Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company announced the presentation of two abstracts at ObesityWeek 2025, highlighting its drug enobosarm's potential in weight management [1][2] Company Overview - Veru Inc. is developing two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making fat loss more tissue-selective while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass in older patients [4] - The study involved 168 older patients (≥60 years) and showed that while weight loss was similar across treatment groups, the preservation of lean mass is expected to enhance energy expenditure [4] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients initiating GLP-1 RA treatment [5][6] - The primary efficacy endpoint for the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5][7]

Core Points - Veru Inc. announced a public offering of 1,400,000 shares of common stock, pre-funded warrants for 7,000,000 shares, and Series A and B warrants for 8,400,000 shares each, with a combined offering price of $3.00 per share [1][2] - The gross proceeds from the offering are expected to be approximately $25.2 million, with potential additional proceeds of about $50.4 million if all warrants are exercised [2] - The net proceeds will primarily fund the development of enobosarm, particularly for the Phase 2b PLATEAU clinical study, and will also cover working capital and general corporate purposes [3] Offering Details - The offering includes common stock, pre-funded warrants, and Series A and B warrants, all sold by Veru under a previously filed shelf registration statement [4] - The offering is expected to close on or about October 31, 2025, pending customary closing conditions [1] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [6]

Core Viewpoint - Veru Inc. has initiated an underwritten public offering of its common stock and related warrants to fund the development of its drug enobosarm, particularly for the Phase 2b PLATEAU clinical study [1][2]. Group 1: Offering Details - The public offering includes shares of common stock, pre-funded warrants, Series A warrants, and Series B warrants, all offered by Veru [1][3]. - The offering is subject to market conditions, and there is no guarantee regarding its completion or the terms [1]. - Canaccord Genuity LLC and Oppenheimer & Co. Inc. are the joint book-running managers for this offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily support the Phase 2b PLATEAU clinical study activities for enobosarm [2]. - Additional proceeds will be allocated for working capital, existing vendor obligations, and general corporate purposes, including collaboration with potential development partners for enobosarm [2]. Group 3: Regulatory Information - The offering is conducted under a shelf registration statement on Form S-3, which was filed with the SEC on March 16, 2023, and declared effective on April 14, 2023 [3]. - A preliminary prospectus supplement will be filed with the SEC and will be accessible on the SEC's website [3].

Group 1: AI Market and Stock Valuations - Concerns are rising on Wall Street regarding stock valuations amid the AI boom, drawing parallels to the dot-com bubble, yet analysts see no signs of slowing AI capital expenditures (CapEx) [1][2] - Analysts believe the AI-led growth is substantial and expect the rally to extend to AI applications, with the S&P 500 potentially reaching 7,000 [2][3] Group 2: DigitalBridge Group Inc (NYSE:DBRG) - DigitalBridge is viewed positively due to its exposure to AI and infrastructure, with expectations of significant embedded gains from technology investments [7][8] - The company is raising its third flagship digital infrastructure fund, which, if successful, could lead to a cheap stock price at current levels [8] Group 3: BlackRock Inc (NYSE:BLK) - BlackRock's assets under management (AUM) have grown to over $10.6 trillion, with a 15% increase in AUM and 13% revenue growth, positioning it as a leader in the ETF market [9][10] - The company is focusing on innovation and technology, which is reshaping wealth management and investment models [10][11] Group 4: Colgate-Palmolive Co (NYSE:CL) - Colgate is expected to see earnings recovery, with projected organic sales growth of 3-5% and a consistent dividend increase over 60 years [11][12] - The company is recognized for its strong capital allocation and significant free cash flow generation [13] Group 5: Repligen Corp (NASDAQ:RGEN) - Repligen is positioned well in the life sciences sector, with a focus on bioprocessing and a consistent growth rate of 8-12% per year [14][15] - The company is expected to benefit from increased drug approvals and a recovery in pharma orders, with anticipated sales growth of 15% in 2025 [15] Group 6: Expedia Group Inc (NASDAQ:EXPE) - Expedia is considered a top pick due to its cheap valuation, trading under market multiples, and potential for growth under new management [16] Group 7: ServiceNow Inc (NYSE:NOW) - ServiceNow is starting to monetize its AI tools, with a target of $1 billion in annual contract value from AI-related products by 2026 [17][18]

