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Earnings Call: Q4 2022

Mar 22, 2023

Operator

Good afternoon. Welcome to the Sera Prognostics Conference Call to review Fourth Quarter and Fiscal Year 2022 Results. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session toward 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 CapComm Partners for a few introductory comments.

Peter DeNardo
Investor Relations Representative, CapComm Partners

Thank you, MJ. Good afternoon, everyone. Welcome to Sera Prognostics Fourth Quarter Fiscal Year 2022 Earnings Conference Call. At the close of the market today, Sera Prognostics released its financial results for the quarter ended December 31, 2022. Presenting for the company today will be Greg Critchfield, Chairman, President, and CEO, and Jay Moyes, our CFO. During the call, we will review 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 seraprognostics.com. This call can be heard live via webcast at seraprognostics.com, and a recording will be archived in the Investors Section of our website.

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. 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 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. As a reminder, webcast replay of this call will be available on the investor section of our website.

I will now turn the call over to Greg, Sera Prognostics Chairman, President, and CEO. Greg?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Thank you, Peter. Good afternoon, everyone. Fiscal 2022 was a solid year of continued progress in positioning Sera Prognostics for commercial growth in the quarters and years ahead. During 2022, we made incremental progress in adding new payer contracts and more recently have publicized new data that we believe will support the growth of our business in future periods. Although our revenue was nominal for the year, we are seeing percentage gross growth in test volumes. For Q4 year-over-year 2022 versus 2021, the increase was 6-fold, and for total units 2022 versus 2021, it was 11-fold. Of course, these are increases from a small baseline in 2021.

While it takes time to broaden commercial relationships, we are seeing positive results from our strategy in terms of both payer and physician response. We look forward to reporting additional traction during 2023. Ultimately, at this time, the single biggest way to further accelerate adoption of our preterm technology and testing volumes is the publication of compelling new data that continues to demonstrate the value of our tests. This growth is first manifested in the use of our technology by early adopters and should result in growing reimbursement by increased numbers of payers while we execute our strategy. We share strong new data that's published from clinical studies. In terms of customers, we maintained a continued focus on early adopter systems. For example, integrated delivery networks or IDNs, hospital systems, and physician practice groups.

We continue to work with early adopter systems not only by sharing data, but also by discussing ways with them to implement the PreTRM testing within their institutions. We anticipate making selective announcements as permitted in the course of bringing the PreTRM Test and treat strategy into these systems. While implementations among these customers take time, we believe there may be an inflection point ahead as multiple customers among our growing relationships reach scale in future quarters, where the number of tests and the amount of revenue increases accordingly. Another important event in our quest to help build up testing volumes among these customers is to broaden PreTRM testing availability while reducing our costs and growing our business. Toward that end, last quarter, I touched on the successful validation of an ambient blood collection transport system for PreTRM testing, which we launched commercially in December.

This not only expands the number of sites where patients' blood can be more easily collected by reducing the need for dry ice availability for transport to our labs, but it also reduces our costs. Just as importantly, we note that ambient shipping, now newly deployed, is growing as a proportion of tests being ordered this year, and we believe that even from these early moments of ambient collection shipping launch, it will continue to contribute to increases in test volume over the next months and years to come. Let's now turn to the growing body of published new data supporting our mission to improve the health of mothers and babies. First, the ACCORDANT study. Building strong evidence for the use of the PreTRM Test is an important part of Sera's strategy.

In terms of addressing healthcare disparities during Q4, we announced the publication of results from ACCORDANT, a clinical utility and cost-effectiveness modeling study based on rigorous clinical utility health economic analysis. This work, published in the Journal of Health Economics, illustrates the impact of Sera's test and treat strategy and its specific benefits in underserved racial and ethnic populations. ACCORDANT was a secondary analysis of 847 women from the multicenter assessment of a spontaneous preterm predictor study or TREETOP study. Findings showcased that care management, with or without pharmaceutical treatment, was effective in reducing maternal and neonatal hospital length of stay. Results indicated that by combining the PreTRM Test with enhanced prenatal care management, real progress may be made in better serving the most disadvantaged populations to enable better medical outcomes.

A bit on new clinical outcomes data supporting the PreTRM test-and-treat strategy, the AVERT PRETERM TRIAL . A few weeks ago, we announced the top-line results for our large AVERT PRETERM TRIAL , which showed statistically significant improvements in both of its primary endpoints: neonatal hospital length of stay and neonatal health as measured by a composite neonatal morbidity and mortality index. We believe these results solidify the benefit of the PreTRM test-and-treat strategy to improve the health of babies, giving those most vulnerable a better chance at a stronger start in life. The detailed results of the AVERT PRETERM TRIAL , including secondary end-endpoints and additional subgroup analyses, are being prepared for submission to a peer-reviewed scientific journal in the coming months.

