Renalytix plc

("Renalytix" or the "Company")

Late Breaking KidneyIntelX data shows care impact  

Data released at National Kidney Foundation Spring Clinical Meeting

LONDON and NEW YORK, 16 April 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a precision medicine company with lead testing service kidneyintelX.dkd, the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment in chronic kidney disease, notes the publication of an abstract entitled: "Impact of KidneyIntelX on Targeted Use of SGLT2i".

The Late Breaking study describes how researchers assessed the increase in prescription rates of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in response to KidneyIntelX testing, and for the first time, compared this increase to a control population who did not receive the KidneyIntelX test but were treated in the same health system over the same time period and were eligible  for testing.

James McCullough, CEO of Renalytix, commented: "This new data continues to demonstrate the powerful utility of KidneyIntelX to drive changes in care for patients who need it most. It is notable that almost 70% of patients in this study are treated at primary care and demonstrates that in the absence of clear and early risk assessment, the opportunity to change the course of disease can be lost resulting in catastrophic outcomes for patients."

The authors report that risk assessment for DKD progression with KidneyIntelX not only resulted in increased use of SGLT2i but importantly, that increase was targeted to those patients at moderate or high-risk of progression. Conversely, new use of SGLT2i in the control group was not optimised for kidney health with the lowest increase observed in patients subsequently identified as high risk. 

The presented data also highlights how patients identified as low risk by KidneyIntelX do not appear to benefit from SGLT2i treatment for kidney health protection while patients in moderate and high-risk groups benefit most from early and targeted intervention.

The lead author is Joji Tokita, MD, from the Icahn School of Medicine Mount Sinai, New York, and was presented at the National Kidney Foundation Spring Clinical Meetings in Boston, MA on 10-13 April 2025. The full abstract and data can be viewed here:

https://cme.kidney.org/spa/app/resource/r649-2025-spring-clinical-meetings/event/home/posters/abstracts?abstractId=7683

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018.

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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.