Announcement • Jun 30
Renalytix Publishes Real World Evidence Study Data For KidneyintelX.dkd Test Renalytix plc announced the publication of results in the peer-reviewed medical journal, Diabetes, Obesity and Metabolism, from its most comprehensive real-world evidence (RWE) study to date for the Company's FDA-approved kidneyintelX.dkd test. Spanning 2,470 patients with type 2 diabetes and early-stage chronic kidney disease (CKD) who were enrolled into the IRB-approved prospective study across two major U.S. health systems, Mount Sinai Health System in New York and Wake Forest/Atrium Health in North Carolina, reveals that kidneyintelX.dkd not only transforms how clinicians assess risk but changes the course of disease over a full two year period, a first for any kidney prognostic tool. The KidneyIntelX real-world evidence program has evolved from the six to 12 to 24-month time periods, demonstrating sustainable clinical improvements tied to how the test's risk stratification successfully informs guideline-directed medical treatment (GDMT). 6-Month RWE: Established that KidneyIntelX risk results changed clinician decision-making and GDMT in a real-world setting. 12-Month RWE: Confirmed that these changes in risk-stratified GDMT were associated with meaningful improvements in kidney, cardiac, and metabolic markers (eGFR slope, UACR, HbA1c, blood pressure). Just released 24-Month RWE data demonstrates that: (1) KidneyIntelX is a dynamic, longitudinal risk tool, not just a one-time test; (2) blood-based biomarkers strongly influence the changes in risk level, (3) robust independent prognostic performance in two contemporary care settings, and (4) significantly increased GDMT (e.g., SGLT2 inhibitors and GLP1 receptor agonists) use post-baseline risk assessment. Prior studies showed the KidneyIntelX test influenced clinical decisions and improved immediate markers of kidney health. The two-year analysis proves these improvements translate into real and lasting benefits for patients. 29% of patients who were retested moved into a lower risk category, accompanied by biomarker reductions. SGLT2 inhibitor use increased substantially across all risk groups over two years, reaching 56% in high-risk patients overall and soaring to 70% in high-risk patients at Mount Sinai. Combination SGLT2 inhibitor and GLP-1 receptor agonist therapy in high-risk patients nearly tripled, rising from 12% to 32% over the same period. Patients who started SGLT2i or GLP-1 RA therapies had nearly double the odds (OR 1.93) of achieving risk reduction - demonstrating a real-world link between treatment informed by kidneyintelX.dkd results and patient benefit. KidneyIntelX demonstrated powerful independent prognostic performance: patients designated as high risk at baseline were 10.4 times more likely to experience significant kidney function decline or kidney failure than low-risk patients, even after adjusting for standard clinical variables. No standard clinical combination - eGFR, UACR, HbA1c - has achieved risk separation of this magnitude. From baseline to 2 years, the rate of eGFR decline improved by 43%, UACR decreased by 23%, and HbA1c decreased by 7.6%, while systolic blood pressure remained stable across all risk groups. 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). Announcement • Feb 12
Renalytix Plc Provides Earnings Guidance for the Year 2026 Renalytix Plc provided earnings guidance for the year 2026. For the year, company expected revenues are now expected to be circa $4.0 Million (FY25 $3.0 Million). 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. Announcement • Jan 12
Renalytix plc Completes Three Additional Health Care Provider Clinical Integrations in United States Renalytix plc with kidney IntelX.dkd announced that during the last quarter of 2025 it successfully completed three additional health care provider clinical integrations in the United States. Initial testing volumes have now commenced across all sites. The Company continues to expand its electronic health care integrated testing with one-click ordering for ease of physician use. The integrations were completed with Joseph P. Addabbo Family Health Center in New York, Central Florida Kidney Specialists in Florida and The Kidney Experts PLLC in Tennessee. All three sites are established regional kidney care providers and the integrations were implemented directly by Renalytix. These integrations enable the use of Renalytix's kidney disease testing solutions within each practice's existing clinical workflow. While each practice currently represents modest initial testing volumes, the Company anticipates growing utilisation over time as adoption expands across their respective patient populations. Renalytix continues to focus on disciplined expansion of its clinical footprint and expects to complete additional integrations with healthcare providers in early calendar year 2026. The Company believes this measured approach supports scalable growth in test utilisation, while maintaining efficient deployment of internal resources. The company continues to work closely with Tempus AI Inc. to advance electronic health record integrated testing and data collection with major US healthcare providers in alignment with its longer-term goal of data-driven kidney disease solutions. personnel from Tempus and Renalytix has been working closely together since this key collaboration was announced in September 2025, to target the healthcare customers integrated with Tempus that have large, costly populations of diabetes and kidney disease patients. The collaboration with Tempus will support the development of solutions to enable future expansion into additional clinical and geographic markets over time. The conference is attended by a broad range of healthcare and life sciences companies, including data and diagnostics partners such as Tempus. The Company looks forward to updating investors on progress, corporate development and trading in February 2026. Announcement • Nov 19
Renalytix plc Announces the Publication of Pivotal New Data in Diabetes Care Renalytix plc announced the publication of pivotal new data in Diabetes Care, the top-ranked global diabetes journal of the American Diabetes Association. The published manuscript, "Baseline Risk and Longitudinal Changes in kidney IntelX.dkd and Its Association with Kidney Outcomes in the CANVAS and CREDENCE Trials," was authored by leading nephrology and metabolism experts from the US, Europe, and Australia. The study evaluated 2,954 patients from the landmark CANVAS and CREDence trials--representing the full intended-use population for kidney IntelX.dkd. Improved CKD risk prediction: kidney IntelX.dkd significantly enhanced risk stratification across all KDIGO guidance categories, delivering more accurate assessment of CKD progression risk and potential kidney failure. Actionable treatment guidance: Among patients classified as moderate or high risk, those treated with frontline SGLT2 inhibitors showed a significant reduction in kidney IntelX.dkD risk levels at one year, with high-risk patients twice as likely to show risk improvement compared with untreated patients. The authors concluded that kidney IntelX.dkd, and its novel kidney biomarkers, enables clinicians to identify patients most likely to benefit from therapy, supporting personalized risk-based care and offering a powerful tool for future clinical trials. Across clinical trials, real-world deployment, and head-to-head performance comparisons, kidney IntelX.dkd continues to show consistent, incremental value as a core component of precision medicine in CKD. These results support its role as a transformative tool in integrated care management--ult ultimately driving significant improvements in patient and health outcomes. Announcement • Nov 06
Renalytix Plc, Annual General Meeting, Dec 09, 2025 Renalytix Plc, Annual General Meeting, Dec 09, 2025. Location: 6 stratton street mayfair, w1j 8ld, london United Kingdom Announcement • Sep 27
Renalytix Plc has completed a Follow-on Equity Offering in the amount of £0.8 million. Renalytix Plc has completed a Follow-on Equity Offering in the amount of £0.8 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 8,421,052
Price\Range: £0.095 
