• ZyVersa is advancing a highly differentiated pipeline focusing on inflammatory and renal diseases with a total accessible market >$100 billion.
• Inflammasome ASC Inhibitor IC 100 is the next evolution of inflammasome inhibitors designed for unparalleled control of disease-causing inflammation by (1) inhibiting multiple inflammasomes activated in numerous diseases, not just NLRP3, and (2) attenuating spread and perpetuation of inflammation by uniquely inhibiting ASC specks.
  • Lead indication: Cardiometabolic conditions associated with obesity
  • Value driving milestones: file IND Q4-2026; Phase 1 SAD read-out H1-2027
• Cholesterol Efflux Mediator VAR 200 is expected to be a disease-modifying renal drug by targeting unaddressed renal lipotoxicity to attenuate renal damage and slow disease progression.
  • Lead indication: orphan disease FSGS (focal segmental glomerulosclerosis)
  • Value driving milestones: initiate P2a trial in patients with FSGS and Alport syndrome H2-2026; Interim Phase 2a read-out ~Q4-2026
• Raised $1 Million in Q1-2026.

LIGHTHOUSE POINT, Fla., May 13, 2026 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (OTCQB: ZVSA), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of inflammatory and renal diseases with high unmet medical needs, reports financial results for first quarter ending March 31, 2026, and provides business update.

"We are pleased to announce that ZyVersa is poised to achieve significant value-driving milestones over the next 12 -15 months," stated Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO, and President.

"The market value of our highly differentiated lead candidate, Inflammasome ASC Inhibitor IC 100, has been validated, we believe, by over $6 billion in recent deals in the inflammasome space, including a January 2026 acquisition for $1.2 billion. Additionally, IC 100 development has been derisked with preclinical proof-of-concept data in ten cardiometabolic, CNS, and non-CNS indications, as well as early phase human data with NLRP3 inflammasome inhibition demonstrating biomarker efficacy in overweight people at risk of cardiometabolic conditions."

"A biomarker-efficacy driven phase 1 trial with IC 100 in healthy overweight subjects at risk for cardiometabolic conditions is slated to begin after clearance of our IND, expected to be filed in Q4-2026 — a read-out of Phase 1a data is planned for H1-2027. The Phase 1 trial will be supported by a preclinical study to be initiated in Q2-2026 in a diet-induced obesity mouse model that develops cardiometabolic conditions. A preliminary read-out will be available around H2-2026."

"A significant turning point has been reached for renal drug development with FDA's approval of Travere's sparsentan for FSGS. With regulatory clarity on proteinuria reduction as the primary endpoint for clinical trials, accelerated drug development and broader investment is expected in the space. Significant unmet needs remain to target unaddressed pathways leading to kidney damage and disease progression — lipotoxicity and inflammation. ZyVersa plans to address lipotoxicity with Cholesterol Efflux Mediator VAR 200, and inflammation with IC 100."

"We plan to initiate a Phase 2a clinical trial with VAR 200 in patients with FSGS and Alport Syndrome in H2-2026, with an interim Phase 2a read-out expected around Q4-2026. Additionally, we will initiate a preclinical study with IC 100 in an orphan renal disease model in H2-2026. A preliminary read-out is anticipated around Q4-2026."

"We look forward to sharing our upcoming data read-outs and the anticipated value they will bring to our shareholders."

FIRST QUARTER 2026 FINANCIAL RESULTS

Net losses were approximately $1.8 million for the three months ended March 31, 2026, with an improvement of $0.5 million or 20.5% compared to a net loss of approximately $2.3 million, for the three months ended March 31, 2025. The decrease in net loss of $0.5 million is due to an overall decrease in expenses of $0.8 million as the company focused mainly on raising capital in this quarter, and offset by $0.3 million of non-cash charges on issuance of convertible notes and warrants.

Research and development expenses were $58 thousand for the three months ended March 31, 2026, a decrease of $201 thousand or 77.6% from the three months ended March 31, 2025. The decrease is attributable to lower research and development payroll costs of $138 thousand due to the retirement of the Chief Medical Officer in October of 2025, lower manufacturing costs of $32 thousand, lower pre-clinical costs of $14 thousand, and lower research and development consultant costs of $17 thousand due to the pause of VAR200 study.

General and administrative expenses were $1.2 million for the three months ended March 31, 2026, a decrease of $639 thousand or 33.9% from the three months ended March 31, 2025. The decrease is primarily attributable to a decrease of $348 thousand in professional fees due to fewer SEC registrations and lower NASDAQ and patent legal fees, a decrease in marketing fees of $244 thousand due to lower investor relations expense, and a $47 thousand decrease in state franchise tax due to decrease in estimated liability.

Based on our current operating plan, ZyVersa expects its cash of $0.3 million as of March 31, 2026, will only be sufficient to fund operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations, pay for its current liabilities, and to meet its stated milestones. ZyVersa will seek to fund its operations and clinical activity through public or private equity, debt financings, or other sources which may include government grants, collaborations with third parties, or outstanding warrant exercises.

ABOUT ZYVERSA THERAPEUTICS, INC.

ZyVersa (OTCQB: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with inflammatory and renal diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies — Inflammasome ASC Inhibitor IC 100, targeting inflammasome-driven inflammatory diseases, and Cholesterol Efflux Mediator VAR 200 for treatment of kidney diseases. For more information, please visit www.zyversa.com. 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These statements are based on management’s current expectations, assumptions, beliefs, or projections and include, for example, our belief that we have sufficient liquidity to fund our business operations on a month-to-month basis; anticipated levels of capital expenditures; the timing, scope, and anticipated results of our planned preclinical and clinical trials for IC 100 and VAR 200; our expectations regarding IND filings, regulatory submissions, and FDA interactions; the therapeutic potential, safety, and efficacy of our product candidates; our commercialization, marketing, and manufacturing strategies; our ability to obtain additional financing; and our research and development plans. These statements are based on management’s current expectations, assumptions, estimates, and projections, which may prove to be incorrect. Forward-looking statements are neither historical facts nor assurances of future performance, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. (“ZyVersa” or the "Company") uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” “poised,” “slated,” and similar expressions, or the negative of such terms, to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are subject to known and unknown risks, uncertainties, and other factors, and actual results may differ materially from those expressed or implied due to a number of factors, including: ZyVersa’s ability to obtain the funding necessary to advance the development of its product candidates and maintain its business operations, including its ability to continue as a going concern; the inherent risks associated with pharmaceutical product development, including the risk that preclinical and clinical trials may not be successful or may be delayed; the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or other regulatory submissions; uncertainties relating to regulatory review and approval processes; ZyVersa’s ability to enroll patients in its clinical trials; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits, safety, efficacy, and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing, and manufacturing capabilities and strategy; ZyVersa’s ability to establish and maintain collaborations or strategic relationships; ZyVersa’s ability to protect its intellectual property position; ZyVersa’s estimates regarding future revenue, expenses, capital requirements, and need for additional financing; and other risks described in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. 

New factors emerge from time to time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

CORPORATE, MEDIA, IR CONTACT

Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com 
786-251-9641