INmune Bio Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: New CEO highlighted that the Phase 2 MINDFUL trial of EXPAREL confirmed Alzheimer’s patients with two or more inflammation biomarkers as the optimal group, showing effect sizes comparable to approved therapies and no ARIA safety events.
  • Neutral Sentiment: Management is exploring strategic partnerships for EXPAREL after the end-of-Phase 2 FDA meeting and peer-review publication, but no agreements are currently in place.
  • Positive Sentiment: Cordstrom is on track for UK and US submissions by mid-2026, may qualify for a Priority Review Voucher, and has potential to expand beyond RDEB into other epidermolysis bullosa indications.
  • Neutral Sentiment: InKmune’s Phase 1/2 data confirmed safety and immune activation in advanced patients, prompting plans to test earlier-stage disease trials where residual tumor burden may yield greater benefit.
  • Negative Sentiment: Second-quarter net loss widened to $24.5 million, driven by a $16.5 million impairment of EXPAREL’s intangible asset, though cash runway extends into 2026.
AI Generated. May Contain Errors.
Earnings Conference Call
INmune Bio Q2 2025
00:00 / 00:00

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Operator

Greetings, and welcome to the Immune Bio Second Quarter twenty twenty five Earnings Call.

Operator

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 a question at any time by pressing star one on your touchtone phone. You may withdraw yourself in the queue by pressing star 2. As a reminder, this conference is being recorded.

Operator

A transcript will follow within twenty four hours of this conference call. At this time, it is my pleasure to introduce Mr. Daniel Carlson, Head of Investor Relations at Immune Bio. Daniel?

Daniel Carlson
Daniel Carlson
Head - IR at INmune Bio

Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for Immune Bio's second quarter twenty twenty five financial results. Presenting on today's call are David Moss, Co Founder and CEO Doctor. CJ Barnum, Head of Neuroscience and Doctor. Mark Lodell, Chief Scientific Officer and Co Founder of Immune Bio.

Daniel Carlson
Daniel Carlson
Head - IR at 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.

Daniel Carlson
Daniel Carlson
Head - IR at INmune Bio

Except as required by law, Immune 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 Moss
David Moss
President, CEO & Director at INmune Bio

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 Immu Bio. I've had the pleasure to meet many of shareholders over the years and as many of you know, I'm very excited with the opportunity with ImmuBio's three 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 Tessi, who has retired and resigned as President and CEO, Chief Medical Officer, Chairman of the Board, and Co Founder of Immune Bio. Along with Mark, myself, and the team at Immune Bio, we acknowledge that RJ has been a driving force behind Immune Bio and his leadership has positioned us for the opportunities we're discussing today.

David Moss
David Moss
President, CEO & Director at INmune Bio

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 EXPAREL and the results from our phase two MINDFUL trial. The trial was designed to define the patient population for registration trial and I'm pleased to report that the data confirms that patients with Alzheimer's disease who exhibit two 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 EXPAREL would benefit patients with the most inflammation, especially in a short trial.

David Moss
David Moss
President, CEO & Director at INmune Bio

As CJ will speak about in more detail shortly, I want to emphasize something that I think is really important about phase two studies, is that the purpose of phase two trial to inform design of a phase three 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 that compromises somewhere between forty percent to sixty percent 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 EXPAREL 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.

David Moss
David Moss
President, CEO & Director at INmune Bio

Big pharma routinely take on programs at this stage and we believe XCRO could be transformative in addition and 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 numbers 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 as 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 EXPAREL to market faster with more efficient use of resources.

David Moss
David Moss
President, CEO & Director at INmune Bio

We'll provide updates on these efforts in the future. Our immediate next steps for EXPAREL and AD include publishing the trial results in a peer reviewed journal and preparing a briefing book for end of phase two meeting with the FDA, which we expect to occur before year's end. While ID 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.

David Moss
David Moss
President, CEO & Director at INmune Bio

We are reevaluating the best opportunity for EXPAREL 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 to this program and our focus is clear. Securing approval in The UK and US for recessive dystrophic epidermolysis bullosa or RDEB. We anticipate filing for approval in both jurisdictions by mid year twenty twenty six.

David Moss
David Moss
President, CEO & Director at INmune Bio

Importantly for us, we believe that Congress is likely to pass the Give the Kids a Chance Act that 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 US. Critically or clinically, we believe Korstrum has shown tremendous promise and its potential extends beyond RDEB to other forms of EB. We also see additional opportunities for Korstrum to expand to other indications. Depending on available capital, we'll aim to develop these opportunities internally with non dilutive funding or partnerships to ensure we fully realize Corstrom's value.

