INmune Bio, Inc. (NASDAQ:INMB) Q3 2025 Earnings Call Transcript

INmune Bio, Inc. (NASDAQ:INMB) Q3 2025 Earnings Call Transcript October 30, 2025

INmune Bio, Inc. beats earnings expectations. Reported EPS is $-0.24, expectations were $-0.31.

Operator: “

Daniel Carlson: “

David Moss: “

Mark Lowdell: “

CJ Barnum: “

Cory Ellspermann: “

Denis Reznik: ” Raymond James Ltd., Research Division

Jason Mccarthy: ” Maxim Group LLC, Research Division

Unknown Analyst: “

Operator: Greetings, and welcome to the INmune Bio Third 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 of INmune Bio. Daniel?

Daniel Carlson: Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for INmune Bio’s Third Quarter 2025 Financial Results. Presenting on today’s call are David Moss, CEO and Co-Founder of INmune Bio; Dr. Mark Lowdell, Chief Scientific Officer and Co-Founder of INmune Bio; Dr. CJ Barnum, Head of Neuroscience; and Cory Ellspermann, INmune Bio’s CFO. Before we begin, 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. It’s now my pleasure to turn the call over to INmune Bio’s CEO, David Moss. David?

David Moss: Thank you, Dan, and good afternoon, everyone. For our third quarter 2025 call, today, I will review key takeaways and provide an update on our platform programs. Following my review of the recent developments at INmune Bio, I will pass the microphone to Dr. Lowdell, INmune Bio’s Chief Scientific Officer and inventor of CORDStrom, who will provide an update on our CORDStrom MSC platform and particularly our RDEB program, along with INKmune. Next, Dr. CJ Barnum, who leads our CNS drug development efforts, will provide an update on the Alzheimer’s program; and then Cory Ellspermann, our CFO, will present our financial results, after which I’ll conclude our prepared remarks with a review of our upcoming catalysts, and then we’ll be happy to take your questions.

Since taking over the role of CEO at INmune Bio in July, it’s been a time of transition for the company. Having spent the last 2 years with our main focus on Alzheimer’s trial, which ended in late June, we’re now able to direct our attention to the next stage of development for our platform drug programs. And we’re highly optimistic that the next couple of years will demonstrate the success of our efforts as we take our programs through key development milestones, which we expect could lead to benefits not only for investors, but for patients suffering from diseases with limited therapeutic options available at this time. CORDStrom is our most advanced program as we are now in the process of preparing for submission for marketing approval to the regulatory bodies in both the U.K. and the U.S. We believe CORDStrom has demonstrated a clear and safe benefit to patients suffering from recessive dystrophic epidermolysis bullosa, also referred to as RDEB, a very debilitating disease.

Patients on the drug had a significantly reduced itch, which not only affects wound healing in these young sufferers, but also reduces the itch-scratch wound cycle. While RDEB primarily manifests as a genetic condition causing skin fragility, blistering and scarring due to mutations of the collagen VII gene, it also involves mucus membrane and internal organs leading to multisystem complications. While RDEB has traditionally been treated topically, RDEB is a systemic disease that has blisters and scarring in the mouth, esophagus, eyes, urethra and anal area causing nutritional deficiencies, emotional stress and other problems. We believe CORDStrom is potentially one of the first systemic treatments for RDEB and made an improvement in the quality of life of the patients treated in our trial.

Looking beyond our initial indications of RDEB, we believe CORDStrom is a platform opportunity for INmune Bio as it has the potential to accomplish all sorts of things in many different diseases. For example, we can genetically modify it to treat cancer cells, which is what it was originally developed for, and there are many other modifications you will hear about in the near future. So there’s a lot of things that we can do with CORDStrom to improve its targeting in a variety of rare diseases and indeed, less rare or more common diseases. We’ll be excited to share these modifications in the future as well as expansions towards other indications. Turning to the XPro platform. We remain confident in its potential to treat neuroinflammation in Alzheimer’s disease.

In September, we submitted a manuscript detailing the results of the Phase II MINDFuL trial for peer-review publication. As we analyze the complete data set, we’re gaining deeper insight into the drug’s activity. Dr. Barnum will — will elaborate, but our findings indicate positive results in patients with higher baseline inflammation. We’re actively pursuing an accelerated regulatory pathway and preparing for our end of Phase II meeting with the FDA. Defining a clear path forward for XPro is a primary objective and may be crucial for strategic funding and partnership discussions. 2025 also saw us complete the Phase II trial of INKmune in prostate cancer ahead of schedule. With the primary endpoint and 2 of the 3 secondary endpoints met, I’m excited to have Mark share more on INKmune later.

