ZyVersa Therapeutics Reports First Quarter 2025 Financial Results and Highlights Pipeline Progress
- Net loss improved by 20.2% YoY to $2.3M in Q1 2025
- R&D expenses decreased by 49.5% to $259K
- G&A expenses reduced by 18.5% to $1.9M
- Promising new data for IC 100 in Parkinson's disease treatment
- FDA's PARASOL Initiative may allow shorter clinical trials with fewer patients for FSGS indication
- Limited cash position of $1.6M as of March 31, 2025
- Additional financing needed to support continuing operations and meet milestones
- Operating on a month-to-month basis due to cash constraints
Insights
ZyVersa shows promising pipeline progress in kidney and inflammatory diseases despite financial challenges requiring additional funding to sustain operations.
ZyVersa Therapeutics' Q1 2025 earnings report reveals a company at a pivotal stage in its development timeline, with two promising clinical assets advancing toward significant milestones. Their lead program, VAR 200 for kidney diseases, is poised to treat its first diabetic kidney disease patient in a Phase 2a trial by end of Q2-2025. This represents a crucial proof-of-concept opportunity before advancing to the company's primary target indication of FSGS (Focal Segmental Glomerulosclerosis).
Their second asset, IC 100 for inflammatory conditions, is progressing with preclinical work in obesity-related cardiometabolic disease, with an IND filing anticipated in H2-2025. The recently published data showing IC 100's ability to block microglial inflammasome activation and reduce alpha-synuclein accumulation suggests potential applications in Parkinson's disease, potentially expanding the drug's market opportunity.
From a financial perspective, ZyVersa reported a narrowing quarterly loss of
The concerning aspect is ZyVersa's explicit statement that current cash will only fund operations "on a month-to-month basis," indicating an urgent need for additional financing to support continuing operations, meet current liabilities, and achieve stated milestones. This precarious financial position creates significant uncertainty despite the promising clinical progress.
The FDA's PARASOL Initiative recommendation for reduced proteinuria as a surrogate endpoint for FSGS drug approval is a positive regulatory development, potentially enabling shorter, smaller clinical trials for VAR 200's lead indication. However, investors should weigh the promising pipeline advancements against the company's challenging financial situation requiring imminent funding.
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 overweight subjects at risk of cardiometabolic diseases.
- Groundbreaking data demonstrating IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation — both key contributors to neurodegeneration and Parkinson’s disease (PD) progression — recently published (study sponsored by Michael J. Fox Foundation, MJFF).
- Invited MJFF grant request submitted for funding PD animal model proof-of-concept studies; response expected in June 2025.
- Raised approximately
$2.0 million in Q1-2025.
WESTON, Fla., May 12, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for the quarter ended March 31, 2025, and provides pipeline update.
“2025 is off to a good start. We have newly published data showing that our Inflammasome ASC Inhibitor IC 100 attenuates microglial inflammasome activation and accumulation of alpha-synuclein, which leads to neurodegeneration in Parkinson’s disease. Additionally, thanks to the efforts of kidney disease experts and the FDA as part of the PARASOL Initiative, it is expected that shorter clinical trials with fewer patients will be required to demonstrate drug efficacy for FSGS, our lead indication for VAR 200. The PARASOL team recommended reduced proteinuria over a two-year period as a surrogate endpoint for full approval of FSGS drugs,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “I am also pleased to report that we have made great progress in development of our renal and anti-inflammatory drug pipelines. Our first-in-human Phase 2a clinical study with Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease is anticipated to begin treating the first patient around the end of June/early July of this year. Likewise, we expect to initiate our first-in-human Phase 1 trial with Inflammasome ASC Inhibitor IC 100 in overweight healthy subjects at risk of cardiometabolic diseases in the first half of 2026. This trial will be supported by an IC 100 preclinical study in a diet-induced mouse model, with an interim data read-out expected in the second half of 2025. We look forward to reporting our near-term data read-outs, and the anticipated value they will bring to our shareholders.”
PIPELINE UPDATE
Cholesterol Efflux MediatorTM VAR 200
Kidney Disease (Global Drug Market:
The first patient is expected to be treated in a phase 2a clinical trial in patients with DKD by the end of June of 2025. The intent of the study is to obtain renal patient proof-of-concept for VAR 200 prior to initiating a larger phase 2a/b for VAR 200’s lead indication, FSGS. The DKD study will evaluate VAR 200’s safety and efficacy (% change in proteinuria from baseline to week 12) in eight patients with type 2 diabetes who have diabetic kidney disease. This data will provide insights for designing the subsequent phase 2a/b FSGS study. The DKD study will be conducted at two clinical research sites.
