PKCε

ROCKVILLE, Md.--( BUSINESS WIRE )-- SYNAPS Dx (SDx) a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), today appointed an accomplished group of physicians, neuroscientists and esteemed leaders in neurodegenerative disease to its newly formed Scientific Advisory Board (SAB), reinforcing its commitment and position as an innovator and first-mover in the AD diagnostics industry. SDx welcomes this remarkable, esteemed group of individuals who will further expand research and market development of its proprietary, highly accurate DISCERN™ test: the first autopsy-validated skin test to demonstrate high specificity and sensitivity distinguishing the disease from non-Alzheimer’s disease in people recently diagnosed with dementia, even those living with mixed-dementia . • Alberto J. Espay, MD, MSc, chairman of the SAB, has over 300 published peer-reviewed research articles and 10 books on neurodegenerative diseases. He offers a deep knowledge of neurology, including the direction of the first biomarker study of aging ( CCBPstudy.com ) designed to match people with neurodegenerative disorders to available therapies from which they are most biologically suitable to benefit, regardless of their clinical diagnoses. • David G. Morgan, PhD, director, Alzheimer’s Alliance and MSU Foundation Professor of Translational Neuroscience at Michigan State University where he studies AD, aging, brain function, immunotherapy and gene therapy to treat the Alzheimer-related pathologies. • Giulio Taglialatela, PhD, serves as the vice chair for research of the Department of Neurology and the director of the UTMB Mitchell Center for Neurodegenerative Diseases. He is also the inaugural director of the newly established UTMB Brain Health Institute under the auspice of which all clinical and basic research neuroscience at UTMB will be located. • Lon S. Schneider, MD, MS, is professor of psychiatry, neurology and gerontology at Keck School of Medicine and Leonard Davis School of Gerontology of the USC; and holds the Della Martin Endowed Chair in Psychiatry and Neuroscience. He directs the USC California AD Center (Dep. of Health) and co-directs the clinical core of the USC NIA AD Research Center. "We hand-picked these individuals who have made significant contributions and pioneered breakthroughs in Alzheimer’s research and therapeutics, and together, they bring a wealth of knowledge, experience and expertise to SDx,” says Paul Tanico, chief strategy officer and executive chairman, SDx. “We are honored to partner with such exceptional thought leaders who are shaping the future of brain health and advancing the biology of memory. Getting an accurate AD diagnosis with the DISCERN test is critically important because treatment options for patients are specific and distinct compared to treatments for patients with other forms of non-Alzheimer’s dementia.” DISCERN is administered as a single skin biopsy by a clinician and is readily accessible in the community office setting. The test informs physician prescribing of new, FDA-approved drugs for AD and supports alternative care plans, including lifestyle changes, that can improve outcomes for patients with non-Alzheimer’s dementia or mild cognitive impairment, reduce costs and reduce caregiver burdens. DISCERN is comprised of three different autopsy-validated assays that assess several critical factors directly related to AD that regulate memory, the formation of synaptic connections among neurons, the levels of amyloid plaques and levels of neurofibrillary tangles in the brain. The MI assay is based on measuring an ensemble of multiple factors such as inflammation, synaptic growth and neuronal death that can be detected in skin fibroblasts. Complementary to the MI assay, the protein kinase C (PKCε) assay includes fibroblasts from the skin biopsy that are cultured and analyzed using the ELISA to measure PKCε levels in relation to Aβ exposure in the brain. The AD-biomarker index also composes one of the three assays and tests skin fibroblasts from biopsies to culture to confluency. About SYNAPS Dx SYNAPS Dx is a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer's disease (AD). The company offers DISCERN™, the first highly accurate, minimally invasive test supporting a clinician's definitive diagnosis of AD versus other forms of dementia, even in people recently diagnosed with dementia. SYNAPS Dx's laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity clinical laboratory testing. Physicians and patients seeking more information can visit https://discerntest.com/ . For more information on the company, visit https://www.synapsdx.com/ . Contact: info@synapsdx.com .

