Good afternoon, and welcome to the Sera 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 DeNardo of CapComm Partners for a few introductory comments.

Thank you, operator. Good afternoon, everyone. Welcome to Sera Prognostics fourth quarter fiscal year 2024 earnings conference call. At the close of the market today, Sera Prognostics released its financial results for the quarter and full year ended December 31, 2024. Presenting for the company today will be Evguenia Lindgardt, President and CEO; and Austin Aerts, 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 sera.com. This call can be heard live via webcast at sera.com and a recording will be archived in the Investors 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. 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, Sera Prognostic's 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 Sera'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 are now poised to take advantage of a new phase following pivotal PRIME study results to pursue evidence 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 fund raise 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 31, and during our virtual R&D event later that day. Prior to that, the 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 the 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 Iriye, 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. Iriye recapped that the PRIME study was conducted at 19 locations and included an intent-to-treat population of 5,018 patients in a randomized controlled trial designed to represent the gold standard evidence in our portfolio. Our PreTRM 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. Iriye 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 health care 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 the current tools. Since we published this meaningful data, the 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 data sets derived from our studies; providing more real-world evidence of the health care 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, as for the SMFM and ACOG position on PreTRM 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 from the Institutional Review Board for a pre-implementation study at a premier hospital network to observe the impact of our PreTRM test with intervention in the real world. We look forward to continuing building awareness of PRIME results at the upcoming American College of Obstetricians and Gynecologists 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 PreTRM 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 key geographies will allow us to drive density of adoption, awareness, and test utilization where we have achieved reimbursement and build 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 the European Union and fund additional studies designed to increase adoption of PreTRM, including monitoring milestones set for FDA oversight of LDTs. 2024 was the third consecutive year the United States received a D+ 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 health care 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 3:1 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 the PRIME study site is located, or where we have strong opinion leader support and where we have line of sight to payer coverage. We're analyzing the geographies where these conditions are met and will 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 PreTRM test. 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 PreTRM test there. With our product pipeline, we continue to work on our time to birth offering, here, just as with PreTRM, publications will help support awareness building and provide real-world evidence of the value of this technology. In early February, work by Sera'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, ADA 12, 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 expected mother's journey with our novel technology. To help advance the market opportunity we see ahead for Sera, 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 also announced today that our long-time Board members, Ryan Trimble and Marcus Wilson are stepping down in June after many years of service and commitment to Sera's mission. We are thankful to them for their role in taking Sera from start-up 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 Sera to the next level. Now I'll turn the call over to Austin. Austin?

Thanks, Zhenya, and good afternoon, everyone. Let me review our financial results for the fourth quarter. I'll then touch on our view of operating expenses for the year ahead and our plan to make selective investments that we believe will expand our commercial reach and revenue over time. Net revenue for the fourth quarter of 2024 was $24,000 compared to $41,000 for the fourth quarter of 2023. Total operating expenses for the fourth quarter of $9.4 million were up 6% from $8.9 million for the same period a year ago. Net loss for the quarter was $8.6 million compared to $7.9 million for the same period a year ago. Research and development expenses were $3.1 million, down from $3.9 million for the fourth quarter of 2023, due primarily to reduced expenses related to our PRIME study, which stopped enrollment at the end of 2023. Selling, general and administrative expenses for the fourth quarter were $6.3 million, up from $5.0 million for the fourth quarter of 2023, due primarily to focused spending on commercial activities aimed at broadening awareness of the PreTRM test to begin growing test volumes and sales over time. As of December 31, 2024, the company had cash, cash equivalents, and available for sale securities of approximately $68.2 million. As noted previously, in February 2025, we raised $57.5 million through a public follow-on offering that allows us to significantly expand our commercial operations in 2025 and beyond, while also securing a cash runway through 2028. Despite the capital markets environment continuing to be extremely challenging, particularly within our space, we believe investors see the promise of what our technology can do to improve the lives of mothers and babies and drive the future growth for Sera. We are thankful for their continued support. We previously communicated that our expectation that 2024 gross cash expense would be less than $30 million and we're pleased that our careful cash management during the year resulted in a gross cash expense of about $28.6 million. For 2025, which will be a year of building our business commercially, our targeted range for cash operating expenses is $30 million to $35 million. With the expectation of PRIME being published, we see this as a pivotal year in which to pursue engagement with and adoption by key stakeholders. As a result, this increase in operating expense is primarily driven by planned new and significant investments in commercialization. While we remain steadfast in prudent oversight of our capital resources, we have begun investing in both broad awareness and targeted education campaigns to begin to build adoption of the PreTRM test on the heels of exciting PRIME study data. Once we have published PRIME Data, we will expand our investment where we believe the commercial opportunities have the highest likelihood of near-term success and return on investment for our business. The amount we ultimately invest in 2025 will be dictated by the timing of a PRIME publication and the commercial opportunities presented for preterm and potentially our pipeline.

