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PresentationSean Joseph SamsonPresident, CEO & Director Good morning, everyone. My name is Sean Samson, and I'm the President and CEO of Clean Energy Transition. It's my pleasure to welcome you to the company's Annual General and Special Meeting of Shareholders. Before we commence the meeting, I'd like to address the meeting structure and note some general reminders. The meeting will consist of the formal business described in the notice of meeting. After the meeting's formal portion, I will open the floor ...

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].

Veru (NasdaqCM:VERU) Q4 2025 Earnings Call December 17, 2025 08:00 AM ET Company ParticipantsRohan Mathur - Biopharma Equity Research AssociateMichele Greco - Chief Financial Officer and Chief Administrative OfficerMitchell Steiner - Chairman, CEO and PresidentSam Fisch - Executive Director of Investor Relations and Corporate CommunicationsConference Call ParticipantsNone - AnalystWilliam Wood - Research AnalystOperatorGood morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. ...

Veru (NasdaqCM:VERU) Q4 2025 Earnings Call December 17, 2025 08:00 AM ET Company ParticipantsRohan Mathur - Biopharma Equity Research AssociateMichele Greco - Chief Financial Officer and Chief Administrative OfficerMitchell Steiner - Chairman, CEO and PresidentSam Fisch - Executive Director of Investor Relations and Corporate CommunicationsConference Call ParticipantsWilliam Wood - Research AnalystOperatorGood morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. All participa ...

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 ...

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company will host a conference call on December 17, 2025, to discuss its fiscal year 2025 financial results and provide a business update [1] 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) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss 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 combined with semaglutide led to greater fat loss and preservation of lean mass in older patients [4] - The upcoming Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [5] - The primary efficacy endpoint of the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5]