Tag: ZVSA

Research News and Market Data on ZVSA

Oct 17, 2024

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• Lead indication for ZyVersa’s Inflammasome ASC Inhibitor IC 100 is obesity with metabolic complications.

WESTON, Fla., Oct. 17, 2024 (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 that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Letter to Shareholders highlighting obesity development plans for Inflammasome ASC Inhibitor IC 100 with anticipated milestones over the next nine months. The full text of the letter follows.

A MESSAGE FROM OUR PRESIDENT AND CHIEF EXECUTIVE OFFICER

To my fellow shareholders,

As announced in late July, ZyVersa selected obesity with metabolic complications as the lead indication for Inflammasome ASC Inhibitor IC 100. Selection of this indication is consistent with our mission to restore health and transform patient lives through innovation. Although GLP-1 agonist therapy has changed the treatment paradigm for obesity with unsurpassed weight loss, significant unmet medical needs remain. A critical unmet need is for therapies to address the chronic systemic inflammation of obesity that causes life-altering metabolic comorbidities such as cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, and even neurodegenerative diseases such as Parkinson’s and Alzheimer’s diseases. Based on IC 100’s highly differentiated mechanism of action, it is anticipated that IC 100 will control the chronic systemic inflammation of obesity, attenuate development and/or progression of associated metabolic comorbidities, and augment weight loss when added to GLP-1 agonist therapy.

Selection of obesity with metabolic complications as the lead indication for IC 100 is also consistent with ZyVersa’s goal to drive shareholder value. The obesity drug revolution has led to a 10-fold increase in private venture dollars flowing into the category over the last 5 years and high deal volume. This is expected to continue with investment opportunities in R&D innovation to develop GLP-1 agonist add-on therapies to address unmet needs. This is exemplified by some of the latest transactions:

• Oct 10, 2024: Lilly announced up to $1.4 billion plus upfront payment and royalties for expanded collaboration with KeyBioscience for rights to dual amylin calcitonin receptor agonists for obesity and complications (e.g., osteoarthritis).
• September 25, 2024: Bioage announced an upsized $198 Million IPO driven by their APJ agonist in development for muscle preservation and improved metabolism to be used in combination with GLP-1 agonist therapy.
• September 23, 2024: Sanofi announced a $27 Million strategic investment in Ventyx Biosciences’ NLRP3 inhibitor VTX3232, which is phase 2 for obesity with cardiovascular complications and Parkinson’s disease.
• September 4, 2024: Lilly announced a collaboration with Haya Therapeutics for up to $1 Billion for drug discovery in obesity and related metabolic conditions.
• August 10, 2024: Novo Nordisk announced acquisition of Inversago Pharma, valued up to $1.075 Billion. Inversago develops CB1 receptor-based therapies for obesity, diabetes, and complications associated with metabolic disorders.

We are excited about the potential for Inflammasome ASC Inhibitor IC 100 as an add-on therapy to GLP-1 agonists to help restore health and transform the lives of patients living with obesity and its associated comorbidities. We recently reviewed the preclinical data supporting IC 100 with our newly formed Obesity, Metabolic, and Inflammatory Disease Scientific Advisory Board. Advisory Board members indicated that IC 100’s mechanism of action supports its rationale for use as an add-on treatment to GLP-1 agonists to address the chronic inflammation of obesity and its associated metabolic complications. They also provided excellent input on our planned DIO obesity model studies to strengthen their design and endpoints for proof-of-concept of IC 100’s potential as a treatment for obesity with metabolic complications.

Following are key IC 100 short-term obesity development milestones that we expect to achieve:

Q4-2024: Initiate IC 100 monotherapy study using semaglutide as a comparator in DIO mice.

Q1- 2025: Initiate IC 100 combination study with semaglutide in DIO mice.

Q2-2025: File IND.

Q3-2025: Initiate IC 100 phase 1 trial in healthy overweight subjects with a BMI 27 – 30.

We appreciate your current and ongoing support that enables us to progress IC 100’s development program to drive shareholder value.

