MIAMI, FL, Feb. 04, 2026 (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 it will host a conference call and audio webcast on Wednesday, February 11, 2026, at 8:00 a.m. ET to discuss its fiscal 2026 first quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of ...

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Meeting Structure - The meeting will consist of formal business as described in the notice of meeting, followed by a Q&A session for shareholders [2] - Voting will be conducted via Zoom poll, and registered shareholders or proxy holders are entitled to vote and speak during the meeting [2][3] Voting Process - Shareholders or proxy holders can register their votes through Zoom when the poll is created, and once registered, the vote is final [3] - It is important for participants to ensure their Zoom username reflects their full legal name for proper voting and attendance count [3]

Enobosarm Treatment and Clinical Studies - Enobosarm demonstrated a 100% relative reduction in lean mass loss compared to placebo + semaglutide at 16 weeks, achieving statistical significance (p<0.001) in preserving total lean body mass [261]. - The enobosarm 6mg dose resulted in a 42% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks (p=0.017), while enobosarm 3mg showed a 12% greater fat loss [262]. - During the maintenance phase, the placebo group regained 43% of the body weight lost, while the enobosarm 3mg and 6mg groups regained only 1.41% (2.73 lbs) and 2.87% (5.29 lbs) respectively, with the 3mg enobosarm significantly reducing weight regain by 46% [267]. - The Phase 2b QUALITY study confirmed that enobosarm treatment preserved more than 100% of lean mass, while the placebo group experienced a loss of lean mass [267]. - The FDA has indicated that incremental weight loss with enobosarm added to GLP-1 RA treatment is an acceptable primary endpoint for approval, and enobosarm 3mg is confirmed as an acceptable dosage for future development [272]. - The planned Phase 2b PLATEAU clinical study will evaluate enobosarm 3mg's effect on total body weight and physical function in approximately 200 patients, with a primary efficacy endpoint of percent change in total body weight at 72 weeks [275]. - The Phase 2b PLATEAU clinical study aims to assess the ability of enobosarm to break through the weight loss plateau observed in patients receiving GLP-1 RA treatment [276]. - Enobosarm treatment resulted in a 59.8% relative reduction in the proportion of subjects losing at least 10% stair climb power compared to placebo + semaglutide (p=0.0006) [269]. - The enobosarm + semaglutide combination showed a positive safety profile, with no increases in gastrointestinal side effects or adverse events related to masculinization or suicidal ideation [265]. - Veru is developing a novel modified release oral formulation for enobosarm, expected to be available for Phase 3 clinical studies and commercialization by July 2025 [278]. - The new formulation showed a significant reduction in maximum plasma concentration (Cmax) and a delayed time to maximum plasma concentration (Tmax) compared to historical values for immediate release capsules [279]. Colchicine and Cardiovascular Research - Colchicine has been shown to reduce major adverse cardiovascular events by 31% in stable coronary artery disease (CAD) patients and by 23% in patients post-myocardial infarction [281]. - A study indicated that colchicine combined with optimal medical therapy reduced low attenuation plaque volume by 40.9% and high sensitivity C-reactive protein by 37.3% [282]. - The FDA approved colchicine in June 2023 for reducing cardiovascular events in adults with established atherosclerotic cardiovascular disease (ASCVD) [283]. - Veru is exploring the development of sabizabulin as a treatment for inflammation in atherosclerotic cardiovascular disease, leveraging its anti-inflammatory properties [285]. - A pre-IND meeting with the FDA confirmed the unmet medical need for sabizabulin in patients with a history of coronary artery disease [287]. Financial Performance and Expenses - The FC2 Business Sale generated net proceeds of $16.5 million after adjustments and costs, with a loss on sale of $4.1 million [290]. - The sale of ENTADFI resulted in a total purchase price of $20.0 million, with $6.0 million received at closing and additional payments structured through promissory notes [292]. - Research and development expenses for fiscal 2025 were $15.6 million, up from $12.8 million in fiscal 2024, indicating continued investment in drug development [294]. - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in fiscal 2024, mainly due to reduced corporate personnel costs [296]. - The Company recorded a gain on the sale of ENTADFI assets of $10.8 million in fiscal 2025, compared to $1.2 million in fiscal 2024 [297]. - The Company recorded a gain on extinguishment of debt of $8.6 million in fiscal 2025 related to the termination of the Residual Royalty Agreement [298]. - The net loss from discontinued operations related to the FC2 Business was $7.0 million in fiscal 2025, an increase from $2.5 million in fiscal 2024 [300]. - Cash, cash equivalents, and restricted cash on hand at September 30, 2025, was $15.8 million, down from $24.9 million at September 30, 2024 [301]. - Operating activities used cash of $30.0 million in fiscal 2025, including a net loss of $22.7 million [304]. - Net cash provided by investing activities was $25.1 million in fiscal 2025, primarily from the sale of the FC2 Business and ENTADFI assets [307]. - Net cash used in financing activities in fiscal 2025 was $4.2 million, related to a change of control payment [310]. - The Company is not profitable and requires substantial capital to support drug development and commercialization efforts [302]. Accounting and Financial Estimates - The Company recorded $6.9 million in goodwill as of September 30, 2025 and 2024, with annual evaluations for impairment sensitivity to projections and assumptions [327]. - Research and development costs are expensed as incurred, including salaries, clinical trial costs, and contract services, with significant judgments made in estimating accrued liabilities [324]. - Fair value measurements for financial liabilities as of September 30, 2024 included embedded derivatives, with estimates based on unobservable inputs requiring subjective judgment [325]. - The Company has investments in Series D Preferred Stock and ONCO Warrant, valued using a Monte Carlo simulation model, with a total purchase price of $12.9 million for 16,099 shares of Series D convertible preferred stock and warrants [326]. - Following the FC2 Business Sale on December 30, 2024, the Company is no longer significantly exposed to market risks related to commodity prices or foreign currency exchange rates [330]. - The Company has experienced increased costs in products, supplies, salaries, and general administrative expenses due to inflation [329]. - The Company’s critical accounting estimates include research and development costs, fair value measurements, and goodwill valuation [323]. - The fair value of embedded derivatives was estimated using a scenario-based method, incorporating projected revenues and cash outflows [325]. - The Company has not experienced material differences between accrued costs and actual costs incurred in research and development [324]. - The Company evaluates its accounting estimates based on historical experience and reasonable assumptions, with potential adjustments affecting reported results [322].

Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [30] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the Phase 2b obesity clinical study for enobosarm [28] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [28] Business Line Data and Key Metrics Changes - The company sold the FC2 Female Condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after adjustments, which allowed the company to focus exclusively on drug development [24][26] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [28] Market Data and Key Metrics Changes - The company reported a cash balance of $15.8 million as of September 30, 2025, down from $24.9 million as of September 30, 2024 [31] - The company generated cash from investing activities of $25.1 million for fiscal 2025, compared to $0.1 million from investing activities in the prior year [32] Company Strategy and Development Direction - The company is focusing on developing enobosarm as a muscle-preserving agent in combination with GLP-1 receptor agonists to enhance fat loss while preserving lean mass, particularly targeting older patients with obesity [5][19] - The planned Phase 2b PLATEAU clinical trial aims to assess the ability of enobosarm to break through the weight loss plateau in patients with a BMI greater than 35 and age greater than or equal to 65 [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the evolving regulatory landscape for muscle-preservation drugs and the potential for multiple pathways to approval based on clinical outcomes [17][19] - The company highlighted the importance of addressing the weight loss plateau experienced by many patients on GLP-1 receptor agonists, indicating a significant market opportunity [18][50] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million, which will support ongoing clinical studies [27][23] - The company reported a loss on the sale of the FC2 Female Condom business of approximately $4.1 million, impacting the financial results for the year [25][31] Q&A Session Summary Question: Will any GLP-1 be allowed in your Phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently as the placeholder [40] Question: How does the FDA's guidance affect the transition from Phase 2 to Phase 3? - Management clarified that the Phase 2b study is designed to mirror Phase 3 conditions, allowing for a clear understanding of incremental weight loss and functional endpoints [43] Question: What patient population is being targeted in the PLATEAU study? - Management explained that the focus is on patients over 65 with physical limitations, as this group is most in need and will provide informative data for the study [46][49]

Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [30] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the phase 2b obesity clinical study for Enobosarm [27] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [28] Business Line Data and Key Metrics Changes - The company sold the FC2 female condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after adjustments, which allowed the company to focus exclusively on drug development [24][26] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [28] Market Data and Key Metrics Changes - The company reported a cash balance of $15.8 million as of September 30, 2025, down from $24.9 million as of September 30, 2024, indicating a need for additional capital to support drug development [31] - The company generated cash from investing activities of $25.1 million for fiscal 2025, compared to $0.1 million from investing activities in the prior year, primarily due to proceeds from the sale of the FC2 business and enteropathy assets [32] Company Strategy and Development Direction - The company is focusing on developing Enobosarm as a muscle-preserving agent in combination with GLP-1 receptor agonists to address obesity, particularly targeting older patients with obesity [5][19] - The planned phase 2b plateau clinical trial will evaluate the effect of Enobosarm on total body weight and physical function in patients aged 65 and older with a BMI greater than or equal to 35 [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the evolving regulatory landscape for muscle-preservation drugs and the potential for multiple pathways to approval based on clinical outcomes [16][17] - The company aims to address the weight loss plateau observed in patients on GLP-1 receptor agonists by combining these treatments with Enobosarm to enhance weight loss and preserve muscle [19][50] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million, which will support ongoing clinical studies [27][23] - The company reported a loss on the sale of the FC2 business of approximately $4.1 million, reflecting the difference between estimated net proceeds and the total carrying value of the business [25] Q&A Session Summary Question: Will any GLP-1 be allowed in your phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently being the placeholder [40] Question: How does the FDA's guidance affect the phase 3 transition? - Management clarified that the phase 2b study is designed to mimic a phase 3 setting, allowing for a clear understanding of the agents' behavior and potential endpoints for the phase 3 study [43] Question: What patient population is being targeted in the plateau study? - Management explained that the focus is on patients over 65 with physical limitations, as this group is most in need and will provide informative data for functional outcomes [46][49]

Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [27] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the phase 2b obesity clinical study for Enobosarm [25] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [25] Business Line Data and Key Metrics Changes - The company sold the FC2 female condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after selling costs, but incurred a loss of approximately $4.1 million on the sale [22][23] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [25] Market Data and Key Metrics Changes - The company reported that as of September 30, 2025, cash, cash equivalents, and restricted cash balance was $15.8 million, down from $24.9 million as of September 30, 2024 [28] - The net working capital was $11.1 million on September 30, 2025, compared to $23.4 million on September 30, 2024 [29] Company Strategy and Development Direction - The company is focusing exclusively on drug development following the sale of the FC2 female condom business, which represents a strategic shift [23] - The planned phase 2b plateau clinical trial will target patients with a BMI greater than or equal to 35 and age greater than or equal to 65, aiming to assess the ability of Enobosarm treatment to break through the weight loss plateau [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory landscape evolving for muscle-preservation drugs for obesity treatment, with at least two possible regulatory pathways for Enobosarm [15] - The company highlighted the importance of addressing the weight loss plateau experienced by many patients on GLP-1 receptor agonists, indicating a significant market opportunity [18][42] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million [24] - The company used cash of $30 million for operating activities in fiscal 2025, compared to $21.7 million in the prior year [29] Q&A Session Summary Question: Will any GLP-1 be allowed in your phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently being the placeholder [32][33] Question: How does the FDA's guidance affect the phase 3 transition? - Management explained that the phase 2b study is designed to mirror phase 3 criteria, allowing for a clear understanding of incremental weight loss and functional endpoints [34][35] Question: What patient population is being targeted in the Plateau study? - The focus is on patients over 65 with physical limitations, as this group is seen as most in need and informative for assessing physical function [37][39]

