Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company")

AGM Statement

LONDON and NEW YORK, 19 December 2024 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), which is commercialising the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment for chronic kidney disease, provides an update to shareholders ahead of its Annual General Meeting ("AGM") today at 6 Stratton Street Mayfair, London W1J 8LD at 11.00 (GMT).

AGM Statement from Julian Baines, Executive Chairman

I am pleased to provide an update to shareholders following our successful £11.8m funding round last month, and the refocusing of the business to deliver scalable commercial revenues with a significantly reduced cost base.

We have commercialized, kidneyintelX.dkd, the first insured, FDA approved advanced prognostic test for progressive kidney disease, one of the leading causes of chronic disease cost and suffering globally. In June, we crossed the major milestone of achieving full Medicare reimbursement at $950 per test, which provides insurance payment for over half of our US addressable patient market. KidneyintelX.dkd is recommended in the international clinical care guidelines, and is now commercially available to around 14 million US diabetic kidney disease patients.

Our new commercial strategy is working and we are delivering growth from our Direct-to-Doctor sales force and our hospital systems partners through electronic health record integration. Electronic health record Integration is a powerful model which automatically alerts doctors to patients who are eligible for kidneyintelX.dkd. We have clear evidence that this approach provides significant leverage to our on-ground sales force and supports busy doctors for repeated testing of new patients in need. The benefits of this integrated approach were proved again with the onboarding of a large New York-based primary care network on board in September.

As expected, our sales representative productivity continues to improve with the current ratio of average tests ordered per month per sales representative at record levels. The need to urgently address the burden of chronic disease within the US health care system continues to resonate with front-line doctors making critical choices for diabetes and kidney disease patients and our conversations with additional large group practices are encouraging, and we expect to update shareholders regarding further new adopters in 2025.

We remain on target to significantly reduce cash burn by June 2025, and we remain confident that continued growth will deliver our estimated $3.2m revenue target for the year ended June 2025. We also remain steadfast in aligning management and shareholder interests through performance related long-term incentive plans and management market share purchases during open periods. Our goal remains that of delivering significant value to our fellow shareholders. Thank you for your support and confidence.

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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).