Good afternoon, and welcome to the Sera Prognostics Conference Call to review Second Quarter Fiscal Year 2025 Results. 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 Second Quarter Fiscal Year 2025 Earnings Conference Call. At the close of the market today, Sera Prognostics released its financial results for the quarter ended June 30, 2025. Presenting for the company today will be Zhenya 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. I will now turn the call over to Zhenya, Sera Prognostics' President and CEO. Zhenya?

Thank you so much, Peter, and good afternoon, everyone. We're continuing to advance Sera'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 societies and 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 PreTRM Test. We remain actively engaged with the reviewers and remain optimistic that 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 SMFM 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 Sera's PreTRM Test. Many state Medicaid programs cover the first 12 months of health care for newborns, and we believe the cost-saving benefits of PreTRM Test 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 PreTRM Test. As a reminder, the average cost of one NICU day is about $4,000, but for the earliest born, 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 health care cost savings amounting to $1,600 per member tested with PreTRM 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 test in that region quickly. We continue to be highly engaged with many health care provider organizations in these targeted states. Regarding Medicaid plan 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 health care 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 PreTRM 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 Sera'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 health care and diagnostics space. He brings to Sera 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 Sera 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 PreTRM Test 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 Sera among the investment community through the recent appointment of Jennifer Zibuda, Head of our Investor Relations. Jen is an experienced buy-side, sell-side, and health care 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 Sera's success. As we stated earlier, we are excited to be sharing new data broadly with the professional societies and clinical communities. We 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. Iriye 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 PreTRM 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 PreTRM Test. 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, Sera has advanced the commercialization preparation of the PreTRM Test in Europe, where the unmet need for preterm birth risk assessment is well recognized. European health care systems acknowledge preterm birth issues and the established pregnancy management protocols are aligned with Sera studies and allow for easy incorporation of the PreTRM Test and there is no effective competition. To enable a successful market entry, we are transitioning the PreTRM Test from mass spectrometry to an immunoassay, focusing initially in the U.K., 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 PreTRM 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 PreTRM Test while further establishing the commercial building blocks needed to grow market awareness and revenue.

Thanks, Zhenya, and good afternoon, everyone. Let me review our financial results for the second quarter. Net revenue for the second quarter of 2025 was $17,000 compared to $24,000 for the second quarter of 2024. Total operating expenses were $9.3 million and flat with the same period a year ago. Research and development expenses of $3.3 million were down from $4.4 million or approximately 24% relative to the prior year period due to lower clinical study costs following the completion of the PRIME study and a shift toward commercialization. Selling, general and administrative expenses for the second quarter were $6.0 million, up from $4.9 million for the second quarter of 2024 as we continue to carefully invest in targeted commercial activities, build market awareness, and recently add strategic headcount to drive future revenue. Net loss for the quarter was $8.0 million, down from $8.3 million for the same period a year ago due to our continued focus on managing capital resources ahead of expected revenue expansion. As of June 30, 2025, the company had cash, cash equivalents, and available-for-sale securities of approximately $108.5 million, which we expect will fund the company across significant adoption and commercial milestones through 2028. We will continue to be good stewards of our cash position as we build towards revenue inflection, and we'll continue to invest where we see opportunities with commercial merit that could expand preterm awareness and test volumes.

We can now please open the call for questions.

This is Maggie Boeye on for Andrew today. Maybe first, just on your commercial efforts, given that you did add Lee in May. Can you talk about how we should be thinking about the different milestones as you continue to build out your commercial sales force? Has there been any shifts or changes since he has joined and potentially added new perspectives?

Maggie, thank you so much for your question. Good to hear you. First of all, of course, Lee brings in decades of experience from traditional commercialization playbook in diagnostics. And one of the first things in his remit was to take a look at our commercial strategy. One of the first elements that he added is the emphasis on just how much the test itself can help augment the care protocols for pregnancy in order to empower the physicians to select the right treatments and intervention methods. So we are very excited to emphasize that in our commercial messages and in the data that we generate and empower our sales team with. Second key priority for him was, of course, expanding our commercial team. And he brought his perspective on who are the types of sales leaders who can really propel us forward in commercial momentum with the strength of the data that we are receiving right now from PRIME study. So we have stepped up the level of seniority and experience in the reps that we brought in under his leadership. Last but not least, he is upgrading capabilities of the team, and that's where market access addition to our team, Chuck Hyde came in and allowing us to fire on all cylinders across both commercial payers, public payers, and generating demand from providers. I hope that's helpful.

That's great. And then just for my follow-up, I know we're anxiously awaiting the PRIME data publication as well as some additional data sets. But can you just update us on how conversations have progressed with guideline bodies thus far and where your expectations are at in terms of getting in guidelines at this point?

