Sera Prognostics Inc - Ordinary Shares Class A Aktie

Ladies and gentlemen, welcome to Sera Prognostics' First Quarter 2026 Financial Results Conference Call. [Operator Instructions] Please be advised that this call is being recorded today, Wednesday, May 6, 2026.

I will now turn the call over to our first 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 31, 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, and 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, 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 first 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 health care channels.

From a provider engagement standpoint, we maintained a strong presence across key clinical forums, including the SMSM Annual Meeting in February, and more recently, the ACOG Annual Clinical and Scientific Meeting. At SMSM, 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 SMSM 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's 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 0.5 million views and continues to drive awareness.

Following that, we engaged the SHE MD to record a new podcast episode releasing May 14 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 PreTRM test needs broad awareness and should be considered as future standard of care. The episode discusses Dr. Aliabadi's experience with PreTRM 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.

As we look ahead, we will also be featured on Medscape Hear From Her, the Women in Healthcare Leadership podcast, engaging in conversation with the podcast host, Jelena Spyropoulos and Dr. Mollie McDonald, Maternal & Fetal Medicine Specialist at St. David's Women's Center 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 third 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 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-based supporting PreTRM. As discussed in our year-end call, European expert commentary on the PRIME trial was published in the Journal of Maternal Fetal and 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 PreTRM approach with existing European health care systems.

Also 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 5 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 health care 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 focused 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 its 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 midyear submission of our CE Marking dossier and have had constructive discussions with regulators and clinical stakeholders. Engagement with our European advisory 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 a 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 PR.

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. And 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, and 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, 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?

[Operator Instructions] Your question comes from Tycho Peterson from Jefferies.

This is [ Lauren ] on for Tycho. A few from me. First on the partner program. So could we get maybe a little bit of color on the kind of profile of the third partner and kind of how it compares to the first 2? And then in terms of kind of the required cadence throughout the rest of the year to hit the goal of 5 to 7 partner programs and what that's going to look like for the next couple of quarters?

And then second, for the new reps, I think you've talked about before how it could take a couple of quarters to kind of see density of adoption and increased productivity. Are you measuring anything in terms of test per rep per month or other KPIs that you're targeting for the second half of the year for these reps?

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 one 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 preterm birth get cared for by the physician offices with the intervention bundle. So we make it as seamlessly integrated into the workflow of those offices as possible. So for us, each of these programs, that's why one 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 intervention bundle. So 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. So it's in all of the partners' interest in these programs to prepare well to get to -- for us to revenue, for them to impact faster.

For many programs, we are engaged deeply with the state as well. So on a quarterly basis, we report out the progress of the programs to the state Medicaid agencies, and these are usually public quorums where other payers are present. And 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. So 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 6 to 9 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. So 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 3 months to execute on the launch of the program. Does that answer the first part of your question?

Yes, that's helpful color.

Perfect. And then 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 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 go the reps and drive towards steady progress. And of course, we're cautiously optimistic, but we want to watch it for another few quarters. We are seeing these metrics move.

Your -- 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 them.

Your next question comes from Dan Brennan from TD Cowen.

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 kind of makes sense logically, but I'm just wondering kind of is there any feedback in the market about timing, how long it's going to take. Or was this in discussion with the Board? Just maybe a little color behind that.

Dan, thank you for the question. That's a very logical one. There's actually 2 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 7-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 PreTRM birth product, R&D and ClinOps capacity.

Of course, we have a pipeline of other products that we're working on, but we had inbound interest from partners to collaborate on R&D and clinical operations efforts in developing new tests. So what you're really seeing as the first impetus is the less demand on R&D and ClinOps capacity internally and the second one is the demand externally. to continue developing the tests.

And as soon as we lock in these partnerships, of course, we'll communicate all of those to you. And you can imagine our R&D proteomics platform is a great asset with a biobank of thousands and perhaps a couple of 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 it'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. So that's the answer on the R&D side. Does that help?

Yes. Yes, that helps. Very logical. Maybe just a couple of other quick ones. Just on the -- I think previously, you talked about low single-digit thousand 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. Low single-digit thousand...

Was talking about volumes for '26.

I got you. 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. And given your question, Dan, and our conversations, of course, we'll -- as soon as we see steadiness, we'll start reporting on it. But yes, that assumption is not unreasonable.

