Sera Prognostics at TD Cowen: Innovative Approaches to Preterm Birth

On Wednesday, 05 March 2025, Sera Prognostics (NASDAQ: SERA) participated in the TD Cowen 45th Annual Healthcare Conference, where President and CEO Zaina Lingard discussed the company’s strategic efforts to combat preterm birth. Lingard emphasized the severity of this issue in the United States, describing it as a "preterm birth pandemic." While the company has shown promising results with its innovative blood test, challenges remain in achieving widespread adoption and reimbursement.

Key Takeaways

• Sera Prognostics’ blood test identifies preterm birth risks, leading to preventive treatments.
• The PRIME study showed a 25% reduction in neonatal morbidity and mortality.
• The company is financially stable, with cash runway through 2028.
• Efforts are underway to include the test in major medical guidelines.
• The economic impact of preterm births in the U.S. is approximately $25 billion annually.

Financial Results

• Economic Impact: The cost of prematurity in the U.S. is about $25 billion each year, with each premature delivery costing $65,000.
• Number Needed to Screen (NNS): To save one NICU day, the NNS is between three and four women, significantly better than current methods.
• Cost Savings: Avoiding NICU days could save nearly $3,000 per day, and Elevance’s model suggests $1,600 savings per member tested.
• Reimbursement: Sera Prognostics has secured a CMS reimbursement code valued at approximately $750.

Operational Updates

• PRIME Study Results: Demonstrated a 25% reduction in neonatal morbidity and mortality and an 18% reduction in neonatal length of stay.
• Preventive Bundle: Includes low-dose aspirin, vaginal progesterone, and weekly nurse calls, which have shown positive feedback from healthcare providers.
• Publication Plans: The company plans to publish further analyses on the drivers of NMI reduction in the coming months.
• Guideline Influence: Collaborating with guideline-setting bodies to facilitate the adoption and reimbursement of their test.

Future Outlook

• Guideline Adoption: Aiming for inclusion in ACOG and SMFM guidelines, a process that has historically taken other companies several years.
• Commercialization: Creating local ecosystems in high preterm birth areas to demonstrate the clinical and economic benefits.
• Research: An investigator-initiated research program will explore which components of the preventive bundle are most effective.

Q&A Highlights

• Preventive Bundle Components: Physicians are interested in understanding which components drive the most impact.
• Corticosteroid Use: Lower in the intervention group (4.3%) compared to the control group (5.6%).
• Publication Strategy: Plans to involve all 19 PIs from the PRIME study in further research and make the dataset available for publication in relevant journals.

For a detailed understanding of Sera Prognostics’ strategies and insights from the conference, please refer to the full transcript below.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Unidentified speaker, Host, TD Cowen: Welcome to day two here or day three, excuse me, of the TD Cowen Global Healthcare Conference. I follow tools and diagnostics. Really pleased to be joined with me here on Sage. Zaina Lingard, who’s the president and CEO of Sarah Prognostics. So Zaina, welcome.

Thank you. So starting off with a high level question, I think, we’d love to hear from you about framing, the issue of preterm birth. How important is this? How material is it or not? Is this something that is, you know, the world should be really focused on?

Zaina Lingard, President and CEO, SARA Prognostics: It’s a huge problem. I would call, especially in The United States, we have a preterm birth pandemic. It’s been a very sticky and intractable issue. And in the last ten, twenty years, the number is not improving. They’re actually getting worse slightly worse year after year.

Approximately one out of ten babies are born preterm in The United States, and prematurity is a leading cause of death for neonates and babies under a year old. For three point seven million births in The United States, about twenty thousand babies die. And, unfortunately, we as a health care system have not been able to address it. Economically, it costs the system about $25,000,000,000, the cost of prematurity, because, each delivery of a premature baby, on average, cost the system $65,000, which is orders of magnitude 10 x of what a term baby cost would be.

Unidentified speaker, Host, TD Cowen: So then how so how is preterm birth diagnosed today? And can you tell us about how SARA aims to change that?

Zaina Lingard, President and CEO, SARA Prognostics: Well, today, there are two risk factors that definitively spelled out by the guidelines to be predictors for preterm birth, which is previous preterm birth, which clearly doesn’t work for first time moms because you don’t have that history to go off of, and short cervix. And only, fewer than two percent of moms present a short cervix early on. When higher risk factors are present, it’s transvaginal ultrasound that allows to monitor the mom and diagnose risk for preterm birth or screen for preterm birth. As you know, it’s expensive and takes a lot of visits and ongoing monitoring. So it’s not optimal for spontaneous preterm birth, and spontaneous preterm birth accounts for more than half of all preterm birth in The United States where the baby comes and there were no other risk factors that allowed the physician to potentially prevent it, with treatment or preventive bundles of interventions, and the baby comes before thirty seven weeks of gestation, the definition of preterm birth.

