Renalytix Plc Stock

Renalytix plc (Renalytix) operates as an artificial intelligence-enabled in vitro diagnostics company.

The company focuses on optimizing clinical management of kidney disease to drive improved patient outcomes.

KidneyIntelX, the company's diagnostic platform, employs a proprietary artificial intelligence-enabled algorithm that combines diverse data inputs, including validated blood-based biomarkers, inherited genetics, and personalized patient data from EHR systems, to generate a unique patient risk score. Additionally, the company has successfully completed a statement of work with AstraZeneca Pharmaceuticals LP (AstraZeneca) to conduct a feasibility study to determine the impact of the use of the company's KidneyIntelX platform to optimize utilization of various CKD agents. As a result of the initial success with AstraZeneca the company plans to pursue further collaborations with pharmaceutical companies and make 'Pharmaceutical Services Revenue' a core part of the business going forward with the goal of improving guideline-based standard-of-care for optimal utilization of existing and novel therapeutics using the KidneyIntelX testing platform and proprietary care management software.

Renalytix focuses on providing doctors around the world with a safe, reliable, and effective tool to identify which patients are or are not in danger of losing significant kidney function and falling into kidney failure and may require long-term dialysis or kidney transplant.

At Renalytix, the company developed KidneyIntelX.dkd, the first U.S. Food and Drug Administration (FDA), authorized in vitro prognostic test that uses an artificial intelligence-enabled algorithm to aid in assessment of the risk of progressive decline in kidney function. The test is designed to predict early in the progression of kidney disease who is at risk for significant sustained decline in kidney function. Prognostic tests, such as KidneyIntelX.dkd, are not intended for diagnosing any disease or for monitoring disease progression or the effect of any therapeutic product. KidneyIntelX.dkd is part of a family of clinical tests being developed from the KidneyIntelX technology platform developed using technology licensed from the Icahn School of Medicine at Mount Sinai in New York, the Joslin Diabetes Center in Boston, and under development through the U.S. and international collaborations.

On June 29, 2023, the first FDA positive decision on a KidneyIntelX technology platform clinical test was achieved with De Novo marketing authorization issued to KidneyIntelX.dkd for the assessment of risk of progressive kidney function decline in adults with diabetes and early-stage kidney disease (also referred to as diabetic kidney disease (DKD). An estimated 14 million Americans adults fall within the U.S. Food and Drug Administration (FDA) authorized indicated use population for KidneyIntelX.dkd.

KidneyIntelX technology addresses challenge as a first-in-class, artificial intelligence-enabled prognostic testing platform to help guide care management for adults with DKD. KidneyIntelX.dkd provides prognostic risk stratification using three discrete risk levels (low, moderate, and high). This result provides timely information on patient risk for progressive decline in kidney function within five years, providing independent information from the current standard of care measures and can be readily deployed at the primary care level where the vast majority of patients with early-stage disease are being treated.

The company maintains a CLIA Certificate of Compliance for its Utah and Florida laboratories that allows it to perform non-waived (moderate and/or high complexity) testing at those sites. In June 2020, the company received CLIA certification for its New York laboratory through the New York State Department of Health.

Technology Platform Solution

The company designed the KidneyIntelX technology platform to enable risk prediction of progressive kidney function decline in patients with CKD. The platform employs an artificial intelligence-enabled algorithm that is capable of using diverse data inputs, including validated blood-based biomarkers from a patient blood draw, inherited genetics and personalized patient data from EHR systems, to generate a unique patient risk score. The unique patient risk score is then reported to the treating clinician through an interface that provides the reportable risk level to help inform guideline-driven clinical actions.

The KidneyIntelX.dkd test comprised the following:

A multiplex electrochemiluminescence assay for the in vitro quantitative determination of tumor necrosis factor receptors 1 and 2 (TNFR-1, TNFR-2), and kidney injury molecule 1 (KIM-1) in human plasma (whole blood K2EDTA blood collection tube). The assay is designed for use with the MESO SECTOR S 600 instrument to quantify the three biomarkers. The assay is performed by trained laboratory personnel at Renalytix using the assay components that includes the KidneyIntelX.dkd 96-well plate, the detection antibody, calibrator, and controls along with the MesoScale Diagnostics diluents, blocker, wash buffer, and read buffer.

The KidneyIntelX.dkd Portal, a cloud-based system that contains the software algorithm provides a KidneyIntelX.dkd Level (High, Moderate, Low) by combining the biomarker results from the assay and patient- specific results for uACR, HbA1C, and BUN. The patient specific clinical data needed for KidneyIntelX.dkd level determination is listed in the KidneyIntelX.dkd Test Requisition Form.

A KidneyIntelX.dkd Test Report containing the KidneyIntelX.dkd level and interpretation of the test result is provided to the ordering physician.

The KidneyIntelX.dkd test is an in-vitro diagnostic performed by Renalytix laboratory and is for a prescription use only.

To support FDA De Novo marketing authorization of KidneyIntelX.dkd, clinical validation studies were performed to demonstrate prognostic performance of the test in representative patient populations. Training of the machine learning algorithm was performed in the UPenn Biobank cohort and validated in an external cohort (BioMe), with excellent performance characteristics.