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

Great question. And I think when we announced it, we -- I believe I even talked through the time line 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. And actually, the 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. And we're looking forward to reporting on how that goes because that is something that will remove a significant barrier in terms of taking the OB/GYN nursing capacity from the office for that care management.

So it took us 6 months to do that. It will take us about 9 to 12 months to fully recruit the program; about 4 to 5 months for the patients to deliver, obviously, on a rolling basis; then 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. And then, 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.

So the tactical time line I laid out nets out to be about 2 years to decision time line for the state. I think that probably has plus or minus a quarter or 2 on each side of that 2-year estimate. It 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's done, but that's the case.

And it requires us to do some data chasing to combine the mom and baby outcomes. So for that program, we expect probably beginning of 2027 to bring the decision and the results of the program to us. And of course, we'll report on that. Does that help?

Yes, that helps a lot.

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, and the engagement we're seeing across stakeholders reinforces our confidence in the opportunity ahead. Thank you so much, everyone, for your time today, and 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 Fourth Quarter 2025 Financial Results Conference Call. [Operator Instructions]. This call is being recorded on Wednesday, March 18, 2026. I would now like to turn the conference over to Jennifer Zibuda. Please go ahead.

Thank you, operator. Welcome to Sera Prognostics fourth quarter and full fiscal year 2025 earnings conference call. At the close of market today, Sera Prognostics released its financial results for the quarter ended December 31, 2025.

Presenting for the company today will be Zhenya Lindgardt, President and CEO; Lee Anderson, Chief Commercial Officer; Dr. 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'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 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's next phase of commercialization, we strengthened our leadership team with Lee Anderson joining us as Chief Commercial Officer, and Dr. 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 on today's call and have them discuss our progress with you.

2025 was a critical year for Sera, 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. 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 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 of Maternal and Fetal Medicine, like studies before it, namely AVERT, reinforces what we've 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 analysis, publication and real-world evidence for 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 Dr. Inglis to speak more about our scientific and guideline engagement shortly. Post publication, we are making meaningful strides in advancing payer 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 reflects the breadth of our commercialization efforts. So we'll speak about those. Last year, we set out to engage with our first wave of 6 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 2 live partner programs. We expect these partner programs to play a critical role in shaping policy, validating economics and informing future contracting discussions. We're 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 5 to 7 partner programs by the end of 2026. Lee will detail our execution, 2026 KPIs for states in active discussions 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 2 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 dossier in the coming months. Importantly, recent European expert 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're 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'll remain disciplined, investing in market access, commercial infrastructure and state expansion in a measured way.

With that, I'll hand it over to Lee to discuss our commercial execution. Lee?

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 5 to 7 active programs by the end of the year. We expanded provider education and awareness via peer-to-peer programs, medical center and 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 on-boarding and are progressing integrations and collaborations so that PreTRM can be incorporated more seamlessly into the everyday clinical workflows. To illustrate how the model comes together, consider a representative region. We align with the payer on a Partner Program to evaluate outcomes and economics. We brief the leading hospital system and its OB/MFM department on PRIME in the care pathway. We also provide targeted onboarding and practice level tools to 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 payers' 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. Adrienne Lugo as the new Head of Sales and Strategic Accounts for Sera. Adrienne 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 acts as a catalyst for consistent evidence-based practice. We're 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're 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're 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 analysis 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've 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 4 states and an additional 10-plus providers across all of our focus 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'll now hand it to Austin for the financials and our capital allocation approach.

Thanks, Tiffany, and good afternoon, everyone. I'll start with our financial results and then discuss our cash runway and capital allocation philosophy.

Starting with the fourth quarter. Revenue for the quarter was $10,000 compared to $24,000 in the fourth quarter of 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 million, down from $9.4 million for the prior year period, reflecting our continued disciplined expense management.

Research and development expenses were $3.2 million compared to $3.1 million 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 $5.7 million versus $6.3 million in the prior year, reflecting our prudent allocation to targeted commercial initiatives and strategic headcount. Net loss for the quarter was $7.9 million compared to a net loss of $8.6 million in the fourth quarter of 2024.

