Renalytix plc

Highlights include:

•

KidneyIntelX included as only biomarker test for prognostic risk assessment in landmark update of international clinical practice guidelines (https://kdigo.org/guidelines/)

•

Medicare Local Coverage Determination draft issued for FDA-authorized kidneyintelX.dkd by Medicare contractor National Government Services (NGS) with final issuance expected in the near term

•

Formal launch of the FDA-authorized kidneyintelX.dkd in April 2024

•

Customer experience improvements implemented including simplified physician order requisition, increased patient access to national blood draw network, revamped marketing and education materials

•

New primary care sales force completed its first quarter of operations with a 33% quarter over quarter increase in independent primary care physician test order volume during the three months ended March 31, 2024

•

Appointed Howard Doran to president concurrent with organizational changes to focus to accelerating sales and marketing of FDA-authorized kidneyintelX.dkd test

•

Formal strategic sale process initiated with multiple potential acquirers now in discussions

•

Completed common stock equity financings raising aggregate gross proceeds of $13.5 million (including post-period activity)

•

Continued operating expense reduction with 50% year-over-year reduction in head count and approximately 40% total lower operating costs

•

With FDA and clinical guidelines achieved, process initiated for potential ex-U.S. partners to improve non-dilutive company cash position and expand incremental sales opportunities

•

U.S. government added the FDA-authorized kidneyintelX.dkd to 10-year Government-wide Acquisition Contract (GWAC) at a price of $950 per reportable result. The contract covers tests provided by any government healthcare facility

•

Total volume of 806 tests during the quarter, of which 82% were billable