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 significant unmet medical needs [5] - The company is advancing a therapeutic development pipeline that includes Cholesterol Efflux Mediator™ VAR 200 for kidney diseases and Inflammasome ASC Inhibitor IC 100 for inflammatory diseases [5] Share Purchase Agreement (SPA) - ZyVersa has entered into a share purchase agreement with Williamsburg Venture Holdings, allowing the company to sell up to $10 million worth of common stock over a 24-month period [3] - The SPA provides ZyVersa with flexibility in planning the timing and amount of equity sales, aiming to minimize dilution while sustaining shareholder value [2][3] - ZyVersa retains control over the timing and amount of all common stock sales, with no associated warrants or derivatives [3] Market Potential - The global drug market for kidney diseases was valued at $18 billion in 2024 and is projected to reach $30 billion by 2034 [1]

Financial Data and Key Metrics Changes - Zyversa Therapeutics reported that proxies have been received for 1,446,712 of the 3,619,456 shares of common stock outstanding, representing approximately 40% of the total outstanding shares, which constitutes a quorum for the meeting [6] Business Line Data and Key Metrics Changes - No specific data on business lines or key metrics changes were provided in the meeting Market Data and Key Metrics Changes - No specific market data or key metrics changes were discussed during the meeting Company Strategy and Development Direction and Industry Competition - The company approved several proposals, including the election of two Class III directors and the ratification of the independent public accounting firm, indicating a focus on governance and compliance [10][13] - The approval of amendments to the equity incentive plan suggests a strategy to attract and retain talent through equity compensation [10] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during the meeting Other Important Information - The meeting was conducted virtually to allow shareholders to participate regardless of location [1] - The final vote results will be reported in a Form 8-K to be filed within four business days [15] Q&A Session Summary - No questions were submitted during the Q&A session, and the meeting concluded without any inquiries from shareholders [16]

Core Insights - ZyVersa Therapeutics, Inc. is developing Inflammasome ASC Inhibitor IC 100 as a potential disease-modifying treatment for Parkinson's Disease (PD), addressing a significant unmet medical need for over 10 million people globally [1][3][9] - Current therapies for PD, which only manage symptoms, generated $6.6 billion in 2024 and are projected to reach $13.3 billion by 2034 [1] Study Findings - A study published in Experimental and Molecular Medicine indicates that microglial-driven inflammation contributes to the progression of neurodegenerative diseases, including PD and Alzheimer's [2][5] - The research shows that controlling microglial inflammation is crucial for slowing the development of PD [3][7] Mechanism of Action - IC 100 is a humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC, reducing microglial inflammation and improving clearance of toxic phosphorylated alpha-synuclein [5][9] - The drug targets multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin, blocking the activation of IL-1β and the inflammatory response [5][9] Future Plans - ZyVersa is preparing to initiate proof-of-concept studies in PD animal models later this year [3][9]