Turning to the full year. Total revenue for 2025 was $81,000, up slightly from $77,000 in 2024. Total expenses were $36.6 million compared to $36.7 million last year as we began our strategy of capital reallocation from R&D to commercial activities in advance of PRIME publication. Research and development expenses for the full year were $13.2 million, down from $14.7 million in 2024 and driven by lower clinical study costs following PRIME completion. Selling, general and administrative expenses were $23.3 million compared to $21.9 million last year due to targeted commercial readiness investments. Net loss for the year was $31.9 million compared to $32.9 million in 2024, again, demonstrating our disciplined approach to capital deployment.

We ended December 31, 2025, with $95.8 million 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 control, strengthened the balance sheet and position the company to execute effectively as we move into a transformative year with the publication of PRIME and our expected commercial expansion.

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 de-risk the commercial model while maintaining the strength of our balance sheet. One, we'll 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 collaborations 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. Operator?

[Operator Instructions] Your first question comes from the line of Andrew Brackmann with William Blair.

I want to go back to something Lee said in his remarks, sort of around sort of converting payer discussions and Partner Programs by using sort of outcomes and some economic data. Can you maybe just expand on that a little bit, just sort of 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 these results to sort of move forward with some of those contracts that you might expect?

Sure. Thank you for the question. I'm also going to list Tiffany on this as well. But by the Partner Program approach, excuse me, you take an entity that's interested and they look at the clinical outcomes, they're also going to look at their books and their numbers and their patient population and equate that to the economic benefit 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's, as you can imagine, very important for state Medicaid agencies or providers throughout the country.

Yes. The only thing I would add, I agree completely is as we look at the results of Prime and that 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's our government or whether that's employer groups or whether that's payers. And so as we think about our partnerships with each of those entities, they've 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 large 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-analysis and evidence generation post-PRIME, the health economic model and the impact to what that looks like will be something that we'll be able to speak even more deeply about from a publication perspective, but we're able to share with our partners now what that 20% NICU reduction really looks like.

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

Yes. No, it's a great question. So the SMFM Conference, the National Conference was in February of this year, 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're continuing on those next steps with our partners there, many of whom are investigators on our study, have been integrally working tightly with SMFM from day one, including the company itself as well.

So really looking at all the next 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 that guidelines and what the changes would look like and how we get to that endpoint, which, again, is just about access for patients to 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've long believed can be supported by an RCT-level evidence. And indeed, it's coming to fruition. It's been only about 10 weeks since the publication took place, but we're incredibly excited about the signal we're seeing from all of these audiences, and we'll 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.

[Operator Instructions] Your next question comes from the line of Tycho Peterson with Jefferies.

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 kind of successful U.S. states versus the capital requirements of the global EU launch? And do you kind of expect to accelerate SG&A spend into this year?

Lauren, thanks for the question. Yes, I think we said this in the last quarter, but I'll reiterate some of the basics, and then I'll get into the questions. So last year, OpEx -- cash OpEx was in the low 30s. We have budgeted the same -- roughly the same cash OpEx this year, and that's 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're doing in the EU, a pretty significant spend that we're doing in the EU to explore the opportunities there as well. Certainly, as the commercial opportunities, domestic or EU continue to develop, we'll continue to shift, reallocate more capital from other areas to the commercial side of the business.

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

Yes. Great question. Multiple partners, multiple partnerships, all of them are a little similar, but all of them different. You hit the nail on the head. Yes, we have large health systems, IDNs that we're negotiating with. We have provider payers we're negotiating with. We have large, large group practices. And then we can't forget the PRIME sites themselves. How do you take the study site from a great study site with PRIME and now implement this into their clinical workflow for their entire organization, so that it's truly standard of care for any woman that comes in and appears to be low risk for preterm birth, they get a PreTRM Test. So there is a very similar aspect of the model, but each payer partner or each partnership 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're entering with them in the first state, and there's a great opportunity for expansion. As Lee said, there is a lot of flavors here. We're partnering far and wide from the legislative bodies at the state level to mid-wife associations to innovative providers of tele-health services and pregnancy. We want to make sure that we capture all of those adopters that are ready to go. Does this help?

There are no further questions. I'll 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 payer and state level engagement and an expanded leadership team in place, we're entering 2026 with strong momentum. This year is about disciplined execution, advancing all of the Partner Programs we've talked about, expanding real-world data and supporting clinicians as they integrate PreTRM into their workflows.

While adoption will be gradual, the foundation we've 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.

Good afternoon, and welcome to the Sera Prognostics Conference Call to review third quarter fiscal year 2025 results. [Operator Instructions] As a reminder, this call is being recorded for replay purposes.