David Moss
David Moss
President, CEO & Director at INmune Bio

Finally, I'd like to touch on Inkmune. Our phase onetwo program is near completion and as Mark will detail shortly, the data demonstrate that InkBune is safe and delivers immunologic benefits. Like many immunotherapies, zinc checkpoint inhibitors, Herceptin, etcetera, InkView 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 the immune's potential.

David Moss
David Moss
President, CEO & Director at INmune Bio

Before I turn this call over to the rest of the team, I'd like to thank all of our investors for 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 and to describe the opportunities in front of us, I'll now hand it over to CJ to dive deeper into the X Pro data.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

CJ. Thank you, David, and good afternoon everyone. I am pleased to share the latest updates on our EXPAREL program, a novel approach that continues to show promise as a potential treatment for Alzheimer's disease. Our Phase two clinical trial has marked an important milestone in EXPAREL'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.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

These patients are identified by the presence of at least two inflammatory biomarkers at baseline. In this subgroup we observed an effect size of 0.27 on the primary endpoint EMAC 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 EXPAREL 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 pTau217 and GFAP suggest that EXPAREL is effectively targeting underlying neurodegenerative processes in alignment with its anti inflammatory mechanism.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

These findings underscore the potential of EXPAREL 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 three. 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 emphasized a clear actionable path forward. The feedback we received highlights that Partner CXPRO is a unique and compelling opportunity in Alzheimer's treatment, extending beyond cognitive benefits to address critical areas of behavior and safety.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

Its targeted effectiveness in patients with eye inflammation reinforces the hypothesis that EXPAREL 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 EXPAREL 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 EXPAREL as a safer and potentially complementary option for combination therapies. With its unique blend of targeted efficacy, behavioral benefits and unmatched safety, EXPAREL stands out as an innovative and broadly appealing option in Alzheimer's treatment.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

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.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

We initially expected that one inflammatory biomarker would be sufficient to show decline over six 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 six months is not enough time to observe potential functional benefits of EXPAREL in this cohort.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

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 two trial MINDFUL has successfully achieved that objective. Looking ahead, we're preparing to apply for breakthrough therapy designation with the FDA, which could expedite EXPAREL's path forward.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

We are also planning an end of Phase two meeting with the FDA to align on the design of our Phase three 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 EXPAREL to patients as quickly as possible. We are deeply encouraged by these results and remain steadfast in our commitment to advancing EXPAREL as a novel, safe and effective therapy for Alzheimer's disease. I look forward to sharing further updates as we progress towards Phase three and work to make a meaningful difference for patients and their families.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

Now I'll hand the call over to Mark to discuss our other platforms.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

Thanks, CJ, and good afternoon, everyone. Thanks for joining the call. So as David said, CHORDstrom is showing great promise in the randomized controlled trial in RDEB, but its potential extends way beyond RDEB to other forms of epidermoid spulosa and indeed other conditions and indications, as David alluded. First, have to remember that the orphan drug designation we received last year was awarded for all forms of epidermoid spilosa, not just IDEP, 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 well placed to treat a much wider group of adult and indeed pediatric AB sufferers, and we are 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 four individual umbilical cord MSC products.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

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 four 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 four 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 are investigating many other potential indications, and will consider genetic modification of cords from products to deliver specific proteins, such as the collagen seven protein and gene which is missing in patients with RDEB.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

Depending on available capital, we aim to develop these opportunities internally or through strategic partnerships to ensure we fully realize Quadstrom's value. As a company, we are keenly focused on preparing the market authorization application for The UK and the biologics license application for The US by mid-twenty twenty six, 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 UK 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 one aspect of our phase one, phase two CARE PC trial in metastatic prostate cancer, having met the primary safety endpoint.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

Importantly, this didn't only confirm safety of INKVIEN at three 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 two trial stage of the trial in February and started to receive the blinded patient blood monitoring samples from the phase one patients. It became apparent very rapidly that some patients were responding to InkVuen as predicted, with increased number 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.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

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 two trials 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 pre existing adequate NK function, which is contrary to what we saw in hematology patients with lymphoma and leukemia. These data allowed us to confirm that two 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 three patients treated at the low dose, six at the intermediate dose, and five at the highest dose level, and to close the trial after follow-up of the current patient who is on treatment.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

In general, immunotherapies are best to target minimal residual disease that's been well known for over thirty years, and that has been our intention with Immune since its conception. 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 Inkmium platforms, and I'd like to turn the call back over to David. David?

