Sera Prognostics, Inc.

Good afternoon and welcome to the SARA Prognostics conference call to review fourth quarter fiscal year 2024 results. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session towards 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' fourth quarter fiscal year 2024 earnings conference call. At the close of the market today, Sarah Prognostics released its financial results for the quarter and full year ended December 31, 2024. Presenting for the company today will be Jenya Lingard, President and CEO, and Austin Erick, 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 sarah.com. This call can be heard live via webcast at sarah.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 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 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, a webcast replay of this call will be available on the Investors section of our website. I will now turn the call over to Zhenya, Sarah Prognostics President and CEO. Zhenya?

Thank you, Peter, and good afternoon, everyone. During 2024 and starting strong in 2025, we effectively executed on our stated plan of putting in place the necessary steps to grow Sarah's business and shareholder value. That included building our evidence portfolio, building awareness, and seeking publication of clinical trial results to drive adoption and inclusion in care guidelines in the future. I'm pleased to report that we have made solid progress on each of these, We believe we're now poised to take advantage of a new phase following pivotal prime study results to pursue evident growth opportunities. Towards leveraging the best of these opportunities, we're grateful for the support of our investors and pleased to have successfully executed our fundraise last month to help fund these endeavors. Added to our strong debt-free balance sheet, this affords us flexibility to cost-effectively invest in those with the best potential commercial return on investment to build awareness and adoption of our solution to preterm birth. Speaking of awareness, we were excited to recently share the full results of our prime study at the Society for Maternal Fetal Medicine 2025 pregnancy meeting on January 31st and during our virtual R&D event later that day. Prior to that, Society for Maternal Fetal Medicine published our abstract as one of just a few late-breaking ones chosen for publication. Furthermore, ours was one of just five studies for which Society for Maternal Fetal Medicine issued a press release out of about 1,200 studies overall reviewed in the pregnancy meeting. Let me briefly review compelling data points Dr. Brian Herrier, maternal fetal medicine expert at the High Risk Pregnancy Center in Las Vegas and principal investigator for PRIME, shared during the January presentation. First of all, Dr. Herrier recapped that the PRIME study was conducted at 19 locations and included an intended treat population of 5,018 patients in a randomized controlled trial designed to represent the gold standard evidence in our portfolio. Our preterm test and treat strategy yielded statistically significant outcomes on both co-primary endpoints in the PRIME study, with a 25% reduction in the neonatal mortality and morbidity index, or NMI, and an 18% reduction in neonatal length of hospital stay. Furthermore, Dr. Erie highlighted a 20% overall reduction in NICU admissions and a much reduced number needed to screen, or NNS, of 41 to prevent a NICU admission. This number needed to screen compared to a number needed to screen of about 150 for the cervical length screening which is the type of screening currently recommended in guidelines for symptomatic women with a history of preterm birth. This significant reduction in NICU admissions is very important, as this is a top focus for payers in reducing healthcare costs for their insured patients. The NICU admission reduction showed that we are keeping one out of five babies out of the NICU with our test and treat strategy. There are various etiologies when it comes to root causes of preterm birth, and each case is patient-specific as to which lever to use, aspirin, progesterone, and care management. But identifying these at risk early is informative, and physicians are excited about the potential for our test to predict which mothers are more likely to deliver prematurely, more accurately than current tools. Since we've published this meaningful data, Society for Maternal Fetal Medicine urges to continue to publish the results of PRIME and our prior trials to build awareness and illustrate real-world utilization. Ultimately, we believe there are three linchpins necessary for professional society recommendation inclusion for preterm, and these are publishing more information from significant datasets derived from our studies, providing more real-world evidence of the healthcare and economic benefits using our test along with an intervention bundle. And lastly, driving clinical community adoption and bringing institutions on board that can effectively use preterm testing and based on their experience improving outcomes for moms and babies, ask for the SMSM and ACOG position on preterm test usage and guidelines. We plan to continue with our primary goal of achieving publication of the full prime study in a peer-reviewed journal, In the meantime, we're continuing to build on our evidence portfolio