Veru (NasdaqCM:VERU) FY Conference February 26, 2026 03:20 PM ET Company ParticipantsMitch S. Steiner - Executive Chairman, President, and CEOConference Call ParticipantsLeland Gershell - Managing Director and Senior Biotechnology AnalystLeland GershellGreat! Thank you. Thanks for joining us here at Oppenheimer's 36th Annual Healthcare Life Sciences Conference. I'm Leland Gershell, one of the analysts with the Biotech Equity Research team at the firm. We're delighted to have with us as our next presenting c ...

Core Viewpoint - Veru Inc. is advancing its clinical programs for innovative treatments targeting cardiometabolic and inflammatory diseases, with a focus on the upcoming presentation at the Oppenheimer 36th Annual Healthcare Life Sciences Conference [1] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company dedicated to developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development pipeline includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Obesity Program - Enobosarm is being developed as a next-generation drug to enhance weight reduction when combined with GLP-1 RA drugs, aiming for more selective fat loss while preserving lean mass [4] - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when used with semaglutide, led to greater fat loss while preserving lean mass and physical function 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 lead to increased energy expenditure and further weight reduction in longer studies [4] Planned Phase 2b PLATEAU Clinical Study - The upcoming Phase 2b PLATEAU clinical trial will evaluate the effects of enobosarm 3 mg on various health metrics in approximately 200 older patients (age ≥ 65) with obesity [5] - The primary efficacy endpoint is the percent change in total body weight at 68 weeks, with an interim analysis planned at 34 weeks [5] - The study aims to assess the ability of enobosarm to overcome weight loss plateaus in patients receiving GLP-1 RA treatment, with a focus on preserving muscle mass and physical function [6]

Financial Performance - Veru Inc. reported no net revenues for the three months ended December 31, 2025, compared to $4.48 million for the same period in 2024[38]. - The company incurred total non-operating expenses of $3.33 million for the three months ended December 31, 2024, contributing to a loss before income taxes of $7.06 million[38]. - The net loss for the three months ended December 31, 2025, was $5,332,579, compared to a net loss of $8,945,347 in 2024, indicating an improvement of 40.5%[99]. - For the three months ended December 31, 2025, total operating expenses were $5,424,015, a decrease of 50.5% from $10,943,943 in 2024[99]. - Research and development expenses for the same period were $1,344,182, down from $5,716,830 in 2024, representing a reduction of 76.6%[99]. - General and administrative expenses decreased to $4,079,833 in 2025 from $5,227,113 in 2024, a decline of 21.9%[99]. - Net cash used in operating activities was $6.2 million for the three months ended December 31, 2025, down from $11.3 million in 2024, a reduction of 45.8%[100]. - Cash, cash equivalents, and restricted cash increased to $32,991,417 as of December 31, 2025, compared to $15,794,562 in 2024, reflecting an increase of 108.5%[100]. Asset Sales and Discontinued Operations - The loss on the sale of the FC2 business was $4.1 million, calculated as the difference between net proceeds of $16.5 million and the total carrying value of $20.6 million[33]. - The purchase price for the FC2 Business Sale was $18.0 million in cash, with net proceeds after costs amounting to $16.5 million[33]. - The FC2 Business Sale represented a strategic shift, with all direct revenues and expenses related to the FC2 business classified within loss from discontinued operations for the three months ended December 31, 2024[35]. - The company sold substantially all assets related to its FDA-approved commercial product, the FC2 Female Condom, on December 30, 2024[22]. - The company recorded a gain of $0.7 million from the sale of ENTADFI assets during the three months ended December 31, 2024[94]. - The company has a total of $20.0 