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 and its associated 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 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 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
kcashmere@zyversa.com
786-251-9641      

Research News and Market Data on ZVSA

Oct 15, 2024

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Lead indication for ZyVersa’s Inflammasome ASC Inhibitor IC 100 is obesity with metabolic complications.

WESTON, Fla., Oct. 15, 2024 (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 that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, was interviewed on the Big Biz Show to address current trends in the obesity drug market and the potential role of inflammasome inhibitors.

Key Points

• Obesity is an international health crisis, with over 50% of the world’s population predicted to be overweight or obese within the next ten years.
• Launch of incretin therapy (GLP-1 agonists) for obesity has resulted in substantial and unsurpassed weight loss, stimulating a drug revolution that has led to a 10-fold increase in venture dollars flowing into the category.
• High levels of investment in the obesity category are expected to continue due to the trend toward development of add-on therapies to GLP-1 agonists to preserve muscle during weight loss and to attenuate obesity-related inflammation that leads to chronic complications such as cardiovascular disease, type 2 diabetes, and even neurodegenerative diseases like Parkinson’s and Alzheimer’s disease. This is reflected in the billion-dollar acquisitions recently made by Novo and Lilly, and Sanofi’s $27 Million strategic investment in Ventyx’s NLRP3 inhibitor to address the complications of obesity.
• ZyVersa’s Inflammasome ASC Inhibitor IC 100 is being developed for use in combination with GLP-1 agonists to control obesity-associated inflammation, attenuate the associated complications, and enhance weight loss. The company is working with renowned experts in the field who are providing guidance to the development program.

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 and its associated 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^TM 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 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 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
kcashmere@zyversa.com
786-251-9641        

Research News and Market Data on ZVSA

Oct 7, 2024

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• New Scientific Advisory Board (SAB) comprised of five leading experts in the areas of obesity and metabolic diseases, and four leading inflammasome experts and inventors of IC 100 from University of Miami Miller School of Medicine who have provided ongoing scientific advisory support for IC 100 since its license.

WESTON, Fla., Oct. 07, 2024 (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 a new SAB to support advancement of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications. Based on its mechanism of action, IC 100, in combination with incretin therapy, is anticipated to augment weight loss, but more importantly, to attenuate the chronic systemic inflammation leading to metabolic complications and other inflammatory comorbidities of obesity.

“We are honored to work with such an accomplished and esteemed group of experts,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our advisors’ combined expertise and insights in the areas of obesity, metabolic diseases, and inflammasomes will be invaluable as we design IC 100’s clinical development program for obesity and metabolic complications.”

Members of ZyVersa’s Obesity, Metabolic and Inflammatory Diseases SAB are listed below. Full biographies are available on ZyVersa’s Website.

Caroline M. Apovian, MD, FACP, FTOS, DABOM

• Co-Director, Center for Weight Management and Wellness, Division of Endocrinology, Diabetes, and Hypertension at Brigham and Women’s Hospital
• Professor of Medicine, Harvard Medical School

Harold Bays, MD, MFOMA, FTOS, FACC, FACE, FNLA, FASPC

• Medical Director and President, Louisville Metabolic and Atherosclerosis Research Center
• Clinical Associate Professor, Endocrinology, University of Louisville School of Medicine
• Chief Science Officer of the Obesity Medicine Association

Helen Bramlett, PhD

• Professor, Department of Neurological Surgery, University of Miami Miller School of Medicine
• The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine

Marc-Andre Cornier, MD

• Professor of Medicine, Medical University of South Carolina
• Director, Division of Endocrinology, Diabetes and Metabolic Diseases, Medical University of South Carolina

Juan Pablo de Rivero Vaccari, PhD

• Associate Professor, Department of Neurological Surgery, University of Miami Miller School of Medicine
• The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
• Distinguished Faculty Member, the Center for Cognitive Neuroscience and Aging, University of Miami Miller School of Medicine

