STOCK TITAN

ZyVersa Therapeutics Reports Full Year 2025 Financial Results and Provides Business Update    

(Neutral)
Tags

ZyVersa Therapeutics (OTCQB: ZVSA) reported full-year 2025 results and a program update. Cash was $0.1M at year-end; the company raised $4.1M in 2025 and $1M in Q1 2026 and issued $1M of convertible notes on Feb 27, 2026.

2025 R&D was $1.1M (down 37.4%), G&A was $5.7M (down 22.1%), and net loss was $25.0M, driven chiefly by an $18.6M impairment. Key milestones: IND filing for IC 100 in Q4-2026, Phase 1 SAD readout Q1-2027, VAR 200 Phase 2a start Q2-2026 with interim readout ~Q4-2026.

Loading...
Loading translation...

Positive

  • VAR 200 Phase 2a initiation targeted Q2-2026
  • IC 100 IND filing planned Q4-2026
  • Phase 1 SAD readout for IC 100 expected Q1-2027
  • Raised $4.1M during 2025 to support programs
  • Issued $1M convertible notes and warrants on Feb 27, 2026

Negative

  • Year-end cash balance of $0.1M
  • Net loss of $25.0M for 2025
  • $18.6M impairment of in-process R&D in 2025
  • Cash expected to fund operations only on a month-to-month basis
  • Company states it will need additional financing to continue operations

Market Context

This announcement combines a detailed pipeline roadmap for IC 100 and VAR 200 with very tight liquid...
Analysis

This announcement combines a detailed pipeline roadmap for IC 100 and VAR 200 with very tight liquidity, including year‑end cash of only $0.1 million, a $25.0 million net loss, and an $18.6 million R&D impairment. Investors may focus on whether the company can secure sufficient funding to reach key 2026–2027 read‑outs. Tracking future financings, trial initiations, and any changes in operating expenses will be important for assessing execution risk.

Key Figures

Addressable market: >$100 billion Capital raised 2025: $4.1 million Capital raised Q1-2026: $1 million +5 more
8 metrics
Addressable market >$100 billion Inflammatory and renal diseases targeted by pipeline
Capital raised 2025 $4.1 million Total raised in 2025
Capital raised Q1-2026 $1 million Raised in Q1-2026
Cash on hand $0.1 million As of December 31, 2025
R&D expenses $1.1 million Year ended December 31, 2025
G&A expenses $5.7 million Year ended December 31, 2025
Net loss 2025 $25.0 million Year ended December 31, 2025
R&D impairment $18.6 million Impairment of in‑process research and development in 2025

Previous Earnings Reports

5 past events · Latest: Nov 19 (Negative)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Nov 19 Q3 2025 earnings Negative +3.7% Higher net loss driven by $18.6M R&D impairment and low cash.
Aug 13 Q2 2025 earnings Positive +6.9% Improved net loss, cost cuts, capital access and clear development milestones.
May 12 Q1 2025 earnings Neutral -4.0% Smaller loss and pipeline updates but continued need for new financing.
Mar 27 FY 2024 results Neutral -5.4% Large improvement vs 2023 loss with ongoing month‑to‑month cash runway.
Nov 14 Q3 2024 earnings Neutral -9.6% Cost reductions and trial plans offset by persistent financing requirements.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings releases often bring financing warnings and going-concern language, with share reactions frequently diverging from the underlying fundamentals.

Recent Company History

Over the last five earnings cycles, ZyVersa repeatedly highlighted progress on VAR 200 and IC 100 while emphasizing the need for additional financing. Prior updates showed shrinking operating expenses, large non‑cash R&D impairments, and month‑to‑month cash visibility. The move to OTCQB, ongoing going‑concern disclosures, and recurring small capital raises frame today’s full‑year 2025 update, which again combines pipeline milestones with very limited cash and a large $18.6 million impairment.

