Sera Prognostics, Inc.

Good afternoon and welcome to the SARA prognostics conference call to review third quarter fiscal year 2022 results. At this time, all participants are in a 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, Danielle. Good afternoon, everyone. Welcome to Sarah Prognostics' third quarter fiscal year 2022 earnings conference call. At the close of the market today, Sarah Prognostics released its financial results for the quarter ended September 30, 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 sarahprognostics.com. This call can be heard via live webcast at sarahprognostics.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 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 8K. 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 in the Investors section of our website. I will now turn the call over to Greg, SARA Prognostics Chairman, President, and CEO.

Greg? Thank you, Peter, and good afternoon, everyone. Today, I'll review some highlights on our execution during the quarter and give some expected upcoming releases of clinical data and other developments. Seroprognostics' vision is to deliver pivotal and actionable information to pregnant women, their physicians, and healthcare payers to significantly improve maternal and neonatal health and to meaningfully reduce healthcare costs. Toward that end, we are establishing a new paradigm in the care of moms and babies with our first-of-its-kind preterm test to determine the risk of spontaneous preterm birth so that proactive steps can be taken to improve health outcomes. The ability to improve these outcomes while decreasing escalating health care costs is particularly attractive to forward-thinking individuals and organizations who are seeking to find new methods to solve big health care problems. A word on commercial progress. on early adopter systems. Over the last couple of quarters, we've communicated that early adopter systems are a strong focus for us and that we have aligned our sales structure to pursue contracts cost-effectively with these types of organizations as a means to efficiently establish revenue while reducing these customers' financial burden for prematurity. We expect revenue growth to accelerate as we implement commercialization in these organizations during 2023 and later. One important example of organizations that tend to be early adopters is integrated delivery networks, IDNs, and our strategy is beginning to pay off. We recently announced teaming up with Banner Health to make CIRA's preterm test available to its university family care access complete care members as part of the routine prenatal care they receive. Through its integrated delivery network, Banner serves more than 300,000 Banner Health Access members in 10 Arizona counties and has a strong commitment to reducing the adverse consequences of preterm birth. Banner is also respected nationwide as an innovative leader in new health care models to optimize members' health and reduce costs. The beauty of working with an integrated delivery network is that there is a focus on making sure that all aspects of care for members are tightly coordinated philosophically, administratively, operationally, clinically, and financially. Such organizations are committed to providing cost-effective solutions for healthcare services. Incentives can be more readily lined up to achieve that goal in such organizations. Given the health and financial consequences of prematurity, These kinds of organizations are well situated to take advantage of the preterm test and treat paradigm. As you can imagine, as preterm testing is deployed across these organizations, communications must take place with key stakeholders. For example, obstetricians, individual physician office staff, IT administration, accounting, laboratories, and patient outreach services in order to enhance the effectiveness of rolling out CIRA's life-changing preterm strategy. We believe that these efforts we are putting in place should accelerate revenues in the quarters and years to come and the lessons learned in the early implementations can be applied to other systems. The Banner Health Opportunity is also reflective of our keen desire to help solve healthcare inequity and disparities among lower income and or underserved populations. This is an important initiative which I'll touch on more in a moment. But specifically, a large number of Medicaid patients are covered under Banner's program, thus enabling these patients to have access to our preterm tests and evidence-based preventive care. Key analyses by outside parties continue to show the profound value that our test and treat strategy provides, as illustrated by our announced collaboration last month with Sunrava Health, a national family of health and wellness companies, which includes Western Dental, and Cerebrae, recently renamed Accorded an innovator in pricing and measuring the financial value of health care. Cerebrae Accorded is a leader in utilizing its technology platform that leverages actuarial and data science to accurately forecast financial risk and monitor a health care solution's performance. Working together, the parties were able to forecast the financial return on investment, the inclusion of the preterm test, for Sundarabia's employees and their growing families is expected to provide. The result was the inclusion of our test in their comprehensive maternity benefits package. This serves as another strong endorsement of the clinical utility of the preterm test and the ability to reduce immediate and long-term treatment costs associated with premature birth when compared to routine care. Our commercial focus then is on early adopter systems, which include integrated delivery networks, managed care Medicaid plans, self-insured employers, hospital systems, and selected large physician practices. These organizations are keenly aware of the fact that there are far too many with significant short and long-term health challenges and costs. In this early period of commercialization, while we focus our sales efforts on these large early adopter organizations, we will be making selective announcements as permitted. but we're now on healthcare disparities. I'd like to highlight aspects of CIRA's long-term commitment and work to address healthcare disparities. From the earliest days at CIRA, we have ensured proper representation of underserved members of society across multiple U.S. and foreign sites that were involved in our studies to discover and validate world-class prediction and impact for preterm birth. The goal has always been to be inclusionary of disadvantaged populations of patients suffering health disparities to ensure that our biomarker predictions would have outstanding performance for those that need them the most. Early on, we made contact with the Gates Foundation, knowing that creating cost-effective biomarker solutions for preterm birth in low- and middle-income countries would also be very informative and helpful for the broadly diverse U.S. population. We have subsequently conducted validations of biomarker prediction for preterm birth in populations located in U.S., Europe, Asia, and Africa. In our prime study recruitment efforts, we are currently including sites where preterm birth rates may be as high as double the average U.S. prematurity rate in order to better evaluate the extent of this problem and demonstrate the value of more proactive care solutions to underserved segments of U.S. populations where the consequences of prematurity are most severe. A rigorous clinical utility economic analysis on applying preterm testing to a diverse population was recently completed. We believe the data in this model will illustrate the clinical benefits and cost effectiveness of the test and treat strategies across individuals with diverse racial and ethnic backgrounds. This work is undergoing scientific review prior to its publication, and we will announce the results publicly when they are available. As a consequence of all these efforts, CERA's preterm test is ideally suited to help make a difference in underserved patients who experience health care disparities here in the U.S. Our company is proud to have worked to create and now to commercialize the preterm test that we believe can have substantial value in addressing the adverse consequences of prematurity in these populations who need it the most. Now a word on the prime study recruitment. As a reminder, the PRIME study is a multi-centered randomized controlled trial across 15 U.S. sites to demonstrate the impact of the preterm test and treat strategy on the consequences of prematurity. As enrollment continues, we are confident of having sufficient numbers of subjects across sites to enable the interim look analysis to take place in 2023. Now some color on our pipeline and sample collection improvements. Beyond our growing list of contracted payers, we continue to make progress in developing new tests that will expand our robust biomarker pregnancy pipeline. We have successfully validated prediction for preeclampsia for blood samples drawn at the same time as our preterm test. We are looking forward to the public release of preeclampsia validation data before year-end. SIRS pregnancy prediction pipeline is on track with validations of other biomarker signatures as well. that additional validated proprietary biomarker signatures will further demonstrate the value of our technology platform and be the basis for future products to benefit moms and babies. Over time, we expect that this growing body of pregnancy products will support our growth in the years ahead and our reputation as the pregnancy company. We're also pleased now to have successfully validated an ambient temperature blood collection transport system for preterm testing, which is expected to facilitate a larger number of sites where patients can have blood conveniently collected and sent to Sarah's lab. This should also reduce our cost of goods sold by eliminating the requirement to use dry ice. I'll now turn over the call to Jay for a review of our third quarter financial results. Jay?