Sera Prognostics, Inc.

Good afternoon, ladies and gentlemen, and welcome to CERA Prognostics Second Quarter 2026 Financial Results Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star 0 for the operator. This call is being recorded on Wednesday, August 12, 2026. I would now like to turn the conference over to Jennifer Zibuda. Head of Investor Relations. Please go ahead.

Thank you, Operator. Welcome to SARA Prognostics' second quarter 2026 earnings conference call. Earlier today, SARA reported financial results for the quarter ended June 30, 2026. Joining me on today's call are Zhenya Lindgardt, President and Chief Executive Officer, and Austin Aerts, Chief Financial Officer. Following our prepared remarks, we will open the call for questions. A copy of today's earnings release can be found in the Investors section of our website at SARA.com, and a replay of this webcast will also be available. Before we begin, please note that today's discussion will include projections or forward-looking statements around events and circumstances that have not yet occurred, including regarding our business, future financial results and performance, and market opportunities. These statements are based on our current expectations and are subject to risk factors and uncertainties that could cause actual results to differ materially and adversely from these expectations and forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, including our most recent forms 10-K, 10-Q, and 8-K, for important information regarding these risk factors. With that, I will turn the call over to Zhenya.

Thank you, Jennifer, and thanks to everyone for joining us this afternoon. Thank you for joining us. We also strengthened our clinical evidence base through publication of prime data in first-time mothers demonstrating significant reductions in NICU admissions and severe neonatal morbidity reductions while continuing to advance our European regulatory and commercialization efforts. Taken together, these achievements reflect increasing alignment among stakeholders around the potential value of preterm test-guided care and reinforce our confidence in a long-term opportunity ahead. We continue to expand payer discussions across the country as we execute our geographically focused commercialization strategy. Opportunities to expand access are being driven through engagements with payers, state agencies and legislators in markets where maternal health outcomes, Medicaid priorities and policy momentum create favorable conditions for converting market access into adoption. These conversations increasingly center not only on the clinical benefits of earlier risk identification, but also on the potential to improve outcomes, reduce the economic burden of preterm birth, and support broader healthcare affordability initiatives. Illinois provides an excellent example of the effectiveness of our commercialization strategy. Illinois was not originally included in the state supporting our peer engagement objectives for 2026. Yet, through increased awareness among providers, policymakers, maternal health advocates, and payers, the state emerged as one of the most active opportunities in our pipeline. While many stakeholders contributed to the legislative outcome, we believe growing recognition of preterm birth as a significant public health challenge and increased awareness of evidence-based solutions help create the momentum that led to statewide Medicaid coverage legislation. Importantly, this illustrates how our strategy extends beyond traditional payer contracting. By combining evidence generation, policy engagement, provider advocacy, and awareness-building activities, we're cultivating an ecosystem from which the conditions necessary for broader market utilization can organically emerge. We're also advancing discussions around innovative implementation models designed to integrate preterm test guided care within existing maternal health programs. This month, we launched our fourth partnership program, expanding implementation of preterm test guided care through a state-based initiative with a national payer. The program is intended to support quality improvement and maternal health objectives through a value-added benefits framework. Importantly, we remain on track towards our goal of establishing five to seven commercial programs as we continue to expand our footprint in targeted geographies. At the beginning of the year, we set a goal of doubling the number of payer discussions across 15 to 17 states during 2026. We're pleased to report that we have exceeded that objective and are currently engaged with more than 20 payer opportunities across over 20 states. Importantly, this expansion into new opportunities is driven through payer referrals and growing market awareness, leading existing payer contacts to introduce us to affiliated plans and decision makers in other states and expanding our pipeline more rapidly than anticipated. We believe this reflects broader acceptance of both the clinical value and health economic impact of preterm test guided care and reinforces the effectiveness of our focused commercialization strategy. As we move through the second half of the year, our emphasis will shift from initiating new conversations to advancing implementation, reimbursement readiness, and adoption within our highest priority opportunities. We believe the market access progress achieved this year has significantly expanded our commercialization pipeline. Today, our opportunities broadly fall into three categories. They are engagement and evaluation, implementation preparation and contracting, and continued provider activation in markets where access has already been secured. Each of these three stages represents a step forward in converting access into clinical uptake and testing volume increase. In many cases, opportunities that have secured access enter an implementation and contracting period that can take approximately six to nine months before utilization begins to scale. As opportunities progress through this commercialization pathway, our focus shifts from securing access to driving utilization. Through provider onboarding, workflow integration, champion development, and targeted awareness initiatives, we're building a repeatable model designed to translate market access into testing volume and revenue growth over time. We believe the breadth and maturity of our pipeline position many of these opportunities to contribute meaningfully as we progress towards early 2027. One of the most significant developments during the quarter was the passage of landmark legislation in Illinois. The new law requires the state's Medicaid program to provide coverage and reimbursement for prescribed proteomic blood tests used to identify and manage the risk of spontaneous preterm birth, along with associated care management services and interventions that have demonstrated improved outcomes. We believe the legislation represents an important milestone for maternal healthcare and validates that earlier identification and management of preterm birth risk can improve outcomes while addressing significant healthcare costs. We have already begun engagement with the Illinois Department of Healthcare and Family Services, managed Medicaid organizations, and provider stakeholders across the state. Over the