Greetings, and welcome to the INmune Bio’s. 2024 Fourth Quarter and Full Year Earnings Call. At this time, all participants are in a listen-only mode. [Operator Instructions]. As a reminder, this conference is being recorded, and the transcript will follow within 24 hours of this conference call. At this time, it is now my pleasure to introduce Mr. David Moss, CFO of INmune Bio. David?

Thank you, Margo, and good afternoon, everyone. We thank you for joining us for the call for INmune Bio’s 2024 fourth quarter and full-year financial results. With me on the call today is Dr. RJ Tesi, CEO and Co-Founder of INmune Bio, who will provide an update on our clinical programs. Also, on the call is Dr. CJ Barnum and Dr. Mark Lowdell, who will be available for Q&A. Before we begin, I remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward-looking statements. Please see the forward-looking statements disclaimer on the company's earnings press release as well as the risk factors in the company's SEC filings, including our most recent quarter filing with the SEC. There's no assurance of any specific outcome. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change. Except as required by law, INmune Bio disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. With that behind us, at this time, I’d like to turn the call over to Dr. RJ Tesi, who will provide an overview of our clinical programs before I discuss the financials, and we will conclude with Q&A. Over to you RJ.

Thank you, David, and thank you to everyone joining our call. These are exciting times at INmune Bio. 2024 was a transitional year for our company. We believe this year will be a transformational year. In less than a hundred days, we expect to announce top-line data for our randomized, blinded, placebo-controlled Phase 2 trial using XPro to treat patients with early AD with inflammation. We call the trial ADO2 or MINDFuL. We have worked tirelessly to get to this point, and I must say hats off to the entire team at INmune Bio for reaching this major milestone. We can't wait to learn the results. INmune Bio's ADO2 Alzheimer's trial stands out from conventional approaches of treating Alzheimer's disease due to a focus on treating neuroinflammation as the primary driver of the disease. Rather than targeting plaques and tangles the dominant traditional targets of Alzheimer's drug development, we have targeted inflammation as the main driver. Because of the frustrating history of failed trials to treat Alzheimer's disease, we adopted a precision medicine approach for our Phase 2 program, that precision is first seen in patient selection. The ADO2 trial uses clinical biomarkers to match the patient's pathophysiology with XPro's mechanism of action that is XPro targets neuroinflammation. Therefore, we enriched the trial with 80 patients who have neuroinflammation driving their Alzheimer's disease. To our knowledge, ADO2 remains the only Alzheimer's trial using biomarkers other than amyloid or tau to guide patient selection. Next, we embraced EMACC as the primary endpoint of the trial. EMACC is designed to accurately test cognitive function in patients with early Alzheimer's disease. We don't understand why others embrace the use of cognitive test designed for staging patients with Alzheimer's disease or develop for use in patients with moderate -- to severe Alzheimer's disease as…

Thank you, RJ. As usual, I'll provide a brief overview of financial results and upcoming milestones before we head to Q&A. During 2024, we raised $29.9 million from the sale of common stock and warrants for cash. In total, the company issued an aggregate 4,145,978 shares of common stock and warrants to purchase an aggregated 3,898,852 shares of common stock. Term of the warrants issued in 2024 may be accelerated with positive ADO2 data as defined in the warrant agreements, which if exercised or cash will raise additional capital to the company. I note that with close to 4 million warrants issued and the ability to accelerate as stated in the filings, this could potentially raise approximately $30 million. In the financings, management, employees and members of the Board of Directors demonstrated a strong participation. I cannot underscore have financially committed and aligned the entire INmune team is to the success of the company. We also greatly appreciate the support we saw in the offering from both new and existing investors along with our team here at INmune Bio. We thank our shareholders who have stuck with us during a very volatile time in drug development. Net loss attributable to common stockholders for the year ended December 31st, 2024 was approximately $42.1 million compared to approximately $30 million for 2023. Research and development expenses totaled approximately $33 million -- $33.2 million for the year ended December 31st, 2024, compared with approximately $20.3 million for 2023. General and administrative expenses was approximately $9.5 million for the year ended December 31st, 2024 compared with approximately $9.6 million for 2023. At December 31st, 2024, the company had cash and cash equivalents of approximately $20.9 million. Since year end, we've raised an additional $5.4 million through the use of the ATM. Based on our…

[Operator Instructions]. While we build that queue, we'll take our first question from George Farmer with Scotiabank. Please go ahead.