W. Dalton Dietrich, III, PhD

• Kinetic Concepts Distinguished Chair in Neurosurgery, and Scientific Director,
• The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
• Senior Associate Dean for Discovery Science and Co-Director, the Institute for Neural Engineering, University of Miami Miller School of Medicine
• Professor, Neurological Surgery, Neurology, Biomedical Engineering, and Cell Biology, University of Miami Miller School of Medicine

Robert W. Keane, PhD

• Professor, Physiology and Biophysics, Neurological Surgery and Microbiology, and Immunology, University of Miami Miller School of Medicine
• The Miami Project to Cure Paralysis. University of Miami Miller School of Medicine

Samuel Klein, MD

• William H. Danforth Professor of Medicine, Washington University School of Medicine
• Director, Center for Human Nutrition, Washington University School of Medicine
• Chief, Division of Nutritional Science and Obesity Medicine, Washington University School of Medicine

Suneil Koliwad, MD, PhD

• Chief, Division of Endocrinology and Metabolism, UCSF Health
• Gerold Grodsky Professor of Diabetes Research, UCSF
• Mount Zion Health Fund Distinguished Professor of Endocrinology, UCSF

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 spread of inflammation 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 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 with 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 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 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
kcashmere@zyversa.com
786-251-9641

Research News and Market Data on ZVSA

Aug 9, 2024

PDF Version

KEY HIGHLIGHTS

• Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease on track to begin H2-2024.
• Obesity with related metabolic complications selected as lead indication for Inflammasome ASC Inhibitor IC 100.
  • Supportive data from preclinical study in atherosclerosis, a common obesity-related metabolic complication, is expected to be available H2-2024.
• IC 100 Investigational New Drug (IND) submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obesity with metabolic complications expected to begin Q1-2025.
• Raised approximately $0.8 million from exercise of investor warrants.

WESTON, Fla., Aug. 09, 2024 (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 June 30, 2024, and provides business update.

“We are pleased to announce that ZyVersa remains on track to achieve key development milestones over the next 3 quarters,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our Phase 2a clinical trial with Cholesterol Efflux Mediator™ VAR 200 in diabetic kidney disease is expected to enroll the first patient(s) within the next few months, with an initial data read-out around the end of the year. In preparation for the planned Q4-2024 IND submission and subsequent phase 1 trial for Inflammasome ASC Inhibitor, a lead indication has been selected, obesity with related metabolic complications. This selection was based on unmet needs and IC 100’s mechanism of action substantiated in its robust preclinical program. By inhibiting ASC, IC 100 targets all four inflammasome pathways associated with obesity and related metabolic complications. Importantly, IC 100 disrupts the structure and function of extracellular ASC specks which perpetuate and spread damaging inflammation leading to obesity-related metabolic complications. We believe our milestone achievement will be a key inflection point for ZyVersa that will drive shareholder value.” 

BUSINESS UPDATE

CHOLESTEROL EFFLUX MEDIATOR™ VAR 200 FOR RENAL DISEASE

• Phase 2a clinical trial in diabetic kidney disease is on target to begin H2-2024.
  • Clinical trial agreements have been successfully negotiated with both sites
  • Clinical trial Site IRB submissions have been approved for both sites
  • Clinical product and lab kits are ready to ship
  • Site initiation visits are scheduled
  • Enrollment of first patient(s) is expected in the next few months