Therefore, for us, having developed a biomarker, which is a simple blood test administered between weeks eighteen and twenty of pregnancy, allows the physician to know that risk, which exists in a healthy singleton asymptomatic pregnancy, is just the physician and the mom don’t know it. And it allows the physician to commence a preventive bundle of safe and efficacious treatments. In our case, we’ve proven in multiple clinical trials that low dose aspirin, vaginal progesterone daily, and a weekly nurse call can make an enormous difference for the health of mom and baby by extending gestation of the baby in utero and have the baby being born healthier and stay in the hospital fewer days.

Unidentified speaker, Host, TD Cowen: Great. So before we jump into the data, maybe it would be helpful to get some background on yourself. You came in as interim CEO back in May of twenty three. You’ve been Uber before that and then a long career at BCG. So what makes you the right person to lead Sarah during this critical phase of corporate life, since they just had their pivotal study, which we’re gonna get to in a moment here, reported out, you know, within the past few months?

And what skills and experience from your prior roles can you draw upon to be successful in this role?

Zaina Lingard, President and CEO, SARA Prognostics: Absolutely. I first was introduced to Sarah’s story by my predecessor, doctor Greg Critchfield, who led the company for over a dozen years. And, he called me up because I was an executive at Uber, and I led the corporate incubator where my job was to scale, small businesses, under a hundred million and get them to be multibillion dollar businesses for Uber on the tech platform. And, we connected immediately because I’m a mom of three girls, and I want them to have a wonderful experience in their pregnancies and have many, many grandchildren, in the next few decades. So I told him that, for women of childbearing age today, we need to introduce technology.

And in order to achieve adoption and drive density of adoption, we really need to blend screening, diagnostic tools, and technology in commercialization and, of course, the test performance. So what I bring to the table is an unusual combination of in-depth knowledge of health care system in The United States and beyond from my twenty years in the Boston Consulting Group, having worked in life sciences in every sector from optimizing provider integrated delivery networks to serving payers to serving biotechs and diagnostics, bringing all of that and big tech unicorn experience in scaling small businesses. Now to take Sarah from this one to 2,000,000,000 stage. Terrific. Well, let’s let’s dig into PRIME, the PRIME study, which is

Unidentified speaker, Host, TD Cowen: your pivotal study. The abstract was out in early January, where you reported the study met both pro both co prime end endpoints, excuse me, and showed a twenty five percent reduction in neonatal morbidity and mortality, or NMI and versus a nineteen percent reduction in the previous overt trial. You also had an eighteen percent reduction in neonatal length of stay versus a twenty seven percent reduction in AVERT. AVERT was one of your prior studies. So maybe just give us a sense, early feedback from doctors, payers about the significance in this data.

And if you wanna frame the data in your own words, that would be helpful.

Zaina Lingard, President and CEO, SARA Prognostics: Thank you so much. Well, the endpoints that we studied in both AVERT and PRIME are the same. And that’s, as you highlighted, very important because we want to show consistency of performance of the test, to, the clinicians, to guidelines and bodies, and that continuous and consistent performance, is something I wanted to highlight first. Number two is whatever the percentages are in reduction in in the endpoints that you laid out, what’s really critical to remember is the difference between the two studies. One has a historical control arm and one has a prospective control arm.

But what’s critical is that if you blend and analyze the data together, they both achieve a really nice stable with a p value that is very credible and strong, twenty two percent reduction in each, the health of the baby, the severe outcomes for the baby, and in the length of stay. So that shows to us that the performance is spectacular in ability to be translated from a single study location to a 19 center national trial and prospective control, and the performance is, is the same.

Unidentified speaker, Host, TD Cowen: So what are you hearing so far in terms of the the endpoints either here that we just mentioned or any other secondary endpoints that are early on resonating with doctors and or payers from your early conversations?

Zaina Lingard, President and CEO, SARA Prognostics: From the conference where we presented the data, and doctor Irie presented the data, at the late breaking session, the first number that jumped out at everybody was keeping babies out of NICU. The twenty, twenty two percent reduction of NICU admission absolutely was perceived as a breakthrough. Basically, one out of five babies doesn’t go into NICU, and those who do end up in the NICU have a reduced length of stay because of the screen and treat intervention bundle. So that was the first major major positive reception of the data. Of course, because everybody saw the overt data, the primary endpoints everybody was excited by but said great.

