Q2 2025 Sera Prognostics Inc Earnings Call

<unk> session towards the end of today's call.

As a reminder, this call is being recorded for replay purposes, I would now like to turn the call over to Peter Denardo of cap Com partners for a few introductory comments.

Thank you operator, good afternoon, everyone welcome to <unk>.

Second quarter fiscal year 2025 earnings conference call.

A close of the market today, Tara Prognostics released its financial results for the quarter ended June 32025.

Waiting for the company today will be Daniel Linde, Gardner, President and CEO and author Eric <unk> our CFO.

Good afternoon and welcome to the Sarah prognostics conference call to review second quarter, fiscal year 2025 results.

During the call we will review the financial results, we released today after which we will host a question and answer session. If you have not had a chance to review our quarterly earnings release. It can be found on our website at <unk> dot.

At this time, all participants are in listen-only mode.

We will be facilitating, a question and answer session towards the end of today's call.

As a reminder, this call is being recorded for replay purposes.

Com.

This call can be heard live via webcast at <unk> Dot com and a recording will be archived in the investors section of our website.

I would now like to turn a call over to Peter dinardo of Capcom partners for a few introductory comments.

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.

Thank you, operator. Good afternoon everyone. Welcome to sap. Prognostic second quarter fiscal year 2025 earnings conference call at the close of the market today. There are prognostics related to financial results for the quarter, end of June, 3020, 2025

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.

Presenting for the company today will be Jenna, lingard president and CEO and Austin. Eric Garcia CFO.

During the call, we were reviewed 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 sarah.com.

<unk> 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 Julia Stewart, Prognostics, President and CEO Julia.

This call can be heard live via webcast at sarah.com, and a recording will be archived in the investors section of our website.

Thank you so much Peter and good afternoon, everyone. We're continuing to advance <unk> 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 opinion leaders to support our role.

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.

Ultimate different materially and adversely from these expectations for a variety of reasons.

Circumstances have not yet occurred including plans and projections for our business future Financial results and market trends and opportunities.

The company.

In terms of data generation, we continue working towards the publication of our full price setting 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 preterm test we remain actively engaged with it.

These statements are based on Management's, current expectations, and the actual events for 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 10K. Its quarterly reports on form 102 and its current reports on Form 8K. These documents identify important risk factors that could cause the actual results to different materially from those contained in our projections and other forward-looking statements I will now turn the call over to Jenna Sarah from Office president and CEO Jenna.

Reviewers and remain optimistic that publication will occur before year end.

We know of obligation is important to our stakeholders and we will keep you apprised and certainly announced publication as soon as at Orion.

We were free to the documents, the company files from time to time for the Securities and Exchange Commission. Specifically, the company's annual report on form 10K. Its quarterly reports of form 102 and its current reports on Form 8K. These documents identify important risk factors that could cause the actual results of different materially. So those contained in our projections and other forward-looking statements, I will now turn the call over to Jena Sarah from Office, president and CEO Jenna.

I will note that from a commercial perspective peers have shown high willingness to engage with us on the abstract and podium presentations by our principal investigator at the society for maternal fetal medicine or <unk> meeting last January allowing us to make progress on our reimbursement strategy.

So after the strong and compelling data from this initial <unk> application, 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, mums and Medicaid expected cost savings of ferrous preterm test.

Thank you so much. Peter and good afternoon everyone. We're continuing to advance Sarah'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 opinion, leaders to support our role as the pregnancy company.

Thank you so much. Peter and good afternoon everyone. We're continuing to advance Sarah'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 opinion, leaders to support our role as the pregnancy company. In terms of data generation, we continue working towards the publication of our full-time 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 preacher.

Many state Medicaid programs cover the first 12 months of health care for newborns and we believe the cost saving benefits of preterm test will be very compelling and state governments seek to reduce overall medical costs.

In terms of data generation, we continue working towards the publication of our full-time, 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 preterm test.

We remain actively engaged with the reviewers and remain optimistic. That publication will occur before year end.

As a reminder, our prime study results reported in January demonstrated that we can save one very expensive neonatal intensive care unit or NICU day by screening on average just three to four patients with the preterm test as a reminder, the average cost of one NICU day is about $4000, but for the earliest.

We know publication is important to our stakeholders and we will keep you apprised and certainly and announce the publication as soon as it arrives.

