REG - Renalytix PLC - AGM Statement

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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 (http://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 or renalytix@walbrookpr.com
                            (mailto:renalytix@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 (http://kidneyintelx.com/) .

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