Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company") 

Renalytix Appoints Daniel J. Levangie to its Board of Directors

Levangie brings extensive commercial operating experience to Renalytix, served on boards of Exact Sciences, Insulet Corporation and Hologic

NEW YORK and SALT LAKE CITY, August 30, 2021 - Renalytix Plc (NASDAQ: RNLX) (LSE: RENX) announces the appointment of Daniel J. Levangie to the Company's board of directors. Mr. Levangie is also appointed as a member of the Company's remuneration committee.

Mr. Levangie is an experienced executive and long-serving board director in the diagnostics and medical devices industry. He is co-founder and manager of ATON Partners, a private investment firm, and president and CEO of CereVasc, LLC, a medical device company. He also has served on the board of directors of Exact Sciences Corporation (NASDAQ: EXAS) since 2010. From 2013 through January 2017, Mr. Levangie served as president of Insulet Drug Delivery Systems and served as a lead director of Insulet Corporation. From 2011 through 2013, Mr. Levangie was chief executive officer of Dune Medical Devices, Inc., and co-founder and managing partner of Constitution Medical Investors, Inc., a Boston-based private investment and product development firm acquired by Roche Diagnostics Corporation in 2013. Previously, Mr. Levangie held executive management positions with Cytyc Corporation including executive vice president and chief operating officer, chief executive officer and president until the acquisition of Cytyc by Hologic, in 2007. He served on the board of Hologic from 2007 to 2009.

"Dan brings extensive commercial experience to Renalytix as we begin implementing our KidneyIntelX national marketing strategy to over 200,000 primary care physicians treating an estimated 12 million diabetic kidney disease patients insured by the Government Services Administration, Medicare and Medicare Advantage programs," said James McCullough, CEO, Renalytix. "He has set a standard for broad-scale up of impactful diagnostic products in the oncology and diabetes markets that will be core to the Renalytix strategy."

"I'm excited to join the Renalytix team as we bring this important innovation to the market. To be involved in the early commercial scale up and execution of the Renalytix national marketing strategy will be a major step forward for the company and for early-stage patients at risk of future kidney failure, where we can have the greatest impact on improving outcomes and reducing costs. We intend to have a significant impact on the course of the disease of these patients," said Mr. Levangie.

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AIM Rule Regulatory Disclosures

In accordance with Schedule 2(g) of the AIM Rules, Daniel Joseph Levangie (aged 71) holds or has held in the past 5 years the following directorships and partnerships:

Save for the disclosures above, there are no further disclosures to be made in accordance with AIM Rule 17 and Schedule 2(g) of the AIM Rules.

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.

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

About KidneyIntelXTM

KidneyIntelX, is a first-of-kind, platform that employs a proprietary artificial intelligence-enabled algorithm to combine diverse data inputs, including validated blood-based biomarkers, inherited genetics, and personalized patient data from electronic health record, or EHR, systems, to generate a unique patient risk score. This patient risk score enables prediction of progressive kidney function decline in chronic kidney disease, or CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.

About Renalytix

Renalytix (LSE: RENX) (NASDAQ: RNLX) is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company's lead product is KidneyIntelX, which has been granted Breakthrough Designation by the U.S. Food and Drug Administration and which 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.

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 28, 2020, 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.

Sources

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