Sera Prognostics, Inc.

Good afternoon and welcome to the CIRA Prognostics conference call to review second quarter fiscal year 2025 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' second quarter fiscal year 2025 earnings conference call. At the close of the market today, Sarah Prognostics released its financial results for the quarter ended June 30, 2025. Presenting for the company today will be Jenya Lingard, President and CEO, 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 serra.com. This call can be heard live via webcast at serra.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. I will now turn the call over to Zhenya, Sarah Prognostics President and CEO. Zhenya?

Thank you so much, Peter, and good afternoon, everyone. We're continuing to advance Sarah's commercial progress and building momentum in our business. Today, I'll review how we plan to grow market awareness through data generation. I'll then review our commercial strategies and tactics and how we're engaging with professional society's opinion leaders, to support our role as the pregnancy company. In terms of data generation, we continue working towards the publication of our full prime study results in a peer-reviewed publication. This first prime publication will include the strong primary outcomes we shared earlier this year, as well as new and compelling data points from the study demonstrating the efficacy of the preterm test. We remain actively engaged with the reviewers and remain optimistic the publication will occur before year end. We know publication is important to our stakeholders, and we will keep you apprised and certainly announce publication as soon as it arrives. I will note that from a commercial perspective, payers have shown high willingness to engage with us on the abstract and podium presentation by our principal investigator at the Society for Maternal Fetal Medicine, or SMSM, meeting last January, allowing us to make progress on our reimbursement strategy. To add to the strong and compelling data from this initial prime publication, we plan to swiftly follow up with additional publications of data on health economic benefits, subpopulation analysis, for example, first versus second, third, fourth time moms, and Medicaid, expected cost savings of Sarah's preterm test. Many state Medicaid programs cover the first 12 months of health care for newborns, and we believe the cost-saving benefits of preterm tests will be very compelling as state governments seek to reduce overall Medicaid costs. As a reminder, our prime study results reported in January demonstrated that we can save one very expensive neonatal intensive care unit, or NICU day, by screening on average just three to four patients with the preterm test. As a reminder, the average cost of one NICU day is about $4,000, but for the earliest born, and depending on the procedures and equipment used, the cost could be up to $20,000 per NICU day. Prime data indicates Medicaid programs can break even and recoup savings without cutting benefits, and our conversations with Medicaid organizations support that view. Beyond NICU savings, in a 40,000-member health economic analysis, Elevance modeled both NICU savings and the first 12 months of healthcare cost savings amounting to $1,600 per member tested with preterm test. Commercially, as I shared before, we're focusing our sales and marketing efforts in several geographies where we see synergistic commercial momentum with Medicaid plan pilots, local opinion leader support, early adopter institutions, prime study site locations, and other opportunities, which we believe could combine to drive clinical utilization of our tests in that region quickly. We've continued to be highly engaged with many healthcare provider organizations in these targeted states. Regarding Medicaid planned pilot programs, while still early in the process, I'm pleased to report that we're seeing notable traction in two particular states with above-average premature birth rates and growing momentum in two additional states. We're hopeful we can execute signing on two to four pilot programs within the next few months and we'll keep you updated on these opportunities in the coming months. Beyond Medicaid, we continue to target other payers of all sizes that have a growing desire to provide attractive healthcare benefits while managing escalating costs. Our focus here is on those that are innovators and have a substantial covered member presence in our target states where we have or are building our sales force to maximize the return on investment relative to our sales efforts and resources. In our sales efforts, we have begun hiring additional sales representatives in these geographies to build awareness and establish the foundations for pull-through as these commercial opportunities launch. We expect that it will take a couple of quarters for each new representative to begin driving adoption of the preterm test within their territory, but we are excited to be investing into these commercial opportunities. We've also recently made key strategic leadership hires in our commercial team and beyond in order to expand Sarah's commercial reach and increase awareness among physicians, patients, partners, and investors. As announced in May, Lee Anderson was appointed Chief Commercial Officer. Lee is an accomplished leader in driving sales within the healthcare and diagnostics space. He brings to Sarah more than 30 years of cross-functional leadership experience in sales, marketing, customer service, strategic accounts, and training. In his first 90 days at the helm, Lee has been focusing on building out our commercial organization, namely sales and market access. In July, Lee brought on board Chuck Hyde, who joined Sarah as the head of market access. Chuck has over 20 years of experience in opening up markets following leadership roles in oncology diagnostics and pharmaceuticals. He also previously held an instrumental role in guiding the payer team for a groundbreaking cancer diagnostic company. Chuck will focus on broadening reimbursement for our preterm tests across government and commercial payers. Now that we have passed through the R&D phase and into what we believe is an evident pathway for commercial and revenue growth, we are also ramping up awareness of SARA among the investment community through the recent appointment of Jennifer Zabuda, head of our investor relations. Jen is an experienced buy-side, sell-side, and healthcare investor relations professional. I hope many of you have a chance to connect with her in the coming weeks. We welcome Lee, Chuck, and many new members of our sales team and Jen on board and look forward to their contributions in growing upon Sarah's success. As we stated earlier, we are excited to be sharing new data broadly with the professional societies and clinical communities. We'll also continue to have a strong presence at upcoming medical conferences. sharing this data with the clinicians. Data on health economic benefits will be shared at a leading European conference this fall. In October, Dr. Iria will be presenting prime data at the First Renaissance Conference, The Three Ages of the Woman, being held in Italy. We also plan to bring additional prime insights to the SMFM annual pregnancy meeting in February, 2026. With the power of real-world evidence on how preterm can support customized treatment, We're planning on getting as much data out there as soon as possible before the American College of Obstetrics and Gynecology, or ACOG, chooses to update guidelines so that our published data is included in their review. Part of this process includes meeting with innovative maternal and fetal medicine clinicians, key opinion leaders, and others who can evaluate the role of newer technologies like preterm tests. As our commercialization gains momentum in the coming quarters, we will start reporting on key commercialization performance indicators and may include sales activity metrics, scale of reach of physicians via direct and digital channels, payer contract wins, and, of course, eventually revenue. The last item I wanted to update you on is the progress we've been making in Europe. Over the last 18 months, SARA has advanced the commercialization preparation of the preterm tests in Europe, where the unmet need for preterm birth risk assessment is well-recognized. European healthcare systems acknowledge preterm birth issues, and the established pregnancy management protocols are aligned with Sarah's studies and allow for easy incorporation of the preterm test, and there is no effective competition. To enable a successful market entry, we are transitioning the preterm test from mass spectrometry to an immunoassay, focusing initially in the UK, France, and Germany. We are engaging with the European regulatory agencies as well as medical leaders to generate evidence that meets the standards required for regulatory approval, reimbursement, and clinical adoption. Our goal is to make a submission to these regulatory agencies in early 2026, sign a commercial partnership agreement, and begin preterm test implementation from mid-2026 onwards. In summary, we believe that through the year end, We will build on the body of evidence illustrating the value of preterm tests while further establishing the commercial building blocks needed to grow market awareness and revenue. Now, I'll turn the call over to Austin. Austin?