ZyVersa Therapeutics, Inc.

What they do

ZyVersa is developing two globally licensed drug platforms discovered by University of Miami researchers. Cholesterol Efflux Mediator VAR 200 (2-hydroxypropyl-beta-cyclodextrin) is an injectable in clinical development for renal diseases, with lead indication focal segmental glomerulosclerosis (FSGS). Inflammasome ASC Inhibitor IC 100 is a humanized monoclonal antibody in preclinical development for inflammatory conditions, with lead indication cardiometabolic conditions associated with obesity. The company has not generated any revenue and does not expect product revenue in the near future.

Revenue drivers

• VAR 200 (renal) — No revenue to date; VAR 200 is in development for FSGS, Alport syndrome and diabetic kidney disease, with a planned Phase 2a basket trial in FSGS and Alport syndrome patients in Q2-2026. No sales or license revenue has been recognized.
• IC 100 (inflammasome/ASC inhibitor) — No revenue to date; IC 100 is a humanized monoclonal IgG4 antibody in preclinical development targeting ASC for inflammatory conditions, with a currently planned IND submission in Q4-2026. No sales or license revenue has been recognized.
• Future licensing or collaboration revenue — Management states it may generate revenue in the future from product sales or payments from collaboration or license agreements, but no such agreements or revenue are reported in the filings.

Recent performance

For the three months ended March 31, 2026, ZyVersa reported a net loss of $1.8 million, compared to a net loss of $2.3 million for the three months ended March 31, 2025. As of March 31, 2026, the company had cash of $0.3 million and an accumulated deficit of approximately $139.4 million. Full-year 2025 net loss was $25.0 million, and operating cash flow was negative $5.1 million. In Q3 2025, pre-tax losses were $20.7 million, including an $18.6 million impairment of in-process research and development. The company has never generated revenue and does not expect product revenue in the near future.

Strategy

ZyVersa's stated strategy is to advance VAR 200 into a Phase 2a basket trial in FSGS and Alport syndrome patients in Q2-2026 and to complete IND-enabling preclinical studies for IC 100, targeting a planned IND submission in Q4-2026 followed by a Phase 1 trial in healthy overweight patients with a BMI between 27 and 30. The company focuses on indication expansion to maximize commercial potential for both platforms. Management expects to fund operations through public or private equity or debt financings, government grants, collaborations, or outstanding warrant exercises. Expenses are expected to increase as development, regulatory, manufacturing, and personnel activities expand.

Risks

• No revenue and no approved products — ZyVersa has never generated revenue from product sales, has no products approved for commercial sale, and may never achieve profitability.
• Substantial doubt about financing — As of March 31, 2026, cash was $0.3 million against total liabilities of $14.9 million and negative shareholder equity of $14.1 million, and management states cash is sufficient only to fund operations on a month-to-month basis.
• Impairment of in-process research and development — In Q3 2025 ZyVersa recorded an $18.6 million impairment of in-process research and development due to the decline in market capitalization and inability to demonstrate assured financing of milestones.
• Listing and market risks — An 8-K filed September 18, 2025 reported a delisting notice or listing-rule failure, and the stock trades on OTCQB under ZVSA.

Outlook

Management plans to initiate a Phase 2a basket trial of VAR 200 in FSGS and Alport syndrome patients in Q2-2026 and to prepare IND-enabling preclinical studies for IC 100, with a planned IND submission in Q4-2026. The company expects to incur significant expenses and operating losses for the foreseeable future and will need additional financing to support continuing operations. Management states that adequate additional financing may not be available on acceptable terms, or at all, and that failure to raise capital as and when needed would have a negative impact on its financial condition and business strategy.