ZyVersa Therapeutics Announces Q1 2024 Financial Results and Business Update

ZyVersa Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel treatments for renal and inflammatory diseases with significant unmet medical needs, has announced key updates and financial results for the quarter ending March 31, 2024. The company is excited about its progress towards major development milestones over the next three quarters, according to Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President.

In the realm of renal disease, ZyVersa is preparing to launch a Phase 2a clinical trial for its Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease in the first half of 2024. The trial, managed by the Clinical Research Organization (CRO) George Clinical, received approval from a central Institutional Review Board (IRB) and has selected two research sites, with contracting near completion. Enrollment of the first patients is anticipated in the coming months.

Regarding inflammatory diseases, ZyVersa's Inflammasome ASC Inhibitor IC 100 is on the cusp of advancing its preclinical program. The Good Laboratory Practice (GLP) toxicology studies for IC 100 are slated to begin in the first half of 2024, with an Investigational New Drug (IND) submission planned for the fourth quarter of 2024, followed by the initiation of a Phase 1 clinical trial in early 2025. The company expects to release preclinical data concerning IC 100's effectiveness in treating atherosclerosis by mid-2024. Additionally, ZyVersa is initiating a preclinical study to explore IC 100’s potential in treating obesity-associated metabolic comorbidities by the second quarter of 2024, aiming for completion by the end of the year.

Financially, ZyVersa reported a net loss of approximately $2.8 million for the three months ending March 31, 2024, marking an improvement from a net loss of about $3.5 million in the same period of 2023. The company attributes this reduction to decreased research and development expenses and lower general and administrative costs. Specifically, research and development costs dropped to $0.5 million, a 51.4% decrease from the previous year, due to reduced manufacturing and payroll expenses. General and administrative expenses also fell to $2.3 million, a 34.6% decrease, attributed to lower payments related to PIPE shares, decreased bonus accruals, and reduced accounting and insurance fees.

As of March 31, 2024, ZyVersa has cash reserves of $2.0 million, which it believes will be sufficient to cover operational expenses on a month-to-month basis. However, the company acknowledges the need for additional financing to support its ongoing operations and achieve its milestones. ZyVersa plans to seek funding through various means, including public or private equity, debt financings, government grants, collaborations, or warrant exercises. In the first quarter, ZyVersa successfully raised approximately $2.7 million through the exercise of investor warrants.

ZyVersa is driven by its mission to address significant unmet medical needs in renal and inflammatory diseases. The company’s pipeline is built around two proprietary technologies: the Cholesterol Efflux Mediator™ VAR 200 for kidney diseases and the Inflammasome ASC Inhibitor IC 100 for a range of CNS and peripheral inflammatory conditions. The company continues to leverage advanced technologies to develop first-in-class drugs aimed at improving patient outcomes.