SERA

Ladies and gentlemen, welcome to Sera Prognostics 1st 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 zero for the operator. Please be advised that this call is being recorded today, Wednesday, May 6, 2026. I will now turn the call over to our 1st speaker today, Jennifer Zibuda, Investor Relations. Please go ahead.

Thank you, operator. Welcome to Sera Prognostics first quarter fiscal year 2026 earnings conference call. At the close of market today, Sera Prognostics released its financial results for the quarter ended March 31st, 2026. 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, the actual events or results may differ materially and adversely from those 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.

Thank you, Jennifer Zibuda, and thank you everyone for joining us today. Given that we reported full-year results just over 6 weeks ago, I'll focus my remarks on several key developments that continue to advance our commercial strategy and expand access to PreTRM. Following the publication of the full PRIME study results in January, our primary focus in the 1st quarter was building awareness with both clinicians and broader stakeholders. Our education and outreach efforts were designed to broaden understanding of preterm birth risk and prevention, including among audiences that are difficult to reach through traditional healthcare channels. From a provider engagement standpoint, we maintained a strong presence across key clinical forums, including the SMFM annual meeting in February and more recently, the ACOG Annual Clinical and Scientific Meeting.

At SMFM, we highlighted key clinical evidence and engaged directly with maternal fetal medicine specialists on PreTRM's role in risk stratification and early intervention. We also engaged with SMFM leadership to discuss PRIME study outcomes. At ACOG, we built on that momentum with a targeted product theater that showcased both the PRIME data and practical implementation strategies, underscoring how PreTRM can be seamlessly integrated into routine clinical care. We have been featured in several targeted podcasts this year, which complements our presence at medical meetings and extends our reach. In March, the SHE MD podcast featured an interview with Hailey Bieber discussing her pregnancy and the PreTRM test, which she received under the care of Dr. Aliabadi, SHE MD co-host and Sera customer. This generated a high level of awareness of PreTRM, given Hailey's global visibility and social following, along with a subsequent People magazine exclusive interview.

The episode surpassed half a million views and continued to drive awareness. We engaged with SHE MD to record a new podcast episode releasing May 14th to coincide with National Women's Health Week. This interview will feature a conversation on the science behind Sera, the clinical evidence from PRIME, and how the preterm test needs broad awareness and should be considered a future standard of care. The episode discusses Dr. Aliabadi's experience with preterm tests over the last few years and the value of prevention and evidence-based risk identification. We hope you will all tune in next week. We will also be featured on Medscape's Hear From Her: The Women in Healthcare Leadership Podcast, engaging in conversation with the podcast host, Jelena Sporopulos, and Dr. Mollie McDonnold, maternal fetal medicine specialist at St. David's Women's Center of Texas in Austin, Texas.

The episode dives into the realities of preterm birth, the need for proper intervention, and what can be done to help patients. Together, these media efforts continue to drive awareness across patients and providers, policymakers, and payers who play an important role in improving pregnancy outcomes. Turning to our commercial progress, our efforts during the quarter remained focused on building sustainable access points and referral pathways that we expect to support our long-term volume and revenue. Adding to our 2 live programs, we launched our 3rd partnership program during the quarter, further expanding education and access to PreTRM.

This program is expected to reach over 350 providers across 3 states, expanding our clinical footprint and advancing earlier identification and intervention for at-risk pregnancies. Beyond these established pro-programs, we are contracting with additional partners and expect to provide more detail as these initiatives transition from contracting into live implementation. In parallel, we are now engaged in active discussions with 13 payers across 15 states, reflecting our strategy to deepen relationships with a focused set of target markets. We believe this concentrated approach is more effective in driving meaningful implementation and adoption than pursuing broader but less integrated engagement. Across all of these efforts, our priorities remain execution, reimbursement, physician awareness, clinical integration, and provider adoption. We view these steps as foundational to broader coverage and scale over time.

In addition to reimbursement, we are making steady progress in our efforts to drive guideline inclusion while continuing to expand the evidence base supporting preterm. As discussed in our year-end call, European expert commentary on the PRIME trial was published in The Journal of Maternal-Fetal & Neonatal Medicine in March. The authors emphasized that current preterm birth prevention strategies failed to identify the majority of women who ultimately deliver preterm and highlighted the alignment of the preterm approach with existing European healthcare systems. In March, results from the PREPARE survey were accepted for publication in the Journal of Women's Health. This survey examined preterm birth awareness and risk perception among women across five European countries and identified a meaningful gap between perceived awareness and actionable understanding, reinforcing the need for earlier and more standardized risk communication. We look forward to the formal publication expected in May.

