Core Insights - ZyVersa Therapeutics, Inc. is developing first-in-class drugs targeting inflammatory and renal diseases, with a focus on the Inflammasome ASC Inhibitor IC 100 for obesity-related metabolic complications [1][7] - Recent data published in Biomedicine & Pharmacotherapy highlights the cardioprotective effects of IC 100, showing improvements in heart function and metabolic parameters in an obese animal model [2][4] Group 1: Key Findings - Inhibition of NLRP3 inflammasome pathways may provide a promising treatment for heart failure with preserved ejection fraction (HFpEF), potentially improving heart function and reducing systemic inflammation [3][4] - IC 100, a humanized IgG4 monoclonal antibody, is designed to inhibit the inflammasome adaptor protein ASC, thereby attenuating the inflammatory response [3][6] Group 2: Study Results - The study demonstrated reduced levels of pro-inflammatory cytokine IL-18, decreased macrophage infiltration in the heart, and improved cardiac diastolic function [5] - IC 100 also led to reduced fat mass and improved glucose homeostasis and insulin sensitivity in the obese mouse model [5][6] Group 3: Future Directions - ZyVersa plans to initiate two preclinical studies in diet-induced obesity mouse models in the first half of the year, comparing IC 100's effects to semaglutide [2][4] - The company is well-positioned in the inflammasome space, with a total accessible market exceeding $100 billion for its therapeutic areas [7]

Core Insights - ZyVersa Therapeutics, Inc. is advancing a pipeline of first-in-class drug candidates targeting inflammatory and renal diseases with high unmet medical needs [3][5] - The company is developing two key drug candidates: Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications and Cholesterol Efflux Mediator VAR 200 for diabetic kidney disease [1][2][5] - The total accessible market for ZyVersa's therapeutic areas exceeds $100 billion, indicating significant growth potential [5] Drug Candidates - Inflammasome ASC Inhibitor IC 100 is designed to reduce disease-causing inflammation, with a lead indication for obesity-related metabolic complications [1][5] - Cholesterol Efflux Mediator VAR 200 aims to facilitate the removal of renal lipids and cholesterol, with a phase 2a clinical trial in diabetic kidney disease expected to commence in Q1-2025 [2][5] Corporate Engagement - Stephen C. Glover, the Co-Founder and CEO, will attend the JPM 43rd Annual Healthcare Conference in January 2025 to discuss ZyVersa's technology and development milestones [3][4] - The company is open to one-on-one meetings with industry strategics and investors to explore value-building opportunities [4]

Clinical Trials and Research - Phase 2a clinical trial for Cholesterol Efflux Mediator VAR 200 in diabetic kidney disease is expected to begin in Q1-2025[1] - Two obesity proof-of-concept studies with IC 100 in diet-induced obesity mouse models are planned, with at least one study targeted to begin in Q4-2024[2] - IC 100 IND submission is planned for Q2-2025, followed by a Phase 1 clinical trial in healthy overweight subjects[6] - The newly formed Obesity, Metabolic & Inflammatory Disease Scientific Advisory Board is supporting the development of IC 100[1] Financial Performance - Net losses for Q3-2024 were approximately $2.4 million, an improvement of approximately $0.5 million or 17.3% compared to a net loss of approximately $2.9 million for Q3-2023[8] - Total operating expenses for September 2024 were $2,269,621, a decrease of 21.8% compared to $2,902,678 in September 2023[16] - The pre-tax net loss for September 2024 was $2,401,256, compared to a loss of $2,902,888 in September 2023, indicating a 17.3% improvement[16] - Net loss attributable to common stockholders for September 2024 was $2,401,256, compared to $2,934,776 in September 2023, reflecting a decrease of 18.2%[16] - The total net loss for September 2024 was $2,401,256, compared to $7,991,736 in September 2023, showing a significant reduction of 69.9%[16] Expenses - Research and development expenses were approximately $0.4 million for Q3-2024, a decrease of approximately $0.2 million or 35.3% from Q3-2023[10] - General and administrative expenses were approximately $1.8 million for Q3-2024, a decrease of approximately $0.4 million or 17.7% from Q3-2023[11] - Research and development expenses decreased to $436,043 in September 2024 from $673,943 in September 2023, representing a reduction of 35.2%[16] - General and administrative expenses were $1,833,578 in September 2024, down 17.7% from $2,228,735 in September 2023[16] - Interest expense for September 2024 was $131,635, compared to $210 in September 2023[16] Financial Position - Cash as of September 30, 2024, was approximately $0.1 million, indicating a need for additional financing to support operations[9] - Total current liabilities as of September 30, 2024, were approximately $11.5 million, an increase from $10.2 million as of December 31, 2023[15] - The weighted average number of common shares outstanding increased to 988,378 in September 2024 from 97,252 in September 2023[16] - There were no impairments recorded for in-process research and development or goodwill in September 2024, compared to impairments of $69,280,171 and $11,895,033 respectively in September 2023[16] Market Potential - The total accessible market for ZyVersa's therapeutic areas is over $100 billion[12]

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 meta ...