Core Viewpoint - Veru Inc. has received regulatory clarity from the FDA regarding enobosarm, a selective androgen receptor modulator, as a muscle preservation drug candidate in combination with GLP-1 RA for obesity treatment, allowing incremental weight loss as an acceptable primary endpoint for approval [2][3][5]. Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases, with enobosarm and sabizabulin as key drug candidates [9]. FDA Meeting Highlights - The FDA has indicated that incremental weight loss with enobosarm added to GLP-1 RA treatment is an acceptable primary endpoint for approval [2]. - Enobosarm 3mg has been confirmed as an acceptable dosage for future clinical development [2]. - The FDA has encouraged the expansion of the enobosarm development program to include younger populations with obesity [2]. Clinical Development Program - The Phase 2b PLATEAU clinical study will evaluate the effect of enobosarm 3mg on total body weight, physical function, and safety in approximately 180 older and younger patients initiating tirzepatide treatment for weight reduction [6][8]. - The primary efficacy endpoint is the percent change from baseline in total body weight at 72 weeks, with key secondary endpoints including total fat mass, total lean mass, and physical function [7]. Phase 2b QUALITY Study Insights - The Phase 2b QUALITY study demonstrated that enobosarm treatment preserved lean mass and improved physical function while leading to greater fat loss during the 16-week active weight loss period [3][10]. - Enobosarm monotherapy was able to prevent weight regain by 46% after discontinuation of semaglutide, resulting in greater fat loss compared to the placebo group [3]. Weight Loss Plateau Context - The weight loss plateau occurs when patients on GLP-1 RA stop losing weight; approximately 88% of patients in the SURMOUNT-1 study reached this plateau by 72 weeks [4]. - Combining tirzepatide with enobosarm is expected to lead to additional fat loss by preserving muscle and physical function, particularly in older patients [4].

Company Developments - Veru Inc. has selected a novel modified-release oral formulation of enobosarm for chronic weight loss management, which aims to enhance fat loss while preserving lean mass [1][4] - The new formulation was developed in collaboration with Laxxon Medical, utilizing proprietary SPID-Technology for advanced oral delivery profiles [2][3] - The modified-release formulation achieved a distinct target product release profile, including a reduction in maximum plasma concentration and a delayed time to maximum plasma concentration [3] - Veru holds a robust patent estate for the new formulation, with protection extending through 2037 and potential expiry of new patent applications expected in 2046 [4] Clinical Study Results - In a Phase 2b clinical study, enobosarm monotherapy reduced weight regain by 46% compared to placebo after discontinuation of semaglutide, while completely preventing fat regain and preserving lean mass [5] Industry Insights - The global anti-obesity drug market was valued at $4.51 billion in 2023 and is projected to grow at a compound annual growth rate of 25.5% through 2032, driven by the increasing prevalence of obesity [6] - Several companies, including Regeneron Pharmaceuticals and Eli Lilly, are advancing obesity treatments, indicating a competitive landscape in the anti-obesity drug market [7][9]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements for June 30, 2025, reflect decreased assets and equity, a $24.2 million net loss, an $8.6 million gain from debt extinguishment, and a going concern uncertainty Unaudited Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheet Data (Unaudited) | Metric | June 30, 2025 | September 30, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and restricted cash | $15,010,154 | $24,916,285 | | Total current assets | $16,193,177 | $35,223,224 | | Total assets | $27,330,758 | $60,418,772 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $6,682,015 | $11,867,968 | | Total liabilities | $11,986,125 | $28,102,060 | | Total stockholders' equity | $15,344,633 | $32,316,712 | - Total assets decreased from **$60.4 million** to **$27.3 million**, and total stockholders' equity decreased from **$32.3 million** to **$15.3 million** between September 30, 2024, and June 30, 2025, largely driven by the sale of discontinued operations (FC2 business) and continued net