Latest news with #ZyVersaTherapeutics
Yahoo
3 days ago
- Business
- Yahoo
ZyVersa Therapeutics Reports Second Quarter 2025 Financial Results and Highlights Key Near-term Value-building Milestones
KEY HIGHLIGHTS First clinical site for Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD) was activated June 2025; patient screening is underway, with interim results expected ~Q4-2025. IND-enabling obesity preclinical study with Inflammasome ASC Inhibitor IC 100 in a diet-induced obesity (DIO) animal model planned to begin ~Q4-2025. Invited MJFF grant request submitted for funding Parkinson's disease animal model proof-of-concept studies; response expected Q3-2025. Raised approximately $2.05 million since the end of Q2-2025; $4.05 million year-to-date. WESTON, Fla., Aug. 13, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (OTCQB: ZVSA, or 'ZyVersa'), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, reports financial results for the quarter ended June 30, 2025, and highlights progress toward achieving key value-building milestones. 'I am pleased to announce that we are well positioned to achieve our near-term development milestones,' said Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO, and President. "In June and July 2025, we closed two financing transactions providing access to $12 million in capital to advance development of our highly differentiated drug therapies for kidney and inflammatory diseases, each of which target untargeted pathways to advance care for these serious conditions. Regarding our kidney disease drug VAR 200, in mid-June we initiated an open-label Phase 2a trial in patients with DKD. VAR 200 uniquely targets lipid accumulation in the kidney's filtration system that triggers inflammation, fibrosis, and progressive kidney damage leading to renal failure if not addressed. Preliminary data are expected in Q4-2025, with final results anticipated H1-2026. The data will provide insights for developing a larger Phase 2a/b protocol in patients with FSGS, our lead indication. Based VAR 200's unique mechanism of action, we were asked and agreed to provide drug and regulatory support under FDA-authorized Emergency Compassionate Use to treat a patient at the University of Miami Miller School of Medicine who has ApoCII amyloidosis, a very rare, life-threatening disease which mainly affects the kidney. Concerning our inflammasome inhibitor IC 100, we are making progress toward IND submission. Preparation is underway with the University of Miami School of Medicine to initiate an IND-enabling preclinical study in a diet-induced obesity (DIO) animal model in Q4-2025. A phase 1 trial in overweight healthy subjects at risk for certain cardiometabolic conditions will be initiated shortly following IND clearance. IC 100 uniquely targets inhibition of the ASC inflammasome component rather than the NLRP3 sensor molecule. By targeting ASC, IC 100 uniquely inhibits multiple inflammasome pathways and their associated ASC specks to alleviate perpetuation and spread of inflammation that damages tissues and organs causing numerous diseases and their progression. We appreciate your support for our efforts to develop groundbreaking drugs to improve patients' health and quality of life.' PIPELINE UPDATE Cholesterol Efflux Mediator™ VAR 200 Kidney Disease (Global Drug Market: $18 Billion in 2024; $30 Billion Projected by 2034) The first patient is expected to be treated in a phase 2a clinical trial in patients with DKD in Q3-2025, with interim results in Q4-2025. 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. Inflammasome ASC Inhibitor IC 100 Inflammatory Diseases (Global Biologics Market: $105 Billion in 2024; $186 Billion Projected by 2034) Obesity with Cardiometabolic Complications In preparation for filing an IND for IC 100, a diet-induced obesity (DIO) mouse model study is expected to be initiated in partnership with University of Miami Miller School of Medicine Q4-2025. 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. Following IND clearance, a phase 1 trial will be initiated with IC 100 in healthy overweight people (BMI: 27 – 30) at risk of cardiometabolic conditions 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. Second Quarter 2025 FINANCIAL RESULTS Cash on hand was $0.1 million as of June 30, 2025. On July 8, 2025, we closed a $2.05M warrant inducement transaction from a current investor. Research and development expenses were $0.4 million for the three months ended June 30, 2025, a decrease of $0.3 million or 42.2% from the three months ended June 30, 2024. The decrease is attributable to lower CRO fees of $0.1 million for VAR 200, lower research and development consultant costs of $0.1 million resulting from fewer consultants, and lower pre-clinical costs of $0.1 million for IC 100, partially offset by an increase in VAR 200 manufacturing stability testing. General and administrative (G&A) expenses were $1.6 million for the three months ended June 30, 2025, a decrease of $0.4 million or 20.1% from the three months ended June 30, 2024. The decrease is primarily attributable to a decrease of $0.1 million in director and officer insurance premiums, a $0.1 million decrease in investor and public relations marketing expense, a $0.1 million decrease in professional fees from lower accounting and legal expense, and a decrease of $0.1 million in stock-based compensation expense resulting from fully amortized options in 2025. Decreased G&A expenses were partially offset by a $0.1 million increase in public company costs due to additional costs associated with our annual shareholder meeting and Nasdaq hearings. Net losses were approximately $2.2 million for the three months ended June 30, 2025, with an improvement of $0.6 million or 20% compared to a net loss of approximately $2.8 million, for the three months ended June 30, 2024. 