ZyVersa Therapeutics Q2 2024 Financial Results and Business Update

ZyVersa Therapeutics, Inc., a clinical-stage biopharmaceutical firm, has announced its financial results for the second quarter ending June 30, 2024, along with significant business updates. The company's primary focus is on developing innovative drugs for renal and inflammatory diseases, addressing high unmet medical needs.

The company is advancing its Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200, targeting diabetic kidney disease, with plans to commence patient enrollment in the latter half of 2024. This trial has already seen successful negotiations of clinical trial agreements and IRB submissions approved at two sites. The clinical products and lab kits are ready for shipment, and site initiation visits are scheduled soon. Enrollment is anticipated to begin within the next few months.

In the field of inflammatory diseases, ZyVersa is working on the Inflammasome ASC Inhibitor IC 100, aimed at treating obesity-related metabolic complications. The company plans to submit an Investigational New Drug (IND) application by the fourth quarter of 2024, with a Phase 1 clinical trial expected to start in the first quarter of 2025. ZyVersa is also concluding a preclinical study on obesity with metabolic complications by the end of the year and planning another study to evaluate the combined treatment of IC 100 and a GLP-1 agonist. Additionally, supportive data from a preclinical study in atherosclerosis is expected in the latter half of 2024, and GLP toxicology studies are scheduled to begin during the same period.

ZyVersa has formed a scientific advisory board consisting of six leading experts in the field of obesity and related metabolic complications to guide the clinical development of IC 100. Recently published preclinical studies have shown that IC 100 can reduce retinal inflammation and improve retinal function in animal models of retinopathy of prematurity (ROP). This adds to the growing body of evidence that IC 100 can attenuate pathogenic inflammasome signaling pathways, thereby reducing inflammation and improving outcomes in conditions like early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury.

Moreover, a preclinical study has reinforced the potential of plasma ASC levels as a biomarker for early cognitive decline, supporting the role of inflammasome-induced inflammation in neurodegenerative diseases such as Alzheimer’s and Parkinson’s. This highlights the potential of IC 100 as a treatment option by inhibiting ASC.

Financially, ZyVersa reported net losses of approximately $2.8 million for the three months ending June 30, 2024, a significant improvement from the $78.5 million net loss in the same period in 2023. This improvement is attributed mainly to the absence of a one-time impairment charge from 2023. Research and development expenses decreased to $0.7 million, largely due to reduced manufacturing costs for IC 100 and lower payroll expenses. General and administrative expenses also saw a decline to $2.0 million, attributed to one-time charges in 2023 and reductions in professional fees, marketing costs, and insurance.

As of June 30, 2024, ZyVersa had $0.1 million in cash, which the company believes will suffice for its operating expenses on a month-to-month basis. However, additional financing will be required to support ongoing operations and achieve stated milestones. ZyVersa plans to seek funding through public or private equity, debt financings, government grants, or collaborations with third parties.

ZyVersa Therapeutics continues to leverage its advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases. With promising developments in both the renal and inflammasome spaces, the company aims to address significant unmet medical needs and improve patient outcomes.

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