losses[15](index=15&type=chunk) Unaudited Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,020,563 | $4,846,156 | $12,669,495 | $9,489,848 | | Selling, general and administrative | $5,010,528 | $5,809,325 | $15,402,074 | $18,364,622 | | Operating loss from continuing operations | ($7,546,476) | ($10,545,481) | ($25,917,435) | ($26,826,098) | | Gain on extinguishment of debt | - | - | $8,624,778 | - | | Net loss | ($7,332,820) | ($10,968,874) | ($24,179,786) | ($29,270,803) | | Net loss per basic and diluted share | ($0.50) | ($0.75) | ($1.65) | ($2.23) | - For the nine months ended June 30, 2025, the company reported a net loss of **$24.2 million**, an improvement from the **$29.3 million** loss in the prior year period, primarily due to an **$8.6 million** gain on debt extinguishment related to the FC2 business sale[16](index=16&type=chunk) Unaudited Condensed Consolidated Statements of Stockholders' Equity - Total stockholders' equity decreased from **$32.3 million** at September 30, 2024, to **$15.3 million** at June 30, 2025, primarily driven by a net loss of **$24.2 million** over the nine-month period, partially offset by **$6.6 million** in share-based compensation[17](index=17&type=chunk)[20](index=20&type=chunk) Unaudited Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows (Unaudited, Nine Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($24,551,752) | ($17,316,239) | | Net cash provided by investing activities | $18,867,232 | $14,714 | | Net cash (used in) provided by financing activities | ($4,221,611) | $36,826,910 | | Net (decrease) increase in cash | ($9,906,131) | $19,525,385 | | Cash at beginning of period | $24,916,285 | $9,625,494 | | Cash at end of period | $15,010,154 | $29,150,879 | - Investing activities provided **$18.9 million** in cash, primarily from the **$16.3 million** net proceeds from the sale of the FC2 business, while financing activities used **$4.2 million** for the extinguishment of the residual royalty agreement liability[21](index=21&type=chunk) Notes to Unaudited Condensed Consolidated Financial Statements Notes detail accounting policies, going concern doubt, FC2 sale impact, SWK debt termination, shareholder litigation, and uncertain ENTADFI asset payments - The company's drug development program focuses on enobosarm for cardiometabolic diseases and sabizabulin for inflammatory diseases, having sold its FC2 business on December 30, 2024, and its ENTADFI assets on April 19, 2023[25](index=25&type=chunk) - Effective August 8, 2025, the company executed a **1-for-10 reverse stock split**, retroactively adjusting all share and per-share amounts in the financial statements[27](index=27&type=chunk)[111](index=111&type=chunk) - Management has concluded that substantial doubt exists about the company's ability to continue as a going concern for at least twelve months, as current cash is insufficient to fund operations over that period[33](index=33&type=chunk)[34](index=34&type=chunk) - The sale of the FC2 business on December 30, 2024, for **$18.0 million** resulted in a loss on sale of **$4.3 million**, with the business results now reported as discontinued operations[35](index=35&type=chunk)[36](index=36&type=chunk)[40](index=40&type=chunk) - In connection with the FC2 sale, the SWK Residual Royalty Agreement was terminated with a **$4.2 million** change of control payment, resulting in a gain on debt extinguishment of **$8.6 million**[59](index=59&type=chunk) - The company is a defendant in several shareholder class action and derivative lawsuits related to public statements about sabizabulin for COVID-19, and a lawsuit from the purchaser of the FC2 business alleging breach of representations[89](index=89&type=chunk)[95](index=95&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Veru, a late-stage biopharmaceutical company, focuses on enobosarm and sabizabulin, with enobosarm's Phase 2b trial meeting its primary endpoint, while facing net losses and going concern doubts after selling commercial assets Overview and Drug Development Programs - Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for cardiometabolic and inflammatory diseases, with two main drug candidates: enobosarm and sabizabulin[114](index=114&type=chunk) - **Obesity Program (enobosarm):** The Phase 2b QUALITY trial for enobosarm, used with semaglutide, met its primary endpoint by preserving **100% of lean body mass** compared to placebo, also showing greater fat loss and preserved physical function, with plans to discuss a Phase 3 program with the FDA[119](index=119&type=chunk)[121](index=121&type=chunk)[131](index=131&type=chunk) - **Atherosclerosis Program (sabizabulin):** The company is developing sabizabulin as a broad anti-inflammatory agent to treat atherosclerotic cardiovascular disease, leveraging a