INFLAMMASOME ASC INHIBITOR IC 100 FOR INFLAMMATORY DISEASES

• IND submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obese patients with metabolic complications expected to begin Q1-2025.
  • IC 100 preclinical study in obesity with associated metabolic complications planned to conclude by year’s end, with a second study evaluating concomitant treatment of IC 100 and a GLP-1 agonist to begin shortly thereafter
  • Supportive data read-out from preclinical study in atherosclerosis expected H2-2024
  • GLP toxicology studies scheduled to begin H2-2024
• ZyVersa has recruited six top-tiered experts in obesity and related metabolic complications for a scientific advisory board, which will be announced in the next few weeks, to guide clinical development plans for IC 100.
• Recently published preclinical study demonstrated that IC 100 attenuates retinal inflammation, abnormal retinal vascularization, and retinal thinning, leading to restored retinal function in an animal model of retinopathy of prematurity (ROP).
  • ROP is the sixth indication with preclinical data demonstrating that IC 100 attenuates pathogenic inflammasome signaling pathways resulting in reduced inflammation and improved histopathological and/or functional outcomes
  • The other indications are early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury
• Recently published preclinical study supports the potential of plasma ASC levels as a biomarker for early stages of cognitive decline, reinforcing the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer’s and Parkinson’s diseases, and the potential of inhibiting ASC with IC 100 as a treatment option.

SECOND QUARTER FINANCIAL RESULTS

Net losses were approximately $2.8 million for the three months ended June 30, 2024, with an improvement of $75.7 million or 96.5% compared to a net loss of approximately $78.5 million, for the three months ended June 30, 2023. This large improvement is due primarily to no further impact from our one-time impairment in 2023 of in-process research and development and goodwill.

Based on its current operating plan, ZyVersa expects its cash of $0.1 million as of June 30, 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 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 $0.7 million for the three months ended June 30, 2024, a decrease of $0.5 million or 41.9% from $1.2 million for the three months ended June 30, 2023. The decrease is primarily attributable to a decrease of $0.4 million in the costs of manufacturing of IC 100 and a decrease in payroll expenses due to employee attrition of $0.1 million.

General and administrative expenses were $2.0 million for the three months ended June 30, 2024, a decrease of $1.9 million or 48.0% from the three months ended June 30, 2023. The decrease is primarily attributable to a one-time 2023 charge of $1.2 million for common stock granted to certain members of the SPAC merger sponsor in exchange for certain concessions to extend the duration of their holding period. Other reductions include professional fees, marketing costs, director and officer insurance totaling $0.6 million, and a $0.1 million decrease in stock-based compensation as a result of options becoming fully amortized in February 2024.

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 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 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, IR Contact

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

View full release HERE.

Research News and Market Data on ZVSA

Aug 7, 2024

PDF Version

• Data demonstrate that extracellular ASC specks, independent of IL-1β, govern the pathogenesis and extent of amyloid A (AA) amyloidosis, which is characterized by deposition of insoluble amyloid fibrils in tissues and organs disrupting their structure and function.
• Extracellular ASC interacts with serum amyloid A (SAA) released by the liver during inflammation, forming a scaffold that accelerates SAA aggregation into amyloid fibrils, which are deposited in tissues and organs.
• Amyloid A amyloidosis occurs in a heterogeneous spectrum of chronic inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, and inflammatory bowel disease.
• ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits intra- and extracellular ASC and specks associated with multiple types of inflammasomes to attenuate damaging inflammation and its perpetuation and spread to surrounding tissues.

WESTON, Fla., Aug. 07, 2024 (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 data published in the peer-reviewed journal, EMBO Molecular Medicine, demonstrating that extracellular ASC has a crucial role in aggregation and deposition of amyloid A fibrils leading to associated chronic inflammatory conditions.

“This research highlighting the role of extracellular ASC specks, independent of IL-1β, in the pathogenesis of chronic conditions associated with amyloid A amyloidosis reinforces our selection of ASC as a target for our inflammasome inhibitor IC 100,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “This paper provides one more piece of evidence that inhibiting extracellular ASC specks associated with multiple types of inflammasomes has potential to control damaging inflammation associated with a broad range of inflammatory diseases.”

The paper titled, The ASC inflammasome adapter governs SAA-derived protein aggregation in inflammatory amyloidosis, summarizes data from in vitro and in vivo research investigating the role of ASC in inflammation-associated amyloidosis. Following is a summary of key findings:

• ASC colocalized tightly with SAA in human AA amyloidosis.
• ASC specks accelerated SAA fibril formation.
• Splenic amyloid load was decreased in a Pycard knock-out mouse model of AA Amyloidosis which lacks ASC.
• Treatment with anti-ASC^PYD antibodies decreased amyloid loads in wild-type mice suffering from AA amyloidosis.

