ZVSA - Earnings announcements

ZyVersa is advancing a highly differentiated pipeline focusing on inflammatory and renal diseases with a total accessible market >$100 billion.Inflammasome ASC Inhibitor IC 100 is the next evolution of inflammasome inhibitors designed for unparalleled control of disease-causing inflammation by (1) inhibiting multiple inflammasomes activated in numerous diseases, not just NLRP3, and (2) attenuating spread and perpetuation of inflammation by uniquely inhibiting ASC specks. Lead indication: Cardiometabolic conditions associated with obesityValue driving milestones: file IND Q4-2026; Phase 1 SAD read-out H1-2027 Cholesterol Efflux Mediator VAR 200 is expected to be a disease-modifying renal drug

ZyVersa is advancing a highly differentiated pipeline focusing on inflammatory and renal diseases with a total accessible market >$100 billion.Inflammasome ASC Inhibitor IC 100 is a next generation drug designed for unparalleled control of disease-causing inflammation by (1) inhibiting multiple inflammasomes activated in numerous diseases, not just NLRP3, and (2) attenuating spread and perpetuation of inflammation by uniquely inhibiting ASC specks. Lead indication: Cardiometabolic conditions associated with obesityValue driving milestones: File IND Q4-2026; Phase 1 SAD read-out Q1-2027 Cholesterol Efflux Mediator VAR 200 is expected to be a disease-modifying renal drug by targeting unaddress

ZyVersa is advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100 for treatment of chronic inflammatory diseases.The lead indication for VAR 200 is focal segmental glomerulosclerosis (FSGS) with potential indication expansion in Alport syndrome and diabetic kidney disease.The lead indication for IC 100 is cardiometabolic conditions, with potential indication expansion in rare kidney diseases.Raised approximately $2.05 million in Q3-2025; $4.05 million year-to-date. WESTON, Fla., Nov. 19, 2025 (GLOBE NEWSWIRE) -- ZyVersa Th

KEY HIGHLIGHTS First clinical site for Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD) was activated June 2025; patient screening is underway, with interim results expected ~Q4-2025. IND-enabling obesity preclinical study with Inflammasome ASC Inhibitor IC 100 in a diet-induced obesity (DIO) animal model planned to begin ~Q4-2025. Invited MJFF grant request submitted for funding Parkinson's disease animal model proof-of-concept studies; response expected Q3-2025. Raised approximately $2.05 million since the end of Q2-2025; $4.05 million year-to-date. WESTON, Fla., Aug. 13, 2025 (GLOBE NEWSWIR

KEY HIGHLIGHTS First patient expected to start therapy by end of Q2-2025 in Phase 2a proof-of concept clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD).Obesity-associated cardiometabolic preclinical proof-of-concept study with Inflammasome ASC Inhibitor IC 100 planned to begin by end of Q2-2025.Investigational New Drug Application (IND) for IC 100 anticipated to be submitted H2-2025, followed by initiation of a Phase 1 clinical trial in healthy overweight subjects at risk of cardiometabolic diseases.Groundbreaking data demonstrating IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation — bot

KEY HIGHLIGHTS: Phase 2a proof-of concept clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD) expected to begin H1-2025. Regulatory path for VAR 200's lead indication, focal segmental glomerulosclerosis (FSGS), expected to be shorter based on FDA's alignment with data supporting proteinuria reduction as a clinical trial endpoint for approval of FSGS drugs (Parasol Initiative). Obesity proof-of-concept studies with Inflammasome ASC Inhibitor IC 100 in diet-induced obesity (DIO) mouse models are planned to begin H1-2025.Investigational New Drug Application (IND) for IC 100 is anticipated to be submitted H2-2025, followed by initiation

KEY BUSINESS HIGHLIGHTS Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease expected to begin Q1-2025.New Obesity, Metabolic & Inflammatory Disease Scientific Advisory Board (SAB) was formed in October 2024 to support development of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications.Two obesity proof-of-concept studies with IC 100 in diet-induced obesity (DIO) mouse models are planned, which will include assessment of various metabolic parameters. At least one of the studies is targeted to begin Q4-2024.IC 100 Investigational New Drug (IND) submission is planned for Q2-2025, and once cleared, will be followed by

KEY HIGHLIGHTS Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease on track to begin H2-2024.Obesity with related metabolic complications selected as lead indication for Inflammasome ASC Inhibitor IC 100. Supportive data from preclinical study in atherosclerosis, a common obesity-related metabolic complication, is expected to be available H2-2024. IC 100 Investigational New Drug (IND) submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obesity with metabolic complications expected to begin Q1-2025.Raised approximately $0.8 million from exercise of investor warrants. WESTON, Fla., Aug. 09, 2024 (

Key Highlights: Second research site selected to enhance enrollment in the Phase 2a clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease planned to begin H1-2024.GLP toxicology studies for Inflammasome ASC Inhibitor IC 100 scheduled to begin H1-2024, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation Q1-2025.Atherosclerosis preclinical data readout for Inflammasome ASC Inhibitor IC 100 on schedule for H1-2024.Initiation of preclinical study to assess Inflammasome ASC Inhibitor IC 100 for obesity-associated metabolic comorbidities scheduled to begin Q2-2024 with completion expected by year's end.R

Key Highlights: Cholesterol Efflux MediatorTM VAR 200 on target to begin Phase 2a clinical trial in patients with diabetic kidney disease H1-2024.Inflammasome ASC Inhibitor IC 100 preclinical program nearing completion, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.Inflammasome ASC Inhibitor IC 100 preclinical research funded by The Michael J. Fox Foundation for Parkinson's Research (MJFF) nearing completion, with potential for a second MJFF grant for further research.Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.Scientif

Key Corporate Highlights: Progressing toward Q1-2024 initiation of a proof-of-concept clinical trial with Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD).Granted a European patent covering use of VAR 200 (2-hydroxypropyl-beta-cyclodextrin) in diabetic nephropathy/diabetic kidney disease.Nearing completion of pre-clinical requirements for GLP toxicology studies and subsequent IND submission. WESTON, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, "ZyVersa"))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory dise

Key Highlights: Advanced clinical development initiatives for Cholesterol Efflux Mediator™ VAR 200, with planned initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024Granted a European patent covering Phase 2a-ready Cholesterol Efflux MediatorTM VAR 200 (2-hydroxypropyl-beta-cyclodextrin) for use in diabetic nephropathy/diabetic kidney diseasePublished new white paper detailing the critical role of inflammasome ASC in inflammatory diseases, and the potential of Inflammasome ASC Inhibitor IC 100 to address multiple CNS and non-CNS diseasesAdded Dr. Douglas Golenbock to ZyVersa's Inflammatory Disease Scientific Advisory Board to support advanc

Key Highlights: Continued progress has been made in advancing an investigator-initiated clinical trial to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200 in patients with renal diseaseAnnounced publication of several peer-reviewed journal articles supporting ASC inhibition as a promising therapeutic target - data continue to demonstrate that multiple types of inflammasomes are activated in various conditions (Alzheimer's disease, traumatic brain injury, and injury from intracortical implants), and substantiate that extracellular release of ASC specks to neighboring cells heighten and perpetuate damaging inflammation leading to disease progression in conditions such as P