mechanism similar to colchicine but with a potentially better safety profile, having completed a pre-IND meeting with the FDA[142](index=142&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) Asset Sales and Discontinued Operations - The company sold its FC2 business on December 30, 2024, for **$18.0 million** in cash, resulting in a strategic shift and classifying the business as discontinued operations, leading to a loss of **$4.3 million**[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) - The company sold its ENTADFI assets to ONCO in April 2023 for a total potential consideration of **$20.0 million** plus milestones, though collection of remaining promissory notes is uncertain, and forbearance agreements have been entered to extend payment deadlines[150](index=150&type=chunk)[152](index=152&type=chunk) Results of Operations Comparison of Operating Expenses (Three Months Ended June 30) | Expense Category | 2025 | 2024 | Change Driver | | :--- | :--- | :--- | :--- | | Research & Development | $3.0M | $4.8M | Decrease due to wind-down of Phase 2b QUALITY clinical study | | Selling, General & Administrative | $5.0M | $5.8M | Decrease primarily due to lower share-based compensation expense | Comparison of Operating Expenses (Nine Months Ended June 30) | Expense Category | 2025 | 2024 | Change Driver | | :--- | :--- | :--- | :--- | | Research & Development | $12.7M | $9.5M | Increase of $4.5M due to costs for the Phase 2b QUALITY clinical study | | Selling, General & Administrative | $15.4M | $18.4M | Decrease primarily due to lower share-based compensation expense | - For the nine months ended June 30, 2025, the company recorded a gain on debt extinguishment of **$8.6 million** from the termination of the Residual Royalty Agreement and a gain on the sale of ENTADFI assets of **$2.2 million**[162](index=162&type=chunk)[163](index=163&type=chunk) Liquidity and Sources of Capital - As of June 30, 2025, the company had **$15.0 million** in cash, cash equivalents, and restricted cash, down from **$24.9 million** at September 30, 2024, with working capital decreasing to **$9.5 million** from **$23.4 million**[166](index=166&type=chunk) - The company has concluded there is substantial doubt about its ability to continue as a going concern, as current cash is insufficient to fund operations for the next twelve months, necessitating additional capital through equity or debt financing[167](index=167&type=chunk)[168](index=168&type=chunk) - In the nine months ended June 30, 2024, the company raised **$36.8 million** from financing activities, primarily from a **$35.2 million** public offering of common stock and **$1.7 million** from its agreement with Lincoln Park Capital[176](index=176&type=chunk)[181](index=181&type=chunk)[183](index=183&type=chunk) - In connection with the FC2 sale, the company made a final change of control payment of **$4.2 million** to SWK, terminating the Residual Royalty Agreement and extinguishing the related debt[179](index=179&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure to raw material prices and foreign currency fluctuations significantly reduced after the FC2 business sale - The company's exposure to market risk from raw material prices and foreign currency exchange rates has been significantly reduced following the sale of the FC2 business[187](index=187&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, 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 June 30, 2025[189](index=189&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[190](index=190&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company faces multiple legal proceedings, including shareholder class action and derivative lawsuits regarding sabizabulin, and a fraud and breach of contract suit from the FC2 business purchaser - The company is a defendant in a putative class action lawsuit (Ewing v. Veru Inc.) and several derivative actions (Maglia, Franchi, Renbarger, Alshourbagy, Ovadias) related to statements made about sabizabulin as a COVID-19 treatment[89](index=89&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) - On August 5, 2025, Clear Future, Inc., the purchaser of the FC2 business, filed a lawsuit against the company alleging fraud, breach of representations and warranties, and breach of contract related to the sale[95](index=95&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant operational, financial, and legal risks, including no commercial revenue, going concern doubts, clinical trial delays, competition, intellectual property challenges, and litigation Risks Related to Regulation and Commercialization - The company currently has no commercial revenue and its profitability depends on obtaining regulatory approval and successfully commercializing its drug