Sera Prognostics 2026 年第二季法說會：伊利諾州醫療補助納保與 PreTRM 商業化加速推進

重點摘要

• 2026 財年第二季營收從去年同期的 17,000 美元增加至 30,000 美元， 淨虧損則從 800 萬美元擴大至 910 萬美元。
• Sera Prognostics 在本季末擁有 8,030 萬美元的現金、現金等價物及備供出售證券。管理層相信這足以為營運提供資金，跨越重要的商業里程碑並延續至 2029 年。
• 伊利諾州頒布了醫療補助 (Medicaid) 給付法案，納入用於評估和管理自發性早產風險的處方蛋白質組學血液檢測。公司已展開簽約、資格審查與醫療提供者導入工作。
• Sera 超額達成其 2026 年保險機構洽談目標，目前正在 20 多個州爭取 20 多個保險機構合作機會。公司還啟動了第四個商業合作計畫，並維持五至七個計畫的目標。
• 針對初產婦進行的 PRIME 次群組分析顯示，新生兒加護病房 (NICU) 入院率降低 22%，嚴重綜合新生兒發病率降低 30%。預防一次 NICU 入院所需的篩檢與治療人數為 28 人。
• 據管理層表示，自 PRIME 研究發表以來，檢測量逐月成長，但由於保險給付與導入工作仍在進行，營收規模依然有限。

關鍵財務數據

業務與營運表現

伊利諾州是本季市場准入的核心進展。新法規定該州醫療補助計畫給付並報銷用於評估自發性早產風險的處方蛋白質組學血液檢測，以及已證實能改善預後的相關照護管理服務與干預措施。

Sera 正在與伊利諾州醫療照護與家庭服務部、五個管理型醫療補助計畫及醫療提供者組織進行洽談。目前的重點工作包含註冊、網路參與、簽約、資格審查、醫療提供者教育及工作流程整合。

該公司還透過一項與全國性保險機構合作的州級倡議，啟動了第四個合作計畫。該計畫採用增值福利架構來支持母體健康與品質提升目標。在更廣泛的推進管線中，Sera 在 20 多個州參與了 20 多個保險機構機會，超越了原先設定在 2026 年將討論範圍加倍涵蓋至 15 到 17 個州的目標。

臨床實證仍是商業化的關鍵驅動力。在約佔美國孕婦 40% 的初產婦中，PRIME 次群組分析顯示：

• NICU 入院率降低 22%。
• 自發性早產後的新生兒 NICU 入院率降低兩倍。
• 嚴重綜合新生兒發病率降低 30%。
• 預防一次 NICU 入院所需的篩檢與治療人數為 28 人。

兩篇與 PRIME 相關的摘要獲選於 10 月舉行的母胎醫學會 (SMFM) 全球大會發表。其中一篇將進行口頭報告，另一篇則獲選為優秀海報展示，重點關注生物標記導向干預措施的經濟影響。

在歐洲，Sera 召集了由九個國家代表組成的專家諮詢委員會。該公司決定在完成 CE 標誌申請文件前，對其基於 ELISA 的檢測進行額外的效能測試，包括樣本穩定性測試。

Sera 還展開了一項由 ARPA-H 支持的合作，旨在開發一種即時診斷技術 (point-of-care)，用於評估分娩過程中的胎兒缺氧風險。該公司正貢獻蛋白質生物標記發現與驗證的專業知識，同時仍將 PreTRM Test 的商業化作為首要重點。

管理層指引

管理層維持建立五至七個商業計畫的目標。在 2026 年下半年，公司計畫將重點從啟動保險機構討論，轉向最高優先級市場的執行、給付準備與採用。

關於伊利諾州，由於簽約與認知推廣仍在進行中，管理層預計 2026 年不會有顯著的滲透率。參考其他診斷與篩檢測試的基準，管理層認為 2027 年達到 1% 至 2% 的滲透率是審慎預估，次年可能升至 2% 至 4%，第三年達到約 5%。

隨著資源轉向商業化，公司預計未來幾期的研發支出將會下降。管理層亦預計其健康經濟學分析將在未來幾個月內發表。

歐洲方面，預計預申請活動將於 2026 年第三季開始，目標是在 2026 年第四季完成提交完整的 CE 標誌申請文件。管理層未提供取得 CE 標誌的時間表。

風險與關注焦點

• 儘管檢測量持續成長，營收規模依然有限，這反映出 Sera 以區域為重點的商業化策略仍處於早期階段與發酵期。
• 取得市場准入並不會立即轉化為營收。州政府註冊與醫療提供者認證可能需要數月至長達一年的時間，而保險機構簽約通常需要六到九個月。
• 全國性保險機構的政策審查通常需要 9 至 12 個月，且保險機構在此過程中不會提供透明的時間表。
• 預計 2026 年伊利諾州的使用率仍將有限，管理層預測此後滲透率將呈現個位數的漸進式成長。
• 未來能否納入指南，取決於 PRIME 分析數據的持續發表，以及包括 ACOG 和 SMFM 在內的機構之後續審查。
• 在完成歐洲監管申請文件之前，需要對 ELISA 檢測進行額外的效能測試。

分析師問答重點

伊利諾州給付與採用：管理層概述了三個階段：州註冊與網路參與、與保險機構簽約，以及醫療提供者啟用。Sera 正同步推進這些活動，重點關注大型機構與母胎醫學意見領袖，以支持婦產科醫師採用。

保險機構機會轉化：20 多個保險機構機會分為三類：正式政策審查、州立或基於價值的聯合計畫，以及透過指定雇主或醫療提供者網路進行導入。全國性政策審查通常需要 9 至 12 個月。

商業計畫成功標準：合作夥伴通常希望確定由 PreTRM Test 導向的照護是否能在真實世界人群中複製臨床試驗結果。根據計畫的不同，成功與否可透過臨床結果、州品質指標或基於價值的照護結果來衡量。

指南策略：ACOG 與 SMFM 建議 Sera 繼續發表實證。公司正在擴大與意見領袖的合作，並儲備了約六項額外的 PRIME 分析，管理層預計將在未來一至兩年內發表。

CE 標誌：管理層表示，額外測試是內部建議，而非來自歐洲諮詢委員會。該工作旨在降低部分與運送到實驗室期間樣本穩定性相關的執行風險。

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管理層陳述

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.

分析師問答

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.