And depending on the procedures and equipment used the cost could be up to $20000 per NICU day.

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 smsm needing last January allowing us to make progress on our reimbursement strategy.

Prime data indicates Medicaid programs can breakeven and recoup savings without cutting benefits and our conversations with Medicaid organizations support that view.

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.

Step population analysis, for example. First versus second third, fourth time moms

NICU savings in the 40000 member health economic analysis elegant model, both NICU savings and the first 12 months of health care cost savings amounting to $600 per member tested with preterm test.

And Medicaid expected cost Savings of serious pre-term test.

Many State Medicaid programs, cover the first 12 months of healthcare for newborns. And we believe that cost-saving benefits of pre-term test will be very compelling as state governments seek to reduce overall, Medicaid costs.

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 Logan local opinion leaders support.

Early adopter institutions Prime study site locations and other opportunities, which we believe combine to drive clinical utilization of our test in that region quickly.

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 preterm test.

We've continued to be highly engaged with many health care provider organizations in these targeted states.

As a reminder, the average cost of 1. NICU day is about 4,000 dollars, but for the earliest born and depending on the procedures and equipment used, the cost could be up to $0 per NICU day.

Regarding Medicaid plan pilot programs, while still early in the process I am pleased to report that we are seeing notable traction in two particular states with above average premature birth rates and growing momentum in two additional states.

Prime data indicates that Medicaid programs can break even and recoup savings without cutting benefits. Our conversations with Medicaid organizations support that view.

We're hopeful we can execute signing on 2% to four pilot programs within the next few months and we'll keep you updated on these opportunities in the coming months.

Beyond Nikki's Savings, in a 40,000 member Health economic analysis, elevance model, both Nikki savings, and the first 12 months of healthcare cost savings amounting to $100 per member tested with pre-term test.

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.

Commercially as I shared before, we're focusing on our sales and marketing efforts in several geographies, where we see synergistic commercial momentum with Medicaid plan Pilots, local local opinion, leaders. Support early, adopter institutions Prime study size locations, and other opportunities which we believe could combine to drive clinical

Utilization of our testing that region quickly.

In our sales efforts, we have begun hiring additional sales representatives in these geographies to build awareness and establish the foundation for pull through.

We've continued to be highly engaged with many healthcare provider organizations in these targeted States.

These commercial opportunities launch, we expect that it will take a couple of quarters for each new representatives to begin driving adoption of the preterm test within their territory, but we are excited to be investing into these commercial opportunities.

Regarding Medicaid plan pilot programs while still early in the process and 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've also recently made key strategic leadership hires in our commercial team and beyond in order to expand Cirrus commercial reach and increase awareness among physicians.

We're hopeful, we can execute signing on 2 to 4 pilot programs within the next few months, and will keep you updated on these opportunities in the coming months.

<unk> partners and investors.

As announced in May Leigh Anderson was appointed Chief Commercial Officer Lee is an accomplished leader in driving sales within the health care and diagnostics space. He brings to <unk> more than 30 years of cross functional leadership experience in sales marketing customer service strategic accounts and training.

Beyond Medicaid. We continue to Target other payers of all sizes that have a growing desire to provide attractive Healthcare 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 his first 90 days of the helm Lee has been focusing on building out our commercial organization, namely sales and market access.

In July Lee brought onboard Chuck Hyde, who joined Sarah 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 groundbreaking cancer diagnostic company.

Additional sales representatives in these geographies will help 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 preterm test within their territory. But we are excited to be investing into these commercial opportunities.

Chuck will focus on broadening reimbursement for our preterm test across government and commercial payers.

We've also recently made key strategic leadership hires in our commercial team and beyond in order to expand serious commercial reach and increase awareness, among Physicians patients partners and investors.

Now that we have passed through the R&D phase and into what we believe is evidenced pathway for commercial and revenue growth. We are also ramping up awareness of Farah among the investment community through the recent appointment of Jennifer the Buda head of our Investor Relations.

<unk> is an experienced buy side sell side and healthcare Investor Relations professional I hope many of you have a chance to connect with her in the coming weeks.

As announced in May, Lee Anderson was appointed, Chief commercial officer, Lee is an accomplished leader in driving sales within the healthcare and Diagnostics space. He brings the Sarah more than 30 years of cross-functional leadership experience in sales marketing, customer service, strategic accounts and training.

