Joining the Jefferies Healthcare Conference. My name is Lauren Timmons. I work on the Life Science Tools and Diagnostics team here at Jefferies. We're happy to have the team from Sera Prognostics here with us today, President and CEO, Zhenya Lindgardt, and Dr. Tiffany Inglis, Chief Medical Officer. I guess just to start, maybe looking back on 1Q, you had the PRIME results published, and you completed a comprehensive business review, redirecting investments from clinical to commercial. Maybe walk a little bit about the strategic rationale behind this shift.
Great to see you, Lauren, and thank you everyone for tuning in. The Q1 results were a culmination of many years of work on the PRIME study, and specifically, the redirect of the investment completed our shift over the last two to three years, post the interim completion of the PRIME study, or stoppage at the interim point for success, to start driving commercialization in full force with the newly published results. For us, it was a final step in a multi-year effort. It is dry powder we need to drive adoption in a clinical practice.
I guess as part of these operational changes, you also reduced part of your workforce. How has this restructuring allowed you to prioritize your focus, and how does it impact day-to-day operations?
Commercialization is our top priority. It doesn't mean we will stop evidence generation. Farthest from that. We are shifting our R&D efforts to collaborative projects, and that allows us to save on some of our capacity and the resourcing, and redeploy it to start growing our field sales and medical presence, as well as grow a lot of really critical functions like access, contracting, and others.
These recent actions also extend your cash runway through 2029. What are some of the key adoption milestones and commercial targets you expect to achieve with this extended capital?
Well, of course, we are driving really hard on reimbursement and coverage milestones this and the next year to really help us jumpstart that revenue inflection. Our pipeline, Dr. Inglis will talk about a lot of our efforts engaging with CMOs of Medicaid payers, as well as commercial payers, and legislators to share the breakthrough that a preterm test could bring to their constituents and to their member populations. Number one, I would say, is look out for the reimbursement milestones for some of these leading indicators, coverage indicators that spell out opportunity for future volume to come with reimbursement. Of course, number two is adoption. It's getting more physicians on board using our terrific data, and data points that we published in Q1 showing that we reduce preterm birth before 32 weeks by over 1/2 are really resonating with the physicians.
Growing numbers of both large and medium-size practices across our target states is something that we'll continue updating all of you on, and that will tell you that we are on the right track.
Perfect. That's a good segue, Dr. Inglis, the landmark PRIME study, and you alluded to some of the metrics that was published in there. What has the on-the-ground response been from OBGYNs now that the results are out there?
Yeah, it's been fantastic. I think a big part of the first few months after publication in January have been awareness, right? Not everybody reads every journal every day, so just getting that notification out there, getting them aware of the test. Sera has worked really hard with MFMs for years to do the science right and to make this test and make it effective and find the right interventions. Now it's about getting to OBGYNs and midwives who are seeing the patients that need the test, and really making sure they understand that it's available, what it does, how easy it is to integrate into their practice, and what it can mean for women's health. Then I also think, to expand a little bit on yours, it's also getting awareness to legislators and state Medicaid agency folks who are making decisions, and payers.
This test isn't just an improvement in clinical outcomes. It is a way to address affordability in healthcare, which we know is so important as we think about the maternal crisis in the country.
No, that's a great point. I guess from a health economics perspective, PRIME demonstrated number needed to screen of 4.2 to save a NICU day. How powerful is this metric when sitting down with health plan administrators and others?
When you think about, it was about four patients needed to screen to prevent one NICU day. It's 38.5 or just slightly under 40 patients needed to screen to prevent one NICU admission. When you think about that in comparison to the things used today to try to predict preterm birth, the most likely comparator is transvaginal ultrasound with vaginal progesterone for short cervix. That catches about 8% of patients who will end up having a preterm birth. Our test catches about 77%. The number needed to screen to prevent a NICU admission for transvaginal ultrasound is 150. This test is 40. From that perspective, I think it's really important to understand the efficiency and the effectiveness of knowing who.
