Renalytix Plc

Again, ladies and gentlemen, please stand by. Again, ladies and gentlemen please stand by. Thank you. Thank you. Thank you. Thank you. Ladies and gentlemen, we do appreciate your patience. Good morning and welcome to the Rinalytics conference call to review third quarter fiscal year 2022 financial results. At this time, all participants are in a listen-only mode. We will be soliciting a question and answer session toward the end of the call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DiNardo of Capcom Partners for a few introductory comments.

Thank you, Tonya. Thank you all for participating in today's call. Joining me today are James McCullough, Chief Executive Officer, Tom McLean, President, and James Sterling, Chief Financial Officer. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Examples of these statements include, without limitation, the potential benefits, including economic savings of kidney intellects, the potential for kidney intellects to receive regulatory approval from the FDA, the commercial prospect of kidney intellects, if approved, including whether kidney intellects will be successfully adopted by physicians and distributed and marketed, our expectations regarding reimbursement decisions and the ability of kidney intellects to curtail costs of chronic and end-stage kidney disease, optimized care delivery, and improved patient outcomes, trends in our market and potential benefits of government policy change, the impact of COVID-19 and other world events on our business, our expectations for hiring, product development, strategic partnerships and collaborations, reimbursement decisions, clinical studies and regulatory submissions, our business strategies and future growth, including plans, expectations, and opportunities for financing our operations, and revenue projections and guidance. These statements involve material risks and uncertainties that could cause actual results or events that materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a description of the risks and uncertainties associated with our business, please refer to the risk factors section of our end report on Form 20F that was filed on October 21, 2021, With the Securities and Exchange Commission, all forward-looking statements made on this call are based on management's current estimates and various assumptions. Renolytics disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, June 30, 2022. And with that, I'll turn the call over to James McCullough. James?

Thank you, Peter. Good morning and good afternoon. This has been an active quarter for Renalytics. Our lead program, Kidney IntellX, continues to secure major reimbursement coverages, generate key utility data from our real-world deployments, and build on core commercialization fundamentals. As of the end of June, Kidney IntellX has now generated 3,253 kidney risk scores at Mount Sinai Health System, across 53 departments and 191 ordering physicians. Importantly this quarter, we have now made the leap to automated eligible patient identification, an important element for scaling Kidney IntellX risk assessment across a complex integrated health system. At Wake Forest Baptist Health, Kidney IntellX has now generated 310 risk scores as of June 26 across 56 ordering physicians. We are now scheduled to expand the Kidney IntellX program to select Wake Forest patients with insurance coverage beginning as early as July. Also, as of the close of this quarter, we are in process of securing approvals to set up testing at 80, I'm sorry, at 59 of a total 171 centers in the Veterans Administration Health System. While the VA medical system implementation has not been easy or straightforward, we have clarified our implementation process over the past six months since we began, and expect Kidney IntellX live testing to occur in eight centers in calendar 2022. This is a significant advancement toward our goal of reaching 20 health system implementations by calendar year end. We are also pleased to have established several new major insurance coverage contracts for Kidney IntellX this quarter, validating our strategy to secure payment early and across broad regional populations. Of note, The first coverage contract secured is with the largest private payer in Illinois, serving 8.1 million lives. In Illinois, 13% of the state's population, or approximately 1.3 million people, are living with diabetes. Chicago will now become a commercial implementation focus for us. Also of note is the coverage contract secured for Kidney IntellX with the largest independent provider network in the tri-state region of North Carolina, South Carolina, and Virginia. with over 100,000 healthcare providers and network. This coverage is particularly important for our commercial rollout with Wake Forest Baptist Health and Atrium Health in the Southeastern United States beginning this summer. Securing payment for Kidney Intellect remains the number one value driver for our business. When insurance reaches a majority of patients in a region, true broad adoption becomes possible because doctors and patients no longer need to worry about receiving a bill for testing. We are now reaching critical coverage tipping points in multiple key regional markets where we have integrated health system partnerships. Please note our ability to press release these coverage wins is limited because it is against the policy of most insurance providers. We have also expanded our Medicare contracting now to 33 states. Medicaid contracting. Medicaid remains a key program for Kidney Intellects given the population size served. government and patient advocates are now fully focused on solving health equity issues and access to medical care and underserved communities. Given the population size of underserved diabetes and kidney disease patients in the Medicaid program, we believe Renalytics is well positioned and committed towards making a difference in the quality of life in this population. We're also pleased this quarter that important new utility data from several years worth of kidney Intellect setup implementation and real world clinical use has now been released. Two studies on over 2,000 kidney IntellX tested patients were presented in June at the American Diabetes Association annual meeting. Real world data is now validating positive change in behavior and action for primary care physicians who have used the power of electronic health record integrated kidney IntellX in their clinics. Most importantly, utility data showed that primary care physicians were seven times more likely to prescribe guideline-directed new therapies to their high-risk patients when Kidney IntellX risk assessment was introduced into practice. The direct takeaway is that Kidney IntellX is working and making a difference in clinical practice. Tom McLean, our president, will discuss the importance of this utility data and its implication for expanding insurance coverage in the next statement. Our significant progress with reimbursement utility data has not gone unnoticed. We are now in advanced discussions with larger potential strategic partners in the pharmaceutical and diagnostic distribution categories who understand that Kidney IntellX is opening a unique market access point to millions of patients and doctors struggling to understand their disease. We expect, should these partnership agreements be fully executed, that they would have a measurable impact on Kidney IntellX usage and would allow us to provide forecast revenue at the appropriate time for fiscal 2023 and fiscal 2024. In these unusual economic times, we will continue to reassess our business and take definitive steps to conserve cash as appropriate. These steps may include narrowing our commercial focus to revenue productive regional market opportunities, operating cost reductions, and or relying more on less expensive third-party providers for non-core services. Key potential catalysts for the second half of calendar 2022, that is the next six months, remain as previously noted including a major expansion of insurance coverage with Medicare as a priority, strategic partnering activity, additional health system partnership announcements, and FDA de novo marketing authorization. I will now turn over to Tom McLean, our president, to discuss data reimbursement and commercial progress. Tom? Tom McLean Thank you, James.