We welcome Lee Chuck and many new members of our sales team and Jen on board and look forward to their contributions and growing upon cerus success.

in his first 90 days of the helm, Lee has been focusing on building out our commercial organization namely sales and Market access

As we stated earlier, we are excited to be sharing new data broadly with a professional societies and clinical communities.

We also continue to have a strong presence at upcoming medical conferences sharing this data with the clinicians.

In July Lee, brought on board Chuck Hyde who joined Sarah as the head of Market access truck has over 20 years of experience. In opening up markets, following leadership roles in oncology Diagnostics and pharmaceuticals,

Data on health economic benefits will be shared at a leading European conference. This fall.

Also, previously held an instrumental role in guiding the payer team for groundbreaking cancer diagnostic company.

In October Dr area will be presenting prime data and the first Renaissance conference. The three ages of the woman being held in Italy.

Chuck will focus on broadening reimbursement for our preterm tests across government and commercial payers.

We also plan to bring additional prime insights to the SSM annual pregnancy meeting in February 2026.

With the power of real World evidence on how preterm can support customize treatment, we're planning on getting as much data out there as soon as possible before the American college of obstetrics and billions of ecology, where equaled chooses to update guidelines. So that our published data is included in their review.

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 Sarah among the investment communities. Through the recent appointment of Jennifer Zab Buddha head of our investor relations.

Jen is an experienced by sight sell side and Healthcare 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, Sarah's success,

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 preterm test.

As our commercialization gained momentum in the coming quarters, we will start reporting on key commercialization performance indicators and may include sales activity metrics scale or reach of physicians via direct and digital channels Payor contract wins and of course eventually revenue.

As we stated earlier, we are excited to be sharing new data, broadly, with the, professional societies and clinical communities. We're 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.

The last item I wanted to update you on the progress we've been making in Europe over the last 18 months Sarah has advanced the commercialization preparation of the preterm test in Europe, where the unmet need for preterm birth risk assessment is well recognized European health care systems acknowledged preterm birth issues and the established pregnancy management protocols.

In October Dr. IA will be presenting Prime data at the first Renaissance conference. The 3 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.

Are aligned with their studies and allow for easy incorporation of the preterm test and there is no effective competition.

To enable a successful market entry we are transitioning the preterm tests from mass spectrometry to an immuno assay focusing initially in the UK, France and Germany.

With the power of real world evidence on how preterm can support customized treatment where planning on getting as much data out there as soon as possible before the American College of Etc and billion ecology or ACOG, choose to update guidelines. So that our published data is included in their review. Part of this process includes meeting with Innovative maternal and field medicine. Clinicians key, opinion leaders and others, who can evaluate the role of newer Technologies like preterm test.

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 agreements and begin preterm test implementation from mid 2026 onwards.

In summary, we believe that through the year and we.

We will build on the body of evidence illustrating the value of preterm 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.

Thank you Danielle and good afternoon, everyone let.

Let me review our financial results for the second quarter net.

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 are making in Europe over the last 18 months. Sarah has advanced the commercialization preparation of the preterm test in Europe, where the unmet need for preterm birth risk assessment is well recognized. European healthcare systems acknowledge preterm birth issues, and the established pregnancy management protocols are aligned with their studies and allow for easy incorporation of the preterm test, and there is no effective competition.

Net revenue for the second quarter of 2025 was $17000 compared to $24000 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.

To enable a successful Market entry. We are transitioning. The preterm test from Mass spectrometry to an immuno assay focusing, initially in the UK, 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.

Selling general and administrative expenses in the second quarter were $6 zero million dollars 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 as strategic headcount to drive future revenue.

Sign, a commercial, partnership agreement and begin pre-term test implementation, from mid 2026 onwards.

in summary, we believe that through the year end,

Net loss for the quarter was $8 $3 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.

we will build on the body of evidence illustrating. The value of pre-term 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, Austin.

Thank you, Virginia and good afternoon, everyone.

Let me review our financial results for the second quarter.

As of June 32025, the company had cash cash equivalents and available for sale securities of approximately $108 5 million, which.

For the second quarter of 2024,

Total operating expenses were 9.3 million and flat with the same period a year ago.

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 will continue to invest where we see opportunities with commercial merit that could expand preterm awareness and test volumes.