In our announcement of the top line AVERT study results, we mentioned that we believe these results bode well for our very large prospective multicenter randomized controlled PRIME study. We are pleased to announce that PRIME has surpassed 2,800 enrolled patients, the number required to enable the pre-planned interim look. Though there are moving parts that can delay such things, we believe that the interim analysis is on track to take place during this year. I would like to take a minute to describe how different pieces of evidence fit together in our broader strategy by clarifying why we believe that AVERT top-line results bode well for PRIME. First, both studies have identical primary endpoints, reduction in neonatal hospital length of stay and decreased neonatal morbidity and mortality.

Second, both studies have a diverse demographic that is representative of broad racial, socioeconomic, and preexisting risk profiles. Third, the multimodal clinical intervention strategies prescribed in the protocols of both studies are the same or similar. Specifically, this includes the use of low-dose aspirin, the same form of progesterone, and additional care management for mothers identified by the PreTRM Test to be at higher risk of premature delivery. Care management consists of more frequent clinical monitoring and more intensive education for higher-risk patients. It is also important to note that while these similarities between AVERT and PRIME give us optimism for the PRIME study, there's always the potential that differences could weigh in the other direction.

To point out a few, the AVERT PRETERM TRIAL was performed within a single health system, while PRIME involves over 15 sites, which could lead to possible differences in administration of the study and adherence to the trial's clinical protocol across these sites. As another difference, all patients who reached term in AVERT were treated before COVID was prevalent locally in Delaware and ended the study early, while some patients in PRIME will have been treated during the pandemic and others after the pandemic has substantially waned. Finally, the prospective randomized controlled design of PRIME is a stronger study design in terms of the evidence generated than that of the historically controlled AVERT PRETERM TRIAL .

Furthermore, though AVERT included approximately 10,000 historical controls, PRIME is a much better powered study in that it includes approximately twice as many subjects as AVERT in its prospective arm at the interim look analysis and almost 4x as many at full enrollment. The larger size of the test and treat arm of the PRIME study helps to provide higher statistical power. Oftentimes, clinical studies are statistically powered at approximately 80% to see the effect of interest, the primary outcomes at full enrollment. The PRIME study was designed to have that level of statistical power for the interim look analysis before the trial is fully enrolled and even higher power for the final readout.

Considering these and other factors, while we believe the AVERT results are encouraging, given these differences, they're clearly not completely predictive of the outcome of the PRIME trial, and we must wait, we must await PRIME's results to know to what extent they support Sera's PreTRM test and treat strategy. In that regard, it's also important to recognize that many studies, and for a number of reasons, interim look analyses, analysis endpoints are rarely met. Studies usually proceed to their original pre-specified final enrollment numbers, at which time the final analysis occurs.

The interim look allows the external monitoring group overseeing the study to determine whether the study enrollment should continue and then recommend either continuing enrollment of the trial, which happens in most cases, or ending enrollment early because the interim look results are good enough that continuing to enroll patients is inadvisable. We are encouraged by the data resulting from controlled prospective studies thus far and look forward to sharing the results of the PRIME study with you as soon as we can. A word on Sera's biomarker pipeline. Lastly, let me take a moment to update you on our biomarker pregnancy pipeline, specifically our preeclampsia prediction.

About 5%-8% of all pregnancies are impacted by preeclampsia, a sizable medical problem among expectant mothers. The most serious preeclampsia is preterm preeclampsia occurring before the 37th week of pregnancy and which is more severe for mothers and babies. Preterm preeclampsia poses a most challenging clinical decision for the physician as to the time of when to deliver the baby, in that there's a need to balance serious adverse outcomes for an incompletely developed newborn against the rapidly deteriorating health of the expectant mother. Medical goals that can be at odds with one another. Identification of these cases well in advance before clinical preeclampsia occurs enables more informed and proactive decision-making and management. Late last year, we successfully clinically validated the prediction of preterm preeclampsia and made the validation data public to the scientific community.

