Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company")

Real world evidence study data published

· Landmark study of 2,470 patients across two U.S. health systems demonstrates sustained risk prognosis, improvements in kidney function, increases in guideline-directed therapy uptake, and measurable reduction in individual patient risk trajectories over 24 months

· No comparable risk assessment tool exists with FDA authorisation and Medicare reimbursement

LONDON and NEW YORK, 30 June 2026 - 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 the publication of results in the peer-reviewed medical journal, Diabetes, Obesity and Metabolism, from its most comprehensive real-world evidence (RWE) study to date for the Company's FDA-approved kidneyintelX.dkd test.

Spanning 2,470 patients with type 2 diabetes and early-stage chronic kidney disease (CKD) who were enrolled into the IRB-approved prospective study across two major U.S. health systems, Mount Sinai Health System in New York and Wake Forest/Atrium Health in North Carolina, reveals that kidneyintelX.dkd not only transforms how clinicians assess risk but changes the course of disease over a full two year period, a first for any kidney prognostic tool.

A LEAP BEYOND PRIOR EVIDENCE

The KidneyIntelX real-world evidence program has evolved from the six to 12 to 24-month time periods, demonstrating sustainable clinical improvements tied to how the test's risk stratification successfully informs guideline-directed medical treatment (GDMT).

· 6-Month RWE: Established that KidneyIntelX risk results changed clinician decision-making and GDMT in a real-world setting.

· 12-Month RWE: Confirmed that these changes in risk-stratified GDMT were associated with meaningful improvements in kidney, cardiac, and metabolic markers (eGFR slope, UACR, HbA1c, blood pressure).

· Just released 24-Month RWE data demonstrates that: (1) KidneyIntelX is a dynamic, longitudinal risk tool, not just a one-time test; (2) blood-based biomarkers strongly influence the changes in risk level, (3) robust independent prognostic performance in two contemporary care settings, and (4) significantly increased GDMT (e.g., SGLT2 inhibitors and GLP1 receptor agonists) use post-baseline risk assessment.

KEY TWO-YEAR DATA HIGHLIGHTS

Prior studies showed the KidneyIntelX test influenced clinical decisions and improved immediate markers of kidney health. The two-year analysis proves these improvements translate into real and lasting benefits for patients.

• 29% of patients who were retested moved into a lower risk category, accompanied by biomarker reductions.

• SGLT2 inhibitor use increased substantially across all risk groups over two years, reaching 56% in high-risk patients overall and soaring to 70% in high-risk patients at Mount Sinai. Combination SGLT2 inhibitor and GLP-1 receptor agonist therapy in high-risk patients nearly tripled, rising from 12% to 32% over the same period.

• Patients who started SGLT2i or GLP-1 RA therapies had nearly double the odds (OR 1.93) of achieving risk reduction - demonstrating a real-world link between treatment informed by kidneyintelX.dkd results and patient benefit.

• KidneyIntelX demonstrated powerful independent prognostic performance: patients designated as high risk at baseline were 10.4 times more likely to experience significant kidney function decline or kidney failure than low-risk patients, even after adjusting for standard clinical variables. No standard clinical combination - eGFR, UACR, HbA1c - has achieved risk separation of this magnitude.

• From baseline to 2 years, the rate of eGFR decline improved by 43%, UACR decreased by 23%, and HbA1c decreased by 7.6%, while systolic blood pressure remained stable across all risk groups.

Dr David Lam, Co-Principal Investigator Endocrinologist at Mount Sinai Health System commented: "These two-year data provide the clearest real-world picture yet of what risk stratification can do when applied consistently at scale in two large health systems. What we see is that a structured, biomarker-guided approach to prescribing translates into targeted therapy decisions - higher-risk patients receiving more intensive treatment, and lower-risk patients largely spared unnecessary escalation. That is what precision medicine is supposed to look like in practice."

Dr Joji Tokita, Co-Principal Investigator Nephrologist at Mount Sinai Health System said: "From a nephrology standpoint, what matters most is whether risk stratification translates into durable kidney protection - and that is what we are seeing here. The attenuation in eGFR decline rate sustained over two years, alongside reductions in UACR, reflects real change. The repeat testing data demonstrate nearly a third of high-risk patients moved to a lower risk category at one year, linked to measurable drops in KIM-1 and to initiation of therapy. This longitudinal signal helps nephrologists make care decisions and assess response to therapy."

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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 diabetic 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 approximately 15 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 diabetic 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.

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