candidates[195](index=195&type=chunk)[201](index=201&type=chunk) - The company faces risks of delays in its planned clinical trials for enobosarm and sabizabulin due to factors like patient enrollment, regulatory holds, or insufficient funding[195](index=195&type=chunk)[208](index=208&type=chunk)[214](index=214&type=chunk) - Reliance on third-party CROs for research and third-party manufacturers for drug supply exposes the company to risks of non-compliance with cGCP and cGMP standards, which could jeopardize clinical data and regulatory approvals[195](index=195&type=chunk)[220](index=220&type=chunk)[223](index=223&type=chunk) Risks Related to Financial Position and Need for Capital - The company has a history of net losses and expects to incur more in the foreseeable future, with its independent auditor including a "going concern" explanatory paragraph in its report, citing losses and the need for additional funding[194](index=194&type=chunk)[241](index=241&type=chunk)[244](index=244&type=chunk) - The company needs to raise substantial additional capital to fund operations and clinical trials, as failure to do so could force it to curtail or cease operations, and future financing may be on unfavorable terms and cause significant dilution[194](index=194&type=chunk)[245](index=245&type=chunk) - There is uncertainty regarding the collection of additional payments from ONCO for the ENTADFI asset sale, as ONCO has previously defaulted and is operating under a forbearance agreement[194](index=194&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk) Risks Related to Our Business - The company faces intense competition in the obesity treatment market, including from major pharmaceutical companies with greater resources[196](index=196&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk) - The company is a defendant in shareholder class action lawsuits and is involved in disputes with the purchaser of the FC2 business, which could result in substantial legal fees and divert management's attention[196](index=196&type=chunk)[267](index=267&type=chunk)[279](index=279&type=chunk) - The company has significant payment obligations of **$8.3 million** to a supplier related to the prior commercialization efforts for sabizabulin[196](index=196&type=chunk)[262](index=262&type=chunk) Risks Relating to Our Intellectual Property - The company's success depends on its ability to obtain and maintain intellectual property rights, with existing patents for enobosarm's composition of matter expiring in 2028 and 2029, increasing reliance on a pending method of use patent application[197](index=197&type=chunk)[284](index=284&type=chunk)[294](index=294&type=chunk) - The company is dependent on license relationships for its sabizabulin and enobosarm drug candidates and could lose commercialization rights if it fails to meet its obligations under these agreements[197](index=197&type=chunk)[295](index=295&type=chunk) - The company may face claims that its intellectual property infringes on the rights of third parties, which could lead to costly litigation, substantial damages, or prevent commercialization[197](index=197&type=chunk)[296](index=296&type=chunk) Risks Related to Ownership of Our Common Stock - Ownership is highly concentrated, with executive officers and directors beneficially owning approximately **15.3%** of outstanding common stock as of August 7, 2025, which could limit the influence of other shareholders[198](index=198&type=chunk)[305](index=305&type=chunk) - The company recently effected a **1-for-10 reverse stock split** to regain compliance with Nasdaq's minimum bid price requirement, with a risk of future non-compliance and potential delisting[198](index=198&type=chunk)[306](index=306&type=chunk) - Previous restatements of financial statements and identified material weaknesses in internal control (now remediated) could harm investor confidence and subject the company to legal or regulatory actions[204](index=204&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk) [Exhibits](index=67&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including asset purchase agreements, corporate governance, and CEO/CFO certifications

