KEY HIGHLIGHTS:
- Phase 2a proof-of concept clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD) expected to begin H1-2025.
- Regulatory path for VAR 200’s lead indication, focal segmental glomerulosclerosis (FSGS), expected to be shorter based on FDA’s alignment with data supporting proteinuria reduction as a clinical trial endpoint for approval of FSGS drugs (Parasol Initiative).
- Obesity proof-of-concept studies with Inflammasome ASC Inhibitor IC 100 in diet-induced obesity (DIO) mouse models are planned to begin H1-2025.
- Investigational New Drug Application (IND) for IC 100 is anticipated to be submitted H2-2025, followed by initiation of a Phase 1 clinical trial in healthy overweight subjects.
- Preclinical study funded by The Michael J. Fox Foundation (MJFF) to evaluate the potential of IC 100 as a treatment for Parkinson’s disease has been completed and a manuscript has been submitted for publication.
- Invited MJFF grant request for funding a second IC 100 preclinical study in Parkinson’s disease animal model submitted; response expected in June, 2025.
- Raised approximately $6.6 million in 2024 and $2.0 million in Q1-2025.
WESTON, Fla., March 27, 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 full year ending December 31, 2024, and provides business update.
“We are pleased to announce that development of our renal and anti-inflammatory pipelines has progressed to value-building milestones that we expect to achieve over the next 12 months,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our first-in-human Phase 2a clinical study with Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease is anticipated to begin enrolling patients in the first half of 2025. Likewise, we expect to initiate our first-in-human Phase 1 trial with Inflammasome ASC Inhibitor IC 100 in overweight healthy subjects in the first half of 2026. This trial will be supported by two IC 100 preclinical studies in diet-induced obesity mouse models, with an interim data read-out for the first study expected 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 Mediator™ VAR 200
Kidney Disease (Global Drug Market: $18 Billion in 2024; $30 Billion Projected by 2034)
A phase 2a clinical trial in patients with DKD is expected to begin in the first half 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, which will provide insights for developing the subsequent FSGS study. The DKD study will be conducted at two clinical research sites.
Inflammasome ASC Inhibitor IC 100
Inflammatory Diseases (Global Biologics Market: $105 Billion in 2024; $186 Billion Projected by 2034)
Obesity with Metabolic Complications
In preparation for filing an IND for IC 100, planned for second half of 2025, we will initiate two diet-induced obesity (DIO) mouse model studies, with the first planned to begin in H1-2025. The studies will evaluate the effects of IC 100 on body weight, body composition, and changes in metabolic and inflammatory parameters in comparison to semaglutide (study 1), and the effects of IC 100 administered concurrently with semaglutide on those same endpoints (study 2). We expect a preliminary read-out of study 1 by end of second half 2025.
Following IND clearance, a phase 1 trial will be initiated with IC 100 in healthy overweight people (BMI: 27 – 30) to evaluate the safety of 3 different doses of IC 100, and to get a signal on the degree of weight loss that can be expected with each dose. Results are anticipated in the first half of 2026.
Parkinson’s Disease
A manuscript highlighting data from preclinical research studies funded by MJFF and conducted by researchers at University of Miami Miller School of Medicine has been submitted and is under peer review. The studies assessed the potential of IC 100 to block the damaging neuroinflammation that induces neural degeneration in Parkinson’s disease.
Based on the promising preclinical results, the MJFF project team suggested that we apply for a second grant for further research. A grant request has been submitted to MJFF proposing funding to conduct proof-of-concept studies in established Parkinson’s disease animal models. An MJFF response to the grant request is expected in June, 2025.
Additional Indications
In 2024, two IC 100 papers were published supporting additional indications.
- Stroke-related cardiovascular disease: IC 100 protected against stroke-related cardiovascular injury and dysfunction in an animal model. IC 100 blocked AIM2 inflammasome activation and cell death (pyroptosis) in the heart and improved cardiac function, following a stroke.
- Retinopathy of Prematurity: IC 100 restored retinal structure and function in a retinopathy of prematurity animal model. IC 100 suppressed retinal microglia activation by interfering with ASC speck formation, attenuating retinal inflammation, abnormal retinal vascularization, and retinal thinning, and it led to restored retinal function.
YEAR END 2024 FINANCIAL RESULTS
Net losses were approximately $9.4 million for the year ended December 31, 2024, with an improvement of approximately $88.9 million or 90.4% compared to a net loss of approximately $98.3 million for the year ended December 31, 2023. The higher net loss reported for 2023 was primarily due to the one-time impairment of in-process research and development and the one-time impairment of goodwill of approximately $81.4 million and $11.9 million, respectively.
Based on its current operating plan, ZyVersa expects its cash of approximately $1.5 million as of December 31, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations, pay its current liabilities, and to meet its stated milestones. ZyVersa will seek to fund its operations and clinical activity through public or private equity or debt financings or other sources, which may include government grants, collaborations with third parties or outstanding warrant exercises.
