Key Business Highlights - The Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease is expected to begin in Q1-2025, with initial data read-out anticipated around mid-2025 [1][4]. - A new Scientific Advisory Board (SAB) for Obesity, Metabolic & Inflammatory Disease was formed in October 2024 to support the development of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications [1][6]. - Two proof-of-concept studies for IC 100 in diet-induced obesity (DIO) mouse models are planned, with at least one study expected to begin in Q4-2024 [1][7]. - An Investigational New Drug (IND) submission for IC 100 is planned for Q2-2025, followed by a Phase 1 clinical trial in healthy overweight subjects at risk for metabolic complications, with safety data expected in H2-2025 [1][5]. Financial Results - For the quarter ended September 30, 2024, the company reported net losses of approximately $2.4 million, an improvement of about $0.5 million or 17.3% compared to a net loss of approximately $2.9 million for the same period in 2023 [7][8]. - Research and development expenses were approximately $0.4 million for the three months ended September 30, 2024, a decrease of about $0.2 million or 35.3% from the same period in 2023 [9]. - General and administrative expenses were approximately $1.8 million for the three months ended September 30, 2024, a decrease of about $0.4 million or 17.7% compared to the same period in 2023 [10]. Cash Position and Funding Needs - As of September 30, 2024, the company had approximately $0.1 million in cash, which is expected to be sufficient for month-to-month operating expenses, but additional financing will be needed to support ongoing operations and clinical activities [8]. - The company plans to seek funding through public or private equity, debt financings, government grants, collaborations, or outstanding warrant exercises [8]. Company Overview - ZyVersa Therapeutics, Inc. is a clinical-stage specialty biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases with high unmet medical needs [2][11]. - The company is positioned in the emerging inflammasome space with its lead compounds, Inflammasome ASC Inhibitor IC 100 for obesity and its associated metabolic complications, and Cholesterol Efflux Mediator™ VAR 200 for focal segmental glomerulosclerosis (FSGS) [11]. - The total accessible market for these therapeutic areas is estimated to exceed $100 billion [11].
ZyVersa Therapeutics Reports Third Quarter, 2024 Financial Results and Provides Business Update