Sera Prognostics 2026财年第二季度业绩电话会议：伊利诺伊州医疗补助计划覆盖与PreTRM商业化推进

核心要点

• 2026财年第二季度营收从去年同期的17,000美元增至30,000美元，净亏损则从800万美元扩大至910万美元。
• 截至本季度末，Sera Prognostics 拥有的现金、现金等价物及可供出售金融资产合计为8030万美元。管理层认为，这笔资金足以支持公司完成重大商业里程碑，并维持运营至2029年。
• 伊利诺伊州出台立法，将用于评估和管理自发性早产风险的处方蛋白质组学血液检测纳入医疗补助（Medicaid）报销范围。公司已启动合同签署、资质认证和医疗服务提供商的入驻工作。
• Sera 超额完成了2026年的支付方对接目标，目前正在20多个州推进20多个支付方合作机会。此外，公司还启动了第四个商业合作项目，并维持5至7个项目的既定目标。
• 针对初产妇的 PRIME 亚组分析显示，新生儿重症监护室（NICU）入住率降低了22%，严重复合新生儿发病率降低了30%。预防一次 NICU 入住所需筛查和治疗的人数为28人。
• 管理层表示，自 PRIME 研究发表以来，检测量呈逐月增长态势，但由于报销和落地推广工作仍在推进中，营收规模目前依然较小。

关键财务数据

业务与运营表现

伊利诺伊州是本季度市场准入方面的核心进展。新法律要求该州医疗补助（Medicaid）计划对用于自发性早产风险的处方蛋白质组学血液检测，以及已证实能改善预后的相关护理管理服务和干预措施进行承保和报销。

Sera 正与伊利诺伊州医疗保健和家庭服务部、5家管理型医疗补助计划以及医疗服务提供商机构展开对接。目前的工作重点是注册备案、网络接入、合同签署、资质认证、提供商教育以及工作流程整合。

此外，公司还通过与一家全国性支付方合作的州级倡议项目，启动了其第四个合作项目。该项目利用增值福利框架来支持母婴健康和质量改进目标。在更广泛的业务管线中，Sera 正在20多个州推进20多个支付方合作机会，超额完成了原定的在2026年将覆盖范围扩大至15到17个州并使对话数量翻倍的目标。

临床证据仍是商业化的关键推动力。在占美国孕妇总量约40%的初产妇群体中，PRIME 亚组分析报告显示：

• NICU 入住率降低22%。
• 自发性早产新生儿的 NICU 入住率降低了一半。
• 严重复合新生儿发病率降低30%。
• 预防一次 NICU 入住所需筛查和治疗的人数（NNST）为28人。

两篇与 PRIME 相关的摘要已被10月份举行的母胎医学会（SMFM）全球大会接收。其中一篇将被作口头报告，另一篇则入选最佳海报展示，重点关注生物标志物指导下干预措施的经济影响。

在欧洲，Sera 组建了一个由来自9个国家代表组成的专家咨询委员会。公司决定在完成 CE 标志认证提交材料之前，对其基于 ELISA 的检测方法进行额外的性能测试，包括样本稳定性相关工作。

Sera 还启动了一项由高级卫生研究计划局（ARPA-H）支持的合作，旨在开发一种床旁诊断（POC）工具，用于评估分娩过程中的胎儿缺氧风险。公司将提供蛋白质生物标志物发现与验证方面的专业知识，同时仍将 PreTRM Test 的商业化作为其首要重点。

管理层业绩指引

管理层维持了建立5至7个商业合作项目的目标。在2026年下半年，公司计划将重点从发起支付方对话转向在最高优先级市场中的项目落地、报销就绪和临床采用。

在伊利诺伊州，鉴于合同签署和市场认知度建设仍在推进中，管理层预计2026年不会出现显著的渗透率。参考其他诊断和筛查检测的基准，管理层认为2027年达到1%至2%的渗透率是较为谨慎合理的预期，次年可能上升至2%至4%，到第三年达到约5%。