The second, most well received was actually a number needed to screen, which is a metric that, the payers frequently use, but clinicians know about, where you measure the effectiveness of the screening or diagnostic test on how many women need to be screened in order to achieve an outcome. And we measured that number needed to screen for saving an NICU day and for reducing a NICU admission. And it’s just three or between three and four women that you need to screen in order to save one NICU day, which is incredibly powerful as a number. For other tests and treatments, that number is orders of magnitude higher. And when you look at how many women need to be screened to prevent a NICU admission, we only need about 41.

And that is more than three times better than the screening test I mentioned in the guidelines, which is transvaginal ultrasound. You need to screen with transvaginal ultrasound hundred and fifty women in order to save one NICU admission. And for us, it’s just forty one. So it’s more than three times better.

Unidentified speaker, Host, TD Cowen: Interesting. How about in terms of early pushback on the data? Has it been any what are what are some of the doctors or folks kinda pointing to?

Zaina Lingard, President and CEO, SARA Prognostics: Well, the first thing they ask is, okay, you guys have this preventive bundle of aspirin, progesterone, and care management. Well, which is it? What drives the most impact? And, because the test is intended to spot abnormalities from multiple etiologies or biological reasons for future development of preterm birth complications, the test does not specify which is the complication that is driving the higher risk. Therefore, it’s not one particular, bundled component that drives the most of it.

Constantly talk about why it’s important to drive all three because for physicians, the symptoms will develop later on in the pregnancy, and they will know what condition is emerging. But these three components of the bundle have shown to be very effective of ameliorating the effects of it on the newborn, mom, and, of course, the hospital stay. We’ll take a look at, at that question because a lot of clinicians came to us and said, let us research and explore the data to see which component. But we’ve launched an investigator initiated research program. Maybe they can help us look at the data.

Unidentified speaker, Host, TD Cowen: Okay. When do you expect to publish additional analysis on what drove the reduction in NMI? Some of the KOLs that we’ve spoken with are interested in knowing which morbidities in the NMI scale were reduced as well as well as whether the reduction in NMI was more driven by days in the NICU or these morbidity events?

Zaina Lingard, President and CEO, SARA Prognostics: That will be broken down in the manuscript, in the publication that is under review and we’re hoping will, will be published in the coming months. Okay. Do you think

Unidentified speaker, Host, TD Cowen: the preterm birth could enhance use of an effectiveness of corticosteroids in the future? You know, we know there’ll be a secondary analysis on the effects of corticosteroids during the trial, But can you speak to any effect you saw for the use of steroids in the trial? That was some feedback that we heard from doctors is that steroid use, if you kinda have a sense when the birth’s gonna come, that actually is effective at delaying that birth. So just speak to how steroids were used and kinda how you think that’ll be analyzed.

Zaina Lingard, President and CEO, SARA Prognostics: We heard the same, and we’re definitely gonna take a look at the data for now. What we showed, what doctor Eri showed at the conference was the level of corticosteroid use in the intervention and in the control arm, which is four point three and five point six percent respectively. But, of course, more data is forthcoming as we do this analysis.

Unidentified speaker, Host, TD Cowen: So you talked about NICU admission just a moment ago. It’s just, you know, one in five babies are spared going to the NICU. Can you frame what that means in terms of an economic cost perspective?

Zaina Lingard, President and CEO, SARA Prognostics: Yeah. And, actually, we’re excited to publish, the data, hopefully, in a peer reviewed journal as another publication to show, the health economic impact. But if we do a back of the envelope on the basis of number needed to screen, we do have a reimbursement code from CMS at about $750 And given the number needed to screen is between three and four, so roughly, you look at $2,200 to save one NICU day. The cost of one NICU day on average in this country is, you know, $5,000 So right there, you’re saving, almost $3,000 Now for some babies who are born really premature, that cost is about $20,000, if there is a lot of procedures and machinery that is used to to keep the baby alive and growing in the NICU. So those savings could be much, much more.

That’s, again, just the back of the envelope, with the number needed to screen, but a lot more data will be forthcoming. Needless to say, it looks really good, and our partner, national payer, Elavance, has run their model to show $1,600 savings per member tested. And, of course, we’re looking forward to, to show the data from our trials to show how well the test performed to compare to that initial estimate from Elevance.

Unidentified speaker, Host, TD Cowen: Right. So what did they use? 1,600 versus you’re showing 3,000. You’re almost double what they were showing. What was something

Zaina Lingard, President and CEO, SARA Prognostics: you It all depends on the, the the other the cost of aspirin, progesterone, care management, what you include. I did the back of the envelope.