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) The company's unaudited Q1 2025 financial statements show a net loss and a significant working capital deficit [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a working capital deficit of $9.9 million and a slight increase in total assets Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $1,612 | $1,531 | | Total Current Assets | $2,110 | $1,716 | | Total Assets | $20,986 | $20,599 | | **Liabilities & Equity** | | | | Total Current Liabilities | $12,004 | $11,231 | | Total Liabilities | $12,855 | $12,083 | | Total Stockholders' Equity | $8,130 | $8,516 | | **Working Capital** | **($9,894)** | **($9,515)** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's Q1 2025 net loss improved to $2.3 million, driven by lower operating expenses Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $259 | $513 | | General and administrative | $1,886 | $2,314 | | **Total Operating Expenses** | **$2,145** | **$2,827** | | Loss From Operations | ($2,145) | ($2,827) | | **Net Loss** | **($2,257)** | **($2,827)** | | Net Loss Per Share | ($0.73) | ($4.53) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash from financing activities offset operating cash use, resulting in a slight increase in cash reserves Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | ($1,772) | ($3,777) | | Net Cash Provided By Financing Activities | $1,853 | $2,673 | | **Net Increase / (Decrease) in Cash** | **$81** | **($1,104)** | | **Cash - End of Period** | **$1,612** | **$2,034** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight a going concern uncertainty, a recent financing, a vendor dispute, and a reverse stock split - **Going Concern:** The company had cash of ~$1.6M, a working capital deficit of ~$9.9M, and an accumulated deficit of ~$114.9M as of March 31, 2025, raising **substantial doubt about its ability to continue as a going concern**[26](index=26&type=chunk)[28](index=28&type=chunk) - **Financing:** In March 2025, the company closed a private placement of pre-funded and common warrants, resulting in **gross proceeds of approximately $2.0 million**[55](index=55&type=chunk) - **Vendor Dispute:** The company is disputing vendor invoices for retroactive interest and unsupported charges, with an **unaccrued disputed amount of $941,074**[42](index=42&type=chunk) - **Subsequent Event:** After March 31, 2025, an investor **exercised 2,105,265 pre-funded warrants** at an exercise price of $0.0001 per share[60](index=60&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=16&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses improved Q1 2025 results but highlights a critical liquidity position and going concern risk - The company is a clinical-stage biopharmaceutical firm focused on developing drugs for renal and inflammatory diseases, with lead candidates **VAR 200 and IC 100**[62](index=62&type=chunk)[63](index=63&type=chunk) - The company has **not generated any revenue to date** and expects to continue incurring significant operating losses for the foreseeable future[64](index=64&type=chunk)[66](index=66&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) The Q1 2025 net loss improved due to significant decreases in both R&D and G&A expenses Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $259 | $513 | $254 | 49.5% | | General and administrative | $1,886 | $2,314 | $428 | 18.5% | | **Total Operating Expenses** | **$2,145** | **$2,827** | **$682** | **24.1%** | - The decrease in R&D costs is attributed to lower IC100 manufacturing costs ($62k), reduced CRO fees for VAR200 ($106k), and lower consultant costs ($95k)[79](index=79&type=chunk) - The decrease in G&A expenses is primarily due to lower stock-based compensation ($156k), reduced director and officer insurance ($143k), and decreased marketing expenses ($119k)[80](index=80&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company's critical liquidity, with cash for only 'month-to-month' operations, necessitates urgent financing - The company's cash of **$1.6 million** as of March 31, 2025 is only sufficient to fund operating expenses and capital requirements on a **month-to-month basis**[86](index=86&type=chunk)[87](index=87&type=chunk) - The company has a **working capital deficiency of $9.9 million** and an accumulated deficit of $114.9 million as of March 31, 2025[86](index=86&type=chunk)[87](index=87&type=chunk) - **Additional financing is needed** to fund operations and complete development of product candidates, but there is no assurance that such financing will be available on acceptable terms, if at all[87](index=87&type=chunk)[90](index=90&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, this disclosure is not applicable - Not applicable[103](index=103&type=chunk) [Controls and Procedures](index=25&type=section&id=ITEM%204.%20Controls%20and%20Procedures.) Management concluded disclosure controls were effective and actions were taken to remediate a material weakness - Management concluded that **disclosure controls and procedures were effective** as of March 31, 2025[105](index=105&type=chunk) - The company has implemented additional controls to address the **material weakness related to segregation of duties** that was identified as of December 31, 2024[106](index=106&type=chunk) [PART II - OTHER INFORMATION](index=26&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=26&type=section&id=ITEM%201.%20Legal%20Proceedings.) The company reported no legal proceedings during the period - None[109](index=109&type=chunk) [Risk Factors](index=26&type=section&id=ITEM%201A.%20Risk%20Factors.) As a smaller reporting company, this section refers to the Annual Report on Form 10-K for risk factors - As a "smaller reporting company", the company is not required to provide this information and refers investors to its **Annual Report on Form 10-K** filed on March 27, 2025[110](index=110&type=chunk) [Other Information](index=26&type=section&id=ITEM%205.%20Other%20Information.) No directors or officers engaged in new or modified Rule 10b5-1 trading arrangements during the quarter - No director or officer adopted, modified, or terminated a **"Rule 10b5-1 trading arrangement"** or "non-Rule 10b5-1 trading arrangement" during the quarter[114](index=114&type=chunk) [Exhibits](index=27&type=section&id=ITEM%206.%20Exhibits.) This section lists all exhibits filed with the report, including financing agreements and certifications - This section lists the exhibits filed with the report, including documents related to the **March 2025 private placement** and required CEO/CFO certifications[116](index=116&type=chunk)

Core Insights - ZyVersa Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases with significant unmet medical needs [2][12] - The company reported a net loss of approximately $2.3 million for Q1 2025, an improvement of 20.2% compared to a net loss of $2.8 million in Q1 2024 [8][20] - ZyVersa anticipates that its cash of $1.6 million as of March 31, 2025, will be sufficient for month-to-month operations but will require additional financing for ongoing operations and clinical activities [9] Pipeline Update - The Cholesterol Efflux Mediator VAR 200 is set to begin a Phase 2a clinical trial for diabetic kidney disease (DKD) by the end of June 2025, with the goal of obtaining proof-of-concept before a larger Phase 2a/b trial for FSGS [4][5] - The Inflammasome ASC Inhibitor IC 100 is preparing for an Investigational New Drug (IND) application in the second half of 2025, with a Phase 1 trial expected to start in healthy overweight subjects at risk of cardiometabolic diseases in early 2026 [5][7] - Recent data indicates that IC 100 effectively blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation, which are critical factors in neurodegeneration and Parkinson's disease [5][6] Financial Performance - Research and development expenses for Q1 2025 were $259 thousand, a decrease of 49.5% from $512 thousand in Q1 2024, attributed to lower manufacturing costs and fewer consultant engagements [10] - General and administrative expenses were $1.9 million for Q1 2025, down 18.5% from $2.3 million in Q1 2024, primarily due to reduced stock-based compensation and lower marketing expenses [11] - The total operating expenses for Q1 2025 were $2.1 million, compared to $2.8 million in Q1 2024, reflecting a significant reduction in costs [20]

