RAB14

HeparDx™ is an investigational MASH (NASH) activity and liver fibrosis blood test designed to diagnose and stage patients, detect at-risk MASH and monitor treatment response to therapy The data presentations add further evidence supporting HeparDx™ as an accurate blood test to detect liver-specific metabolic dysfunction-associated steatohepatitis (MASH) New findings independently correlate PLIN2 with inflammation and lobular ballooning in a 198-patient analysis from the previous prospective study published in Guti LONDON and WINTER SPRINGS, Fla., June 4, 2024 /PRNewswire/ -- PR Newswire – MetaDeq Ltd. and MetaDeq Diagnostics, Inc., a private medical diagnostic company developing tests for MASH (fatty liver) and liver fibrosis, announced that two posters will be presented at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The presented data shed new light on the PLIN2 component of the HeparDx™ diagnostic blood test and provide a further understanding of PLIN2's mechanism of action for detecting MASH. The abstracts can be found on the EASL website at and will be available for viewing on Wednesday June 5, 2024 at 8 :30am CEST. Continue Reading HeparDx™ is able to identify and quantify inflammation and ballooning in blood monocytes with high accuracy and correlation to liver cells as assessed by liver biopsy. This detection appears to be liver-specific and not associated with inflammation seen in subjects with cardiovascular disease (CVD). There is a clear unmet medical need to improve accuracy for non-invasive tests (NITs) for MASH. HeparDx™ is a blood test comprised of two biomarkers, one for inflammation and ballooning associated with MASH activity (PLIN2), and one for liver fibrosis (RAB14). MetaDeq believes its diagnostic blood test ultimately may enable physicians to: 1. Diagnose MASH patients before significant disease progression occurs, 2. Use it as a pre-treatment medical decision-making tool, and 3. Monitor patient response to treatment. HeparDx™ is a non-invasive blood test aimed to detect MASH activity, their individual components and liver fibrosis. Post this Prof. Sven Franque, abstract author and collaborating clinician, comments: "After encouraging data published in 2023, at this year's Liver Congress in Milan, Poster WED-296 undertakes an important analysis to determine if PLIN2 over-expression occurs in other tissues. Cardiac tissue from subjects with cardiovascular disease generally has inflammation as a hallmark characteristic. In this dataset, PLIN2 levels are elevated in liver tissue in subjects with MASH, but not in subjects with cardiac disease; this helps provide evidence that HeparDx™ appears to be liver-specific. I look forward to seeing continued data generation in additional patient cohorts throughout this year." POSTER PRESENTATIONS Title: HeparDx™ (by MetaDeq, Inc.) is a reliable biomarker of MASH capable of detecting the presence of inflammation and ballooning Authors: Giulia Angelini, Sara Russo, Erminia Lembo, Ornella Verrastro, Antonio Liguori, Stephen Harrison, Aldo Trylesinski, Luca Miele, Geltrude Mingrone Poster Number: WED-215 Date/Time: Wednesday, June 5th, 8:30 am CEST Summary: PLIN2 expression is significantly increased in subjects with at-risk MASH (NAS ≥4 and clinically significant fibrosis) compared with subjects without MASH. In 198 subjects with histologically proven at-risk MASH, HeparDx™ analysis for the detection of presence/absence of MASH produced an AUROC of 96.8% vs. liver biopsy, with a sensitivity and specificity of 93.5% and 90.2%, respectively. HeparDx™ was able to detect inflammation and ballooning as individual components, each with high sensitivity and specificity. Title: PLIN2 is a specific marker for liver related disease Authors: Giulia Angelini, Sara Russo, Federico Biscetti, Andrea Flex, Jérôme Boursier, Sven Francque, Aldo Trylesinski, Stephen Harrison, Geltrude Mingrone Poster Number: WED-296 Date/Time: Wednesday, June 5th, 8:30 am CEST Summary: Plasma PLIN2 is significantly higher in subjects with MASH as compared to subjects without MASH. In 100 subjects analyzed, HeparDx™ clearly showed the ability to detect MASH activity in the liver, but in subjects with CVD and early atherosclerosis, no significantly elevated levels of PLIN2 were detected. Hence, PLIN2 appears to be specific for liver activity related to MASH and is not confounded with inflammation in other tissues, such as cardiac. Aldo Trylesinski, M.D., Consulting Chief Medical Officer, comments: "The two posters presented at EASL further validate the scientific basis behind HeparDx™ as a non-invasive blood test aimed to detect MASH activity, their individual components and liver fibrosis. Further validation in other patient cohorts is currently ongoing, but up to now, the evidence described in these posters, coupled with the data published in Gut earlier last year, point to a very encouraging signal." In Memory and Acknowledgement: Earlier this year, the liver community lost a brilliant physician, leader, clinical trial investigator and true champion of patients, Dr. and Colonel (Ret.) Stephen A. Harrison. With Stephen's passing, we at MetaDeq, and many, many others, lost a friend and advisor. Stephen's work and insight into liver diseases will continue to inspire us. Stephen had been serving as Chair of the MetaDeq Scientific Advisory Board and was an early believer in our technology. About MASH (NASH) Metabolic dysfunction-associated steatohepatitis (MASH) is a leading cause of cirrhosis, liver failure, liver transplant, and hepatocellular carcinoma. Liver biopsy is the diagnostic reference standard, but it is expensive, time consuming, and carries multiple risks to the patient. With the first FDA-approved therapeutic on the market, the need for a highly accurate and reliable non-invasive test (NIT) is imperative to diagnose and monitor patients on therapy. In the U.S., over 25% of adults have metabolic dysfunction-associated steatotic liver disease (MASLD), of which 20%, or 12 million adults, will progress to MASHii. In June 2023, the American Diabetes Association recommended all 28 million people with Type 2 diabetes be tested for MASLD/MASHiii. About HeparDx HeparDx™ is an investigational novel blood test to accurately diagnose, stage, and monitor MASH being developed by MetaDeq Diagnostics. HeparDx™ includes two biomarkers correlated with MASH activity and fibrosis in the liver to accurately diagnose MASH patients and potentially replace liver biopsies. Clinical data from a prospective study in 250 patients undergoing liver biopsies has been peer-reviewed and published in Gut1, a leading medical journal, and multiple additional abstracts have been presented at medical congresses. HeparDx™ appears to have the potential to measure, independently, each inflammation and ballooning component in MASH vs. only steatohepatitis. About MetaDeq Diagnostics MetaDeq is committed to delivering diagnostics that help physicians identify, diagnose, stage and monitor MASLD and MASH patients with a simple and accurate blood test. MetaDeq's lead product is HeparDx™, a blood test based on two biomarkers to detect MASH activity and liver fibrosis. For more information, please visit: . Contacts i Gut Feb 2023, 72 (2) 392-403; DOI: 10.1136/gutjnl-2022-327498 ii Int J Mol Sci, 2019; ; Clin Diabetes and Endocrinology, 2020; Gosalia, et al, Diagnostics 2022 iii SOURCE Metadeq

HeparDx is an emerging NASH/MASH and liver fibrosis blood test designed to diagnose patients earlier and monitor disease progression The data presentations add further evidence supporting HeparDx™ as an accurate blood test to detect non-alcoholic (or metabolic dysfunction-associated) steatohepatitis (NASH/MASH). New finding correlates PLIN2 and RAB14 mRNA expression level changes with NASH/MASH activity, as well as with patient fibrosis severity and status. Study comparing HeparDx™ to three non-invasive tests (NITs) resulted in a superior AUROC for HeparDx. LONDON and WINTER SPRINGS, Fla., Sept. 20, 2023 /PRNewswire/ -- Metadeq Diagnostics, Inc., a private medical diagnostic company developing tests for NASH/MASH and liver fibrosis, today announced the presentation of three posters at the EASL SLD Summit 2023 in Prague, Czech Republic. The presented data support existing data published in Gut[i] and provide further evidence that HeparDx could become the standard of care for the diagnosis of NASH/MASH and liver fibrosis. There is a clear unmet medical need to provide an alternative or complement to liver biopsy procedures for the detection of NASH/MASH, as well as need for improved blood tests to detect liver fibrosis. HeparDx™ is a blood test comprised of two monocyte biomarkers, one for NASH activity and one for liver fibrosis, which have been shown to be highly correlated to detecting patients with NASH/MASH and liver fibrosis. Metadeq believes its diagnostic ultimately may enable hepatologists, gastroenterologists, other specialists and PCPs/GPs to identify NASH/MASH patients before significant disease progression occurs, as well as to monitor treatment responses. HeparDx has the potential to lower treatment costs and improve patients' lives. Stephen Harrison, M.D., Metadeq Advisory Board Chairman, comments: "The three posters presented at EASL SLD further validate the scientific basis behind HeparDx™ as a non-invasive blood test aimed to detect both NASH activity and liver fibrosis. Further validation in other patient cohorts will be necessary, but up to now, the evidence described in these posters, coupled with the data published in Gut earlier this year, point to a very encouraging signal." POSTER PRESENTATIONS Title: Validation of HeparDx™ score (by Metadeq, Inc.) as a non-invasive test for the diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) Authors: G. Angelini, S. Sabatini, E. Lembo, O. Verrastro, A. Daly, O. Govaere, S. Cockel, Q. Anstee, A. Gastaldelli, G. Mingrone