随着资源向商业化倾斜，公司预计未来期间的研发支出将有所下降。管理层还预计其卫生经济学分析将在未来几个月内发表。

对于欧洲市场，预申请活动预计将于2026年第三季度开始，目标是在2026年第四季度完成完整的 CE 标志认证材料提交。管理层未给出获得 CE 标志的具体时间表。

风险与关注事项

• 尽管检测量有所增加，但营收仍保持较低水平，这反映出 Sera 聚焦特定区域的商业化战略尚处于早期阶段和推进过程中。
• 获得市场准入并不能立即转化为收入。州级注册备案和医疗服务提供商识别可能需要几个月到长达一年的时间，而支付方合同签署通常需要6到9个月。
• 全国性支付方的政策审查通常需要9到12个月，且支付方在此过程中不会提供透明的时间表。
• 预计2026年伊利诺伊州的使用率仍将有限，管理层预测此后渗透率将呈现个位数的缓慢爬坡。
• 未来能否纳入临床指南取决于 PRIME 分析结果的持续发表以及包括美国妇产科医师学会（ACOG）和母胎医学会（SMFM）在内的机构的后续审阅。
• 在完成欧洲监管申请材料之前，还需要对 ELISA 检测方法进行额外的性能测试。

分析师问答亮点

伊利诺伊州报销与采用情况：管理层概述了三个阶段：州级注册备案与网络接入、与支付方签署合同，以及医疗服务提供商激活。Sera 正在同步推进这些活动，重点关注大型医疗机构和母胎医学领域的核心意见领袖，以促进妇产科医师的采用。

支付方机会转化：20多个支付方机会分为三类：正式政策审查、州级或基于价值的联合项目，以及通过选定的雇主或服务商网络落地。全国性政策审查通常需要9到12个月。

商业项目成功标准：合作伙伴通常希望确定在 PreTRM Test 指导下的护理能否在真实世界人群中重现临床试验结果。根据项目的不同，成功与否可以通过临床预后、州级质量指标或基于价值的护理结果来衡量。

指南策略：ACOG 和 SMFM 建议 Sera 继续发表证据。公司正扩大与核心意见领袖的合作，并储备了大约6项额外的 PRIME 分析，管理层预计将在未来一到两年内发表。

CE 标志认证：管理层表示，额外的测试是内部建议而非欧洲咨询委员会的要求。该项工作旨在降低执行风险，部分与样本运输至实验室过程中的稳定性有关。

业绩电话会议完整文字记录

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完整财报电话会议逐字稿

管理层陈述

Operator

Good afternoon, ladies and gentlemen, and welcome to Sera Prognostics Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] This call is being recorded on Wednesday, August 12, 2026.

I would now like to turn the conference over to Jennifer Zibuda, Head of Investor Relations. Please go ahead.

Jennifer Zibuda

Thank you, operator. Welcome to Sera Prognostics Second Quarter 2026 Earnings Conference Call. Earlier today, Sera reported financial results for the quarter ended June 30, 2026.

Joining me on today's call are Zhenya Lindgardt, President and Chief Executive Officer; and Austin Aerts, Chief Financial Officer. Following our prepared remarks, we will open the call for questions. A copy of today's earnings release can be found in the Investors section of our website at sera.com, and a replay of this webcast will also be available.

Before we begin, please note that today's discussion will include projections or forward-looking statements around events and circumstances that have not yet occurred, including regarding our business, future financial results and performance and market opportunities. These statements are based on our current expectations and are subject to risk factors and uncertainties that could cause actual results to differ materially and adversely from these expectations and forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, including our most recent Forms 10-K, 10-Q and 8-K for important information regarding these risk factors.

With that, I will turn the call over to Zhenya.

Evguenia Lindgardt

Thank you, Jennifer, and thanks to everyone for joining us this afternoon. The second quarter was marked by significant wins across key drivers of long-term adoption for PreTRM Test-guided care. During the quarter, we expanded commercial engagement through the launch of the fourth partnership program and increased payer activity across our target geographies. An important policy milestone was unlocked with Illinois Medicaid coverage legislation, which provides access to evidence-based preterm birth risk assessment for tens of thousands of Medicaid pregnancies annually.

We also strengthened our clinical evidence base through publication of PRIME data in first-time mothers, demonstrating significant reductions in NICU admissions and severe neonatal morbidity reductions, while continuing to advance our European regulatory, and commercialization efforts.

Taken together, these achievements reflect increasing alignment among stakeholders around the potential value of PreTRM Test-guided care and reinforce our confidence in the long-term opportunity ahead. We continue to expand payer discussions across the country as we execute our geographically focused commercialization strategy.