What PRIME showed is that the intervention works, and that you can actually do something about it, which I think has always been the biggest thing is, great, we can know the risk, but can you do anything? PRIME showed, yeah, we can.
Just to underscore, Lauren, the equation here, transvaginal ultrasound costs about $200- $800 every time. It's a serial, meaning every two weeks, on sometimes more frequently, OBGYNs call back the patient and monitor the patient from trimester two in pregnancy, so sometimes for several months. 150 patients with three to six ultrasounds at least, that is an enormous cost. When Tiffany speaks about cost efficiency, this is one blood test.
Yeah
Compared to serial transvaginal ultrasound. An enormous cost-effectiveness argument for us that we're bringing to payers, and it's resonating.
Yeah, it's also highlighting that we're finding it before the symptoms exist, which is truly preventative care.
You're also publishing sub-analyses on PRIME regarding Medicaid outcomes, first-time mothers. Could you speak about that a bit and how will this aid commercial efforts?
Yeah. Will be more to come in the near weeks that we can share more details on, but there's two Medicaid sub-analyses that are in review for print right now. There's two more that will be presentations at some point. There's multiple others that are beyond the sub-analyses, looking at the cost savings of this model. A 20% NICU reduction is absolutely impactful. Even with any additional spend that we may see on care for these patients who do screen higher risk, we see significant cost savings, and we're excited for what we're going to have there. There's lots and lots to come in the next few weeks. We're sitting on a lot of really interesting data that helps us understand how the test works, why the intervention works, and how we can better supply physicians with an understanding about why they should use it.
No, that's perfect. To round out the data discussion, so you have a wide breadth of studies across PRIME and AVERT supporting the data set. Do you think this completes, in terms of clinical utility and clinical evidence for payers, the data set, or do you think additional real-world evidence studies will be needed?
I think some of the deeper sub-analyses, bringing some of our studies together and pooling some of that data, and we're doing all that work right now, can really help them to see that the one thing that's really interesting about PRIME is, and we've talked a lot about PRIME, as we should, but it is the third of three clinical intervention studies that showed impact to NICU utilization and neonatal morbidity. When we think about how we talk about this test, it's not a one and done. There are multiple studies that have shown impact, and repeated impact in studies with different setups is hard to do if it's not real.
It provides a lot of strength in that this test is very good at what it does, and that the intervention put forward does impact. I think as we look at this next year, and we do some of the things, and then I think the other thing that will help is we're really partnering with folks to do some implementation.
Real-world evidence. I think that also helps in this space, in the women's health space, for people to understand how to deploy innovation. Unfortunately, there's not as much innovation in women's health as there is in other areas.
Sometimes it takes a little bit more hand-holding, and that's what we want to do.
Kind of transitioning to the commercialization, a really important update just happened across Illinois legislature. Mandated Medicaid coverage for proteomic blood tests with published peer review clinical results. Maybe talk to us about that a little bit. Sera fits that perfectly. Kind of how that's going to change your timeline from initial to active reimbursement and how that will look like for the rest of the states.
Let me start. The Illinois State Senate and House last week at the end of session included our test as a screening tool for preterm birth as a mandated coverage for Medicaid patients in Illinois. Essentially then any treatments that those higher-risk patients would be needed based on research and evidence, which is really we're the only ones in that space. It's really exciting, and the Governor has it on his list of things to sign off. The expectation is that he will be signing it. From there, I think there is a very clear path to all of the things that have to happen to truly get live and get orders and get coverage from each of the managed care organizations. Working through that list now. We've been aware that this was out there.
We've been watching and waiting to see what Illinois will do. Yeah.
You can imagine that we're working with multiple states to accelerate legislation like this to be adopted. This was part of our strategy to ensure that this public health test and the impact it can have, makes it to the pregnant moms and babies as soon as possible. You mentioned timeline. As Tiffany mentioned, there's a governor signature, which is coming within 60 days. Our implementation is starting immediately. The next steps will be to work with every payer in the state that carries the lives and covers the lives and engage with them on the PRIME data, on the health economics argument, and start contracting. That is not an overnight process.
It's certainly exciting to see 4.5 months post-publication, or is it five months by now?