Key Terms

inflammasome, asc specks, phase 1, phase 2a, +2 more
6 terms
inflammasome medical
"Inflammasome ASC Inhibitor IC 100 is a next generation drug..."
A cellular protein assembly that senses danger or infection and turns on a rapid inflammatory response by activating enzymes that release signaling molecules and can trigger a controlled form of cell death. Think of it as a built‑in smoke detector and alarm system for immune cells: useful short-term to alert the body, but if it stays on it can cause chronic inflammation. Investors watch inflammasomes because they are drug targets and biomarkers that can affect a therapy’s effectiveness, safety profile, and regulatory path.
asc specks medical
"...attenuating spread and perpetuation of inflammation by uniquely inhibiting ASC specks."
ASC specks are tiny clumps formed when the ASC protein gathers inside immune cells and acts like a cellular alarm that turns on intense inflammation. Investors care because these specks serve as measurable signs of inflammatory disease activity and as drug targets—reducing or clearing ASC specks in studies can suggest a therapy is actually changing disease processes, which can influence trial success, regulatory approval chances, and commercial potential.
phase 1 medical
"File IND Q4-2026; Phase 1 SAD read-out Q1-2027"
Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.
phase 2a medical
"Initiate P2a trial in patients with FSGS and Alport syndrome Q2-2026..."
Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.
orphan disease regulatory
"Lead indication: Orphan disease FSGS (focal segmental glomerulosclerosis)"
A rare medical condition that affects a very small number of people, often so few that standard drug development and commercial sales are impractical. For investors it matters because treatments for these conditions can qualify for special regulatory incentives, faster approval paths and price premiums, so a successful therapy is like owning a product that dominates a tiny but underserved niche market — high potential reward but also higher scientific and commercial risk.
convertible promissory notes financial
"we issued convertible promissory notes and warrants in an aggregate principal amount..."
A convertible promissory note is a loan a company takes that can later be turned into shares instead of being paid back in cash; think of lending money now in exchange for a voucher that can become ownership later. Investors care because it mixes credit risk and potential ownership upside—it can protect lenders if a company struggles while also diluting existing shareholders when converted, affecting future share value and investor returns.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
  • 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 a next generation drug 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 Q1-2027

  • 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 Q2-2026; Interim Phase 2a read-out ~Q4-2026

  • Raised $4.1 Million in 2025; $1 Million in Q1-2026

LIGHTHOUSE POINT, Fla., March 31, 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 full year ending December 31, 2025, and provides business update.

“The next 18 months are poised to be transformative for ZyVersa,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President.

“We are nearing completion of our preclinical program for Inflammasome ASC Inhibitor IC 100, with plans to file an IND in Q4-2026, followed by initiation of a Phase 1 trial in overweight healthy subjects at risk of cardiometabolic conditions. The SAD Phase 1 read-out is expected in Q1-2027. The Phase 1 trial will be supported by a preclinical study to be initiated in Q2-2026 in a diet-induced obesity mouse model, which develops cardiometabolic conditions. A preliminary read-out will be available around Q3-2026. We will also initiate in Q2-2026 a preclinical study in an orphan renal disease animal model to support potential indication expansion in this area, with a preliminary read-out around Q3-2026.”

“We have a clinical research organization in place to initiate a Phase 2a clinical trial with Cholesterol Efflux Mediator VAR 200 in patients with FSGS and Alport Syndrome in Q2-2026. An interim Phase 2a read-out is planned around Q4-2026.”

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

YEAR END 2025 FINANCIAL RESULTS

Cash on hand was $0.1 million as of December 31, 2025. On February 27, 2026, we issued convertible promissory notes and warrants in an aggregate principal amount of $1 million.

Research and development expenses were approximately $1.1 million for the year ended December 31, 2025, a decrease of approximately $0.7 million or 37.4% from the year ended December 31, 2024. The decrease is attributable to fewer consultants utilized in 2025 for a decrease of $0.3 million, retirement of Chief Medical Officer in late 2025 for a net decrease of $0.1 million, decrease in VAR 200 clinical patient trial expense of $0.1 million, as program paused in 2025, and a decrease in preclinical bioassay IC 100 work of $0.1 million which was completed in 2024.

General and administrative expenses were approximately $5.7 million for the year ended December 31, 2025, a decrease of approximately $1.6 million or 22.1% from the year ended December 31, 2024. The decrease is attributable to $0.5 million decrease in director and officer insurance due to reduced costs in the third year of being a public company, a $0.4 million decrease in stock-based compensation as a result of options becoming fully amortized in 2025, a $0.4 million decrease in marketing expense due to fewer investor relations and public relations firms used in 2025, and a $0.2 million decrease in Delaware franchise tax as a result of a decrease in total assets.

Net losses were approximately $25.0 million for the year ended December 31, 2025, with a decline of approximately $15.6 million or 165% compared to a net loss of approximately $9.4 million for the year ended December 31, 2024. The higher net loss reported for 2025 was primarily due to the impairment of in-process research and development of approximately $18.6 million.

Based on our current operating plan, we expect our cash and cash equivalents 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 and anticipated levels of capital expenditures for the coming months or year. 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,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are subject to risks and uncertainties, 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; 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; 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 protect its intellectual property position; ZyVersa’s estimates regarding future revenue, expenses, capital requirements, and need for additional financing; and the risks described in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.