I would now like to turn the call over to Jennifer Zibuda, Sera's Head of Investor Relations for a few introductory comments. Sarah, (sic) [ Jennifer ], please go ahead.

Thank you, operator. Good afternoon, everyone. Welcome to Sera Prognostic's Third Quarter Fiscal Year 2025 Earnings Conference Call. At the close of market today Sera Prognostics released its financial results for the quarter ended September 30, 2025. 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 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.

Thank you, Jennifer, and good afternoon, everyone. Building on the momentum from our PRIME study and ongoing commercialization efforts in the third quarter of 2025 marked continued progress in our transition towards preterm test adoption. We advanced our geographically focused strategy. In these regions, we are executing an integrated approach to achieving fair coverage, physician education and patient awareness.

We've continued to build visibility through key industry events and data presentations. Earlier this week, we presented health economics data at the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, Europe Conference. In October, Dr. Brian Erie delivered a compelling presentation of PRIME study outcomes at the Inaugural Renaissance Conference, the 3 ages of the women-- titled Dismantling the Preterm Barrier: Biomarker-guided Bundled Care to Improve Neonatal Outcomes. Links to both the poster and the presentation are now available in our press release issued today.

We remain on track to publish the full results of our PRIME study in a peer review journal by the end of the year. We're very far along through the process of preparing a publication and we look forward to sharing it with all stakeholders. What you can expect from us is a press release upon acceptance for publication followed by an investor and analyst event with our principal investigators to discuss the strong primary outcomes we shared earlier this year as well as some new and compelling data points from the study, demonstrating the efficacy of the preterm test.

Following prime, we plan to maintain a steady cadence of data publications and presentations focused on key topics, including health economic benefits, population analysis, for example, first-time moms versus other moms and Medicaid expected cost savings associated with ser-preterm test. These data subsets will build on the robust evidence base, already established by our PRIME and VERT clinical studies. Together, they will not only reinforce the clinical and economic value preterm, but also help support its adoption into standard prenatal care.

Let's now shift to our commercial strategy and progress. And for those newer to our story, I'll start with a quick overview. Our sales and marketing efforts are concentrated in select regions where we see strong alignment across several factors, headway with payer and Medicaid program discussions, support from influential local opinion leaders, engagement from early adopter institutions and presence of PRIME study sites. By focusing on areas where these elements converge, we are creating conditions for meaningful clinical update of the preterm test.

We've made real strides with Medicaid plan pilot programs and our inaugural pilot in Nevada, is actively enrolling patients. We're engaging payers in our first wave of 6 started states, collectively representing a strong commercial opportunity, covering approximately 33% of U.S. births and 35% of Medicaid births annually. Beyond this first wave, we've initiated outreach to the next year of target states, expanding our footprint of states in discussion to 13 in total.

We're also in discussions with organizations with regional and national reach across multiple lines of business. These early signals of market engagement give us confidence that we are well positioned to drive meaningful coverage and adoption in our target states and beyond. Our commercialization strategy is anchored in getting coverage first. It is built on a 2-pronged approach. First, targeting state engagement across first and second wave states. -- for example, Nevada, Texas and Massachusetts that have shown interest, face high preterm births and have leveraged tools to adopt innovative programs in prenatal care.

Second, they are driven adoption through pilots and alignment to value-based care programs. By engaging state and payer leadership and connecting to the efforts of local institutions driving improvement in prenatal and maternal care quality outcomes, we're building a local flywheel of adoption that aims to accelerate provider buy-in and lay the groundwork for broader coverage. With Medicaid financing over 40% to 3.6 million U.S. births annually, the opportunity to drive meaningful cost savings and improve outcomes is substantial. We believe the preterm test offers a differentiated, data-driven solution for states seeking to reduce neonatal complications and manage Medicaid expenditures more efficiently.

Our health economics data shows potential in-year savings from preterm test screening of low-risk pregnancies. The path from initial state Medicaid director engagement to a state coverage decision takes time. Initially, we anticipate a cycle of about 24 months or more driven by the nature of prenatal testing and claims data availability. For example, the blood draw occurs between weeks 18 and 20 of pregnancy and followed by 4 to 5 months until delivery of babies and another 3 months or so for claims data to become available for analysis. Once the data is reviewed, we present the pilot results to the Medicaid plan and other state stakeholders to inform coverage decisions.

