Renalytix Plc

Good morning, and welcome to the Rinalytics conference call to review first quarter fiscal 2023 financial results. At this time, all participants are in a listen-only mode. We will be facilitating a question and answer session toward the end of today's 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, Cherie. Thank you all for participating in today's call. Joining me today from RenoLytics are James McCullough, Chief Executive Officer, and James Sterling, Chief Financial Officer, to provide formal remarks, and Tom McLean, President, and Fergus Fleming, Chief Technology Officer, are also on hand for the Q&A session. 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 security's 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 clearance from the FDA, the commercial prospects of kidney intellects, 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, optimize care delivery, and improve patient outcomes, friends 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 to 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 in our annual report on Form 20F that was filed on October 31, 2022 with the Securities and Exchange Commission. All forward-looking statements made on this call are based on management's current estimates and various assumptions. Renalytics defends any intention or obligation except as required by law to update or revise any projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information. It is only accurate as of the live broadcast today, November 30, 2022. I'll now turn the call over to James McCullough. James?

Thank you, Peter. Good morning and good afternoon. Since we reported our year-end results just a month ago, my comments will be focused on summarizing recent achievements in the setup for a successful beginning to calendar 2023. Since July, the start of our fiscal year 2023, we can look back at several important milestones, including publication of key utility data showing effectiveness of Kidney IntellX in the primary care office, expanding on multiple categories of insurance payment for Kidney IntellX, including Blue Cross Blue Shield, Medicaid, and Medicare, demonstrating continued growth and testing adoption with our first million-dollar revenue quarter ending this September, and pivoting to a lower overhead structure to extend cash runway. Progress with insurance continues to be an important highlight. In the September quarter alone, we have secured new major insurance contracts and established Medicare payment. This brings our total number of secured contracts to 30, excluding Medicare and Medicaid. We have also begun detailing plans with a large U.S. health insurance company to provide kidney Intellix testing directly to their own physician care network. This insurance company has also agreed to provide us with coverage concurrent with this direct to physician program. We believe partnering with insurance companies to implement testing across physician managed networks can be a significant driver for expanding kidney Intellix adoption in calendar 2023. and will demonstrate the value of Kidney IntellX for improving care for millions of patients. Our stakeholders should look forward to additional payer contract disclosures in coming months. A primary contributing factor for our success in securing insurance coverage is real-world evidence that Kidney IntellX is working. This body of evidence, which takes years to design and implement, is now showing that Kidney IntellX can make a real difference in helping doctors and care for patients. This week we announced newly released utility data for over 1,600 patients, results across 75 doctors at 20 clinical sites showing the importance of kidney IntellX testing in helping head off the worst effects of kidney disease and diabetes at the primary care office. These results were just published in the widely read Journal of Primary Care and Community Health. We have already started pulling together subsequent monitoring patient test data and expect to continue publishing rolling results on the effectiveness of kidney intellect in the real world throughout calendar year 2023. As a reminder, real-world evidence results will now begin to be incorporated from multiple medical center sources, including Wake Forest Baptist Health in North Carolina. From an operations and test processing standpoint, our laboratories conform to the highest quality and regulatory standards. This is obviously essential if we are to be prepared to support patient testing nationally post-FDA de novo marketing authorization. Our systems and laboratories have now been subject to and passed 12 inspections from multiple agencies. This level of quality assurance is another important facet that instills confidence in doctors when it comes to kidney IntellX testing results. Of note, the regulatory environment is evolving. Congress recently passed the Medical Device User Fee Agreement, or MEDUFA V. MDUFA V is a five-year agreement that provides operation funding for FDA and provides additional incentive funding if the agency meets key performance goals. We believe MDUFA V is a factor in improving FDA's ability to help innovative companies bring lifesaving technologies to the market. FDA has also issued a proposed rule to drive towards convergence between the current FDA regulations and ISO 13485 requirements. Renalytics has pursued and achieved full ISO 13485 compliance and certification. We welcome this proposed rule and believe that Kidney IntellX is well positioned from a competitive industry standpoint. As we discussed in previous quarterly call, we can expect to look forward to a milestone heavy short term. In terms of our FDA process, while there is never a guarantee, We believe we are reaching a logical conclusion in the process with a de novo marketing authorization decision as early as the March quarter. As previously discussed on our call, on our last call, Medicare coverage through a local coverage determination is also a potential for kidney and telex in the first half of calendar 2023. I would now like to turn over to James Sterling, who will discuss our financial results for the quarter. James.