Now the manuscript is being prepared to submit the data shortly for publication in a peer-reviewed scientific journal. As the only rigorously validated preeclampsia predictor when a patient is asymptomatic, we believe that our work on preterm preeclampsia is groundbreaking and valuable. We will determine how and when it is commercially into Sera's broader portfolio of pregnancy tests that provide valuable information to doctors and patients. In summary, we are continuing to build the solid foundation of data to enable us to carefully implement our commercial strategy as we also work to extend our runway. We are pleased to see the progress and expect it to continue strongly during this year. I'll now turn over the call to Jay for a review of our fourth quarter financial results.

Jay Moyes
CFO, Sera Prognostics

Thanks, Greg. Good afternoon, everyone. Let me briefly review our financial results for the fourth quarter. Then I'll provide some color on what our views are for 2023. Revenue for the fourth quarter of 2022 was $65,000 compared to $26,000 for the fourth quarter of 2021. As we noted in our last earnings call, we expect the testing adoption and commercial traction will be more impactful on our top line in 2023. Total operating expenses for the fourth quarter of $10.5 million were down from $12.6 million for the same period a year ago. Research and development expenses for the fourth quarter were $3.5 million compared to $3.1 million for the fourth quarter of 2021 as a result of increased headcount and research activities.

Selling, general, and administrative expenses for the fourth quarter of 2022 were $6.9 million. This was down significantly from $9.5 million for the same period a year ago, due primarily to the steps we outlined in our prior earnings call to streamline our sales force and focus our commercial strategy on early adopter systems. It is noteworthy that this significant decrease in SG&A did not negatively impact our revenue during the year. Net loss for the fourth quarter of 2022 was $9.7 million, down from $12.5 million for the fourth quarter of 2021.

As of December 31, 2022, the company had cash equivalents, and available for sale securities of approximately $104 million, which did not include a receivable of approximately $6 million collected in the first week of January. With the cost reduction actions we took in the third quarter of last year, coupled with our solid balance sheet and prudent management of our capital resources, we continue to expect this will give us operational room to execute our strategy into 2026 without having to raise additional capital.

Given that we are still in the early stage of market development, the availability of new positive data, both the AVERT PRETERM TRIAL and other readouts later this year, all of which are of keen interest to early adopter customers and the growth we experienced last year on a small base, it is still difficult to predict precisely what the revenues will be for this year. However, we currently believe that 2023 revenues will be less than $1 million. I'll now turn the call back to Greg. Greg?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Thank you, Jay. Thanks to all of you for attending our call today. We are looking forward to an exciting 2023 and see a number of valuable achievements potentially taking place this year. This includes the anticipated positive impact of the AVERT study, additional study results being published, completion of the interim look analysis of PRIME, and announcements of additional commercial implementations. We are strongly positioned to address prematurity and other adverse conditions of pregnancy. This is what drives us, improving the health of both mothers and babies by providing valuable pregnancy information to the medical community and patients. The improvement of health can actually drive down healthcare costs. We believe that this provides a win for all parties, mothers, babies, families, as well as medical professionals and payers. With that, we'll open up the line for questions. Operator?

Operator

Thank you, Greg. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw from the question queue, please press star then two. At this time, we will pause momentarily to assemble our roster. Today's first question comes from Patrick Donnelly with Citi. Please go ahead.

Patrick Donnelly
Managing Director, Equity Research, Citi

Hey, guys. Thank you for taking the questions. Greg, maybe one on the AVERT interim readout there. Obviously, the data looks pretty good. Can you just talk about, you know, the potential for that to increase, you know, some payer conversations? Is that enough where folks, you know, you can kind of bring that? I know a lot of the reimbursement kind of was thinking, you know, come after the full trial readout. Does this you know, start some of those conversations and maybe pull forward potential payer decisions, maybe just help frame up how we should think about that?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

G reat question, Patrick. First of all, the AVERT readout was not an interim look, just to be clear. Those were top-line results from the final analysis. I wanna make sure that's clear to people. You're absolutely right. There's been keen interest in the announcement. The payers always want to see a peer-reviewed publication that more fully reports the results of the AVERT trial and others. That process can typically take months, the impact on 2023 revenues is not yet clear. I can tell you that following that announcement, there's been keen interest on the part of the payers with whom we are having conversations, and we anticipate that to accelerate as the results themselves become available.

Patrick Donnelly
Managing Director, Equity Research, Citi

Okay. No, that's helpful. Then maybe on the sales side, I think Jay touched on, you know, the expense side a little bit there at the end. Just how do you think about '23 on the expense side in terms of scaling up the sales force, maybe just in terms of head count, whatever the best metrics are, just how you think about spend for this year and just as we think about the model, and then also just the sales force side.

