Core Viewpoint - ZyVersa Therapeutics is positioned to advance its pipeline of first-in-class drugs for renal and inflammatory diseases despite challenging market conditions, emphasizing the importance of continued investor support [2][3][4]. Financial Developments - In Q2-2025, ZyVersa secured $12 million in capital through two financing transactions: a $2 million warrant inducement transaction and a Share Purchase Agreement for up to $10 million with Williamsburg Venture Holdings [5]. Product Pipeline - VAR 200 targets kidney diseases by addressing lipid accumulation in the kidneys, with ongoing trials for focal segmental glomerulosclerosis (FSGS) and diabetic kidney disease (DKD) [6][8]. - Preliminary data for the Phase 2a trial in DKD is expected in Q4-2025, with final results anticipated in H1-2026 [6]. - IC 100 is an inflammasome inhibitor aimed at treating obesity and potentially neurological diseases, with preclinical studies planned for Q3-2025 [11]. Market Opportunity - Kidney disease affects over 850 million people globally, with significant unmet medical needs and limited treatment options, representing a substantial market opportunity [8][9]. - The U.S. spends over $130 billion annually on kidney disease, accounting for approximately 25% of Medicare spending [9]. Regulatory Environment - Regulatory bodies like the FDA and EMA are facilitating innovation in kidney disease treatment through accelerated pathways, which may reduce barriers to drug development [14].

Core Insights - ZyVersa Therapeutics is advancing its Cholesterol Efflux Mediator VAR 200, which has received FDA authorization for Emergency Compassionate Use in a patient with ApoCII amyloidosis [2][3] - The company is conducting a Phase 2a clinical trial for diabetic kidney disease (DKD) to gather data that will support the ongoing development of VAR 200 [3][4] - ZyVersa has entered into a warrant inducement agreement with an institutional investor, raising $2 million through the exercise of Series A-2 and A-3 warrants at a reduced price [7] Company Developments - VAR 200 is an injectable drug in Phase 2 development aimed at reducing renal lipid accumulation, which is critical for kidney health [4][5] - Preclinical studies have shown that VAR 200 can lower cholesterol and lipid levels, protect against renal injury, and improve proteinuria in animal models [5][6] - The company is exploring additional indications for VAR 200, including Alport Syndrome and diabetic kidney disease, as part of its indication expansion strategy [6] Market Performance - ZyVersa's stock (ZVSA) experienced a significant increase of 56%, reaching $1.03, with a trading volume of 160.9 million shares compared to the average of 4.03 million [1][7]

Core Viewpoint - ZyVersa Therapeutics, Inc. has entered into a warrant inducement agreement with an institutional investor, which includes the immediate exercise of existing warrants and the issuance of new warrants at a reduced exercise price of $0.67, generating approximately $2.0 million in gross cash proceeds for working capital and corporate purposes [1][2]. Group 1 - The agreement involves the immediate exercise of Series A-2 Warrants for up to 957,200 shares and Series A-3 Warrants for up to 2,105,265 shares at an exercise price of $0.67 [1]. - The investor will receive new Series A-4 Warrants to purchase up to 6,124,930 shares, which will be exercisable upon stockholder approval and will expire five years from that date [2]. - The transaction is expected to close on or about July 9, 2025, pending customary closing conditions [2]. Group 2 - A.G.P./Alliance Global Partners served as the exclusive financial advisor for this transaction [3]. - The new warrants were offered in a private placement under an exemption from the registration requirements of the Securities Act, and the company plans to file a registration statement with the SEC for the resale of common stock upon exercise of the new warrants [4]. Group 3 - ZyVersa Therapeutics is a clinical stage specialty biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases, utilizing proprietary technologies such as Cholesterol Efflux Mediator™ VAR 200 and Inflammasome ASC Inhibitor IC 100 [6].