Core Insights - ZyVersa Therapeutics, Inc. is advancing its Inflammasome ASC Inhibitor IC 100 as a complementary therapy to GLP-1 agonists for treating obesity-associated cardiometabolic complications [1][13] Industry Overview - Obesity affects over 40% of Americans and is projected to reach 51% globally within 12 years, linked to chronic diseases like type 2 diabetes and cardiovascular disease [2] - The economic burden of obesity is expected to exceed $4.32 trillion annually by 2035 without improved treatment options [2] Product Development - IC 100 is designed to inhibit ASC and ASC specks, targeting the inflammatory processes that contribute to obesity-related conditions [6][7] - Preclinical data suggest that IC 100 can reduce inflammation and plaque in atherosclerosis models, indicating its potential in addressing cardiometabolic comorbidities [7] - The company plans to initiate a preclinical study in a diet-induced obesity mouse model in H1-2025 and submit an IND application for IC 100 in H2-2025 [16] Strategic Collaborations - ZyVersa has established a Scientific Advisory Board with experts in obesity and metabolic diseases to guide the development of IC 100 [11] - The company is also exploring the potential of IC 100 in treating Parkinson's disease through preclinical collaborations [12] Clinical Insights - GLP-1 agonists have high discontinuation rates, with around 65% of non-diabetic patients stopping treatment within a year due to gastrointestinal side effects [8] - IC 100 may enhance weight loss and fat reduction while preserving lean mass compared to monotherapy with GLP-1 agonists [8]

Core Insights - ZyVersa Therapeutics, Inc. announces promising data for its Inflammasome ASC Inhibitor IC 100, which may slow the progression of Parkinson's disease [1][3] - The study published in npj Parkinson's Disease shows that IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation, both critical in Parkinson's disease progression [2][7] Company Overview - ZyVersa is a clinical stage specialty biopharmaceutical company focused on developing first-in-class drugs for inflammatory and renal diseases, with a significant market opportunity exceeding $100 billion [10] - The company is advancing its lead candidate IC 100, a humanized IgG4 monoclonal antibody targeting inflammasome adaptor protein ASC, which is designed to mitigate inflammatory responses [6][10] Study Findings - The research indicates that IC 100 uniquely inhibits ASC speck activity and misfolded protein aggregates, making it a strong candidate for treating neurodegenerative diseases, including Lewy body dementia and Alzheimer's Disease [5] - The study highlights the presence of ASC and NLRP1 in alpha-synuclein aggregates in neuronal Lewy bodies, suggesting a link between inflammasome activation and neurodegeneration in Parkinson's disease [8] Market Context - The global Parkinson's disease drug market was valued at $6.6 billion in 2024 and is projected to reach $13.3 billion by 2034, indicating significant growth potential for innovative treatments [7]

Core Insights - ZyVersa Therapeutics is focused on developing first-in-class drugs for renal and inflammatory diseases, specifically targeting chronic inflammatory conditions with its Inflammasome ASC Inhibitor IC 100 [1][2] Industry Overview - The global market for anti-inflammatory biologics was valued at $105 billion in 2024 and is projected to reach $186 billion by 2034, driven by the increasing incidence of chronic inflammatory diseases due to aging populations, lifestyle changes, and environmental factors [2] - Over the past five years, there have been over $7 billion in strategic collaborations and M&A activities in the inflammasome inhibitor development space, indicating strong interest and investment in this area [3] Development Trends - The development of inflammasome inhibitors is at a critical juncture, with many developers completing preclinical programs and early-phase clinical trials showing promising safety and efficacy signals [5] - Initial indications for inflammasome inhibitors are being identified, with many companies moving into phase 1b and phase 2 clinical trials, which are expected to yield data by the end of the year [5] Product Development - IC 100 is designed to uniquely inhibit ASC and ASC specks, aiming to control inflammation more effectively than targeting a single inflammasome [6][8] - A proof-of-concept study for IC 100 in a diet-induced obesity mouse model is planned for H1-2025, with preliminary results expected in H2-2025 [11] - An Investigational New Drug Application (IND) for IC 100 is anticipated to be submitted in H2-2025, followed by a Phase 1 clinical trial in overweight subjects [11]

WESTON, Fla., April 08, 2025 (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 diseases who have unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Shareholder Letter addressing the recent PARASOL recommendations expected to shorten drug development time and approval fo ...

KEY HIGHLIGHTS: Phase 2a proof-of concept clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD) expected to begin H1-2025. Regulatory path for VAR 200’s lead indication, focal segmental glomerulosclerosis (FSGS), expected to be shorter based on FDA’s alignment with data supporting proteinuria reduction as a clinical trial endpoint for approval of FSGS drugs (Parasol Initiative). Obesity proof-of-concept studies with Inflammasome ASC Inhibitor IC 100 in diet-i ...