Opportunities to expand access are being driven through engagements with payers, state agencies and legislators in markets where maternal health outcomes, Medicaid priorities and policy momentum create favorable conditions for converting market access into adoption. These conversations increasingly center not only on the clinical benefits of earlier risk identification, but also on the potential to improve outcomes, reduce the economic burden of preterm birth and support broader health care affordability initiatives.

Illinois provides an excellent example of the effectiveness of our commercialization strategy. Illinois was not originally included in the states supporting our payer engagement objectives for 2026, yet through increased awareness among providers, policymakers, maternal health advocates and payers the state emerged as one of the most active opportunities in our pipeline.

While many stakeholders contributed to the legislative outcome, we believe growing recognition of preterm birth as a significant public health challenge and increased awareness of evidence-based solutions like PreTRM Test helped create the momentum that led to statewide Medicaid coverage legislation.

Importantly, this illustrates how our strategy extends beyond traditional payer contracting. By combining evidence generation, policy engagement, provider advocacy and awareness building activities, we're cultivating an ecosystem from which the conditions necessary for broader market utilization can organically emerge.

We're also advancing discussions around innovative implementation models designed to integrate PreTRM Test-guided care within existing maternal health programs. This month, we launched our fourth partnership program, expanding implementation of PreTRM Test-guided care through a state-based initiative with a national payer.

The program is intended to support quality improvement and maternal health objectives through a value-added benefits framework. Importantly, we remain on track towards our goal of establishing 5 to 7 commercial programs as we continue to expand our footprint in targeted geographies.

At the beginning of the year, we set a goal of doubling the number of payer discussions across 15 to 17 states during 2026. We're pleased to report that we have exceeded that objective and are currently engaged with more than 20 payer opportunities across over 20 states.

Importantly, this expansion into new opportunities is driven through payer referrals and growing market awareness, leading existing payer contacts to introduce us to affiliated plans and decision-makers in other states and expanding our pipeline more rapidly than anticipated.

We believe this reflects broader acceptance of both the clinical value and health economic impact of PreTRM Test-guided care and reinforces the effectiveness of our focused commercialization strategy.

As we move through the second half of the year, our emphasis will shift from initiating new conversations to advancing implementation, reimbursement readiness and adoption within our highest priority opportunities. We believe the market access progress achieved this year has significantly expanded our commercialization pipeline.

Today, our opportunities broadly fall into 3 categories: payer engagement and evaluation, implementation preparation and contracting, and continued provider activation in markets where access has already been secured. Each of these 3 stages represents a step forward in converting access into clinical uptake and testing volume increase.

In many cases, opportunities that have secured access enter an implementation and contracting period that can take approximately 6 to 9 months before utilization begins to scale. As opportunities progress through this commercialization pathway, our focus shifts from securing access to driving utilization. Through provider onboarding, workflow integration, champion development and targeted awareness initiatives, we're building a repeatable model designed to translate market access into testing volume and revenue growth over time.

We believe the breadth and maturity of our pipeline position many of these opportunities to contribute meaningfully as we progress towards early 2027. One of the most significant developments during the quarter was the passage of landmark legislation in Illinois. The new law requires the state's Medicaid program to provide coverage and reimbursement for prescribed proteomic blood tests used to identify and manage the risk of spontaneous preterm birth, along with associated care management services and interventions that have demonstrated improved outcomes.

We believe the legislation represents an important milestone for maternal health care and validates that earlier identification and management of preterm birth risk can improve outcomes while addressing significant health care costs. We have already begun engagement with the Illinois Department of Healthcare and Family Services, managed Medicaid organizations and provider stakeholders across the state.

Over the coming quarters, we will work towards contracting, credentialing, provider education, workflow integration and implementation readiness. With coverage established, attention turns to execution. Illinois is now progressing through the next phase of our commercialization playbook, which we refer to as implementation readiness and contracting. We are advancing contracting and provider onboarding activities to support integration of PreTRM Test-guided care across both Medicaid and commercially insured populations eligible for testing.

As the first state to formally recognize the clinical and health economic value of PreTRM Test-guided care, we believe Illinois can serve as a blueprint for similar initiatives nationwide. Evidence generation remains the cornerstone of our strategy, and we continue to strengthen our already substantial body of clinical and economic data supporting PreTRM guided care.

