Sera Prognostics, Inc.

Good afternoon and welcome to the SARA prognostics conference call to review the first quarter fiscal year 2023 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'll now like to turn the call over to Peter Donato of Capcom Partners for a few introductory comments. Please go ahead.

Thank you, Darcy. Good afternoon, everyone. Welcome to Sarah Prognostics' first quarter fiscal year 2023 earnings conference call. At the close of the market today, Sarah Prognostics released its financial results for the quarter ended March 31, 2023. Presenting for the company today will be Greg Critchfield, Chairman, President, CEO, and Jay Moyes, 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 view our quarterly earnings release, it can be found on our website at sarahprognostics.com. This call can be heard via live webcast at sarahprognostics.com, and a recording will be archived in the investors 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 and 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 early reports on Form 10-Q, and its current reports on Form 8-K. 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'll now turn the call over to Greg, Sarah Prognostic's Chairman, President, and CEO. Greg?

Thank you, Peter, and good afternoon, everyone. The start of fiscal 2023 has been both exciting and encouraging for us in our pathway toward more broadly commercializing our preterm tests while fostering early revenue growth. Kicking off what we expect will be a strong year of solid developments for seroprognostics with the announcement in February of positive top-line results from our overt preterm trial conducted at ChristianaCare Wilmington, Delaware. We are pleased to see increased numbers of tests being ordered by physicians as we continue to expand the number of providers who are offering preterm testing to their patients. A year-over-year comparison of the first quarters of 2023 and 2022 showed a 320% increase in tests reported. While these are admittedly on a small yet growing base, we are continuing to see demand grow. While we are unable to speak about many or most of the early adopter customer groups, we are making progress with hospital systems and selected physician practices who are beginning to contribute to the increased numbers of orders we are seeing. There are also early adopter integrated networks who have requested to see avert preterm trial and other clinical data that are being prepared for submission to scientific and clinical journals. A bit more on the preterm trial. If I may remind you of some key outcomes for this trial, both the co-primary outcomes, reduction of severe neonatal morbidity or neonatal death, and decreased length of neonatal hospital stay, met their endpoints. With the improvements in outcomes, with our preterm test and treat approach being statistically significant. Notably, these results demonstrate the generalizability of the preterm test and treat strategy in achieving meaningful clinical results in more widely diverse U.S. populations. The AVERT preterm trial builds on solid results from prior studies, including paper, treetop, accordant, and prevent PTV. There are two key points I would like to highlight with regard to the AVERT preterm trial findings. The announcement of these results in February resulted in our seeing increased interest from health systems parties with discussions underway. Some of the volume of our preterm testing has been driven by early adopters as they have learned of the first public availability of compelling new overt preterm trial data showing the clinical utility of our preterm test and treat strategy in a previously unstudied diverse population. And as mentioned on our last call, The detailed results of the AVERT trial, including secondary endpoints and additional subgroup analyses, are being prepared for submission to a peer-reviewed scientific journal in the coming months. We are encouraged that the publication of these results should drive growing interest by physicians, payers, and health systems. We believe that the results of AVERT and prior studies show a growing body of evidence for the preterm test clinical benefit to mothers and babies. And now a bit on the prime study. Let me briefly recap a few important points about prime and how it relates to the positive results of our EPRS study. For starters, during the recently completed quarter, increased prime study subject enrollment continued, surpassing more than 2,800 subjects required to be enrolled for the trial in the trial for the interim look analysis to occur, and we continue to believe that the interim look analysis will take place by year end. The timing for this event requires delivery, discharge of mothers and babies from the hospital, and final data cleanup prior to this analysis. We provided quite a bit of transparency on the similarities and differences between the AVERT and PRIME studies on our last call, so I'll simply summarize them today. The AVERT and PRIME studies have identical co-primary endpoints for reduction in neonatal hospital length of stay and decreased neonatal morbidity and mortality. Both have diverse demographics and preexisting risk profiles. And finally, multimodal clinical intervention strategies prescribed in the protocols for both, including care management, are similar. These similarities are compelling for the potential for positive PRIME study results, but We caution that there are some noted and possible differences that could cause results to be different. AVERT was performed in a single health system versus in at least 15 sites for PRIME, leading to possible differences in administration of the study and adherence to the clinical protocol across this number of sites. Another difference is that all enrolled patients that reached term in AVERT were treated before COVID was prevalent in the study area and ended the study early, while some prime patients will have been treated during the pandemic and others after the pandemic substantially waned. Prime subjects are receiving the same interventions, whereas avert subjects were able to elect for some interventions and opt out of others. The avert preterm trial analysis is expected to report out data from a composite set of 1,453 actively enrolled patients, and approximately 10,000 historical controls who had completed pregnancies during the two years before the trial began. We anticipate and currently believe that the PRIME study will provide strong clinical utility evidence as a rigorous multicenter RCT design by enrolling concurrently randomized control in active arms. To clarify a point from last quarter's call on the numbers of patients in each study, PRIME is a much better-powered broadly representative in contemporary randomized control study compared to Evert, by including approximately twice as many prospectively enrolled subjects, 2,800 total, with 1,400 active and 1,400 controlled patients at the interim look, and almost four times as many at full enrollment. Most important, we believe, is prime strong statistical power of approximately 80% at the interim look analysis, with even greater statistical power at final readout with higher numbers of completed pregnancies. Ultimately, although the results are encouraging, there are no guarantees of a similar outcome for PRIME, and we are hopeful the results will be positive since the availability of compelling data is a key enabler of driving test volumes as well as revenue over time. In addition to PRIME, We anticipate further publication of new, compelling clinical data to take place later this year. And now, more information on CIRA's pregnancy pipeline. We continue to make good progress on our robust pregnancy pipeline using our biobank and advanced data science methods to create meaningful predictions. A first step in developing products is to discover and validate the predictions. To that point, Our preterm preeclampsia validation data are ready for submission for scientific review prior to publication. We also made excellent progress on validating a time to birth prediction to better inform patients on the personalized timing of individual deliveries for planning purposes. We have discovered a strong mid-pregnancy gestational diabetes predictor. We will determine the best timing and ways to monetize these predictions and will communicate the timing as appropriate. We believe all these efforts help Sarah in its quest to be the pregnancy company, providing valuable pregnancy information to improve the well-being of mothers and babies and the economics of health care delivery. I'll now turn over the call to Jay for a review of our first quarter financial results.