“Our findings might have therapeutic implications that advance the fields of protein misfolding disorders (PMDs) and chronic inflammatory diseases in general as ASC could be a target of disease-modifying therapies that aim to reduce amyloid deposition and pathology in various proteinopathies,” concluded the authors.

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 and its associated 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^TM 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 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 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
kcashmere@zyversa.com
786-251-9641

Research News and Market Data on ZVSA

Jul 29, 2024

PDF Version

• This data supports the potential of plasma ASC levels as a biomarker for early stages of cognitive decline, based on elevated ASC levels in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (N_I) compared to ASC levels in those who:
  1. Were cognitively normal at both baseline and 1 year later (N_N), and
  2. Were cognitively impaired at both baseline and one year later (I_I)
• Inflammasome-induced neuroinflammation has been associated with early stages of cognitive decline in dementia associated with Alzheimer’s and Parkinson’s diseases.
• Excessive inflammasome activation leads to cell death (pyroptosis) and systemic release of cell contents, including ASC that can be measured in the plasma.

WESTON, Fla., July 29, 2024 (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 that leading inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed International Journal of Molecular Sciences demonstrating that plasma levels of inflammasome ASC show promise as a biomarker of early cognitive decline in older adults.

“Elevations in plasma ASC in early cognitive decline reinforce the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer’s and Parkinson’s diseases,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation pathogenic in neurological and other inflammatory diseases, such as obesity and its metabolic complications, our lead indication.”

The paper titled, The Inflammasome Adaptor Protein ASC in Plasma as a Biomarker of Early Cognitive Changes, summarizes biomarker assessments in older adults at baseline and at one-year follow-up. Following is a summary of key findings:

• Plasma ASC levels were elevated in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (N_I) compared to ASC levels in those who remained cognitively normal one-year post-baseline assessment (N_N). The increase in ASC levels was even higher in people who were 70 years or older.
• Likewise, plasma ASC levels in the N_I group were elevated compared to ASC levels in older adults who demonstrated cognitive impairment at both baseline and one year later (I_I), indicating that plasma ASC levels are increased in the early stages of cognitive decline. Again, the increase in ASC levels was even higher in people who were 70 years or older.
• In the group over 70 years old, area under the curve (AUC) for plasma levels of ASC in group N_I versus group N_N was 0.81, indicating excellent ability to differentiate between people with cognitive decline at one year versus those who were cognitively normal both at baseline and at one year. AUC is used to determine the diagnostic power of a biomarker.

“Dementia affects 57 million people worldwide, and the incidence is expected to double by 2040. There is an unmet need to develop minimally invasive, reliable biomarkers to diagnose early brain impairments so that emerging interventions can be applied before brain degeneration,” said Dr. Juan Pablo de Rivero Vaccari, Associate Professor of Neurological Surgery and The Miami Project to Cure Paralysis and Distinguished Faculty of the Center for Cognitive Neuroscience and Aging at the University of Miami Miller School of Medicine. “Our data indicate that plasma levels of ASC are a strong early indicator of the eventual development of cognitive impairment, especially in persons older than 70 years.”

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 and its associated 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^TM 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 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 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
kcashmere@zyversa.com
786-251-9641        

Research News and Market Data on ZVSA

Jul 18, 2024

PDF Version

• Publication showed that 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.
• Retinopathy of Prematurity (ROP), affecting very low birth weight premature infants is a leading cause of childhood blindness worldwide.
• ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation and its perpetuation and spread to surrounding tissues.

WESTON, Fla., July 18, 2024 (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 that acclaimed inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed journal, Angiogenesis. The paper demonstrates the crucial role of inflammasome ASC and ASC specks in the development of oxygen-induced retinopathy and provides data showing that Inflammasome ASC Inhibitor IC 100 attenuates impairment of retinal structure and function.