To conclude my remarks before I turn the call over to the team to discuss the individual programs, I’d like to thank the patients that participated in our trials, the clinical trial sites and our dedicated team for helping us execute these very complex trials. I also want to thank our investors for their continued belief in our novel platforms and support. Our decision to develop 3 very different drug platforms in parallel to provide strength and opportunity has borne fruit. INmune now has 2 later-stage platform therapeutics that have demonstrated success in clinical trials and are ready to advance to the next stage of development and a third which completed a Phase II trial successfully. Our value proposition to shareholders and patients is clear.

First is to get CORDStrom from to MAA in the U.K., followed by a BLA in the U.S. Meanwhile, for XPro, we await regulatory alignment with the end of Phase II study to determine next steps. We anticipate all of this will happen in ’26, an exciting year for the company. Now I’ll turn the call over to Mark Lowdell for more color on CORDStrom and INKmune. Mark?

Mark Lowdell: Good afternoon, everybody, and thank you, David, for the introduction. As you’ve heard, we’re progressing towards drug registration, firstly in the U.K. and then the U.S. with CORDStrom in RDEB as our initial indication, whilst developing other indications for the platform at the same time. This is a truly debilitating disease, which presents itself in the first months of life and for which there is no cure currently. The median survival for those with severe disease is fewer than 30 years. And although skin wounds are the most apparent manifestations of the disease, the lesions, as David has told you, are present throughout the gastrointestinal tract inside the nose and behind the eyes. The disease is driven by inflammation and CORDStrom provides systemic suppression of inflammation.

Most importantly, CORDStrom is most effective when activated by the inflammatory cytokines at the sites, so its effect is somewhat targeted. During the MissionEB randomized placebo-controlled trial in the U.K., over 120 infusions of CORDStrom were administered to over 30 children without any severe adverse reactions or adverse events. As David has said, reduction in systemic itch was a major reported benefit by patients some as young as 2 years old who used a cartoon depiction of whole body itch to demonstrate their experience severity. Itch control is important because the resulting scratch initiates new skin wounds and increases risk of infection, which is part of the disease cycle. And I can’t emphasize how much important — how very important itch is to these children as it drives a vicious itch scratch wound cycle but impairs wound healing by separating skin layers and forming new blisters.

These rupture easily creating open wounds or exacerbating existing wounds, delaying healing and creating this terrible feedback loop. It’s painful for these children with intense itch causing a poor quality of life with distress, sleep loss and emotional burden. Breaking this itch-scratch wound habit is difficult and highlights one of the special aspects of CORDStrom. MissionEB was an investigator-led trial. It wasn’t sponsored or funded by INmune. We secured access to the entire trial data pack in August and have appointed an independent group of clinical statisticians to analyze all of the data in depth. This is critical for our submission to regulatory agencies and is well underway. In the trial, all patients received both CORDStrom and placebo, separated by 6 months, some treated first with placebo and then CORDStrom and the other half treated with CORDStrom first and then placebo.

These in-depth analysis of these data show improvements in disease activity scores in all patient subgroups after CORDStrom compared to their previous placebo treatment. In preparation for registration filing, INmune in the U.K. has now relocated into rented CGMP manufacturing space, which is compliant with commercial production as a licensed medicine. We successfully completed the technology transfer earlier this month, and we’re on track to be ready for U.K. filing at the end of Q2 next year. But alongside the CGMP work, we’re confirming the complex mechanisms of action of CORDStrom in RDEB and validating assays to test drug batches at the end of manufacture. This work is very critical since FDA and other agencies require robust tests of drug potency and failures to get these right with cellular drugs have delayed other drug approvals for many years.

This year also saw the completion of the Phase II aspect of our trial of INKmune in patients with castration-resistant prostate cancer. As David said, we met the primary endpoint of the trial in Q1 of this year, and analysis of the first 9 patients showed evidence of NK cell proliferation in vivo and generation of the functional memory-like NK cells that we understand INKmune generates in 4 of the 6 patients treated at the lowest and intermediate dose levels. The data from the patients in the highest dose cohort are awaiting analysis, but the team is tied up with CORDStrom at the moment. Thus 2 of the secondary endpoints were met. The final secondary endpoint was reduction in tumor load, and our primary measure was PSMA PET scans. But it was obvious from the analysis of the first 6 subjects that the patients being enrolled had very high disease burden beyond that, which would respond to immunotherapy.

