Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company")

KidneyIntelX™ Clinical Decision Impact / Validation and Health Economic Data to be Presented at Upcoming Scientific Conferences

Four new data presentations, including late breaking clinical study data, underscores the value of KidneyIntelX testing in helping slow progression of chronic kidney disease in type 2 diabetes patients

LONDON and SALT LAKE CITY, June 15, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced that three scientific abstracts have been accepted at the upcoming American Diabetes Association 83rd Scientific Sessions (June 23-26, 2023) in San Diego, California and another abstract has been accepted at the American Association of Nurse Practitioners National Conference (June 20-25, 2023) in New Orleans, Louisiana.

Accepted abstracts reflect the growing body of scientific evidence demonstrating the important role KidneyIntelX serves towards advancing patient care and awareness for early-stage diabetic kidney disease. The presentations at the American Diabetes Association 83rd Scientific Sessions meeting include late-breaking data from a multi-year real-world evidence study, extended validation of KidneyIntelX, and a cost-effectiveness analysis addressing economic benefit in the VA population. In addition to multiple data presentations, Renalytix will be hosting three medical education events covering real-world evidence data unveiled at the conference so that clinicians may discuss and engage with the Renalytix leadership team as well as their peers in nephrology, endocrinology, and primary care providers.

American Diabetes Association 83rd Scientific Sessions presentations will be displayed over three days June 24-26, 2023, and moderated at the specified times below. Presentations related to KidneyIntelX will also be published on the journal Diabetes® website.

KidneyIntelX is a blood test that assesses risk for rapid progressive decline in kidney function and is intended for use in adult patients with type 2 diabetes and early-stage CKD (stage 1-3). The KidneyIntelX risk score can assist clinicians, including primary care providers and endocrinologists, in guiding resource utilization, prescription of new therapeutic agents and improve efficiency of care among physicians. For more information about Renalytix hosted medical education events while at the 83rd Scientific Sessions of the American Diabetes Association, please email info@renalytix.com.

For further information, please contact:

About Kidney Disease

Kidney disease is a public health epidemic affecting over 850 million people globally.1 The Centers for Disease Control and Prevention estimates that 15% of U.S. adults, or over 37 million people2, have chronic kidney disease (CKD). Nearly 95% of people with CKD are in early stages 1-33. Despite its magnitude, early-stage (1-3) CKD is underdiagnosed and undertreated, largely because it's asymptomatic at this time in the disease. As many as 9 in 10 adults with CKD, and 2 in 5 adults with severe CKD do not know they have the condition.3

About Renalytix

Renalytix (NASDAQ: RNLX) (LSE: RENX) is an in-vitro diagnostics and laboratory services company that is the global founder and leader in the new field of bioprognosis™ for kidney health. The leadership team, with a combined 200+ years of healthcare and in-vitro diagnostic experience, has designed its KidneyIntelX laboratory developed test to enable risk assessment for rapid progressive decline in kidney function in adult patients with T2D and early CKD (stages 1-3). We believe that by understanding how disease will progress, patients and providers can take action early to improve outcomes and reduce overall health system costs. For more information, visit www.renalytix.com.

About KidneyIntelX™

KidneyIntelX™ is a laboratory developed test demonstrated to be a reliable, bioprognostic™ methodology that yields a simple-to-understand, custom risk score, enabling prediction of which adult patients with T2D and early CKD (stages 1-3) are at low, intermediate or high risk for rapid progressive decline in kidney function. By combining information from KidneyIntelX with newer cardio- and reno-protective therapies, doctors will have more information in determining which patients are at higher versus lower risk for rapid disease progression and may be able to more appropriately target resources and guideline-recommended treatments to advance kidney health. KidneyIntelX is supported by a growing body of clinical, utility and health economic studies (including a validation study of two large cohorts) and has a demonstrated a 72% improvement in predicting those patients who are at high risk for rapid progressive decline in kidney function versus the current standard of care (eGFR and UACR). KidneyIntelX has received Breakthrough Device Designation from the U.S. Food and Drug Administration and Renalytix has submitted for De Novo marketing authorization. To learn more about KidneyIntelX and review the evidence, visit www.kidneyintelx.com.

KidneyIntelX, is a commercially available, New York State Department of Health approved predictive test that combines patient information and biomarker results. KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to Renalytix. Mount Sinai faculty and Mount Sinai have equity ownership in Renalytix. 

Sources

1 https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/2 https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html3 https://www.cdc.gov/kidneydisease/basics.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 impact KidneyIntelX can have on patients' enhanced understanding of kidney disease and motivation to make lifestyle changes, the potential for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether and to what extent 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, address systemic inequalities 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 31, 2022, 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.