Hi, good afternoon. Thanks for taking my questions. A couple from me, regarding the RDEB program. It says in the press release you're doing this 12-month open label trial. Is that required for filing? And is there different requirements do you think for FDA approval and UK approval?

Mark, you want to handle that?

Yes. We're gathering the -- as I think we said in February, we now have access to all of the clinical data from the current trial, Mission EB Part one. And we are those are the data that the FDA have seen. We spoke to the FDA in that discussion about this being adequate for a BLA and we still believe that it will be. Obviously, that's a decision the FDA will take. So, I can't predetermine what the FDA will say, but they did not tell us that we would not be eligible for BLA. So, we're working towards that and we are doing the considerable amount of work, not just on the data analysis as the data are made more available to us, but also in developing the rest of the database that will be needed to submit a BLA with respect to the understanding of the product, manufacturing and all of the rest of those data. In terms of the MHRA, they approved the trial initially as a well, they didn't approve it, but it went to them initially as a registration trial. And we expect to be able to share the data with the MHRA and get a formal opinion on that early next year. They will also want to see the CMC data that we have to put together with it. So, at the moment, the answer is we are waiting to hear from regulators when we're able to show them the data that we have. We still intend to go ahead with the open label because it tells us an awful lot more about the persistence of the effects and the best way to deliver the drug in terms of number of repeat treatments and the timing of those repeat treatments. And we will plan to do that trial both in the U.S. and in the UK.

Okay. Thanks. And then on EXPAREL, I think we've talked about how you intend to release the data in June. Thanks for the clarity, RJ. There is the EMACC endpoint, but there's also the CDR endpoint. And I believe you said that those results would be staggered. Is that correct? And is that still how you're thinking about communicating the top-line results?

CJ?

Yes. Thanks for the question. So, what we're going to be able to do is we're going to provide cognitive and functional evidence, so all the assessments that assess both cognition and function will be available at the time of release. We have not said that before, we wanted to make sure that we could do all those things and we've worked really hard with our vendors to make sure that we have the data cleaned. We have the data analyzed so that you're getting the most accurate data at the time. We will have all those clinical endpoints available.

In June…

George, that means both, both EMACC and CDR will be released, when…

At the same time…

When the data becomes public.

Okay. Thanks, RJ.

And we'll next go to Paul Rader with BTIG. Please go ahead.

Is that me, Paul Rader?

I think that's Tom Shrader.

We knew who it was by the last name, go ahead Tom.

I thought I'd been fired. Anyways. Good luck. It's going to be the longest hundred days of your lives, but I don't.

It is.

Just remind us where the FDA is on EMACC is, a lot of the acceptance going to come from this trial, if it aligns closely with CDR or do you think the FDA is already there? And then just to clarification, you said you'd screened 800, that was 800 after they were already neuro or inflamed, or is that 800 totals? And then one quick follow up on TR -- if I ask quick follow-up on TRD, do all the same cuts in patients there make sense? Will it be peripheral inflammation? Is that going to be basically the same enriched population? Thanks

CJ…

Let me take the last one first. So, they are in enriched. We're using CRP and we're using a behavioral marker of enrichment of anhedonia that is tied really closely to not only peripheral inflammation, but the biological response to inflammation, which is this sort of functional dysconnectivity within the CNS. And we can talk more about that. So similar but a little bit different. And it's really based more on the disease specifics. Regarding EMACC, the FDA doesn't comment on it until they see the data. Their comment has always let us see the data. But what we've done is we've made sure that we've follow there, and I think we said this before, they have a playbook. We've followed it, and we think we've got as good a chance as I need to get them to agree to it. We don't see too many holes, but I also don't know what they're thinking. And as that I'm always surprised by what the FDA says. So, I think that's something to be aware of. And I forgot the third question.

The screening -- screen failure question.