Financial Data and Key Metrics Changes - The company reported a net loss of $7.3 million or $0.50 per diluted common share for the three months ended June 30, 2025, compared to a net loss of $10.3 million or $0.71 per diluted common share in the prior year's quarter [24] - For the nine months ended June 30, 2025, the net loss from continuing operations was $17 million or $1.16 per diluted common share, compared to a net loss of $26.7 million or $2.04 per diluted common share in the prior period [26] - Research and development costs decreased to $3 million from $4.8 million in the prior quarter, primarily due to the wind down of the Phase 2b quality clinical study for Inovasaram [22] Business Line Data and Key Metrics Changes - The company initiated the Phase 2b quality clinical study for Inovasaram during the quarter ended June 30, 2024, and completed it during the quarter ended June 30, 2025 [22] - Selling, general and administrative expenses decreased to $5 million from $5.8 million in the prior quarter, mainly due to a decrease in share-based compensation [23] Market Data and Key Metrics Changes - The company has identified a significant market opportunity, with 47.4 million patients over the age of 60 enrolled in Medicare Part D, of which 41.5% could benefit from the drug for overweight or obesity [18] - Up to 34.4% of patients over the age of 60 with obesity in the United States have sarcopenic obesity, indicating a high-risk population for developing critically low muscle mass when taking currently approved GLP-1 receptor agonists [19] Company Strategy and Development Direction - The company is focusing exclusively on drug development following the sale of the FC2 Female Condom business, which represented a change in strategy [26] - The company plans to advance the modified release oral formulation of Inovasaram for chronic weight management into Phase III clinical studies, with a unique manufacturing process protected by global patents [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about receiving regulatory clarity for the GLP-1 receptor agonist and Inovasaram combination Phase III program, with an end of Phase II FDA meeting scheduled [16] - The management highlighted the importance of preserving lean mass and improving physical function in older patients, which aligns with the FDA's expectations for the drug's efficacy [17] Other Important Information - The company completed a one-for-ten reverse stock split on August 8, 2025, which did not change the total number of shares authorized or par value per share [20][21] - The cash balance as of June 30, 2025, was $15 million, down from $24.9 million as of September 30, 2024, indicating a need for additional capital to support drug development [28][29] Q&A Session Summary Question: Can you discuss the modified release formulation of Inovasaram and its potential for fixed dose combinations? - Management confirmed that the new formulation can allow for fixed dose combinations with oral GLP-1s and is actively discussing partnerships in this area [34][36] Question: What are the expectations for the end of Phase II meeting with the FDA? - Management anticipates clarity on endpoints and patient populations, with a focus on retaining muscle in the older population, which is at high risk [44][46] Question: Will the new formulation have a better side effect profile than the current formulation? - Management indicated that the new formulation is expected to have a better safety profile due to reduced Cmax and delayed Tmax, while maintaining similar efficacy [53][55] Question: What is the design of the Phase III trial? - The Phase III trial design includes a double-blind randomized placebo-controlled study with a focus on physical function as the primary endpoint, incorporating both short-term and long-term assessments [60][62] Question: How will the company communicate the outcome of the FDA meeting? - Management plans to communicate the feedback from the FDA around September, following the official written response [49][50]

[Overview and Key Announcements](index=1&type=section&id=Veru%20Reports%20Fiscal%202025%20Third%20Quarter%20Financial%20Results%20and%20Clinical%20Program%20Progress) Veru Inc. reported Q3 FY2025 financial results and clinical program advancements, including a new enobosarm formulation and anticipated FDA feedback [Report Highlights](index=1&type=section&id=Report%20Highlights) Key updates include a new enobosarm formulation, awaited FDA guidance, and positive Phase 2b QUALITY study results for lean mass preservation - A novel modified-release oral formulation of enobosarm has been selected after a successful pharmacokinetic clinical study[1](index=1&type=chunk) - The company is awaiting FDA feedback to clarify the regulatory pathway for enobosarm for preserving lean mass in conjunction with chronic weight loss treatments[1](index=1&type=chunk)[3](index=3&type=chunk) - Positive efficacy and safety data were reported from the Phase 2b QUALITY study, showing enobosarm with semaglutide preserved muscle, increased fat loss, and reduced GI side effects compared to semaglutide alone[4](index=4&type=chunk) - The Phase 2b QUALITY Maintenance Extension study demonstrated that enobosarm significantly reduced body weight regain and preserved lean mass after discontinuing semaglutide[4](index=4&type=chunk) [Enobosarm Clinical Program