Greetings, and welcome to the INmune Bio Second Quarter 2025 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. Daniel Carlson, Head of Investor Relations at INmune Bio. Daniel?

Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for INmune Bio's second quarter 2025 financial results. Presenting on today's call are David Moss, Co-Founder and CEO; Dr. CJ Barnum, Head of Neuroscience; and Dr. Mark Lowdell, Chief Scientific Officer and Co-Founder of INmune Bio. Before we begin, however, I remind everyone that except for statements of historical fact, 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 risk factors in the company's SEC filings, including our most recent quarterly filings with the SEC. There is 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. Now it's my pleasure to turn the call over to our CEO. David?

Good afternoon, everyone, and thank you for joining us for this investor update. I'm David Moss, and I'm honored to address you today as the new Chief Executive Officer of INmune Bio. I've had the pleasure to meet many of our shareholders over the years. And as many of you know, I'm very excited with the opportunity with INmune Bio's 3 therapeutic platforms and the opportunity they present to patients and shareholders. Before we dive into our progress, I want to take a moment to acknowledge RJ Tesi, who has retired and resigned as President and CEO, Chief Medical Officer, Chairman of the Board and Co-Founder of INmune Bio. Along with Mark, myself and the team at INmune Bio, we acknowledge that RJ has been a driving force behind INmune Bio and his leadership has positioned us for the opportunities we're discussing today. As RJ transitions to retirement, we wish him all the best and extend our deepest gratitude for his contributions. I'm excited to step into this role and build on the strong foundation he has laid. So let's start with XPro and the results from our Phase II MINDFuL trial. The trial was designed to define the patient population for a registration trial and I'm pleased to report that the data confirms that patients with Alzheimer's disease who exhibit 2 or more biomarkers of inflammation are the optimal candidates for XPro. The trial confirms our original hypothesis and fully aligns with our novel approach to Alzheimer's that XPro would benefit patients with the most inflammation, especially in the short trial. As CJ will speak about in more detail shortly, I want to emphasize something that I think is really important about Phase II studies is that the purpose of Phase II trial which is to inform design of…

Thank you, David, and good afternoon, everyone. I am pleased to share the latest updates on our XPro program, a novel approach that continues to show promise as a potential treatment for Alzheimer's disease. Our Phase II clinical trial has marked an important milestone in XPro's development, providing both encouraging data and valuable insights. While the trial did not meet its primary endpoint in the overall population, it revealed notable benefits in a key subgroup, Alzheimer's patients with a high burden of inflammation. These patients are identified by the presence of at least 2 inflammatory biomarkers at baseline. In this subgroup, we observed an effect size of 0.27 on the primary endpoint, EMACC, and 0.23 on a key secondary behavioral endpoint, the neuropsychiatric inventory. Although modest, these effect sizes are comparable to or even exceed those achieved by currently approved Alzheimer's disease therapies, indicating that XPro could provide a meaningful real-world benefit for patients with high inflammation. Furthermore, favorable trends were noted across multiple endpoints with effect sizes nearing 0.2 in other cognitive measures, patient-reported outcomes and biomarker data. Notably, biomarker trends, including P-Tau 217 and GFAP suggests that XPro is effectively targeting underlying neurodegenerative processes in alignment with its anti-inflammatory mechanism. These findings underscore the potential of XPro as a promising therapeutic option for Alzheimer's patients. For potential partners, the key question is whether there's a clear signal and a viable path to Phase III. We believe the answer is a resounding yes. Early feedback from the Alzheimer's Association International Conference indicates strong interest from industry partners who recognize the promising results as appropriate for this stage of development and emphasize the clear actionable path forward. The feedback we received highlights that partners see XPro as a unique and compelling opportunity in Alzheimer's treatment, extended beyond cognitive benefits to…

