INmune Bio - Earnings Call - Q3 2025

Executive Summary

• Q3 2025 EPS of $-0.24 beat Wall Street consensus ($-0.325), driven by sharply lower R&D spending; net loss improved to $6.5M from $24.5M in Q2 (which had a $16.5M impairment) and $12.1M in Q3 2024.
• Cash and cash equivalents were $27.7M; management guided cash runway “into Q4 2026,” extending from “into 2026” in Q2.
• Program updates: CORDStrom on track for UK MAA mid-2026 and BLA a few months thereafter; XPro EOP2 meeting shifted to Q1 2026 with no ARIA safety signal; INKmune CARE-PC trial closed to recruitment, informing a randomized Phase 2 design in less advanced disease.
• Near-term catalysts (Q4 2025): CORDStrom additional data, MINDFuL imaging endpoints, and final INKmune CARE-PC data — potential stock reaction on regulatory clarity and efficacy signal reinforcement.

What Went Well and What Went Wrong

What Went Well

• EPS beat vs consensus with disciplined OpEx: Q3 EPS $-0.24 vs consensus $-0.325; R&D down to $4.9M (vs $10.1M YoY) and G&A $2.5M (vs $2.2M YoY), reflecting tighter spend while advancing programs.
• Regulatory and manufacturing execution for CORDStrom: successful pilot-scale runs at CGT Catapult; on track for UK MAA mid-2026 and BLA shortly thereafter — “we are now in the process of preparing for submission for marketing approval”.
• XPro safety and enriched efficacy signals: no ARIA even among high-risk patients; dose-compliance analyses show larger effect sizes (EMACC 0.27; NPI -0.23; pTau217 -0.18) in the predefined ADi population, supporting a targeted path forward.

What Went Wrong

• XPro regulatory timeline slipped: End of Phase 2 meeting moved from Q4 2025 to Q1 2026 to finalize data; management cited need for more data and conservative timing for FDA minutes.
• INKmune trial recruitment halted: CARE-PC closed to recruitment due to very high disease burden limiting tumor-load reduction by PSMA-PET, necessitating a randomized trial in earlier-stage patients; tumor response endpoints not met in advanced disease.
• No revenue and limited near-term catalysts to de-risk financing: revenue was $0 in Q3; while cash runway extended, partnership timing for XPro likely post-EOP2/FDA feedback, pushing potential non-dilutive funding out.

Transcript

Operator (participant)

Greetings and welcome to the INmune Bio third quarter 2025 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask questions by pressing the star and one on your telephone keypad. You may withdraw yourself from the queue by pressing star two. 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 (Head of Investor Relations)

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 Corey Elsperman, 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. We 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 (CEO)

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, 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 Corey Elsperman, our CFO, will present our financial results. After that, 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 two years with our main focus on the 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. 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 7 gene, it also involves mucous membrane and internal organs, leading to multi-system 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. There are many other modifications you will hear about in the near future. There are 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 2 Mindful trial for peer-reviewed publication.

As we analyze the complete data set, we're gaining deeper insight into the drug's activity. Dr. Barnum will elaborate. 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 2 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 2 trial of INKmune in prostate cancer ahead of schedule, with the primary endpoint and two of the three secondary endpoints met. I'm excited to have Dr. Mark Lowdell 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 three very different drug platforms in parallel to provide strength and opportunity has borne fruit. INmune now has two 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 2 trial successfully. Our value proposition to shareholders and patients is clear. First is to get CORDStrom 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 2 study to determine next steps. We anticipate all of this will happen in 2026, 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 (CSO)

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. 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 Mission EB 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 two years old, who used a cartoon depiction of whole-body itch to demonstrate their experienced severity. Itch control is important because the resulting scratch initiates new skin wounds and increases the risk of infection, which is part of the disease cycle. I can't emphasize how important itch is to these children, as it drives a vicious itch-scratch-wound cycle that 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. Mission EB 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 six months. Some treated first with placebo and then CORDStrom, and the other half treated with CORDStrom first and then placebo. These in-depth analyses 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. 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 2 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 nine patients showed evidence of NK cell proliferation in vivo and generation of the functional memory-like NK cells that we understand INKmune generates in four of the six 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, two of the secondary endpoints were met. The final secondary endpoint was reduction in tumor load, and our primary measure was PSMA PET scans. It was obvious from the analyses of the first six subjects that the patients being enrolled had very high disease burden beyond that which would respond to immunotherapy.