Together, these publications support our stakeholder engagement efforts in Europe and underscore the global relevance of risk-based preterm birth prevention as healthcare systems increasingly emphasize prevention, education, and cost-effective maternal care. Looking ahead, we remain on track to publish several additional PRIME sub-analyses in 2026, including a highly anticipated health economic study, Medicaid population outcomes of the PRIME study, and a focus analysis of first-time moms, further strengthening the clinical and economic foundation for adoption. During the quarter, we also continued to advance our advocacy strategy. Preterm birth is not only a clinical challenge, but a public health and policy issue. We're engaging with stakeholders across multiple states to monitor and, where appropriate, support legislative initiatives and policy discussions focused on earlier identification and prevention, particularly in Medicaid and value-based care settings.

We also recently launched a targeted letter-writing campaign designed to encourage physicians and patients to engage with state Medicaid programs on reimbursement for the PreTRM test. The initiative is intended to amplify at the local level the existing clinical voice calling for access for at-risk populations. To date, we've seen encouraging participation with multiple letters submitted across several states reflecting growing physician advocacy and awareness. We believe these grassroots efforts will play an important role in advancing broader coverage discussions over time. Through these efforts, we continue to build awareness and alignment well in advance of formal coverage decisions and to help policymakers understand both the clinical and the economic burden of preterm birth. We view advocacy as an important complement to our commercial and scientific strategies. In Europe, we continue to make progress towards commercialization readiness.

We remain on track for a mid-year submission of our CE marking dossier and have had constructive discussions with regulators and clinical stakeholders. Engagement with our European advisor group continues to reinforce alignment around clinical utility, evidence requirements, and implementation considerations. On capital deployment, we have completed the next phase of our evolution from a clinical stage company to a commercial organization driven to secure reimbursement and revenue. Following comprehensive business review, we realigned resources, identified significant operational efficiencies, and streamlined R&D and G&A functions. We are prioritizing investments in payer engagement, market access, and clinical adoption of PreTRM. As part of this realignment, we are intentionally shifting capital away from R&D and Clinical Operations towards commercial and medical activities that directly support access and adoption.

Over time, this results in a meaningfully higher proportion of our operating spend focused on commercialization and medical engagement, with R&D becoming a smaller share of our overall expense base as we move into 2027 and beyond. These actions are expected to reduce our base operating expenses by nearly $10 million annually while enhancing our ability to focus capital on commercialization efforts. At this new operating level, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through 2029. By extending our runway by an additional year, we have positioned the company to capitalize on meaningful growth expected over the next 12 months and to achieve key access and commercialization milestones in the years to come.

To wrap up, the first quarter was characterized by awareness building and intentional positioning, expanding access points, strengthening referral pathways, advancing advocacy efforts, and continuing to build the scientific foundation necessary for long-term adoption. Everything we've discussed today reflects a consistent strategy focused on establishing the prerequisites for durable, scalable adoption. While these adoption cycles take time, we remain encouraged by the level of engagement we are seeing and confident that the foundation we are laying will support meaningful long-term pull-through. With that, I'll turn the call over to Austin.

Thanks, Zhenya, good afternoon, everyone. Revenue for the quarter was $14,000 compared to $38,000 in the first quarter of 2025. As expected, revenue in the quarter remained modest, reflecting the timing and nature of our geographically targeted commercialization strategy and our ongoing effort to build advocacy and awareness following the PRIME publication. Operating expenses for the quarter were $9.4 million, up slightly from $9.3 million in the prior year period, consistent with our expectations and reflecting disciplined cost management alongside continued investment in evidence generation, regulatory preparation, and advocacy activities. As discussed, following our business review, we expect to reduce our operating expense base by nearly $10 million on an annualized basis.

The benefit in 2026 will be limited due to the phasing of activities and related charges, with the majority of the savings expected to be realized in 2027 and beyond. Research and development expenses were $3.0 million compared to $3.3 million in 2025. With the PRIME study now published, R&D expenses will continue to decrease as we focus resources on activities that more directly drive commercialization and awareness building. Selling general and administrative expenses were $6.3 million versus $5.9 million in the prior year, reflecting our transition from clinical stage investments toward targeted commercial initiatives and strategic headcount. Net loss for the quarter was $8.4 million compared to a net loss of $8.2 million in the first quarter of 2025.

We ended March 31, 2026, with $86.8 million in cash equivalents, and available for sale securities. Based on our measured commercialization strategy and a more sustainable cost base resulting from the activities discussed earlier, we believe our capital resources will be sufficient to fund the company across significant adoption and commercial milestones through 2029. As Zhenya outlined, our strategy prioritizes building durable prerequisites for adoption. From a financial perspective, that means revenue in 2026 could remain modest and uneven as we continue pushing reimbursement, awareness and advocacy campaigns, and as programs move from setup to implementation, with increasing pull-through anticipated later in the year and into 2027. In summary, the first quarter reflects continued financial discipline alongside steady progress in laying the groundwork for broader adoption. We remain focused on execution as these initiatives mature.