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.

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

Thank you.

Ladies and gentlemen, we will now begin the question and answer session.

Should you have a question. Please press the star followed by the number one on your Touchtone phone.

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 has strategic headcount to drive future Revenue.

You'll hear a prompt that you had has been raised.

Should you wish to decline from the polling process. Please press the star followed by the number too.

If you are using a speaker phone.

Net loss for the quarter was 8.0, million down from 8.3 million dollars for the same period. A year ago, due to our continued focus on managing capital resources ahead of expected Revenue expansion.

Please lift the handset before pressing any keys.

One moment. Please for your first question.

Your first question is from Andrew <unk> from William Blair. Please go ahead.

Hi, everyone. This is Maggie bouley on for Andrew today. Thanks for taking our question 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.

continue to be good stewards of our cash position as we build towards Revenue, inflection and will continue to invest where we see opportunities with commercial Merit, that could expand pre-term awareness, and test volumes,

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

Thank you.

Shifts or changes since he has joined and potentially added new prospectus.

Ladies and gentlemen, we will now begin the question-and-answer session.

Maggie Thank you so much for your question and good to hear you.

Should you have a question, please? Press the star, followed by the number 1 on your touchtone phone.

You will hear a prompt that your hand has been raised.

First of all of course Lee brings in decades of experience of traditional commercialization playbook and diagnostics.

Should you wish to decline from Napoleon process? Please press the star, followed by the number 2.

if you are using a speakerphone,

And one of the first things in his.

Please lift the handset before pressing any keys.

1 moment, please, for your first question.

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.

Your first question is from Andrew brackman from William Blair, please go ahead.

Augment the care protocols for the pregnancy in order to empower the physicians to select the right.

Treatment and intervention intervention methods. So we're very excited too to emphasize that in our commercial messages and in the data that we generate and empower our sales team with.

Hi everyone. This is Maggie. Buoy on for Andrew today. Thanks for taking our questions. Can you first just on your, um, 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? So they're just has there been any shifts or changes um since he has joined and potentially added New Perspectives. Thanks.

A second.

Key priority for him was of course, expanding our commercial team.

Maggie. Thank you so much for your question. Good to hear you.

Um,

And he brought his perspective on who are the types of sales leaders and who can really propel us forward and commercial momentum.

first of all, of course, Lee brings in um, Decades of experience of traditional commercialization playbook in Diagnostics and um 1 of the first things uh, in his

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's upgrading capabilities of the team and that's where market access.

Um, remit was to take a look at our commercial strategy, uh, 1 of the first, um, elements that he added is the emphasis on just how much the test itself can help, um, augment the care protocols for the pregnancy. In order to empower the Physicians

Addition to our team Chuck hide came in and.

Allowing us to fire on all cylinders across both commercial payers and public payers.

To select the right uh treatment and intervention intervention methods. So we're very excited to uh to emphasize that in our commercial messages and in the data that we generate and Empower our sales team with

And generating demand from providers.

I hope that's how great. Thank you yeah. That's great. Thank you and then just for my follow up I know, we're anxiously awaiting the prime data publication as well as some additional datasets, but can you just update us on how conversations have progressed.

<unk> guideline bodies, thus far and where your expectations are at in terms of getting and guidelines at this point thanks for taking our questions.

Uh second um key priority for him was of course, expanding our commercial team and um, he brought his perspective on who are the types of uh, sales leaders who can really Propel us forward in commercial momentum. Um, with the strength of the data that uh, that we are receiving right now from Prime study.

No. That's a great question and I assure you we are exactly where you are eagerly awaiting the.

So we have um, um stepped up the level of seniority and experience in the Reps that we brought in under his leadership.

Publications are all of the results and we will keep all of you updated on that.

Um, last but not least, uh, he is upgrading capabilities of the team and that's where Market access. Um,

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.

addition to our team, Chuck hide came in and um, allowing us to fire on all cylinders, across both commercial payers, uh, public payers and generating demand, uh, from providers

Brian steady deliberate a very rich dataset 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 said that we were hoping to to leave for follow on publications.

I hope that helps great. Thank you. Yes, that's great. Thank you. Um, 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 um, with guideline bodies thus far? And where your expectations are at in terms of getting in guidelines at this point. Thanks for taking our questions.