As additional pilots launch, we will use the resulting data to demonstrate feasibility and build a strong business case for statewide coverage. Our commercialization strategy in the immediate term will focus on the target geography adoption wave by wave until guideline inclusion. Success of these efforts depends on achieving coverage in Medicaid and commercial plans value-based care arrangements and activating physician adoption and advocacy. Engagement with clinical leaders and alignment on target populations will be critical to securing guideline inclusion and accelerating adoption.

Post guidelines will scale nationally with a field sales force aiming for broader air coverage and expand national awareness building through traditional marketing channels. Although guideline inclusion is a longer-term milestone, our focused efforts, both in evidence generation, KOL engagement, targeted state coverage and physician adoption are all needed to support it. Ultimately, the strategy positions us to drive meaningful revenue growth while improving outcomes from mothers and babies nationwide in helping address health care utilization trends, including rising costs associated with rising NICU admission rates and longer hospital stays surrounding maternal and neonatal care.

To provide clear visibility into our accelerating commercial execution, even at this early stage, we will begin sharing some key traction indicators such as Medicaid pilot momentum, including a number of live pilots, enrollment completion milestones and expanding pipeline of states and discussions that will serve as tangible markers of progress as we build towards sustainable revenue growth. We're gaining meaningful traction across the payer landscape. We're actively engaging with 10 payers across 13 states, a diverse mix, both national and regional, Medicaid and commercial, who are focused on offering a competitive health care benefits while managing rising costs.

Our strategy targets forward-thinking organizations with strong member bases in key states where our sales reps are positioned well to maximize pull-through. We're also prioritizing institutions with value-based payment models, aligning incentives for providers and payers in preventing preterm growth complications. PRIME and AVERT data strongly support value-based approach and can accelerate preterm uptake where positive outcomes translate into payer, provider and patient success. To recap our commercial progress, momentum is building. Our first Medicaid pilot is now live. We are in active dialogue with all 6 of our initial target states, and we've already begun engagement with the next wave of states, setting the stage for broader adoption and impact.

To support our fundamental clinical and commercial efforts, we've made high-impact leadership appointments to the Sera team. As announced in October, Dr. Tiffany Inglis, who was appointed Chief Medical Officer, an accomplished OBGYN with over 20 years of experience, including a decade in clinical practice and recent leadership at Eleven Health and Carillon Health. Dr. Inglis excels at driving women's health initiatives their coverage and cost-effective outcomes. She will spearhead our medical affairs and strategy to accelerate preterm test adoption and establish it as a standard of care for preterm birth risk.

In preparation for broader adoption of the preterm test and our target states and beyond, we appointed Marisol Orvana as the Head of Commercial Operations. With 20 years of health care experience and a proven track record in diagnostics, her leadership will be instrumental in accelerating customer onboarding and supporting clinical integration, key enablers of commercial traction during this foundational growth period. Complementing this leadership, we have successfully completed the hiring of sales representatives across all 6 of our target states and are well positioned to expand market access and preterm utilization.

Lastly, beyond our progress in the United States, we continue to explore Europe in a region that fully appreciates the pressing gap in preterm birth risk screening. We remain engaged in productive discussions with European regulatory bodies and are on track to submit our dossiers in early 2026.

In closing, we've made significant strides in laying a strong foundation for adoption and reimbursement, setting the stage for future growth. Looking ahead, we're optimistic about the flywheel effect on these initiatives, which we believe will drive meaningful adoption and contribute to better maternal neonatal outcomes.

With that, I'll turn it over to Austin, our CFO, for a review of our financial results. Austin?

Thanks, Zhenya, and good afternoon, everyone. I'll provide an overview of our financial performance for the third quarter of 2025 and our balance sheet position. Net revenue for the third quarter was $16,000 compared to $29,000 in the same period last year. During the quarter, we received a $100,000 prepayment from the first Medicaid pilot in Nevada, which increased our deferred revenue balance as of September 30, 2025.

Total operating expenses for the quarter were $9.0 million compared to $8.9 million in the third quarter of 2024. Research and development expenses were $3.3 million, down from $3.5 million for the third quarter of 2024, primarily due to lower clinical study costs, following the completion of the pivotal PRIME study and as the company shifts towards commercialization.

Selling, general and administrative expenses were $5.7 million, up from $5.4 million for the prior year period, a modest increase as we carefully invest in targeted commercial activities and strategic headcount additions while building market awareness and preparation for the publication of PRIME study data.