million in purchase price from the sale of ENTADFI assets, with $6.0 million paid at closing and additional payments structured through promissory notes[92]. - There was a net loss from discontinued operations of $(7,135,444) in 2024, which did not occur in 2025[99]. Financial Position and Capital Needs - The company had negative cash flow from operations and requires substantial capital to support drug development and commercialization efforts[30]. - As of the issuance date of the financial statements, the company's cash and cash equivalents were insufficient to fund operations for the next twelve months[30]. - 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[31]. - The Company has an allowance for credit losses of $3.9 million related to receivables from The Pill Club due to its Chapter 11 bankruptcy filed on April 18, 2023[44]. Shareholder and Legal Matters - The company is involved in multiple shareholder lawsuits, collectively referred to as "Shareholder Litigation," but is unable to estimate potential losses related to these lawsuits[85]. - The company has not recorded a liability for future milestone payments related to technology or intellectual property licenses, as these are not reasonably estimable[87]. Stock and Equity Transactions - The Company completed a public offering on October 31, 2025, raising approximately $23.4 million in net proceeds from the sale of 1,400,000 shares of common stock and warrants[57]. - The Company issued 7,000,000 pre-funded warrants with an exercise price of $0.001 during the three months ended December 31, 2025[58]. - The Company issued 16,800,000 warrants with an exercise price of $3.00 during the three months ended December 31, 2025[59]. - The Company entered into a Lincoln Park Purchase Agreement allowing the sale of up to $100 million of common stock over 36 months, later amended to $50 million until at least $50 million is sold[60]. - As of December 31, 2025, the Company sold 302,500 shares under the Lincoln Park Purchase Agreement, generating proceeds of $3.1 million[64]. - The Company issued 80,000 shares to Lincoln Park as consideration for the Purchase Agreement, valued at $1 million[65]. - The aggregate number of shares that can be sold under the Lincoln Park Purchase Agreement is capped at 1,767,850 shares, approximately 19.99% of the outstanding shares prior to the agreement[63]. - The Company has 400,000 shares available for issuance under the 2022 Employment Inducement Equity Incentive Plan as of December 31, 2025[67]. Accounting and Compliance - The company is currently evaluating the impact of adopting new accounting standards, including ASU 2023-09 and ASU 2024-03, which may affect future disclosures[26][27]. - The company has a full valuation allowance for deferred tax assets, resulting in zero income tax expense for the periods presented[90]. Other Financial Metrics - 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 in connection with the FC2 Business Sale[50]. - The company experienced a change in fair value of equity securities, resulting in a loss of $(120,078) in 2025, compared to a loss of $(349,078) in 2024[99]. - The company has a tail product liability insurance coverage amounting to $10.0 million for claims arising from previously sold products[79]. - The total lease cost for the three months ended December 31, 2025, was $194,118, compared to $190,092 in 2024[76]. - The weighted-average remaining lease term for operating leases as of December 31, 2025, was 4.2 years, with a weighted-average discount rate of 7.1%[78]. - The Company recorded a reduction in share-based compensation expense of $44,000 for stock options forfeited during the three months ended December 31, 2025[70]. - The Company has unrecognized compensation expense of approximately $2.4 million related to unvested stock options, expected to be recognized over a weighted average period of 2.4 years[73]. - Goodwill remained unchanged at $6.9 million for both December 31, 2025, and September 30, 2025[47]. - Total property and equipment net value decreased to $336,615 as of December 31, 2025, down from $364,808 as of September 30, 2025[46].

