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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, 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, 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 population¹. 

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 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.

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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 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.