With that, let's open the line for questions. Operator.

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number 1 on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any keys. Please be advised to ask 1 question and 1 follow-up. Your question comes from Tycho Peterson from Jefferies. Please go ahead.

Hey, team. This is Lauren on for Tycho. A few from me. First on the partner program. Could we get maybe a little bit color on the kind of profile of the 3rd partner, and kind of how it compares to the 1st 2? In terms of kind of the required cadence throughout the rest of the year to hit the goal of 5-7 partner programs, what that's gonna look like for the next 2 quarters. Second, for the new reps, I think you've talked about before how it could take 2 quarters to kind of see density of adoption and increased productivity. Are you measuring anything in terms of tests per rep per month or other KPIs that you're targeting for the 2nd half of the year for these reps? Thanks.

Lauren, thank you so much for the questions. On the programs, indeed, very exciting. The way we planned our pipeline of the potential programs is to launch roughly 1 a quarter to make sure that we swarm the organization and stand them up well. Each program typically is a combination of a payer and provider groups to ensure that the pull-through can happen on the ground in the offices quickly. We've learned over the last couple of years that it takes a few months to iron out how the patients who test for higher risk of PreTRM birth get cared for by the physician offices with the intervention bundle. We make it as seamlessly integrated into the workflow of those offices as possible.

For us, each of these programs, that's why 1 a quarter, roughly, and we're right on track with that with another launch this quarter. We first select how will the test get paid for, engage on reimbursement, then, with the payers, figure out what is the set of providers that are going to partner with us to adopt the test and get them ready for seamless integration to their workflow and delivery of the, of the intervention bundle. That is critical for fast recruitment, and delivery of the test to the participant, which of course in turn gives the results to, both payers and providers faster.

It's in all of the partners' interests in these programs to prepare well to get to, you know, for us to revenue, for them to impact faster. For many programs, we are engaged deeply with the state as well. On a quarterly basis, we report out the progress of the programs to the state Medicaid agencies, and these are usually public forums where other payers are present. Another reason why one a quarter is because there's a fair bit of follow-up with other payers in the state that have the Medicaid plans who are starting to also reach out and want to participate. We're excited to report that our pipeline of payers that we're engaged with is growing steadily from 10 payers in 13 states, which we reported last quarter, to 13 payers in 15 states.

We're still sticking to our target states, but what we're seeing happen is the payers that we're running the program with now for six to nine months, are introducing us to other parts of their organization that cover plans in other states, which is exactly what we were hoping for, and expanding with these payers into other regions. That's why we're pacing it one a quarter roughly, and you can certainly anticipate us announcing one per quarter.

Of course, we'll go faster if we can go faster, but I described the activities so that you get a feel for what an undertaking it is to stand up these pretty substantial provider institutions who partner with us, obviously, of course, because we, with the payers, select large volume institutions so that we could get the density of test ordering, after we get reimbursement, to go faster and the pull-through to be clear, for about once a quarter to give us three months to execute on the launch of the program. Does that answer the first part of your question?

Yeah, that's helpful, Koller. Thank you.

Perfect. The second question, of course. Rep productivity is critical. Actually, our Chief Commercial Officer and our Head of Sales, that's exactly how they engage with Austin Aerts and me on our forecasting on the number of reps and the number of tests per month per rep that is anticipated, so that we can goal the reps and drive towards steady progress. Of course, we're cautiously optimistic, but we want to watch it for another few quarters. We are seeing these metrics move. The question behind the question probably is, when are you guys going to report on some of these metrics? Let us see the steady progress on them internally first, and as soon as we see the steady up and up, we will start reporting on those.

That's great. Thank you.

Your next question.

Appreciate it. Thanks, Laura.

Thank you. Your next question comes from Daniel Brennan from TD Cowen. Please go ahead.

Great. Thank you. Thanks for the questions. Maybe first one just on, you both talked about the shift to a more direct commercial effort, maybe pulling back some resources on the R&D side, extend the cash runway. Just, I guess, what prompted the shift? It kinda makes sense logically, but I'm just wondering, kind of, is there any feedback in the market about timing, how long it's gonna take, or was this in discussion with the board? Just maybe a little color behind that.

Dan, thank you for the question. It's a very logical one. There's actually two root causes that drove that happening now. First, of course, as you know, the R&D and Clinical Operations efforts, both of these groups, were incredibly focused on PRIME, and that was a seven-year effort, if you can believe it, with very, very heavy resourcing devoted to that. As we're shifting towards now publishing as much as possible with a couple of dozen publications in the pipeline from our data, we realized that we need less capacity specifically for our preterm birth product, R&D and Clinical Operations capacity. Of course, we have a pipeline of other products that we're working on. We had inbound interest from partners to collaborate on R&D and Clinical Operations efforts in developing new tests.

