Earnings Call Transcript - INMB Q2 2025

Operator, Operator

Greetings, and welcome to the INmune Bio Second Quarter 2025 Earnings Call. 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?

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 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?

David J. Moss, CEO

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 about 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 a Phase II trial, which is to inform the design of a Phase III program, of which clear identification of the target population is critical. These findings reinforce our hypothesis that XPro is uniquely suited to address Alzheimer's disease patients with elevated inflammation levels, a group we estimate comprises somewhere between 40% to 60% of all Alzheimer's cases. We believe strongly that we have a potential first-in-class drug to treat Alzheimer's that is unique and differentiated from current treatments. We believe the XPro program represents a significant opportunity for a strategic partner. Advancing to the next phase will require substantial investment in manufacturing and clinical trials, but we believe the potential is massive. Big pharma routinely takes on programs at this stage, and we believe XPro could be a transformative addition to their pipelines, addressing a critical unmet need in Alzheimer's disease. While we have not yet entered into any strategic partnerships, we have begun exploring potential opportunities and have held preliminary conversations with a limited number of parties. XPro is a unique drug that has potential multi-targeted therapeutic applications that could be very meaningful to the right partner and our shareholders, and we intend to prudently pursue these avenues while also being creative to advance them on our own with limited resources. Beyond Alzheimer's, XPro has a multi-targeted drug with broad potential. We are actively exploring the shorter, faster pathways to market, including opportunities potentially in rare disease, to maximize its impact and accelerate patient access. Targeting the rare disease pathway would enable us to bring XPro to market faster with a more efficient use of resources. We'll provide updates on these efforts in the future. Our immediate next steps for XPro and AD include publishing the trial results in a peer-reviewed journal and preparing a briefing book for our end of Phase II meeting with the FDA, which we expect to occur before year's end. While AD trials are inherently challenging, the data from this study underscores XPro's potential as a best-in-class treatment for Alzheimer's patients with inflammation. This is a significant development for patients, families, and our shareholders, and we're committed to charting the best path forward with XPro. Before I move to CORDStrom, I want to highlight that the company has made the decision to not pursue treatment-resistant depression at this time. We are reevaluating the best opportunity for XPro beyond AD that combines efficiencies with cost and shortest timeline to approval for targeted diseases where TNF plays a vital role. These likely include rare diseases, as I mentioned earlier. Now turning to CORDStrom. We believe there is tremendous underappreciated value in this program, and our focus is clear; securing approval in the U.K. and U.S. for Recessive Dystrophic Epidermolysis Bullosa or RDEB. We anticipate filing for approval in both jurisdictions by midyear 2026. Importantly for us, we believe that Congress is likely to pass the Give Kids a Chance Act, which would extend the PRV voucher or the Priority Review Voucher program through 2029. We believe that CORDStrom will qualify for a PRV if approved in the U.S. Critically or clinically, we believe CORDStrom has shown tremendous promise and its potential extends beyond RDEB to other forms of EB. We also see additional opportunities for CORDStrom to expand to other indications. Depending on available capital, we'll aim to develop these opportunities internally with nondilutive funding or partnerships to ensure we fully realize CORDStrom's value. Finally, I'd like to touch on INKmune. Our Phase I/II program is near completion. And as Mark will detail shortly, the data demonstrate that INKmune is safe and delivers immunologic benefits. Like many immunotherapies, think checkpoint inhibitors, Herceptin, etc., INKmune is most effective when administered earlier in the disease course, targeting residual disease rather than late-stage metastatic disease with heavy tumor burden. Immunotherapies require time and multiple doses to achieve their full effect. With this in mind, we plan to explore a trial focused on earlier-stage disease to optimize INKmune's potential. Before I turn this call over to the rest of the team, I'd like to thank all of our investors for your continued support. It's an honor to take over the role of CEO and I'm confident in our path forward and excited about the opportunities ahead. We have a tremendous team of people and exciting clinical programs, and the opportunities in front of us. I'll now hand it over to CJ to dive deeper into the XPro data. CJ?

