Sera Prognostics, Inc. (NASDAQ:SERA) Q4 2022 Earnings Call Transcript

Jay Moyes: Yes. I think, we just have to understand that we’re in the early days of commercialization, and where we believe we’re typical of companies in diagnostic space. Beyond that, I don’t have a whole heck of a lot to add, other than what we mentioned in the call. So we look forward to more data coming out and we believe that that’ll be helpful in growing our revenues.

Operator: The next question comes from Andrew Brackmann with William Blair.

Dustin Scaringe : This is Dustin on for Andrew. 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 towards 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 timeframe on PRIME for this year?

Greg Critchfield: 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. So that will help. There are some early adopter payers, who say, there would 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 want to wait until the final results are available from PRIME. And 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 to the final after the last child or mother who 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. Then the analysis is performed and then the results occur. So what we can commit to right now is that, everything is in place for that trial to have its interim look by the end of the year. And 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. So we will see where that goes. But we think that we are fairly confident that the interim look will be able to take place during this year.

And that’s the first step. Then the final analysis, again, patients will be enrolled in that study during this year. The final analysis will be available once the last patient has — once the data points out for the final. Interim look is first and the final analysis is second. Does that help?

Dustin Scaringe: Yes. It does. So 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 of them more promising than the others, such as like universities or self-insured employers? And then what is really required to drive the utilization once these networks are signed?