INmune Bio Q4 2025 Earnings Call - CORDStrom on track for U.K. MAA mid-2026, BLA targeted end-2026

Chloe, Conference Moderator: Greetings, and welcome to the INmune Bio’s 2025 fourth quarter and year-end 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 now my pleasure to introduce Mr. Daniel Carlson, Head of Investor Relations of INmune Bio. Daniel.

Daniel Carlson, Head of Investor Relations, INmune Bio: Thank you, Chloe, and good afternoon, everyone. We thank you for joining us on the call for INmune Bio’s 2025 fourth quarter and year-end 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. Christopher Barnum, Head of Neuroscience, INmune Bio, and Cory Ellspermann, Interim Chief Financial Officer, INmune Bio. Before we begin, I remind everyone that except for statements of historical fact, the statements made by management in 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 expressed in such forward-looking statements.

Please see the forward-looking statements disclaimer on the company’s earnings press release, as well as risk factors in the company’s SEC filings, including our most recent quarterly filings with the SEC. There is no assurance of any specific outcome. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made as the facts and circumstances underlying these forward-looking statements may change. Except as required by law, INmune Bio disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. It’s now my pleasure to turn the call over to INmune Bio CEO, David Moss.

David Moss, CEO and Co-founder, INmune Bio: Thank you, Dan, and good afternoon, everyone. Thank you for joining us for INmune Bio’s fourth quarter and full year 2025 earnings call. Today, I’ll begin with an overview of our progress and strategic priorities across the business. Mark will then provide an update on our CORDStrom platform with a focus on our RDEB program. CJ will follow with an update on XPro and our Alzheimer’s disease development efforts. Corey will then review our financial results. After that, I’ll return to highlight our key upcoming milestones before we open the call to questions. 2025 was a pivotal year for INmune Bio. We completed our MINDFuL Alzheimer’s trial, advanced CORDStrom towards registration, and continued to position each of our platform programs for the next stage of development.

As we move into 2026, our focus is very clear. Execute against the most important regulatory, clinical, and strategic milestones across the portfolio. Starting with CORDStrom, this remains our most advanced program and a major value driver for the company. We recently presented additional patient data that further reinforces the therapeutic profile of CORDStrom in recessive dystrophic epidermolysis bullosa or RDEB. These data showed clinically meaningful wound healing, reductions in itch, and improvements in quality of life, all with a favorable safety profile. Based on this progress, we’re in the final stages of preparing our regulatory submissions in both the U.K. and the United States, and we remain on track to file the MAA in the U.K. by the end of summer of 2026. As Mark will tell you shortly, CORDStrom has a clear batch-to-batch manufacturing consistency which makes the product reproducible, ensuring commercial grade uniformity.

Further, the clinical mechanism of action of CORDStrom for RDEB has been worked out along with the potency assays, which is an important step for regulators. The repeatable manufacturing reliability with the worked out MOA along with CMC readiness, safety, and clinical results is what gives us confidence in CORDStrom for RDEB. Importantly, we want to highlight that CORDStrom is not simply a single asset opportunity, but as a platform with broader potential. Beyond RDEB, we believe the biology underlying the program may support development in additional inflammatory and degenerative conditions, and over time, may also enable genetically modified applications in oncology and rare disease settings. Our immediate priority is to bring this therapy to patients with RDEB while also building the foundation for long-term platform expansion.

Personally, there is no greater mission in my career than delivering CORDStrom to the children and families living with RDEB. Behind every trial result is a story that I’ve read and a face that I’ve seen in the video shared by these incredibly brave families. These images serve as a constant reminder of why we do what we do. Our team is deeply motivated by the human element of this condition, and we are working with an absolute urgency to bring this therapy to patients who need it most. Furthering our mission to develop medicines to unmet needs, I now turn to XPro for Alzheimer’s disease. We believe this program is in the strongest position it has ever been. We completed MINDFuL, we’ve aligned with the FDA on the development path, and we’re now preparing for a phase III.