Christopher Barnum, Head of Neuroscience

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, extending beyond cognitive benefits to address critical areas of behavior and safety. Its targeted effectiveness in patients with high inflammation reinforces the hypothesis that XPro delivers the greatest impact within this subgroup, providing meaningful benefits to those who need it most. Furthermore, improvements in the neuropsychiatric inventory scores demonstrate its ability to reduce behavioral symptoms, issues that often weigh more heavily on caregivers than cognitive decline. This positions XPro as a comprehensive solution for Alzheimer's care. Perhaps most importantly, the complete absence of amyloid-related imaging abnormalities or ARIA, even in high-risk patients underscores its exceptional safety profile, distinguishing XPro as a safer and potentially complementary option for combination therapies. With its unique blend of targeted efficacy, behavioral benefits, and unmatched safety, XPro stands out as an innovative and broadly appealing option in Alzheimer's treatment. We're excited to further explore these opportunities. Some investors have raised questions about why we missed the primary endpoint in the overall population. The explanation is straightforward. The placebo group did not decline. It is impossible to test a drug's ability to slow, stop or reverse disease progression if the comparison group remains stable. We initially expected that one inflammatory biomarker would be sufficient to show decline over 6 months. This was not the case. In this cohort, a higher inflammatory burden was necessary. This is part of the learning process. Additionally, our data revealed that 6 months is not enough time to observe potential functional benefits of XPro in this cohort. While this is unfortunate, it's not entirely unexpected as functional improvement often lags behind cognitive improvements and can require longer trials to demonstrate meaningful differences. This too, is part of the learning process and underscores why clinical development progresses through multiple phases. Each phase builds on the previous one, providing the critical information needed to advance. Our Phase II trial, MINDFuL has successfully achieved that objective. Looking ahead, we're preparing to apply for breakthrough therapy designation with the FDA, which could expedite XPro's path forward. We are also planning an end of Phase II meeting with the FDA to align on the design of our Phase III trial. Additionally, we are actively exploring strategic partnerships to support the program's continued advancement. These steps are essential to maintaining our momentum and bringing XPro to patients as quickly as possible. We are deeply encouraged by these results and remain steadfast in our commitment to advancing XPro as a novel, safe and effective therapy for Alzheimer's disease. I look forward to sharing further updates as we progress towards Phase III and work to make a meaningful difference for patients and their families. Now I'll hand the call over to Mark to discuss our other platforms.