Update](index=2&type=section&id=Enobosarm%20for%20Chronic%20Weight%20Loss%20Management%20Program) This section details the latest clinical trial results and formulation advancements for enobosarm in chronic weight loss management [Phase 2b QUALITY Study Results](index=2&type=section&id=Phase%202b%20QUALITY%20study) The Phase 2b QUALITY study demonstrated enobosarm's efficacy in preserving lean mass and enhancing fat loss when combined with semaglutide - The primary endpoint was met, with the enobosarm 3mg + semaglutide group showing a statistically significant **100% average preservation of total lean mass** compared to the placebo + semaglutide group at 16 weeks (p<0.001)[7](index=7&type=chunk) - The tissue composition of weight lost was **100% fat** for the enobosarm 3mg group, compared to 66% fat and 34% lean mass for the placebo group[7](index=7&type=chunk) - Enobosarm treatment provided a **59.8% relative reduction** in the proportion of subjects who experienced a clinically significant decline (>10%) in stair climb power compared to the placebo group (p=0.006)[7](index=7&type=chunk) - The combination of enobosarm and semaglutide demonstrated a positive safety profile in the Phase 2b trial[7](index=7&type=chunk) [Phase 2b Maintenance Extension Study Results](index=2&type=section&id=Phase%202b%20QUALITY%20Maintenance%20Extension%20study) The Maintenance Extension study showed enobosarm monotherapy significantly reduced weight regain and preserved lean mass after semaglutide discontinuation - Enobosarm 3mg monotherapy significantly reduced body weight regain by **46%** after semaglutide was discontinued (p=0.038)[9](index=9&type=chunk) - The tissue composition of regained weight was **100% lean mass** in the enobosarm groups, versus 28% fat and 72% lean mass in the placebo group[9](index=9&type=chunk) - By the end of the full study, the enobosarm 6mg group showed a **93% greater loss of fat** compared to the placebo group (p=0.008)[9](index=9&type=chunk) - Enobosarm monotherapy had a positive safety profile with virtually no gastrointestinal side effects and no other significant adverse events of special interest after semaglutide discontinuation[9](index=9&type=chunk) [Novel Modified Release Oral Enobosarm Formulation](index=4&type=section&id=Novel%20Modified%20Release%20Oral%20Enobosarm%20Formulation) A new modified-release enobosarm formulation with a distinct pharmacokinetic profile has been selected, enhancing intellectual property protection - The new formulation demonstrated a distinct release profile with reduced Cmax, delayed Tmax, and a secondary peak concentration, while maintaining similar overall absorption (AUC)[10](index=10&type=chunk) - The novel formulation is planned for future clinical studies and commercialization[10](index=10&type=chunk) - Intellectual property has been strengthened, with new patent filings on the modified-release formulation potentially extending expiry to **2046**[10](index=10&type=chunk) [Financial Performance](index=4&type=section&id=Financial%20Performance) This section provides an overview of Veru's financial results for Q3 and year-to-date fiscal 2025, including key statements [Financial Summary](index=4&type=section&id=Financial%20Summary) Veru reported reduced Q3 FY2025 operating and net losses, with year-to-date net loss also decreasing, and a cash position of $15.0 million Q3 Fiscal 2025 vs Q3 Fiscal 2024 | Metric | Q3 2025 | Q3 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $3.0M | $4.8M | -37.5% | | SG&A Expenses | $5.0M | $5.8M | -13.8% | | Operating Loss (Continuing Ops) | $7.5M | $10.5M | -28.6% | | Net Loss (Continuing Ops) | $7.3M | $10.3M | -29.1% | | Net Loss per Share (Continuing Ops) | $0.50 | $0.71 | -29.6% | YTD Fiscal 2025 vs YTD Fiscal 2024 | Metric | YTD 2025 | YTD 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $12.7M | $9.5M | +33.7% | | SG&A Expenses | $15.4M | $18.4M | -16.3% | | Operating Loss (Continuing Ops) | $25.9M | $26.8M | -3.4% | | Net Loss (Continuing Ops) | $17.0M | $26.7M | -36.3% | | Net Loss per Share (Continuing Ops) | $1.16 | $2.04 | -43.1% | - Cash, cash equivalents, and restricted cash stood at **$15.0 million** as of June 30, 2025, down from $24.9 million as of September 30, 2024[13](index=13&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) Condensed consolidated financial statements detail the company's financial position, operational performance, and cash flows for Q3 and YTD FY2025 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets, liabilities, and stockholders' equity as of June 30, 2025, primarily due to discontinued operations Key Balance Sheet Items (unaudited) | Metric | June 30, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $15,010,154 | $24,916,285 | | Total current assets | $16,193,177 | $35,223,224 | | Total assets | $27,330,758 | $60,418,772 | | Total current liabilities | $6,682,015 | $11,867,968 | | Total liabilities | $11,986,125 | $28,102,060 | | Total stockholders' equity | $15,344,633 | $32,316,712 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statement of operations shows a reduced net loss for both the three and nine months ended June 30, 2025, with a significant debt extinguishment gain Key Statement of Operations Items (unaudited) | Metric | Three Months Ended June 30, 2025 | Nine Months Ended June 30, 2025 | | :--- | :--- | :--- | | Research and development | $3,020,563 | $12,669,495 | | Selling, general and administrative | $5,010,528 | $15,402,074 | | Operating loss | $(7,546,476) | $(25,917,435) | | Net loss from continuing operations | $(7,323,101) | $(16,985,397) | | Net loss | $(7,332,820) | $(24,179,786) | | Net loss per share | $(0.50) | $(1.65) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statement indicates net cash used in operating activities, offset by investing activities, resulting in a net cash decrease for the nine months Key Cash Flow Items (Nine Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(24,551,752) | $(17,316,239) | | Net cash provided by investing activities | $18,867,232 | $14,714 | | Net cash (used in) provided by financing activities | $(4,221,611) | $36,826,910 | | Net (decrease) increase in cash | $(9,906,131) | $19,525,385 | | Cash at end of period | $15,010,154 | $29,150,879 | [Corporate Information and Forward-Looking Statements](index=4&type=section&id=About%20Veru%20Inc.) This section provides an overview of Veru Inc. and includes standard forward-looking statements with associated risk disclosures [Company Overview](index=4&type=section&id=Company%20Overview) Veru Inc. is a late clinical-stage biopharmaceutical company focused on cardiometabolic and inflammatory diseases with key pipeline assets enobosarm and sabizabulin - Veru is a late clinical stage biopharmaceutical company[14](index=14&type=chunk) - The company's focus is on cardiometabolic and inflammatory diseases[14](index=14&type=chunk) - Key pipeline assets are enobosarm for body composition and sabizabulin for cardiovascular inflammation[14](index=14&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains standard forward-looking statements, outlining risks related to clinical trials, regulatory approvals, funding, competition, and intellectual property - The press release includes forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995[16](index=16&type=chunk) - Key risks include potential for unsuccessful clinical trials, uncertainty of FDA approval, ability to fund operations, and competition[16](index=16&type=chunk)[17](index=17&type=chunk)

Core Insights - The company reported positive efficacy and safety data from the Phase 2b QUALITY study, indicating that enobosarm combined with semaglutide led to muscle preservation, increased fat loss, and fewer gastrointestinal side effects compared to semaglutide alone [1][3] - The Phase 2b Maintenance Extension study showed that enobosarm significantly reduced body weight regain and fat regain while preserving lean mass after discontinuation of semaglutide [1][7] - A novel modified release oral formulation of enobosarm has been selected for further clinical studies following a pharmacokinetic clinical study [1][9] Clinical Development - The Phase 2b QUALITY study involved 168 older patients (≥60 years) and demonstrated that the 3mg enobosarm dose preserved 100% of total lean mass compared to placebo + semaglutide at 16 weeks (p<0.001) [4][8] - Enobosarm treatment resulted in a 42% greater relative loss of fat mass with the 6mg dose compared to placebo + semaglutide at 16 weeks (p=0.017) [4][8] - The study found that 44.8% of the placebo + semaglutide group experienced at least a 10% decline in stair climb power, indicating a risk of physical function loss [5][8] Safety and Efficacy - Enobosarm plus semaglutide treatment maintained similar mean body weight loss as semaglutide alone while preserving lean mass [4][7] - The enobosarm 3mg monotherapy significantly reduced body weight regain by 46% after semaglutide discontinuation [8] - The safety profile of enobosarm was positive, with no gastrointestinal side effects or evidence of drug-induced liver injury observed [8][9] Financial Overview - As of June 30, 2025, the company reported cash, cash equivalents, and restricted cash of $15.0 million, down from $24.9 million as of September 30, 2024 [12][19] - Research and development expenses decreased to $3.0 million from $4.8 million year-over-year [15][21] - The net loss from continuing operations decreased to $7.3 million, or $0.50 per share, compared to $10.3 million, or $0.71 per share in the previous year [15][22]