Poster Number: P01-06 Title: High tyrosine and PLIN2 and low beta-hydroxybutyrate characterize subjects with metabolic dysfunction-associated steatohepatitis (MASH) Authors: P. Infelise, S. Sabatini, G. Angelini, F. Carli, S. Pezzica, O. Verrsastro, E. Lembo, G. Mingrone, A. Gastaldelli Poster Number: P03-19-YI Title: Analytical and clinical comparison of three non-invasive tests for the diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) Authors: S. Sabatini, G. Angelini, E. Lembo, O. Verrastro, F. Carli, G. Mingrone, A. Gastaldelli Poster Number: P06-06-YI Stephen Harrison, M.D., Metadeq Advisory Board Chairman, comments: "The three posters presented at EASL SLD further validate the scientific basis behind HeparDx™ as a non-invasive blood test aimed to detect both NASH activity and liver fibrosis. Further validation in other patient cohorts will be necessary, but up to now, the evidence described in these posters, coupled with the data published in Gut earlier this year, point to a very encouraging signal." David Nikodem, Ph.D., Metadeq Chief Executive Officer, adds: "EASL SLD is an important Congress focused on steatotic liver disease, and we appreciate the opportunity to present the most recent HeparDx™ data to the hepatology community. The presented data shed light on the correlation between PLIN2 and RAB14 with liver health, specifically on NAFLD Activity Score (NAS) and liver fibrosis. We continue to focus on validating HeparDx™ to aid in better identifying patients with NASH/MASH and as a potential replacement for liver biopsy procedures. Our goal is to provide physicians with an NIT that allows them to detect and monitor NASH/MASH activity in their patients without a liver biopsy." About NASH/MASH Non-alcoholic fatty liver disease ('NAFLD' - evolving in nomenclature to metabolic dysfunction-associated steatotic liver disease, or 'MASLD') is a "silent" disease that, if left undiagnosed, can lead to Non-alcoholic (or Metabolic) Steatohepatitis (NASH/MASH), a leading cause of cirrhosis, liver failure, liver transplant, and hepatocellular carcinoma. Liver biopsy is the diagnostic reference standard of care, but is expensive, time consuming, and carries multiple risks to the patient. Therapeutics are nearing FDA approval, making the need for an accurate and reliable non-invasive test (NIT) imperative to diagnose and monitor patients on therapy. In the U.S., over 25% of adults have NAFLD (approximately 62 million), of which 20%, or 12 million adults, will progress to NASH[ii]. In June 2023, the American Diabetes Association recommended all 28 million people with Type 2 diabetes be tested for NAFLD/NASH. About HeparDx™ HeparDx™ is an investigational novel blood test to accurately diagnose, stage, and monitor NASH/MASH developed by Metadeq Diagnostics. HeparDx™ includes two biomarkers correlated with NASH/MASH activity and fibrosis in the liver to accurately diagnose NASH/MASH patients and potentially replace liver biopsies. Clinical data from a prospective study in 250 patients undergoing liver biopsies has been peer-reviewed and published in Gut, a leading medical journal. About Metadeq Diagnostics Metadeq, Inc., is committed to delivering diagnostics that help physicians identify, diagnose, stage and monitor NAFLD (MASLD) and NASH (MASH) patients with a simple and accurate blood test. Metadeq's lead product is HeparDx™, a blood test based on two biomarkers to detect NASH/MASH activity and liver fibrosis. For more information, please visit: . Contacts Important Notice This press release may contain certain forward-looking statements and information relating to Metadeq, Inc. a Delaware corporation (the "Company"), that are based on the beliefs of our management as well as the assumptions made by and information currently available to our management. All statements, other than statements of historical facts, contained in this press release, including statements regarding our ability to commercialize a non-invasive test to identify and monitor patients with NASH/MASH, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The projections used in this presentation are forward-looking statements. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Such statements reflect the current views of our Company's management, some of which may not materialize or may change. These statements are subject to certain risks, uncertainties and assumptions. You are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties, including, but not limited to: our failure to successfully commercialize our products; costs and delays in development; and supply chain; our inability to maintain or enter into, and the risks resulting from our dependence upon, contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales, and distribution of any products; competitive factors; our inability to protect our proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. All forward-looking statements in this press release are expressly qualified by reference to this cautionary statement. [i] Gut Feb 2023, 72 (2) 392-403; DOI: 10.1136/gutjnl-2022-327498 [ii] Int J Mol Sci, 2019; ; Clin Diabetes and Endocrinology, 2020; Gosalia, et al, Diagnostics 2022 SOURCE Metadeq

