US Patent Office Allows Patent Claims for IP

LONDON and SALT LAKE CITY - October 6, 2023 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX), the first company to commercialize an FDA authorized artificial intelligence (AI) enabled blood test to assess risk of progressive kidney function decline for individuals with type 2 diabetes and early-stage chronic kidney disease, announces that the US Patent Office has issued a new notice of allowance of claims surrounding the biomarkers sTNFR1 and sTNFR2 used in the kidneyintelX.dkd test. These claims were filed under US Patent Application No. 16/671.256 by the Joslin Diabetes Center and this patent is exclusively licensed to Renalytix. KidneyintelX.dkd received Food and Drug Administration de Novo marketing authorization on June 29, 2023.

The newly allowed claims further strengthen the core intellectual property underpinning the KidneyIntelX technology by directly incorporating sTNFR1 and sTNFR2 into a set of consolidated claims directed towards identifying risk of early kidney function decline, thereby enabling therapeutic strategies for those at increased risk of progressive decline.

The Company believes this development reflects the Renalytix strategy of innovation in biomarker research, development and translation in collaboration with the Joslin Diabetes Center and other leading research partners globally. When taken together with other key milestones, such as FDA De Novo marketing authorization, broad insurance coverage and published clinical utility and outcomes data, Renalytix believes this increases its competitive advantage. The Company also believes this creates further barriers to entry in the large addressable market for optimizing clinical management of kidney disease to drive improved patient outcomes. A similar strategy to protect Renalytix's intellectual property is being pursued in Europe, which also presents a large opportunity for KidneyIntelX expansion.

About Type 2 Diabetes

Sources

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/