We thus decided that since we’ve met the primary and 2 of the secondary endpoints at both low and intermediate doses, we had identified the dose to take forward to a randomized Phase II trial and so we could close the current trial to recruitment. We’re analyzing the blood samples and the PET scans from the final 3 patients at present, and we’ll report them to you as soon as they become available. Now we plan to work on the design of the randomized trial during 2026 as resources become available. So 2025 has been incredibly busy for the U.K. team in supporting both INKmune and CORDStrom, but all the staff remain fully dedicated to delivering the goals we’ve set, and we look forward to providing more good news as the data become available. Now I’ll hand over to CJ to report on the company’s progress with XPro and look forward to any questions later in the call.

CJ?

CJ Barnum: Thank you, Mark, and good afternoon, everyone. We have established 4 strategic priorities for XPro. First, to secure regulatory alignment with the FDA at our forthcoming end of Phase II meeting; second, to pursue an accelerated approval pathway. third, to publish comprehensive insights from our Phase II MINDFuL trial; and fourth, to advance discussions with potential partners to support late-stage clinical development. During the third quarter, we achieved an important milestone by submitting the Phase II MINDFuL trial results for peer-reviewed publication. A preprint manuscript is now available on MedRx, providing the scientific community and our stakeholders with expanded insights. While much of the data has been previously presented, this manuscript introduces new analyses from the dose-compliant patient set.

These are patients who received at least 21 of the 23 scheduled doses. This population reflects the impact of sustained therapy and has been recognized by the FDA as a potential indicator of disease modifications. The findings demonstrate that longer treatment durations with XPro are associated with greater improvements in neuropsychiatric symptoms and biomarkers, including pTau217 and GFAP. We continue to build a robust evidence base to advanced analysis of neuroimaging endpoints. These focus on white matter integrity, an indicator of myelin preservation and gray matter metrics related to neurodegeneration. Emerging results are expected to further substantiate XPro’s potential as a differentiated disease-modifying therapy, and we plan to share these findings as they become available.

There remains substantial unmet need beyond existing anti-amyloid treatments, particularly for patients with a strong inflammatory profile or those unable to receive anti-amyloid therapies due to safety concerns such as ARIA. XPro is uniquely positioned to address this gap as no ARIA-related safety signals were observed even among high-risk individuals. Despite the challenges inherent in Alzheimer’s drug development, XPro continues to distinguish itself through its targeted patient selection, compelling safety profile and growing body of evidence. Our disciplined data-driven approach, which prioritizes scientific rigor, regulatory engagement and financial responsibility supports the long-term goal of establishing XPro as a transformative therapy and delivering sustained value to patients, partners and shareholders.

We look forward to providing ongoing updates as we advance toward key clinical and regulatory milestones. I will now turn it over to Cory for the financial update.

Cory Ellspermann: Thank you, CJ. At this time, I’ll provide a brief overview of our financial results. Net loss attributable to common stockholders for the quarter ended September 30, 2025, was approximately $6.5 million compared with approximately $12.1 million for the comparable period in 2024. Research and development expenses totaled approximately $4.9 million for the quarter ended September 30, 2025, compared with approximately $10.1 million for the comparable period in 2024. General and administrative expenses were approximately $2.5 million for the quarter ended September 30, 2025, compared with approximately $2.2 million for the comparable period in 2024. At September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million.

And based on our current operating plan, we believe our cash is sufficient to fund our operations into Q4 2026. As of October 30, 2025, the company had approximately 26.6 million shares of common stock outstanding. Now I’ll pass it back to David.

David Moss: Thank you, Corey. Now I’d like to present upcoming milestones for the company, and then we can start the Q&A session. For our CORDStrom program, we have a number of significant events in front of us. In Q4, we’ll present additional data from the trial. In mid-’26, we expect to file a marketing authorization application in the U.K. A few months after filing the marketing authorization application, we expect to file a BLA, biologics licensing application with the FDA. We’d expect to hear back from the FDA sometime by the middle of ’27 or later. For XPro, we expect to accomplish a lot in the next few quarters. In Q4, we anticipate getting more MRI data conducted during the MINDFuL trial. With this data, we hope to show improvements in myelin, gray matter and white matter, which would support the cognitive and biomarker findings of XPro’s benefits that CJ spoke about earlier.