We thus decided that since we'd met the primary and two of the secondary endpoints at both low and intermediate doses, we had identified the dose to take forward to randomized Phase 2 trial, and so we could close the current trial to recruitment. We're analyzing the blood samples and the PET scans from the final three 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. 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 (Head of Neuroscience)

Thank you, Mark, and good afternoon, everyone. We have established four strategic priorities for XPro. First, to secure regulatory alignment with the FDA at our forthcoming end of Phase 2 meeting. Second, to pursue an accelerated approval pathway. Third, to publish comprehensive insights from our Phase 2 Mindful trial. 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 2 Mindful trial results for peer-reviewed publication. A preprint manuscript is now available at 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 PTAL 217 and GFAP. We continue to build a robust evidence base to advance analyses 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. 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'll turn it over to Corey for the financial update.

Corey Elsperman (CFO)

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 30th, 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 30th, 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 30th, 2025, the company had cash and cash equivalents of approximately $27.7 million. Based on our current operating plan, we believe our cash is sufficient to fund our operations into Q4 2026. As of October 30th, 2025, the company had approximately 26.6 million shares of common stock outstanding.

Now I'll pass it back to David.

David Moss (CEO)

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-2026, 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 with the FDA. We'd expect to hear back from the FDA sometime by the middle of 2027 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 2026, and we anticipate having the minutes from the end of the Phase 2 meeting sometime in Q1 of 2026. A lot happening in 2026. At this point, I'd like to hand the call back to the operator to poll for questions.

Operator (participant)

Thank you. At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may withdraw your question from the queue by pressing star two. Once again, to ask a question, please press the star and one on your telephone keypad. We'll take our first question from Gary Nachman with Raymond James. Please go ahead. Your line is open.

Denis Reznik (Senior Equity Research Associate)

Hey, guys. This is Denis Reznik on for Gary Nachman. Thanks for taking our questions. Just a couple from us. On XPro, as you're preparing for this end of Phase 2 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? I believe you were previously saying that the meeting could occur before year-end, and now you're guiding to the meeting occurring in Q1. Could you just speak as to why this likely occurred? I've got one follow-up.

David Moss (CEO)

Yeah. 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 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. 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.

We're being relatively conservative, saying in Q1, which is not only the period of time you have the response from the FDA, but 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 (Head of Neuroscience)

Yeah. I mean, I think there's a few obvious ones out there. One of them that we've 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. This is somewhat novel in this space, enriching for these biomarkers. These are the sorts of questions that we need to ask. 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 before the drug can be commercialized. I think those are sort of the obvious ones.

There are some other nuanced ones as well, but those are the big questions that I think we can discuss at this point.

Denis Reznik (Senior Equity Research Associate)

That's super helpful. Sticking with XPro on the partnership conversations, can you provide some color 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? 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 this out? Thanks so much, guys.

David Moss (CEO)

Appreciate it, Denis.

CJ Barnum (Head of Neuroscience)

Yeah.

David Moss (CEO)

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 our investors, they want to see what the regulatory feedback and alignment looks like. On top of that, they want to see more of the data set. 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, that's going to be, I think, very compelling. We're still gathering all the package together. We want to deliver a complete package, but we have really serious discussions. Mark, do you want to comment about INKmune?

