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 ...

The paper titled, "IC 100, a humanized therapeutic monoclonal anti-ASC antibody alleviates oxygen-induced retinopathy in mice," summarizes research evaluating mouse models representative of ROP. Following is a summary of key findings: "This research highlighting that Inflammasome ASC Inhibitor IC 100 attenuated retinal inflammation, abnormal retinal vascularization, and retinal thinning leading to restored retinal function in an animal model of ROP supports the broad range of indications that IC 100 has pot ...

ZyVersa is advancing a dynamic pipeline of drug candidates with multiple programs built around two proprietary technologies – Phase 2a Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100 for treatment of obesity and its associated metabolic complications, among other inflammatory diseases. Mr. Glover welcomes one-on-one meetings with registered participants. Details regarding Mr. Glover's Presentation follow: About ZyVersa Therapeutics, Inc. WESTON, F ...

Financial Performance - ZyVersa Therapeutics reported a net loss of $2,826,737 for Q1 2024, a decrease of 20.2% compared to a net loss of $3,543,950 in Q1 2023[76] - Total operating expenses for Q1 2024 were $2,827,000, down 38.4% from $4,592,000 in Q1 2023[88] - Research and development expenses decreased by 51.4% to $513,000 in Q1 2024 from $1,056,000 in Q1 2023, primarily due to lower manufacturing costs and payroll[89] - General and administrative expenses were $2,314,000 in Q1 2024, a decrease of 34.6% from $3,536,000 in Q1 2023, attributed to reduced payments and accruals[90] - Net cash used in operating activities was $3.8 million for Q1 2024, compared to $4.6 million for Q1 2023, reflecting a decrease of $812,000[92] - Net cash provided by financing activities was $2.7 million in Q1 2024, a significant increase from a net cash used of $35,000 in Q1 2023[93] Financial Position - As of March 31, 2024, ZyVersa had an accumulated deficit of approximately $106.0 million and cash of $2.0 million[76] - Current assets as of March 31, 2024, were $2,900,000, while current liabilities were $9,583,000, resulting in a working capital deficiency of $6,683,000[94] - As of March 31, 2024, the company has approximately $9.6 million in current liabilities for accounts payable and accrued expenses[96] Future Outlook - The company has not generated any revenue since inception and anticipates continued operating losses until significant revenue can be generated from product candidates[78] - ZyVersa expects to require additional financing to support ongoing operations and development activities, with no assurance that such financing will be available on acceptable terms[77] - The company expects to incur substantial additional operating losses for at least the next several years as it continues to develop product candidates and seek marketing approval[100] - Future capital needs will depend on various factors, including the initiation and progress of clinical trials for product candidates[101] Strategic Plans - The company plans to commit substantial resources to research and development, clinical trials, and potential product acquisitions to grow its business over the long term[102] - The company intends to raise additional capital through equity, equity-linked securities, or debt in subsequent offerings[98] - If the company raises additional funds through collaboration and licensing arrangements, it may need to relinquish valuable rights to its technologies or future revenue streams[103] - The company has no current arrangements for acquisitions or in-licensing but continues to evaluate strategic relationships with established pharmaceutical companies[102] Compliance and Governance - The company expects to incur significant costs related to compliance with corporate governance and internal controls as a public company[100] - There are no off-balance sheet arrangements that materially affect the company's financial conditions or results[107] Investment Strategy - The company’s cash equivalents will primarily be invested in money market funds to preserve principal balance and provide liquidity[99]