David Moss
David Moss
President, CEO & Director at INmune Bio

Yeah. Thank you, Mark and CJ. Some of you may know Corey Elsperman, who has been with the company for many years now. He's been a key person of finance and accounting and has recently been appointed interim CFO for Inmune. Corey and I have worked together almost since the start of Immune when he was a consultant, and I can tell you, not only do we work incredibly well together, but he is more than capable to take a strong leadership role as interim CEO.

David Moss
David Moss
President, CEO & Director at INmune Bio

I have full confidence and support in Corey and his ability to help take Immune forward. Now let me move on to the financials. Net loss attributable to common stockholders for the quarter ended 06/30/2025 was approximately $24,500,000 compared with approximately $9,700,000 for the comparable period in 'twenty four. Research and development expense totaled approximately $5,800,000 for the quarter ended June '5, compared with approximately $7,100,000 for the comparable period in 2024. General and administrative expenses were approximately $2,300,000 for the quarter ended 06/30/2025 compared with approximately 2,800,000.0 for the comparable period in 2024.

David Moss
David Moss
President, CEO & Director at INmune Bio

Impairment of acquired in process research and development intangible assets was 16,500,000.0 compared with zero during the comparable period in 2024. Following the release of phase two, mindful data, the company has decided to take a very conservative approach and to halt immediate plans to further develop EXPAREL and ED at this time given the cost of a phase three program as it seeks partnerships. Since we can't guarantee a partnership, we thus took the conservative approach and wrote off the value of EXPAREL's intangible asset value. As of 06/30/2025, the company had cash and cash equivalents of approximately $33,400,000 Based on our current operating plan, we believe our cash is sufficient to fund operations into 2026. As of 08/07/2025, the company had approximately 26,600,000.0 shares of common stock outstanding.

David Moss
David Moss
President, CEO & Director at INmune Bio

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 two meeting with the FDA to take place sometime in Q4 of this year. As Mark had mentioned, the company is working vigorously on authorization application and the Biologics licensing application to file by midyear or earlier 2026.

David Moss
David Moss
President, CEO & Director at INmune Bio

In addition, the company expects to have additional Cordstrom data to hopefully share in q four, as Mark had mentioned earlier. In closing, I want to emphasize that Immune Bio is at a pivotal moment. With Cordstrom, Xpro and InCommunion, we have a robust pipeline with 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 prior to review voucher program through bills like the Create Hope Authorization Act of 2024 position us to capitalize on significant market opportunities. We are committed to executing our strategy with discipline, exploring strategic partnerships to help fuel our growth and complete trials, and deliver therapies that have the potential to transform lives.

David Moss
David Moss
President, CEO & Director at INmune Bio

Your support of 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

Thank you. At this time, we will open the floor for questions. We'll take our first question from Gary Nachman with Raymond James.

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

Hey guys, this is Dennis Resnick on for Gary Nachman. Congrats on the new role David and thanks for taking our questions. So first you had mentioned that you plan to conduct the end of Phase two meeting with the FDA in the fourth quarter of EXPAREL. 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 at the agency?

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

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 Moss
David Moss
President, CEO & Director at INmune Bio

No, I appreciate that. I'll answer the first question and then I'll let CJ talk about AAIC. We have not yet filed the 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, think there's a sixty day window before you hear about the date.

David Moss
David Moss
President, CEO & Director at INmune Bio

It should fall sometime November, December if we get it in on our target date. So that's with regards to the end of phase two meeting to the FDA. Sige, you wanna discuss the mood at AAIC?

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

Thanks. So some that I addressed in script, but to add a little more color to it, I have to say it was even more promising, the feedback, than that I expected. I think one of the interesting things about it is as we walked through the data, you could see, you know, the the clinicians and the experts in the field sort of, you know, nodding their head as well. Yeah. This is the logical step.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

Yes. That makes sense. That's how you would proceed. And, you know, we really didn't get too many questions about the science per se because it was at least based on the feedback, was pretty obvious that this is the appropriate subgroup, it aligns with your hypothesis, these are the endpoints that are expected to change. So I think that was really good.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

