Steno Diabetes Center (Copenhagen) Collaboration

Renalytix and Steno Diabetes Center Announce Precision Medicine Collaboration Marking First Expansion for KidneyIntelX Platform Beyond US

LONDON and NEW YORK, July 11, 2024 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, announces a collaboration with the Steno Diabetes Center ('Steno'), Copenhagen, to advance translation of precision medicine solutions for patients with Diabetes and Chronic Kidney Disease (DKD). The initial focus of the collaboration will be on developing a roadmap for implementation of KidneyIntelX at the Steno Diabetes Center and affiliated practices.

Through this collaboration Renalytix and Steno will investigate core elements necessary for successful clinical translation of KidneyIntelX in a European context, beginning with integration of the biomarker testing into laboratory workflows, education of clinicians and patients on the role of KidneyIntelX risk assessment in the continuum of care and, leveraging of electronic health record systems for efficient, risk-based care management. Importantly, this is expected to launch the first use of Renalytix's KidneyIntelX platform outside the US to showcase the clinical utility in the EU by utilizing advanced technology to provide better informed care for solving chronic kidney disease.

Professor Peter Rossing, Senior Principal Investigator at the Steno Diabetes Center said: "The availability of multiple proven therapies in recent years to slow or prevent kidney function decline in patients with diabetes presents us with an opportunity to significantly reduce the suffering of patients. Access to biomarker-based, precision medicine tools such as KidneyIntelX in clinical practice will be critical in ensuring individual patients receive the right treatment as early as possible in the disease cycle."

Steno Diabetes Center Copenhagen, which offers tailored diabetes treatment for people with diabetes, has been at the forefront of innovation in diabetes care since its inception and has been proclaimed by the World Economic Forum to be a world-leading role model from which other countries and healthcare systems can learn.

• Frederik Persson, Head of Clinic at Steno Diabetes Center added: "At Steno, we recognize the importance of bridging the translation gap for novel technologies to clinical practice so that our patients and providers have access they need for optimized care and outcomes. We look forward to working with Renalytix in introducing the FDA approved KidneyIntelX test to patients in our practices and beyond."

Additional elements to be addressed include requirements for CE marking in the EU under the In-Vitro Diagnostic Regulation, clinical utility data, cost effectiveness analysis and, ultimately, clinical adoption in accordance with national and international clinical guidelines. The outputs of the collaboration will contribute to defining a framework for implementation of precision medicine solutions based on novel biomarkers in clinical practice, including helping to define requirements for future product development of tests by Renalytix to predict and monitor therapeutic response in DKD.

Fergus Fleming, CTO of Renalytix commented: "We welcome the opportunity to work with such a prestigious team at Steno Diabetes Center as we seek to expand access to KidneyIntelX and the promise of precision medicine to patients in Europe and other territories internationally. The insights gained from this collaboration will be pivotal in informing our commercialization and product development activities in the US and abroad."

Renalytix and Steno are partners in PRIME-CKD (https://www.prime-ckd.com/), funded by the European Union Research and Innovation programme, advancing personalized drug treatment in patients with CKD.

Steno Diabetes Center

Steno Diabetes Center Copenhagen is an internationally leading diabetes hospital, established in 1932. Steno Diabetes Center Copenhagen is based in Greater Copenhagen, as a public-private partnership between the Capital Region of Denmark and the Novo Nordisk Foundation, which is supported by a donation of 0,4 billion Euro from Novo Nordisk Foundation the Novo Nordisk Foundation. Steno Diabetes Center Copenhagen's purpose is not only to improve the quality of the diabetes treatment in the Capital Region, but also nationally and globally to contribute to the development of new models for a value-based healthcare system. Steno Diabetes Center Copenhagen is Scandinavia's largest diabetes hospital.