In July, we published a prime subgroup analysis focused on first-time mothers, a population for which traditional risk assessment tools have limited predictive value. The findings demonstrated a 22% reduction in NICU admissions, a twofold reduction among newborns following spontaneous preterm birth and a 30% reduction in severe composite neonatal morbidity.

The study also showed a number needed to screen and treat of just 28 patients to prevent 1 NICU admission. First-time mothers account for approximately 40% of pregnancies in the United States, making this an important population for broader adoption of biology-based risk assessment. We also remain on track for publication of our health economics analysis in the coming months. This work will further quantify the economic impact of PreTRM Test-guided care and will be an important component of payer and reimbursement discussions.

We were also pleased that 2 PRIME-related abstracts were accepted for presentation at the Society for Maternal-Fetal Medicine Global Congress in October. One abstract was selected as an oral presentation and focuses on outcome in first-time mothers.

The second was recognized among the top poster presentations and highlights the economic impact of screen guided interventions using our biomarker platform. These selections represent important external validation from the maternal fetal medicine community, and reflects growing recognition of both the clinical and economic value demonstrated in the PRIME trial.

Importantly, our pathway towards future guideline inclusion remains straightforward. continue publishing high-quality evidence, expand collaboration with a broader network of key opinion leaders who are exploring the PRIME data set and generate new clinical and economic publications that further strengthen the evidence supporting PreTRM Test-guided care.

Another highlight this quarter was the start of an ARPA-H-supported collaboration, which provides important validation of our scientific platform and biomarker discovery capabilities. The multi-institutional program is focused on developing a novel point-of-care diagnostic to help clinicians assess fetal hypoxia risk during labor and delivery, with Sera contributing its expertise in protein biomarker discovery and validation.

More broadly, partnerships, grants and collaborative research programs are an important component of our innovation strategy. These relationships allow us to advance our pipeline, expand our scientific leadership position and pursue new opportunities with limited incremental investment from Sera, while maintaining our primary focus on the successful commercialization of PreTRM Test-guided care. We believe this collaborative approach enables us to create long-term pipeline value without diverting material resources from our core commercial priorities.

Building awareness is a critical pillar of our commercialization strategy. In Q2, we advanced our thought leadership and educational initiatives with an on-demand webinar titled, Improving Outcomes of Preterm Birth, featuring Dr. Tiffany Inglis, and PRIME lead investigator, Dr. Brian Iriye.

We also participated in a Medscape Hear From Her podcast, featuring our team and PRIME investigator, Dr. Mollie McDonnold. Importantly, we continue to execute these initiatives with a disciplined approach to spending, leveraging scalable digital platforms and third-party partnerships to maximize reach and impact. We also scaled digital and social engagement to reach patients, providers and maternal health advocates.

Here's why this matters to our broader strategy. Preterm birth is one of the most common serious pregnancy complications, yet most women remain unaware of it until it affects them personally. Over the course of a pregnancy, women spend roughly 200x more time on social media than with their provider. That's where awareness can begin.

When patients learn to ask about preterm birth risk, they raise it with their OB/GYN, and this is one of the ways that physician behavior can follow. Our consumer efforts reinforce rather than compete with our provider and payer strategies.

Similar approaches have proven effective across diagnostics and health care innovation, helping drive awareness, access and ultimately the adoption of evidence-based care. While still early, the initiatives in Illinois, partnerships with providers and payers and the education and awareness for patients and providers are demonstrating their potential to accelerate provider integration into clinical practice and payer coverage, driving improved access is a fully integrated part of our commercialization strategy.

Our European strategy also advanced during this quarter. European expert commentary supporting the role of biomarker-based risk prediction and biology-driven prevention strategies was published, and we convened a European expert advisory board representing 9 countries.

Participants recognized the PreTRM Test as the first validated risk prediction tool for expectant mothers and affirmed the potential role of biology-driven prevention strategies across European health care systems. To support the strongest possible regulatory submission, we have elected to complete additional performance testing in our ELISA-based assay platform, a decision we believe strengthens the overall package while reducing execution risk. We expect pre-application activities to commence in the third quarter with submission of our full CE marking package to conclude in the fourth quarter of this year.

