongoing legal proceedings, and collection uncertainty from the ENTADFI asset sale - **Going Concern:** Management concluded there is substantial doubt about the company's ability to continue as a going concern for the next twelve months due to insufficient cash to fund operations (Note 2)[32](index=32&type=chunk)[33](index=33&type=chunk) - **Discontinued Operations:** The company sold its FC2 business on December 30, 2024, for **$18.0 million**, resulting in a loss on sale of **$4.2 million** (Note 3)[34](index=34&type=chunk)[35](index=35&type=chunk) - **Debt Extinguishment:** A **$4.2 million** payment was made to terminate the Residual Royalty Agreement, resulting in an **$8.6 million** gain on extinguishment of debt (Note 8)[57](index=57&type=chunk) - **Legal Proceedings:** The company faces several shareholder lawsuits related to statements about sabizabulin for COVID-19 and has resolved a commercial dispute with a supplier for **$8.3 million** (Note 12)[87](index=87&type=chunk)[94](index=94&type=chunk) - **ENTADFI Sale:** The company continues to face collection uncertainty from the sale of ENTADFI assets to ONCO, which has defaulted on payments and is operating under a forbearance agreement (Note 15)[100](index=100&type=chunk)[107](index=107&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift to focus on developing enobosarm for obesity and sabizabulin for atherosclerosis following asset divestitures, reviewing operating results, liquidity, and capital resources, and disclosing substantial doubt about its going concern ability [Overview and Drug Development Programs](index=28&type=section&id=Overview%20and%20Drug%20Development%20Programs) Veru has transitioned into a late-stage biopharmaceutical company focused on enobosarm for muscle loss in obesity and sabizabulin for atherosclerosis, reporting positive Phase 2b QUALITY study results for enobosarm and divesting commercial assets - The company's primary focus is now on two clinical-stage assets: enobosarm for preventing muscle loss in obese patients on GLP-1 RAs, and sabizabulin for treating inflammation in atherosclerotic cardiovascular disease[109](index=109&type=chunk)[133](index=133&type=chunk) - The Phase 2b QUALITY trial for enobosarm met its primary endpoint, demonstrating a statistically significant preservation of lean body mass (**71% relative reduction in lean mass loss**), and the company plans to request an End of Phase 2 meeting with the FDA[116](index=116&type=chunk)[123](index=123&type=chunk) - The FC2 business was sold on December 30, 2024, for **$18.0 million** in cash, resulting in a **$4.2 million** loss and the extinguishment of associated debt[139](index=139&type=chunk)[140](index=140&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) For the three months ended March 31, 2025, R&D expenses increased by $0.9 million, while SG&A decreased by $0.7 million, with the six-month period significantly impacted by an $8.6 million gain on debt extinguishment and a $7.2 million net loss from discontinued operations Change in Operating Expenses (Six Months Ended March 31) | Expense | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $9.6M | $4.6M | +$5.0M | | Selling, general and administrative | $10.4M | $12.6M | -$2.2M | - The increase in R&D expenses is primarily attributed to costs associated with the ongoing Phase 2b QUALITY clinical study for enobosarm[147](index=147&type=chunk)[152](index=152&type=chunk) - The six-month period includes a significant one-time gain of **$8.6 million** from the extinguishment of the Residual Royalty Agreement debt, related to the FC2 business sale[155](index=155&type=chunk) [Liquidity and Sources of Capital](index=35&type=section&id=Liquidity%20and%20Sources%20of%20Capital) As of March 31, 2025, the company held $20.0 million in cash, which management deems insufficient for the next 12 months, leading to substantial doubt about its going concern ability and a need for additional capital - The company had **$20.0 million** in cash, cash equivalents, and restricted cash at March 31, 2025[158](index=158&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern, as current cash is insufficient to fund operations for the next twelve months[159](index=159&type=chunk)[160](index=160&type=chunk) - During the six months ended March 31, 2025, investing activities provided **$18.4 million** (primarily from the FC2 sale), while operating activities used **$19.1 million** and financing activities used **$4.2 million**[161](index=161&type=chunk)[164](index=164&type=chunk)[166](index=166&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Following the sale of its FC2 business, the company is no longer subject to significant market risks related to raw material commodity prices or foreign currency exchange rates - After the FC2 Business Sale, the company is no longer exposed to significant market risk from raw material commodity prices or foreign currency exchange rate fluctuations[178](index=178&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, deemed the company's disclosure controls and procedures effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[179](index=179&type=chunk) - No material changes were made to the company's internal control over financial reporting during the most recently completed fiscal quarter[180](index=180&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) This section directs readers to Note 12 of the unaudited condensed consolidated financial statements for a detailed description of the company's material pending legal proceedings - For a description of material pending legal proceedings, the report refers to Note 12, Contingent Liabilities, in the financial statements[181](index=181&type=chunk) [Risk Factors](index=40&type=page&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive overview of significant risks facing the company, including those related to regulation, commercialization, financial position, business operations, intellectual property, and common stock ownership [Risks Related to Regulation and