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]

Key Business Highlights - The Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease is expected to begin in Q1-2025, with initial data read-out anticipated around mid-2025 [1][4]. - A new Scientific Advisory Board (SAB) for Obesity, Metabolic & Inflammatory Disease was formed in October 2024 to support the development of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications [1][6]. - Two proof-of-concept studies for IC 100 in diet-induced obesity (DIO) mouse models are planned, with at least one study expected to begin in Q4-2024 [1][7]. - An Investigational New Drug (IND) submission for IC 100 is planned for Q2-2025, followed by a Phase 1 clinical trial in healthy overweight subjects at risk for metabolic complications, with safety data expected in H2-2025 [1][5]. Financial Results - For the quarter ended September 30, 2024, the company reported net losses of approximately $2.4 million, an improvement of about $0.5 million or 17.3% compared to a net loss of approximately $2.9 million for the same period in 2023 [7][8]. - Research and development expenses were approximately $0.4 million for the three months ended September 30, 2024, a decrease of about $0.2 million or 35.3% from the same period in 2023 [9]. - General and administrative expenses were approximately $1.8 million for the three months ended September 30, 2024, a decrease of about $0.4 million or 17.7% compared to the same period in 2023 [10]. Cash Position and Funding Needs - As of September 30, 2024, the company had approximately $0.1 million in cash, which is expected to be sufficient for month-to-month operating expenses, but additional financing will be needed to support ongoing operations and clinical activities [8]. - The company plans to seek funding through public or private equity, debt financings, government grants, collaborations, or outstanding warrant exercises [8]. Company Overview - ZyVersa Therapeutics, Inc. is a clinical-stage specialty biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases with high unmet medical needs [2][11]. - The company is positioned in the emerging inflammasome space with its lead compounds, Inflammasome ASC Inhibitor IC 100 for obesity and its associated metabolic complications, and Cholesterol Efflux Mediator™ VAR 200 for focal segmental glomerulosclerosis (FSGS) [11]. - The total accessible market for these therapeutic areas is estimated to exceed $100 billion [11].

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]

"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, ...

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 ...