Mark William Lowdell, Chief Scientific Officer

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 on available capital, we aim to develop these opportunities internally or through strategic partnerships to ensure we fully realize CORDStrom's value. As a company, we're keenly focused on preparing the market authorization application for the U.K. and the biologics license application for the U.S. by mid-2026, as David said. Now we understand the aggressiveness of these timelines, and I'll not bore you with all of the details required to meet these goals, but I would like to thank our team in the U.K. for working so hard to keep these timelines and remain confident that the external third parties who we have to work with and who are critical to this will also remain on track to allow us to meet this timeline. On the other side, with regards to INKmune, we've continued to develop the manufacturing data to support commercial development and make it the least expensive cellular drug in the field of oncology. In Q1 this year, we closed the Phase I aspect of our Phase I, Phase II CaRe PC trial in metastatic prostate cancer, having met the primary safety endpoint. Importantly, this didn't only confirm the safety of INKmune at 3 dose levels, but it also demonstrated the ease with which it could be delivered to patients in a day clinic setting without hospitalization overnight. This is unique in the field of a cellular oncology drug. We moved into the Phase II trial stage of the trial in February and started to receive the blinded patient blood monitoring samples from the Phase I patients. It became apparent very rapidly that some patients were responding to INKmune as predicted with increased numbers of NK cells in their circulation and in vivo stimulation of memory-like function. Independent analysis of the PSMA PET scans, which is the assay we've chosen to measure disease burden, showed that despite worsening disease in all of these heavily pretreated and advanced-stage patients, some individual lesions had reduced in size and others appeared to resolve completely. I was fortunate to present these data at the Innate Killer Summit in San Diego in March and got a lot of very interesting feedback and intrigue from the field. The Phase II trial enrolled patients through Q2 at both intermediate and high doses. Again, analysis of blood samples confirmed the effect of INKmune on increasing NK cell numbers and activation. And crucially, it became apparent that these effects are limited to patients who started with impaired NK function at the time of enrollment. In other words, in this patient group, INKmune only improved dysfunctional NK immunity and did not supercharge NK cells in patients with preexisting adequate NK function. This is contrary to what we saw in the hematology patients with lymphoma and leukemia. These data allow us to confirm that 2 of the most important secondary biomarker endpoints have been met. First, the increased NK cell count following treatment, and second, the increased NK cell function. There was no significant impact on disease burden as measured by PSMA PET. So we decided last month to close the trial to recruitment with 3 patients treated at the low dose, 6 at the intermediate dose, and 5 at the highest dose level and to close the trial after follow-up of the current patient who is on treatment. In general, immunotherapies are best to target minimal residual disease. That's been well-known for over 30 years, and that has been our intention with INKmune since its inception. These data showing safety and in vivo NK cell priming potency allow us to move forward in planning a trial in a less advanced patient group, either alone or with suitable partners. So that ends my update on the CORDStrom and the INKmune platforms, and I'd like to turn the call back over to David. David?

David J. Moss, CEO

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 in 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 CFO. 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, we believe our cash is sufficient to fund operations into Q3 of 2026. As of August 7, 2025, the company had approximately 26.6 million shares of common stock outstanding. Now let me move and talk about some key upcoming milestones. We expect to have the manuscript and the peer-reviewed publication filed on the MINDFuL trial sometime this month and it should be available to the public as well. We expect to have the end of Phase II meeting with the FDA to take place sometime in Q4 of this year. As Mark had mentioned, the company is working vigorously on the CORDStrom marketing authorization application and the biologics licensing application to file by midyear or earlier in 2026. In addition, the company expects to have additional CORDStrom data to hopefully share in Q4, as Mark had mentioned earlier. In closing, I want to emphasize that INmune Bio is at a pivotal moment. With CORDStrom, XPro, and INKmune, we have a robust pipeline with a clear path to potential value creation. The recent progress in our programs, combined with the opportunities like the potential extension of the Rare Pediatric Disease Priority Review Voucher Program through bills like the Create Hope Authorization Act of 2024, positions us to capitalize on significant market opportunities. We are committed to executing our strategy with discipline, exploring strategic partnerships to help fuel our growth, complete trials, and deliver therapies that have the potential to transform lives. Your support as shareholders is critical to our success, and I'm confident that together we can achieve great things. Stephanie, at this point, I'd like to turn it over to you to poll for questions.

Operator, Operator

We'll take our first question from Gary Nachman with Raymond James.

Denis Reznik, Analyst

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.

David J. Moss, CEO

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 in November or 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?

Christopher Barnum, Head of Neuroscience

I addressed some of that in the script, but to elaborate, the feedback was even more positive than I expected. As we reviewed the data, I noticed that the clinicians and experts were agreeing with the approach, acknowledging that it made sense and was a logical progression. We didn’t receive many questions about the science because it was clear from the feedback that this is the right subgroup and that it aligns with our hypothesis. The expected endpoints were also identified, which was encouraging. I was somewhat surprised by the strong interest in the neuropsychiatric inventory and its potential. For those unfamiliar, the behavioral changes in Alzheimer's patients can be quite debilitating and often lead them to seek medical attention more so than cognitive decline after a certain point. This is distressing for patients, caregivers, and physicians alike. Having a differentiated mechanism to address neuropsychiatric symptoms offers a new option and shows promise as a disease-modifying therapy, which has resonated well with stakeholders. Additionally, the absence of ARIA, even among patients with high-risk factors, is something the field is keen on, especially as we move towards combination therapies that may have safety signals linked to ARIA. These three aspects were well received by the community, which recognizes that the results are fitting for a Phase II study and provide a clear path forward—exactly what we're aiming for at this stage of development, and what the scientific community seeks. The feedback has been very positive overall.

