Sera Prognostics, Inc. (NASDAQ:SERA) Q3 2023 Earnings Call Transcript

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Second is, we had a different rate of compliance with treatment, higher. And last but not least, we now have the benefit of the AVERT data to see what impact was achieved with the high-risk treated population, as I just shared in my remarks, in that study. So, armed with those three new pieces of data, we felt that given we are so far along at recruiting the full patient population, it is better if we are fully powered for the final readout and just go ahead and complete the study, then miss the timeline of interim look by enrolling more into the interim study. So, that’s why we made that call. Now, your question was specific. Are we going to see any data? The answer is no. Unfortunately, we are not going to see the data. That said, we are very confident now with the updated model that we will see very, very strong results when PRIME is completed because we are seeing now the benefit of the AVERT study.

And of course, we are in communication with the sites, so far everything is going well. So, we will be delighted when we hear from DSMB, which is reviewing the interim data without showing us and will give us a feedback in December, and we are counting on continuing the study to full enrollment and coming back to all of you with great results, hopefully, by the time the study concludes. Does that help?

Tom Stevens: Yes. That’s really helpful color there. If I could ask just another follow-up there, should we expect in the PRIME study that there is any kind of incremental information on potentially widening the patient population or maybe narrowing the patient population? Any color you have around that would be really, really helpful. Thank you.

Zhenya Lindgardt: Another excellent question with a lot of discussions we are having underway with the learnings from the recent papers we submitted for publications and the questions we are getting from payers and providers. We are exploring how rich can we make the data set from PRIME and reviewing that right now. I don’t have a specific answer for you right now on extension or narrowing of the target population, but I promise to come back to you when we know more. I will tell you that the endpoints are very similar or they are exactly the same between AVERT and PRIME. So for sure, expect the same data we reported from AVERT today to come from PRIME, and I believe given we have a bit of time to continue shaping what analysis are done, we will do our best to make this very significant – actually the most significant investments Sera has made to-date into PRIME data to really help drive adoption with our customers by answering as many questions as we can.

So, thank you for raising that.

Tom Stevens: Thanks. I am going to squeeze one more in just because I guess in your other test offerings coming on the pipe, do you have any timelines as to when you could give us potential timelines on that part of data readouts and maybe just updates in kind of alpha development? That would be wonderful for our own calendars.

Zhenya Lindgardt: Yes, absolutely. We are focusing to bring them to market as quickly as possible. I will say that for the products we have described that are on our corporate deck, we have moved each one of them into the next stage of our development this quarter, which is a big milestone, a lot of work underway with completing research and teeing up for clinical validation. While I don’t have for you exact launch date, as I mentioned in my remarks, we are hoping to give you a much deeper update on new product timeline stage in Q1 analyst call – Q4 analyst call that will happen early next year.

Tom Stevens: Perfect. Thanks very much.

Zhenya Lindgardt: Thank you.

Operator: [Operator Instructions] No further questions. I would like to turn the conference back over to Zhenya Lindgardt for any closing remarks.

Zhenya Lindgardt: Thank you, operator, and thank you so much everyone for attending our call today. We continue to be really excited about the study results and the data that our studies show, including the word that we shared today that support the benefits for patients, physicians and insurance companies in the form of improved healthcare outcomes and care cost reductions in utilizing PreTRM test-and-treat strategy. These results indicated that our technology can afford better futures, better health for expectant mothers and babies, along with reduced healthcare costs. We see Sera’s role as a pregnancy company, key in enabling a paradigm change that is overdue going forward to help reduce the impact of premature birth on families and our society overall. And we are really grateful to all of our investors for their support and pursuit of that endeavor. Thank you so much, and we are now turning it over to you, operator, to conclude the call. Operator?

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

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