Five months.
It's June. Post-publication to see the legislators move so quickly to make this test available, I think it's a huge signal in how Medicaid and government stakeholders are taking this problem seriously.
Taking reimbursement requirement into their hands, which will, of course, help us accelerate reimbursement wins.
Also on the roadmap, you recently launched your third partnership program, which spans 350 providers. What are the subsequent steps to that to ensure successful clinical implementation in these networks?
I'll let Tiffany supplement what I'm about to say, but we've talked quite a bit about the importance of educating the providers and getting them on board with programs like this to show that the clinical workflow implementation is seamless. This simple finger prick blood test does not add to their visits, and allows them to take care of the patients better, to either give them the peace of mind and the patient the peace of mind that they're not higher risk and it's a normal pregnancy, or they might need extra care. We anticipate that the rollout across the 350 providers will take place in stages. That's the current plan. Our team is training. Actually, some of them are being trained in a week and a half.
We look forward to first getting all of the providers on board with a test, equipping them with ability to order the test very quickly. Of course, getting the first few orders allows them to start feeling very comfortable ordering it for all of their low-risk patients.
You're also actively engaged in discussions with 13 payers across 15 states. Can you discuss the cadence of these conversations and kind of typical timeline from an initial pilot to statewide coverage?
Yeah. When you think about the work with payers, it's not a fast process. Importantly so, they have very specific processes they follow when they change their coverage, whether that's for a pilot or whether that's for broad changes. We working through their processes and really just slowly sort of chipping away and as we go, providing all the additional evidence that you asked about before is really helpful. It is very clear when we talk to them, NICU spend and trend is a huge issue in this country. It's a huge issue for payers. This test, very pointedly, with a very easy-to-implement, safe, and inexpensive intervention and test, solves that problem for them in a way that they've never seen before, and drives that into the cost-saving, I would say, column of that work.
It's very clear that as they see the science, we're seeing this, I call this tipping point from, "Why would I do that?" to, "Why am I not doing that?
That's what I've been seeing over the last four months, is really thinking through that. You still have to just acknowledge the fact that payers don't always move quickly through to just standing up a pilot. They want to be conscientious of their process and their regulatory requirements, and so we're just really trying to work alongside them.
As you onboarded Chief Commercial Officer Lee Anderson, what are some of his immediate priorities in terms of adoption of PreTRM this year?
With our strategy being incredibly clear on what are the target geographies, he has been focused on building the team around to make sure that we've got very strong presence in those geographies and have fundamental scaling, commercialization scaling capabilities in our commercial operations team, in our access team, to be able to support that inflection point. That's number one. Number two is, of course, partnering with the medical team to ensure that all of our customers, large institutions in particular, are well-equipped and driving a lot of programs to educate both residents and existing OBGYNs as well as MFMs across the country. That has been his focus. Supporting physician implementation being number one priority, and then partnering with medical and access teams to support pull-through on the coverage programs that we launch.
As you're deploying these regional managers into these target states, what metrics are you tracking to evaluate rep productivity?
A lot of the ones that you probably anticipate. Number of new customers, volume per customer, the speed with which we can move the customers from the initial engagement to ordering at scale for all of their low-risk patients. We look forward, as you know, we don't guide yet on revenue and volume, but we look forward to seeing those metrics move consistently over the next few quarters in order to be able to start sharing them with the investors and the community.
Regarding the national field sales force, apart from the targeted approach that you're going after now, do you anticipate certain milestones before pivoting from targeted geography approach to broader adoption?
Yes. There are a couple of triggers that could accelerate it and really push us towards that. Number one would be a national payer coverage commences, and we need to drive pull-through across more states than the existing targeted set. Number two is guidelines. As you know, it's a huge priority for us. They don't happen overnight. It's a diligent work with a lot of publications, with a lot of opinion leader engagement. Both of those are a key milestone that would switch us to national presence. More broadly, I would say there is so much volume, so much work for us to do right now, that we can create substantial volume with the existing states. Given the news with Illinois, is if a few more states start converting coverage that are outside of our target set, that might push us over as well.