What you're really seeing as the first impetus is the less demand on R&D and Clinical Operations capacity internally, and the second one is the demand externally to continue developing the tests. As soon as we lock in these partnerships, of course, we'll communicate all of those to you. You can imagine, our R&D proteomics platform is a great asset with a biobank of thousands and perhaps tens of thousands of samples, which will allow us to support other diagnostic and screening tests in pregnancy, perhaps also support therapeutics of screening in for eligibility for drug interventions in pregnancy.

You can imagine that's a strategic move, as well as just simply less demand internally for now until we pick up in this collaborative model on other assets. That's the answer on the R&D side. Does that help?

Yep. Yeah, that helps. Yep. No, very logical. Maybe just a couple other quick ones. Just on the, I think previously you talked about low single-digit 1,000 volumes this year. Is that still on track or just maybe kind of how should we think about that?

Dan, I didn't hear you quite well. A low single-digit thousand volumes?

40, I was talking about, volumes for 2026.

I got you. I got you.

Yeah. How do we think about it?

Yeah, that's not unreasonable. That's not unreasonable. As you know, we don't report the volume of orders, but it's certainly not an unreasonable number to be thinking about. Given your question, Dan, in our conversations, of course, we'll as soon as we see steadiness, we'll start reporting on it. Yes, that assumption is not unreasonable.

Got it. Maybe just on, you know, the first Medicaid program that began, I think of, you know, a little over a year ago, when can you see that program potentially turn into a positive coverage decision, do you think?

Great question. I believe I even talked through the timeline for that particular program. We believe it will take us, it took us about 6 months to stand it up with EMR integration and all of the provider setup, to provide care management for the patients. Actually that set of collaborators are now piloting a digital tool with us that allows the providers to deliver care management a lot more efficiently with weekly symptom check tooling. We're looking forward to reporting on how that goes 'cause that is something that will remove a significant barrier in terms of taking the OBGYN nursing capacity from the office for that care management.

It took us 6 months to do that. It will take us about 9-12 months to fully recruit the program. About 4-5 months for the patients to deliver, obviously on a rolling basis. A couple of months to collect data on the outcomes, NICU admissions, health of the baby, weight of the baby, all of the other outcomes we typically would monitor in these implementation studies. Of course, take it to the state. I will tell you the state is not waiting for it. The state already engaged with us on for that particular program on what would coverage mean, why is it needed. We are mobilizing our clinical advocates in that state, and that's what I meant when I said our letter-writing campaign.

We're asking every provider to write to the state Medicaid and advocate why this test needs to be paid for in the state for all of the pregnant moms there. You know, the tactical timeline I laid out nets out to be about 2 years to decision timeline for the state. I think that's, you know, that probably has plus or minus a quarter or 2 on each side of that 2-year estimate. Could go faster, it could go a little bit slower if data is messy, for example, because in some states, they assign the baby into a different Medicaid plan at birth. Don't ask me why that gets done, that's the case. It requires us to do some data chasing to combine the mom and baby outcomes.

For that program, we expect, probably beginning of 2027, to bring the decision, and the results of the program, to us. Of course, we'll report on that. Does that help?

Yep. Yeah, that helps a lot. Terrific. All right. Well, thanks a lot.

There are no further questions.

Thank you for the question.

Sorry. There are no further questions at this time. I will now turn the call over to Zhenya Lindgardt, President and CEO. Please continue.

Thank you so much, operator. In summary, we're building the medical reimbursement and advocacy foundations necessary for commercialization and guideline inclusion efforts. The engagement we're seeing across stakeholders reinforces our confidence in the opportunity ahead. Thank you so much, everyone, for your time today. We look forward to continuing to share our progress steadily each quarter.

Ladies and gentlemen, this concludes today's conference call. Thank you for participation. You may now disconnect.

Good afternoon, ladies and gentlemen, and welcome to the Sera Prognostics, Inc. Fourth Quarter 2025 Financial Results Conference Call. At this time, all lines are in a 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 0 for the operator. This call is being recorded on Wednesday, 03/18/2026. I would now like to turn the conference over to Jennifer Zebuda. Please go ahead.

Thank you, operator. Welcome to Sera Prognostics, Inc.'s Fourth Quarter and Full Fiscal Year 2025 earnings conference call. At the close of market today, Sera Prognostics, Inc. released its financial results for the quarter ended 12/31/2025. Presenting for the company today will be Zhenya Lindgardt, President and CEO; Lee Anderson, Chief Commercial Officer; Doctor Tiffany Inglis, Chief Medical Officer; 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 have not had a chance to review our quarterly earnings release, it can be found on our website at seraprognostics.com. This call can be heard live via webcast at seraprognostics.com; a recording will be archived in the Investors section of our website. Please note that some of the information presented today may contain 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 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-Ks, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-Ks. These documents identify important risk factors that could cause 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.

