The University of Miami Leonard M. Miller School of Medicine

Recent evidence links obesity-driven inflammation to diminished brain health and neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseasesThe newly published data show that obesity leads to progressive brain inflammation in a mouse model, and that the proinflammatory processes worsen with prolonged obesity and with increased ageThis research supports our selection of obesity with associated comorbidities as the lead indication for Inflammasome ASC Inhibitor IC 100IC 100 inhibits intra- and extracellular ASC and specks associated with multiple types of inflammasomes to attenuate damaging neurologic and systemic inflammation WESTON, Fla., Oct. 22, 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 published in the peer-reviewed journal, Aging Cell, demonstrating that obesity in older adults or prolonged duration of obesity in the younger population resulted in inflammation and suppression of neurotrophic/neuroprotective factors in the brain, indicating that age and duration of obesity are critical risk factors for neurodegenerative diseases. “With IC 100’s demonstrated penetration of the brain and key organs affected by obesity, such as heart, kidney, and liver, and its unique anti-inflammatory mechanism of action, IC 100 has potential to control the CNS and systemic inflammation of obesity and attenuate development and/or progression of associated comorbidities, such as Parkinson’s and heart diseases,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “The potential for IC 100 to attenuate the damaging neuroinflammation leading to Parkinson’s disease is supported by data from a recently completed in vitro study demonstrating IC 100’smechanistic proof-of-concept in this indication. The study was funded by the Michael J. Fox Foundation and conducted by researchers at the University of Miami Miller School of Medicine. Future Parkinson’s animal model studies are planned.” The paper titled, Age and duration of obesity modulate the inflammatory response and expression of neuroprotective factors in mammalian female brain, summarizes research conducted in a diet-induced obesity (DIO) mouse model. To characterize the effects of age and duration of obesity, adolescent (5 weeks old) and mature adult (14 weeks old) female mice were fed a high fat diet (HFD) for either 13 or 26 weeks. Age-matched control mice were fed a standard diet. Key findings: HFD induced a typical obesity phenotype in mice independent of age and duration Significant weight gain, increase in fat cell size, and subcutaneous adipose tissue inflammation At 13 weeks, adolescent obese mice developed a limited inflammatory response in the hypothalamus, but when the duration was extended to 26 weeks: A systemic inflammatory response was demonstratedInflammation was demonstrated in visceral adipose tissue, which is responsible for comorbidities, and in all three brain regions studied (hypothalamus, hippocampus, and cerebral cortex)Neurotrophic/neuroprotective factors were suppressedMicrogliosis and astrogliosis developed, which are associated with brain damage Unlike adolescent mice at 13 weeks, mature adult mice demonstrated systemic inflammation and suppression of neurotrophic/neuroprotective factors in all three brain regions studied. This was sustained through the 26-week study, suggesting that advanced age may negatively affect obesity outcomes earlier than in younger individuals “From the translational perspective, the findings of the present study highlight the importance of early interventions to combat obesity and, thus, to avoid the associated comorbidities,” 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 MediatorTM 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 CashmereChief Commercial Officerkcashmere@zyversa.com786-251-9641

PURCHASE, N.Y., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, has released a new Conversations video podcast episode. The new episode, which has been launched during DLB Awareness Month, is titled “Executing Clinical Research in Dementia with Lewy Bodies (DLB).” This conversation features a panel of experts who discuss the similarities and differences between DLB and Alzheimer’s disease, as well as the unique constellation of symptoms experienced by DLB patients. Panelists also discuss the design of the SHIMMER study of CT1812 in mild-to-moderate DLB, and the value of identifying signals of clinical and functional benefit in a condition for which there are currently no approved disease-modifying therapies. Anthony Caggiano, M.D., Ph.D. CMO and head of R&D for Cognition Therapeutics moderates the discussion with three leading experts: James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine;Lawrence S. Honig, MD, PhD, FAAN, professor of neurology at Columbia University Irving Medical Center; andDavid Shprecher, D.O., movement disorder director at Banner Sun Health Research Institute and a clinical associate professor at the University of Arizona. Listen to episode nine, “Executing Clinical Research in Dementia with Lewy Bodies (DLB)” on the Conversations tab of the Cognition website. This conversation is presented in 3 Chapters: 1) Comparing Alzheimer’s disease and DLB; 2) SHIMMER Design and Outcomes; and 3) Metrics for Success in a Signal-finding Study. Health Care Disclaimer Our podcast series does not constitute the practice of medical advice, diagnosis or treatment. Always talk to your health care provider for diagnosis and treatment, including your specific medical needs. If you have or suspect that you have a medical problem or condition, please contact a qualified health care professional immediately. About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We currently are investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these degenerative diseases, with an approach that is functionally distinct from other treatments. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com. About the SHIMMER StudyThe SHIMMER study (NCT05225415) is a double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB. Participants were evenly randomized to receive either placebo or one of two oral once-daily doses of CT1812 (100 mg or 300 mg) for six months. Participants are assessed throughout the study using the Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE), which track cognitive performance; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; and the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism. The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million and is being conducted in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). The SHIMMER study is being conducted at over 30 sites in the United States, many of which are LBDA centers of excellence. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including CT1812, and any expected or implied benefits or results, including that initial clinical results observed with respect to CT1812 will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of CT1812 and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information:Cognition Therapeutics, Inc.info@cogrx.comCasey McDonald (media) Tiberend Strategic Advisors, Inc.cmcdonald@tiberend.comMike Moyer (investors)LifeSci Advisors mmoyer@lifesciadvisors.com This press release was published by a CLEAR® Verified individual.

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 HospitalProfessor of Medicine, Harvard Medical School Harold Bays, MD, MFOMA, FTOS, FACC, FACE, FNLA, FASPC Medical Director and President, Louisville Metabolic and Atherosclerosis Research CenterClinical Associate Professor, Endocrinology, University of Louisville School of MedicineChief Science Officer of the Obesity Medicine Association Helen Bramlett, PhD Professor, Department of Neurological Surgery, University of Miami Miller School of MedicineThe Miami Project to Cure Paralysis, University of Miami Miller School of Medicine Marc-Andre Cornier, MD Professor of Medicine, Medical University of South CarolinaDirector, 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 MedicineThe Miami Project to Cure Paralysis, University of Miami Miller School of MedicineDistinguished 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 MedicineSenior Associate Dean for Discovery Science and Co-Director, the Institute for Neural Engineering, University of Miami Miller School of MedicineProfessor, 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 MedicineThe 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 MedicineDirector, Center for Human Nutrition, Washington University School of MedicineChief, Division of Nutritional Science and Obesity Medicine, Washington University School of Medicine Suneil Koliwad, MD, PhD Chief, Division of Endocrinology and Metabolism, UCSF HealthGerold Grodsky Professor of Diabetes Research, UCSFMount 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 CashmereChief Commercial Officerkcashmere@zyversa.com786-251-9641