AGM Statement

Renalytix

09/12/2025 07:00

RNS Number : 7296K

Renalytix PLC

09 December 2025

 

Renalytix plc

("Renalytix" or the "Company")

 

AGM Statement

 

LONDON and NEW YORK, 9 December 2025 - 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, provides an update to shareholders ahead of its Annual General Meeting ("AGM") today at 6 Stratton Street Mayfair, London W1J 8LD at 10.00 (GMT).

 

AGM Statement from Julian Baines, Executive Chairman

I am very pleased to provide a short update for shareholders ahead of our AGM today as we continue to work towards wider adoption of the KidneyintelX.dkd test, the first FDA-approved advanced prognostic blood test with Medicare reimbursement coverage, to identify those at-risk of progressive kidney disease and allowing early interventions to improve outcomes and reduce high costs associated with chronic disease management.

 

We have made good progress in increasing testing volumes across the four target states where we have direct presence: Florida, Texas, New York, and more recently Arizona. In the new financial year we recorded our first revenues from Arizona, including tests ordered by one of the largest nephrology practices in the United States.

 

Whilst this is encouraging, our main growth strategy is to deliver significant testing volume ramp-up through business development initiatives with important strategic partnerships that can target adoption by larger health centres across the whole of the US. To this end, in mid-September we were delighted to secure a definitive agreement with NASDAQ listed Tempus AI Inc ("Tempus"), which has an established network of healthcare institutions already utilising its precision medicine solutions. We believe this collaboration will allow us to significantly expand patient and clinician access to kidneyintelX and we have been encouraged by our first few months of engagement. Engaging with large healthcare systems presents inherent challenges, particularly due to lengthy implementation and approval processes that are often outside of our direct control, but we are satisfied that with partnerships such as Tempus and MVP Health Care, this strategy will deliver long-term value for shareholders.

 

We have also narrowed an extensive list of potential partners for our next Electronic Health Record (EHR) integration and have made significant progress with several priority targets. These targets are large healthcare systems, which we expect to generate meaningful testing volumes and become key customers for years to come.

 

In parallel, we are increasingly utilising data analytics to identify physicians with a high population of eligible patients, as well as those where a higher prevalence of eligible patients is expected. This capability enables us to provide valuable and actionable insights to clinicians and practices, complementing the clinical value of our KidneyIntelX.dkd test, while ensuring our limited commercial resources are directed toward the highest-opportunity accounts.

 

Finally, we have commenced the transition to a new laboratory facility. This move is expected to significantly increase our testing capacity and deliver substantial operating cost savings over the next five years, supporting both growth and operational efficiency.

 

Looking ahead, the Company is focused on converting ongoing business development activity into contracted relationships, expanded EHR integrations, and growing testing volumes. While the timing of commercial outcomes-particularly with large healthcare systems-remains difficult to predict, the Board and management are confident that the foundations being put in place today position the Company well for sustainable revenue growth, increased operating leverage, and long-term value creation for shareholders.

The Company will issue a trading update for the six months to 31 December 2025 by the end of January 2026.

 

For further information, please contact:

 

Renalytix plc
www.renalytix.com
James McCullough, CEO
Via Walbrook PR
SP Angel Corporate Finance LLP (Nominated Adviser and Joint Broker)
Tel:+44 (0)20 3470 0470
Jeff Keating / David Hignell(Corporate Finance)
Vadim Alexandre (Corporate Broking)
Oberon Capital (Joint Broker)
Tel: +44 (0)20 3179 5300
Mike Seabrook / Nick Lovering
Walbrook PR Limited
Tel: +44 (0)20 7933 8780 orrenalytix@walbrookpr.com
Paul McManus / Alice Woodings
Mob: +44 (0)7980 541 893 / +44 (0)7407 804 654


 

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 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 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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