Renalytix Plc

Good morning, ladies and gentlemen, and welcome to the Renalytics Conference call to review first quarter fiscal year 2024 financial results. At this time, all participants are in 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, Livia. Thank you all for participating in today's call. Joining me today from Renalix to provide formal remarks are James McCullough, Chief Executive Officer, Howard Doran, Chief Business Officer, Tom McClain, 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 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 intellect to curtail costs of chronic and end-stage kidney disease, optimize care delivery, and improve patient outcomes, fends in our market and potential benefits of government policy change, the impact of COVID-19 and other world events on our business, our expectations regarding 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 or 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 of our annual report on Form 10-K that was filed on September 28, 2023 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, November 14, 2023. I'll now turn the call over to James McCullough. James?

Thank you, Peter. Good morning. Good afternoon. Given lousy sector market conditions in the early stage of our commercial rollout, we have been proactively organizing the company to last long-term while we leverage our proprietary technology to unlock value. First, we are in discussions to raise long-term funding, which would extend our operating runway considerably. While there are certainly no guarantees, we are targeting funding to be in place before year's end. Second, now that we have achieved FDA and published Kidney Intellect's real-world outcomes performance data, we are in a position to substantially reduce our spend rate. This includes a more than 35% reduction in payroll expense and a more than 30% reduction in SG&A. These cuts are across the company, including executive compensation, and while it is difficult for those employees affected, it is the right thing to do given the current environment and the opportunity to maximize resources against our sales efforts. We have and are continuing to shift the composition of the company to focus on sales. With this commercial realignment, approximately half of our employee base is now directly responsible for sales and revenue recognition. Our new Chief Business Officer, Howard Duran, will detail Salesforce efforts and related initiatives shortly. Third, we are optimistic that short-term events in fiscal 2024 can help spur testing growth. These include, one, Kidney IntellX Epic integration into Atrium Health, which should be finalized in December. Two, other anticipated hospital systems coming online with Kidney IntellX for calendar 2024. three expected inclusion of kidney intellex in the final updated international kidney guidelines publication shortly four progress towards the medicare local coverage determination or lcd with national government services the medicare contractor governing our new york lab five initiation of payment on kidney intellex billing from a second medicare contractor first coast options last month six additional expected major insurance coverage decisions this fiscal year And seven, importantly, publication of new Kidney IntellX outcomes data already submitted for peer review. Following FDA de novo marketing authorization June 29th, draft guidelines inclusion, comprehensive reimbursement, and proven published performance to improve diabetes and kidney health, Kidney IntellX is in a unique position to change preventative medicine in this very large and costly population health menace. Recent news highlighting potential breakthrough performance against diabetes and kidney disease, including the early stoppage of the Nordisk flow trial for their GLP-1 therapeutic of Zempic, signal a new era in kidney disease preventative medicine. There are now at least three classes of drugs available for treatment in the space, with more to follow. As we saw this month at the American Society of Nephrology Kidney Week Conference in Philadelphia, There is a market shift towards preventative medicine in the kidney space that will place increasing burden on primary care to understand which patients are at risk and what medication should be used when. We firmly believe that knowing the patient biology with a blood biomarker driven FDA approved and widely reimbursed kidney and telex will be a critical part of the strategy to balance ballooning treatment costs, potential side effects, and cocktail therapeutic applications in this era. We are pursuing programs to validate kidney and telex technology drug response scores to these various therapeutics with pharma industry players and our partners at Johnson Diabetes Center and the Mount Sinai Health System. A kidney and telex technology therapeutic response clinical program is something we hope to be able to report on as early as next calendar year. Our experience with the FDA de novo pathway in achieving broad scale reimbursement and artificial intelligence enabled blood biomarker diagnostics should prove especially valuable in commercial efforts here. We look forward to updating you through 2024 and all of these developments, and I will now turn over to Howard Duran, our Chief Business Officer, to discuss aspects in sales. Good morning, Howard.