Thanks, CJ, and good afternoon, everyone. Thanks for joining the call. So as David said, CORDStrom has shown great promise in the randomized controlled trial in RDEB, but its potential extends way beyond RDEB to other forms of epidermolysis bullosa and indeed other conditions and indications, as David alluded. First, we have to remember that the orphan drug designation we received last year was awarded for all forms of epidermolysis bullosa, not just RDEB and the excellent safety data and ease of administration in the real-world clinical setting that we saw in the RDEB trial mean that we're well placed to treat a much wider group of adult and indeed pediatric AD sufferers, and we're developing plans for this. However, the umbilical cord-derived MSC product we've developed is truly revolutionary in the MSC field since it's manufactured from 4 individual umbilical cord MSC products. It gives it excellent stability unlike conventional MSC drugs and crucially allows us to tailor the final product to target different disease indications. Because we can test the potency of the individual single cord MSC seed stocks for different functional characteristics, we can then combine a specific number of 4 with the optimal potencies for different indications to create a different type of CORDStrom. For example, the CORDStrom product for RDEB can be made from 4 MSC seed stocks with the best wound healing capacity and those which secrete the right cytokines to enhance wound repair and suppress itch. For an indication such as osteoarthritis, however, we would select MSC seed stocks with the greatest secretion of anti-inflammatory factors. At the moment, we're investigating many other potential indications, and we'll consider genetic modification of CORDStrom products to deliver specific proteins such as the collagen VII protein in gene, which is missing in patients with RDEB. Depending…

Yes. Thank you, Mark and CJ. Some of you may know Cory Ellspermann, who has been with the company for many years now. He's been a key person of finance and accounting and has recently been appointed Interim CFO for INmune. Cory and I have worked together almost since the start of INmune when he was a consultant. And I can tell you, not only do we work incredibly well together, but he is more than capable to take a strong leadership role as Interim CEO. I have full confidence and support in Cory and his ability to help take INmune forward. Now let me move on to the financials. Net loss attributable to common stockholders for the quarter ended June 30, 2025, was approximately $24.5 million compared with approximately $9.7 million for the comparable period in '24. Research and development expense totaled approximately $5.8 million for the quarter ended June 30, ' 25, compared with approximately $7.1 million for the comparable period in '24. General and administrative expenses were approximately $2.3 million for the quarter ended June 30, 2025, compared with approximately $2.8 million for the comparable period in 2024. Impairment of acquired in-process research and development intangible assets was $16.5 million compared with 0 during the comparable period in 2024. Following the release of Phase II MINDFuL data, the company has decided to take a very conservative approach and to halt immediate plans to further develop XPro and AD at this time, given the cost of a Phase III program as it seeks partnerships. Since we can't guarantee a partnership, we thus took the conservative approach and wrote off the value of XPro's intangible asset value. As of June 30, 2025, the company had cash and cash equivalents of approximately $33.4 million. Based on our current operating plan,…

[Operator Instructions] We'll take our first question from Gary Nachman with Raymond James.

This is Denis Reznik on for Gary Nachman. Congrats on the new role, David. So first, you had mentioned that you plan to conduct the end of Phase II meeting with the FDA in the fourth quarter for XPro. We just want to confirm, has the specific meeting date been set yet? And has there been any changes to anyone you've been previously communicating with the agency? And then can you talk a little bit more about the atmosphere at AAIC and what the takeaways were from various thought leaders and KOLs to your presentation there? And I've got one follow-up.

No, I appreciate that. I'll answer the first question, and then I'll let CJ talk about AAIC. We have not yet filed a briefing book with the FDA. We're preparing that along with the manuscript and we expect to have that in soon. And as you know, I think there's a 60-day window before you hear about the date. It should fall sometime November, December if we get it in on our target date. So that's with regards to the end of Phase II meeting to the FDA. CJ, do you want to discuss the mood at AAIC?