Touching on a few of those points, can you provide us an update on the Elevance Health collaboration, how you're leveraging their network to drive adoption?
Yeah. There's a long partnership there, and really just working through their process. They are looking at their broader coverage process at this time, I believe, and just working through things like Illinois coverage, and where they're going to potentially have plans or partners with their Blues partners, and how we'll work forward with those health plans. Then thinking about pilots in those markets where they may want to test. Really just the same process we have with the other payers, but definitely, with those tight relationships and collaboration in play.
What helps us is that, in the last couple of years, we developed implementation plans, understanding specifically where the priorities are for Elevance plans across geographies, and where we, together, can achieve higher impact faster.
You mentioned it already, but ACOG guidelines. They recently updated Clinical Consensus to emphasize individual prenatal care. How perfectly does this align with PreTRM and with the shift towards personalized pregnancy for ACOG as a whole?
Yeah. In 2025, before PRIME was published, ACOG had a publication come out. It was Tailored Prenatal Care clinical consensus. It's the first of its kind to say, "Maybe we shouldn't give everybody the same care." It was really a nod and an acknowledgment to the fact that personalizing care makes sense, and we do see value in it from a research perspective. Our study in PRIME just continues to grow that body of evidence, and it fits perfectly into that space of why and how you could personalize the preterm birth risk, and then deploy, again, a safe, effective, inexpensive bundle of interventions that works and actually shows that you can change the trajectory of that care for mom and baby.
I think maybe to add, this is a tidal shift for the society. It's a first umbrella publication noting the shift to personalization. All of the individual guideline bulletins will need to catch up with that. The society will be very busy updating them over the next decade, I would say. A plus could be that this spells that the fit of our test could mean acceleration of them taking a look at some of the areas that need updating the most.
I guess coinciding with that, Dr. Inglis, from a practice standpoint, how easily does the PreTRM blood draw at 18-20 weeks for patients and subsequent intervention protocol seamlessly integrate into current pregnancy protocols?
Yeah. Between 18 and 21 weeks, patients are getting mid-pregnancy ultrasounds. They're often being seen in the office. Even as you look at in that Tailored Prenatal Care bulletin or Clinical Consensus, they actually posted what an example patient experience or flow could look like. You'll see there's a lab test, an ultrasound, and a visit that all fall in that window. And that's just an example. It wasn't meant to be how everyone has to do it. Again, it's an example of how to personalize.
When you think about that, the timing of the test is good. It makes sense to have the timing where it is from a placental implantation, implant, and then from what we see in the blood, that's why we know that window is the perfect window. When we take that blood at that time, it also aligns beautifully with then the fact that patients who are identified as higher risk, they do recommend increased frequency of visits, and then tailoring that prescription care to them. From that perspective, we are not seeing physicians struggle.
Then the implementation package, we also have a separate implementation package for providers. As we're getting people live, we're going in and we're providing them all of those materials so that they can provide the patient with the education they need, the staff with the education they need, and make it seamless and work within their flow.
Do you expect to be a hurdle for the inertia of legacy preterm birth implementations that are happening now, such as clinical history or cervical length, which are the majority of at-risk patients are undergoing?
We excluded those patients from our studies. We do not view, and I don't think the society or the leaders in the MFM space view this as a competitor to that test.
This is truly an augmentation. Transvaginal ultrasound only identifies about 8% of subsequent preterm births. It really is not the end-all be-all in understanding who's really at risk. We're missing 50%-60% of preterm births today until they show up in labor. Oh, by the way, a short cervix is already a physical sign of preterm birth.
From that perspective, this is truly going, I think of it as going upstream and really getting to that preventative place. We're working with those leaders in the space that have spent their lives studying transvaginal ultrasound and progesterone, and they are super supportive of the test and the science and where this is going. I don't view it as a competitor at all. I think that it is very helpful to define the population that we've been missing for years.
I guess just to round out, if you think about realistic timeline for ACOG and SMFM and some of these other guidelines, what can you anticipate there?