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 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 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 CashmereChief Commercial Officerkcashmere@ ZYVERSA THERAPEUTICS, CONSOLIDATED BALANCE SHEETS June 30,2025 December 31,2024 (Unaudited) Assets Current Assets: Cash $ 72,086 $ 1,530,924 Prepaid expenses and other current assets 378,749 184,873 Vendor deposits 98,234 - Total Current Assets 549,069 1,715,797 In-process research and development 18,647,903 18,647,903 Vendor deposit 69,477 178,476 Deferred offering costs 374,662 57,238 Total Assets $ 19,641,111 $ 20,599,414 Liabilities and Stockholders' Equity Current Liabilities: Accounts payable $ 9,774,230 $ 9,337,267 Accrued expenses and other current liabilities 2,915,448 1,894,041 Total Current Liabilities 12,689,678 11,231,308 Deferred tax liability 851,659 851,659 Total Liabilities 13,541,337 12,082,967 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 June 30, 2025 and December 31, 2024 - - Series B preferred stock, 5,062 shares designated, 5,062 shares issued and outstanding as of June 30, 2025 and December 31, 2024 1 1 Common stock, $0.0001 par value, 250,000,000 shares authorized; 4,873,463 and 2,508,198 shares issued as of June 30, 2025 and December 31, 2024, respectively, and 4,873,456 and 2,508,191 shares outstanding as of June 30, 2025 and December 31, 2024, respectively 487 251 Additional paid-in-capital 123,207,260 121,155,922 Accumulated deficit (117,100,806 ) (112,632,559 ) Treasury stock, at cost, 7 shares at June 30, 2025 and December 31, 2024 (7,168 ) (7,168 ) Total Stockholders' Equity 6,099,774 8,516,447 Total Liabilities and Stockholders' Equity $ 19,641,111 $ 20,599,414 ZYVERSA THERAPEUTICS, CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) For the Three Months Ended June 30, 2025 2024 Operating Expenses: Research and development $ 409,937 $ 709,049 General and administrative 1,634,195 2,044,929 Total Operating Expenses 2,044,132 2,753,978 Loss From Operations (2,044,132 ) (2,753,978 ) Other (Income) Expense: Interest expense 130,036 58 Change in fair value of equity payable 37,149 - Pre-Tax Net Loss (2,211,317 ) (2,754,036 ) Income tax benefit - (9,707 ) Net Loss $ (2,211,317 ) $ (2,763,743 ) Net Loss Per Share - Basic and Diluted $ (0.46 ) $ (3.31 ) Weighted Average Number of Common Shares Outstanding - Basic and Diluted 4,814,115 834,915
Yahoo
07-05-2025
- Health
- Yahoo
ZyVersa Unveils Groundbreaking Potential of Inflammasome Inhibitors in Combination with GLP-1 Agonists to Address Unmet Medical Needs of People Living with Obesity; Provides R&D Update
Available inflammasome inhibitor preclinical data in diet-induced obesity animal models provide proof-of-concept for inflammasome inhibitors as promising therapeutic options for obesity and its associated cardiometabolic conditions when used as add-on therapy to GLP-1 agonists. Importantly, GLP-1 agonists do not fully address the inflammasome-driven chronic, systemic inflammation affecting the hypothalamus that drives obesity, as well as adipose tissue, liver, pancreas, muscle, and gut that dysregulate metabolism in these tissues leading to comorbid conditions Around 65% of non-diabetic patients discontinue GLP-1 agonist treatment within a year and 85% within 2 years - a key driver is GI side effects, which affect 40% - 70% of patients Muscle loss is common, with patients losing 20% to 40% of muscle along with their fat loss Obesity has reached pandemic proportions, affecting over 40% of Americans, with a projected increase to 51% of the global population within 12 years if current trends continue. This condition is intricately linked to various chronic diseases, including type 2 diabetes, cardiovascular disease, non-alcoholic fatty liver disease, and certain cancers. The economic impact is staggering, with global costs projected to exceed $4.32 trillion annually by 2035 without improved prevention and treatment options. WESTON, Fla., May 07, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA), a clinical-stage biopharmaceutical company specializing in first-in-class therapies for inflammatory and renal diseases, announces significant developments for Inflammasome ASC Inhibitor IC 100. CEO Stephen C. Glover issued a shareholder letter detailing the company's strategy to position IC 100 as a complementary therapy to GLP-1 agonists to treat obesity-associated cardiometabolic complications. Story Continues There is also potential to reduce the dose of GLP-1 agonists with add-on inflammasome inhibitor treatment to help alleviate GI side effects and thus improve duration of anti-obesity therapy. IC 100: Targeting the