So, we're going to have a poster that describes that next week. So, I won't give too much detail because that information is embargoed. But I will say that, no, the screening is not a function of the inflammatory biomarker. In fact, the screen failure due to the inflammatory biomarker is very low on the list. It's actually less than 10% of patients that didn't make it. Most of them didn't make it because of more typical things, like a diagnosis and that sort of thing. And the screen failure rate, which is about 72%, is really spot on compared to what you see with all the other ad trials, somewhere around 70% -- mid 70%. And that was obviously a concern of ours, is what would happen when we sort of superimpose inflammation on that. Would we see more screen failures? And the answer is no. And I think that's a testament to the fact that most of these patients that have Alzheimer's disease actually have underlying inflammation. So, I think that's a good thing.

If I can just add to if I can just add, reinforce what CJ said that next week is ADPD, which is the largest Alzheimer's meeting in Europe, and we have a poster that was accepted that discusses the, shall we say, the profile of the patients that were enrolled. And you'll see a presser on that and then a link to the poster, I think on Wednesday or Thursday. So, I encourage you to look at it because it's kind of fun reading because you've been hearing about it for a couple of years, and you'll see what the actual data are.

And, Tom, one last thing is I encourage you to go back and look at the EMACC webinar because there's actually a, Sarah Barnum actually goes over the, variables that the FDA requires for approval with EMACC and it's and she highlights all of the key criteria and what we've done to meet them. It's actually, worth your time.

Great. Thank you.

Next, we'll go to Gary Nachman with Raymond James. Please go ahead.

Good afternoon. This is Denis Reznik on for Gary Nachman. Thanks for taking the questions and congrats on all the progress. So first, on the EXPAREL Phase two trial, are you aware of any dropouts occurring? And if they are occurring, is it in the range that you were expecting? And what might be some of the main reasons behind those dropouts? And then if you think a little bit further down the line, assuming positive results that suggest progressing this asset forward, how soon could you start a Phase III trial? And then any additional color as to what a Phase three could look like in terms of the amount of patients being enrolled, duration and the endpoints you consider? And then I've got one follow-up.

CJ, start with the dropout.

Yes. So, I think the spirit of your question, if I'm wrong, please correct me, is, are we concerned that there's too many patients dropped out that we're not going to have enough power? And the answer is no. We account for that. And, I would say that, I don't know the exact number off the top of my head, but it's less than what we expected. The most common reason for dropouts, quite honestly, is just, what you get with elderly patients. So, we're not seeing anything that indicates patients are dropping out, at a high rate due to a potential drug efficacy or safety impact. It's mostly just elderly related issues. So, I think that's a good thing. And the second thing, regarding a phase two trial, I don't know how to answer that. I think a lot of it depends on the data. It depends on, the discussion with the FDA. I mean, we may see incredible results that suggests we could power a study with 50 patients. The FDA may come back and say no, you need a larger safety database. We want a thousand patients. So, I think there's so much that's up in the air. I think it also depends on whether or not they like the EMACC. They may say, yes. Great. Do the EMACC, then we can do fewer patients. Or they may say, no. We want you to do the CDR, and we may have to power it differently. So, I think what the trial is going to look like, what it's going to cost, and when we can start is really going to be dependent on that conversation with the FDA. But the expectation is we'll we're going to move as fast as we can to get it going very quickly.

That’s very helpful thank you. And then just I know it's still early, but on the potential commercial launch of CORDStrom, what's your current thinking about how you plan to commercialize that? Would that be by yourself or would you look for a partner for that?

Go ahead, David.

Yes. I'll jump in. That's a great question. And I think that's actually probably also a prize with EXPAREL. We always say you never build a company for acquisition, you build to be standalone. Our goal is to really move it forward to get it to commercialization.I do fully expect we will probably get a partner when it gets that close just because we are not distribution experts or marketing experts and we don't recreate that wheel.But at this point, we're really heads down on focusing on getting that regulatory document in so that we can get to that point. Once we get close, I think there'll be a lot more interest in what we're doing. Same thing goes for XPro, I mean, we're working to get to a Phase 3 program. I do believe that if we have the accomplishments that we all believe we're going to have, there'll be a lot of interested parties. And again, we don't want to recreate the wheel in drug distribution and so on, but we're prepared to go it alone if we have to. I doubt that'll be the case. I'll also say that, when it comes to partnerships and when it comes to M&A or whatever it may be, we have pretty lofty goals if we're successful and we want to make sure if it's done, it's done right.