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

I'll make just some general comments, and Jay, you can add anything to this. Our focus is really on early adopter systems, and we're configuring our sales force to make sure that we can go after them effectively. That's one of the things that we're really looking at as we go into this year. Clearly, those discussions are beneficial because you. It's not like getting a single doctor office to order a test. You're getting a system to adopt doing the testing. The potential is much, much larger, and we believe it's a more efficient way of addressing the market. That's what we're doing.

As we identify regions, and sometimes there are people that self-nominate because they have high interest in the test, they contact us, and it may be in an area where we don't yet have people, we evaluate those in real time, and we decide where it makes sense to deploy our people. Of course, if a customer is interested in doing something, we will always talk to them about ways that they could bring the testing on. We react to the data, and that allows us to efficiently grow the market as demand itself grows. Jay, any comments?

Jay Moyes
CFO, Sera Prognostics

Patrick, that there won't be an appreciable increase in 2023.

Patrick Donnelly
Managing Director, Equity Research, Citi

Okay. Maybe just last one, just on the revs, Jay, I think you said kind of below $1 million for 2023. We were a little bit above that, and the street was a little bit above. You know, is that just be payers coming on a little slower? Is it volumes? I'm just trying to figure out the delta here. W e were thinking a little more back half ramp. Maybe it's some conservatism. Maybe just talk about, I guess, the moving pieces and then also just the potential upside. Is it if you get a couple payers on board, does that number move meaningfully? Would just love some more color on that.

Jay Moyes
CFO, Sera Prognostics

W e just have to understand that we're in the early days of commercialization, and we believe we're typical of companies in the diagnostic space. B eyond that, I don't have a whole heck of a lot to add other than what we mentioned in the call. W e look forward to more data coming out, and we believe that that'll be helpful in growing our revenues.

Patrick Donnelly
Managing Director, Equity Research, Citi

Understood. Thanks, guys.

Operator

The next question comes from Andrew Brackmann with William Blair. Please go ahead.

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Hi, Andrew.

Dustin Scaringe
Equity Research Associate - Healthcare, William Blair

Hey, guys. This is Dustin up for Andrew.

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Hey, Dustin.

Dustin Scaringe
Equity Research Associate - Healthcare, William Blair

Hey, how are you doing? To maybe follow on Pat's question, I know there's a lot of uncertainty this year, and it's hard to predict revenues, but is that signaling maybe that PRIME comes in toward the end of the year, like maybe end of third quarter, fourth quarter, and that doesn't allow adopters to really pick up any utilization of the test there? Is that any signaling of a later than expected time frame, PRIME for this year?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

That's a really good question. Let me give some clarity to the expectations. First of all, as we said earlier, payers want to see final publications ultimately, as indicative of showing benefit. We will have this year, we have some anticipated events this year that we expect to see more publications this year and being able to show people more data as we move forward. That will help. There are some early adopter payers that say there will be enough data with those kinds of things that they will be willing to move forward in advance of PRIME, while there are other payers that say they wanna wait until the final results are available from PRIME.

Remember, it's the interim look that we are going to have this year with the 2,800 patients being enrolled. It takes time for those patients to deliver. It takes several months. It takes time to get the data after the last child or mother leaves the hospital. It takes time to clean it up, and we do that in real time to try and speed it up, but there are some requirements there. The analysis is performed, and then the results occur. What we can commit to right now is that everything is in place for the, that for that trial to have its interim look by the end of the year.

What we will be doing for sure, we will be giving a statement of when we complete enrollment. It could happen this year or it may happen later. We'll see where that, where that goes. We think that we're fairly confident that the interim look will be able to take place during this year. That's the first step. The final analysis, again, with patients will be enrolled in that study during this year. The final analysis will be available once the last patient has delivered, once the data are cleaned up for the final. Interim look is first, and the final analysis is second. Does that help?

Dustin Scaringe
Equity Research Associate - Healthcare, William Blair

Yes, that does. More on the early adopter systems. I was wondering if you could go into more detail on the willingness of each of those to interact with you. Have some been more promising than the others, such as like universities or self-insured employers? What is really required to drive the utilization once these networks are signed?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Yeah, a great question. What I would say is that the Integrated Delivery Networks of the physician groups, physician hospital groups, and managed Medicare groups are very, very interested. The discussions are very positive about how we could move forward toward implementation. Those are key targets that we're really going after. What does it take? It takes a commitment and a coordination of all the activities so that the physicians that are parts of these systems, and the operation parts of the system can be coordinated to actually perform the testing.