Mark Lowdell (CSO)

Yes. Thanks for the question. As you know, we've published data on INKmune potentiating NK responses to a number of different tumors, both hematological and solid. There are plenty of opportunities to take INKmune into Phase 2 trials now that we've completed one Phase 2 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. I think from our perspective at the moment is to get more Phase 2 data in randomized trials in at least prostate and then maybe other diseases as funds become available.

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.

Denis Reznik (Senior Equity Research Associate)

Great. Thank you so much.

David Moss (CEO)

Thanks, Denis. Thank you, Mark. Next question, please.

Operator (participant)

We will move next with Jason McCarthy with Maxim Group. Please go ahead. Your line is open.

Jason McCarthy (Research Analyst)

Hey, guys. Thanks for the questions or taking the questions. I'm going to concentrate them on the CORDStrom activity. First, has there been any feedback from European regulators with any specifics you can provide us for potential MAA filing? Do you think if you could file the MAA, that would be further supportive with regulators here in the U.S.?

Mark Lowdell (CSO)

Another good question. We're waiting for our scientific meeting with the MHRA. I sit on the British Pharmacopeia, which is part of the MHRA, so I do get unofficial conversations with colleagues at the agency. They have been very supportive of us taking this through for scientific advice before the end of the year. 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. 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, an advisory company called TMC Pharma that works with rare diseases and has taken a lot of these through the agency. 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. As David said, we are still on track to deliver the MAA submission to the MHRA by Q2 next year or in Q2 next year. Regulatory agencies talk to each other a lot, as I'm sure you know, and none likes to gainsay another. 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 any improvements that they come up with, we can put into the FDA document. I think if we have got an MAA being considered by the UK agency, that will feed into the FDA's opinion of the same data. Obviously, these are agencies, so we can't really comment on their activities and the way in which they review other people's data.

Jason McCarthy (Research Analyst)

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 two that are on the market, as you know, and potential use in the setting of some of these gene therapies. As you'd imagine, many of these kids going forward are going to probably try this.

Mark Lowdell (CSO)

Yes, absolutely. Neither of those provide a systemic solution. This is what we believe makes CORDStrom unique. Also, the side effects associated with those therapies, one of the major side effects that was reported is itch. 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. 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. 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 (Research Analyst)

Just one mechanistic question, sort of a two-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 (CSO)

Absolutely. I could talk for hours on that. The first question was about inflammation. We know that for some functions of some MSCs, they require what's called licensing. They need to be activated by inflammatory cytokines. We have evidence in vitro that 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. As I'm sure you know, cytokines don't really work systemically in vivo. They are signaling molecules between cells, and they normally operate over sort of nano distances. What we know is that these patients have inflammatory cytokines being generated at the site of itch, actually, and then the wound. The itch response is driven by a particular T cell called TH2 releasing a cytokine called IL-31.

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. Yes, we think that these cells have a targeted effect in vivo. Your second question was about CORDStrom being used in other indications and what makes CORDStrom truly unique. There are, as you say, many MSCs that have been put into trial, and there are at least three products which are now licensed around the world. None of those use MSCs from four pooled donors. What we do is we take our molecular 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.

If we know the mechanism of action we want in a particular disease, we choose four cords that have that particular strength in their mechanism of action, and we pool them. CORDStrom for EB is from four pooled donors that we have characterized very well. We have other donors with the same characteristics, which we've also pooled and shown we make the same product. CORDStrom EB is one derivation of CORDStrom, but we can select donor cords with different characteristics that might, some of them are specific to chondrocyte interactions and an anti-inflammatory response that could be targeted to osteoarthritis, for example. We've used another pool to treat SLE patients in a trial in France, which is published.

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. That's why we're really excited about it as a platform for multiple different indications.

Jason McCarthy (Research Analyst)

Sorry, David, a quick one for you. 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 state, particularly around MSCs and cell therapy in general, because as you guys both know, there was one approved, the first one in the United States was approved last year for GVHD. There could be another filing for heart failure soon. You know where Capricor is and DMD. Here you guys are coming with, that's not an MSC, but Capricor is cell therapy, potentially for RDEB next year.