Positive changes in ALS gene expression and increased cellular viability met with statistical significance of p<.001 NEW YORK, Sept. 7, 2023 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced findings from an independent study demonstrating the potential for Bryostatin-1 as a treatment strategy for amyotrophic lateral sclerosis ("ALS"), also known as Lou Gehrig's Disease. An open access article about the study was published in a special issue of the International Journal of Molecular Sciences titled "Neurodegenerative Disease: From Molecular Basis to Therapy." Under the leadership of Professor Sebastiano Cavallaro, an internationally recognized expert in the genetics of ALS, the study was conducted by scientists at the Institute for Biomedical Research and Innovation and the National Research Council of Italy, in collaboration with the University of Catania. Dr. Cavallaro has served for over 20 years as Research Director for the Institute for Biomedical Research and Innovation. The new article demonstrates that the gene encoding for the enzyme protein kinase C epsilon ("PKCε"), the primary initial target of Bryostatin-1, showed an expression level that was significantly reduced (p<.001, 2-tailed) in the motor cortex samples taken from a genetically identified population of ALS patients when compared to control patients. Furthermore, in pre-clinical murine motor neurons genetically engineered to model the genetic signature of these ALS patients, there was a significant (p<.001, 2-tailed) reduction in the level of activated PKCε. Bryostatin-1 treatment of these ALS motor neurons significantly reversed the PKCε deficits. Dr. Sebastiano Cavallaro stated, "Taken together, our findings suggest that PKCε alteration could play a role in ALS pathophysiology, and that PKCε agonism by Bryostatin-1 may represent a potential neuroprotective strategy against motor neuronal degeneration — at least in a specific subgroup of sporadic ALS patients." Dr. Alan Tuchman, Chief Executive Officer of Synaptogenix, commented, "We are excited about the statistical significance Bryostatin-1 achieved in improving ALS gene expression and increasing cellular viability. The therapeutic potential for this drug platform supports our work for indications with significant unmet needs including Alzheimer's disease, multiple sclerosis (MS), and the rare disease Fragile X Syndrome. Third party validation of Bryostatin-1 in ALS is of great value to our Company as we continue to review options for our lead compounds. In keeping with our international outlook for potential acquisitions of asset rights or R&D funding for other assets, we are exploring opportunities with world-leading institutions on cutting edge treatment innovations for central nervous system diseases." Dr. Daniel Alkon, President and Chief Scientific Officer of Synaptogenix, added, "The difference between the biochemical PKC measurement in genetically engineered murine motor neurons that were treated with Bryostatin-1 versus those untreated was statistically significant (p<.001). This study provides evidence that two key disease factors for ALS are deficits in the gene for the PKCɛ enzyme and deficits in the amount of the activated PKCε in neurons from the motor cortex of ALS patients. It is encouraging that Bryostatin-1 reversed these deficits in motor neuron models of the ALS cells." ALS is a fatal adult-onset neurodegenerative disorder characterized by the progressive degeneration of upper and lower motor neurons in the cortex, brainstem, and spinal cord. Motor neuron deterioration results in muscle weakness and, ultimately, death due to respiratory failure, typically within three to five years after diagnosis. The global ALS market value is projected to reach $1 billion by 2032.1 About Synaptogenix Synaptogenix is a clinical-stage biopharmaceutical company that has historically worked to develop novel therapies for neurodegenerative diseases. Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease. Preclinical studies have also demonstrated bryostatin's regenerative mechanisms of action for multiple sclerosis, amyotrophic lateral sclerosis (ALS), Fragile X syndrome, and for other neurodegenerative disorders such as stroke and traumatic brain injury. The U.S. Food and Drug Administration has granted Orphan Drug Designation to Synaptogenix for Bryostatin-1 as a treatment for Fragile X syndrome. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety database that will further inform clinical trial designs. Additional information about Synaptogenix, Inc. may be found on its website: Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over. There can be no assurance that the clinical program for Bryostatin-1 will be successful in demonstrating safety and/or efficacy, that the Company will not encounter problems or delays in clinical development, or that Bryostatin-1 will ever receive regulatory approval or be successfully commercialized. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Additional factors that may influence or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, the Company's patent portfolio, the Company's inability to expand its business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of the Company's raw materials, existing or increased competition, stock volatility and illiquidity, and the Company's failure to implement its business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to update these forward-looking statements. Contact 800-811-5591 [email protected] 1 Allied Medical Research, Global Opportunity Analysis and Industry Forecast, 2023-2032. April 2023. SOURCE Synaptogenix, Inc.