BOSTON, July 15, 2022 /PRNewswire/ -- Metadeq Inc., a global NASH and metabolic diseases diagnostics company, today announced a breakthrough non-invasive blood test that utilizes two novel circulating proteins to accurately diagnose Non-alcoholic steato-hepatitis (NASH) and liver fibrosis, and can score the stages of both diseases, without the need for invasive liver biopsy. The study which details the new blood test – just revealed in Gut, a leading hepatology and gastroenterology journal published by BMJ – was led by King's College London Professor Geltrude Mingrone, in collaboration with Metadeq. Approximately one in four people worldwide, or approximately two billion people, have Non-alcoholic fatty liver disease (NAFLD) and therefore are at risk of developing NASH. NASH is the most severe form of NAFLD, a silent disease associated with fatty deposit build-up of the liver. NASH leads to advanced liver diseases such as liver fibrosis (scarring), cirrhosis, and liver cancer, and may ultimately result in death. The annual cost to the US healthcare system alone has been estimated to be over $100 billion per year. Currently, the only way to diagnose NASH is through the standard of diagnosis, invasive liver biopsy, which is expensive and is associated with significant complications and discomfort. Until now, no reliable blood test has been developed for NASH, nor liver fibrosis. Most importantly, no available test can define the severity (stage), or monitor the progression, of either NASH or liver fibrosis. Professor Geltrude Mingrone from the School of Cardiovascular and Metabolic Medicine & Sciences at King's College London, who is one of the most widely cited and influential researchers globally for metabolic diseases and disorders, set out to discover a more accurate liquid biopsy test in support of patient care and in collaboration with Metadeq. The resulting study was published today in leading journal, Gut. This study identified two novel protein biomarkers, PLIN2 and RAB14, to assist in the diagnosis of patients with NASH and/or liver fibrosis. The ability of these proteins to detect both diseases was tested in cohorts with either NASH and/or liver fibrosis that were confirmed with liver biopsy, the current standard of diagnosis. "This blood test will allow researchers and clinicians to define the prevalence of NASH across populations, including children and adolescents, avoiding the need for invasive liver biopsy," said Professor Mingrone. "Critically, it will allow care-givers to monitor the efficacy of NASH treatments over time, reducing screen failures and helping generate better drugs." "Since HEPAR-QTM is the only diagnostic modality that can diagnose NASH and fibrosis staging we expect it to be instrumental in the development of new therapeutics for the management of patients," said Frank Jaksch, Chairman of Metadeq. "We believe that HEPAR-QTM will advance for the benefit of patients the problem of regular screening, that has resulted in late drug failures during clinical trials, since it is now possible to accurately measure the severity of disease in a non-invasive manner." The Metadeq predictive algorithm, which uses A.I., provided unprecedented sensitivity (88-95%), specificity (90-100%), and overall accuracy (92-93%) for NASH, and also has near-perfect sensitivity (99%-100%), specificity (90%-96%), and accuracy (98%-99%) for liver fibrosis. The test results show that the proteins can provide rapid and cost-effective testing to combat the growing epidemic of NASH and liver fibrosis. This could be an invaluable tool in diagnosing and monitoring cases of liver diseases, allowing people to receive earlier treatment, from lifestyle adjustments to surgical and pharmacological interventions. Currently no NASH drug has been approved by either the FDA or EMA, which may be a direct result of the lack of an accurate, reliable, and non-invasive test. More than 65% of patients who enroll in clinical trials for NASH-related therapies are found to be ineligible for the trial due to screen failure, which causes major monetary losses to companies developing and testing NASH drugs. The improved accuracy and ability to detect NASH staging will help in identifying and enrolling the appropriate people in clinical trials, speeding up the development of NASH drugs. About Metadeq Metadeq Corp. is a diagnostics company that provides innovative liquid biopsy solutions for liver and metabolic diseases. For the first time, Metadeq allows people to measure the whole spectrum of liver diseases – from NAFLD, to NASH, and liver fibrosis – with a blood test. www.metadeq.com