ACOG reviews their guidelines, their practice bulletins every two to five years. They do not deviate from that structure. We have had great conversations with them. We are working with authors and leaders in the space. They are very aware of the test. They see how we look at implementation and how that can help them define what they'll say over the next year and two. I don't expect them to deviate from their timelines. They are very conservative. They are self-described slow.
They do that because that works for them, and they feel like it gives them time to really understand what that implementation looks like. Again, this is our time to just really make sure we dive deep into the data we have, publish these sub-analyses, publish, publish, get everything out we can, and then also work with providers in the field to understand how is this working for them, how do we help them, how do we make sure the awareness is there.
That's a perfect segue. In the meantime, you're taking an omni-channel approach to marketing, direct consumer-facing platforms like the "SHE MD" podcast. How is patient-directed awareness helping drive awareness of preterm?
A lot of, I won't speak to physicians, I will let Dr. Inglis speak to that, but a lot of physicians tell us that they would prefer that the patient comes in educated about the risks of preterm birth so that they don't need to spend as much of their precious time in the conversation describing and educating them for the first time about the risks of preterm birth. We're taking that on to help the physicians to make sure that when the physician mentions, "This is a great test to help understand your risk for low-risk patient," she already knows about it. We think that creating the broad awareness is an absolutely essential part of commercialization.
We need to start punching above our weight of our budget to get out there and make sure that it becomes a household name, that women know as much about preterm birth as gestational diabetes, as NIPT testing. As you know, it took years, multiple companies, to get the society's awareness of it. Right now, unfortunately, it's a desert. Women are not aware of the risk of one out of 10 will give birth prematurely. It's a lot more frequent than any genetic abnormalities that are currently routinely screened for. There's a lot of work for us to do. When we do lay media and consumer outreach, we're catching OBGYNs as well, because guess what. These days, physicians are online on their devices, scrolling and seeing the news as much as all of the rest of us do.
I think patients are smarter than they've ever been. We have a lot of tools at all of our disposal to learn in a way that we didn't have in the past. I'll also say, people are disappointed in women's health and the perpetual poor outcomes. Patients also are saying, "What should I be doing? How should I be thinking about it?" I think to Zhenya's point, getting education out there for them to understand that your biggest risk in this pregnancy is actually preterm birth at one in 10. Understanding what that risk is, understanding it early, and you can do something about it, which I think is hugely impactful. Letting them drive that conversation and at least bring that conversation to their providers.
Also to her point, all of these avenues we're working towards, they all have physicians on these as listeners too. We had a physician this week. Our staff went into an office and they're like, "Oh my gosh. I saw the podcast. I heard about it. I've been waiting for you guys to come." I do think it's really helpful. Physicians are busy people who really want to do right by patients, but they don't always have time to research everything on their own. That's really why our commercial focus will help them and make sure that it's easy for them to understand how to order the test, when to order the test, and how to get it to their patients.
I guess in the last minute here or so, you're also expanding into Europe markets, and there are kind of markets there take preterm birth and health outcomes differently and usually better than the U.S. As you advance towards the CE mark with regulatory submission, what does the anticipated timeline look like in the E.U.?
Yeah, no, spot on. We're very excited about engaging, and we've been engaging with regulators across the countries there. We're anticipating the early next year receipt of the CE mark, but the conversations with potential partners, and we are aiming to start commercialization with the partners, are in full swing. We're discussing terms and the portfolio of partners or individual partners that we will bring on board. What we're aiming to do is start that implementation as soon as the CE mark is received, but collaboration plans to be solidified later in the year.
That's great. As we look at your successful transition from clinical stage entity to a commercial organization, what do you view as the single biggest risk or hurdle to achieving widespread adoption, and how are you guys mitigating it?
I would say awareness because the path to coverage, as you see, is paved. We're seeing the payers resonating with health economic story. You see the legislators starting to adopt the test. It's how fast we're able to drive broad awareness so that it can get us the pull-through of orders on the coattails of that success.
Well, thank you guys so much for being here.
Thank you.
Thank you for inviting us, Lauren.