Financial Data and Key Metrics Changes - For the three months ended December 31, 2025, the net loss was $5.3 million or $0.26 per diluted common share, compared to a net loss of $8.9 million or $0.61 per diluted common share in the prior year's quarter [20] - Research and development costs decreased to $1.3 million from $5.7 million in the same period last year, primarily due to the wind-down of the phase II-B QUALITY clinical study [17] - General administrative expenses were $4.1 million compared to $5.2 million in the prior quarter, mainly due to a decrease in share-based compensation [17] Business Line Data and Key Metrics Changes - The company is focused on two main drug development programs: enobosarm and sabizabulin, with enobosarm being developed for obesity treatment in combination with GLP-1 receptor agonists [3][4] - The completed phase II-B QUALITY clinical trial demonstrated that enobosarm could lead to greater fat loss while preserving lean mass compared to GLP-1 receptor agonist treatment alone [6][7] Market Data and Key Metrics Changes - The FDA has provided regulatory clarity for the development of enobosarm in combination with GLP-1 receptor agonists, indicating at least two possible regulatory pathways for approval based on weight loss outcomes [8][9] - The company noted that GLP-1 receptor agonist therapy can lead to significant weight loss but often results in the loss of lean mass, which enobosarm aims to address [5][10] Company Strategy and Development Direction - The company is strategically focusing on developing combination therapies that enhance weight loss while preserving lean mass and physical function, particularly for older patients with obesity [4][6] - The planned phase II-B PLATEAU clinical study aims to evaluate the effect of enobosarm on various health metrics in older patients initiating semaglutide treatment [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's cash position, stating that current funds are expected to support operations through the interim analysis of the phase II-B PLATEAU clinical study [21] - The management highlighted the importance of demonstrating functional benefits, such as physical function preservation, as a potential pathway for regulatory approval [26][36] Other Important Information - The company completed a public offering of 1.4 million shares, generating approximately $23.4 million in net proceeds [16] - The cash balance as of December 31, 2025, was $33 million, an increase from $15.8 million as of September 30, 2025 [20] Q&A Session Summary Question: Why not use oral semaglutide in the PLATEAU study? - Management explained that the injectable form of semaglutide is preferred to minimize differences in outcomes compared to the phase II-B QUALITY study [25] Question: Did the FDA discuss the stair climb test for functional endpoints? - Management confirmed discussions with the FDA regarding the stair climb test, emphasizing its sensitivity in measuring patient function [27][29] Question: Are there pre-specified decision rules for the interim analysis? - The Chief Scientific Officer clarified that there are no futility analyses or sample size re-estimations associated with the interim analysis [34] Question: What degree of weight loss is needed for functional benefit assessment? - Management indicated that greater than 5% weight loss is a clear threshold, but less than 5% could still support approval if functional benefits are demonstrated [36]

Financial Data and Key Metrics Changes - For the three months ended December 31, 2025, the net loss was $5.3 million or 26 cents per diluted common share, compared to a net loss of $8.9 million or 61 cents per diluted common share in the prior year's quarter [19] - Research and development costs decreased to $1.3 million from $5.7 million in the same period last year, primarily due to the completion of the Phase 2b QUALITY clinical study [17] - General administrative expenses were $4.1 million compared to $5.2 million in the prior quarter, mainly due to a decrease in share-based compensation [17] - Cash, cash equivalents, and restricted cash balance was $33 million as of December 31, 2025, compared to $15.8 million as of September 30, 2025 [19] Business Line Data and Key Metrics Changes - The company is focused on two main drug development programs: enobosarm and sabizabulin, targeting obesity and cardiovascular diseases respectively [3][4] - Enobosarm has shown potential in a Phase 2b clinical trial for obesity, demonstrating selective fat loss while preserving lean mass [6][7] Market Data and Key Metrics Changes - The FDA has provided regulatory clarity for enobosarm in combination with GLP-1 receptor agonists, indicating at least two possible pathways for approval based on weight loss metrics [8][9] Company Strategy and Development Direction - The company aims to develop enobosarm as a next-generation obesity treatment that preserves lean mass and physical function, addressing the limitations of current GLP-1 receptor agonists [4][5] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effects on weight loss and physical function in older patients initiating semaglutide treatment [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's cash position to fund operations through the interim analysis of the Phase 2b PLATEAU study [20] - The company is not currently profitable and has experienced