Renalytix Plc Regulatory News (RENX)

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN ARTICLE 7 OF MAR. THE PERSON RESPONSIBLE FOR ARRANGING THE RELEASE OF THIS ANNOUNCEMENT ON BEHALF OF RENALYTIX IS JAMES MCCULLOUGH, CEO.

Renalytix plc

("Renalytix" or the "Company")

Payer coverage expansion of KidneyIntelX

LONDON and SALT LAKE CITY - September 22, 2023 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX), the first company to commercialize an FDA approved artificial intelligence (AI) enabled prognostic blood test for individuals with type 2 diabetes and chronic kidney disease, discloses that it has signed a contract with BlueCross and BlueShield of Texas (BCBSTX), the largest statewide health care plan serving 7 million members in all 254 Texas counties, to expand insurance coverage of KidneyIntelX™ in the state of Texas.

In addition, Renalytix has executed a contract with Parkland Community Health Plan (PCHP), a Dallas based insurance plan with over 300,000 covered lives and service in seven counties, for insurance coverage of KidneyIntelX.

BlueCross and BlueShield Texas works with more than 140,000 physicians and healthcare practitioners, and 520 hospitals. The BlueCross and BlueShield of Texas agreement complements coverage already secured with several other Blues plans including Wellmark Blue Cross Blue Shield in Iowa and South Dakota (estimated 2.1 million covered lives), BlueCross BlueShield of Illinois (estimated 8.1 million covered lives) and CareFirst BlueCross BlueShield (estimated 3.4 million covered lives). The Company believes that achieving payer coverage with these large state-wide plans is a critical component to bringing the benefits of KidneyIntelX prognostic technology to large populations of adults with type 2 diabetes and early-stage kidney disease.

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About Chronic 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, more than 37 million people4, currently have chronic kidney disease (CKD). Diabetes is the leading cause of kidney failure, accounting for 44% of new cases. 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.5 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 Type 2 Diabetes

More than 37 million Americans have diabetes (about 1 in 10)1, and approximately 90-95% of them have type 2 diabetes. Type 2 diabetes most often develops in people over age 45, but more and more children, teens, and young adults are also developing the disease6. Type 2 diabetes symptoms often develop over several years and approximately 23% of adults with Type 2 Diabetes are undiagnosed7. Type 2 diabetes affects many major organs, including the heart, blood vessels, nerves, eyes and kidneys. Diabetic kidney disease develops in 30-50% of Type 2 diabetes patients4.

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 rapidly 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 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). To learn more about KidneyIntelX and review the evidence, visit www.kidneyintelx.com.

Sources

1. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/index.html

2. Gheith O, Farouk N, Nampoory N, et al. Diabetic kidney disease: worldwide difference of prevalence and risk factors. J Nephropharmacol. 2015 Oct 9;5(1):49-56. PMID:

28197499; PMCID: PMC5297507

3. Wu B, Bell K, Stanford A, et al. Understanding CKD among patients with T2DM: prevalence, temporal trends, and treatment patterns-NHANES 2007-2012. BMJ

4. https://www.cdc.gov/kidneydisease/basics.html

5. https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/

6. https://www.cdc.gov/diabetes/basics/type2.html

7. https://www.cdc.gov/diabetes/data/statistics-report/index.html

Forward Looking Statements

Statements contained in this Current Report on Form 8-K 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 commercial prospects of KidneyIntelX and kidneyintelX.dkd, including whether KidneyIntelX and kidneyintelX.dkd will be successfully adopted by physicians, inform clinical guidelines, achieve expanded insurance coverage and be successfully distributed and marketed, the potential for KidneyIntelX and kidneyintelX.dkd to be expanded and approved for additional indications and in additional jurisdictions, our expectations regarding reimbursement decisions and the ability of KidneyIntelX and kidneyintelX.dkd 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 and kidneyintelX.dkd are 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 Current Report on Form 8-K 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.