So some of that I addressed in the script, but to add a little more color to it, I have to say it was even more promising, the feedback than I expected. And I think one of the interesting things about it is as we walked through the data, you could see the clinicians and the experts in the field sort of nodding their head as, yes, this is a logical step. Yes, that makes sense. That's how you would proceed. And we really didn't get too many questions about the science per se because it was -- at least based on the feedback, it was pretty obvious that this is the appropriate subgroup. It aligns with your hypothesis. These are the endpoints that are expected to change. And so I think that was really good. I think one of the things I was perhaps maybe a little surprised about was the real interest in the neuropsychiatric inventory and the potential there. So for those of you that aren't familiar, the behavioral changes that occur in Alzheimer's patients are really quite debilitating. And as the disease progresses, it's one of those things that really brings patients to the physicians often, it's really not the cognitive decline after a certain period of time. And it's quite distressing to both patients and caregivers, not to mention the physicians. So to have another option with a differentiated mechanism that can treat the neuropsychiatric symptoms really provides in some ways, a separate avenue, but for it to be also promising as a disease-modifying therapy, I think people are really responding to. And then, of course, as it relates to the lack of ARIA, despite the fact that most of our patients had high risk factors associated for developing ARIA, I think that's something that the field is really looking for, especially because combination therapies are where we're going. And when you start thinking about putting 2 therapies together, especially those that potentially have safety signals associated with ARIA, it really makes -- it stifles that quite a bit. So I think that was -- those 3 things were really well received by the community. And they understand that the results are appropriate for a Phase II study and it's sort of what you would expect and it provides a clear path forward. And that's really what we're looking for at this stage of development, at least that's what the scientific community is looking for. And so yes, really great feedback all around.

That was great color. And then if I can ask about how the strategic partnerships to accelerate XPro are going. Can you just provide some more color about how those conversations are going, what you're specifically looking for in a partner? And what an ideal partnership from a financial perspective looks like to you? And is it likely that you'll have to meet with the FDA for your end of Phase II meeting before signing the partnership? Or could we see a partnership announced before then?

No. I mean, look, that's a very detailed question and smart of you to ask. I don't expect the partnership to occur until after we've had -- if there is going to be one that occurs until after we've had the end of Phase II meeting with the FDA. I think that's a critical component. I think the partners are going to want to see the publication. They're going to want to dig into the data and they're going to want to see what the FDA thinks. Now keep in mind that depending on who you partner with, most partners are going to have their own regulatory view on how they want to push this through the regulatory process. And that could have geographic input as well. But I don't suspect that a partnership for XPro is any time in the short period of time. It's going to be more of a long-term type of approach, most likely leading into next year or the first half of next year, if it occurs at all. What do we want out of a partnership? We believe that XPro can address a major population in Alzheimer's disease with a therapy that's never been addressed before, which is neuroinflammation. If you think about the trial that we ran, it really was an incredibly novel trial. It's something that no one has ever done before and it's really amongst the first to truly address neuroinflammation. I mean, if you think about it, we've always said that the higher levels of neuroinflammation you have, the faster you decline. And that showed with whether you had 1 or 2 biomarkers, right? We kind of confirm that in this trial. So my belief is that I think everybody knows that there's more and more research coming out about neuroinflammation and neurodegenerative disease and specifically Alzheimer's. I think that we've got a tremendous amount of data from this Phase II program. And the partner we're going to look for is the one that's going to help us get it -- be able to help finance a registration trial to get this to approval. How that's structured financially, I couldn't tell you at this point. That's a negotiation to be had.

We'll take our next question from Tom Shrader with BTIG.

This is Jenny Shen on for Tom Shrader. I wanted to ask about the biomarkers of your trial, particularly in the EMACC, knowing what you do now, would there be any refinements you would make to measure this marker? And for the behavioral marker NPI from a registrational point of view, has it been used before in trials or in conversations with the FDA?

You cut out a little bit. Yes, you cut out a little bit. So I think I understand -- and just to clarify if I don't have this right. So you're asking about the EMACC as a biomarker? Or are you referring to the 2 blood biomarkers in relation to EMACC?

EMACC as a marker in general.

Yes. Okay. So good question. So the question regarding how we see that as it relates to the FDA or how we would refine our Phase II based on the EMAC, did I have that right?

Yes.

Okay. Sorry, I'm glad we got it clarified. So I think from a performance perspective, the EMACC did what it was supposed to do in the sense that it captured change that it is sensitive to capture change in these patients. Now we could see in the placebo group, that also means that you don't get as much decline. So it performed as expected in the right patient population, the patients that had high enough inflammation did decline. And so from the pure performance perspective, we're very happy with the performance of the EMACC. We think that the psychometric properties more broadly, so how the test performs as it relates to being able to measure cognitive change in early AD patients really aligns well with what the FDA has put in their guidance to what a new therapy or new -- I'm sorry, a new scale should look like. So I actually am pretty confident that the FDA is going to have a favorable opinion on the EMACC. Now they do have some things in the guidance. One of them is that I think is less clear or somewhat vague is there has to be scientific consensus around that. And it's not clear what that really means. But what I can tell you is that there are at least 4 companies that have used or are using EMACC, including ourselves. There are additional companies that are now going to be looking to put it into the clinical trial. And the neuropsych groups that were developing EMACC are at the point of publishing a couple of papers on it. So I think that the EMACC is going to be well received. it remains to be seen what the decision will be. But I feel pretty confident. Does that address the question?