Thank you, Jennifer, and good afternoon, everyone. I will start with an overview of our 2025 progress, and Lee and Tiffany will speak about our commercial and medical affairs efforts, and Austin will provide a recap of our financial results. As we shared last year, to support Sera Prognostics, Inc.'s next phase of commercialization, we strengthened our leadership team with Lee Anderson joining us as Chief Commercial Officer and Doctor Tiffany Inglis as our Chief Medical Officer, enhancing our commercial and clinical depth, and I wanted to use this opportunity to introduce them to all of you in today's call and have them discuss our progress with you. 2025 was a critical year for Sera Prognostics, Inc., finalizing our PRIME publication to advance our evidence portfolio, setting up for commercial push in 2026, building our organization, ensuring we have capital to deploy in our commercialization efforts, and laying groundwork for potential international expansion. Our goal was simple: to build the evidence, access, and commercial infrastructure required to drive PreTRM adoption at scale. Across all of these dimensions, we made meaningful progress. We began 2025 focused on strengthening the clinical and scientific foundation supporting our commercialization strategy. The presentation of PRIME study at Society for Maternal-Fetal Medicine meeting in Q1 was a major milestone, followed as expected late in the year when our pivotal PRIME study was accepted for publication in December, with a full manuscript published in January 2026. The publication reported important new data showing that the PRIME study resulted in an amazing 56% and 32% fewer babies born before 32 and 35 weeks of gestation, respectively. The full peer-reviewed publication of PRIME in the Pregnancy Journal of Society for Maternal-Fetal Medicine, like studies before it—namely AVERT—reinforces what we have long believed: that biomarker-based identification of women at higher risk of preterm birth paired with a preventive treatment protocol can deliver meaningful reductions in preterm birth rates and drive improved health outcomes for babies. As we move into 2026, we plan to extend this momentum through a thoughtful further analyses, publication, and real-world evidence generation strategy designed to communicate and replicate PRIME outcomes across diverse populations, geographies, and care models. These data will be essential as we engage payers and broaden awareness across the clinical community. I will ask Doctor Inglis to speak more about our scientific and guideline engagement shortly. Post-publication, we are making meaningful strides in advancing coverage and access as our top priority. A central part of the strategy has been launching targeted programs, particularly in Medicaid in high preterm birth burden states, to generate outcomes data that support both clinical adoption and reimbursement expansion. Historically, we referred to these efforts as Medicaid pilot programs. However, with additional real-world experience, it is clear that these programs take many forms, and our discussions involve both Medicaid and commercial payers. As a result, we believe partner programs more accurately reflect the breadth of our commercialization efforts, so we will speak about those. Last year, we set out to engage with our first wave of six target states and to launch partner programs. We exceeded our state engagement goals in 2025, expanding discussions to 13 states, and met our goal of engaging in now two live partner programs. We expect these partner programs to play a critical role in shaping policy, validating economics, and informing future contracting discussion. We are maintaining our disciplined geographic-focused approach, targeting expansion of up to 15 to 17 states by year end, representing 58% to 60% of U.S. births. This strategy allows us to deepen our traction in our existing target states while thoughtfully adding new ones. With this focused growth plan, we are on track to be running five to seven partner programs by the end of 2026. Lee will detail our execution 2026 KPIs for states in active discussion and partner programs, as well as how we expect to convert engagements into coverage pathways. In Europe, we continue to make steady progress towards unlocking a significant, largely unaddressed obstetric care opportunity. Over the last two years, we have advanced our regulatory pathway for the PreTRM Global test and are working towards CE marking approval. We remain on track to submit our European dossiers in the coming months. Importantly, recent European experts' commentary published in the Journal of Maternal-Fetal and Neonatal Medicine reinforces that current prevention strategies miss most women who deliver preterm and highlights our PRIME study approach as well aligned with European health care systems. Alongside ongoing engagement with regulators, clinical leaders, and patient advocacy groups, we are building the foundation needed for successful market entry following regulatory clearance. We continue to expect revenue growth to build gradually as partner programs mature and real-world evidence results are generated and disseminated. We remain disciplined, investing in market access, commercial infrastructure, and state expansion in a measured way. With that, I will hand it over to Lee to discuss our commercial execution.

