Sera Prognostics, Inc.

Good afternoon, and welcome to the SARA Prognostics Conference Call to review third quarter fiscal year 2023 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, Operator. Good afternoon, everyone. Welcome to Sarah Prognostics' third quarter fiscal year 2023 earnings conference call. At the close of the market today, Sarah Prognostics released its financial results the quarter ended September 30, 2023. Presenting for the company today will be Xenia Lingard, President and CEO, and Austin Ayerts, our CFO. During the call, we will review the financial results we released today, after which we will host a question and answer session. If you've not had a chance to review our quarterly earnings release, it can be found on our website at serapognostics.com. This call can be heard live by webcast at serapognostics.com, and a recording will be archived in the investor section of our website. Please note that some of the information presented today may contain projections or other forward-looking statements. about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results, and market trends and opportunities. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections and other forward-looking statements. As a reminder, a webcast replay of this call will be available on the Investors section of our website. I will now turn the call over to Xenia, Sarah Pognostic's President and CEO. Xenia?

Thank you so much, Peter, and good afternoon, everyone. Since our last quarterly call, we've continued to evaluate the best means to pursue near-term revenue and position the company for a long-term success, all the while being vigilant over controlling our costs and preserving solid balance sheet, which is free of debt and we believe comprised of sufficient cash to generate shareholder value in the coming years. We expect the balance sheet strength and managing operating expenses while focusing on the best means to accelerate revenue will take us to a leading position in the pregnancy and women's health market in the future. As we continue to develop evidence to support adoption of the preterm test, we're also focused on developing new products to address many unmet needs in the pregnancy market. One example is a clinical test to provide a risk assessment tool for multiple pregnancy complications, assessing both high-risk, roll-in, and low-risk, roll-out results in a single test. Another is our work on a product to provide a more accurate estimate of when a baby will arrive to help a mother in planning maternity leave, travel, and other important milestones. These are all critical pathways towards additional revenue for SARA. Key to establishing further adoption of our technology is publication of study results with supporting compelling data that showcases the benefits of our technology. With that in mind, let me start with a detailed update on our AVERT preterm trial. Detailed results of AVERT, which was conducted at Christiana Care in Wilmington, Delaware, from June 2018 to September 2020, have been submitted for publication in a peer-reviewed journal. This study was designed to determine neonatal outcomes after risk assessment using our preterm tests and using guided intervention after targeting those with elevated risk for preventive treatment. Let me summarize the results of the study as provided in the preprint manuscript. A total of 1,463 women were screened and tested before research was ceased due to the COVID-19 pandemic, and three women were subsequently deemed ineligible after screening. Of these, roughly 35% or 507 patients were deemed high-risk, with roughly 56% or 286 of these accepting interventions. Pregnancies identified by the test to be at elevated risk for preterm birth were offered 81 milligrams of aspirin daily, 200 milligrams of vaginal progesterone daily, and care management. Our goal was to compare outcomes for women who screened either low-risk or higher-risk and accepting treatment with those in a historical study arm of 10,000 pregnancies. Our co-primary outcomes were neonatal hospital stay and ordinal neonatal morbidity index score. The primary analyses found that neonates in the prospective arm were discharged from the hospital earlier and had lower neonatal morbidity index scores. Preterm test impact showed driving two and a half week improvement in gestational age of infants most at risk for early delivery. 21% reduction in neonatal hospital length of stay, 18% reduction in severe neonatal morbidity and mortality, and an impressive 28-day reduction in neonatal intensive care unit length of stay for infants born before 32 weeks. We're really pleased to note that AVERT validated our proteomic blood test for preterm birth risk, which improved neonatal outcomes compared to controls in a racially diverse cohort when the test was coupled with treatment to those at risk. With these results, we believe our test and treatment strategy shows significant promise for mitigating and hopefully in some cases eliminating the negative impacts of premature birth among those at risk. Moving on to the update on our PRIME study, having observed the results from the AVERT study, we now have an updated model to project anticipated patient and physician compliance rate and the expected impact of our test and treat strategy. Armed with those insights, we believe the prime study will be stronger if we add up to 1,000 more patients to have a sufficient number of high-risk treated patients. At current rates, we expect enrolling these additional patients to only add a few months to the study, so we do not believe this change will impact our overall plan to have final prime results in 2025. We also decided to shift statistical power from the interim look to the final readout to favor success in the final study readout and to give us an opportunity to enroll additional individuals without delaying the interim look. As a result, there are three possible outcomes in the interim look that we expect to be completed in December. One, the Data Safety Monitoring Board, GSMB, concludes that the study may proceed to full enrollment and the final readout. Second, the DSMB instructs that the study should stop for safety reasons, although highly unlikely given that the interventions in the study are well tolerated in common use for other indications and are viewed as very low risk by the obstetrical community. Three, the benefit is statistically demonstrated at the interim look, also highly unlikely due to the shift of power from the interim to final. We would be very pleased with the scenario number one, which would result in full enrollment, delivery of all babies, and their outcomes available and recorded, which we anticipate will all be known, analyzed, and reported in 2025. We expect the prime interim look to be completed as expected and communicated before by the end of this year. As a reminder, the prime interim look and the timing for this event requires delivery, hospital discharge of mothers and babies, and final cleanup of the data prior to the analysis of study results all of which are progressing as planned. On to provide a commercial progress update. We're excited to be adding new large institutional customers to our roster this quarter and have rolled out care coordination offering for women identified at high risk alongside with that. We expect new institutional customers to help us evaluate and identify what works best in coordinating care for expectant mothers that are facing the risk of preterm birth. We believe that our service offering to such patients can improve test adoption by their physicians by providing better overall care. Given the size of these institutional customers, we expect to scale volume of testing within these institutions gradually over time. SARA-provided care coordination is built for separately, though we don't expect the service to become a major source of revenue for SARA in the short to medium term, but rather serve as a catalyst for better patient care and adoption. We're looking forward to providing two important for commercial traction updates to you in our next Q1 2024 analyst briefing. First, on our new product development progress as we've moved to new products through the next stages of their development. And second, on the improvements we're making to logistics of blood collection to enhance our customer experience. With that, I'll now turn over the call to Austin for a review of our third quarter financial results. Austin?