ZyVersa Therapeutics Inc Stock Price, News & Analysis

ZyVersa Therapeutics announces breakthrough data for their Inflammasome ASC Inhibitor IC 100 in treating Parkinson's Disease (PD). The study, published in npj Parkinson's Disease and supported by the Michael J. Fox Foundation, shows IC 100's potential to slow PD progression.

Key findings demonstrate that IC 100 effectively blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation - two major factors in PD progression. The research, conducted at the University of Miami Miller School of Medicine, reveals the first evidence linking ASC speck assembly, NLRP1 inflammasome activation, and alpha-synuclein aggregation in PD patients' neurons.

The global PD drug market, valued at $6.6 billion in 2024, is projected to reach $13.3 billion by 2034. Unlike current treatments that only address symptoms, IC 100 shows promise as a disease-modifying therapy. ZyVersa plans to begin proof-of-concept animal studies later this year.

ZyVersa Therapeutics (NASDAQ: ZVSA) has issued a shareholder letter highlighting key developments in inflammasome inhibitor research and their IC 100 program. The global anti-inflammatory biologics market, valued at $105 billion in 2024, is projected to reach $186 billion by 2034.

The company's IC 100, an Inflammasome ASC Inhibitor, is being developed for chronic inflammatory diseases, focusing initially on obesity-associated cardiometabolic conditions. Key upcoming milestones include:

• Proof-of-concept study in diet-induced obesity mouse model starting H1-2025
• IND submission planned for H2-2025
• Phase 1 clinical trial initiation in overweight subjects following IND approval
• Completion of preclinical study for Parkinson's disease treatment, funded by The Michael J. Fox Foundation

ZyVersa Therapeutics (NASDAQ: ZVSA) announces significant developments regarding their drug VAR 200 for Focal Segmental Glomerulosclerosis (FSGS). The PARASOL initiative's recent recommendations are expected to streamline FSGS drug development by accepting proteinuria reduction over 24 months as a surrogate endpoint for regulatory approval, replacing the need for long-term kidney failure outcomes.

The company plans to initiate a Phase 2a proof-of-concept trial for VAR 200 in Diabetic Kidney Disease (DKD) patients in the first half of 2025, before proceeding with FSGS trials. This strategic approach aims to gather preliminary human renal data and optimize future FSGS study protocols.

FSGS affects approximately 40,000 people in the US and currently has no approved drug therapies. The global kidney disease drug market reached $18 Billion in 2024 and is projected to reach $30 Billion by 2034. VAR 200, targeting cholesterol accumulation in kidney filtration systems, is positioned as an add-on therapy to existing treatments.

ZyVersa Therapeutics (ZVSA) reported its full year 2024 financial results and provided pipeline updates. The company plans to begin a Phase 2a clinical trial for VAR 200 in diabetic kidney disease patients in H1-2025, and expects to submit an IND for IC 100 in H2-2025.

Key financial highlights include:

• Net loss of $9.4 million for 2024, improved 90.4% from $98.3 million in 2023
• R&D expenses decreased 44.5% to $1.8 million
• G&A expenses reduced 34.4% to $7.4 million
• Raised approximately $6.6 million in 2024 and $2.0 million in Q1-2025

The company's cash position of $1.5 million as of December 31, 2024, will fund operations on a month-to-month basis, requiring additional financing to support continuing operations and meet stated milestones.

ZyVersa Therapeutics (NASDAQ: ZVSA) has highlighted new animal model data showing that inflammasome inhibition can help treat obesity-associated cardiomyopathy (OAC), a condition with less than 50% five-year survival rate. The study, published in the Journal of the American Heart Association, demonstrated that NLRP3 inflammasome inhibition produced several positive outcomes in obese mice, including:

• Reduced body weight and fasting blood glucose
• Decreased cardiac inflammation
• Prevented enlarged heart muscle and fibrosis
• Improved cardiac dysfunction
• Reduced cardiac lipid accumulation

The findings support the potential of ZyVersa's Inflammasome ASC Inhibitor IC 100 as a treatment for obesity-related cardiovascular conditions. IC 100 targets the ASC component of inflammasomes, inhibiting multiple inflammasomes (NLRP1, NLRP3, NLRC4, and AIM2) and ASC Specks that spread inflammation.

ZyVersa Therapeutics (NASDAQ: ZVSA) has highlighted new data showing how inflammasome inhibition reduces neuroinflammation and amyloid beta (Aβ) buildup in Alzheimer's disease (AD) mouse models. The research, published in Immunity journal, demonstrates that NLRP3 inhibition significantly attenuates AD pathology development.

The study reveals that initial Aβ deposition triggers NLRP3 inflammasome activation, leading to ASC specks release which enhances Aβ aggregation. This creates a cycle of inflammation and Aβ deposition in the brain. ZyVersa's Inflammasome ASC Inhibitor IC 100 shows potential as a treatment for neurodegenerative diseases by targeting ASC and inhibiting multiple inflammasome pathways.

Key findings show that NLRP3 inhibition:

• Increased degradation and elimination of Aβ in microglia through phagocytosis
• Enhanced microglial metabolic activity through increased glutamine utilization
• Improved mitochondrial function

ZyVersa Therapeutics (ZVSA) has announced a $2.0 million private placement agreement with a single healthcare-focused U.S. institutional investor. The deal includes:

- Sale of 2,105,265 shares of common stock at $0.95 per share
- Warrants to purchase up to 2,105,265 additional shares at $1.00 per share, exercisable for 5 years upon shareholder approval
- Expected closing date: March 7, 2025

Additionally, existing warrants for 957,200 shares will be amended, reducing the exercise price from $2.06 to $1.00 per share, subject to shareholder approval. The company plans to use proceeds for general working capital. A.G.P./Alliance Global Partners serves as the sole placement agent.

ZyVersa Therapeutics (NASDAQ: ZVSA) has highlighted new data showing positive effects of NLRP3 inflammasome inhibition in treating heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes in obese animal models.

The study demonstrated that inflammasome inhibition led to:

• Reduced inflammation and macrophage activation in cardiac and visceral adipose tissue
• Improved cardiac function and decreased cardiac hypertrophy and fibrosis
• Better glucose homeostasis and insulin sensitivity

These findings support the potential of ZyVersa's Inflammasome ASC Inhibitor IC 100 as a treatment for obesity and related cardiovascular and metabolic conditions. The company plans to initiate two preclinical studies in diet-induced obesity mouse models in H1 2025, comparing IC 100 to semaglutide and assessing their combined effects.

ZyVersa Therapeutics (NASDAQ: ZVSA) announces CEO Stephen C. Glover's attendance at JPM's 43rd Annual Healthcare Conference 2025 in San Francisco from January 13-16, 2025. The company is developing two key drug candidates: IC 100, an Inflammasome ASC Inhibitor targeting obesity with metabolic complications, and VAR 200, a Cholesterol Efflux Mediator for kidney diseases.

VAR 200 is expected to begin Phase 2a clinical trials for diabetic kidney disease in Q1-2025. The company's CEO will be available for one-on-one meetings to discuss ZyVersa's technology, pipeline assets, and development milestones with industry strategics and investors during the conference.