Core Viewpoint - ZyVersa Therapeutics, Inc. is positioned for transformative growth over the next 18 months, focusing on developing first-in-class drugs for inflammatory and renal diseases with significant unmet medical needs [1]. Financial Results - As of December 31, 2025, the company reported cash on hand of $0.1 million and raised $1 million through convertible promissory notes and warrants in February 2026 [3][5]. - Research and development expenses for the year ended December 31, 2025, were approximately $1.1 million, a decrease of 37.4% from 2024, attributed to reduced consultant usage and program pauses [4]. - General and administrative expenses were approximately $5.7 million for the year ended December 31, 2025, a decrease of 22.1% from 2024, due to lower insurance costs and reduced marketing expenses [6]. - The net loss for the year ended December 31, 2025, was approximately $25.0 million, a significant increase from a net loss of $9.4 million in 2024, primarily due to an impairment of in-process research and development [7][15]. Pipeline and Development Plans - ZyVersa is advancing a differentiated pipeline targeting inflammatory and renal diseases, with a total accessible market exceeding $100 billion [5]. - The company is nearing completion of its preclinical program for Inflammasome ASC Inhibitor IC 100, with plans to file an IND in Q4-2026 and initiate a Phase 1 trial in Q1-2027 [2]. - A Phase 2a clinical trial for Cholesterol Efflux Mediator VAR 200 in patients with FSGS and Alport Syndrome is set to begin in Q2-2026, with an interim read-out expected around Q4-2026 [2][5]. Funding and Financial Outlook - The company anticipates needing additional financing to support ongoing operations and meet clinical milestones, exploring options such as public or private equity, debt financing, and collaborations [8].

Core Viewpoint - ZyVersa Therapeutics, Inc. reported significant financial losses for the third quarter of 2025, primarily due to an impairment of in-process research and development, necessitating additional financing to sustain operations and development initiatives [2][5][6]. Financial Results - Cash on hand as of September 30, 2025, was $0.5 million, indicating a need for additional financing to cover operating expenses and liabilities [2]. - Research and development expenses decreased by 16.3% to $0.4 million compared to the same period in 2024, attributed to lower consultant costs [3]. - General and administrative expenses were $1.7 million, a decrease of 5.1% from the previous year, mainly due to lower insurance premiums and professional fees [4]. - Pre-tax losses increased to $20.7 million, up from $2.4 million in the same quarter of 2024, largely due to an $18.6 million impairment related to research and development [5]. - Net losses for the quarter were approximately $19.8 million, compared to $2.4 million in the prior year, with a deferred tax benefit of $0.9 million [6]. Company Overview - ZyVersa is a clinical-stage biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases [7]. - The company is advancing a therapeutic pipeline that includes Cholesterol Efflux Mediator VAR 200 for kidney diseases and Inflammasome ASC Inhibitor IC 100 for chronic inflammatory diseases [8]. - In Q3 2025, ZyVersa raised approximately $2.05 million, totaling $4.05 million year-to-date [8].

The Securities Act of 1933 As filed with the Securities and Exchange Commission on August 1, 2025 Registration No. 333-288470 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 To FORM S-1 REGISTRATION STATEMENT Under (I.R.S. Employer Identification Number) 2200 N. Commerce Parkway, Suite 208 Weston, FL 33326 (754) 231-1688 (Address, including zip code, and telephone number, including area code, of Registrant's principal executive offices) Stephen C. Glover Chief Executi ...

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]