No, it's a great question. And I assure you, we are exactly where you are eagerly awaiting the publications of all of the results, and we'll keep all of you updated on that. The conversations around PRIME have been incredibly rich, both with the opinion leaders that influence and set guidelines as well as clinicians and payers. PRIME study delivered a very rich data set that is exciting for all involved because of the breakthrough results we're seeing. So they're asking us great questions. And the reason it's taking a bit of time is that it required, in some cases, additional analysis of the data set that we were hoping to leave for follow-on publications. But it's exciting that the community is very engaged, very interested and sees how much of a breakthrough saving one out of five babies from going into the NICU will be in today's day and age when the chances of a newborn ending up in the NICU are multifold higher than they were five, ten years ago. Thank you for the questions, Maggie.

This is William Ruby on for Dan. I guess my first question would be on the EU's plan to go to the EU. Just kind of wanted to get a little bit more of your rationale for doing that, just given the large market in the U.S. Is that going to increase cost at all? Just wondering if you could just give some rationale on the EU plan. And I'll just start with that.

William, great question. And for us, the opportunity for global impact has always loomed large, even if the U.S. market is absolutely by far the largest in that. That said, over the years, we've engaged with many European opinion leaders at various conferences. And they held up a mirror and said, why are you just focusing on the U.S., we really need it in Europe? And asked us to take our action to Europe as well even before we achieve significant trajectory in the U.S. So we decided to do that and started about 18 months ago working very closely with European opinion leaders in our focus markets because they felt we have a huge opportunity to achieve impact for moms and babies there as well. In terms of your question on additional cost, we're not intending to build out our own large footprint in Europe. We are aiming to and have been in deep discussions with partners across Europe to help us commercialize the test on the ground. So from that perspective, it would be an arrangement that is based on revenue sharing and the cost of commercialization falling on the partner balance sheet and P&L. So from that perspective, we're not anticipating a significant cost increase. We, of course, did need to invest to make the product ready for commercialization. But that we anticipate will have a very high ROI once we begin striking the commercialization partnerships next year.

Got it. And then wondering how many reps you've hired in the quarter? And then also just how getting coverage in a few of these high population Medicaid states drive hiring of additional sales reps?

Great question. So we have about a 10% sales force right now and are ready to hire more as soon as we see traction. Our approach has been to start with creating a fertile ground for reimbursement in particular geographies, and this is why I report the number of states where we see traction. Ideally, by the end of the year, we will see four to six geographies where that fertile ground of reimbursement has been achieved and staffing those geographies to allow us to drive density of adoption among the providers because, of course, we can share the good news with them that there is reimbursement for the test in their area. That is our approach, and we frequently talk about a phased rollout across states. So as soon as we get good reimbursement context for our sales team and we see traction, we will go ahead and take that commercial model to other states. Our access team is actually reaching out to a much broader set of states to start preparing this reimbursement engagement in an additional half a dozen states every six months or so. Does that answer your question?

If I could just ask one more question. Just going back, I think we talked about on the last call, there are some positive feedback with the ACOG 234 bulletin talking about the need for something for preterm birth. I'm just wondering if you had any more positive feedback with that ACOG 234 bulletin from just KOLs or physicians.

The discussions are not limited to the bulletin governing spontaneous preterm birth treatment. However, I did mention the significant change in ACOG's approach, where ACOG is now pursuing a tailored approach to care for all conditions in pregnancy. It has not always been a one-size-fits-all approach. There is a differential diagnosis, and physicians have treated it accordingly. For most low-risk women in pregnancy, which is the target audience for our test, there was a standard care protocol previously. With ACOG's announcement in April, there will be a much deeper integration of tailored care pathways, even for what were previously considered lower-risk pregnancies, by using additional risk stratifiers. This new integration allows for changes in care protocols based on findings and includes patients in shared decision-making with physicians, which is excellent news for us. For conditions in pregnancy that may lead to spontaneous preterm birth but do not typically show clear signs, this change sets the stage for us to propose a tool and evaluate all tools in the market, where we have a competitive advantage due to our test's strong data validating its clinical utility and analytical performance. We are excited about ACOG's movement in this direction. While we cannot discuss specific conversations with opinion leaders, they are closely watching the data we will release in the coming months to evaluate the incorporation of innovative risk certification tools into this new model of tailored care for higher-risk pregnancies using new instruments.

There are no further questions at this time. Ms. Lindgardt, please proceed with closing remarks.

Thank you, operator, and thank you all for attending our call today. Over the coming months, we look forward to sharing progress updates and additional data with our medical community stakeholders and Sera shareholders. This data will help us grow our business and Sera's impact on premature birth in the United States and, of course, abroad. We are excited by what lies ahead to take Sera to the next level. I'll now turn it back over to the operator to conclude the call.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.