David Moss (CEO)

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. A lot of companies 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. CORDStrom and INKmune both solve that problem, right? We can get the cost down dramatically. We can provide a repeatable batch and so on. 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 consistently, 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. 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 of 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, truly kind of this process engineering mindset from the start. Big advantage.

From a regulatory standpoint, it's nice to see that they're approving products like this. I like to think that CORDStrom's the most advanced mesenchymal stromal cell program out there, at least as far as I have seen. I think it's designed with the regulators in mind from the very beginning.

Jason McCarthy (Research Analyst)

Got it. Thank you guys for taking all the questions. Appreciate it.

David Moss (CEO)

You got a lot, Jason. Next question, please.

Operator (participant)

We will move next with James Molloy with Alliance Global Partners. Please go ahead. Your line is open.

Hey, guys. Matt on for Jim today. Thank you for taking our questions. First, on CORDStrom, I wanted to ask about the current treatment paradigm for RDEB in the U.K. and how that looks and where CORDStrom might slot in there. I understand Krystal's Vyjuvek is approved there but not Abeona's EB-101.

Mark Lowdell (CSO)

Yes. It is approved. It's not approved by NICE for reimbursement through the NHS. There is no RDEB-specific treatment available to be prescribed and paid for by the U.K. government in our healthcare system. 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. They are weekly calling me up and saying, "How can we open the next phase of the trial for the patients who were treated?" 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 their price, their price point. We have a drug here that can come in well below those current price points and have a systemic effect.

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. 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. We have a lot of push in the U.K. to make this drug available to patients as soon as possible. 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 US. It's 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 (CEO)

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. These children, it's just heartbreaking to see. We cheer them on. 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's overlooked. A byproduct of all of the three approved products in the U.S. is an increase in itch. If you look at the label, it'll say itch. That's really part of the process of healing, right? The more healing you have, the itch. If you're going to itch, you're going to itch this cream off. You've got to cover it up. It's tremendously painful.

If you look at the list of the top complaints from RDEB patients, usually number one is itch, even before pain. It's been described to us as like being bitten by a mosquito 1,000x a day. It's just chronic itch. It should slot nicely with the competitors. Keep in mind, we're conscious on the margins of the product from day zero before we even started the trial.

Got it. Thank you for the color. 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 eyelids and stuff like that?

Mark Lowdell (CSO)

Yeah. 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 as a systemic disease, effectively. 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. We'll be getting those data, but I haven't seen them, so I'm unable to comment on them. When they come through, we will be sharing them.

David Moss (CEO)

Yeah. I'll just add from an anecdotal standpoint because it's a very good question. The patients in the trial could pretty much identify whether they're on drug or placebo. One of the patients, unbeknownst to us, ended up speaking to the BBC, and the BBC published an article about it. He talked about his massive improvement in quality of life, being able to do things he wasn't able to do before. This is something that we heard from some of the PIs as well. Visually, they saw an improvement in the quality of life of these children, and their wounds looked different to them as well. 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 Mission EB trial from CORDStrom.

Got it. Thank you.

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?

Yeah. Q1's a big timing period for us for XPro. We should have very clear clarity on an accelerated pathway, end of phase two 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 into Q4. Obviously, 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 should have some of the cytokine data and additional data around the Mission EB program towards the end of this year as well. A number of milestones before we run out of cash.

Understood. Thank you guys for taking our questions.

Thank you.

Operator (participant)

Thank you. This does conclude our Q&A session. I will now turn the call back to David for closing remarks.

David Moss (CEO)

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 and Alzheimer's disease and in other diseases. Meanwhile, we're very optimistic about filing an MAA and BLA in CORDStrom 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 (participant)

Thank you. This does conclude today's program. Thank you for your participation. You may disconnect at any time.