Sera Prognostics, Inc.

Good afternoon and welcome to the SARA prognostics conference call to review fourth quarter and fiscal year 2022 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, MJ. Good afternoon, everyone. Welcome to Sarah Prognostics' fourth quarter fiscal year 2022 earnings conference call. At the close of the market today, Sarah Prognostics released its financial results for the quarter ended December 31, 2022. Presenting for the company today will be Greg Critchfield, Chairman, President, and 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 review our quarterly earnings release, it can be found on our website at seraprognostics.com. This call can be heard live via webcast at seraprognostics.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 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, webcast replay of this call will be available in the investor section of our website. I will now turn the call over to Greg, Sarah Prognostics Chairman, President, and CEO.

Greg? Thank you, Peter, and good afternoon, everyone. Fiscal 2022 was a solid year of continued progress in positioning seroprognostics for commercial growth in the quarters and years ahead. During 2022, we made incremental progress in adding new payer contracts and more recently have publicized new data that we believe will support the growth of our business in future periods. Although our revenue was nominal for the year, we are seeing percentage growth in test volumes. For Q4, year-over-year 2022 versus 2021, the increase was six-fold. And for total units 2022 versus 2021, it was 11-fold. Of course, these are increases from a small baseline in 2021. While it takes time to broaden commercial relationships, we are seeing positive results from our strategy in terms of both payer and physician response. And we look forward to reporting additional traction during 2023. Ultimately, at this time, the single biggest way to further accelerate adoption of our preterm technology and testing volumes is the publication of compelling new data that continues to demonstrate the value of our tests. This growth is first manifested in the use of our technology by early adopters and should result in growing reimbursement by increased numbers of payers while we execute our strategy. And we have strong, we share strong new data is published from clinical studies. In terms of customers, we maintain a continued focus on early adopter systems. For example, integrated delivery networks, or IDNs, hospital systems, and physician practice groups. We continue to work with early adopter systems, not only by sharing data, but also by discussing ways with them to implement the preterm testing within their institutions. We anticipate making selective announcements as permitted in the course of bringing the preterm test and treat strategy into these systems. While implementations among these customers take time, we believe there may be an inflection point ahead as multiple customers among our growing relationships rescale in future quarters where the number of tests and the amount of revenue increases accordingly. Another important event in our quest to help build up testing volumes among these customers is to broaden preterm testing availability while reducing our costs and growing our business. Before that end last quarter, I touched on the successful validation of an ambient blood collection and transport system for preterm testing, which we launched commercially in December. This not only expands the number of sites where patients' blood can be more easily collected by reducing the need for dry ice availability for transport to our labs, but it also reduces our costs. Just as importantly, we know that ambient shipping now newly deployed is growing as a proportion of tests being ordered this year, and we believe that even from these early moments of ambient collection shipping launch, it will continue to contribute to increases in test volume over the next months and years to come. Let's now turn to the growing body of published new data supporting our mission to improve the health of mothers and babies. First, the Accordance Study. Building strong evidence for the use of the preterm test is an important part of CIRA's strategy. In terms of addressing healthcare disparities, during Q4, we announced the publication of results from Accordant, a clinical utility and cost effectiveness modeling study based on rigorous clinical utility health economic analysis. This work, published in the Journal of Health Economics, illustrates the impact of CIRA's test and treat strategy and its specific benefits in underserved racial and ethnic populations. was a secondary analysis of 847 women from the multi-center assessment of a spontaneous preterm risk predictor study, or TREATOP study. Findings showcased that care management with or without pharmaceutical treatment was effective in reducing maternal and neonatal hospital length of stay. Results indicated that by combining the preterm test with enhanced prenatal care management, real progress may be made in better serving the most disadvantaged populations to enable better medical outcomes. Now a bit on new clinical outcomes data supporting the preterm test and treat strategy, the AVERT preterm trial. A few weeks ago, we announced the top line results for our large AVERT preterm trial, which showed statistically significant improvements in both of its primary endpoints, neonatal hospital length of stay and neonatal health as measured by a composite neonatal morbidity and mortality index. We believe these results solidify the benefit of the preterm test and treat strategy to improve the health of babies, giving those most vulnerable a better chance at a stronger start in life. 