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 undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

CORPORATE, MEDIA, IR CONTACT

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


 
ZYVERSA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
 
   December 31,
    2025   2024 
      
Assets
   
      
Current Assets:   
 Cash $101,778  $1,530,924 
 Prepaid expenses and other current assets 231,639   184,873 
 Vendor deposits 14,484   - 
  Total Current Assets 347,901   1,715,797 
      
In-process research and development -   18,647,903 
Vendor deposit -   178,476 
Deferred offering costs -   57,238 
      
  Total Assets$347,901  $20,599,414 
      
Liabilities and Stockholders' (Deficit) Equity   
      
Current Liabilities:   
 Accounts payable$10,123,391  $9,337,267 
 Accrued expenses and other current liabilities 2,611,296   1,894,041 
  Total Current Liabilities 12,734,687   11,231,308 
Deferred tax liability -   851,659 
  Total Liabilities 12,734,687   12,082,967 
      
      
Stockholders' (Deficit) Equity:   
 Preferred stock, $0.0001 par value, 1,000,000 shares authorized:   
 Series A preferred stock, 8,635 shares designated, 50 shares issued   
 and outstanding as of December 31, 2025 and 2024 -   - 
 Series B preferred stock, 5,062 shares designated, 5,062 shares issued   
 and outstanding as of December 31, 2025 and 2024 1   1 
 Common stock, $0.0001 par value, 250,000,000 shares authorized;   
 8,095,928 and 2,508,198 shares issued as of December 31, 2025 and   
 2024, respectively, and 8,095,921 and 2,508,191 shares outstanding   
 as of December 31, 2025 and 2024, respectively 809   251 
 Additional paid-in-capital 125,204,509   121,155,922 
 Accumulated deficit (137,584,937)  (112,632,559)
 Treasury stock, at cost, 7 shares at December 31, 2025 and 2024 (7,168)  (7,168)
  Total Stockholders' (Deficit) Equity (12,386,786)  8,516,447 
      
  Total Liabilities and Stockholders' (Deficit) Equity$347,901  $20,599,414 
      


 
ZYVERSA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
      
   For the Year Ended
   December 31,
    2025   2024 
Operating Expenses:   
 Research and development$1,113,105  $1,779,275 
 General and administrative 5,731,682   7,357,559 
 Impairment of in-process research and development 18,647,903   - 
  Total Operating Expenses 25,492,690   9,136,834 
      
  Loss From Operations (25,492,690)  (9,136,834)
      
Other (Income) Expense:   
 Interest expense 513,209   269,856 
 Change in fair value of equity payable (201,862)  - 
      
  Pre-Tax Net Loss (25,804,037)  (9,406,690)
  Income tax benefit (provision) 851,659   (6,745)
  Net Loss$(24,952,378) $(9,413,435)
      
  Net Loss Per Share   
  - Basic and Diluted$(4.18) $(8.48)
      
  Weighted Average Number of   
  Common Shares Outstanding   
  - Basic and Diluted 5,963,943   1,110,033 

FAQ

How long is ZyVersa (ZVSA) expected to fund operations with current cash?

The company expects cash to fund operations only on a month-to-month basis. According to ZyVersa, year-end cash was $0.1M, requiring near-term additional financing to support operations and milestones.

When will ZyVersa (ZVSA) file the IND for Inflammasome ASC Inhibitor IC 100?

ZyVersa plans to file an IND for IC 100 in Q4-2026. According to ZyVersa, IND filing is a key value-driving milestone ahead of a Phase 1 SAD readout expected in Q1-2027.

What is the timeline for ZyVersa's (ZVSA) VAR 200 Phase 2a trial in FSGS and Alport syndrome?

ZyVersa plans to initiate the VAR 200 Phase 2a trial in Q2-2026 with an interim readout around Q4-2026. According to ZyVersa, a CRO is in place to start the study as scheduled.

Why did ZyVersa (ZVSA) report a larger net loss in 2025 compared to 2024?

The larger 2025 net loss was mainly due to an $18.6M impairment of in-process R&D. According to ZyVersa, net loss for 2025 was approximately $25.0M, compared with about $9.4M in 2024.

What recent financings did ZyVersa (ZVSA) complete to support operations?

ZyVersa raised $4.1M in 2025 and $1M in Q1-2026 and issued $1M of convertible promissory notes on Feb 27, 2026. According to ZyVersa, these financings aim to support near-term program activities.