Financial Performance - For the nine months ended September 30, 2024, the net loss was approximately $7.99 million, a decrease of 90.6% compared to a net loss of $84.96 million for the same period in 2023[82]. - Net loss for the nine months ended September 30, 2024 was approximately $8.0 million, a significant decrease from a net loss of $85.0 million for the same period in 2023[92]. - The accumulated deficit was $111.2 million as of September 30, 2024, indicating ongoing financial challenges[92]. Expenses - Research and development expenses for the nine months ended September 30, 2024, were approximately $1.66 million, a decrease of 43.8% from $2.95 million for the same period in 2023[84]. - General and administrative expenses for the nine months ended September 30, 2024, were approximately $6.19 million, a decrease of 36.1% from $9.69 million for the same period in 2023[85]. - Total operating expenses for the nine months ended September 30, 2024, were approximately $7.85 million, a decrease of 91.6% from $93.82 million for the same period in 2023[82]. - Research and development expenses for the three months ended September 30, 2024, were approximately $0.44 million, a decrease of 35.3% from $0.67 million for the same period in 2023[78]. - General and administrative expenses for the three months ended September 30, 2024, were approximately $1.83 million, a decrease of 17.7% from $2.23 million for the same period in 2023[79]. Cash Flow and Financing - Net cash used in operating activities was approximately $6.3 million for the nine months ended September 30, 2024, compared to $5.9 million for the same period in 2023[89]. - Net cash provided by financing activities was $3.3 million for the nine months ended September 30, 2024, up from $1.6 million in the same period in 2023[90]. - The company raised an aggregate of $3.1 million from stock warrant exercises and its "at-the-market" facility subsequent to September 30, 2024[93]. - The company anticipates needing additional financing to support ongoing operations and development activities[67]. - The company plans to raise additional capital to fund continued development of product candidates VAR200 and IC100[95]. Market and Operations - The company has not generated any revenue to date and does not expect to do so in the near future[70]. - The total accessible market for the company's therapeutic areas is over $100 billion[65]. - As of September 30, 2024, the accumulated deficit was approximately $111.2 million, with cash reserves of $0.1 million[66]. Assets and Liabilities - Current assets as of September 30, 2024 were $390,000, a decrease from $3.35 million as of December 31, 2023[91]. - Current liabilities increased to $11.54 million as of September 30, 2024, compared to $10.20 million as of December 31, 2023[91]. - Working capital deficiency was $11.15 million as of September 30, 2024, compared to $6.84 million as of December 31, 2023[91]. Impairment - Impairment of in-process research and development was $69.3 million and impairment of goodwill was $11.9 million for the nine months ended September 30, 2023[86].

Key Highlights - ZyVersa Therapeutics is on track to begin a Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease in H2-2024 [1][4] - The lead indication for Inflammasome ASC Inhibitor IC 100 has been selected as obesity with related metabolic complications, with supportive data from preclinical studies expected in H2-2024 [1][3] - An Investigational New Drug (IND) submission for IC 100 is planned for Q4-2024, followed by a Phase 1 clinical trial expected to start in Q1-2025 [1][4] - The company raised approximately $0.8 million from the exercise of investor warrants [1] Business Update - The Phase 2a clinical trial for VAR 200 is expected to enroll the first patient(s) within the next few months, with initial data read-out anticipated by the end of the year [3][4] - The IND submission for IC 100 is planned for Q4-2024, with a preclinical study in obesity concluding by year-end [4] - ZyVersa has recruited six experts in obesity and related metabolic complications for a scientific advisory board to guide clinical development plans for IC 100 [4] Financial Results - For the quarter ended June 30, 2024, ZyVersa reported net losses of approximately $2.8 million, an improvement of $75.7 million or 96.5% compared to a net loss of approximately $78.5 million for the same period in 2023 [6] - Research and development expenses were $0.7 million, a decrease of $0.5 million or 41.9% from $1.2 million for the same period in 2023 [8] - General and administrative expenses were $2.0 million, a decrease of $1.9 million or 48.0% from the same period in 2023 [9]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class Trading Symbol Name of each exchange on which registered Common Stock, $0.0001 par value per share ZVSA The Nasdaq Capital Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ t ...

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 ...

"Elevations in plasma ASC in early cognitive decline reinforce the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer's and Parkinson's diseases," stated Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO, and President. "ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation pathogenic in neurological and other inflammatory diseases, ...

WESTON, Fla., July 25, 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 obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100. Why Obesity and Related Metabolic Complications as an Indication? 1. Nutrient overload triggers inflammasome-induced inflammatio ...