4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)

4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)

4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)

4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)

4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)

4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)

4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)

SC 13G/A - ZyVersa Therapeutics, Inc. (0001859007) (Subject)

Strokes affect 795,000 people annually in the US. Obesity, a top risk factor for strokes, is associated with around one out of five strokes.Cardiac complications following a stroke are a leading cause of mortality and morbidity, second only to acute neurological injury.The pathomechanism underlying cardiac dysfunction following a stroke includes a surge of catecholamines, such as epinephrine, which induces inflammasome activation triggering a systemic inflammatory response.The published data showed that following a stroke, Inflammasome ASC Inhibitor IC 100 blocked AIM2 inflammasome activation and cell death (pyroptosis) in the heart and improved cardiac function.Data from this article suppor

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

During obesity, inflammasome-driven inflammation results in significant loss of pancreatic islet beta cell mass, severely impairing the insulin secreting capacity of the remaining beta cells.Preserving pancreatic islet beta cell function is key to prevention of insulin resistance and development of type 2 diabetes.The published data showed that inflammasome NLRP3 inhibition was protective of pancreatic islet beta cells, restoring their function and improving metabolic status in an obesity DIO mouse model.Data from this article support ZyVersa's development of Inflammasome ASC Inhibitor IC 100 for obesity and its associated comorbidities to be used as an add-on to incretin therapy. WESTON, F

Obesity, due to its associated chronic, systemic inflammation, increases the risk for metabolic diseases, atherosclerosis, various malignant tumors, and numerous immune-mediated disorders.With weight loss, less inflammation is expected, but adipose tissue inflammation can persist long after weight loss. One study showed that immediately after weight loss fat breakdown releases fatty acids triggering an increase in adipose tissue (AT) proinflammatory macrophages and inflammation. Over time, there is a gradual decline in inflammatory processes.The NLRP3 inflammasome and its release of pro-inflammatory cytokines, IL-1β and IL-18, by AT macrophages is essential in development of obesity-related

Recent evidence links obesity-driven inflammation to diminished brain health and neurodegenerative diseases such as Alzheimer's and Parkinson's diseasesThe newly published data show that obesity leads to progressive brain inflammation in a mouse model, and that the proinflammatory processes worsen with prolonged obesity and with increased ageThis research supports our selection of obesity with associated comorbidities as the lead indication for Inflammasome ASC Inhibitor IC 100IC 100 inhibits intra- and extracellular ASC and specks associated with multiple types of inflammasomes to attenuate damaging neurologic and systemic inflammation WESTON, Fla., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Zy

Lead indication for ZyVersa's Inflammasome ASC Inhibitor IC 100 is obesity with metabolic complications. WESTON, Fla., Oct. 17, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or "ZyVersa"))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Letter to Shareholders highlighting obesity development plans for Inflammasome ASC Inhibitor IC 100 with anticipated milestones over the next nine months. The full text of the letter follows. A MESSAGE FROM OUR PRESIDENT AND CHIEF EXECUT

WESTON, Fla., Oct. 15, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or "ZyVersa"))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, was interviewed on the Big Biz Show to address current trends in the obesity drug market and the potential role of inflammasome inhibitors. Key Points Obesity is an international health crisis, with over 50% of the world's population predicted to be overweight or obese within the next ten years.Launch of incretin therapy (GLP-1 agonists) for obesity has re

New Scientific Advisory Board (SAB) comprised of five leading experts in the areas of obesity and metabolic diseases, and four leading inflammasome experts and inventors of IC 100 from University of Miami Miller School of Medicine who have provided ongoing scientific advisory support for IC 100 since its license. WESTON, Fla., Oct. 07, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or "ZyVersa"))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces a new SAB to support advancement of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications. Based on its

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 (

Data demonstrate that extracellular ASC specks, independent of IL-1β, govern the pathogenesis and extent of amyloid A (AA) amyloidosis, which is characterized by deposition of insoluble amyloid fibrils in tissues and organs disrupting their structure and function.Extracellular ASC interacts with serum amyloid A (SAA) released by the liver during inflammation, forming a scaffold that accelerates SAA aggregation into amyloid fibrils, which are deposited in tissues and organs.Amyloid A amyloidosis occurs in a heterogeneous spectrum of chronic inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and inflammatory bowel disease.ZyVersa is developing Inflammasome ASC Inhibitor IC

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

Key Highlights: Closed business combination with Larkspur Health Acquisition Corp. in December 2022 and began trading on Nasdaq Global Market under the ticker symbol "ZVSA"Planning underway with nephrologists for an investigator-initiated clinical trial in focal segmental glomerulosclerosis ("FSGS") and up to two other renal populations to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200Recently published data in peer-reviewed journals detail the mechanism of action of inflammasome ASC inhibitor IC 100, and support its CNS activity in preclinical models of aging and Alzheimer's diseaseAdded three new Board members and three new members to Renal Scientific Advisory Board

ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or "ZyVersa"))))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100.

Publication showed that IC 100 suppressed retinal microglia activation by interfering with ASC speck formation, attenuating retinal inflammation, abnormal retinal vascularization, and retinal thinning, and it led to restored retinal function. Retinopathy of Prematurity (ROP), affecting very low birth weight premature infants is a leading cause of childhood blindness worldwide.ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation and its perpetuation and spread to surrounding tissues.

ZyVersa Therapeutics's (NYSE:ZVSA) short percent of float has fallen 96.61% since its last report. The company recently reported that it has 15 thousand shares sold short, which is 2.06% of all regular shares that are available for trading. Based on its trading volume, it would take traders 1.0 days to cover their short positions on average. Why Short Interest Matters Short interest is the number of shares that have been sold short but have not yet been covered or closed out. Short selling is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises. Short in

ZyVersa Therapeutics (NASDAQ:ZVSA) reported quarterly losses of $(4.53) per share which missed the analyst consensus estimate of $(3.70) by 22.43 percent.

Shares of Clever Leaves Holdings Inc. (NASDAQ:CLVR) fell sharply during Monday's session after the company announced that it will voluntarily delist its common shares from the Nasdaq and deregister its Securities to terminate and suspend its reporting obligations. Clever Leaves Holdings shares dipped 60% to $1.6498 on Monday. Here are some other stocks moving in today’s mid-day session. Gainers Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) shares climbed 73% to $25.36 after the company announced it will be acquired by ONO Pharmaceutical for $25.60 per share in cash. Collective Audience, Inc.  (NASDAQ:CAUD) gained 50.4% to $0.6002 after the company announced a strategic partne

ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA) shares are trading higher Monday after the company announced the publication of a scientific paper in a peer-reviewed journal that reinforces the rationale for inhibiting ASC with IC 100 to potentially attenuate cardiac comorbidities in patients with Alzheimer’s Disease. The Details: Researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100, published a scientific paper in the peer-reviewed journal, “Frontiers in Molecular Neuroscience”, highlighting how inflammasome-mediated inflammation in Alzheimer’s disease can trigger inflammation in the heart. “This research reinforces the impo

 ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or ", ZyVersa", ))))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that acclaimed inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100, have published a scientific paper in the peer-reviewed journal, Frontiers in Molecular Neuroscience, highlighting how inflammasome-mediated inflammation in Alzheimer's disease can trigger inflammation in the heart.