Yes. And also [Technical Difficulty].

I'm sorry, I didn't get that at all.

Yes, that question cut out quite a bit, CJ. I think she was talking about NPI.

I didn't get that. I'm sorry, David. Did you?

Yes. No, she's cutting out. I'm sorry, I think we're going to have to go to the next question, but I think she was asking something about NPI.

We'll take our next question from James Molloy with Alliance Global Partners.

I couldn't hear the question on this end either. On the part, I guess it's probably safe to assume that potential partnership, there isn't -- no one is in the data room yet. It will be a post end of Phase II -- end of Phase II meeting. And then should we anticipate '26, '27 potential partnership, again, assuming things go well at the end of Phase II with the EMACC endpoint and all that?

Yes, I think that's fair to assume, Gary (sic) [ James ].

Any comments from the experts on the EMACC endpoint as well and sort of their thoughts?

So I don't think we've had any detailed discussions about EMACC as an endpoint in a way that would sort of satisfy your question. What I can tell you is that we've had some of the early interest, the quick interest at AAIC around EMACC as a valid endpoint was really had with the neuropsychs and consultants in the industry that are really interested in that sort of thing. And I can tell you that those conversations were extremely supportive. And I think to me, that's a good sign because that's where you develop that scientific consensus. So not a whole lot of, I would say, conversation -- in-depth conversation with partners. But I will say we didn't get pushback. So I think that in and of itself is a good sign.

Best to RJ in his retirement.

Thank you so much.

We'll take our next question from Boris Tolkachev with Freedom Broker.

I'd like to switch gears a bit to CORDStrom. First, regarding the ongoing preparations for the BLA submission. As I understood from the press release, the clinical data are currently undergoing independent statistical analysis. So are you expecting any new insights from that process or just more of a final quality check to make sure things ready for submission? And additionally, could you elaborate a bit on the details of planned open-label post-BLA trial of CORDStrom? So is there any intention to eventually include the results of this trial in the BLA package?

Good question, Boris. Mark?

Yes. Thanks very much, Boris. So first off, the statistical analysis plan that was designed by the sponsor of the crossover trial wasn't really adequate for true detailed analysis of the patient populations. We've looked at that statistical analysis plan and identified great improvements. And I do believe that the plan we put together with Veramed, the independent consultants, is likely to identify significantly improved data that will help our submission, both for MAA and BLA. I can't be certain of that because I haven't seen the data. They're blinded to us. But I think the analysis plan that we put together is certainly likely to come up with a more intuitive analysis of data. And I had stronger data to present to the regulators. In terms of the open label, our plan is from our discussions with both the formal discussions with the FDA and informal discussions with the MHRA, we believe that we have data that are adequate from the crossover trial. Bear in mind that this is the first ever fully randomized controlled crossover placebo-controlled trial on multicenter sites done in this patient group anywhere in the world. And it's done in the 2 largest centers in Europe for RDEB -- pediatric RDEB. So the data really can't be improved upon in terms of patient number. What we expect to do after we've submitted our MAA and BLA applications is to go to look at the open label. The trial protocol is still under negotiation. In fact, I was discussing it with the clinical leads today looking at that open label. And we will move forward probably early 2027 to make certain that those data start to be acquired after we've submitted the BLA submissions. Does that answer your question?

Yes.

This does conclude our question-and-answer session. I'd like to now turn it back to our presenters for any additional or closing remarks.

Thank you, Stephanie, and thank you, everyone, for joining us. INmune Bio has come a long way over the last few years and we have a very exciting future ahead of us. We thank you greatly for your support and look forward to sharing more accomplishments with you in the near future. Thank you.

Thank you, ladies and gentlemen. This does conclude today's presentation. You may now disconnect.