Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company")

Pivotal kidneyintelX.dkd data published in Diabetes Care Journal of the American Diabetes Association

Presentation of 3 abstacts highlighting clinical utility at American Society of Nephrology Kidney Week

LONDON and NEW YORK, 12 November 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a precision medicine diagnostics company, with kidneyintelX.dkd, the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment in chronic kidney disease, announces a manuscript titled "Baseline Risk and Longitudinal Changes in kidneyintelX.dkd and Its Association With Kidney Outcomes in the CANVAS and CREDENCE Trials" has been published in the highest ranked diabetes journal globally, Diabetes Care, from the American Diabetes Association.

The study was co-authored by global thought leaders from Europe, US and Australia and included analysis of the kidneyintelX.dkd test in a combined cohort of 2,954 subjects from the completed CANVAS and CREDENCE clinical trials meeting the intended use of the test. Among a number of significant findings reported, are the following:

- kidneyintelX.dkd provides improved risk classification across all of the established risk groups as presented in the KDIGO clinical guidelines

- Treatment with SGLT2i front line therapy in patients classified as moderate or high risk by kidneyintelX.dkd resulted in a significant risk reduction, with the high risk treated group twice as likely to reduce their kidneyintelX.dkd risk level at 1 year compared to those not receiving treatment.

The authors concluded that kidneyintelX.dkd facilitated the identification of patients most likely to respond to therapy through personalized risk assessment with the potential for monitoring in clinical practice and a role in future clinical studies.

Associate Professor Brendon Neuen of The George Institute for Global Health, Sydney, who co-authored the paper, commented: "With multiple recent breakthroughs in therapies to reduce kidney function decline, the time for risk-based implementation in CKD has arrived. Incorporating novel biomarkers, as done with kidneyintelX.dkd, holds strong promise to guide risk-based care. The data published in this study provides a compelling example of how we can build on well established clinical parameters to deliver more personalized care and reduce the risk of adverse clinical outcomes."

Associate Professor Brendon Neuen is an internationally recognised expert on cardio-kidney-metabolic health. He is Program Lead, Renal and Metabolic at The George Institute for Global Health and a Staff Specialist Nephrologist and Director of Kidney Trials at Royal North Shore Hospital (full biography available below).

This most recent kidneyintelX.dkd publication co-incides with the presentation of three abstracts at ASN Kidney Week, held in Houston Texas from November 5-9. A summary of these abstract are as follows;

1. PO0330: Successful Implementation of KidneyIntelX in a Large Integrated Health System for Risk-Based Management of Diabetic Kidney Disease

The abstract highlighted a framework for deployment of kidneyintelX.dkd and precision medicine into a large integrated health system to achieve sustained population and patient level adoption, thereby eliciting personalised improvements in care management.

2. PO0331: Decision Impact Study of kidneyintelX.dkd on provider management and patient engagement in a community care practice environment

87% of patients reported improved understanding of their kidney risk and 98% found the kidneyintelX.dkd test helped in understanding their kidney and importance of overall health. 86% of physicians in this community setting reported the test result informed care management decisions.

3. PO0332: Comparison of kidneyintelX.dkd and KFRE for Predicting Progression of Diabetic Kidney Disease

The kidneyintelX.dkd test outperformed the Kidney Failure Risk Equation (KFRE) in predicting decline in kidney function or kidney failure in patients with DKD. The demonstrated improved discrimination and performance of kidneyintelX.dkd compared with the known variability in the KFRE routine clinical features, highlighted the utility of the kidneyintelX.dkd test, particularly in early stage disease.

Taken together, these data presentations reinforce the incremental and consistent value of the kidneyintelX.dkd test as a standard for precision medicine in CKD, and as a core element of integrated care management across multiple health care settings ultimately, driving significant improvements in patient care and health outcomes.

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About Renalytix (www.renalytix.com)

Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes. Renalytix has received FDA approval and Medicare reimbursement for kidneyintelX.dkd which is now offered commercially in the United States.

Unrecognized and uncontrolled kidney disease remains one of the largest barriers to controlling cost and suffering in the United States and the United Kingdom's medical system, affecting over 14 million and 8 million people, respectively. After five years of development and clinical validation, kidneyintelX.dkd is the only FDA-approved and Medicare reimbursed prognostic tool capable of understanding a patient's risk with kidney disease early where treatment has maximal effect. kidneyintelX.dkd is now being deployed across large physician group practices and health systems in select regions of the United States.

The over 15,000 patients that have been tested by kidneyintelX.dkd have produced a substantial body of real-world performance data. In patient populations where kidneyintelX.dkd has been deployed, a demonstrated and significant increase in diagnosis, prognosis, and treatment rates have been recorded. kidneyintelX.dkd now has full reimbursement established by Medicare, the largest insurance payer in the United States, at $950 per reportable result. kidneyintelX.dkd is also recommended for use in the international chronic kidney disease clinical guidelines (KDIGO).

KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to Renalytix AI, Inc. Mount Sinai faculty members are co-founders and equity owners in the Company. In addition, the Icahn School of Medicine at Mount Sinai has equity ownership in Renalytix. For information about the kidneyintelX,dkd test, visit kidneyintelx.com.

About A/Prof Brendon Neuen

Associate Professor Brendon Neuen is Program Lead, Renal and Metabolic at The George Institute for Global Health and a Staff Specialist Nephrologist and Director of Kidney Trials at Royal North Shore Hospital. He graduated in medicine at James Cook University with 1st Class Honours and an Academic Medal; completed a Masters in Global Health and Epidemiology from the University of Oxford; a PhD from the University of New South Wales; and a Postdoctoral Fellowship at Brigham and Women's Hospital, Harvard Medical School. He is a Fellow of the Royal Australasian College of Physicians and a Fellow of the American Society of Nephrology.

He is an internationally recognised expert on cardio-kidney-metabolic health and serves as the Secretariat (Co-Chair) of the SGLT2 Inhibitor Meta-Analysis Cardio-Renal Trialists' Consortium (www.SMART-C.net), which brings together data from over 90,000 patients from large-scale randomized trials to better understand the effects of this class of medicine in major patient groups. In addition, A/Prof Neuen is involved in the leadership of multiple ongoing international multi-centre randomized trials evaluating treatments to prevent kidney failure, cardiovascular events, or both. His work has directly informed more than 30 major international and national clinical practice guidelines, position papers and scientific statements which define best practice for the care of people with chronic kidney disease, including the Kidney Disease Improving Global Outcomes (KDIGO) Guidelines and the American Diabetes Association (ADA) Standards of Care.

A/Prof Neuen is the author of over 150 peer-reviewed publications in general medical journals including The Lancet, JAMA and Nature Medicine, and specialty journals including Lancet Diabetes and Endocrinology, Circulation, and the Journal of the American Society of Nephrology. He serves on the Editorial Boards of flagship journals of the American Society of Nephrology and European Renal Association. His work is supported by the National Health and Medical Research Council of Australia, New South Wales Health, the Ramaciotti Foundation, as well as philanthropic sources, and has been recognised through multiple awards, including the Royal Society of New South Wales Ida Browne Medal, and the American Heart Association's Paul Dudley White International Scholar Award.