Thank you, Zhenya, and hello, everyone. In 2025, we refined a region-first approach pairing payer engagement with OB/GYN and maternal-fetal medicine education, health system outreach, and patient awareness to build local market density. That integrated model now guides our early commercialization across all target states. Following PRIME's publication, we saw strong interest across the payer landscape. Our team engaged broadly with Medicaid agencies, commercial plans, and related organizations nationwide, leading to a meaningful cohort of payers reengaging to begin or advance internal reviews. These interactions reinforce the value of our partner program approach, a flexible model that adapts to each state, payer, and population. As Zhenya mentioned, in 2025, we were in active discussions with 10 payers across 13 states. Looking towards 2026, we expect to expand our efforts to be in active discussions with 15 to 17 states, and we will double the number of payers we are engaged with. As these discussions mature, our goal is to convert these engagements into positive coverage decisions or formal partner programs that support broader access and utilization. For partner programs, we expect to be running five to seven active programs by the end of the year. We expanded provider education and awareness via peer-to-peer programs, medical center in-service sessions, and digital education through leading clinical platforms. Building clinical champions and strengthening relationships across OB/GYN and MFM practices while supporting early health systems conversations. Operationally, we refined the ordering experience, expanded field education, enhanced onboarding, and are progressing integrations and collaborations so that PreTRM can be incorporated more seamlessly into everyday clinical workflows. To illustrate how the model comes together, consider a representative region: we align with a payer on a partner program to evaluate outcomes and economics. We brief the leading hospital system and its OB/MFM department on PRIME and the care pathway. We also provide targeted onboarding and practice-level tools so ordering is simple, and we activate a localized awareness effort so that patients and providers understand the why and the how. Over time, we focus on repeat ordering within early adopters, then widen access as results occur and the payer's review process advances. While each region is different, this playbook helps us drive consistent execution without overextending resources. Our near-term commercial priorities are to convert payer discussions and partner programs into contracted coverage pathways using outcomes and economic data; scale repeat ordering within our current early-adopter providers and health systems by driving workflow reliability and clinical habit formation; and to expand provider awareness and educational efforts. Before I turn the call over to Tiffany, please join me in welcoming Ms. Adrian Lugo as the new Head of Sales and Strategic Accounts for Sera Prognostics, Inc. Adrian brings more than 20 years of leadership experience in women's health and molecular diagnostics along with a strong track record of building high-performing teams, expanding market access, and partnering with health systems to drive adoption of innovative testing solutions. Her strategic expertise will be instrumental as we scale commercial execution and accelerate adoption of our technology to advance improved outcomes in maternal health. With that, Tiffany will provide a clinical and evidence update.

Thank you, Lee, and good afternoon. Our medical affairs work in 2026 is focused on ensuring PRIME as a catalyst for consistent evidence-based practice. We are emphasizing three themes. One is identify risk early in the second trimester before symptoms are present. Second, we deploy a standardized test-and-treat pathway consistent with PRIME. And lastly, we support improved neonatal outcomes with the potential to reduce avoidable neonatal hospital utilization. We are partnering closely with clinicians on patient selection, timing, and care pathway deployment while expanding our clinical champion network and peer partnerships. In practical terms, PreTRM is designed to provide early, individualized risk information from a routine blood draw—information that clinicians can act on through a standardized care pathway. The goal is straightforward. Know who is at elevated risk early, before symptoms begin; intervene with measures that are already familiar to providers and safe for patients; and do so in a consistent way that has been proven to support both quality and affordability across populations. To complement PRIME, we are generating real-world evidence results across diverse populations, care settings, and payer environments. This includes outcomes tracking within partner programs, health economic and outcomes research, assessment of budget impact, population-level analyses for state and payer decision-making, and collaborations with academic centers to broaden the evidence base beyond the PRIME cohort. These efforts are foundational to guideline inclusion, payer policy updates, and thoughtful adoption. We continue to partner with Society for Maternal-Fetal Medicine and ACOG and other payer guideline committees, providing evidence-based packages that include clinical outcomes, safety considerations, implementation data, and economic modeling aligned to each group's evaluation framework. Our goal is to demonstrate how incorporating PreTRM into care pathways supports early, proactive identification of need, complements existing risk tools, improves episode-of-care quality metrics, and addresses affordability by leveraging a major driver of maternity cost. In addition to these education initiatives, we have also launched a campaign to assist providers in requesting coverage for the PreTRM test. This campaign is available broadly, with multiple providers confirming submission of requests in four states, and an additional 10-plus providers across all of our states in the process of submitting additional requests. Beyond our efforts, several state Medicaid agencies and state legislatures have begun exploring policy approaches to address the significant clinical and economic burden of preterm birth. This could come in the form of a bill, budget appropriation, or coverage from the Medicaid department mandating that payers cover the PreTRM test. While we have been engaged when asked to provide education and perspective, these discussions have largely been driven by the state's recognition of the unmet need, their focus on health equity, the impact preterm birth has on their communities, and the financial burden it places on Medicaid budgets. I will now hand it to Austin for the financials and our capital allocation approach.

