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Sera Prognostics, Inc.
3/18/2026
Good afternoon, ladies and gentlemen, and welcome to the Sarah Prognostics fourth quarter 2025 financial results conference call. At this time, all lines are in a listen-no-we mode. Following the presentation, we will conduct a question and answer session. If at any time during this call we require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, March 18, 2026. I would now like to turn the conference over to Jennifer Zibuda. Please go ahead.
Thank you, operator. Welcome to Sarah Prognostics' fourth quarter and full fiscal year 2025 earnings conference call. At the close of market today, Sarah Prognostics released its financial results for the quarter ended December 31st, 2025. Presenting for the company today will be Eugenia Lingard, President and CEO, Lee Anderson, Chief Commercial Officer, Dr. Tiffany Inglis, Chief Medical Officer, and Austin Ertz, 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 your 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 actual results to differ materially from those contained in our projections and other forward-looking statements. I will now turn the call over to Zhenya. Thank you, Jennifer, and good afternoon, everyone.
I will start with an overview of our 2025 progress, and Lee and Tiffany will speak about our commercial and medical affairs efforts, and Austin will provide a recap of our financial results. As we shared last year, to support Sarah's next phase of commercialization, we strengthen our leadership team, with Lee Anderson joining us as Chief Commercial Officer and Dr. Tiffany Inglis as our Chief Medical Officer, enhancing our commercial and clinical depth And I wanted to use this opportunity to introduce them to all of you in today's call and have them discuss our progress with you. 2025 was a critical year for SARA, finalizing our prime publication to advance our evidence portfolio, setting up for commercial push in 2026, building our organization, ensuring we have capital to deploy in our commercialization efforts, and laying groundwork for potential international expansion. Our goal was simple. to build the evidence, access, and commercial infrastructure required to drive preterm adoption at scale. Across all of these dimensions, we made meaningful progress. We began 2025 focused on strengthening the clinical and scientific foundation supporting our commercialization strategy, the presentation of prime study at society for maternal and fetal medicine meeting in Q1. A major milestone followed as expected late in the year when our pivotal prime study was accepted for publication in December with a full manuscript published in January, 2026. The publication reported important new data showing that the prime study resulted in an easing 56% and 32% fewer babies born before 32 and 35 weeks of gestation respectively. The full peer-reviewed publication of PRIME in the pregnancy journal of Society of Maternal and Fetal Medicine, like studies before it, namely AVERT, reinforces what we've long believed, that biomarker-based identification of women at higher risk of preterm birth, paired with a preventive treatment protocol, can deliver meaningful reductions in preterm birth rates and drive improved health outcomes for babies. As we move into 2026, We plan to extend this momentum through a thoughtful further analysis, publication, and real-world evidence for generation strategy designed to communicate and replicate prime outcomes across diverse populations, geographies, and care models. These data will be essential as we engage payers and broaden awareness across the clinical community. I will ask Dr. Inglis to speak more about our scientific and guideline engagement shortly. Post-publication, we're making meaningful strides in advancing payer coverage and access as our top priority. A central part of the strategy has been launching targeted programs, particularly in Medicaid in high preterm birth burden states, to generate outcomes data that support both clinical adoption and reimbursement expansion. Historically, we referred to these efforts as Medicaid pilot programs. However, with additional real-world experience, It is clear that these programs take many forms, and our discussions involve both Medicaid and commercial payers. As a result, we believe partner programs more accurately reflect the breadth of our commercialization efforts, so we'll speak about those. Last year, we set out to engage with our first wave of six target states and to launch partner programs. We exceeded our state engagement goals in 2025, expanding discussions 13 states, and met our goal of engaging in now two live partner programs. We expect these partner programs to play a critical role in shaping policy, validating economics, and informing future contracting discussions. We're maintaining our disciplines, geographic-focused approach, targeting expansion of up to 15 to 17 states by year-end, representing 58 to 60 percent of U.S. birth This strategy allows us to deepen our traction in our existing target states while thoughtfully adding new ones. With a focused growth plan, we are on track to be running five to seven partner programs by the end of 2026. Lee will detail our execution, 2026 KPIs for states in active discussions and partner programs, as well as how we expect to convert engagements into coverage pathways. In Europe, We continue to make steady progress towards unlocking a significant, largely unaddressed obstetric care opportunity. Over the last two years, we have advanced our regulatory pathway for the preterm global test and are working towards CE marking approval. We remain on track to submit our European dossiers in the coming months. Importantly, recent European expert commentary published in the Journal of Maternal, Fetal, and Neonatal Medicine reinforces that current prevention strategies miss most women who deliver preterm and highlights our prime study approach as well aligned with European healthcare systems. Alongside ongoing engagement with regulators, clinical leaders, and patient advocacy groups, we're building the foundation needed for successful market entry following regulatory clearance. We continue to expect revenue growth to build gradually as partner programs mature and real-world evidence results are generated and disseminated. will remain disciplined, investing in market access, commercial infrastructure, and state expansion in a measured way. With that, I'll hand it over to Lee to discuss our commercial execution. Lee?
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