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Renalytix plc

("Renalytix" or the "Company")

Key regulatory milestones achieved in support of scaling of kidneyintelX.dkd

·      New laboratory enables 3.5x increase in testing volumes at reduced operating cost

·      Submission of Technical Review for the CE marking of kidneyintelX.dkd completed

LONDON and NEW YORK, 22 April 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 successful completion of the transfer of laboratory operations to a state of the art facility in New York.

The new facility significantly enhances operational capability, increasing testing capacity by more than 3.5x and providing a scalable infrastructure to support growth to in excess of 100,000 tests per annum. This expanded capacity positions the Company to efficiently meet growing demand and support broader commercial adoption. Execution of the transfer included comprehensive analytical validation of the kidneyintelX.dkd assay and regulatory inspection of the facility by the New York State Department of Health.

The transition also delivers immediate cost efficiencies, materially reducing the Company's fixed cost base in the near term, with the potential to generate substantial longer-term value with expected cost savings of over $2.6 million on a net present value basis over five years. The reduced cost base is expected to deliver immediate gross margin gains and drive meaningful operating leverage as testing volumes scale.

Additionally, the Company announces that it has completed, to schedule, the submission for CE marking of the technical file for kidneyintelX.dkd.  As previously announced, achievement of CE marking is a core strategy to enable use of kidneyintelX.dkd in global pharma clinical trials while at the same time, enabling commercialisation of kidneyintelX.dkd in certain European markets. The Company expects to finalise the CE marking process in Q3 2026 with initial testing of patients and data generation from the Steno Diabetes Center expected in Q4 2026 and expanding to services revenue generating testing at multiple sites in 2027.

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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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