We expect to hear from the FDA on accelerated pathway sometime in Q1 of ’26, and we anticipate having the minutes from the end of the Phase II meeting sometime in Q1 of ’26. So a lot happening in ’26. At this point, I’d like to hand the call back to the operator to poll for questions.

Q&A Session

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

Denis Reznik: This is Denis Reznik on for Gary Nachman. So just a couple from us. So on XPro, as you’re preparing for this end of Phase II meeting with the FDA, can you just walk us through what some of the biggest questions or discussion topics that you’re hoping to get more clarity on? And then I believe you were previously saying that the meeting could occur before the year-end, and now you’re guiding to the meeting occurring in 1Q. So could you just speak as to why the slight delay occurred? And I’ve got one follow-up.

David Moss: Yes. No, I appreciate it, Denis. Let me start with the second part of your question, and then I’ll let CJ jump to the first part. We anticipated getting everything together, but we weren’t able to get enough of the data in time to really get it to the FDA to have the meeting at the end of Q4. I will say, though, that we’re very close. It still could happen. We’re going by the end of the date that the FDA puts forward. I don’t know what that’s going to look like. And then keep in mind that you don’t get the minutes for the meeting until approximately 30 days after. Our experience with the FDA in the past has been that we usually get it on day 30 or very close to day 30. So we’re being relatively conservative saying in Q1, which is the — not only the period of time you have the response from the FDA, but the 30 minutes — the 30 days to get the written minutes.

CJ, I’ll let you respond to the type of questions. I’m not sure we’re going to publicly disclose them, but I’ll tell you that they relate around setting up a registration study. CJ?

CJ Barnum: Yes. I mean I think there’s a few obvious ones out there. One of them is that we talked about quite a bit is EMACC, right? We want to understand the agency’s view on EMACC. Another one of the key questions is the enrichment biomarkers. It’s clear from our data that the patients that had greater inflammation were the ones that are more likely to respond. And this is somewhat novel in this space, enriching for these biomarkers. So these are the sorts of questions that we need to ask. And as David said, because our goal is to really get alignment on how we move this into a registration trial, another key question is the safety database, right? The agency usually requires a certain number of patients to be treated prior to — before the drug could be commercialized.

So I think those are sort of the obvious ones. There’s some obvious or some other nuanced ones as well, but those are sort of the big questions that I think that we’re — that we can discuss at this point.

Denis Reznik: That’s super helpful. And then sticking with XPro on the partnership conversations, can you provide some color as to how those are progressing or at least maybe compare the tone of the conversations as to where they were at the end of last quarter? And then separately, on INKmune, can you just talk a little bit more about how you view the future of that asset? Is this something that you’re going to take through development yourself? Or would you consider partnering with?

David Moss: Appreciate it, Denis. So I’ll let Mark jump in on INKmune. Let me just jump in a little bit further. I think that before we really have aggressive partnering discussions, there’s been very top-level discussions with a handful of groups. I think like our investors, they want to see what the regulatory feedback and alignment looks like. And on top of that, they want to see more of the dataset. I think if we’re able to provide imaging data, white and gray matter that aligns with what we saw in our highly inflamed patient group, I mean, that’s going to be, I think, very compelling. So we’re still gathering all the package together. We want to deliver a complete package where we have really serious discussions. Mark, do you want to comment about INKmune?

Mark Lowdell: Yes. Thanks for the question. So as you know, we’ve published data on INKmune potentiating NK responses to a number of different tumors, both hematological and solid. So there are plenty of opportunities to take INKmune into Phase II trials now that we’ve completed one Phase II trial in other disorders and indeed going now into prostate and looking at patients with better risk disease. I’m always very keen to talk to potential partners and others that would want to invest in or buy the asset. But I think from our perspective at the moment is to get more Phase II data in randomized trials in at least prostate and then maybe other diseases as funds become available. And then, yes, indeed, look for partnership opportunities in the first instance and potentially keeping it within the company depending upon funding and taking it through to commercial in the way that we’re hoping to do with or expecting to do with CORDStrom.

