Renalytix Reports Full Year Fiscal 2021 Results

October 21, 2021

Renalytix announced its results for the twelve months ended 30 June 2021. 

Highlights: 

Regulatory & Reimbursement 

• • Government-wide contract granted by the U.S. General Services Administration for KidneyIntelXTM testing services at $950 per reportable result; applies to more than 140 U.S. government departments, agencies, and affiliates including U.S. Veterans Administration (VA), Department of Defense military branches (Army, Navy, Air Force, and Marines), and Indian Health Services 
• • Accepted provider in 27 Medicaid state programs (including post-period approvals) with additional applications pending 
• • Ongoing process with Medicare Contractor organizations for Medicare local coverage 
• • Positive coverage determinations from 20 regional and local private health insurance payors to date including the first Blue Cross Blue Shield coverage contract and coverage with HealthFirst, one of New York State’s largest not-for-profit health insurance companies with over 1.5 million members 
• • Ongoing process with FDA towards anticipated De Novo marketing authorization under Breakthrough Device designation 
• • Full CLIA certification of Salt Lake City laboratory facility 

Commercial / Partnerships 

• • KidneyIntelX launched within the Mount Sinai Health System, validating the electronic health record (EHR) integrated care pathway; subsequent (post-period) volume scale-up announced 
• • Collaboration with AstraZeneca to develop and launch precision medicine strategies for cardiovascular, renal and metabolic diseases to potentially expand Renalytix’s portfolio 

Partnership with Atrium Health, Wake Forest Baptist Health and Wake Forest School of Medicine to implement advanced clinical care models to improve kidney health and reduce kidney disease progression and kidney failure; expected go-live testing starting in November 

• • Partnership with the University of Utah to implement KidneyIntelX and advanced clinical management care pathway to reduce the risk of kidney failure 
• • Collaboration with DaVita to enable first-of-its-kind program combining early risk assessment and comprehensive care management to improve early to late-stage patient outcomes and provide meaningful cost reductions for health care providers 
• • Exclusive option to license novel biomarkers with Joslin Diabetes Center, which could provide additional clinical utility for understanding early disease progression, risk of kidney failure, therapeutic response, and the mechanistic pathways of kidney disease beyond the markers that are currently captured by KidneyIntelX. 

Operations & Finance 

• • Senior leadership and management hires in preparation for expanded commercialization 
• • Achieved dual listing on Nasdaq Global Market and associated $85.1 million gross equity financing 
• • Completed spin-out of Verici Dx; shares in Verici were distributed to Renalytix shareholders, and Verici subsequently listed on the AIM market of the London Stock Exchange 
• • Cash and equivalents of $65.1 million at 30 June 2021 

Clinical / Validation 

• • Peer-reviewed publication in Diabetologia demonstrating KidneyIntelX more accurately predicted progressive kidney function decline and kidney failure in a multi-center, diverse cohort of 1,146 type 2 diabetes patients with early-stage (stages 1-3) kidney disease versus the current standard of care 
• • Data presented at World Congress of Nephrology (WCN) showing that the KidneyIntelX algorithm published in Diabetologia and currently deployed commercially accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS) with early-stage DKD (stages 1-3) 
• • Data presented at the American Diabetes Association (ADA) Annual Scientific meeting from the CANVAS trial demonstrating KidneyIntelX can be effective at monitoring therapeutic response and improvements in kidney health over time in adults with type 2 diabetes 
• • Peer-reviewed submission accepted by American Journal of Nephrology summarizing the aforementioned findings presented at the WCN and ADA from the analyses in the CANVAS clinical trial cohort. 

Post Period End 

• • Scale-up of Mount Sinai Health System KidneyIntelX population health care-navigated risk assessment program with a target run rate of 300 patient tests per week 
• • Launch program for KidneyIntelX initiated for Veterans Health Administration with target of 43 sales personnel plus supporting medical science liaison and technical infrastructure 
• • Achieved first Blue Cross Blue Shield private insurance coverage contract in October 2021 
• • Welcomed new board members Ann Berman and Daniel Levangie both with extensive backgrounds in healthcare company growth and finance 
• • Peer-reviewed publication in Journal of Medical Economics supporting payer coverage for early-stage risk assessment and care management in the primary care office; projecting significant savings from KidneyIntelX testing at primary care level. 

Investors are advised to read the results for the 12 months ended 30 June 2021, which have been filed with the U.S. Securities and Exchange Commission under Form 20-F concurrently with this results announcement. 

Analyst Conference Call 

The Company will hold an analyst conference call at 8:30 a.m. (EDT) / 1:30 p.m. (BST) on Thursday 21 October 2021. James McCullough, CEO and O. James Sterling, CFO will discuss the financial results and key topics including business strategy, partnerships and regulatory and reimbursement processes. 

Conference Call Details: US/Canada Participant Toll-Free Dial-In Number: (833) 614-1551 US/Canada Participant International Dial-In Number: (914) 987-7290 United Kingdom International Dial-In Number: 0800 0288 438 United Kingdom Local Dial-In Number: 0203 1070 289 Conference ID:6364722 

Webcast Registration link: https://edge.media-server.com/mmc/p/r4ezp7bk 

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Read the full report here »