The paper titled, “IC 100, a humanized therapeutic monoclonal anti-ASC antibody alleviates oxygen-induced retinopathy in mice,” summarizes research evaluating mouse models representative of ROP. Following is a summary of key findings:

• ASC specks, which lead to inflammasome activation, were significantly increased in animal model retinas and colocalized with the abnormal vasculature, along with increased microglial activation indicative of retinal inflammation that leads to retinal damage and disease progression.
• IC 100 decreased expression of inflammasome-related molecules (ASC, gasdermin D), inflammatory cytokines (IL-1β, IL-6, and TNF), and VEGF in animal model retinas.
• Importantly, IC 100 reduced ASC speck formation and microglial activation, attenuating inflammation, abnormal vascularization, retinal thinning, and retinal dysfunction.
• The structural and functional improvements demonstrated with IC 100 treatment correlated with corrections of hyperoxia-modulated gene pathways associated with eye development, leukocyte migration, angiogenesis, inflammation, neurogenesis, and VEGF signaling.

“We have demonstrated that IC 100 effectively treated both phases of oxygen-induced retinopathy in a mouse model that resembles ROP in preterm infants, as it decreased retinal vaso-obliteration and intravitreal vascularization,” said Dr. Shu Wu, Professor of Pediatrics at the University of Miami. “Our data suggest that IC 100 may have potential therapeutic use in the treatment of preterm infants with ROP.”

“This research highlighting that Inflammasome ASC Inhibitor IC 100 attenuated retinal inflammation, abnormal retinal vascularization, and retinal thinning leading to restored retinal function in an animal model of ROP supports the broad range of indications that IC 100 has potential to treat. ROP is the sixth indication with preclinical data demonstrating that IC 100 attenuates pathogenic inflammasome signaling pathways resulting in reduced inflammation and improved histopathological and/or functional outcomes,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “The other promising indications are early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury.”

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 and its associated 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 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 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
kcashmere@zyversa.com
786-251-9641        

Research News and Market Data on ZVSA

May 15, 2024

PDF Version

Key Highlights:

• Second research site selected to enhance enrollment in the Phase 2a clinical trial for Cholesterol Efflux Mediator^TM VAR 200 in patients with diabetic kidney disease planned to begin H1-2024.
• GLP toxicology studies for Inflammasome ASC Inhibitor IC 100 scheduled to begin H1-2024, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation Q1-2025.Atherosclerosis preclinical data readout for Inflammasome ASC Inhibitor IC 100 on schedule for H1-2024.
• Initiation of preclinical study to assess Inflammasome ASC Inhibitor IC 100 for obesity-associated metabolic comorbidities scheduled to begin Q2-2024 with completion expected by year’s end.
• Raised $2.7 million from exercising of investor warrants.

WESTON, Fla., May 15, 2024 (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, 2024 and provides business update.

“We are pleased to announce that ZyVersa is on track to achieve key development milestones over the next 3 quarters,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our Phase 2a clinical trial with Cholesterol Efflux Mediator^TM VAR 200 in diabetic kidney disease is expected to enroll the first patient(s) within the next few months, with initial data read-out in the second half of the year. Inflammasome ASC Inhibitor IC 100’s indication expansion studies are nearing completion for atherosclerosis, expected to conclude in June, and obesity-associated metabolic comorbidities, expected to conclude by year’s end. IND preparation has been initiated for IC 100, with submission targeted for year’s end, and initiation of a phase 1 clinical trial in first quarter 2025. We believe achievement of these milestones is a key inflection point for ZyVersa and for shareholder value.” 

BUSINESS Update

CHOLESTEROL EFFLUX MEDIATOR^TM VAR 200 FOR RENAL DISEASE

• Phase 2a clinical trial in diabetic kidney disease is on target to begin H1-2024
  • CRO, George Clinical, was engaged in December 2023 to initiate and manage the trial.
  • A central Institutional Review Board (IRB) approved the clinical trial protocol for trial initiation.
  • Two clinical research sites have been selected, with contracting nearing completion.
  • Enrollment of first patient(s) is expected in the next few months.

