Imunon, Inc. (NASDAQ:IMNN) Q2 2023 Earnings Call Transcript

Corinne Le Goff: What I’d like to add as well, David, is we believe that the increased expression of the antigen or longer expression of the antigen is in fact a benefit, because it gives time to your immune system to build memory cells, right, and that’s maybe the concern, a little bit with the RNA but you know memory cells are not too much present.

David Bautz: Okay, that sounds good. And then as far as the Phase I study goes, I guess how do you determine what variant you’re going to target for that? And then can you change which variant you target, between going from say the Phase I to the Phase II?

Corinne Le Goff: That’s a good question. So, you know I mentioned that the FDA every year will tell manufacturers which variant to go after. So they are going to use the same principle as they do for the flu vaccines, right. So they met the VPAC make in 2015 that said what the manufacturers need to put into production is Omicron XBB 1.5, which is what we did. The FDA agreed that that was the right thing for us, and then we’ll do a Phase I/II, which means that as soon as we start the Phase I, when we get the safe dose from the Phase I, we’ll go immediately into Phase II program with the same variants.

David Bautz: Okay. So is this system being set up kind of like the flu vaccine, where you’re not going to have to basically do animal studies again every year with a different variant. You’re just going to be able to plug it in and whichever variant – okay.

Corinne Le Goff: And that’s what I just mentioned. That’s why we’re so pleased that the FDA confirmed what we call our plug-and-play strategy, but then you don’t have to redo your TUC [ph] studies in animals when you change the cases.

David Bautz: Okay, great. Thanks for taking the questions.

Operator: The next question comes from Kemp Dolliver from Brooklyn Capital Markets.

Kemp Dolliver : Great, thank you. Just to continue on with the vaccine discussion. So do you expect you would have Phase I data in the second half of ’24, given the timing of the IND filing?

Corinne Le Goff: I believe so. That’s what we’re planning to do again.

Kemp Dolliver : Okay. All right, thank you. And then you had originally hoped to file the IND by the end of the year. We’re not talking about a significant change in the timeline. But I’m curious, does the change in the timeline reflect the timing of FDA feedback or reflect the pre-IND functions that – or the IND enabling functions that you’re doing now?

Corinne Le Goff: Right, thank you. Yes, we thought we could be a bit faster with our IND filing, you’re correct. I think the shift in the timelines reflect the fact that we wanted to here – to make sure that we would pursue a variant that is the one recommended by the FDA. So we wanted to wait for the June 16 meeting. And then of course, the feedback on our Pre-IND package was a bit delayed compared to what we had thought as well, so that’s the reason.

Kemp Dolliver : Great. Thank you very much.

Operator: [Operator Instructions] Our next question comes from James Molloy of Alliance Global Partners. Please go ahead.

James Molloy : Hi, good morning. Thank you for taking my questions. Most of them have been answered, but I had a question on the combo with AVASTIN, Phase I/II underway. What’s the expectation for the potential interim look for that and moving into a Phase II portion of that trial?