Unidentified speaker, Host, TD Cowen: Got it. Okay. So talk about guidelines are gonna be critical, right, in the commercial outlook now that the data is out. So walk through your high level plan and framework for getting the data published, working towards developing any additional evidence for guidelines, and and then we can kinda go from there.

Zaina Lingard, President and CEO, SARA Prognostics: So, of course, first and foremost, we stay in touch with guidelines sending bodies and ask them what can we do to help them make a recommendation for usage of the test and screen strategy, in the community. And what they told us is publish, publish, publish, which was delightful because it didn’t say run three more studies. They just said publish more data out of this, this spectacular set dataset that we’ve pulled together. So we’re going to do just that. We’re going to offer all of the 19 PIs in the study to research more and make the dataset available to them and support them to get as much as possible of the data out.

So that’s strategy number one, as recommended by the professional societies themselves. Second is, they recommended that we work together with some partners to lay out what is the protocol and how to implement it, and importantly, how to help physicians get paid for it. So we’ll work, to make sure that that’s really clear, you know, whether it is in in collaboration with a professional society or they do it themselves. The the societies felt like that would be really important. Fourth thing we’re going to do is, of course, get the major institutions to start adopting this protocol based on the published data so that it nudges, the questions to professional societies that these institutions are using the test, clinicians are using the test.

What is your position, on usage of this test so that it can be prioritized for guidelines review? It’s important to note that ACOG bulletin two thirty four, which currently governs protocol for preterm birth management, already mentions biomarkers and development and cites our validation study that we’ve done, many years ago. So for us, it’s about updating the guidelines, which means it needs to be prioritized to be one of two or three per just two or three per year that gets updated. When a committee of about 20 feet people of OB GYNs, MFMs, health economists, neonatologists gets formed to review the evidence that has emerged in the last three years to update this bulletin. Last time it was updated was August 2021.

So it’s really good timing on the coattails of breakthrough data and hopefully several publications, that we aim to make available to this committee should this topic be prioritized quickly. What are

Unidentified speaker, Host, TD Cowen: the types of publications? Because I know investors or scientists and guidelines, I’m sure, look at the level of quality. New England Journal of Medicine is always like a premier publication, obviously. But for this particular area for women’s, for women’s health, what what are the types of publications that, you know, kind of in an a category, the b category? How do we think about that?

Is that important?

Zaina Lingard, President and CEO, SARA Prognostics: Well, of course, impact factor of the journal, is important, generally speaking. That said, guideline setting bodies, specifically ACOG and SMFM, you know, in our space, but, of course, the USPS, which is a very important, I would say, Uber guideline setting body that payers look at, also look at specific publications to that specialty. So for us, it’s, of course, AJOG, American Journal of Obstetrics and Gynecology, which is the top journal, and there are many in in that, in that roster. And we’ve published there. We’ve published in many other journals.

And not to be forgotten, the new journal that Society for Maternal and Fetal Medicine launched just this year called The Pregnancy, which is poised to be the leading journal in the next ten years for specifically higher risk pregnancy management. So we’re looking at, which journals are important for our space as well as general readable journals by physicians so that we have a mix of journals with these half a dozen publications that are imminent. What’s important to know is that there is grading level when guidelines are set. There’s a great assessment of the quality of evidence. It’s not just the publication quality itself, but the study design.

So, of course, the gold standard level one is an RCT, which is what we have with PRIME. And then acceptable are level twos and level threes, which is like an RWE study, which we’re launching actually as we speak. So we hope that AVERT and our future RWEs and all of the investigator initiated research we’re going to sponsor and support, are going to make it into the great assessment and the evidence that will be evaluated in the guidelines.

Unidentified speaker, Host, TD Cowen: So in terms of trying to, you know, influence guideline members, I know you’ve gotten, or you do have a fair number of guideline members that were involved with the clinical trial. Can you just speak to that a little bit? Because I know there are other diagnostic companies that have had this really rigorous process towards trying to promote their test and and ensuring that guideline members are involved throughout the process. Just speak to the strategy that Sarah has followed there.

Zaina Lingard, President and CEO, SARA Prognostics: Well, we deploy the playbook that works in the industry, number one. But number two is we aim to do it the right way, without biasing the guideline committee and making sure that the evidence speaks for itself, but we’re doing our job to make sure that all of the stakeholders are aware and we bring them the data. We keep them updated on our publication plans, on the studies, what questions they might have that we should look into. So that collaboration without overdue influence, which can backfire Right. In them saying you guys are too close to us.

Let us do our job. We’re letting them do their job and, following their recommendations on what we can do.

Unidentified speaker, Host, TD Cowen: But you do have I mean, there were a number of guideline members that were involved with the study. Is that fair?