But it's exciting that the community is very engaged very interested and sees how much of a breakthrough.

Saving one out of five babies from going into the NICU.

We'll be in today's day and age when the chances of a newborn ending up in the NICU are multifold are higher than they were 510 years ago.

Thank you for the questions Maggie.

No, that's a it's a great question and I assure you we are exactly where you are, eagerly waiting, um, uh, the publications of all of the results and we'll keep all of you updated on that. Um, the conversations around uh, Prime have been incredibly Rich. Um, both with the opinion leaders, um, that influence um and set guidelines as well as Clinic.

Definitions as well as uh, payers.

Your next question is from Dan Brennan from TD Cowen. Please go ahead.

Hi, guys. This is William Ruby on for Dan.

I guess my first question would be on the EU. The <unk> 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 I was wondering if you could just give some rationale on the EU plan.

I'll start with that.

William Great question.

And for US the opportunity for global impact has always loomed large even if U S market is oh, 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 hold up a mirror and said why are you just focusing on the U S. We really needed in Europe.

Um will be in today's day and age when the chances of uh a newborn ending up in the NICU are multiple uh higher than they were 5 10 years ago.

Thank you for the questions, Maggie.

And asked us to to take our action to Europe as well even before.

Your next question is from Dan Brennan from TD Cowen, please go ahead.

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.

Hi guys. This is uh William Ruby on for Dan. Um 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 US. Um is that going to increase cost at all? I was wondering if you could just give some rationale on the EU plan and I'll just start with that.

Because they felt we have a huge opportunity to achieve impact for moms and babies there as well.

William, great question.

and um, for us

In terms of your question on additional cost, we're not intending to build out our own a.

A 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 anticipate.

The opportunity for Global impact has always loomed large. Even if US market is, uh, absolutely by far, the largest, um, uh uh, in that that said over the years, we've engaged with many European opinion leaders at various conferences. Um and they uh held up a mirror and said why are you just focusing on the us? We really need it in Europe. Um and asked us to um

To take our action, uh, to Europe as well. Uh, even before, um, we achieve significant trajectory in the US.

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.

So we decided to do that and uh started about 18 months ago. Working very closely with European opinion leaders um in our uh Focus markets um because they felt we have a huge opportunity to achieve impact from moms and babies there as well.

Got it thanks, and then I'm wondering how many reps you I think you said you'd hired some additional reps in like target regions wondering how many reps you hired.

In the quarter and then also just how were getting coverage and have high population Medicaid States drive hiring.

Uh, in terms of your question on additional cost, we're not intending to build out our own, um, large footprint in Europe. We are aiming to and have been uh, in deep discussions with Partners across Europe.

Additional sales reps.

Great question. So we have about a 10 person 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 four to six geographies where that.

Fertile ground of reimbursement.

Has been achieved.

To help us commercialize the test on the ground. So from that perspective, it would be an arrangement, um, that is based on Revenue sharing and um, the cost of um, commercialization falling on the partner, um, balance sheet and uh, and pnl. So, from that perspective, we're not anticipating a significant cost increase. We of course, did need to invest to, um, make the product ready for commercialization, um, but that we anticipate will have a very high Roi once we, um, begin striking the commercialization partnership next year.

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 a reimbursement.

For the test in their area that is our approach and we frequently talked about at waived rollout across the states. So as soon as we get them.

Got it. Thanks. And then, um, wondering how many reps you? I think you said you'd hire some additional reps in like in your target. Regions. Wondering how many reps you've hired uh, in the quarter and then also just how getting coverage in a few of these high population. Medicaid States, Drive hiring, uh, of additional sales reps.

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 I'm actually reaching out to a much broader set of states to start preparing this reimbursement engagement.

In additional half a dozen states every six months or so.

Does it answer your question, yes. Thank you.

If I could just ask one more question just circling back I think we've talked about on the last call.

There is a positive feedback with like the <unk> hundred 34, Bolton is talking about.

I think I just talked about.

The need for preterm birth I was wondering if you had any more positive feedback with that call. It two to three for Bolton from kols or or oppositions.