coming quarters, we will work towards contracting, credentialing, provider education, workflow integration, and Implementation Readiness. With coverage established, attention turns to execution. Illinois is now progressing through the next phase of our commercialization playbook, which we refer to as Implementation Readiness and Contracting. We are advancing contracting and provider onboarding activities to support integration of preterm test guided care across both Medicaid and commercially insured populations eligible for testing. As the first state to formally recognize the clinical and health economic value of preterm test guided care, we believe Illinois can serve as a blueprint for similar initiatives nationwide. Evidence generation remains the cornerstone of our strategy, and we continue to strengthen our already substantial body of clinical and economic data supporting preterm guided care. In July, we published a prime subgroup analysis focused on first-time mothers, A population for which traditional risk assessment tools have limited predictive value. The findings demonstrated a 22% reduction in NICU admissions, a two-fold reduction among newborns following spontaneous preterm birth, and a 30% reduction in severe composite neonatal morbidity. The study also showed a number needed to screen and treat of just 28 patients to prevent one NICU admission. First-time mothers account for approximately 40% of pregnancies in the United States, making this an important population for broader adoption of biology-based risk assessment. We also remain on track for publication of our health economics analysis in the coming months. This work will further quantify the economic impact of preterm test-guided care and will be an important component of payer and reimbursement discussions. We were also pleased that two crime-related abstracts were accepted for presentation at the Society for Maternal Fetal Medicine Global Congress in October. One abstract was selected as an oral presentation and focuses on outcomes in first-time mothers. The second was recognized among the top poster presentations and highlights the economic impact of screen-guided interventions using our biomarker platform. These selections represent important external validation from the maternal fetal medicine community and reflect growing recognition of both the clinical and economic value demonstrated in the PRIAM trial. Importantly, our pathway towards future guideline inclusion remains straightforward. continue publishing high-quality evidence, expand collaboration with a broader network of key opinion leaders who are exploring the prime data set, and generate new clinical and economic publications that further strengthen the evidence-supporting preterm test guided care. Another highlight this quarter was the start of an ARPA-H-supported collaboration, which provides important validation of our scientific platform and biomarker discovery capabilities. The multi-institutional program is focused on developing a novel point-of-care diagnostic to help clinicians assess fetal hypoxia risk during labor and delivery, with SARA contributing its expertise in protein biomarker discovery and validation. More broadly, partnerships, grants, and collaborative research programs are an important component of our innovation strategy. These relationships allow us to advance our pipeline, expand our scientific leadership position, and pursue new opportunities with limited incremental investments from SARA while maintaining our primary focus on the successful commercialization of preterm test-guided care. We believe this collaborative approach enables us to create long-term pipeline value without diverting material resources from our core commercial priorities. Building awareness is a critical pillar of our commercialization strategy. In Q2, we advanced our thought leadership and educational initiatives with an on-demand webinar titled Improving Outcomes of Preterm Birth featuring Dr. Tiffany Inglis and Prime Lead Investigator Dr. Brian Erie. We also participated in a Medscape Hear From Her podcast featuring our team and Prime Investigator Dr. Molly McDonald. Importantly, we continue to execute these initiatives with a disciplined approach to spending, leveraging scalable digital platforms and third-party partnerships to maximize reach and impact. We also scaled digital and social engagement to reach patients, providers, and maternal health advocates. Here's why this matters to our broader strategy. Preterm birth is one of the most common serious pregnancy complications, yet most women remain unaware of it until it affects them personally. who, over the course of a pregnancy, women spend roughly 200 times more time on social media than with their provider. That's where awareness can begin. When patients learn to ask about preterm birth risk, they raise it with their OBGYN, and this is one of the ways that physician behavior can follow. Our consumer efforts reinforce, rather than compete with, our provider and payer strategies. Similar approaches have proven effective across diagnostics and healthcare innovation, helping drive awareness, access, and ultimately the adoption of evidence-based care. Still early, the initiatives in Illinois, partnerships with providers and payers, and the education and awareness for patients and providers are demonstrating their potential to accelerate provider integration into clinical practice and payer coverage, driving improved access in the fully integrated part of our commercialization strategy. Our European strategy includes also advanced during this quarter. European expert commentary supporting the role of biomarker-based risk prediction and biology-driven prevention strategies was published, and we convened a European expert advisory board representing nine countries. Participants recognized the preterm test as the first validated risk prediction tool for expectant mothers and affirmed the potential role of biology-driven prevention strategies across European healthcare systems. To support the strongest possible regulatory submission, we have elected to complete additional performance testing in our ELISA-based assay platform, a decision we believe strengthens the overall package while reducing execution risk. We expect pre-application activities to commence in the third quarter with submission of our full CE marking package to conclude in the fourth quarter of this year. Finally, we continue strengthening our leadership team and governance structure. During this quarter, we added key leadership capabilities in marketing and payer strategy, while also welcoming Mark Capone to our board. These additions further enhance our ability to advocate against our commercial and strategic priorities. In summary, the second quarter demonstrated meaningful progress across the key drivers of market uptake. We expanded payer engagement, saw an important Medicaid policy milestone in Illinois, strengthened our clinical evidence-based advanced our European strategy, and continued building awareness among providers and patients. While we remain in the early stages of commercialization, we believe these achievements further strengthen the foundation for future adoption and long-term growth. With that, I'll turn the call over to Austin to review our second quarter financial results.