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

RJ Tesi: Yeah. Tom, RJ here. I mean, that’s that is obviously a question we talked about a lot. We have done a bit of a deep dive. There is no — to our knowledge, and if someone has one, please contact us. To our knowledge, there’s no rodents, rat or mirroring model of area. In other words, if you give an anti-amyloid drug to a rat or a mouse, nothing happens. To our knowledge, the only area model is a spontaneous area model in a some strain of monkey, which is not one of the standard strains. And these animals are extremely rare. So it’s not like we could just buy a bunch of monkeys, give them an anti-amyloid drug and see who develops area and then treat it because that would be the fastest way forward. We have some ideas.

We’re talking to people, but we believe we agree with you that the Achilles Heel of the anti-amyloid strategies aside , if I can be snarky, besides the fact that they only work somewhat versus well. They only work somewhat is their safety signals associated with ARIA. And I think that moving forward, people will be a lot more comfortable using a drug with its efficacy profile. If the safety profile can be solved. So it’s on our radar screen and stay tuned.

Tom Shrader: Great. Thank you.

Operator: Thank you. Our next question is from Daniel Carlson with Tailwind Research. Please proceed with your question.

Daniel Carlson: Hi, guys. Thanks for taking my questions. Just a quick one on the timeline for the AD MCI trial. Does the second half of 2024, do you need U. S. approval at some point to reach that timeline or is that based on just what you have going on?

RJ Tesi: So thanks, we’ve — I hate to say this, but we’re quite confident we’re going to be off. We’ll solve the FDA problems this year and so we’ll include patients. But the more successful we are in getting sites up and running outside of the U.S. and how fast they enroll some of these areas we’re looking at are historically quite rapid enrollers, dictates whether it’s going to be midyear or later in the year. So at the end of the day, it’s going to be 2024. It’s going to be the second half. Don’t let us get a little farther on, and there will be U.S. patients in that — in the Phase II trial. It’s just — I don’t want to give you what the percentage will be at this point.

Daniel Carlson: Okay. Fair enough. Thanks. And then CJ had mentioned that you’re going to get some data from the open-label extension, you said in due time. So I was wondering if you could just sort of tell us what to expect from that? And I was curious in particular if you’re measuring cognition in the open-label extension, if we’ll get a chance to see that at some point.

RJ Tesi: CJ?

CJ Barnum: Hey, Dan. So yeah, so we will be measuring all the clinical rating scales that we have in the AD02 study will be continued in the open-label extension study. So we’ll get those every three months along with MRI data. Like I said, our intention is to share that data, but I don’t have a timeline as to when we’ll see that at this point.