Ladies and gentlemen, we will now begin the question-and-answer session. Your first question comes from the line of Dan Brennan from TD Cowen. Please go ahead.

Great. Thanks for the questions. Maybe just the first one on the three tenants of your plan to get into guidelines. You talked about publishing more information, providing more real-world evidence on health care and economic benefits and then driving clinical community adoption, and getting institutions on board. Can you just elaborate a little bit on each of those and kind of things investors should be looking for in 2025 on each of those fronts, that will give people confidence that you're making progress?

Absolutely. Great question. So first, on the publications front, as you can imagine, with our 5,000 patient trial PRIME, we have unleashed an enormous treasure trove of data and have 19 PIs who are currently looking at the data and have discussed plans for further analysis of the data set and discussing half a dozen to a dozen potential topics that may end up in additional publications from the PRIME data set. We think that the more value can be derived from the PRIME data set in new publications, the more evidence there will be in the market about the value of the test and treat strategy of PreTRM test. Of course, PRIME is not the only data set we have. We are looking forward to broader analyses from the other studies that we have conducted, namely, potentially prevent and, of course, any future evidence we generate. So that's on the publication front. The second tenet is real-world evidence. We truly believe that learning how the test performs in the real world and partnering with leading institutions to study aspects of it, both in different populations in the context of health disparities, for example, will be accretive to adoption and awareness building across the clinical community. So as I mentioned, we are kicking off the first real-world evidence study this year. And with a preeminent institution, we will absolutely publish on the results of this study and look forward to sharing the outcomes of that work. We're planning to launch more real-world evidence trials and generate a continuous flow of evidence on how well the test is performing. Additionally, we've launched an investigator-initiated research program at the Society for Maternal Fetal Medicine Meeting in January, and are looking forward to all of the submissions review and communicating back to the investigators on the results of which studies will support come April of this year. We're hoping that the investigator-initiated research will also provide a lot of interesting evidence around the test that will help whenever the professional society chooses to review the policy and recommendations on preterm birth care to take into account all of the evidence that these three levers generate. The last tenant, I talked about was generating clinical adoption, of course. As you can imagine, a lot of the early adopter physicians and institutions will put the test to use in the real world. And the more adoption we generate, the more, of course, questions will be raised to the professional societies on what is their formal position on utilization of PreTRM test and our screen and test strategy. So we believe that all these three avenues of supporting evidence generation and momentum for PreTRM test will pull forward getting to professional recommendations on how this test should be used in the community.

Great. As a follow-up to your prepared remarks about Medicaid, where you mentioned it covers 43% of births and highlighted Nevada and Louisiana, could you elaborate on the Medicaid opportunity and your plans moving forward? Additionally, what are the expectations regarding how Medicaid will evaluate a test like this? Is it a lengthy process for Medicaid to approve coverage for this test, or could it happen more quickly?