INFLAMMASOME ASC INHIBITOR IC 100 FOR INFLAMMATORY DISEASES

• Inflammasome ASC Inhibitor IC 100’s preclinical program nearing completion, with GLP toxicology studies expected to begin H1-2024. IND submission is planned for Q4-2024, followed by initiation of a Phase 1 clinical trial in Q1-2025.
• Data from a scientific collaboration with an undisclosed partner to assess the potential of Inflammasome ASC Inhibitor IC 100 as a treatment for atherosclerosis in a well-established animal model is expected in June.
• A scientific collaboration with inflammasome and neurology experts at University of Miami Miller School of Medicine to assess the potential of Inflammasome ASC Inhibitor IC 100 as a treatment for obesity-associated metabolic comorbidities is expected to begin in Q2-2024, with completion in Q4-2024.
• In vitro preclinical research funded by The Michael J. Fox Foundation (MJFF) and conducted by researchers at University of Miami (UM) Miller School of Medicine supported Inflammasome ASC Inhibitor IC 100’s mechanism of action and potential to block damaging neuroinflammation that induces neural degeneration in Parkinson’s disease. At the suggestion of MJFF, UM researchers are developing a grant request to further the research in an established animal model.

FIRST QUARTER FINANCIAL RESULTS

Net losses were approximately $2.8 million for the three months ended March 31, 2024, with an improvement of $0.7 million or 20.2% compared to a net loss of approximately $3.5 million, for the three months ended March 31, 2023.

Based on its current operating plan, ZyVersa expects its cash of $2.0 million as of March 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 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. During Q1, ZyVersa raised approximately $2.7 million from investors exercising in-the-money warrants.

Research and development expenses were $0.5 million for the three months ended March 31, 2024, a decrease of $0.5 million or 51.4% from $1.1 million for the three months ended March 31, 2023. The decrease is attributable to lower manufacturing costs of IC 100 of $0.4 million and lower research and development payroll costs of $0.2 million due to fewer employees. This was offset by an increase in CRO fees of $0.1 million for VAR 200.

General and administrative expenses were $2.3 million for the three months ended March 31, 2024, a decrease of $1.2 million or 34.6% from $3.5 million for the three months ended March 31, 2023. The decrease is primarily attributable to a decrease of $0.4 million in payments for the Effectiveness Failure related to the PIPE shares, a decrease of $0.4 million for bonus accruals, a $0.2 million decrease in accounting fees and a $0.1 million decrease in director and officer insurance.

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 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, IR Contact

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

View full release HERE.

Research News and Market Data on ZVSA

Apr 29, 2024

• This publication, authored by leading experts in inflammasome-mediated inflammation and neurology at University of Miami Miller School of Medicine, demonstrates that multiple inflammasome triggers (NLRP1 and pyrin) govern the inflammatory response in Alzheimer’s Disease (AD), and that release of inflammasome laden extracellular vesicles (EV) into the blood induce significant inflammation in cardiovascular cells.
• ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes, including NLRP1 and pyrin, and their associated ASC specks that trigger damaging inflammation and its spread to surrounding tissues.
• AD, a progressive neurodegenerative disease affecting 6.7 million people in the US, is associated with many comorbidities, especially heart disease and stroke, resulting in increased morbidity and mortality.

WESTON, Fla., April 29, 2024 (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 that acclaimed inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100, have published a scientific paper in the peer-reviewed journal, Frontiers in Molecular Neuroscience, highlighting how inflammasome-mediated inflammation in Alzheimer’s disease can trigger inflammation in the heart.

