INmune Bio, Inc. (NASDAQ:INMB) Q1 2024 Earnings Call Transcript

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Dr. RJ Tesi: I hesitate to ask that question because each of them is a little bit different. I think the MHRA tends to be one that I think is a little more independent thinking. The EMA tends to think very much like the FDA, and we certainly haven’t seen a lot of innovation of regulatory innovation in Alzheimer’s disease, but I have to say some of that is just because they haven’t had many swings at the ball, right? Then, for all practical purposes, the only drugs that have come through are the anti-amyloids and that’s kind of they all look pretty much the same. I don’t know. We’ll see. And I think that, let’s we need right now to get this Phase II enrolled, number one. We need to get it analyzed. And then when we see that top line data then we’ll both have the resources and the insight to move as quickly as we can. And believe me, we’ll be making every attempt we can to move quickly.

Daniel Carlson: Yes. So that’s great. I look forward to seeing what happens when you ring the bell there. So, just one question about TRD. Now that you’ve got some more capital in, can you just sort of refresh the timeline and you get more resources to put there and tell us about this trial and what when we can expect something out of it?

Dr. RJ Tesi: Yes. Expect something out of it. Once again, it’s a blindly randomized placebo-controlled trial. So, actually, getting data the first thing you’re going to hear is that, this is the way it’ll go. The FDA will announce that the FDA has accepted the IND and the trial is open. First patient enrolled, and then we’ll be moving it forward. The amount of — the speed of the trial will directly be related to how much resources we can put behind it. Right now, the NIH grant only funds about third of the trial. So, we have to be careful because our primary mission, as we’ve said, is number one, Alzheimer’s and then number two, the INKmune CaRePC. But we think we’ll be able to move that ahead. And then as our resources expand, we’ll be able to put the pedal through the metal on treatment-resistant depression.

But this year, the two milestones you should hear from, as David said, is that the FDA has allowed us to open the IND because it is a U.S. Trial. And the second thing will be the first patient enrolled. That’s our goal.

Operator: And that will conclude today’s question-and-answer session. I will now turn the conference over to RJ for any additional closing remarks.

Dr. RJ Tesi: Thank you. Yes, with the success of the fundraising, we now have the capital to comfortably complete AD02, the early Alzheimer’s trial and support CaRePC into some of the open-label data in metastatic castrate resistant prostate cancer. Our goal is to provide positive readout in these problems. With positive readouts, we expect we’ll be able to access capital markets in a way to allow the Company to become more aggressive in pursuing its goals. Both of these products have uses beyond their primary indication. And we believe that with the resources — with given the resources we hope to get, we have the expertise and the teams who can to capitalize on these other activities either alone or with partners. For now, we appreciate your support. Thank you very much.

Operator: This does conclude today’s conference call. Thank you for your participation. You may now disconnect.

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