Our net loss for the quarter was $7.8 million, down from $7.9 million in the third quarter of 2024 as we continued our focus on managing our capital resources ahead of revenue expansion in the future.

As of September 30, 2025, we had cash, cash equivalents and available for sale securities of approximately $102.4 million. We are encouraged by the commercial momentum that Zhenya discussed, including our first Medicaid pilot program in Nevada. We are diligently working to translate our foundational progress into tangible outcomes and significant growth opportunities.

In the meantime, we continue to manage our capital prudently, prioritizing high ROI opportunities to support commercialization while maintaining a strong balance sheet to fuel our growth strategy.

Operator, we can now open the line for questions.

[Operator Instructions] And your first question comes from the line of Dan Brennan from TD Cowen.

Great. Maybe just on the Medicaid pilots, Nevada. You've got 6 other states behind it or 5 other states behind it. I know at the Q2 call, you discussed 2 to 4 pilots signed up, kind of, I don't know what the time frame was, but it was kind of in the near term. So do you feel like progress is going on track. Do you feel ahead of plan, behind plan in terms of getting Nevada signed up? And when do you think you'd have -- get to or get to the 6 pilots signed up?

Dan, thank you so much for the question. We are very much on track. One is launched in recruiting, another one is in contracting. And so that gets us to -- and we believe a couple more shortly in active discussions with the payers in other states.

So with that, the fact that we've expanded to the next wave of states tells you that we're very much on track on getting a foot in the door in each of the states and going beyond because we feel we have good traction even in the first wave of the states. So we'll definitely continue communicating progress once the pilots are up and running.

Obviously, while we're in contracting, we're going to probably not communicate what the states and the payers are. But once we are underway with their permission, we'll share it with all of you.

And how big are the pilots? So Novadi, you said 100,000 prepayments? Just how do we think about -- I know the criticality is to get it established, you can eventually get state Medicaid coverage. But just speak to during the pilot phase, like what's the economics? Like what are you getting to run these tests? How big is the Nevada program? Just any color around that?

Sure. The trade-off here, Dan, are how fast we want results. So the fewer patients in the pilot, the faster the decision on coverage, which, of course, would be best to driving outcomes for moms and babies sooner. The drive to have a bigger pilot, of course, is powering the pilot to show great results. because, again, we are looking at reasonably rare events of significant preterm birth that we want to ameliorate.

So from that perspective, the typical size of a pilot would probably be a few hundred patients. However, I will tell you, as we're engaging with plans and state Medicaid directors, we're not only suggesting that we pilot, but we are in active discussions with some value-based health care arrangements and contracts where we can show what the test can do when screening the moms in the state with achieving quality metrics and putting some dollars at risk as opposed to setting up a similar conversation in context of a pilot. So it's hard to tell you specifically because each state has a slightly -- or each payer has a slightly different arrangement and size and scale of the program. Some payers and states are looking for a state-wide contract that is value-based. So obviously, that would be many thousands of patients as opposed to a few hundred. Does that help?

Okay. And -- okay. And are you collecting like full price when you -- even though it's small, like hundreds of thousands are you collecting the full preterm birth price? Or is the discount and just how does that work?

So again, the specifics I won't get into, but we are very happy with the price realization in these early engagements with payers and state Medicaid. We don't know how that will evolve when we get to full scale coverage for the state, but we're optimistic with what we've seen to date.

Got it. And then just in terms of PRIME, so timing-wise, you guys still feel confident it will come before year-end. So we've got whatever 8 weeks -- excuse me, like 6 weeks after you think it will come before then. So maybe just any more color on the confidence there if it slips a little bit, I guess no big deal.

But then, b, just remind us of the additional data we're going to get and what's going to be impactful that will come out in the publication that we didn't see so far?

Yes. No, Dan, we are -- I know we've been talking about any day now for the last few quarters, but it truly is super close now, and we are confident it is in the coming weeks, ideally before the end of the year. And in terms of specific data, of course, it would be impossible to highlight the data before the publication itself. But what I can promise is as soon as the publication is out, we'll have an in-depth event to go over all of the new insights.

I will highlight that the insights are coming from engagement with the reviewers. And as you know, we've talked about a series of publications coming out of mining an incredibly rich data set that comes out from PRIME. So we pulled forward some of the insights that we coming in future publications because of the requests of the reviewers to add that to the publication. So look forward to sharing that, but unfortunately, I can't highlight those until publication dates.