The paper titled, “Extracellular vesicles mediate inflammasome signaling in the brain and heart of Alzheimer’s disease mice,” summarizes research evaluating serum and tissue cultures from an AD mouse model, and experiments of adoptive transfer of EV from AD patients into cardiovascular cells. Following is a summary of key findings:

• NLRP1, pyrin, caspase-1, and ASC were significantly elevated in the cortex of AD mice.
• In AD mice, there was a heightened level of inflammatory proteins circulating in the body via EVs containing an inflammasome protein cargo.
• Inflammasome activation was demonstrated in the heart of AD mice, associated with an increase in ASC oligomerization into specks.
• In adoptive transfer experiments, EVs released from AD patients induced significant inflammation in cardiovascular cells when compared to EVs from healthy individuals.

“Our data provide evidence that there is a neural-cardiac axis mediated by EVs in AD. Therefore, inflammasomes may provide a novel therapeutic target for the treatment of cardiac comorbidities in AD and beyond,” said Juan Pablo de Rivero Vaccari, Associated Professor of Neurological Surgery and The Miami Project to Cure Paralysis at the University of Miami.

“This research reinforces the importance of attenuating activation of multiple types of inflammasomes that govern the inflammatory response in AD and mediating systemic inflammatory signals in EVs to control the spread of damaging inflammation to cardiovascular and other cells,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa’s Inflammasome ASC inhibitor IC 100 is designed to inhibit formation of multiple types of inflammasomes to attenuate initiation of the inflammatory cascade and to inhibit their associated ASC specks to reduce spread and perpetuation of damaging inflammation.”

To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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.

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 other 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 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
kcashmere@zyversa.com
786-251-9641     

Research News and Market Data on ZVSA

Apr 4, 2024

PDF Version

• Atherosclerosis (AS) and its sequelae are the most common cause of death in diabetic patients and one of the reasons why diabetes has entered the top 10 causes of death worldwide.
• The published data show that inhibiting the NLRP3 inflammasome pathway significantly reduces atherosclerotic lesions and improves hyperglycemic-induced plaque instability.
• ZyVersa is developing IC 100, a monoclonal antibody targeting inflammasome ASC and ASC specks from multiple types of inflammasomes, including NLRP3, to block initiation and perpetuation of damaging inflammation that promotes atherosclerosis and its progression, among numerous other inflammatory diseases.

WESTON, Fla., April 04, 2024 (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, highlights data from a peer-reviewed article published in Biochemical and Biophysical Research Communications. This article demonstrates that NLRP3 inhibition results in improved glucose tolerance and markedly smaller and more stable atherosclerotic lesions in a diabetic mouse model.

In the paper titled, “High glucose levels accelerate atherosclerosis via NLRP3-IL/ MAPK/ NF-κB-related inflammation pathways,” the authors evaluated serum and coronary artery tissues from patients with coronary artery disease (CAD), with and without diabetes and they conducted a study in diabetic mouse models. Key findings include:

• Patients with comorbid CAD and diabetes had higher serum levels and expression of NLRP3 in their coronary arteries, and increased serum levels of IL-1β and IL-6 than those with CAD only.
• Diabetic mouse models showed a significantly higher atherosclerotic plaque/vessel area ratio than non-diabetic mice, which was markedly reduced with NLRP3 inhibition and the resulting reduction in levels of proinflammatory cytokines and inflammation.

The authors concluded, “Our research offers new understanding of the pathological mechanisms of diabetes-accelerated AS and provide a novel and promising target for treating diabetes-accelerated AS.” To review the publication, Click Here.

“We are excited about the data published in Biochemical and Biophysical Research Communications demonstrating that inhibiting inflammasome NLPR3 pathways has potential to attenuate the development and progression of AS in patients with diabetes, a leading cause of morbidity and mortality,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “We look forward to seeing our preclinical data with Inflammasome ASC Inhibitor IC 100 in an animal model of atherosclerosis in the first half of this year. We believe that by inhibiting multiple types of inflammasomes and disrupting the structure and function of their associated ASC specks to attenuate initiation and perpetuation of inflammation, that IC 100 has promise to effectively control AS development and progression.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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.

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 other 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 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
kcashmere@zyversa.com
786-251-9641