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

Operator: . The next question comes from Francois Brisebois from Oppenheimer. Please go ahead.

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

Greg Critchfield: Yes. 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. So with the top line data, and with a publication coming, we believe it will be months before we see it in publication, but we are able to share data very, very carefully with certain individuals. And that get — that’s something that we are — 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 a 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 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. And 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 has an economic impact. Those kinds of discussions are happening in real time with payers. It’s an ongoing. Does that help?

Francois Brisebois: No, that helps a lot. And then, but I — what I was also wondering there is — understood that AVERT was full data, but in terms of PRIME, you — I assume you will not — unless the interim is so strong that they advise you to stop the study, and then I guess you can have a publication on it. But is it — I guess my question is, is it going to be as important to the payers to see the publication on PRIME? Or the top line might be more telling given it won’t be historical data as a control here?

Greg Critchfield: Well, the — if one or more of the influences that, the modest board could say stop the trial now. But while that — until the time that, that happens, we are continuing to enroll patients. So the actual number of patients that will be finally enrolled is much larger than the 2,800 that are there in place now for the interim look to take place. And it takes time, again, for those deliveries to be completed until 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, we want to see that card slip before we decide to cover.