Got it. And maybe one more. Just in terms of the path forward, $100 million in cash, you have these pilot studies in the background and then the PRIME study and then obviously, guidelines. But as we think about the next 1, 2, 3 years, getting PRIME out, getting the pathway to guideline inclusion, whatever you need to do there and then simultaneously, like you said, with these pilot studies. But on the guideline, you said in the past, I think, typical cadence is what, 24 to 48 months post publication. Is that still your best guess right now such that the publication, let's say, comes out in the next month? The end of '25, are we thinking more like end of '27. End of '29 is when guidelines could occur? And then I guess the focus between then and now would just be these pilot studies?

Okay. So a couple of questions on that one. Yes, we are -- that is still 24 to 36 months, still a pretty good guesstimate, I would say. We are -- we've developed an engine to mine the data and add real-world evidence to our portfolio that certainly is going to be the best thing we can do to influence and create literature for review for the guidelines to be updated with the new tools that are available to clinicians. So that is a critical work stream for us, and we're hoping that we'll be a truly a steady stream of data.

In addition to mining PRIME data, of course, we talked about a real-world evidence, which should see its first publication next year as well as the data that's coming out of engagement with the plans and the states. Until the guidelines, I do think the key focus is this geographic focus in driving density of adoption in specific states, given our first target states represents over 1/3 of births in the United States, that's not small volume at all. There is plenty of work to get done and volume to drive. I don't want to just zero-in and call it pilot engagement. Not at all. It's going to be much broader than that, including policy -- positive policy coverage achievement across plans and value-based care contract arrangements and just driving physician adoption, institution by institution in some of the multi-hospital systems and women's health clinics. So a lot more to come on that, but please don't just focus on the pilots. Pilots is one tool in our toolkit. But indeed, it's going to be a geography-focused effort and post guidelines, we're going to move to a nationwide commercialization.

Got it. Okay. Great. I've taken up by 4 questions. So I guess I'll stop there.

No problem at all. Thank you for the great questions.

[Operator Instructions] And your next question comes from the line of Andrew Brackmann from William Blair.

This is Maggie Boeye on for Andrew today. Maybe first just to start, can you walk through just once you have the PRIME publication in your hands, what your plans are there? And how you think about organizational readiness at this point once the PRIME publication comes hopefully before year-end?

Thank you so much, Maggie. Organizational readiness, we've been preparing for quite a few quarters for PRIME to come out. So what we've done is prepared the dialogue that can commence once the data is out, specifically policy review by payers.

As you can imagine, without a peer-reviewed publication, engagement is on the pilot basis and early engagement. However, once we have the publication, the formal processes of review can commence within the payer institutions. So number one priority, as we mentioned, is getting coverage and reimbursement. So that's the first thing that organization will drive upon publication.

Second, of course, is dissemination of information with clinicians, education awareness building. What you can anticipate is presence at conferences, Ecog district conferences, seminars, CME events. We really want to get the data out to as many physicians and opinion leaders as possible. In parallel, of course, we are engaging with opinion leaders on the new data that is coming out of the PRIME that will shape new publications coming out of the data.

Our field force is going to use as a third key thrust, the PRIME publication to make sure that in all of our target states, we are driving physician adoption with the major institutions and hospitals who have been engaging with us under CDA around the data to go ahead and drive education with all of their clinicians with the publication in hand. So we feel the organization is very much ready with all of the appointments we've made this year with our Chief Commercial Officer, Lee Anderson; with our Chief Medical Officer, Dr. Tiffany Inglis. A lot of roles within the commercial organization and hiring our sales force. We are in great shape to press go on our planned post publication.

And then maybe just one, just on the commercial team. How should we be thinking about that build out as we get into 2026 once the PRIME publication is out there? And then just with that, how should we think about your expense in 2026.

Great question. I'll start with the commercial team size and then Austin, if you want to talk through the SG&A question, that would be great.

So Maggie, what we're aiming to do as we expand the engagement with states and the payers and have the initial coverage established. We plan to expand the sales force to drive the pull-through in those geographies. So each of the waves is about 4 to 6 states, so we've staffed the first wave of 6 states. You can anticipate that we will bring new sales reps and medical science liaisons to the next wave of states as traction in those geographies is achieved.

