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, UK, and Winter Springs, FL, September 19, 2023 – PR Newswire – 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 Guti 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 NASHii. 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: www.metadeq.com.

Contacts
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Metadeq
Daniel Whittaker
Chief Commercial Officer
d.whittaker@metadeq.com

Oratorium Group
Juliane Snowden
Founder
jsnowden@oratoriumgroup.com

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; www.liverfoundation.org; Clin Diabetes and Endocrinology, 2020; Gosalia, et al, Diagnostics 2022