negative cash flow from operations, but the recent public offering has bolstered its financial position [19][22] Other Important Information - The company completed a public offering of 1.4 million shares, generating approximately $23.4 million in net proceeds [16] - The company recorded a gain on the sale of the FC2 Female Condom business in the prior year, which is now classified under discontinued operations [17][18] Q&A Session Summary Question: Why not use the oral semaglutide in this study? - Management explained that the injectable form of semaglutide is preferred to minimize differences in outcomes compared to previous studies [24] Question: Did you discuss the stair climb test with the FDA? - Management confirmed discussions with the FDA regarding the stair climb test as a sensitive measure for assessing physical function in the study [26] Question: Are there any pre-specified decision rules for the interim analysis? - It was clarified that there are no futility analysis or sample size re-estimation associated with the interim analysis [32] Question: What degree of weight loss needs to be seen for functional benefit assessment? - Management indicated that greater than 5% weight loss is a clear criterion, but less than 5% could still be acceptable if accompanied by significant functional benefits [34]

Financial Data and Key Metrics Changes - For the three months ended December 31, 2025, the net loss was $5.3 million or $0.26 per diluted common share, compared to a net loss of $8.9 million or $0.61 per diluted common share in the prior year's quarter [18] - Research and development costs decreased to $1.3 million from $5.7 million in the same period last year, primarily due to the wind-down of the Phase 2b QUALITY clinical study [16] - General administrative expenses were $4.1 million compared to $5.2 million in the prior quarter, mainly due to a decrease in share-based compensation [16] Business Line Data and Key Metrics Changes - The company is focused on two main drug development programs: enobosarm and sabizabulin, targeting obesity and cardiovascular diseases respectively [3][4] - The completed Phase 2b QUALITY clinical trial demonstrated that enobosarm, in combination with a GLP-1 receptor agonist, could lead to more selective fat loss while preserving lean mass [6] Market Data and Key Metrics Changes - The FDA has provided regulatory clarity for the development of enobosarm in combination with a GLP-1 receptor agonist, indicating at least two possible regulatory pathways for approval based on weight loss outcomes [7][8] Company Strategy and Development Direction - The company aims to develop enobosarm as a next-generation obesity treatment that preserves lean mass and physical function, addressing the limitations of current GLP-1 receptor agonist therapies [4][5] - The planned Phase 2b PLATEAU clinical study will evaluate the effects of enobosarm on weight loss and physical function in older patients initiating semaglutide treatment [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's cash position, stating that current funds are expected to support operations through the interim analysis of the Phase 2b PLATEAU clinical study [19] - The company is not yet profitable and has experienced negative cash flow from operations, but the recent public offering has strengthened its financial position [18][20] Other Important Information - The company completed a public offering of 1.4 million shares, generating approximately $23.4 million in net proceeds [15] - The cash balance as of December 31, 2025, was $33 million, up from $15.8 million as of September 30, 2025 [18] Q&A Session Summary Question: Why not use oral semaglutide in the PLATEAU study? - The company aims to minimize differences between the Phase 2b QUALITY study and the PLATEAU study, opting for the injectable form of semaglutide for consistency [22] Question: Did the FDA discuss the stair climb test for functional endpoints? - Yes, the FDA was consulted about the stair climb test, which has been validated through extensive prior studies, and they requested specific testing protocols [24] Question: Are there pre-specified decision rules for the interim analysis? - No, there are no futility analysis or sample size re-estimation rules associated with the interim analysis [30] Question: What degree of weight loss is needed for approval if functional benefits are observed? - Greater than 5% weight loss is required for approval, but if less than 5% is observed, significant functional benefits could still support approval [32]

Financial Performance - Veru reported cash, cash equivalents, and restricted cash of $33.0 million as of December 31, 2025, compared to $15.8 million as of September 30, 2025, indicating a significant increase[11] - The operating loss from continuing operations decreased to $5.4 million from $10.2 million year-over-year, indicating improved financial performance[14] - Net loss decreased to $5.3 million, or $0.26 per share, compared to $8.9 million, or $0.61 per share, demonstrating a reduction in losses[14] - The net loss from continuing operations for the three months ended December 31, 2025, was $5,332,579, compared to a net loss of $1,809,903 for the same period in 2024[23] - The basic and diluted net loss per share for the three months ended December 31, 2025, was $0.26, compared to $0.61 for the same