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. In our announcement of the top-line AVERT study results, we mentioned that we believe these results bode well for our very large prospective multicenter randomized controlled PRIME study. We are pleased to announce that PRIME has surpassed 2,800 enrolled patients, the number required to enable the pre-planned interim learning. And though there are moving parts that can delay such things, we believe that the interim analysis is on track to take place during this year. I would like to take a minute to describe how different pieces of evidence fit together in our broader strategy by clarifying why we believe that overt top-line results bode well for PRIME. First, both studies have identical co-primary endpoints, reduction in neonatal hospitalizing of stay and decreased neonatal morbidity and mortality. Second, both studies have a diverse demographic that is representative of broad racial, socioeconomic, and pre-existing risk profiles. Third, the multimodal clinical intervention strategies prescribed in the protocols of both studies are the same or similar. Specifically, this includes the use of low-dose aspirin, the same form of progesterone, and additional care management for mothers identified by the preterm test to be at higher risk of premature delivery. Care management consists of more frequent clinical monitoring and more intensive education for higher risk patients. It is also important to note that while these similarities between AVERT and PRIME give us optimism for the PRIME study, there's always the potential that differences could weigh in the other direction. To point out a few, the AVERT preterm trial was performed within a single health system, while PRIME involved over 15 sites, which could lead to possible differences in administration of the study and adherence to the trial's clinical protocol across these sites. As another difference, all patients who reached term in avert were treated before COVID was prevalent locally in Delaware and ended the study early, while some patients in prime will have been treated during the pandemic and others after the pandemic has substantially waned. Finally, the prospective randomized controlled design of prime is a stronger study design in terms of the evidence generated than that of the historically controlled AVERT preterm trial. Furthermore, though AVERT included approximately 10,000 historical controls, PRIME is a much better powered study in that it includes approximately twice as many subjects as AVERT in its prospective arm at the interim look analysis and almost four times as many at full enrollment. The larger size of the test and treat arm of the PRIME study helps to provide higher statistical power. Oftentimes, clinical studies are statistically powered at approximately 80% to see the effect of interest, the primary outcomes, at full enrollment. The PRIME study was designed to have that level of statistical power for the interim look analysis before the trial is fully enrolled and even higher power for the final readout. Considering these and other factors, while we believe the results are encouraging given these differences, they're clearly not completely predictive of the outcome of the PRIME trial and we must await crime results to know to what extent they support CIRA's preterm test and treat strategy. In that regard, it's also important to recognize that many studies, and for a number of reasons, interim look analysis endpoints are rarely met, and studies usually proceed to their original, pre-specified final enrollment numbers, at which time the final analysis occurs. The interim look allows the external monitoring group overseeing the study to determine whether the study enrollment should continue, and then recommend either continuing enrollment of the trial, which happens in most cases, or ending enrollment early because interim results are good enough that continuing to enroll patients is inadvisable. We are encouraged by the data resulting from controlled prospective studies thus far and look forward to sharing the results of the prime study with you as soon as we can. Now a word on SIRS-BioWorker pipeline. Lastly, let me take a moment to update you on our biomarker pregnancy pipeline, specifically our preeclampsia prediction. About 5% to 8% of all pregnancies are impacted by preeclampsia, a sizable medical problem among expectant mothers. The most serious preeclampsia is preterm preeclampsia, occurring before the 37th week of pregnancy, and which is more severe for mothers and babies. Preterm preeclampsia poses a most challenging clinical decision for the physician as to the time of when to deliver the baby, in that there's a need to balance serious adverse outcomes for an incompletely developed newborn against the rapidly deteriorating health of the expectant mother, medical goals that can be at odds with one another. Identification of these cases well in advance before clinical preeclampsia occurs enables more informed and proactive decision-making and management. Late last year, we successfully clinically validated the prediction of preterm preeclampsia and made the validation data public to the scientific community. And now, the manuscript is being prepared to submit the data shortly for publication in a peer-reviewed scientific journal. As the only rigorously validated preeclampsia predictor when a patient is asymptomatic, we believe that our work on preterm preeclampsia is groundbreaking and valuable. We will determine how and when it gets commercially into CIRA's broader portfolio of pregnancy tests to provide valuable information to doctors and patients. In summary, we are continuing to build the solid foundation of data to enable us to carefully implement our commercial strategy as we also work to extend our runway. We are pleased to see the progress and expect it to continue strongly during this year. I'll now turn over the call to Jay for a review of our fourth quarter financial results.