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 ...

Financial Performance - For the six months ended June 30, 2023, the net loss was $82.1 million, compared to a net loss of $5.8 million for the same period in 2022, reflecting a significant increase in operating losses [97]. - The company recorded a pre-tax net loss of $86.3 million for the three months ended June 30, 2023, compared to a pre-tax net loss of $2.0 million for the same period in 2022, indicating a substantial increase in losses [112]. - The company incurred a net loss of $82.1 million for the six months ended June 30, 2023, compared to a net loss of $5.8 million for the same period in 2022, resulting in an accumulated deficit of $87.0 million [128]. Expenses - Research and development expenses for the three months ended June 30, 2023, were $1.2 million, an increase of 69.7% from $0.7 million in the same period in 2022, primarily due to increased manufacturing costs for IC 100 [113]. - General and administrative expenses for the three months ended June 30, 2023, were $3.9 million, a 237.5% increase from $1.2 million in the same period in 2022, driven by stock grants and increased professional fees [114]. - Total operating expenses for the three months ended June 30, 2023, were $86.3 million, a dramatic increase of 4338.6% compared to $1.9 million in the same period in 2022 [112]. - Research and development expenses increased to $2.3 million for the six months ended June 30, 2023, up $0.5 million or 27.4% from the same period in 2022 [119]. - General and administrative expenses rose to $7.5 million, an increase of $4.0 million or 115.4% compared to the prior year, primarily due to stock grants and professional fees [120]. - Impairment of in-process research and development was $69.3 million for the three months ended June 30, 2023, compared to none in the same period in 2022, due to a decline in stock value [115]. - Impairment of in-process research and development and goodwill totaled $69.3 million and $11.9 million, respectively, compared to none in the prior year, reflecting a decline in stock value [121]. Cash Flow and Financing - Net cash used in operating activities was $5.0 million for the six months ended June 30, 2023, compared to $0.7 million in the same period of 2022, driven by a net loss of approximately $82.1 million [124]. - Cash provided by financing activities was negative $0.7 million for the six months ended June 30, 2023, primarily due to the redemption of Series A Preferred Stock [125]. - The company will seek additional financing through public or private equity or debt financings to support its operations, as adequate financing may not be available on acceptable terms [98]. - The company plans to raise additional capital to fund operations and the development of product candidates VAR200 and IC100 [131]. - Future operations depend on successful capital raising efforts, as the current cash balance is only sufficient for month-to-month operational expenses [128]. Current Assets and Liabilities - Current assets decreased to $1.1 million as of June 30, 2023, from $6.4 million at the end of 2022, while current liabilities increased to $10.5 million [127]. - The company had an accumulated deficit of approximately $87.0 million as of June 30, 2023, with cash reserves of only $0.2 million [97]. - The company has significant contractual obligations totaling approximately $10.5 million for accounts payable and accrued expenses as of June 30, 2023 [129]. Future Outlook - The company has not generated any revenue to date and does not expect to do so in the near future, relying on future collaborations or regulatory approvals for potential revenue [99]. - The company anticipates continued significant expenses related to ongoing research and development activities, which are expected to increase as clinical trials progress [103].

Financial Performance - ZyVersa Therapeutics reported a net loss of $3,543,950 for the three months ended March 31, 2023, compared to a net loss of $3,748,495 for the same period in 2022, reflecting a decrease of 5.5%[77][90] - The company incurred a net loss of $3.5 million for the three months ended March 31, 2023, compared to a net loss of $3.7 million for the same period in 2022, with an accumulated deficit of $8.5 million as of March 31, 2023[100] - Total other income (expense), net was $1,000 for the three months ended March 31, 2023, a significant improvement from a net expense of $380,000 in the same period of 2022[94] Operating Expenses - Total operating expenses for the Successor Period were $4,592,000, an increase of 36.3% from $3,368,000 in the Predecessor Period[90] - General and administrative expenses increased to $3,536,000 for the three months ended March 31, 2023, up by 53.7% from $2,301,000 in the prior year, primarily due to higher costs in insurance and marketing[92] - Research and development expenses remained consistent at approximately $1,056,000 for the three months ended March 31, 2023, with a slight decrease of 1.0% from $1,067,000 in the same period of 2022[91] Cash Flow and Liquidity - Net cash used in operating activities was $4,589,000 for the three months ended March 31, 2023, compared to $374,000 for the same period in 2022[96] - The company had an accumulated deficit of approximately $8.5 million as of March 31, 2023, with cash reserves of $1.3 million[77] - As of March 31, 2023, current assets were $2.835 million, down from $6.363 million in 2022, while current liabilities increased to $8.578 million from $8.188 million, resulting in a working capital deficiency of $5.743 million compared to $1.825 million in 2022[98] - Cash requirements for current liabilities as of March 31, 2023, include approximately $8.6 million for accounts payable and accrued expenses[101] Future Financing and Development Plans - The company has not generated any revenue to date and does not expect to do so in the near future, relying on future financing to support operations[79][78] - The company expects to seek additional financing through public or private equity or debt financings to support ongoing operations[78] - The company plans to raise additional capital through equity or equity-linked securities to fund continued development of its product candidates[104] - The company plans to continue increasing research and development expenses as it advances its product candidates VAR 200 and IC 100[81] - Future operating cash and capital requirements will depend on various factors, including clinical trial costs and regulatory requirements[107] - The company intends to commit substantial resources to research and development, clinical trials, and potential product acquisitions to grow its business over the long term[108] Regulatory and Compliance - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay compliance with new accounting standards[110] - There are no off-balance sheet arrangements that could materially affect the company's financial conditions or results of operations[113] - The company anticipates needing additional financing to fund operations and product development, with no assurance that such financing will be available on favorable terms[100]