Drug Development Focus - The company is focused on developing drugs for chronic renal and inflammatory diseases, addressing high unmet medical needs[18] - The company aims to expand its product portfolio through indication expansion for VAR 200 and IC 100, as well as potential in-licensing opportunities[27] - The company is focused on developing drugs for chronic renal and inflammatory diseases, with a mission to improve health outcomes and quality of life for patients[18] Lead Indications and Trials - The lead indication for VAR 200 is focal segmental glomerulosclerosis (FSGS), with approximately 40,000 patients affected in the U.S.[24] - VAR 200 has received FDA approval to proceed to a Phase 2a trial for FSGS, with a small open-label Phase 2a trial for diabetic kidney disease planned for H1-2024[20] - The company anticipates submitting an IND for IC 100 in Q4-2024, targeting multiple sclerosis and acute respiratory distress syndrome[21] - The company plans to select lead indications for IC 100 based on preclinical data prior to the IND filing[29] Market Opportunity and Unmet Needs - Chronic kidney disease (CKD) affects over 75 million people globally, with significant economic burdens, including $130 billion in Medicare spending in 2018[22] - The economic burden of CKD and the lack of disease-modifying therapies create a significant market opportunity for the company's products[22] - Current drugs for FSGS and other renal diseases do not effectively delay or halt disease progression, creating a significant unmet need in the market[31] - The company believes there is a significant unmet need for effective FSGS-specific treatments to improve patients' quality of life and reduce health economic burden[87] - There are currently no commercially available disease-specific treatments for AS, highlighting a significant unmet need for effective therapies[90] Product Development and Efficacy - VAR 200 is an injectable drug in clinical development targeting chronic glomerular diseases, with a Phase 2a trial in diabetic kidney disease expected to start in H1-2024[36] - VAR 200 demonstrated significant reduction in proteinuria in FSGS mouse models, indicating its potential to delay kidney disease progression[46] - VAR 200 significantly reduced renal damage and proteinuria in Alport Syndrome models, suggesting its protective effects on kidney function[53] - IC 100 targets the ASC component of inflammasomes, which are linked to various chronic inflammatory diseases, presenting a competitive advantage[26] - IC 100 has shown pharmacologic proof-of-concept data in animal models for ARDS and MS, with ongoing studies for Parkinson's disease, atherosclerosis, and obesity[60] Regulatory and Compliance - The FDA regulates drug products and requires extensive data demonstrating quality, safety, and efficacy before approval[126][127] - The FDA requires a user fee payment exceeding $2.5 million for each NDA or BLA submission, unless a waiver applies[142] - The FDA aims to review standard NDAs or BLAs within 12 months and prior review biologics within 8 months from submission[146] - The FDA may issue a complete response letter if the application is not ready for approval, which may require additional clinical data or trials[147] - The company is subject to extensive regulations from multiple authorities, including the FDA and CMS, which could impact its operational flexibility[177] Financial and Operational Aspects - Research and development expenses totaled approximately $5.4 million for the Predecessor period and $3.2 million for the year ended December 31, 2023[116] - The company currently relies on third-party suppliers for the manufacturing, testing, and distribution of its product candidates VAR 200 and IC 100[114] - The company is facing increasing pressure on product pricing due to regulatory changes and managed healthcare practices in the United States, which may lead to lower average selling prices[174] - The company must comply with various healthcare laws, including the False Claims Act and the Anti-Kickback Statute, which could impact sales and marketing activities[176] Employee and Operational Structure - As of December 31, 2023, the company had seven full-time employees, indicating a lean operational structure[185] - The company has a good relationship with its employees, which is crucial for maintaining operational efficiency[185] Strategic Partnerships and Agreements - The company has entered into a License Agreement with L&F Research, involving an upfront fee of $200,000 and potential milestone payments up to $21.5 million[104] - The InflamaCORE License Agreement includes an upfront fee of $346,321.08 and potential milestone payments up to $22.5 million, with royalties ranging from 5% to 10% on net sales[111] Competitive Landscape - The pharmaceutical and biotechnology industry is highly competitive, with many competitors having greater financial and technical resources[118] - VAR 200 is believed to be the only drug in development addressing lipid accumulation in the glomerulus, while IC 100 may be the only monoclonal antibody targeting the ASC component of the inflammasome[120][121]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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 September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number: 001-41184 ZYVERSA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 86-268 ...