Thanks, Tiffany, and good afternoon, everyone. I will start with our financial results and then discuss our cash runway and capital allocation. Starting with the fourth quarter, revenue for the quarter was $10,000 compared to $24,000 in 2024. As a reminder, revenue remains modest and can fluctuate from period to period in this early commercial stage. We continue to expect revenue expansion as we move towards broader commercialization following the PRIME publication. Operating expenses for the quarter were $9,000,000, down from $9,400,000 for the prior-year period, reflecting our continued disciplined expense management. Research and development expenses were $3,200,000 compared to $3,100,000 in 2024. With the completion of the PRIME study, R&D expenses will likely decrease as we focus resources on activities that support commercialization and awareness building. Selling, general, and administrative expenses were $5,700,000 versus $6,300,000 in the prior year, reflecting our prudent allocation to targeted commercial initiatives and strategic headcount. Net loss for the quarter was $7,900,000 compared to a net loss of $8,600,000 in 2024. Turning to the full year, total revenue for 2025 was $81,000, up slightly from $77,000 in 2024. Total expenses were $36,600,000 compared to $36,700,000 last year as we began our strategy of capital reallocation from R&D to commercial activities and advanced PRIME publication. Research and development expenses for the full year were $13,200,000, down from $14,700,000 in 2024 and driven by lower clinical study costs following PRIME completion. Selling, general, and administrative expenses were $23,300,000 compared to $21,900,000 last year due to targeted commercial readiness investment. Net loss for the year was $31,900,000 compared to $32,900,000 in 2024, again demonstrating our disciplined approach to capital deployment. We ended 12/31/2025 with $95,800,000 in cash, cash equivalents, and available-for-sale securities. Based on our current operating plan and commercialization strategy, we believe this capital will fund the company across significant adoption and commercial milestones through 2028. In summary, 2025 was a year of important financial and operational progress. We maintained tight expense controls, strengthened the balance sheet, and positioned the company to execute effectively as we move into a transformative year with the publication of PRIME and our expected commercial extension. Before we open the call for questions, I will provide a brief overview of our capital allocation philosophy for the near term. Our approach is anchored in disciplined deployment toward milestones that derisk the commercial model while maintaining the strength of our balance sheet. One, we will prioritize market access, making investments that accelerate coverage decisions, such as partner programs that include quality-of-care and health economic outcomes research. Two, focus on commercial scale-up, concentrating resources where we see the greatest adoption potential, like regions with payer engagement, clinical champions, and health system readiness. Three, fund additional evidence-generating programs, such as RWE and targeted clinical collaboration that could support guideline inclusion and payer policy updates. And four, maintain financial discipline and flexibility, pacing spending in line with key milestones and emerging adoption or reimbursement tailwinds. As sales volumes build following payer decisions and broader access, we will sequence certain commercial and infrastructure investments when appropriate. This ensures our ability to preserve runway while supporting a healthy, sustainable ramp from early adoption to repeat ordering. Regarding this last point, concurrent with today's 10-K filing, we reestablished our at-the-market, or ATM, facility. While we have no immediate plans to issue shares, maintaining an ATM is the best practice in corporate hygiene for companies at our stage. It provides the optionality of an efficient and low-cost tool to maintain financial flexibility and provide sustainable ramp as we advance payer coverage, commercial adoption, and key milestones for PreTRM. With our current cash position providing runway through 2028, this does not reflect any change in the capital allocation priorities I discussed or any near-term funding needs. It simply renews our access to our existing shelf registration and maintains financial preparedness. With that, let's open the line for questions.

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. You will hear a prompt that your hand has been raised. Should you wish to cancel your request, please press the star followed by the two. I would like to advise everyone to have a limit of one question and one follow-up. If you are using a speakerphone, please lift up the handset before pressing any keys. Your first question comes from the line of Andrew Brockman with William Blair. Please go ahead.

Hi. Afternoon. Thanks for taking the questions. I want to go back to something Lee said in his remarks, sort of converting payer discussions and partner programs by using outcomes and some economic data. Can you maybe just expand on that a little bit, just in practical terms? How does that work with each of these partners? And then, typically, what do you expect that these partners will look for in those results to move forward with some of those contracts that you might have sketched out?

Thank you for the question. I am also going to enlist Tiffany on this as well. But by this partner program approach, you take an entity that is interested, and they look at the clinical outcomes. They are also going to look at their books and their numbers and their patient population and equate that to the fact that if they adopted PreTRM and the treatment regimen as standard of care, what could that do for their patient base, so to speak? So as we have these discussions, we are not only highlighting the clinical outcome improvement, but also the health economic outcome improvement. And that is, as you can imagine, very important for state Medicaid agencies or providers throughout the country.

Yes, I will make that add—agree completely. As we look at the results of 20% reduction in NICU admissions, NICU utilization is a huge driver of spend and trend for those who are paying the bill on the backside, whether that is our government, or whether that is employer groups, or whether that is payers. So as we think about our partnerships with each of those entities, they have really struggled with how to control that spend and trend, and this is really an avenue for them to have a significant impact on something that drives a cost driver for many of them, as well as something that drives things like high-cost claimants and things like that on their books. So as we continue to do sub-analyses and evidence generation post-PRIME, the health economic model and the impact to what that looks like will be something that we will be able to speak even more deeply about from a publication perspective, but we are able to share with our partners now what that 20% NICU reduction really looks like.