Finally, we continued strengthening our leadership team and governance structure. During this quarter, we added key leadership capabilities in marketing and payer strategy while also welcoming Mark Capone to our Board. These additions further enhance our ability to execute against our commercial and strategic priorities.

In summary, the second quarter demonstrated meaningful progress across the key drivers of market uptake. We expanded payer engagement, saw an important Medicaid policy milestone in Illinois, strengthened our clinical evidence base, advanced our European strategy and continued building awareness among providers and patients. While we remain in the early stages of commercialization, we believe these achievements further strengthen the foundation for future adoption and long-term growth.

With that, I'll turn the call over to Austin to review our second quarter financial results.

Austin Aerts

Thanks, Zhenya, and good afternoon, everyone.

Revenue for the quarter was $30,000 compared to $17,000 in the second 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.

Importantly, though, we are encouraged by the traction we see across the business. Since publication of the PRIME study earlier this year, testing volumes have increased steadily month-to-month, reflecting growing provider awareness and engagement.

Operating expenses for the quarter were $10 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.

Research and development expenses were $3.5 million compared to $3.3 million in 2025, reflecting restructuring-related costs. We do expect R&D spending to decline in future periods as we continue to focus resources on our commercialization efforts.

Selling, general and administrative expenses were $6.5 million versus $6.0 million in the prior year, reflecting investments in targeted commercial activities, marketing programs and strategic commercial hires.

Net loss for the quarter was $9.1 million compared to a net loss of $8.0 million in the second quarter of 2025. We ended June 30, 2026, with $80.3 million in cash, cash equivalents and available-for-sale securities, which we believe will be sufficient to fund the company across significant adoption and commercial milestones through 2029.

As we continue to build the foundational elements necessary for broad adoption, including reimbursement progress, clinical validation and commercial execution, and with testing volumes continuing to increase, we believe the company is entering the second half of the year with strong momentum and a solid financial position.

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

Operator

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

分析师问答

Unknown Analyst

This is Lauren on for Tycho. Congrats again on securing Illinois in the quarter. Maybe just one question around that. Like what are the specific steps to move from provider notice to active reimbursement for individual claims and kind of what that ramp looks like? And then given your presence in first wave states, which of these geographies is likely to follow the Illinois mandate? And then I have a follow-up.

Evguenia Lindgardt

Wonderful. Good to hear your voice, Lauren. Thank you for the question. It's a great opportunity for me to recap on the important sequence of steps that need to be put in place in order to start driving meaningful utilization and volume in any state where we secure access.

So first steps have to do with provider registration in the state and getting into network with the payers. Step #2 is understanding the end contracting with all of the payers present. Specifically in Illinois, there are 5 plans. And you can imagine it will take significant effort to reach out and contract in parallel with the 5 payers on all of the Medicaid population in the state.

While the first step, the registration and getting provider ID in the state might take from a couple of months up to a year, and we have started it across many states. The contracting timeline is a little bit tighter. So instead of a couple of months to a year, it's typically 6 to 9 months for the step #2, actual contracting for reimbursement with all of the payers.

And then the third is provider activation and reaching out sometimes alongside the payer to ensure all of the providers are on board that we activate the champions to educate the provider community since a lot of OB/GYNs are affiliated with hospitals, we typically focus on major institutions who hold MFM opinion leaders among their staff and work with them to have events and programs to ensure quick OB/GYN onboarding and test and intervention bundle adoption. So these 3 steps are typical to convert access like what we've achieved in Illinois to actual meaningful volume. So that's your -- the first half of the question.

Second half is in which other states are likely to follow. There are several other states we believe are close and have prioritized preterm birth as one of their health care priorities to focus on in their communities that allocate health care budget towards such priorities. The time line here is different, though, state by state. So while some states may have prioritized the preterm birth reimbursement higher, their legislative session does not start for another few months.

So what I promise we will do is provide greater transparency as we see public signals from the states that they are moving through evaluation and decision-making on reimbursing preterm test and funding preterm prevention priorities in their state.

Unknown Analyst

Great. That was helpful color. And then just the second one around the SMFM meeting in October. I guess, how will your presence and the nature of your conversations differ this year versus last year now that PRIME and some of the sub-analyses are out there?