Great. Another great question. Well, Medicaid, as you can imagine is our single biggest payer in the United States. And 27% of all inpatient costs that Medicaid covers are related to childbirth and neonatal care. So of course, maternal care and neonatal care slice of Medicaid budget is substantial, with tens of billions of dollars that are spent on both childbirth and the first year of a baby's life that is covered in most cases by Medicaid. So our test and its very low number needed to screen to save a NICU day and again, very low number to save a NICU admission is an enormous opportunity for Medicaid leaders to reduce Medicaid budget costs without cutting benefits. We think at this moment in time when, unfortunately, the United States has struggled to reduce the rates of preterm births in spite of many innovations in the last couple of decades. We now have both the momentum of the community around clinical breakthrough research and also focus by Medicaid administrators on cost reduction. We believe that, that momentum of both innovation, support of research, and potential to save money will be a catalyst for Medicaid moving faster than usual in covering the innovations that can help the community. So of course, it will be different state by state, given a different plan shape across the states. But the reason we want to start focusing on the states most hard hit by preterm birth, is that's where it will become a priority for the administrators to adopt innovations that can make a difference in clinical outcomes as well as save on the budget. So we look forward to and are engaging as we speak, with Medicaid plans across the country and are looking forward to coming back to which states would jump in with us to start adopting our screen and treat strategy. It is unusual for a screening test to generate savings and especially generate savings within a year, given the test is administered in the second trimester, and within six months, the baby is born, and therefore, the savings are realized. So we think it could be not a multiyear affair, but we could make some really nice inroads even this year. So we'll, of course, keep the community appraised of our progress.

Perfect. And then maybe just on the guidelines. So between SMFM and ACOG are both important is one more important than the other? And any way to think through given the feedback so far from the PIs and the doctor community in your plans? Is this possible in the next year, two, three or is this something that given predicates could take four, five, six years? Just any thoughts on how investors might contemplate the opportunity for you to get in guidelines?

Great. Well, it's hard to say which society is more important because ACOG and SMFM work together on the guidelines. And specifically on the ACOG Bulletin 234 that governs preterm birth, which is an ACOG bulletin, but the Society for Maternal Fetal Medicine is an enormous influencer and partner in developing those guidelines given their expertise in addressing higher risk pregnancies and preterm birth. And in this case, we think that they will work together. There are precedents when the Society for Maternal Fetal Medicine went ahead with practice advisory separately for ACOG, but given how important preterm birth is to the community, we think they will very, very likely work together on it and will be equally important. Hence, we're engaging with both sets of experts and opinion leaders from both societies. Now as far as the feedback so far from opinion leaders, that we are hearing, of course, everybody is eager to dig into the data, like, investors and analysts, we frequently get the question, when is the publication coming? To which our answer is, we don't know quite yet, but we're working very hard on it. And hopefully, it is imminent in the coming months. Happy to dive deeper into the questions around the data, which you can probably anticipate questions like what subpopulations, for example, first-time moms or second, third-time moms, are there performance differences for the screen and treat strategy, other differences in the usage of particular intervention levers like aspirin, etc., etc. But we are working with our principal investigators to see them the questions that we receive and hope that they pick them up and address them in the publications. What RPI is saying, all of our principal investigators are incredibly committed to bringing innovative solutions and bringing great research and rigorous science to the community. And we're excited that we have seen several of them step up and start discussing with us what potential topics they might want to take up and look at the data for a possibility of a publication or post-recession or digging into the analysis and the data of it. So we're excited about their level of engagement. And given the 19 sites and 19 PIs, we're definitely hoping to generate a lot of evidence coming out of that work, which, of course, is critical in terms of the number of references that will exist for ACOG and SMFM committee, which whether it is one, two, three years from now or more will be formed to review all of the available literature and evidence. The more we can create evidence, the better. And to your fundamental question, what is our best guess if it could happen in the one, two, three year time frame or it could take longer? It is incredibly difficult to predict. However, I will say that the last time, the ACOG Bulletin 234 was updated was August 2021, and the societies typically update these bulletins every 24, 36, or 48 months. So it is prime time, no pun intended to potentially review these. However, we will be delighted if we have a bit more time to put more evidence out there, more publications out there for the review to take those into account. So it is very plausible that the review and update of Bulletin 234 will happen in the next one, two, or three years.