ROCKVILLE, Md.--(BUSINESS WIRE)-- SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), is pleased to announce the publication of “Clinical Utility of a Novel Test to Diagnose Alzheimer’s Disease in Patients with Suspected Dementia” in Annals of Clinical Cytology and Pathology. The study indicates that 90% of physicians would order and routinely use the results of the DISCERN™ test to more accurately diagnose AD, prescribe medications for AD cognitive impairment, refer to a neurologist or prescribe a disease-modifying drug. DISCERN is an autopsy-validated diagnostic test that assesses the factors directly related to the formation of synaptic connections in the brain impacting loss of memory and cognition in people living with AD as well as regulators of amyloid plaque and tau formation, hallmarks of AD at autopsy. “Our study demonstrates that the DISCERN test is an objective contributor to physician decision-making, associated with significantly higher clinician confidence in an AD diagnosis, especially in those recently diagnosed with dementia,” says Frank Amato, CEO and president, SDx. “The availability of a test like DISCERN is of critical importance as the Alzheimer’s Association recently noted that 50-70% of symptomatic patients are misdiagnosed in the primary care setting, primarily due to the lack of objective, easily accessible, time- and cost-effective, accurate diagnostic tools.” The study relied on a survey to estimate treatment decisions from a sample of 402 primary care physicians (PCPs) including 250 PCPs, 102 neurologists and 50 geriatricians. A majority of clinicians in the study expressed dissatisfaction with the current diagnostic pathway, citing high subjectivity and a significant patient burden. Clinicians indicated that a DISCERN result was the most important attribute in decision making scenarios, indicating that with a positive DISCERN test, they were five times more likely to diagnose and three times as likely to prescribe disease modifying drugs for AD. “With the potential FDA-approval of drugs for AD coming this year, payers will be facing challenges regarding prescribing and coverage determinations for new, expensive treatments for the most appropriate patients,” says Frederick Huie, M.D., SDx advisory council member and co-author of the paper. “Physicians indicated they were not only more likely to diagnose AD with a positive DISCERN test result versus without a test, but also were more likely to establish an appropriate course of treatment, which may include prescribing disease-modifying drugs once they become available. Physician confidence in diagnosing AD is becoming increasingly more important as data suggest that disease modifying treatments, including lifestyle and disease modifying drugs may slow cognitive decline.” The three DISCERN biomarkers assess several critical factors directly related to AD with only a small skin sample required to analyze the biomarkers, which consist of: Morphometric Imaging (MI): In a clinical trial with the MI Assay, patients with autopsy-confirmed AD could be accurately distinguished from patients with non-AD dementia and age-matched controls with 100% sensitivity and specificity. PKCε Assay: In a clinical trial with the PKCε Assay, patients with autopsy-confirmed AD could be accurately distinguished from patients with non-AD dementia and age matched-controls with 100% sensitivity and 96% specificity. AD-Index: In a clinical trial with AD-Index Assay, patients with autopsy-confirmed AD could be accurately distinguished from patients with non-AD dementias and age-matched controls with 97% sensitivity and 94% specificity. Amato continues, “With use of the DISCERN test, PCPs have a greater confidence in the diagnosis of AD, potentially avoiding unnecessary, invasive and expensive diagnostic procedures and identifying patients with AD dementia who are appropriate candidates for treatment.” About SYNAPS Dx SYNAPS Dx is a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD). The Company offers DISCERN™, the first highly accurate, minimally invasive test supporting a clinician’s definitive diagnosis of AD versus other forms of dementia, even in people recently diagnosed with dementia. SYNAPS Dx’s laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. Physicians and patients seeking more information can visit . For more information on the Company, visit . Contact: info@synapsdx.com.