At the core of the company's approach is an artificial intelligence-enabled algorithm capable of synthesizing a set of current and diverse data inputs, such as biomarkers, EHR data, genomics, patient-generated digital data, environmental information, clinical utility, and actuarial, and clinical compliance information.

Strategy

The key elements of the company's strategy are to continue to build integrated partnerships with healthcare systems on a population health basis; further expand insurance payor coverage; continue to pursue permanent Medicare coverage through a local coverage determination (LCD) and a national coverage determination (NCD); build substantial repository of kidney disease-related data; expand its product portfolio; publish and present this data in various formats, including in peer-reviewed publications and at major medical conferences; and launch in major international markets.

Key Agreements

Mount Sinai Health System

In May 2018, the company entered into a license agreement, (the Mount Sinai Agreement) with the Icahn School of Medicine at Mount Sinai pursuant to which it obtained a worldwide, royalty-bearing, exclusive license under certain patents and a worldwide, royalty-bearing, non-exclusive license under certain know-how of Mount Sinai to develop and commercialize licensed products in connection with the application of artificial intelligence for the diagnosis of kidney disease. Pursuant to the terms of the Mount Sinai Agreement, the company is obligated to use commercially reasonable efforts in connection with the development and commercialization of the licensed products, including in accordance with certain diligence milestones.

Joslin Diabetes Center

In July 2017, EKF Diagnostics Holding Plc (EKF) entered into a license agreement (the Joslin Agreement) with the Joslin Diabetes Center, Inc. (Joslin). In October 2018, EKF assigned to the company all of its rights, title, interest, and benefit in the Joslin Agreement.

Pursuant to the Joslin Agreement and the related assignment from EKF, the company obtained a worldwide, royalty- bearing, exclusive license under any patents and any related know-how of Joslin related to the patent application filed with respect to the use the TNFR1 and TNFR2 biomarkers for determining whether a patient has an increased risk of developing CKD or ESKD (the Joslin IP) to make, have made, use, offer for sale and sell licensed products covered by claims in the Joslin IP, and to perform, practice offer for sale and sell certain licensed processes related to the Joslin IP.

In April 2021, the company entered into an exclusive option agreement (the Joslin Option Agreement) with Joslin for patent filings on certain additional novel biomarkers in kidney disease for development and deployment in the KidneyIntelX platform. The company has entered into a multi-year program to these novel biomarkers in expanded clinical validation studies which began in the second half of 2021.

AstraZeneca

In July 2020, the company entered into a statement of work (the AZ SOW), with AstraZeneca Pharmaceuticals LP (AZ) in advance of entering into a more comprehensive master services agreement. Pursuant to the AZ SOW, the company completed a feasibility study to determine the impact of the use of its KidneyIntelX platform to optimize utilization of various CKD agents and reported trial data its KidneyIntelX platform and care management improve uptake and adherence of certain CKD agent. The SOW is now complete.

Commercialization

The company plans to deploy KidneyIntelX to patient populations with DKD on a regional basis through partnerships with healthcare systems and insurance payors that provide coverage to those healthcare systems' patients.

Intellectual Property

In-Licensed Intellectual Property

The KidneyIntelX diagnostic is covered by a published Patent Cooperation Treaty (PCT) application filed in December 2009 that has been in-licensed from Joslin. National phase applications from this PCT were filed in the United States and Europe. There are two issued United States patents, which will both expire in December 2029. The claims are directed to methods of determining whether a human subject has an increased risk of developing CKD or ESKD or both. There is also a pending United States divisional patent application. There is an issued European patent, which will expire in December 2029. The claims are directed to methods of determining whether a human subject has an increased risk of developing early renal function decline. The European patent is regionally validated in Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, and Spain; and additionally in Hong-Kong. There is also a pending divisional EP patent application.

In addition, the KidneyIntelX diagnostic is covered by two provisional patent applications that have been in-licensed from the Mount Sinai School of Medicine. These provisional patent applications were filed in February 2020 and April 2020, respectively. If issued, these patents will expire in February 2041 and April 2041, respectively.

Research and Development

The company's research and development expenses included $14.3 million for the year ended June 30, 2023.

Competition

The company faces competition from clinical reference laboratories and diagnostics manufacturers, including large diagnostic laboratories, such as Quest Diagnostics Inc. and Laboratory Corporation of America Holdings (LabCorp); and large diagnostics manufacturers, such as ThermoFisher Scientific Inc., Danaher Corporation, Roche Holding AG, Abbott Laboratories, Bio-Rad Laboratories, Inc., Ortho Clinical Diagnostics NV, and Siemens Healthineers AG.

Regulations

The company's in vitro testing products are considered by the FDA to be subject to regulation as medical devices.

The company is subject to the federal physician self-referral prohibitions, commonly known as the Stark Law, and to comparable state laws.

History

Renalytix Plc was founded in 2018. The company was incorporated under the laws of England and Wales in 2018.