David Moss: Next question please.

Operator: We will move next with Jason McCarthy with Maxim Group.

Jason Mccarthy: I’m going to concentrate them on the CORDStrom activity. First, has there been any feedback from European regulators with any specifics you could provide us for potential MAA filing? And do you think if you could file the MAA, that will be further supportive with regulators here in the States?

Mark Lowdell: So another good question. So we are waiting for our scientific meeting with the MHRA. I sit on the British Pharmacopoeia, which is part of the MHRA. So I do get unofficial conversations with colleagues at the agency. And they have been very supportive of us taking this through for scientific advice before the end of the year. So we’re putting that package together, and we will submit it as soon as we’ve got the data from the enhanced statistical analyses that are being done at the moment. So I’m expecting early next month to submit the data to the agency for a scientific advice meeting, which we may well get before the end of the year, but it’s probably going to be early next year and then move ahead with our program.

We have contracted a specialist advisory group that work or advisory company called TMC Pharma that works with rare diseases and has taken a lot of these through the agency. And so they’re giving us a lot of daily feedback really. They’re doing all of our paperwork for that filing to the MHRA and then for the MAA. So as David said, we are still on track to deliver the MAA submission to the MHRA by the end — by Q2 next year or in Q2 next year. And then the regulatory agencies talk to each other a lot, as I’m sure you know, and none likes to gain say another. So I’m confident that if we address the subtle differences for U.S. use compared to European use and get those data ready in the months after our MAA filing, we’ll be in a good position to file a BLA by the end of the year, by which time the MHRA will have had their first opportunity, they have their 80-day line to come back to us with comments, and we can — any improvements that they come up with, we can put into the FDA document.

So I think if we have got an MAA being considered by the U.K. agency that will feed into the FDA’s opinion of the same data. But obviously, these are agencies, so we can’t really comment on what they — on their activities and the way in which they review other people’s data.

Jason Mccarthy: It’s part of that discussion — thank you, Mark. It’s part of that discussion to include at least conversation or anecdotal thoughts around limitations of gene therapy, given that they are topical, there’s now 2 that are on the market, as you know, and potential use in the setting of some of these gene therapies because you’d imagine many of these kids going forward are going to probably try this.

Mark Lowdell: Yes, absolutely. But the — neither of those provide a systemic solution. So this is what we believe makes CORDStrom unique. But also the side effects associated with those therapies, one of the major side effects that was reported is itch. So even if it was an additional therapy to address the itch that isn’t addressed by these topical therapies, there’s a rationale there for CORDStrom’s use in patients who are potentially being treated with the gene therapies. But as I say, the data we’re getting at the moment, which once we’ve got them audited and good enough to share or secure enough to share, are already demonstrating changes in systemic cytokines associated with CORDStrom treatment. So we believe that the strength of this drug will be its ability to have a systemic effect on inflammatory cytokines and therefore, downstream as the patients get treated for longer. in terms of the overall disease pathway.

Jason Mccarthy: And just one mechanistic question, sort of a 2-part question. First, you had mentioned, can you talk a little bit about the uniqueness of cytokine-based activation for CORDStrom once it is given systemically, at least in a setting of inflammation like in RDEB and also the ability to use the CORDStrom platform and tailor it to specific disease types. Obviously, that would be beyond RDEB and how that separates itself from other MSC therapies that are out there.

Mark Lowdell: Absolutely. I could talk for hours on that. But the first question was about inflammation. And we know that for some functions of some MSCs, they require what’s called licensing. So they need to be activated by inflammatory cytokines. And indeed, we have evidence in vitro that cause there’s a ton of things that CORDStrom cells do without being activated by inflammatory cytokines. And then there are additional cytokines and functions that they perform in the presence of inflammatory cytokines. Now as I’m sure you know, cytokines don’t work — don’t really work systemically in vivo. They are signaling molecules between cells, and they normally operate over sort of nano distances. But — so what we know is that these patients have inflammatory cytokines being generated at the site of itch actually and then the wound.

And the itch response is driven by a particular T cell called Th2 releasing a cytokine called IL-31. And we know that the CORDStrom suppresses those Th2 cells and suppresses the myeloid cells that are also producing inflammatory cytokines, and they are induced by the inflammatory cytokines that are there. So yes, we think that these cells have a targeted effect in vivo. But your second question was about CORDStrom being used in other indications. And what makes CORDStrom truly unique? There are, as you say, many MSCs have been put into trial and there are at least 3 products, which are now licensed around the world. But all of — none of those use MSCs from 4 pooled donors. So what we do is we take our [ molecical ]cords, we get them from cord blood banks in the U.K. And we isolate the MSCs from those individual cords and then we test them for their various different potencies.