Evguenia Lindgardt

Thank you for the question. So first of all, the dialogue and the depth of dialogue and the tenor of the dialogue has shifted dramatically. With the PRIME data out there, we went from communicating the basics of clinical utility and the major endpoint results into much deeper conversations around the biology, the literature expectation of all of the biomarker pathways and how PRIME study and the 2 studies AVERT and PREVENT before the PRIME study came out, showed the same results and very much validated what literature expected SHBG and IBP4 biomarkers to show. And what this signals to me is that the clinical community very quickly passed through the -- does this test work? Into, of course, it works because it validates a lot of what literature said about these 2 biomarkers before and starting to ask questions on what other conditions does the test enrich for.

So a lot of our discussions with opinion leaders are starting to focus on those topics. And that's actually tremendously exciting because it confirms that the validation stage and the convincing stage is almost over, and now we're moving towards the acceptance and implementation and adoption question. Does that help?

Operator

Your next question comes from Daniel Brennan from TD Cowen.

Daniel Brennan

Maybe first one, just on the 4 programs that you've signed, could you just remind us about across the programs, how we should think about those developing, meaning like what are the program directors looking for when will you share info and then what happens at the end of the program? Like what would be a success?

Evguenia Lindgardt

Great. Dan, thank you so much for the question. Different program directors and typically, we work directly with the Chief Medical Officers for either the plan or the state or employer or provider network for these programs. And their goals typically differ in size and scope, but they typically have to do with showing that we're able to replicate the tremendously successful outcomes from our clinical trials in real life in their patient population. That's very typical.

And with this latest program that just launched, it's very typical. This national payer took the quality metrics that they're accountable for to the state and knowing that PreTRM Test has the opportunity to impact their achievement. would like to see in the program population us moving the needle on those metrics.

And the spectrum of flavors that these programs take may include value-based care. Some partners look at what will be the outcomes and how much value is created and others really focus on just clinical outcomes. Does this help?

Operator

Yes. That's good. Maybe back to the first question in terms of -- I know Austin was talking a lot about as you guys migrate your focus maybe towards more -- start to think about more execution, delivery of volumes. But from the first question, obviously, on the Illinois, given the steps that have to occur in terms of activation outreach and whatnot, it sounds like really the impact there could be more '28 than '27, it feels like.

So correct me if I'm wrong there. But assuming it's more '28 when everything is in place, could you walk us through like you talked about 50,000 eligible births in the press release, like over the first, say, 3 years, I mean, is 10%, 15%? Like what's the way you think about when everything is set in Illinois, like how you might be able to ramp that 50,000 opportunity?

Evguenia Lindgardt

Great question, Dan, and thank you for cutting right to the chase on penetration percentages, which we often think about internally, how quickly can we ramp those. We -- so using the steps that I described in the conversation in the question earlier, we are in the midst of contracting with payers. So that is step number one. In parallel, of course, engaging with all the providers to educate them and running awareness campaigns. So that is step number one.

But I would say from July 1, when reimbursement took place, and we ramped our team immediately on the ground, do take the first 6 months for the contracting, and if I can call it, awareness building. So I do not expect a ton of penetration of these 50,000 Medicaid lives in 2026.

Then when we looked at the benchmarks of how other leading diagnostic and screening tests performed as far as penetration in years 1, 2 and 3 post access, we learned that 1% or 2% is good, 2% to 3% is outstanding and 5% is frequently not achieved until year 3. So we'd like to outperform -- but I would imagine that following that benchmark is at the least we are aiming to achieve.

So if we look at 2027 as full year 1, looking at the single-digit percentage points would be prudent, so 1% to 2% penetration following year, let's say, 2% to 3%, 2% to 4% and growing that to 5% in year 3 would be commensurate with the benchmarks we've seen. But of course, we'll keep you posted and talk a lot about how Illinois is going because that trajectory and that ramp will show you what we can do in other states once access is achieved there. Does this help?

Daniel Brennan

Yes. No, that's great. And maybe I'll just ask one more. So the engagement with 20 payers across 20 states, like what's the -- how do we think about the path there for converting those opportunities in reimbursement?

Evguenia Lindgardt

Yes. So I mentioned that engagement follows a pretty typical pathway after the introductory call and getting everybody familiar with the data. The second step usually is the triage on the payer side. Are they going to put us through their policy review? Are they going to take a path of thinking about a program together in any particular geography or exploration of a value-based arrangement or a conversation around partnering with one of their customers, let's say, an employer or a provider.

