Khursheed Anwer: Right. Apologize if there was any signal issue. So what we had said, in response to, I believe, James question, that initial set of data would be safety, of course, because AVASTIN has not been combined with GEN-1. So we hope to finish that Phase I part of the study out. I mean, it all depends on the enrollment. Four sites have been put into place initially, but if we’re trying to expand that, and I think second quarter, would be more of a safety clearance that, indeed, this new combination is safe in patients and then from second quarter on, if you get more sites on board, we can probably get more enrollment and begin to update on the secondary laparoscopy results over time, and perhaps maybe in quarterly update or so.
But in terms of completing that study, I would say Corinne and even Jeff can chime in here, I would say at least about two years to complete the enrollment and at least with these three sites, plus a couple more sites. So I think immediate, is the safety data and sort of efficacy data, maybe trickle down, we can update this open-label study. So I would say within two years, maybe some significant data but overall survival is a longer endpoint, that will probably take long time to mature. But certainly second look laparoscopy, you could good get within two years some meaningful data, hopefully. Again, this is what we are anticipating and we’ll also get at fast rate with more sites.
Corinne Le Goff: Right. And Kemp, as this stage, we cannot give a very precise timelines while we’re waiting for most interest to enroll. So it’s a preliminary assessment, really.
Khursheed Anwer: Correct.
Kemp Dolliver: That’s super. Thank you. And just the last questions for Jeff, and it relates to the trial and the Break Through Cancer reimbursement. Will those essentially — the reimbursements just net against your R&D expense or will those show up as grant revenue?
Jeffrey Church: It’ll be the former, as we anticipate. We will just treat what we’re going to be paying as R&D expense.
Kemp Dolliver: Fabulous. Thank you very much.
Operator: The next question comes from David Bautz from Zacks Small-Cap Research. Please go ahead.
David Bautz: Hey, good morning, everyone. Thanks for the update this morning. I just have a question on the COVID seasonal booster vaccine plan for the Phase I/II trial. So I’m assuming that the Phase I trials is going to be a safety study in healthy volunteers but then will you look to do an efficacy study in Phase II?
Corinne Le Goff: David, thank you for your question. Yes, so, in vaccine development in Phase I already we will have immune response data right. So you will have the neutralizing antibody data that you get quite rapidly after the injection of the vaccine. So the Phase I will already give us that data and that’s why in the design of our program, we are looking for Phase I/II. So we’ll simply continue enrolling in a Phase II program with the chosen dose.
David Bautz: Okay. Now, will the Phase II have an efficacy outcome?
Corinne Le Goff: The Phase II will have efficacy outcome, immunogenicity, heterogeneity as well.
Khursheed Anwer: Vaccine trials efficacy is really now challenging human being right. So it’s really the titers of the antibodies — neutralizing antibody, really, that’s what you look at, above baseline. So I think that’s essentially maybe what you’re probably referring to efficacy part. So in Phase II, we’ll be looking at that, that so much of a titers from baseline have gone up against this particular variant that we are targeting and the variant of the concern at that time. So, basically neutralizing antibody titers above the baseline, that’s the measure of efficacy in vaccine studies, typically, as opposed to a therapeutic marker, right in cancer. So yeah, we will be looking at that in Phase II.
David Bautz: Okay, great. Thanks for taking the question.
Khursheed Anwer: You are welcome.
Corinne Le Goff: Thank you, David.
Operator: This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.
Corinne Le Goff: Thank you. So we believe that our technology holds excellent promise in immuno-oncology as our work in providing options to women with ovarian cancer looks very interesting. And we are excited about reporting Phase II data here on next spring, next summer. We’ve also been using the phrase vaccine of the future to describe our work and that’s exactly what our vision is, to be the provider of safe and effective vaccines that are superior to current vaccines in terms of durability and breadth of protection, are stable at workable temperatures, can be manufactured rapidly to respond to evolving pathogen and offer better compliance for mass immunization with no need for device or virus. We very much look forward to keeping you informed of our progress. Have a very nice afternoon.
Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.