Source of Inflammation While most inflammasome inhibitors in development are small molecules targeting NLRP3, IC 100 was designed to uniquely inhibit ASC and ASC specks to attenuate not only initiation of the inflammatory cascade, but more importantly to attenuate the perpetuation and spread of inflammation contributing to development of obesity-associated cardiometabolic comorbidities. By targeting ASC, IC 100 also inhibits activation of multiple types of inflammasomes that are associated with obesity and its associated complications: Obesity: AIM2, NLRP3 Insulin Resistance: AIM2, NLRP1, NLRP3, NLRC4, NLRP6 Diabetic Nephropathy: AIM2, NLRP3 Preclinical data available to date demonstrate IC 100's potential to address cardiometabolic comorbidities: In an ApoE knockout model of atherosclerosis, IC 100 demonstrated a reduction in inflammation and plaque in the aorta In an obese animal model of diabetic kidney disease, IC 100 lowered fasting blood glucose levels, suggestive of reduced insulin sensitivity In multiple studies in numerous disease states, including CNS and peripheral diseases, IC 100 blocked proinflammatory cytokines, IL-1β, IL-18, and IL-6 that drive inflammation Strategic Development Plans and Milestones ZyVersa has outlined a comprehensive development plan for IC 100, with key milestones anticipated over the next 12 months: H1-2025: Initiate preclinical study in diet-induced obesity (DIO) mouse model to evaluate IC 100's efficacy as monotherapy and in combination with semaglutide H2-2025: Submit an Investigational New Drug (IND) application for IC 100 H1-2026: Commence Phase 1 clinical trials in overweight subjects (BMI 27–30) with cardiometabolic risk factors to assess safety and biomarkers of cardiometabolic risk These studies aim to demonstrate that IC 100, when added to GLP-1 agonist therapy, can reduce the underlying inflammation of obesity, with potential to reduce progression to associated cardiometabolic comorbidities, while augmenting weight loss. Collaborations and Scientific Advisory Support To support the development of IC 100, ZyVersa has formed a Scientific Advisory Board comprising leading experts in obesity, metabolic diseases, and inflammasome biology. This board will provide strategic guidance as the company advances IC 100 through clinical development. Additionally, ZyVersa has engaged in preclinical collaborations to explore the potential of IC 100 in treating Parkinson's disease, further expanding the therapeutic applications of this novel inflammasome ASC inhibitor. Conclusion With the development of IC 100, ZyVersa Therapeutics is poised to make significant strides in the comprehensive treatment of obesity and its associated cardiometabolic complications. By targeting the root cause of chronic inflammation, IC 100 has the potential to complement existing therapies, offering a more holistic approach to managing obesity and improving patient outcomes. The company's strategic development plan, coupled with expert collaborations, underscores its commitment to addressing the unmet medical needs in this critical area of healthcare. We look forward to updating you on our value-building near-term results from our IC 100 development program. Thank you for your continued support. Sincerely, Stephen C. Glover Co-Founder, Chairman, Chief Executive Officer, and President ZyVersa Therapeutics 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 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 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 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 or 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 applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Corporate, IR, and Media Contact Karen Cashmere Chief Commercial Officer kcashmere@ 786-251-9641
Associated Press
29-04-2025
- Health
- Associated Press
ZyVersa Therapeutics Announces Published Data Showing Inflammasome ASC Inhibitor IC 100 Decreases Microglial Inflammasome Activation and Alpha-Synuclein That Contribute to Neurodegeneration in Parkinson's Disease
WESTON, Fla., April 29, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or 'ZyVersa'), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces newly published data supporting the potential of its Inflammasome ASC Inhibitor IC 100 to slow the progression of Parkinson's disease. Published in npj Parkinson's Disease, a peer-reviewed journal from Nature, the study presents groundbreaking findings from researchers at the University of Miami Miller School of Medicine. The research demonstrates that IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation—both key contributors to PD progression. 'These are the first data to link ASC speck assembly, NLRP1 inflammasome activation, and alpha-synuclein aggregation in neurons of Parkinson's disease patients,' said Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO and President. 