Denis Reznik, Analyst

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?

David J. Moss, CEO

No, I don't expect the partnership to occur until after we've had the end of Phase II meeting with the FDA, if a partnership happens at all. This meeting is crucial, as partners will want to see the publication, examine the data, and understand the FDA's perspective. Depending on the partner, they may also have their own regulatory views regarding the process, which could vary by region. Therefore, I don't anticipate a partnership for XPro in the short term; it's likely to be a long-term approach, possibly leading into next year or the first half of next year, if it happens. We aim for a partnership that will help address a significant population in Alzheimer's disease through a therapy focused on neuroinflammation, an area that hasn't been explored before. The trial we conducted was quite innovative and one of the first to focus on neuroinflammation. We've always stated that higher levels of neuroinflammation correlate with a faster decline, a finding echoed in our trial regardless of the number of biomarkers. There's increasing research linking neuroinflammation to neurodegenerative diseases like Alzheimer's. We have extensive data from the Phase II program, and we're looking for a partner who can assist us financially in conducting a registration trial to achieve approval. The financial structure of such a partnership is still to be determined and will be subject to negotiation.

Operator, Operator

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

Jenny Shen, Analyst

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?

Christopher Barnum, Head of Neuroscience

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 two blood biomarkers in relation to EMACC?

Jenny Shen, Analyst

EMACC as a marker in general.

Christopher Barnum, Head of Neuroscience

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 EMACC, did I have that right?

Jenny Shen, Analyst

Yes.

Christopher Barnum, Head of Neuroscience

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 a 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?

Jenny Shen, Analyst

Yes.

David J. Moss, CEO

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

Operator, Operator

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

James Francis Molloy, Analyst

I couldn't hear the question on this end either. I suppose it's safe to assume that regarding a potential partnership, no one is in the data room yet. It will be after the end of Phase II meeting. Should we expect a partnership in '26 or '27, assuming things go well at the end of Phase II with the EMACC endpoint and everything?

Christopher Barnum, Head of Neuroscience

Yes, I think that's fair to assume, Gary.

James Francis Molloy, Analyst

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

Christopher Barnum, Head of Neuroscience

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.

James Francis Molloy, Analyst

Best to RJ in his retirement.

Raymond Joseph Tesi, Analyst

Thank you so much.

Operator, Operator

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

Boris Tolkachev, Analyst

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 the 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?

David J. Moss, CEO

Good question, Boris. Mark?

Mark William Lowdell, Chief Scientific Officer

Yes, thank you, Boris. To start, the statistical analysis plan created by the sponsor of the crossover trial was not sufficient for a thorough analysis of the patient populations. We have reviewed that plan and found significant improvements. I believe that the plan we developed in collaboration with Veramed, the independent consultants, should yield substantially better data to support our submissions for both the MAA and BLA. While I can't confirm this since we have not seen the blinded data, I am confident that our analysis plan will provide a more intuitive review of the data and offer stronger information for regulators. Regarding the open-label study, based on our discussions with the FDA and MHRA, we believe the data from the crossover trial is sufficient. It’s worth noting that this is the first fully randomized, controlled crossover placebo trial conducted in this patient group globally, specifically in the two largest pediatric RDEB centers in Europe. Thus, the patient numbers are robust. After we submit our MAA and BLA applications, we aim to focus on the open-label trial. The protocol for the trial is still under discussion; I spoke with the clinical leads about it today. We expect to proceed early in 2027 to ensure that we begin collecting data after the BLA submissions. Does that address your question?

Boris Tolkachev, Analyst

Yes.

Operator, Operator

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.

David J. Moss, CEO

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.

Operator, Operator

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