Perfect. That is really, really helpful. And then I want to go back to the comment made around SMFM was earlier in the year. It has been a couple months now. Can you maybe just talk about some of the feedback that you received at the conference? And then since then, how the conversations may be changed now that PRIME is published? You have gone through that conference, and sort of where we are at today. Thank you.

Yes. No, it is a great question. So, the SMFM conference, the national conference, was in February, and it was shortly after we obviously had our publication go live in the Pregnancy Journal, which is the SMFM journal. And it was a great conference, a ton of engagement with providers, but also with the leadership at SMFM and really understanding next steps and how we work together and how we make this test more accessible to women. And so we are continuing on those next steps with our partners there, many of whom are investigators on our study and have been integrally working tightly with SMFM from day one, including the company itself as well. So really looking at all the steps—what does that look like—and then opportunities for rapid response or other things like that with those partners so that we can understand what those guidelines and what the changes would look like and how we get to that endpoint, which, again, is just about access for patients for this test and for providers for this test to be able to change those outcomes for moms and babies.

And I will add, Andrew, that the team has seen a marked improvement in engagement across providers, payers, state legislators, key opinion leaders, societies, employers. The study really proved and gave us credibility. We have long believed PreTRM can be supported by an RCT level evidence and, indeed, it is coming to fruition. It has been only about 10 weeks since the publication took place, but we are incredibly excited about the signal we are seeing from all of these audiences. And we will keep reporting on engagement specifically with the guideline-setting bodies and the signals that we can send to the market about where the standards of care are evolving to.

Again, if you would like to ask a question. Your next question comes from the line of Tycho Peterson with Jefferies. Please go ahead.

This is Lauren on for Tycho. My first question, I guess, is around the cash runway into 2028. How are you guys planning to balance investments in successful U.S. states versus the capital requirements of the global EU launch? And do you expect to accelerate SG&A spend into this year? Thanks.

Yes. Hi, Lauren. Thanks for the question. Yes, I think we said this in the last quarter, but I will reiterate some of the basics, and then I will get into the question. So last year, OpEx—cash OpEx—was in the low thirties. We have budgeted roughly the same cash OpEx this year, and that is with reallocating a significant amount of our spending from our clinical and R&D activities more towards our commercial activities, which does include the work we are doing in the EU, a pretty significant spend that we are doing in the EU to explore the opportunities there as well. Certainly, as the commercial opportunities—domestic or EU—continue to develop, we will continue to shift, reallocate more capital from other areas to the commercial side of the business.

Great. Thank you. And I guess one more going back to the second active partnership program. Could you elaborate a bit more on the profile of this new partner, whether it is a regional health system, national commercial carrier? And whether or not and how their model differs from your first partnership? Thanks.

Great question. Multiple partners, multiple partnerships. All of them a little similar, but all of them different. You hit the nail on the head. Yes. We have large health systems, IDNs that we are negotiating with. We have provider-payers we are negotiating with. We have large, large group practices. And then we cannot forget the PRIME sites themselves. You know, how do you take the study site from a great study site with PRIME and now input this into their clinical workflow for their entire organization so that it is truly standard of care for any woman that comes in and appears to be low risk preterm birth—they get a PreTRM test. So there are very similar aspects of the model, but each payer partner or each partner is going to be a bit different. Our goal is to fill the needs of that partner: what works best for them, and what are they looking to achieve?

And I will just add that the second partner is an example of an employer collaborative that is multistate, and we are entering with them in the first state, and there is a great path for expansion. As Lee said, there are a lot of flavors here. We are partnering far and wide from the legislative bodies at the state level to midwife associations to innovative providers of telehealth services in pregnancy. We want to make sure that we capture all of those adopters that are ready to go.

There are no further questions. I will hand the call back over to Zhenya for closing remarks.

Sounds great. Thanks, Vincent. Before we close, I wanted to leave you with how we see the year ahead. With PRIME now published, a growing base of peer and state-level engagement, and an expanded leadership team in place, we are entering 2026 with strong momentum. This year is about disciplined execution, advancing all of the partner programs we have talked about, expanding real-world data, and supporting clinicians as they integrate PreTRM into their workflows. While adoption will be gradual, the foundation we have built gives us confidence in the path forward. We believe the combination of compelling clinical evidence, increasing payer engagement, and thoughtful commercial scale-up positions us to unlock meaningful value in a large underserved market. Thank all of you so much for your continued support as we work to improve outcomes for mothers and babies and deliver long-term value for our shareholders. Over to you, operator, to close the call.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.