Great. Maybe one last question, and I apologize for asking so many. This one is for Austin. Regarding the cash on the balance sheet today and the increase in burn rate, could you walk us through how long you anticipate the cash will last? What are some key assumptions behind that projection? Also, any insights on where costs are headed this year? Thank you.

Thank you, Dan. We believe our cash runway extends into 2028 based on our current operating plans, which, as mentioned in our prepared remarks, include a range of cash operating expenses between $30 million and $35 million for this year. The specific amount we will spend within that range will depend on the commercial opportunities that arise. The majority of the increase in spending compared to last year's approximately $29 million will be allocated to commercial investment. Over the next two to three years, we expect the primary increase in operating expenses to focus on this commercial investment. To reach the 2028 target, we anticipate some rise in spending over the next three to four years, which will be partially offset by net assumptions or modest revenue expectations, though we hope actual revenues will exceed these modest estimates during that timeframe.

Your next question comes from Andrew Brackmann from William Blair. Your line is now open.

Hi, everyone. This is Maggie Boeye on for Andrew Brackmann. Thanks for taking our questions. Maybe first, if you could just dive into those commercial investments you were just talking about. What can we expect for 2025 and here on out for what the focus will be? What you're thinking about how big your commercial organization needs to be as you continue to build PRIME evidence and drive adoption of PreTRM? Thanks.

Hi, Maggie, it's great to speak with you. Let me address your last question about the size of our commercial organization and our plans for growth in this area. We are currently focused on building our sales team with regional account managers to enhance on-the-ground adoption in targeted states. This involves creating a strong network of influence with opinion leaders and clinicians, organizing speaker programs, and securing institutional support and individual clinician adoption in those states. We are collaborating with our partners to ensure awareness and coverage from public payers to support these initiatives. Additionally, we are enhancing our medical liaison team, having added a head last year, and we anticipate increasing our field presence in select states as needed. We also expanded our revenue cycle organization last year and aim to optimize it this year based on the pace of uptake, as it's essential for revenue collection. Finally, we are looking to grow our payer group to improve reimbursement relationships with both government and commercial payers and engage with employers, consultants, and others. As we gain momentum and more states come into focus, we will continue to expand our commercial presence progressively across different regions. I hope this provides clarity.

Got it. Thanks. Yeah. Thanks so much. And then just maybe one on the pipeline. Can you talk about what we should be expecting for pipeline initiatives in the near term? And just kind of level set us on where things stand around the launch of the time to birth assay? And then just relatedly, any update on how you're thinking about the pricing of that test when launched? Thank you.

Definitely. So, as we've talked about before, we've prioritized two products from our pipeline to bring to market near term, that's the Time to Birth product, which we are targeting in the second half of this year. And the second one is the Predictive Analytics product, which we are beta testing across the country and are hoping to get to production scale release in the second half of this year as well. In terms of pricing of the Time to Birth product, it is truly a consumer-directed test, even though it will be helpful for both consumers and physicians. So as an immunoassay, it's priced at $150 or around that. So it should be accessible and affordable.

Great. Thanks so much for taking our question.

Thank you for the questions.

There are no further questions at this time. So I'm going to go ahead and turn the call over to Mr. Zhenya Lindgardt for closing comments. Ma'am, please go ahead.

Thank you, operator. Thank you all for attending our call today. We are really pleased with our progress during the year, and of course, more recently in being able to share the results of PRIME as we await expected publication of the full study results, which will provide more evidence of the value of utilizing our PreTRM Test and Treat strategy. We're thankful for the support of our investors, including those who participated in our recent fund raise that see the great opportunity that lies ahead for Sera. I’ll now turn it back over to the operator to conclude the call. Operator?

This concludes today's conference call. Thank you, everyone for your participation. You may now disconnect.