'IC 100, which unlike NLRP3 inhibitors, targets ASC, ASC specks, and multiple types of inflammasomes, blocked microglial NLRP1 inflammasome activation and reduced alpha-synuclein accumulation. These results strengthen our belief in IC 100 as a potential disease-modifying therapy for Parkinson's, and we're preparing to initiate proof-of-concept studies in animal models later this year.' Study Highlights 'Our findings demonstrate that targeting inflammasomes and ASC specks may be a promising approach not only for PD but also for Lewy body dementia (LBD) and Alzheimer's Disease,' said Dr. Robert W. Keane, Professor of Physiology and Biophysics, Neurological Surgery, and Microbiology & Immunology at the University of Miami, and lead author of the study. 'IC 100's mechanism, which uniquely inhibits both ASC speck activity and misfolded protein aggregates, makes it a strong candidate for treating neurodegenerative diseases.' About Inflammasome ASC Inhibitor IC 100 IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity with certain metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here. 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 inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator™ VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a 'pipeline within a product,' with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit 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 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 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 or 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 applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Corporate, Media, and IR Contact: Karen Cashmere Chief Commercial Officer
Yahoo
10-04-2025
- Business
- Yahoo
Why ZyVersa Therapeutics, Inc. (ZVSA) Went Down On Thursday?
We recently published a list of . In this article, we are going to take a look at where ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA) stands against other stocks that fall behind amid market optimism. Wall Street's main indices rebounded from hefty losses on Wednesday after President Donald Trump announced that the US will pause the imposition of higher tariffs on 75 countries for 90 days. In a post on Truth Social, Trump said that more than 75 countries have called to negotiate and have not retaliated in any way. 'I have authorized a 90-day PAUSE, and a substantially lowered Reciprocal Tariff during this period, of 10%, also effective immediately,' he noted. Following the announcement, the Dow Jones jumped by 7.87 percent, the S&P 500 surged by 9.52 percent, and the tech-heavy Nasdaq soared by 12.16 percent. Despite the overall market optimism, 10 companies, predominantly in the biopharmaceutical sector, registered losses amid the lack of fresh developments to spark buying appetite. In this article, we listed Wednesday's 10 worst performers and detailed the reasons behind their drop. To come up with the list, we considered only the stocks with over $1 million in trading volume. A close-up of a biotechnology machine working on an oncology therapy. ZyVersa Therapeutics dropped its share prices by 18.90 percent on Wednesday to finish at $1.03 apiece, following a surge in its stock price the prior day. The latest stock price was just 3-cents shy anew of the $1 minimum bid price requirement of the Nasdaq, having surged to $1.27 on Tuesday from $0.5820 last Monday. Tuesday's return to the $1 level snapped 24 consecutive days of trading below the minimum bid price requirement. Under the Nasdaq rules, companies are required to stay afloat at the $1 minimum bid price in order to stay listed. In recent news, ZVSA said it narrowed its net loss last year by 90 percent to $9.4 million from $98.3 million in 2023, on the back of the absence of impairment charges that were recorded in 2023. The company said it continues to focus on the development of its drug candidates, VAR 200, aimed at treating renal diseases, and IC 100, for the treatment of inflammatory conditions. Both candidates are in various stages of preclinical and clinical development. Overall, ZVSA ranks 3rd on our list of stocks that fall behind amid market optimism. While we acknowledge the potential of ZVSA as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than ZVSA but that trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Associated Press
08-04-2025
- Business
- Associated Press
ZyVersa Therapeutics CEO Issues Shareholder Letter on PARASOL Recommendations Expected to Reduce Drug Development Barrier for Rare Kidney Disease, Focal Segmental Glomerulosclerosis (FSGS)
WESTON, Fla., April 08, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; 'ZyVersa'), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Shareholder Letter addressing the recent PARASOL recommendations expected to shorten drug development time and approval for rare kidney disease, FSGS. The full text of the letter follows. A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER ZyVersa is developing Cholesterol Efflux Mediator™ VAR 200 for treatment of chronic kidney diseases, initially focusing on FSGS as the lead. Plans for indication expansion include treatments for Alport Syndrome and Diabetic Kidney Disease. The global drug market for kidney diseases was $18 Billion in 2024, with $30 Billion projected by 2034 (Precedence Research). Today, I am thrilled to update you on a recent advancement that is expected to be a giant step forward in FSGS drug development and anticipated to derisk development of VAR 200 for its lead indication, FSGS. Prior to conducting Phase 2 clinical trials in FSGS, we are initiating a small Phase 2a