ZyVersa Therapeutics reports Q2 EPS (46c) vs. ($3.31) last year

“I am pleased to announce that we are well positioned to achieve our near-term development milestones,” said Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “In June and July 2025, we closed two financing transactions providing access to $12 million in capital to advance development of our highly differentiated drug therapies for kidney and inflammatory diseases, each of which target untargeted pathways to advance care for these serious conditions. Regarding our kidney disease drug VAR 200, in mid-June we initiated an open-label Phase 2a trial in patients with DKD. VAR 200 uniquely targets lipid accumulation in the kidney’s filtration system that triggers inflammation, fibrosis, and progressive kidney damage leading to renal failure if not addressed. Preliminary data are expected in Q4-2025, with final results anticipated H1-2026. The data will provide insights for developing a larger Phase 2a/b protocol in patients with FSGS, our lead indication. Based VAR 200’s unique mechanism of action, we were asked and agreed to provide drug and regulatory support under FDA-authorized Emergency Compassionate Use to treat a patient at the University of Miami Miller School of Medicine who has ApoCII amyloidosis, a very rare, life-threatening disease which mainly affects the kidney. Concerning our inflammasome inhibitor IC 100, we are making progress toward IND submission. Preparation is underway with the University of Miami School of Medicine to initiate an IND-enabling preclinical study in a diet-induced obesity (DIO) animal model in Q4-2025. A phase 1 trial in overweight healthy subjects at risk for certain cardiometabolic conditions will be initiated shortly following IND clearance. IC 100 uniquely targets inhibition of the ASC inflammasome component rather than the NLRP3 sensor molecule. By targeting ASC, IC 100 uniquely inhibits multiple inflammasome pathways and their associated ASC specks to alleviate perpetuation and spread of inflammation that damages tissues and organs causing numerous diseases and their progression. We appreciate your support for our efforts to develop groundbreaking drugs to improve patients’ health and quality of life.”