So we'll continue following our philosophy of investing behind the wins to put field personnel in place to drive engagement on the ground with physicians, with practices, with office managers and opinion leaders.

So Austin, do you want to talk through on the parameters of our SG&A change anticipated in 2026?

Sure. Maggie, thanks for the question. We're aiming next year to keep expenses relatively similar to the way they are this year, while also shifting a lot of our capital allocation certainly towards sales and marketing activities. So we do expect to see relatively significant increase on the sales and marketing line, while overall expenses stay relatively flat.

In from our main evidence-generating activities over the last couple of years.

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

Thank you so much. Before we close the call, I just want to emphasize the strong foundation we've built this quarter. with advancing the evidence generation, accelerating commercial execution and strengthening our leadership team. With the first Medicaid pilot live and active engagement across 13 states and key hires in place, we're really well positioned to drive adoption of the test and delivering meaningful impact in maternal and neonatal outcomes.

Looking ahead, we remain focused on disseminating prime results, expanding payer coverage and working towards guideline inclusion. Thank you all so much for the continued support as we work towards transforming prenatal care and creating long-term value for patients, providers and shareholders. Over to you, operator, to close the call.

Thank you. And this concludes today's call. Thank you for participating. You may all disconnect.

Good afternoon, and welcome to the Sera Prognostics Conference Call to review Second Quarter Fiscal Year 2025 Results. [Operator Instructions] 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 1 very expensive neonatal intensive care unit or NICU day by screening on average, just 3 to 4 patients with the PreTRM Test. As a reminder, the average cost of 1 NICU day is about $4,000, but for the earliest born and 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 tractions in 2 particular states with above-average premature birth rates and growing momentum in 2 additional states. We're hopeful we can execute signing on 2 to 4 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.

Now I'll turn the call over to Austin. Austin?

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.

Operator, we can now please open the call for questions.

[Operator Instructions] Your first question is from Andrew Brackmann from William Blair.

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? Is there just -- 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 of 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 the 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 as well as 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 because 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 1 out of 5 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 5, 10 years ago. Thank you for the questions, Maggie.

Your next question is from Dan Brennan from TD Cowen.

This is William Ruby on for Dan. I guess my first question would be on the EU -- the 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 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 -- I think you said you'd hired some additional reps in like -- in your target regions. 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 -- stand ready to hire more as soon as we see traction. Our approach has been, 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 4 to 6 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 talked about a waived 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. And our access team is actually reaching out to a much broader set of states to start preparing this reimbursement engagement in additional half a dozen states every 6 months or so. Does that answer your question?

Yes. 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 like the ACOG 234 bulletin is talking about -- I think it talked about the need for something preterm birth. I'm just wondering if you had any more positive feedback with that ACOG 234 bulletin from just KOLs or physicians.

So the discussions are not specific to the bulletin that governs spontaneous preterm birth treatment. However, I did, you're absolutely right, speak about the change -- momentous change in ACOG approach, where now ACOG pursues across all of the conditions in pregnancy a tailored approach to care. It's not that it's always been just one size fits all. Of course, there's a differential diagnosis, the physicians treated it appropriately. However, for vast majority of low-risk women in pregnancy, which is the target audience that we address with our test, there was a standard care protocol before.

Now with the April announcement that ACOG put out, there is going to be much more -- much deeper integration of tailored care pathways even for what used to be so-called lower-risk pregnancies by using additional risk stratifiers, which, of course, we fit into and therefore, changing care protocols based on those findings and including patients into shared decision-making with the physician, which, of course, was great news for us because for conditions in pregnancy that lead to spontaneous preterm birth that don't typically have clear signs that spontaneous preterm birth could happen. It basically sets the stage for proposing a tool and evaluating all tools in the market where we advantageously stand out because we do have a test with a lot of data validating the test in the clinical utility domain, analytical domain to propose that to physicians.

So what was exciting to us was ACOG's movement towards that. And of course, we can't share specific conversations with opinion leaders, but they're all -- they have the eyes on what data we will put out in the coming months so that they can appropriately evaluate inclusion of innovative risk certification tools into this new paradigm of tailoring care to pregnancies that are higher risk and identifying them with new instruments.

[Operator Instructions] 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 lays ahead to take Sera to the next level.

I'll now turn it back over to the operator to conclude the call. Operator?

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