I think one of the things I was perhaps maybe a little surprised about was the real interest in the neuropsychiatric inventory and the potential there. So for those of you that aren't familiar, the behavioral changes that occur in Alzheimer's patients are really quite debilitating and as the disease progresses, it's one of those things that really brings patients to the physicians often certainly not the cognitive decline after a certain period of time. And it's quite distressing to both patients and caregivers, not to mention the physicians. So to have another option with a differentiated mechanism that can treat the neuropsychiatric symptoms really provides in some ways a separate avenue, but for it to be also promising as disease modifying therapy I think people are really responding to and then of course as it relates to the lack of ARIA despite the fact that most of our patients had high risk factors associated for developing ARIA, I think that's something that the field is really looking for, especially because combination therapies are where we're going and when you start thinking about putting two therapies together especially those that potentially have safety signals associated with ARIA, it really makes it stifles that quite a bit.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

So I think that was those three things were really well received by by the community and and, know, they understand that, you know, the results are appropriate for a phase two study and it's sort of what you would expect and it provides a clear path forward and that's really what we're looking for at this stage of development. At least that's what the scientific community is looking for and so yeah, really great feedback all around.

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

That was great color. Thank you so much. 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 two meeting before signing the partnership? Or could we see a partnership announced before then? Thanks so much, guys.

David Moss
David Moss
President, CEO & Director at INmune Bio

No. I mean, look, that's a very detailed question and smart of you to ask. I don't expect the partnership to occur until after we've had an if there is going to be one that occurs, until after we've had the end of phase two meeting with the FDA. Think that's a critical component. I think the the partners are gonna wanna see the publication.

David Moss
David Moss
President, CEO & Director at INmune Bio

They're gonna wanna dig into the data, and they're gonna wanna see what the FDA thinks. Now, keep in mind that depending on who you partner with, most partners are gonna have their own regulatory view on how they want to push this through the regulatory process. Then that could have geographic input as well. But I don't I don't suspect that a partnership for X Pro is anytime in the short period of time, it's gonna be more of a long term type approach, most likely leading into next year or the first half of next year if it occurs at all. What do we want out of a partnership?

David Moss
David Moss
President, CEO & Director at INmune Bio

You know, we believe that EXPAREL can address a major population in Alzheimer's disease with a therapy that's never been addressed before, which is neuroinflammation. If you think about the trial that we ran, it really was an incredibly novel trial. It's something that no one has ever done before and it's really amongst the first to truly address neuroinflammation. I mean, if you think about it, we've always said that the higher levels of neuroinflammation you have, the faster you're declined. And that showed with whether you had one or two biomarkers, right?

David Moss
David Moss
President, CEO & Director at INmune Bio

We kinda confirmed that in this trial. So my belief is that I think everybody knows that there's more and more research coming out about neuroinflammation and neurodegenerative disease and specifically Alzheimer's. I think that we've got a tremendous amount of data from this phase two program. And the partner we're gonna look for is the one that's gonna help us get it be able to help finance a registration trial to get this to approval. How that's structured financially, I couldn't tell you at this point. That's a negotiation to be had.

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

Thanks for the color guys.

Operator

Thank you. We'll take our next question from Tom Schrader with BTIG.

Analyst

Hi, this is Jenny Kim on for Tom Schrader. Thank you for taking my question. I wanted to ask about the biomarkers of your trial, particularly in the EMAC. Knowing what you do now, would there be any refinements you would make to measure this marker? And for the behavioral marker, NPI, from registrational point of view, has it been used before in trials or in conversations with the FDA? Thank you.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

You cut out a little bit. Yeah, you cut out a little bit. So I think I understand. And just to clarify if if I don't have this right. So you're asking about the the the EMAC is a biomarker or are you referring to the the the true blood biomarkers in relation to EMAC?

Analyst

EMAC as a marker in general.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

Yes. Okay. So good question. So is the question regarding how we see that as it relates to the FDA or how we would interface two based on the EMAK. Did I have that right?

Analyst

Yes.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

So, okay, sorry. I'm glad we got it clarified. So I think from a performance perspective, the EMAC did what it was supposed to do in the sense that it captured change that it was sensitive to capture change in these patients. We could see in the placebo group that you know, that also means that you don't get as much decline. So it performed as it expected in the right patient population, the patients that had high enough information did decline.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

And so from the pure performance perspective, were very happy with the performance of the EMAC. 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 gonna have a favorable opinion on the EMAC. Now they do have some things in the guidance and one of them is that I think is is less clear, somewhat vague is 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 four companies that have used or are using EMAC, 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 EMAC are at the point of publishing a couple papers on it. So I think the EMAC is gonna be well received, You know, it remains, you know, it remains to be seen what the decision will be. But I I feel pretty confident. Does that address the question? I'm sorry. I didn't get that at all.