period in 2024[23] Expenses Management - Research and development expenses decreased to $1.3 million from $5.7 million year-over-year, reflecting a reduction in spending[14] - General and administrative expenses decreased to $4.1 million from $5.2 million year-over-year, showing cost management efforts[14] - Total operating expenses for the three months ended December 31, 2025, were $5,424,015, down from $10,943,943 in the same period of 2024, a decrease of 50.5%[23] - The company reported a net cash used in operating activities of $6,169,490 for the three months ended December 31, 2025, compared to $11,332,987 in 2024, a reduction of 45.5%[25] Clinical Trials - The Phase 2b PLATEAU clinical trial is expected to initiate in the first quarter of calendar 2026, with an interim analysis planned for the first quarter of calendar 2027[10] - The Phase 2b PLATEAU clinical trial will evaluate the effect of enobosarm 3 mg on total body weight, fat mass, lean mass, and physical function in approximately 200 older patients with obesity[7] - The primary efficacy endpoint of the Phase 2b PLATEAU study is the percent change from baseline in total body weight at 68 weeks[7] - FDA feedback indicated that a primary endpoint for enobosarm in combination with GLP-1 RA could be a placebo-corrected weight loss difference of at least 5% at 52 weeks[5] - The Phase 2b QUALITY clinical trial demonstrated that enobosarm plus semaglutide led to greater fat loss while preserving lean mass, confirming its potential as a next-generation obesity treatment[4] Assets and Liabilities - Total current assets increased to $36,806,716 as of December 31, 2025, compared to $18,915,118 on September 30, 2025, reflecting a growth of 94.6%[21] - Total liabilities decreased to $10,442,989 from $11,503,049, a reduction of 9.2%[21] - Cash, cash equivalents, and restricted cash at the end of the period increased to $32,991,417 from $15,794,562, marking a rise of 108.5%[25] Business Risks - The company has ongoing risks related to regulatory approvals and potential disruptions that could affect business operations[17]

Core Insights - Veru Inc. is advancing its Phase 2b PLATEAU clinical trial, which evaluates enobosarm in combination with semaglutide for older patients with obesity, set to initiate this quarter [1] - The company reported financial results for Q1 FY2026, showing a significant reduction in operating loss and net loss compared to the previous year [10][11] Clinical Development - The Phase 2b PLATEAU trial aims to address the weight loss plateau experienced by 88% of patients on GLP-1 receptor agonists, with enobosarm potentially aiding in fat loss while preserving lean mass [2][8] - Enobosarm has demonstrated the ability to burn fat and preserve muscle, which may help patients achieve incremental weight reduction beyond the plateau [2][3] - The trial will involve approximately 200 older patients (age ≥ 65) and will assess various endpoints including total body weight, fat mass, lean mass, physical function, and bone mineral density [7][8] Financial Performance - As of December 31, 2025, the company reported cash and cash equivalents of $33.0 million, a significant increase from $15.8 million at the end of September 2025 [10] - Research and development expenses decreased to $1.3 million from $5.7 million, while general and administrative expenses also saw a reduction [11] - The net loss for the first quarter was $5.3 million, or $0.26 per share, down from $8.9 million, or $0.61 per share in the same period last year [11][21] Regulatory Insights - The FDA has provided regulatory clarity for enobosarm in combination with GLP-1 RA, indicating two potential pathways for approval based on weight loss outcomes [4][5] - The FDA confirmed that enobosarm 3 mg is an acceptable dosage for future clinical development [5] Research Highlights - The Phase 2b QUALITY trial demonstrated that enobosarm combined with semaglutide led to greater fat loss while preserving lean mass, indicating a higher quality of weight reduction [3][14] - The FDA has recognized total hip bone mineral density as a validated surrogate endpoint for drug development in postmenopausal women with osteoporosis, which could be relevant for enobosarm's development [6]

Core Viewpoint - Veru Inc. is set to host a conference call on February 11, 2026, to discuss its fiscal 2026 first quarter financial results and provide a business update [1] 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 Obesity Program - Enobosarm is being developed as a next-generation drug to enhance weight reduction when combined with GLP-1 RA drugs, aiming for more selective fat loss while preserving lean mass [4] - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass and physical function in older patients [4] - The Phase 2b PLATEAU clinical trial is planned to evaluate the effect of enobosarm on total body weight, fat mass, lean mass, and physical function in approximately 200 older patients initiating GLP-1 RA treatment [5][6] Planned Clinical Studies - The primary efficacy endpoint of the Phase 2b PLATEAU study is the percent change from baseline in total body weight at 68 weeks, with an interim analysis at 34 weeks [5] - The study aims to assess the ability of enobosarm to overcome weight loss plateaus in patients receiving GLP-1 RA treatment [6]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]