Thanks, so much.

Next, we'll go to Elemer Piros with Rodman. Please go ahead.

I think all of my ad related questions were answered, so thank you. But I just wanted to clarify on the RDEB program, did I understand correctly that you would need the balance of the year to complete the CMC and actually consider filing both in the UK and in the US and probably in the early part of 2026?

Mark?

Yes, that's true. We are in -- the team in the UK manufactures and does all the process development and regulatory filing for both INmune and CORDStrom. And so now that INmune, all of the drug is made to complete the Phase 2 trial, that team is swinging entirely into CORDStrom, and we are appointing additional staff. So, it will take us until the end of the year to get the answers to some of the questions that the FDA raised in our last filing. But yes, we expect to have all of those questions answered, all of the data ready for US filing, as David said in the first half and the first quarter of 2025. And those staff posts are being filled at the very moment. So yes, those data are ongoing and we will have those data ready. We are also looking at a third party to do an external review of the data that we have and to do a gap analysis and inform us from their regulatory expertise that we will be ready by the end of Q1 next year.

Thank you. And maybe just a little follow-up there, but you are able to start the Open Label extension trial earlier then next year?

Yes, as soon so the Open Label trial in the UK is ready to go. We already have the first dosage manufactured, and that's subject to Great Ormond Street being ready to open. We are currently putting together the paperwork for an IND to open parallel trial in the US, and that's subjects to the funding environment which we live. But yes, we have an IND plan for the U.S. and the CTA is already approved in the UK.

Thank you, very much.

And our last question, our last question comes from James Molloy with Alliance Global Partners.

I had a question on the CORDStrom platform with the BLA coming in first quarter ‘26. Do you run up into any issues with the getting under the wire for the PRV program being granted, and any thoughts on what's going on with the PRV that's going to be renewed or not?

Yes, Jim...

I’ll leave that to David.

Yes, Jim, I appreciate it. Look, if we get it in -- it's about a six-month process. Since we have ODD designation already. We're going to -- we're working as quickly and diligent we can to make that the deadline is really the end of September for approval. My guess is that program gets extended, and the reason I think it gets extended is because truly there's no cost at all to the U.S. government. They're very obviously focused on cutting costs. And, this program actually provides no cost. It provides benefit. In fact, I think it's very clear to them that, because of the PRV program, it's one of the reasons why there is so much ultra-rare and rare disease drug development. I cannot see the rare disease programs necessarily going forward that are, small unless they have a program like this in place. So, I really see no reason why it doesn't get extended, but we're planning just in case it doesn't. My guess is we probably know, by the way, before the end of this year if it gets extended or not, and we'll plan accordingly. But our goal as we did with the INmune submission, the INKBN IND is to do one submission and try and get it through in one pass. So, we're really going to spend a lot of time on the quality of these applications.

I'd like to now turn the call back over to Dr. R.J. Tesi for closing remarks.

So, we are busy. It's heads down at INmune Bio as we get ever closer to our important readout in ADO2. But as a three-platform company, we have not taken our eye off our cell therapy programs, which are pretty exciting and quite novel. We are confident in these programs because we have compelling science, excellent drugs. When we do clinical trials, they're well-designed, and we execute them with care. But as far as ADO2 goes and Alzheimer's, the idea that inflammation, immune dysfunction are drivers of this awful disease is no longer considered novel by the scientific and biopharma community. We believe INmune Bio is the leader in this neuroinflammation space and look forward to presenting our data to the world in June. These are exciting times, and we greatly appreciate our committed shareholder base, and we thank them for investing alongside us as we work to achieve our goals. Thank you very much.

Thank you. And ladies and gentlemen, that does conclude today's conference. We appreciate your participation, and you may disconnect at any time.