INmune Bio, Inc. (NASDAQ:INMB) Q4 2022 Earnings Call Transcript

So yeah, I think what we’re looking at here is going for a tumor where there is good evidence from public literature that the number of NK cells that are there. And the type of NK cell is potentially prognostically valuable. So that’s another good reason for prostate cancer.

Jason McCarthy: Got it. And just shifting gears to the Alzheimer’s side, if you enroll all the patients in the AD trial before you get off clinical hold? Does it hurt any standing with the company and the FDA?

RJ Tesi: Good question. The answer is absolutely not. I think, I’ve been clear that we will — we’re going to have to do a Phase 3 trial. The Phase 3 trial will look — we assume is going to look very similar because of what this Phase 2 trial looks like. So it will be a global trial that will include obviously North America, Europe and parts of Asia. So the U.S. will be a very big part of that. So there will be — there’s absolutely zero risk that even if we enroll every patient as outside the U.S. that will compromise our ability to move forward.

Jason McCarthy: Okay. Are you selecting countries or more international countries for this trials? So it does set the stage then for

RJ Tesi: Yeah. Absolutely. I mean, all of the countries we’re selecting would be countries that you would have on your list for a global regulatory Phase 3.

Jason McCarthy: And just like — I just brief your last question if you combine or when — as you are combining the MCI and mild AD trials and so one, €œearly AD trial€ how does it not increase the trial size or what will the total trial size end up being now?

RJ Tesi: Yes. CJ, why don’t you go ahead there?

CJ Barnum: Can you hear me?

Jason McCarthy: Yes.

CJ Barnum: So it’s a good question. Really, I mean, it comes down to when you’re powering the study and what your assumptions are. So the assumptions that MCI patients will perform better than even mild AD patients. So when we do that power calculation, we actually increased our likelihood of seeing a positive result on the EMACC. Now it’s going to treat — we believe it’s going to increase the trial size a little bit. But we’re talking 10, 20 patients, not talking 100 patients.

Jason McCarthy: So the total size would be range.

RJ Tesi: So it’s 20-ish (ph), I mean, about that. Don’t hold us to that number, but that’s the kind of magnitude we’re looking at. It’s not adding the two trials together. It’s not 204 plus 60. It’s 220. Okay?

Jason McCarthy: Got it. Okay. Great. Thank you, guys.

RJ Tesi: Yes, just to reinforce what just to reinforce what CJ said, remember, the trial power comes from the difference between the treatment arm and the placebo arm. And the kind of the unsung hero here is that by taking — doubling the length of the MCI trial, as CJ said in his comments, means you get — we anticipate more response in the MCI group. So you will increase that delta between the MCI treatment group and the placebo group and that — and only good things happen when you do that.

Jason McCarthy: Got it. Thank you guys.

Operator: Thank you. Our next question is from Tom Shrader with BTIG. Please proceed with your question.

Tom Shrader: Good afternoon, and thank you, Mark for asking or answering my big question about why castrate-resistant prostate cancer because that’s a tough one. And another one, I wanted to ask about the new program in DMD. You commented that there’s a little bit of a historical issue with conventional TNF scavengers, the XPro might get around some of those issues. I think you mentioned cardiac-tox. I would ask, how derisked is that idea or the XPro gets around it or would a partner need to do some work to show that this is no longer an issue. And then I have an AD question later on?