to corroborate our test and treat strategy in real world evidence studies, the first of which is already underway. We recently received approval by an institutional review board for a pre-implementation study at a premier hospital network to observe the impact of our preterm test with intervention in real world. We look forward to continuing building awareness of PRIME results at the upcoming American College of Obstetrics and Gynecology meeting in May in Minnesota. With the publication of AVERT and anticipated publication of PRIME, we have entered a new phase of commercialization focused on driving awareness, seeking reimbursement, adding to evidence for guideline inclusion, and accelerating preterm adoption in the United States, as well as exploring international expansion. This is the time for us to put our money to work in a focused approach. Building our presence in waves of geographies will allow us to drive density of adoption, awareness, and test utilization where we have achieved reimbursement and built opinion leadership. During this phase, we expect to leverage cash from our recent capital raise to maximize opportunities. Net proceeds from the offering are expected to enable measured expansion in our commercial infrastructure and capabilities in the United States, as well as opportunities that we've created. In addition, this will help accelerate preparations for possible expansion into European Union and fund additional studies designed to increase adoption of preterm, including monitoring milestones set for FDA oversight of LDTs. 2024 was the third consecutive year the United States received a D-plus grade from the March of Dimes annual report card for our persistently high preterm birth rate. This needs to change, and we can do more to create a paradigm shift to improve outcomes and reduce healthcare costs. Following the availability of AVERT and PRIME data, in our conversations with payers, two key results resonated strongly. First is the reduction in NICU admissions, and second, the number needed to screen of only three or four moms to drive savings of one NICU day. We are continuing to share with them our economic model of the value delivered which exceeds their target of three to one ROI. In addition, we are starting a program with a key payer to monitor the cost of care to build on the evidence we have in deploying our test and treat strategy. In the United States, Medicaid pays for approximately 43% of births. Given the burden on public health agencies, we expect to pursue partnerships to measure and demonstrate our impact on the patient population. Specific early states of focus may include Nevada, Louisiana, Texas, and California. According to the March of Dimes, the first two of these states have nearly 50% higher preterm birth rates than the national average. Our goal is to focus on geographies where the need is the greatest, where a prime study site is located, or where we have strong opinion leader support, and where we have line of sight to pair coverage. We're analyzing the geographies where these conditions are met, and we'll deploy both digital awareness campaigns at scale and regional account managers to drive adoption. To address conditions specific to the European market, in February, we executed an agreement with a lab to develop an immunoassay version of preterm tests. These types of assays enable a decentralized commercialization model better suited to health systems in Europe. We believe that once this is successfully completed, it will allow us the opportunity to strategically partner with other organizations in addressing preterm birth in Europe in commercializing preterm tests there. With our product pipeline, we continue to work on our time to birth offering. Here, Just as with preterm, publications will help support awareness building and provide real-world evidence of the value of this technology. In early February, work by Sarah's Key researchers was published by the journal Life. This study showed the ability to accurately predict the delivery dates of term pregnancies by examining 15-clock proteins found to have direct association with time to birth. These findings suggest that one of these proteins, ADA12, as well as potentially other clock proteins, may serve as predictors of term delivery date in uncomplicated pregnancies. This study further illustrates our role in supporting an expectant mother's journey with our novel technology. To help advance the market opportunity we see ahead of Pacera, we are pleased to announce today the appointment of Jeff Elliott to our Board of Directors. Jeff brings two decades of experience and expertise in guiding companies in the medical diagnostics industry, including as chief financial and chief operating officer at Exact Sciences during its high growth phase. His appointment broadens the depth and breadth of expertise on our board. We're also announced today that our longtime board members, Ryan Trimble and Marcus Wilson, are stepping down in June after many years of service and commitment to their mission. We're thankful to them for their role in taking SARA from startup to commercialization. In summary, we believe we have momentum behind us and are in a better position than ever to expand our commercialization, grow adoption and revenue, and take SARA to the next level. Now, I'll turn the call over to Austin. Austin?