So if we know the mechanism of action we want in a particular disease, we choose 4 cords that have that particular strength in their mechanism of action, and we pool them. So CORDStrom for EB is from 4 pooled donors that we have characterized very well, and we have other donors with the same characteristics, which we’ve also pooled and shown we make the same product. So CORDStrom is one — CORDStrom EB is one derivation of CORDStrom, but we can select donors cords with different characteristics that might — some of them are specific to chondrocyte interactions and anti-inflammatory responses that could be targeted to osteoarthritis, for example. We’ve used another pool to treat SLE patients in in a trial in France, which is published. So we can — the reason it’s a platform is because by selecting different cords, it becomes a different drug because the potency data, the potency selection are different, and therefore, the potency assays and release assays are different.

So that’s why we’re really excited about it as a platform for multiple different indications.

Jason Mccarthy: Sorry, David, a quick one for you. Just we discussed this, you and I at length a couple of weeks back, but just some high-level thoughts of the regulatory environment here in the States, particularly around MSCs and cell therapy in general because as you guys both know, there is one approved — the first one in the United States was approved last year for GVHD. It could be another filing for heart failure soon, and you know where Capricor is in DMD. And then here, you guys are coming with Well, that’s not an MSC, but Capricor cell therapy potentially for RDEB next year?

David Moss: Sure. I think the beauty of Mark and his team and when Mark comes up with an idea, he wouldn’t pursue it if he knew that he couldn’t manufacture it consistently in large scale to deliver not dozens of doses or hundreds of doses, but tens of thousands of doses at a commercial scale cost for a drug. Whereas a lot of companies, they get in love with the science and they develop a drug and then they go back if they get approval to figure out how to manufacture it and the manufacturing cost ends up being so high. A lot of it has to do with staff and facilities and time. And CORDStrom and INKmune both solve that problem, right? I mean we can get the cost down dramatically. We can provide a repeatable batch and so on. So I think that what Mark has done is exactly what the agencies want to see.

They want to see a product that batch to batch consistency. It’s the same. They know that if Mark produces a batch today or produces it 10 years from now, it’s not a different product. And then from an end user standpoint, an insurance standpoint and a payment standpoint, yes, these are ultra-rare diseases, so the prices are high because the volume is low, but still the margins are there. Typically, cell therapies, oftentimes, the margins are a little bit tight. We’ve seen some companies that have some approvals with some cell therapies, and they charge very high prices for it. But what they’re making net is a challenge. They’ve got a lot of work to streamline their manufacturing. Those are not things we have to worry too much about with CORDStrom because that’s the way Mark has built it.

Truly kind of this process engineering mindset from the start. big advantage. So from a regulatory standpoint, it’s nice to see that they’re approving products like this. We’ve — I like to think that CORDStrom is the most advanced mesenchymal stromal cell program out there, at least as far as I have seen. And I think it’s designed with the regulators in mind from the very beginning.

Operator: We will move next with James Molloy with AGP Alliance Global Partners.

Unknown Analyst: Matt on for Jim today. First, on CORDStrom, I wanted to ask about the treatment paradigm, the current treatment paradigm for RDEB in the U.K. and how that looks and where CORDStrom might slot in there? I understand Krystal VYJUVEK is approved there, but not Abeona’s EB?

Mark Lowdell: Yes. So it is approved. It’s not approved by NICE for reimbursement through the NHS. So there is no RDEB-specific treatment available to be prescribed and paid for by the U.K. government for — in our health care system. So it’s only available for self-payers in the U.K. and I’m not aware of it being widely used, if at all. Certainly, the largest center for pediatric RDEB in the U.K. is Great Ormond Street, where the trial was led from. And they are weekly calling me up and saying, how can we open the next phase of the trial for the patients who were treated. So there is a big demand for this. I think alluding to what David was saying, the challenge here with the therapies that are available in RDEB is the price, the price point, and we have a drug here that can come in well below those current price points and have a systemic effect.