So with these 20 payers plus across 20-plus states, the segments fall into these 3 categories. There is a swath of payers where we are being taken through the policy review process. With national payers, the process typically takes 9 to 12 months. None of the payers make it transparent how long their policy review process takes. But typically, once that process concludes, there is a definitive decision for now on where does our product fall in their reimbursement schedule.

The second segment is where they chose to let's do something together like you, Sarah are doing in XYZ state with such and such payer. We would like to do something similar. So we're discussing which states, which geographies would be valuable to them. And payers typically look at both where the need is the highest for the patients, where the cost of care is the highest and where they have an opportunity to win new business. So specifically on Medicaid, they're looking to achieve quality metrics required by Medicaid, leveraging the test. And we've got quite a few payers thinking about which locations we might want to run a program or they might want to implement the test first.

And third set of payers, the engagement is around, okay, well, let's look for a set of customers that would be excited to implement this or a set of providers where the implementation could take place efficiently and they could see real time how quickly we're able to drive results. So if that helps, that's a quick segmentation for lack of a better term of the landscape of payer engagement across the states.

Operator

Next question comes from Bill Bonello from Craig-Hallum.

William Bonello

Just a question on any updated thoughts in terms of guidelines?

Evguenia Lindgardt

Bill, thank you for the question. We are working diligently on the strategy we laid out in our previous calls, namely, as you know, ACOG and SMFM are facing a long list of priorities of topics that need guideline updates, and they prioritize the topics that need to be updated based on the literature that has come out recently with new information that may change the guidelines.

So both societies advised us to publish, publish, publish. That's why we've doubled down, not let up after PRIME publication, but doubled down and increased our resources to look at the PRIME data set, expand the set of opinion leaders to engage them to look at our PRIME data set together and continue publishing as much as we possibly can in the near future. And that's why we were highlighting the publication of sub-analysis on the first-time moms -- this is exactly the kind of activity that ensures that the bulletin 2,3,4, which is where update of the guidelines will be most immediate for us is on our priority list and the community received incredibly warmly the analyses that we are conducting. And we've got a pipeline of another half a dozen that will come out in the coming year or 2.

So that is the biggest update. We are executing on the ask from both societies to mine the treasure trove of the PRIME data set and publish as much as possible about the PreTRM Test effectiveness to put it out into the community so that data can be included in the guidelines review when the time comes.

William Bonello

That's helpful. And then just in terms of the oral presentation upcoming at the SMFM, what -- is that going to be new data that above and beyond what was published in July? Or is the presentation essentially of a recap of what was published?

Evguenia Lindgardt

It's data that was published, indeed, the new data that just came out.

Operator

And your next question comes from Matt Larew from Blair -- William Blair.

Matthew Larew

Just one for me, which is on CE Marking. Things targeting fourth quarter now or I guess, by year-end for submission versus midyear. I think you mentioned some additional data that was asked for. Just kind of curious, was that after convening the Advisory Board, was that data they suggested might augment your package? Or was it a feedback in terms of addressing any specific shortcomings in the package? Just kind of curious what led to that decision and if you're still -- I guess, kind of what the confidence is to get it by the end of the year?

Evguenia Lindgardt

Thank you so much, Matt. No, it did not come out from the Advisory Board. It was our internal team's recommendation and actually it had to do with looking at the stability of the samples as they travel to the lab for analysis and a couple of other things.

So to derisk execution, as I mentioned, it would be good to be extra sure given you've heard the heat waves, you've heard that we are pursuing ELISA, and there's a slightly different pathway in Europe that we're taking from the blood draw to the lab where it's analyzed. So that's been the driver, not the Advisory Board. We are working with great consultants, regulatory consultants and are very happy with all of the regulatory interactions and remain on track to get to our CE mark as soon as possible.

Operator

[Operator Instructions] There are no further questions at this time. I will now turn the call over to Zhenya Lindgardt for her closing remarks. Please continue.

Evguenia Lindgardt

Thank you so much, everyone, for your time today. With growing market access, clinical evidence and encouraging commercial indicators, we believe the business is building meaningful momentum as we move through the second half of 2026, and we look forward to updating you on our progress in another quarter. Thank you so much.

Operator

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