proof-of-concept trial with VAR 200 in the first half of this year in patients with DKD. The intent of the study is to quickly obtain first in human renal data prior to initiating a larger phase 2a/b trial in patients with FSGS. The DKD data will also provide insights to help optimize protocol design for the subsequent FSGS study. FSGS is a devastating, progressive, and complex rare kidney disorder affecting around 40,000 people in the US. It is a leading cause of kidney failure, requiring dialysis and transplant for survival. With FSGS, it is common for patients to need more than one kidney transplant since the disease can affect the new kidney in a relatively short period of time. FSGS has an overwhelming negative impact on daily living and quality of life. Disease symptoms, such as fatigue and chronic severe swelling, and the number of required drugs and their side effects interfere with daily activities. It is common for patients to miss a large percentage of school or work days making it challenging to graduate or hold a job. Likewise, patients, especially children, are often hospitalized missing holidays and family celebrations, including their own birthdays. Additionally, patients with FSGS experience a substantial degree of anxiety and emotional impact from fear of needing dialysis or transplant, and from concern about exposure to infectious diseases resulting from the immunosuppressive drugs they are on. This leads to social isolation and loneliness. Kidney failure not only affects patients' quality of life but has a high economic burden. In 2023, an estimated $28 billion was spent on dialysis care and $3.4 billion on transplant patient care. To date, there are no approved drug therapies that effectively prevent or delay FSGS progression to kidney failure. One reason for the lack of drug treatments is the high regulatory hurdle requiring drug developers to demonstrate a substantially reduced FSGS progression to kidney failure. FSGS trials can require decades of follow-up in large study populations to measure kidney failure. This is generally not feasible in clinical trials, especially for rare kidney diseases. Thanks to the initiative of a multi-stakeholder group of rare kidney disease experts and the FDA to identify a robust surrogate endpoint to replace long-term kidney failure outcomes (the PARASOL initiative), it is expected that shorter clinical trials with fewer patients will be required to demonstrate FSGS drug efficacy. The Parasol group recommended a reduction in proteinuria (spillage of protein into the urine) over 24 months as a surrogate endpoint for full regulatory approval of FSGS drugs. According to Dr. Aliza Thompson, PARASOL's Co-chair and Director of the Cardio-Renal Division at the FDA, 'Data supporting the recommendation came from over 25 studies conducted all over the globe and involved more than 1,600 patients, providing a robust foundation for informed regulatory decisions.' Travere is likely to be the first company to benefit from the PARASOL group's recommendations. Despite a 50% reduction in proteinuria, FDA previously denied accelerated approval for Filspari (sparsentan) for FSGS because the drug failed to demonstrate a reduced progression to kidney failure (based on surrogate marker eGFR). The recent PARASOL recommendations are expected to pave the way for FSGS approval for Filspari. Following a promising Type C meeting with the FDA in February, Travere filed a supplemental New Drug Application (sNDA) on March 17, 2025, seeking priority review for traditional approval of FILSPARI® for treatment of FSGS. FDA approval is anticipated in the third quarter of this year, with launch by year's end. In an April 3, 2025 analyst update on Travere, Guggenheim indicated that they believe investors underappreciate the FSGS commercial opportunity, which is substantially larger than that for IgAN. This is based on a higher unmet need for effective FSGS drug therapies since patients progress to kidney failure at twice the rate as IgAN patients, and there are fewer expected competitors reducing price sensitivity. Guggenheim has projected $2 Billion in peak sales for Filspari in FSGS. We are excited about the potential approval of Filspari for FSGS based on a reduction in proteinuria, as it will further support proteinuria as the primary endpoint for VAR 200's FSGS clinical trials. Because VAR 200 targets a unique pathway leading to development and progression of FSGS and other kidney diseases (accumulation of cholesterol and lipids in the kidney's filtration system), VAR 200 will be used as add on therapy to Filspari and other standard of care drugs such as steroids and calcineurin inhibitors. For more information about Cholesterol Efflux Mediator™ VAR 200, Click Here. We thank you for your continued support. Sincerely, Stephen C. Glover Co-Founder, Chairman, Chief Executive Officer, and President ZyVersa Therapeutics 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 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 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. 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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 applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Karen Cashmere 786-251-9641
