REG - Renalytix PLC - H1 Trading update

RenalytixAnnouncement

11/02/2026 07:00

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RNS Number : 4996S  Renalytix PLC  11 February 2026

 

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Renalytix plc

("Renalytix" or the "Company")

 

H1 Trading update

 

LONDON and NEW YORK, 11 February 2026 - Renalytix plc (LSE: RENX) (OTCQB:
RNLXY), a precision medicine diagnostics company, whose product
kidneyintelX.dkd, is the only FDA-approved and Medicare-reimbursed prognostic
test to support early-stage risk assessment in chronic diabetic kidney
disease, provides a trading update for the six months ended 31 December 2025
("H1 FY26").

 

Current trading

·    H1 FY26 unaudited revenues of $1.6m and FY26 revenue guidance of $4m
to 30 June 2026 (up 33% YoY).

·    Three new integrations implemented in H1 FY26, compared to one in
FY25, with additional integrations expected in H2 FY26. Revenue acceleration
in H2 FY26 from recent integrations.

·    New large-scale hospital group integration, with an initial proposed
1,000 patient pilot in 2026, and potential to reach over 40,000 CKD patients.

 

Real World Evidence Study

·    Renalytix is advancing an innovative real-world evidence (RWE) study
designed to further validate and expand the clinical and economic utility of
kidneyintelX.dkd in kidney and cardiovascular disease management. The
programme is expected to generate unique outcomes data to support broader
clinical adoption, payer engagement, and strengthening the strategic
positioning of kidneyintelX.dkd within population health and value-based care
frameworks.

·    As part of this study, kidneyintelX.dkd is expected to be integrated
into up to five additional large healthcare organisations electronic medical
record (EMR) systems, which would expand automated patient identification and
testing access through deployment into routine clinical workflows.

·    To support the RWE study, Renalytix is also in discussion with larger
strategic partners regarding potential investment and/or logistics support,
reflecting external interest in the programme and its ability to drive
scalable clinical and commercial impact.

 

Trading update

H1 FY26 unaudited revenues were $1.6m. Revenue ramp-up during H1 FY26 was
slower than expected due to longer lead times and complexities with larger
healthcare system electronic medical record system (EMR) implementations.

 

As announced on 12 January 2026
(https://investors.renalytix.com/news-release/three-kidneyintelx-dkd-clinical-integrations/)
, three new US healthcare provider groups have now been integrated with EMR
test ordering capabilities, with an additional three integrations on boarding
 in the current quarter. This additional test distribution will contribute to
FY26 revenues during the second half of the financial year. FY26 full year
revenues are now expected to be circa $4.0m (FY25 $3.0m). The sales pipeline
that is currently being onboarded will significantly expand the EMR integrated
testing footprint of kidneyintelX.dkd in 2026 and provide multiple
opportunities with large healthcare systems in western and eastern United
States.

 

The Company is in implementation planning stage for a new large-scale
integration, with an initial proposed 1,000 patient pilot in 2026 at one of
the largest regional healthcare systems in the US.  When fully completed,
this has the potential to be one of the larger patient populations to have
access to kidneyintelX.dkd, which has full reimbursement by Medicare at $950
per reportable result. Further announcements regarding the integration and
pilot study will be made as soon as practicable.

 

Continued progress with Tempus AI Collaboration

Renalytix continues to make progress with Tempus AI, Inc. ("Tempus") to
advance EMR-integrated testing and data collection with other US healthcare
providers. A joint working group, established as part of the previously
announced collaboration with Tempus AI
(https://investors.renalytix.com/news-release/tempus-ai-inc-collaboration-agreement/)
, is discussing the value of  combining advanced AI enabled diagnostics
offering in kidney disease and cardiovascular disease. Renalytix believes this
represents a unique opportunity for the partnership to take a leadership
position in the Cardio-Kidney-Metabolic (CKM) health initiative, which affects
up to 80% of the diabetic kidney disease population(1).

 

Further operational improvements and cost savings

During H1 FY26, the Company activated the relocation of its laboratory
operations, with the new facility to become fully operational during H2 FY26.
This move should significantly increase testing capacity and deliver over $1m
of operating cost savings over the next five years, supporting both growth and
operational efficiency. The Company continues to focus on and implement cost
reduction initiatives and maintained a cash balance of approximately $6
million as of 31 December 2025.

 

Additional supportive data expected before financial year end

The Company continues to generate and publish data on the clinical and
operational value of kidneyintelX.dkd, including a recently announced
(https://www.londonstockexchange.com/news-article/RENX/pivotal-kidneyintelx-dkd-data-published/17322708)
manuscript in Diabetes Care. A major milestone has been reached with
finalization of the two-year clinical outcome data now being prepared for
submission for peer-reviewed publication. The public read-out of this is
anticipated before the end of the fiscal year and is expected to be an
important asset in supporting clinical adoption and informing national
commercial insurance payment coverage.

 

Renalytix anticipates providing an overview of the update in an online
presentation via Investor Meet Company and will provide details in due course.
The Company will announce its unaudited interim results for the six months
ended 31 December 2025 before the end of March 2026.

 

Notes

(1) Arnold SV, Kosiborod M, Wang J et a., Burden of cardio-renal-metabolic
conditions in adults with type 2 diabetes within the diabetes collaborative
registry. Diabetes. Obe Metab. 2018;20:2000-2003.

 

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 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 (http://kidneyintelx.com/) .

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