Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company")

Middle East Distribution Agreement with Vector Pharma

Commercial availability of kidneyintelX.dkd™ expanded to an estimated

4 million DKD Patients in the Middle East

Distribution agreement opens kidneyintelX.dkd testing to address early-stage kidney disease in region with one of the highest incidence rates for type 2 diabetes globally

LONDON and SALT LAKE CITY, July 21, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces opening the commercial availability of kidneyintelX.dkd™ testing in Saudi Arabia, Bahrain, Qatar, Oman, Kuwait, and United Arab Emirates through a distribution agreement with Vector Pharma. Following the recent announcement of FDA marketing authorization for kidneyintelX.dkd, Renalytix will take advantage of select opportunities to expand testing services outside the US market with qualified distribution partners.

In the six markets of the Gulf Cooperation Council (GCC), the International Diabetes Federation (IDF) has reported high prevalence rates of diabetes, with more than 20% of the population being diabetic and more than 15% being pre-diabetic in most GCC countries. These are among the highest reported incidence rates for diabetes globally1. Chronic kidney disease (CKD) is a significant complication of type 2 diabetes (T2D) in this region. An estimated 58% of individuals with T2D develop CKD, which concurrently increases the risk of heart failure and myocardial infarction2.

The agreement with Vector Pharma brings established distribution and market access capabilities with a strong GCC footprint. Vector Pharma will initially focus on building awareness and driving adoption to achieve specified annual sales targets by territory with kidneyintelX.dkd.

"As in the United States, patient care for early-stage diabetes and kidney disease is in the hands of primary care clinicians," said Tom McLain, President, Renalytix. "Traditional laboratory distributors do not call on primary care practices. Our partnership with Vector Pharma, a pharmaceutical distributor with proven access and contacts in primary care, will accelerate efforts to introduce kidneyintelX.dkd and expand test adoption."

Vector Pharma Chief Executive Officer, Patrick Jordan, commented: "When you consider the markets in the Middle East are experiencing high rates of T2D and CKD, diabetic kidney disease management has become a core tenet of many Ministries of Health in the GCC. Being able to introduce kidneyintelX.dkd™ to complement the current care protocols will not only benefit the management of individual patients, but it will also address significant objectives to improve chronic disease diagnosis and treatment for the healthcare ecosystem as a whole."

Notes

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6047189/;

https://diabetesatlas.org/idfawp/resource-files/2021/11/IDF-Atlas-Factsheet-2021_MENA.pdf

2 https://onlinelibrary.wiley.com/doi/10.1111/1753-0407.13266

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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 38 million people, 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.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 Type 2 Diabetes

More than 37 million Americans have diabetes (about 1 in 10), 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 disease2. Type 2 diabetes symptoms often develop over several years and approximately 23% of adults with type 2 diabetes are undiagnosed3. 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.

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/diabetes/basics/type2.html

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

4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/

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 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 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.