Veru(US:VERU)2025-12-17 15:49Enobosarm 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].