Core Viewpoint - ZyVersa Therapeutics, Inc. has received FDA authorization for Emergency Compassionate Use of its investigational drug Cholesterol Efflux Mediator™ VAR 200 for a patient with ApoCII amyloidosis, a condition with no effective treatment options available [1][4]. Group 1: Product Development and Clinical Trials - VAR 200 is currently in phase 2 development aimed at treating renal lipid accumulation, which is critical for protecting kidney function and preventing disease progression [5][8]. - The drug is being administered at the University of Miami under the supervision of Dr. Alessia Fornoni, who is also the inventor of VAR 200 [2]. - Preclinical studies have shown that VAR 200 can reduce cholesterol and lipid levels, protect against renal injury, and improve proteinuria in various kidney disease models [6][8]. Group 2: Company Overview and Future Directions - ZyVersa is focused on developing first-in-class drugs for renal and inflammatory diseases, leveraging proprietary technologies [9]. - The company is advancing a therapeutic pipeline that includes VAR 200 for kidney diseases and another product, Inflammasome ASC Inhibitor IC 100, targeting CNS and peripheral inflammatory diseases [9]. - The lead indication for VAR 200 is orphan kidney disease, specifically focal segmental glomerulosclerosis (FSGS), with ongoing trials expected to provide quicker proof-of-concept [7].

Core Insights - ZyVersa Therapeutics, Inc. has initiated patient recruitment for its VAR 200 Phase 2a clinical study targeting diabetic kidney disease (DKD) [1][2] - VAR 200 is designed to address renal lipotoxicity by removing excess lipids from the kidneys, which is a significant factor in the progression of kidney diseases [3][7] - The study aims to evaluate the efficacy and safety of VAR 200 in patients with type 2 diabetes and DKD, with preliminary data expected in the second half of 2025 [7] Company Overview - ZyVersa is a clinical stage specialty biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases with significant unmet medical needs [8] - The company is advancing a therapeutic pipeline that includes VAR 200 and another program targeting inflammation [8] Clinical Study Details - The VAR 200 Phase 2a trial will be an open-label study conducted at one to two US sites, enrolling an adequate number of subjects to complete eight [2][7] - The primary efficacy endpoint is the percent change from baseline to week 12 in urinary albumin to creatinine ratio, with treatment lasting 12 weeks followed by a four-week follow-up [2][7] Drug Mechanism and Indications - VAR 200, a Cholesterol Efflux Mediator™, is an injectable drug that aims to reduce renal lipid accumulation, which damages the kidney's filtration system [3][5] - Preclinical studies have shown that VAR 200 can reduce cholesterol and lipid levels, protect against renal injury and fibrosis, and improve proteinuria in various kidney disease models [4][7] Future Prospects - The lead indication for VAR 200 is focal segmental glomerulosclerosis (FSGS), with plans to expand indications based on the results of the ongoing trials [5][7] - The initiation of patient recruitment is considered a key milestone in the development of VAR 200, with the potential to be a first-in-class treatment for kidney disease [7]

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]

ZyVersa Therapeutics (ZVSA) FY 2025 Annual General Meeting June 11, 2025 09:00 AM ET Speaker0 Good morning and welcome to the Zyversa Therapeutics twenty twenty five Annual Stockholders Meeting. My name is Stephen Glover. I'm Chief Executive Officer, President and Chairman of the Board of Zyversa Therapeutics. I am pleased that you could join us today. This meeting is being held virtually to enable shareholders and stockholders to attend regardless of their location. As is our custom, we will conduct the bu ...

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)

KEY HIGHLIGHTS First patient expected to start therapy by end of Q2-2025 in Phase 2a proof-of concept clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD).Obesity-associated cardiometabolic preclinical proof-of-concept study with Inflammasome ASC Inhibitor IC 100 planned to begin by end of Q2-2025.Investigational New Drug Application (IND) for IC 100 anticipated to be submitted H2-2025, followed by initiation of a Phase 1 clinical trial in healthy overweigh ...