As I said before in my remarks, not only are we talking about the data and how important the data are, but we're actually exploring ways to help them to implement the testing within their systems.

Dustin Scaringe
Equity Research Associate - Healthcare, William Blair

Okay, great. Thank you.

Operator

As a reminder, to ask a question, you may press the star key followed by one. The next question comes from Tom Stevens with TD Cowen. Please go ahead.

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Hi, Tom.

Tom Stevens
Equity Research Associate - Life Science Tools and Genomics, TD Cowen

Hey, everyone. Thanks for taking the question here. This is gonna be more focused on kind of PRIME and what your AVERT results kind of mean there. If we assume you kind of hit statistical significance in that interim look, what's the material impact on kind of NICU mortality there? You know, how does the materiality of that impact your ultimate ASP you hope to get from PRIME?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

I'll let Jay talk about the ASP. What I'm gonna do, I'll talk about the material impact. A positive interim means that one or the other or both of the primary endpoints have been met. Okay? That's in the case of the AVERT PRETERM TRIAL , both of them were met. With that, it substantiates even more strongly the benefit of the test and treat strategy that we have for our preterm test. That allows discussions to take place with systems and for people to be thinking about what this means in terms of their risk. As with any new product, there are early adopters and mid adopters and late adopters.

We believe that they will be beneficial. More positive data is always beneficial. Our strategy is to ultimately get to a point where the data are overwhelmingly strong from multiple studies showing that there's a positive impact on the outcomes that matter most. Those are length of stay because that's what generates costs. Secondly, and most important for the individual, a benefit in neonatal health. Those are the primary outcomes in those studies. Jay, do you want to say anything about costs?

Jay Moyes
CFO, Sera Prognostics

Yeah, sure. I think that anytime you get stronger data, it's gonna help improve, you know, our ASPs as more payers adopt the, you know, strong reimbursement of the PreTRM Test.

Tom Stevens
Equity Research Associate - Life Science Tools and Genomics, TD Cowen

Got it. Thanks for that. Just kind of looking long-term. It sounds like, you know, interim much later this year, full read out maybe mid-2024, and then there's gonna be a ramp alongside let's get reimbursement there. Just a couple of details on the reimbursement angle and then just, you know, a question on kind of the maturity of revenue when you kind of get there. On the first one, just like, yeah, I mean, is that the right timeline to think about, you know, ramping things up? Secondarily, will they also reimburse all the kind of follow-up treatment required and treatment and interventions required to actually see those cost benefits? How do those play into your health economic models?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Okay. I'll try and answer those. Make sure I get it right, okay, Tom? Just make sure. With regard to the readouts and the timeline, what we're the guidance that we're giving to people on those events are this year we will complete the interim look of the PRIME study. Once the PRIME study is fully enrolled. That could be at the time of the interim look. Once it is fully enrolled, at that point then, you still have to wait for the babies that are most recently enrolled to be born for the outcomes to be known and for the data cleanup and the analysis activities take place. It's several months.

We're not prepared to tell you precisely at this point in time. What we can tell you is we have the 2,800 patients needed for the interim look to take place this year. It would be later that the final look would be available. Does that make sense?

Tom Stevens
Equity Research Associate - Life Science Tools and Genomics, TD Cowen

That makes a lot of sense. Just following up, just, you know, on the reimbursement side. If you get a positive PRIME readout, do you expect, you know, insurance to cover all the other interventions required to ensure that you know, you get the impact on NICU mortality y ou're testing?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

You actually answered the question somewhat, and I'll expand it. The health economics are really important. What we've demonstrated in multiple health economic analyses is that it is very cost-effective and that the savings to payers are enormous, it like, it through the implementation of the test and treat strategy. By identifying the patients who have higher risk of preterm delivery, and as the clinical data are showing, by impacting them positively, they spend less time in the NICU. They have fewer complications. The babies are healthier and that pays benefits to the child and mother first, to families, to the medical community, and to payers.

we believe that it's totally aligned with the idea of saving money. That also gives you a sense of the amount of savings that is generated, gives you some sense of where pricing makes good decisions about pricing. We believe that that increases the value of the test. Continued positive results are what we're looking for. We will know when the studies have read out in their final forms. Have a good idea.

Have a good idea when I think we'll have a pretty good idea from the interim looks, where it should track.

