Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company")

Trading Update

LONDON and NEW YORK, 27 January 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), which is commercialising kidneyintelX.dkd, the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment for chronic kidney disease, provides an unaudited trading update for the six months ended 31 December 2024 ("H1 FY25") and confirmation that the Company remains on track to deliver against revenue and expense targets for the year ended June 2025.

The Company expects to report revenues for H1 FY25 of $1.3m relating to commercial sales of kidneyintelX.dkd. The Company remains on track to deliver against financial expectations for FY25 and FY26, which assume an average of 20% quarterly revenue testing volume growth.

The number of tests received from the Company's direct-to-doctor channel continued to rise significantly during the period, with the number of doctors ordering kidneyintelX.dkd totalling 142 at the end of H1 FY25. Sales representative productivity continued to improve with the number of average tests ordered per month per sales representative tripling over the last year reaching 24 in December 2024 (December 2023: 8).

The onboarding of a large New York-based primary care network in September has supported growth in H1 FY25 and provides confidence that this growth will continue in the second half. As confirmed in the Company's AGM statement, the Company expects further new adopters to come on board in 2025.

The Company is well financed following the successful £11.8m funding in November of 2024.

Renalytix expects to announce its unaudited results for H1 2025 in March 2025.

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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 10,000 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).