KidneyintelX.dkd data presented at ERA Congress

LONDON and NEW YORK, 17 June 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a precision medicine company with kidneyintelX.dkd, the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment in chronic kidney disease, announces that new pivotal data demonstrating how kidneyintelX.dkd enhances risk assessment over standard clinical measures alone thereby enabling more efficient treatment allocation, was presented at the prestigious European Renal Association Congress 2025 held in Vienna on 4-7 June.

The presentation titled "Evaluating KDIGO and KidneyintelX.dkd for Risk Stratification in Diabetic Kidney Disease: Insights from CANVAS and CREDENCE" was selected as one of the highest scoring abstracts for presentation.

The analysis included 2,954 subjects from the CANVAS and CREDENCE clinical trials who met the kidneyintelX.dkd intended use criteria and were randomized to treatment with SGLT2i or Placebo and followed for up to five years. The kidneyintelX.dkd risk level was assessed at baseline and at the one-year timepoint post randomization. Some of the key findings reported include:

• The kidneyintelX.dkd test reclassified 40% of patients to a different risk from baseline KDIGO risk levels category (e.g. from moderate to high/low, low to moderate, or high to moderate/low)
• Over the follow-up period, patients in the kidneyintelX.dkd high-risk level at baseline displayed a >20 times observed risk (after adjustment) compared to those classified as lowest risk by KDIGO
• Treatment with SGLT2i reduced the kidneyintelX.dkd levels significantly after one year compared to those not treated, with almost a 20% between group difference in the changes observed
• Patients who remained at high risk after one year had >4 times higher risk of events than those who were re-classified to moderate risk

Commenting on the newly presented data, Fergus Fleming, Chief Technology Officer, said: "The kidneyintelX.dkd data highlights the importance of implementation of risk assessment and adoption of novel therapies such as SGLT2 inhibitors in early-stage chronic kidney disease as reflected in the 2024 KDIGO guidelines. The data shows that by targeting care to patients at highest risk of progression, a significant reduction in risk can be achieved in the short-term leading to improved outcomes for patients in the long-term. We believe there is strong clinical support to accelerate the implementation of guideline directed care to prevent unnecessary patient suffering and healthcare cost, and kidneyintelX.dkd is ideally placed to enable this."

The data analysis and presentation were co-authored by Renalytix and the University Medical Center Groningen as part of the PRIME-CKD consortium (https://www.prime-ckd.com/). Additional insights from the analysis will be presented at the American Diabetes Association Scientific Sessions on 19-23 June highlighting how kidneyintelX.dkd should be considered for enriching clinical trials and assessing treatment response:

Abstract 420-P, Baseline Risk and Longitudinal Changes in kidneyintelX.dkd Scores and Their Association with Kidney Outcomes in the CANVAS and CREDENCE Trials, H.L. Heerspink et al

The complete analysis is being prepared for peer-reviewed publication later this year.