Zaina Lingard, President and CEO, SARA Prognostics: Yes. That’s exactly right. We also have a number of ex presidents of of the society, that have worked with us in the seventeen years that Sarah has been in existence, so we’re not a spring chicken. Mhmm. That’s why the community knows us.

It’s also a small community. So, that’s why we feel we’re well positioned. That said, we also understand that, in the guideline setting process, we want to make sure a broader set of KPN leaders know us, not just a few influencers, because some of them may have to recuse themselves because they’ve been affiliated.

Unidentified speaker, Host, TD Cowen: You mentioned earlier that you said when you spoke with the guideline members and you asked them what to do, they said publish and they didn’t say run another study. Would they have told you to run another study? Like, is it an official statement back from the guidelines? Like, how does that communicate to them?

Zaina Lingard, President and CEO, SARA Prognostics: There’s no, guideline setting process is laid out really nicely in ACOG bulletins. What does it take, for the guidelines to be revised? Industry should not influence that. Industry can ask questions, and that’s what we’re doing. Mhmm.

And, the there’s no official advice. It’s not like an FDA, which is a rigorous process, and you know what to expect. We understand fully the process, but our job is create evidence and clinicians and researchers’ job is to discuss that evidence and make conclusions.

Unidentified speaker, Host, TD Cowen: Got it. In terms of are there any surrogates that you might point to in terms of the pathway forward to have your tests, actually get into guidelines in terms of how long it would take or the level of the level of evidence that you’ve put forth?

Zaina Lingard, President and CEO, SARA Prognostics: Definitely. So for us, of course, ACOG and SMFM, two professional societies collaborate on guidelines. There there has been one precedent when one society, SMFM, went alone. It’s actually a recent one. Panorama, Cologuard, etcetera.

And how long did it take? And I Panorama, Cologuard, etcetera. And how long did it take the NIPT? How long did it take them to get into guidelines? And I won’t tell you something you don’t know.

Many of you are experts in this space. But for Exact Sciences, it took seven years, for example, to get into guidelines with their test. For Panorama, it took ten years. And for NIPT, you know, for broad based adoption, it took even longer. But it took shorter to get into the higher risk population.

So it’s important to note, however, that, the world is evolving and preterm birth is a big challenge for the community. There are no other tools. This is a breakthrough innovation and is recognized as such. So there is a catalyst to look and perhaps move faster, and that recognition will help change the timelines. Additionally, the change of guidelines may come gradually, with levels.

So for example, commentary letter, not a full blown recommendation and change in the bulletin, recommendation or practice advisory, which already will start being a huge support to the community to start experimenting and adopting this innovation.

Unidentified speaker, Host, TD Cowen: So what can you do now? What could, in terms of your commercial plans while you’re building the evidence and producing future evidence and working with, you know, publications and things of that sort, consulting with doctors. How about on the front of beginning to market this test? Like, when will that start, while you have this time period, which could be hopefully a lot sooner than seven to ten years, but, you know, we don’t know.

Zaina Lingard, President and CEO, SARA Prognostics: Yeah. Well, we hope so as well. Usage in the community. It’s a big, big, big factor because, of course, when clinicians say we’re using this test, society please share your position on how this test should be used in practice, that is number one lever we have. And the more, opinion leaders in major institutions that are recognized as leading obstetric and gynecology centers or maternal fetal medicine, specialists are using it, the more opportunities for the dialogue among clinical leaders to take place.

So that’s number one, and we’re driving that. Number two, of course, is reimbursement. You know, as payers starting to recognize the value, clinical and economic value this test brings to the country, that also makes a huge difference. So what we’re doing right now is creating local ecosystems of where clinicians are excited to be putting the test to use in hard hit by preterm birth areas and payers and moms and clinicians and make sure that we drive the density of adoption to showcase what this can do economically and clinically for high preterm birth prevalence areas.

Unidentified speaker, Host, TD Cowen: In terms of your cash runway, you just did the $50,000,000 raise. What are your thoughts in terms of having that cash way last you into the future?

Zaina Lingard, President and CEO, SARA Prognostics: We are unique and very fortunate in the diagnostic space for a company that is just launching their broad scale adoption journey to have at least through 2028 cash runway, and that is not even including any proceeds from revenue. You know, for sure, it will be extended much farther as we ramp the revenue. So we think that’s plenty of time to get to significant scale and maybe even break breakeven, timescale.

Unidentified speaker, Host, TD Cowen: Terrific. So I think with that, we’re out of time. So, Zaina, thank you very much for being here.

Zaina Lingard, President and CEO, SARA Prognostics: Thank you for the amazing questions. Good to see you. Thank you.

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