Inflammasome ASC Inhibitor IC 100
Inflammatory Diseases (Global Biologics Market:
Obesity with Cardiometabolic Complications
In preparation for filing an IND for IC 100, planned for the second half of 2025, we will initiate a diet-induced obesity (DIO) mouse model study, anticipated to begin by the end of June 2025. The study will evaluate the effects of IC 100 on body weight, body composition, and changes in cardiovascular, metabolic, and inflammatory parameters in comparison to semaglutide, and when administered concurrently with semaglutide. We expect a preliminary data read-out in the second half of 2025.
Following IND clearance, a phase 1 trial will be initiated with IC 100 in healthy overweight people (BMI: 27 – 30) at risk of cardiometabolic diseases to evaluate the safety of 3 different doses of IC 100, and to get a signal on the degree of weight loss, and changes in cardiometabolic biomarkers that can be expected with each dose. Results are anticipated in the first half of 2026.
First Quarter 2025 FINANCIAL RESULTS
Net losses were approximately
Based on its current operating plan, ZyVersa expects its cash of
Research and development expenses were
General and administrative expenses were
ABOUT ZYVERSA THERAPEUTICS, INC.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory 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 – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.
CAUTIONARY STATEMENT 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. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, 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”) 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 based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s ability to obtain the funding necessary to advance the development of our product candidates and maintain its business operations; plans to develop and commercialize its product candidates, 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; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits 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; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
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 obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
CORPORATE, MEDIA, IR CONTACT
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641
| ZYVERSA THERAPEUTICS, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | 1,611,532 | 1,530,924 | ||||||
| Prepaid expenses and other current assets | 498,778 | 184,873 | ||||||
| Total Current Assets | 2,110,310 | 1,715,797 | ||||||
| In-process research and development | 18,647,903 | 18,647,903 | ||||||
| Vendor deposit | 178,476 | 178,476 | ||||||
| Deferred offering costs | 48,852 | 57,238 | ||||||
| Total Assets | 20,985,541 | 20,599,414 | ||||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | 9,604,568 | 9,337,267 | ||||||
| Accrued expenses and other current liabilities | 2,398,964 | 1,894,041 | ||||||
| Total Current Liabilities | 12,003,532 | 11,231,308 | ||||||
| Deferred tax liability | 851,659 | 851,659 | ||||||
| Total Liabilities | 12,855,191 | 12,082,967 | ||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, | ||||||||
| Series A preferred stock, 8,635 shares designated, 50 shares issued | ||||||||
| and outstanding as of March 31, 2025 and December 31, 2024 | - | - | ||||||
| Series B preferred stock, 5,062 shares designated, 5,062 shares issued | ||||||||
| and outstanding as of March 31, 2025 and December 31, 2024 | 1 | 1 | ||||||
| Common stock, | ||||||||
| 2,568,198 and 2,508,198 shares issued as of March 31, 2025 and | ||||||||
| December 31, 2024, respectively, and 2,568,191 and 2,508,191 shares outstanding | ||||||||
| as of March 31, 2025 and December 31, 2024, respectively | 257 | 251 | ||||||
| Additional paid-in-capital | 123,026,749 | 121,155,922 | ||||||
| Accumulated deficit | (114,889,489 | ) | (112,632,559 | ) | ||||
| Treasury stock, at cost, 7 shares at March 31, 2025 and December 31, 2024, | (7,168 | ) | (7,168 | ) | ||||
| Total Stockholders' Equity | 8,130,350 | 8,516,447 | ||||||
| Total Liabilities and Stockholders' Equity | 20,985,541 | 20,599,414 | ||||||
| ZYVERSA THERAPEUTICS, INC. | |||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
| (Unaudited) | |||||||||
| For the Three Months Ended | |||||||||
| March 31, | |||||||||
| 2025 | 2024 | ||||||||
| Operating Expenses: | |||||||||
| Research and development | $ | 258,876 | $ | 512,937 | |||||
| General and administrative | 1,885,695 | 2,313,699 | |||||||
| Total Operating Expenses | 2,144,571 | 2,826,636 | |||||||
| Loss From Operations | (2,144,571 | ) | (2,826,636 | ) | |||||
| Other (Income) Expense: | |||||||||
| Interest expense | 119,559 | 101 | |||||||
| Change in fair value of equity payable | (7,200 | ) | - | ||||||
| Net Loss | $ | (2,256,930 | ) | $ | (2,826,737 | ) | |||
| Net Loss Per Share | |||||||||
| - Basic and Diluted | $ | (0.73 | ) | $ | (4.53 | ) | |||
| Weighted Average Number of | |||||||||
| Common Shares Outstanding | |||||||||
| - Basic and Diluted | 3,106,928 | 623,600 | |||||||
FAQ
What were ZyVersa Therapeutics (ZVSA) Q1 2025 financial results?
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