Renalytix plc

("Renalytix" or the "Company")

Renalytix Convenes Expert Panel at VA Healthcare Summit

Leading clinicians discuss enabling long-term kidney health in Veterans with type 2 diabetes and early-stage chronic kidney disease

NEW YORK and SALT LAKE CITY, November 10, 2021 - In recognition of National Diabetes Month and concurrent with the launch of KidneyIntelX in the Veterans Health Administration health system, Renalytix (NASDAQ: RNLX) (LSE: RENX) convened a multidisciplinary panel to discuss advances in kidney health through early-stage prognosis and intervention of chronic kidney disease (CKD) in patients with type 2 diabetes. Clinical experts shared patient case studies drawing from their experience adding KidneyIntelX into clinical care. The KidneyIntelX enabled care pathway being implemented in the Mount Sinai Health System is a model that can be used in implementing the new Veterans Health Administration CKD Directive and joint VA and Department of Defense guideline, driving care earlier to prevent progression and kidney failure. The panel event took place at The Institute for Defense and Government Advancement (IDGA) VA Healthcare Summit on Wednesday, October 27, 2021.

The panel, "Breakthrough Diagnostic Approach for Type 2 Diabetes and Early-Stage Chronic Kidney Disease (CKD): Today's Precise Answer, Tomorrow's Kidney Health," included renowned thought leaders who highlighted the importance of early detection and intervention to promote long-term kidney health and improve clinical outcomes in their type 2 diabetes patients.  

Commenting on the Summit discussion, panelists said:

Michael J. Donovan, PhD, MD, Chief Medical Officer at Renalytix: "This roundtable discussion provided a unique opportunity for clinical experts to highlight the impact of KidneyIntelX risk assessment on patient-specific management decisions. Their remarks highlighted how KidneyIntelX testing can help address the challenges they face when relying on current clinical tools. The panel also reviewed the practice-changing evidence from recent therapeutic trials. The discussion underscored the importance of a systems approach to managing care for chronic kidney disease patients given the intimate association of cardiovascular and kidney function."

David Lam, MD, Assistant Professor of Medicine (Endocrinology, Diabetes and Bone Disease) at the Icahn School of Medicine at Mount Sinai and Medical Director at the Mount Sinai Clinical Diabetes Institute, NYC, NY: "As an endocrinologist, I see patients living with diabetes day in and day out. Diabetes care is a team effort. I co-manage diabetic patients with other trained professionals, all working towards the care of patients to help them thrive.  KidneyIntelX has helped me to identify patients with early-stage diabetic kidney disease earlier and has enabled me to deploy the right care path, direct care resources and provide treatment guidance based on my patients' risk level at the right time." 

Joseph Vassalotti, MD, FASN, Clinical Professor of Medicine (Nephrology) at Icahn Mount Sinai and Chief Medical Officer of the National Kidney Foundation, NYC, NY: "13.1 % of the US population has diabetes, most with type 2 diabetes, but about 40% also have low kidney function and/or increased albumin, a type of protein, in the urine.  Early risk stratification for these patients with kidney disease informs their care management. KidneyIntelX combines biomarkers and the data from the patients' health record, to produce a risk score that is easy to understand.  For patients, reviewing the results of that risk score helps motivate them to take additional action toward their kidney health that is proportional to the risk. As a nephrologist it helps me think about the types of lifestyle modification, patient engagement, medication management and interdisciplinary care that is optimal for my patients."

Katherine Tuttle, MD, FASN, FACP, FNKF, Professor of Medicine in Nephrology at the University of Washington, the Executive Director for Research at Providence Health Care, and a Co-Principal Investigator at the Institute for Translational Health Sciences: "KidneyIntelX leads into more effective therapeutic management which should lead to improved outcomes in a value-based system. For example, heart failure and chronic kidney disease occur concomitantly. If we reduce heart failure hospitalization by identifying and managing higher risk patients more effectively, that would be a huge savings to the health care system.  If we also prevent cases of kidney failure, and the costs associated with treating patients with kidney failure, we will realize enormous cost savings. The triangulation between diabetes, heart failure and chronic kidney disease accounts for one third of the Medicare budget and this cost is extensive in the veteran population as well."

As the largest integrated health care network in the United States, the U.S. Department of Veterans Affairs is tasked with providing care to America's Veterans. One in four veterans have diabetes and many have comorbid conditions including kidney disease. Renalytix is committed to promoting kidney health in veterans by aligning care models that proactively protect kidneys from avertable harm.

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About Kidney Disease

Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control and Prevention (CDC) estimates that 15% of US adults, or 37 million people, currently have chronic kidney disease (CKD). Further, the CDC reports that 9 out of 10 adults with CKD do not know they have it and one out of two people with very low kidney function who are not on dialysis do not know they have CKD.¹ Kidney disease is referred to as a "silent killer" because it often has no symptoms and can go undetected until a very advanced stage. Each year kidney disease kills more people than breast and prostate cancer. Every day, 13 patients in the United States die while waiting for a kidney transplant.

About KidneyIntelX

KidneyIntelX, is a first-of-kind solution that enables early-stage diabetic kidney diseases (DKD) progression risk assessment by combining diverse data inputs, including validated blood-based biomarkers, inherited genetics, and personalized patient data from electronic health record, or EHR, systems, and employs a proprietary algorithm to generate a unique patient risk score. This patient risk score enables prediction of progressive kidney function decline in CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.

About Renalytix

Renalytix (NASDAQ: RNLX) (LSE: RENX) is the global founder and leader in the new field of bioprognosis^TM for kidney health. The company has engineered a new solution that successfully enables early-stage chronic kidney disease, progression risk assessment. The Company's lead product, KidneyIntelX, has been granted Breakthrough Designation by the U.S. Food and Drug Administration and is designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery (visit www.kidneyintelx.com). For more information, visit www.renalytix.com.

KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to Renalytix, and is currently utilized in sponsored research by Renalytix at Mount Sinai. Mount Sinai and Mount Sinai faculty, including Dr. Steve Coca and Dr. Girish Nadkarni, have a financial interest in Renalytix. Mount Sinai has representation on the Renalytix Board of Directors.

Sources

1 https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html 

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential benefits, including economic savings, of KidneyIntelX, the potential for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, our expectations regarding reimbursement decisions and the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes. Words such as "anticipates," "believes," "estimates," "expects," "intends," "plans," "seeks," and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have only recently commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" section of our annual report on Form 20-F filed with the SEC on October 21, 2021, and other filings we make with the SEC from time to time. All information in this press release is as of the date of the release, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.