Financial Performance - Veru reported a net loss of $22.7 million, or $1.55 per share, for fiscal year 2025, a decrease from a net loss of $37.8 million, or $2.80 per share, in fiscal year 2024[18]. - Operating loss for 2025 was $24.8 million, compared to $36.2 million in 2024, representing a 31.7% improvement[28]. - Net loss from continuing operations decreased from $35.3 million in 2024 to $15.7 million in 2025, a reduction of approximately 55.5%[28]. - Basic and diluted net loss per share improved from $(2.80) in 2024 to $(1.55) in 2025, reflecting a 44.6% reduction in loss per share[28]. Expenses - Research and development expenses increased to $15.6 million from $12.8 million, while general and administrative expenses decreased to $19.9 million from $24.6 million[18]. - Research and development expenses increased to $15.6 million in 2025 from $12.8 million in 2024, an increase of 22.4%[28]. - Total operating expenses decreased from $37.4 million in 2024 to $35.5 million in 2025, a reduction of approximately 4.9%[28]. Assets and Liabilities - Total current assets decreased from $35.2 million in 2024 to $18.9 million in 2025, a decline of approximately 46.3%[26]. - Cash, cash equivalents, and restricted cash at the end of 2025 were $15.8 million, down from $24.9 million at the end of 2024, a decrease of 36.6%[30]. - Total liabilities decreased from $28.1 million in 2024 to $11.5 million in 2025, a decline of approximately 59.0%[26]. Clinical Trials and Research - The Phase 2b QUALITY study demonstrated a 100% average preservation of total lean mass in the enobosarm 3 mg + semaglutide group compared to placebo + semaglutide at 16 weeks[7]. - Enobosarm 3 mg + semaglutide treatment resulted in a 12% greater fat loss at 16 weeks compared to placebo + semaglutide[7]. - 65.4% of patients in the enobosarm 3 mg + semaglutide group lost at least 5% of body weight at 16 weeks, compared to 47.4% in the semaglutide alone group[7]. - The planned Phase 2b PLATEAU clinical trial will evaluate the effect of enobosarm 3 mg on total body weight and physical function in approximately 200 patients aged 65 and older with obesity[14]. - The FDA confirmed that enobosarm 3 mg is an acceptable dosage for future clinical development[13]. - The company aims to address the weight loss plateau experienced by 88% of patients on GLP-1 RA monotherapy through the Phase 2b PLATEAU clinical trial[5]. - The Phase 2b QUALITY study confirmed that enobosarm plus semaglutide led to greater fat loss while preserving lean mass, indicating a higher quality weight reduction[10]. Other Financial Activities - The company completed a public offering post fiscal year end, generating net proceeds of approximately $23.4 million[2]. - Gain on sale of ENTADFI® assets was $10.8 million in 2025, significantly higher than $1.2 million in 2024[28]. - Net cash used in operating activities increased to $30.0 million in 2025 from $21.7 million in 2024, an increase of approximately 38.2%[30].

Core Insights - The company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA, indicating that incremental weight loss is an acceptable primary endpoint for approval [1][10] - The Phase 2b PLATEAU clinical study is planned to start in Q1 2026, focusing on older patients with obesity [1][12] - The company completed a public offering post fiscal year end, raising approximately $23.4 million [1][19] Clinical Development - The Phase 2b QUALITY study demonstrated that enobosarm, when combined with GLP-1 RA, selectively promotes fat loss while preserving lean mass and physical function in older patients [4][17] - The FDA has confirmed that enobosarm 3 mg is an acceptable dosage for future clinical development [11] - The Phase 2b PLATEAU study will evaluate the effects of enobosarm on body weight, physical function, and safety in patients aged 65 and older with a BMI of 35 or higher [12][13] Financial Performance - For fiscal year 2025, research and development expenses increased to $15.6 million from $12.8 million, while general and administrative expenses decreased to $19.9 million from $24.6 million [14] - The operating loss from continuing operations decreased to $24.8 million from $36.2 million [14] - The net loss from continuing operations decreased to $15.7 million, or $1.07 per share, compared to $35.3 million, or $2.61 per share in the previous year [19]

Veru Inc. (NASDAQ:VERU) will release earnings results for its fourth quarter before the opening bell on Wednesday, Dec. 17.Analysts expect the Miami, Florida-based company to report quarterly loss at 39 cents per share, versus a year-ago loss of 52 cents per share, according to Benzinga Pro.On Oct. 30, Veru announced pricing of $25 million public offering of 1.4 million shares of common stock at a price of $3.00 per unit.Shares of Veru fell 1.2% to close at $2.39 on Monday.Benzinga readers can access the la ...