So we already have — this trial was driven by NIHR. It was a publicly funded trial, and we were paid to supply the drug. We didn’t run the trial, as I said. And that — the NIHR, which is part of NHS England, specifically said they wanted this drug to be developed as a commercial product if the trials were successful. So we have a lot of push in the U.K. to make this drug available to patients as soon as possible. And I don’t see a problem in terms of competing drugs at the moment. What will happen in the U.S., I’m uncertain because obviously, those drugs are already licensed and are being used in the U.S. But it going to come down to efficacy and cost at the end of the day in terms of which ones survive and which ones and where CORDStrom comes within that.

David Moss: No, sorry to interrupt. I just want to add, if you don’t mind. We cheer on all the competitor products. When you see this disease, it’s a huge unmet need in these children, it’s just heartbreaking to see — and so we cheer them on. But I think that the one thing to really keep in mind is that it’s typically looked at as a dermatologic disease from a topical nature, but the systemic system is overlooked. But a byproduct of all of the 3 approved products in the United States is an increase in itch. If you look at the label, it will say itch. And that’s really part of the process of healing, right? So the more healing you have the itch. And again, if you’re going to itch, you’re going to itch this cream off, you’ve got to cover it up, tremendously painful.

And if you look at the list of the top complaints from RDEB EB patients, usually #1 is itch, even before pain. It’s been described to us as like being bitten by mosquito 1,000 times a day. It’s just chronic itch. And so it should slot nicely with the competitors. And again, keep in mind, we’re conscious on the margins of the product from day 0 before we even started the trial.

Unknown Analyst: Got it. And in terms of data points suggesting CORDStrom has a systemic effect, I know you mentioned the cytokines, but do you have any anecdotal or quantitative data suggesting symptomatic relief for patients in terms of systemic like wounds behind the eyelid and stuff like that?

Mark Lowdell: Yes. So the data that are published from the trial by Great Ormond Street that were published a few months ago demonstrated the systemic effects that are associated with itch is a systemic disease effectively. But yes, there are systemic data reports from that. What we’re looking at now are getting into those data much more acutely, and that’s being done independently and blinded from us to guarantee that when we have the data to take to the agencies, there’s no question that we have manipulated it. So we’ll be getting those data, but I haven’t seen them, so I’m unable to comment on them. But when they come through, we will be sharing them.

David Moss: Yes. And I’ll just add from an anecdotal standpoint, because a very good question. The patients on the trial could pretty much identify whether they’re on drug or placebo. And one of the patients to us ended up speaking to the BBC and the BBC published an article about it, and he talked about his massive improvement in quality of life, being able to do things he wasn’t able to do before. And this is something that we heard from some of the PIs as well. And visually, they saw an improvement in the quality of life of these children and their wounds look different to them as well. But if you type in BBC and RDEB into Google, I think it’s the first thing that pops up, but that is a child that describes his experience on the MissionEB trial from CORDStrom.

Unknown Analyst: Got it. And then just lastly, on cash runway. Where does your current cash position get you out to in terms of milestones with CORDStrom and also with XPro as well?

David Moss: Yes. So Q1 is a big timing period for us for XPro. We should have very clear clarity on an accelerated pathway, end of Phase II meeting and certainly the imaging data by then. Our cash runway, as we’ve reported in the quarter is really to the end of next year in Q4. And then obviously, we’ve got — we’re getting close to the MAA, which will be around the middle of next year. On top of that, as Mark had alluded earlier, we’ll have — we should have some of the cytokine data and additional data around the MissionEB program towards the end of this year as well. So a number of milestones before we run out of cash.

Operator: And this does conclude our Q&A session. I will now turn the call back to David for closing remarks.

David Moss: Appreciate it. I’d like to wrap up our prepared remarks by saying that we’re as excited as ever about the future of INmune Bio. Despite the setbacks of missing the top line on the MINDFuL trial, we’re convinced in the prospects for XPro in the Alzheimer’s disease and in other diseases. Meanwhile, we’re very optimistic about filing an MAA and BLA in course from next year, and we believe that platform has far greater potential than the market is giving it credit for. We’ve had a number of attainable goals in front of us, and we appreciate your support as we go about achieving them. As always, we thank our stakeholders for your continued support and look forward to updating you on our progress on the discussion milestones. Thank you, everybody.

Operator: Thank you. And this does conclude today’s program. Thank you for your participation. You may disconnect at any time.