ZVSA Overview

Therapeutic Development: ZyVersa Therapeutics is advancing its pipeline with two proprietary technologies: VAR 200 for kidney diseases and IC 100 for chronic inflammatory diseases, targeting conditions like focal segmental glomerulosclerosis and cardiometabolic issues.

Financial Performance: In Q3 2025, ZyVersa raised approximately $2.05 million, but reported a significant increase in net losses to about $19.8 million, primarily due to an $18.6 million impairment in research and development.

Cash Position: As of September 30, 2025, ZyVersa had $0.5 million in cash, indicating a need for additional financing to support ongoing operations and development initiatives.

Operating Expenses: Research and development expenses decreased by 16.3% year-over-year, while general and administrative expenses also saw a slight decline, reflecting cost management efforts amidst rising overall losses.

ZyVersa's VAR 200 Development: ZyVersa Therapeutics is developing Cholesterol Efflux Mediator™ VAR 200 to remove excess cholesterol and lipids from kidney cells, aiming to mitigate renal disease progression by addressing inflammation, fibrosis, and oxidative stress.

Clinical Trials and Market Potential: A Phase 2a clinical trial for VAR 200 in diabetic kidney disease patients has begun, with preliminary results expected by Q4-2025, while the global kidney disease drug market is projected to grow from $18 billion in 2024 to $30 billion by 2034.

Diabetes and Kidney Damage: Research indicates that diabetes-related metabolic issues lead to lipid accumulation in kidneys, causing inflammation and fibrosis, which contribute to chronic kidney disease (CKD) progression.

ZyVersa's VAR 200 Development: ZyVersa Therapeutics is developing VAR 200, a treatment aimed at removing excess lipids from kidneys, with a Phase 2a clinical trial underway for diabetic kidney disease (DKD), highlighting the urgent need for therapies targeting kidney lipotoxicity.

Company Update: ZyVersa Therapeutics has announced significant advancements in its R&D pipeline, including two financing transactions totaling $12 million to support the development of its kidney disease treatment VAR 200 and inflammatory disease treatment IC 100, with key milestones expected in late 2025.

Market Context: The CEO highlighted the challenging biotech environment but emphasized the company's commitment to innovation in renal and inflammatory diseases, aiming to address significant unmet medical needs while building long-term value for shareholders.

ZyVersa Therapeutics Updates: ZyVersa Therapeutics' stock (ZVSA) surged 56% following the FDA's Emergency Compassionate Use authorization for their cholesterol efflux mediator VAR 200, aimed at treating ApoCII amyloidosis and currently in Phase 2 trials for diabetic kidney disease.

Clinical Development Insights: The company is focusing on VAR 200's potential to improve kidney health by removing excess lipids, with plans to expand indications to orphan kidney diseases like focal segmental glomerulosclerosis (FSGS) and Alport syndrome.

ApoCII Amyloidosis and VAR 200: ApoCII amyloidosis is a rare condition affecting the kidneys, leading to proteinuria and chronic kidney disease. A patient receiving standard treatments continues to progress in kidney disease, prompting the use of VAR 200 under Emergency Compassionate Use, which aims to reduce lipid accumulation and improve kidney function.

ZyVersa Therapeutics' Role: ZyVersa Therapeutics supports the compassionate use of VAR 200 for the patient, highlighting its potential benefits based on preclinical studies. The company is advancing its clinical development pipeline for kidney diseases, including ongoing trials for diabetic kidney disease and plans for future indications.