Commercialization](index=42&type=section&id=Risks%20Related%20to%20the%20Regulation%20and%20Commercialization%20of%20Our%20Products%20and%20Drug%20Candidates) The company faces substantial risks in regulation and commercialization, with no current commercial revenue and profitability dependent on obtaining regulatory approval for its drug candidates, alongside reliance on third-party CROs and manufacturers - The company currently has no commercial revenue and may never become profitable, as its future depends on the successful development and commercialization of its drug candidates[192](index=192&type=chunk) - The clinical development programs for enobosarm and sabizabulin are subject to significant risks, including trial delays, unfavorable results, and potential FDA disagreement with trial designs[205](index=205&type=chunk)[206](index=206&type=chunk) - Reliance on third-party CROs and manufacturers creates risks related to performance, quality control, and compliance with cGCP and cGMP standards[210](index=210&type=chunk)[213](index=213&type=chunk) [Risks Related to Financial Position and Need for Capital](index=50&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Capital) The company's financial position is precarious, marked by a history of net losses and a 'going concern' warning, requiring significant additional capital for operations and clinical trials, with uncertainty regarding future payments from the ENTADFI asset sale - The company's independent registered public accounting firm has issued a 'going concern' opinion, highlighting substantial doubt about its ability to continue operations due to losses and the need for additional funding[234](index=234&type=chunk) - Veru needs to raise substantial additional capital to fund its operations, particularly for pivotal Phase 3 trials, and failure to do so could force the company to curtail programs or cease operations[235](index=235&type=chunk) - There is significant uncertainty regarding the collection of remaining payments from ONCO for the ENTADFI sale, as ONCO has previously defaulted and is operating under a forbearance agreement[242](index=242&type=chunk)[243](index=243&type=chunk) [Risks Related to Business and Operations](index=53&type=section&id=Risks%20Related%20to%20Our%20Business) The company faces significant business and operational risks, including intense competition in the obesity treatment market, ongoing shareholder lawsuits, and potential disputes arising from the recent sale of the FC2 business - The company faces intense competition for its lead candidate, enobosarm, from major pharmaceutical companies with substantially greater resources[245](index=245&type=chunk)[246](index=246&type=chunk) - Veru is a defendant in several shareholder class action and derivative lawsuits, which could result in substantial legal fees and potential damages[257](index=257&type=chunk) - The sale of the FC2 business carries risks, including potential disputes over working capital adjustments and indemnification claims, with the purchaser already submitting an insurance claim alleging breaches of representations by Veru[270](index=270&type=chunk)[272](index=272&type=chunk) [Risks Relating to Intellectual Property](index=58&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) The company's success depends on protecting its intellectual property, facing risks that patents may expire, be invalidated, or not be granted, particularly for enobosarm, and is reliant on third-party licenses which could be terminated - The company's commercial success depends on its ability to obtain, maintain, and defend intellectual property rights, which is an uncertain process[274](index=274&type=chunk) - Intellectual property protection for enobosarm in the obesity market is not secure, as it relies on a pending method of use patent application that may not be granted or may be too narrow[285](index=285&type=chunk) - The company is dependent on license relationships for its key drug candidates, sabizabulin and enobosarm, and could lose the rights to these assets if it fails to comply with license obligations[286](index=286&type=chunk) [Risks Related to Ownership of Our Common Stock](index=62&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Stockholders face risks including high ownership concentration, a Nasdaq delisting notice for failing to maintain a minimum $1.00 bid price, and potential harm to investor confidence from past financial restatements and internal control weaknesses - As of May 5, 2025, executive officers and directors beneficially owned approximately **15.2%** of the company's common stock, giving them significant influence over corporate matters[296](index=296&type=chunk) - The company received a delisting notice from Nasdaq due to its stock price falling below **$1.00**, and has until August 25, 2025, to regain compliance, which may necessitate a reverse stock split[297](index=297&type=chunk)[298](index=298&type=chunk) - Previous financial restatements and identified material weaknesses in internal controls (though now remediated) pose risks to investor confidence and could lead to further legal or regulatory scrutiny[301](index=301&type=chunk)[302](index=302&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In March 2025, the company issued 200,000 shares of common stock to a third-party consultant, claiming exemption from registration under Section 4(a)(2) of the Securities Act of 1933 and/or Regulation D - The company issued **200,000 shares** of common stock to a third-party consultant in March 2025, claiming the transaction was exempt from registration[316](index=316&type=chunk) [Exhibits](index=66&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including the FC2 business sale agreement, ENTADFI asset purchase agreement amendments, corporate governance documents, and required certifications - Key filed exhibits include the purchase agreement for the FC2 Business Sale and limited waivers related to the Onconetix promissory notes[317](index=317&type=chunk)[320](index=320&type=chunk)

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]

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].