David Moss
David Moss
President, CEO & Director at INmune Bio

Yeah. That quest that question cut out quite a bit, CJ. I think she's talking about NPI.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

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

David Moss
David Moss
President, CEO & Director at INmune Bio

Yeah. No. I she's cutting out. I think we're going to have to go to the next question. But I think she was asking something about NPI.

Operator

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

James Molloy
MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners

Hey guys, thank you for taking my question. I couldn't hear that question on this end either. On the part, guess it's probably safe to assume that potential partnership there isn't no one's in the data room yet. It'll be a post end of Phase two meeting. And then should we anticipate 2627 potential partnership again assuming things go well at the end of Phase two with the EMAC endpoint and all that?

David Moss
David Moss
President, CEO & Director at INmune Bio

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

Operator

Thank you. We'll go ahead. Then any other comment

David Moss
David Moss
President, CEO & Director at INmune Bio

Sorry. Sorry.

James Molloy
MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners

Any comments from the experts on the EMAC endpoint as well and that's sort of their thoughts?

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

So so I don't think we've had any detailed discussions about EMAC 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 that AIC around EMAC as a a valid endpoint was really had with the 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 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 of, I would say, in-depth conversation with with partners.

Christopher Barnum
Christopher Barnum
VP - Neuroscience at INmune Bio

But I will say we didn't get pushed back. So I think that in and of itself is a is a good sign.

James Molloy
MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners

Okay. Great. Thank you for taking the questions and best to RJ in his retirement.

David Moss
David Moss
President, CEO & Director at INmune Bio

Thank you so much.

Operator

Thank you. We'll take our next question from Boris Tokovchev with Freedom Broker.

Boris Tolkachev
Boris Tolkachev
Analyst at Freedom

Good afternoon, and thanks for taking my questions. I'd like to switch gears a bit to Kordstrom. First, regarding the ongoing preparations for the BLA submission. As I understood from the press release, the clinical data 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 everything's ready for submission?

Boris Tolkachev
Boris Tolkachev
Analyst at Freedom

And additionally, could you elaborate a bit on the details of planned open label post BLA trial of Cordstrom? So is there any intention to eventually include the results of this trial in the BLA package? Thank you.

David Moss
David Moss
President, CEO & Director at INmune Bio

Good question, Boris. Mark?

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

Yes. Thanks very much, Boris. So first off, the statistical analysis plan that was designed by the sponsor of crossover trial wasn't really adequate for true detailed analysis of the patient populations. We've looked at that statistical analysis plan and identified great improvements and I do believe that the plan we put together with Feramed, the independent consultants, is likely to identify significantly improved data that will help our submission both for MAA and BLA. I can't be certain of that because I haven't seen the data there they're blinded to us but I think the analysis plan we put together is certainly likely to come up with a more intuitive analysis of data and stronger data to present to the regulators.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

In terms of the open label, plan is from our discussions with both the formal discussions with the FDA and informal discussions with the MHRA, we believe that we have data that are adequate from the crossover trial. Bear in mind that this is the first ever fully randomized controlled crossover placebo controlled trial on multi center site done in this patient group anywhere in the world and it's done in the two largest centers in Europe for RDEB, pediatric RDEB. So the data really can't be improved upon in terms of patient number. What we expect to do after we've submitted our MAA and BLA applications, is to go to look at the open label. The trial protocol is still under negotiation.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

In fact, I was discussing it with the clinical leads today, looking at that open label, and we will move forward probably early twenty twenty seven to make certain that, those data start to be acquired after we've submitted the BLA submissions. Does that answer your question?

Boris Tolkachev
Boris Tolkachev
Analyst at Freedom

Yes. Thank you so much. I appreciate the answers. Thank you.

Mark Lowdell
Mark Lowdell
Chief Scientific Officer & Chief Manufacturing Officer at INmune Bio

No, thank you, David.

Operator

Thank you. 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 Moss
David Moss
President, CEO & Director at INmune Bio

Thank you, Stephanie, and, thank you everyone for joining us. EMU 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

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

Executives
    • Daniel Carlson
      Daniel Carlson
      Head - IR
    • David Moss
      David Moss
      President, CEO & Director
    • Christopher Barnum
      Christopher Barnum
      VP - Neuroscience
    • Mark Lowdell
      Mark Lowdell
      Chief Scientific Officer & Chief Manufacturing Officer
Analysts
    • Denis Reznik
      Senior Equity Research Associate at Raymond James
    • Analyst
    • James Molloy
      MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners
    • Boris Tolkachev
      Analyst at Freedom
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