Great question. So we have about a 10% sales force right now and uh our stand ready to hire more. Um as soon as we see traction our approach has been start with um, creating a fertile ground, um, for reimbursement in particular geographies. And this is why I report the number of states where we see traction. Um, ideally by the end of the year, we will see 4 to 6 geographies where that, uh, fertile ground of reimbursement. Um, has been, uh, achieved and um, uh, 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, um, there is, uh, reimbursement, uh, for the test in their area. That is our approach and um, we frequently, uh, talked uh, about a waived roll out across States. So,

So the discussions are not specific to the bulletin that governs spontaneous preterm birth treatment. However, I did youre absolutely right speak about the change momentous change in a cog approach, we're now a cargo pursues across all.

Of the.

Conditions in pregnancy, a tailored approach to care.

As soon as we get, um, good reimbursement, uh, context, uh, 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 um, actually reaching out to a much broader set of states to start preparing. Um this uh reimbursement engagement um in additional half a dozen states every 6 months or so.

<unk>.

It's not that it's always been just one size fits all of course, if there's a differential diagnosis the physicians treated it appropriately however for a 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.

Does it answer your question? Yeah. Uh, yes. Thank you.

Great. Um, if I could just ask 1 more question, um, just going back, I think we talked about on the last call. Um there's a positive feedback with like the ACOG 234 bolts and just talking about um,

you know, I I think it I had talked about

Sure.

Now with the April announcement that <unk> put out there is going to be much more a much deeper integration of tailored care pathways, even for what used to be so called lower risk pregnancies by using additional risk stratified which of course.

Positions.

We fit into and are 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.

So, uh, the the the discussions are not specific to the bulletin that governs spontaneous picture and birth treatment. However, I did, you're absolutely right speak about the change momentous change in ACOG approach. Um, where now ACOG pursues across all of the um, conditions in pregnancy, a tailored approach to care. Um,

Preterm birth that don't typically have clear signs that the spontaneous preterm birth could happen. It basically sets the stage for proposing a tool and evaluating all tools in the market.

It's not that it's always been just 1 size fits, all, of course. If 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 tests. Uh, there was a standard care protocol before.

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 equalled movement towards that and of course, we can't share specific conversations with opinion leaders, but they're all.

They have all the eyes on what data, we will put out in the coming months. So that they can appropriately evaluate inclusion of innovative risk stratification tools into this new paradigm of tailoring care.

Now with the April announcement that ACOG put out there is going to be much more uh, much deeper integration of tailored care Pathways even for what used to be. So-called lower risk pregnancies by using additional risk stratifi, which of course, we fit into, and, uh, 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, uh, for conditions in pregnancy,

Two pregnancies that are higher risk and identifying them with new.

New instruments.

Got it thank you I appreciate it.

Thank you for the question.

Ladies and gentlemen, as a reminder, should you have any questions. Please press the star key followed by the number one.

There are no further questions at this time.

Excellent.

Please proceed with closing remarks.

See, that lead to spontaneous preterm birth that don't typically have clear signs that spontaneous preterm birth Could Happen. Um, it basically sets the stage for proposing, a tool, um, and evaluating all tools in the market, um, where we advantageously stand out because we do have a test with a lot of data validating, um, the test, uh, in the clinical utility domain, um, analytical domain, um, to propose that to Physicians. So what was exciting to us, uh, was acog's movement towards that, and, of course, we can't share specific conversations with opinion leaders but they're all

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 sheer Sarah shareholders. This data will help us grow our business and there is impact on premature births in the United States and of course.

Abroad. We are excited by what lays ahead that takes era to the next level I'll now turn it back over to the operator to conclude the call operator.

They have all the eyes on what data we will um uh put out in the coming months so that they can appropriately evaluate inclusion of innovative, uh risk certification tools uh into this new paradigm of tailoring care. Um, to pregnancies that are higher risk and identifying them with new um, new instruments.

Got it. Thank you. I appreciate it.

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

Thank you for the question.

Ladies and gentlemen, as a reminder, should you have any questions, please press the star key followed by the number 1?

There are no further questions at this time.

Miss lingard.

Please proceed with closing remarks.

Okay.

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 shareholders. This data will help us grow our business and Sera’s impact on premature birth in the United States and, of course, abroad. We are excited by what lies ahead to take Sera to the next level. I'll now turn it back over to the operator to conclude the call. Operator.

Ladies and gentlemen, this concludes your conference call for today.

We thank you for participating and ask that you, please disconnect your lines.

Yes.