Research and development expenses were approximately $1.8 million for the year ended December 31, 2024, a decrease of approximately $1.4 million or 44.5% from the year ended December 31, 2023. The decrease is primarily attributable to a decrease of $1.4 million in manufacturing and pre-clinical costs of IC 100 in order to conserve cash.
General and administrative expenses were approximately $7.4 million for the year ended December 31, 2024, a decrease of approximately $3.9 million or 34.4% from the year ended December 31, 2023. The decrease is attributable to a $0.7 million decrease in professional fees related to changes in public auditors and legal counsel, a $1.1 million decrease due to the prior 2023 lock up share agreement entered into previously with members of Larkspur Health Acquisition Corp., a $0.6 million decrease in director and officer insurance costs, a $0.4 million decrease in registration delay fees, a $0.4 million decrease in stock-based compensation as a result of options becoming fully amortized in 2024, a $0.4 million decrease due to no employee bonus accrual in 2024, and a $0.1 million decrease in marketing costs.
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; 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. | ||||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||||
| December 31, | ||||||||||
| 2024 | 2023 | |||||||||
| Assets | ||||||||||
| Current Assets: | ||||||||||
| Cash | $ | 1,530,924 | $ | 3,137,674 | ||||||
| Prepaid expenses and other current assets | 184,873 | 215,459 | ||||||||
| Total Current Assets | 1,715,797 | 3,353,133 | ||||||||
| Equipment, net | - | 6,933 | ||||||||
| In-process research and development | 18,647,903 | 18,647,903 | ||||||||
| Vendor deposit | 178,476 | 98,476 | ||||||||
| Deferred offering costs | 57,238 | - | ||||||||
| Operating lease right-of-use asset | - | 7,839 | ||||||||
| Total Assets | $ | 20,599,414 | $ | 22,114,284 | ||||||
| Liabilities and Stockholders' Equity | ||||||||||
| Current Liabilities: | ||||||||||
| Accounts payable | $ | 9,337,267 | $ | 8,431,583 | ||||||
| Accrued expenses and other current liabilities | 1,894,041 | 1,754,533 | ||||||||
| Operating lease liability | - | 8,656 | ||||||||
| Total Current Liabilities | 11,231,308 | 10,194,772 | ||||||||
| Deferred tax liability | 851,659 | 844,914 | ||||||||
| Total Liabilities | 12,082,967 | 11,039,686 | ||||||||
| Stockholders' 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, 2024 and 2023 | - | - | ||||||||
| Series B preferred stock, 5,062 shares designated, 5,062 shares issued | ||||||||||
| and outstanding as of December 31, 2024 and 2023 | 1 | 1 | ||||||||
| Common stock, $0.0001 par value, 250,000,000 shares authorized; | ||||||||||
| 2,508,198 and 405,212 shares issued at December 31, 2024 and 2023, | ||||||||||
| respectively, and 2,508,191 and 402,205 shares outstanding as of | ||||||||||
| December 31, 2024 and 2023 | 250 | 40 | ||||||||
| Additional paid-in-capital | 121,155,923 | 114,300,849 | ||||||||
| Accumulated deficit | (112,632,559 | ) | (103,219,124 | ) | ||||||
| Treasury stock, at cost, 7 shares at December 31, 2024 and 2023 | (7,168 | ) | (7,168 | ) | ||||||
| Total Stockholders' Equity | 8,516,447 | 11,074,598 | ||||||||
| Total Liabilities and Stockholders' Equity | $ | 20,599,414 | $ | 22,114,284 | ||||||
| ZYVERSA THERAPEUTICS, INC. | |||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
| For the Year Ended | |||||||||
| December 31, | |||||||||
| 2024 | 2023 | ||||||||
| Operating Expenses: | |||||||||
| Research and development | $ | 1,779,275 | $ | 3,207,573 | |||||
| General and administrative | 7,357,559 | 11,213,201 | |||||||
| Impairment of in-process research and development | - | 81,438,426 | |||||||
| Impairment of goodwill | - | 11,895,033 | |||||||
| Total Operating Expenses | 9,136,834 | 107,754,233 | |||||||
| Loss From Operations | (9,136,834 | ) | (107,754,233 | ) | |||||
| Other (Income) Expense: | |||||||||
| Interest (income) expense | 269,856 | (457 | ) | ||||||
| Pre-Tax Loss | (9,406,690 | ) | (107,753,776 | ) | |||||
| Income tax (provision) benefit | (6,745 | ) | 9,455,830 | ||||||
| Net Loss | (9,413,435 | ) | (98,297,946 | ) | |||||
| Deemed dividend to preferred stockholders | - | (7,948,209 | ) | ||||||
| Net Loss Attributable to Common Stockholders | $ | (9,413,435 | ) | $ | (106,246,155 | ) | |||
| Net Loss Per Share | |||||||||
| - Basic and Diluted | $ | (8.48 | ) | $ | (1,089.70 | ) | |||
| Weighted Average Number of | |||||||||
| Common Shares Outstanding | |||||||||
| - Basic and Diluted | 1,110,033 | 97,500 | |||||||