Tom Stevens
Equity Research Associate - Life Science Tools and Genomics, TD Cowen

Got it. Great. Just this last quick one. You kind of assume a $250 ASP in 2025. What kind of gross margin should we be expecting on that?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

We've not really talked about a $250 ASP for any. We haven't put anything down like that. Jay, do you have a?

Jay Moyes
CFO, Sera Prognostics

No. We haven't put any guidance out on ASP or gross margins.

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Yep, that's right.

Tom Stevens
Equity Research Associate - Life Science Tools and Genomics, TD Cowen

I got it. Yep, I'll get back to.

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

We expect it to change. We believe that the ASP and gross margins will change as the volumes get larger, as we get more payers under contract. All those things, we believe will cause changes in them. We can't quantify the magnitude of them yet, but it's certain that they will not stay identical forever.

Tom Stevens
Equity Research Associate - Life Science Tools and Genomics, TD Cowen

All right. Great. Thank you.

Operator

As a reminder, to ask a question, you may press star then one. The next question comes from François Brisebois from Oppenheimer. Please go ahead.

François Brisebois
Managing Director and Senior Biotechnology Research Analyst, Oppenheimer

Hi. Thanks for taking the question. I dropped off for a second but came back on, so apologize if you mentioned this. You talked about the importance of after the top line data for AVERT, the importance of the publication. Can you just maybe explain why, you know, the publication? Is there something specific in there that we should really pay attention to that people are gonna wanna see? I guess the follow-up to that question is when the interim PRIME top line comes out, which I assume will be similar, you know, readout in terms of format that you did for AVERT, is that enough? Or at that point, are people gonna wanna see that publication as well? If so, I assume you would not have a publication on interim look. Thank you.

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Yeah. I'll answer the first question. With regard to the AVERT study, we announced top line data. That's not an interim look, it's top line data. With the top line data, and with a publication coming, we believe it will be months before we see it in publication. We are able to share data very carefully with certain individuals. That's something that we take very seriously as a company to make sure that we do things in accordance with the desires of the authors of these things. They want a publication to come out.

We're working as fast as we can with them to help them to be able to submit the paper for review and to get it published as soon as you can. The payers like to, especially the medical policy side of payers, they want to understand deeply what the source of the data, what the source of data is. They want to know what the differences are in the controls and the population that's intervened upon. They want to try and see what the benefits of the strategy actually end up being exhibited as. To do that, they oftentimes would like to see the full publication.

They'll talk about it ahead of time, and those kinds of conversations are taking place with people as we prepare clinical data that have an economic impact. Those kinds of discussions are happening in real time with payers with a number of them. Does that help?

François Brisebois
Managing Director and Senior Biotechnology Research Analyst, Oppenheimer

No, that helps a lot. What I was also wondering there is understood that AVERT was full data, but in terms of PRIME, I assume you will not, you know, have unless the interim is so strong that they advise you to stop the study. I guess you can have a publication on it. You know, I guess my question is it going to be as important for the payers to see the publication on a PRIME or the top line might be more telling given that it won't be historical data as a control here?

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

Well, if one or more of the endpoints is met, the monitor board could say, "Stop the trial now." But while Up until the time that that happens, we are continuing to enroll patients. The actual number of patients that will be finally enrolled is much larger than the 2,800 that are there, that are in place now for the interim look to take place. It takes time, again, for those deliveries to be completed and for the data to be looked at.

There are some payers and some systems that are early adopters that say, having a look at data thus far gives us a lot of information and we're comfortable moving forward earlier than the final readout of the PRIME study. There are others that will say, "Oh, we wanna see that card slip before we decide to cover." It's variable. It depends on what their interests are. It depends, for some systems, it depends on what they're experiencing with regard to prematurity. If they have extremely high complications, high rate of complications occurring in the population that they're insuring and it's a pain point for them, they are oftentimes more apt to want to move forward sooner. It's really variable if you look across all sorts of payers.

François Brisebois
Managing Director and Senior Biotechnology Research Analyst, Oppenheimer

Understood. That's very helpful. Thank you.

Greg Critchfield
Chairman, President, and CEO, Sera Prognostics

You bet.

Operator

Again, if you have a question, please press star then one. Seeing no further questions in the queue, I would like to turn the call back over to Mr. Peter DeNardo for any closing remarks.

Peter DeNardo
Investor Relations Representative, CapComm Partners

Thank you, MJ. This concludes the call, and we look forward to providing an update on our business when we report First Quarter 2023 Financial Results. Thank you, and good afternoon, everyone.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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