This alignment effectively creates a pre-approved blueprint for a partner to execute. CJ will give you the full picture shortly. On INmune Bio, we completed our phase II trial in metastatic castration-resistant prostate cancer ahead of schedule and under budget. The study met its primary endpoint and two of its three secondary endpoints. Mark will explain more on this later. Before I hand the call over, I want to thank patients and family who participated in the clinical studies, the investigators and trial sites who supported this work, and our employees for their continued commitment and execution throughout the years. I also want to thank our shareholders for their continued support. Our strategy of advancing multiple differentiated platforms in parallel continues to create meaningful opportunities for value creation.

We now have one platform approaching the regulatory stage, another with a completed phase II study and important translational data, and a third that has also generated encouraging clinical results. We believe 2026 will be an important year for INmune Bio as we work to advance CORDStrom towards approval, further clarifying the next steps for the phase II B trial for XPro, and continue to build the partnerships and resources we need to move our programs forward. With that, I’ll turn the call over to Mark Lowdell for an update on CORDStrom. Mark.

Dr. Mark Lowdell, Chief Scientific Officer and Co-founder, INmune Bio: Thank you, David, and thank you to everyone who’s joined the call today. Welcome. As David said, CORDStrom showed great promise in the randomized placebo-controlled trial in RDEB, but its potential extends way beyond RDEB to other forms of epidermolysis bullosa and indeed to other conditions and indications. CORDStrom remains truly revolutionary in the MSC field. Last year we reported on the fact that since it’s created from mesenchymal stromal cell banks from four or more pooled donors, it really has unrivaled stability and reproducibility as compared to all of the other mesenchymal stromal or stem cell products that are being developed or are on the market.

Moreover, what we found is that the pooling allows us to select the individual mesenchymal stromal cell donor seed stocks, and we can choose those that have the appropriate potency characteristic for each disease indication, which allows us to tailor the final product to target different disease indications and thus have different drugs. As you know, RDEB is our first disease indication, and over the past six months, we’ve been able to dissect the precise mechanisms of action of CORDStrom in RDEB. That’s pretty unique for a mesenchymal stromal cell product, where the diversity of the product means that working out quite how it delivers its effect is actually very challenging. But we now know that CORDStrom works by secreting an array of chemical messengers called cytokines, which are used by the body to control inflammation.

We know that RDEB is predominantly a disease of inflammation, and it’s driven by cells in the skin which are called type one macrophages or M1 cells. These M1 cells secrete inflammatory cytokines which drive the itch and lead to the scratching, which causes the skin wounds so prevalent in RDEB patients and which you’ll be familiar with. M1 cells in normal skin also induce itch when provoked, but in RDEB patients, the absence of the protein which binds the skin layers together means that the itch-scratch cycle causes those very severe lesions that are so famous. One of the cytokines secreted by CORDStrom drives the M1 cells in the skin to mature into an M2 non-inflammatory wound-healing cells. We all have these, and these M2 cells secrete a cytokine called IL-10, which switches off other immune cells driving the itch-inducing cytokines.

In parallel, the M2 cells also secrete other chemical messengers, cytokines, which enhance wound repair. When we looked at the serum samples from the patients who were treated with CORDStrom on the U.K. trial and compared those to those treated with placebo, the CORDStrom recipients all had in their blood cytokines that our mechanisms of action predicted. Those patients that had the highest concentration reported much less pain, less itch, and had better skin scores. They scored better in all measures of well-being and increased ability to eat. This is the first RDEB treatment to have such diverse whole body clinical benefits over and above those which we see from the skin treatments that are already licensed. The patients, their caregivers, and their doctors all want to continue to have access to CORDStrom.

As David said, we’re working tirelessly at present to submit the applications for marketing authorizations in the U.K., and then the European Union and finally the U.S. before the end of the year. We’re driving forward, so they’re all completed by the end of this year, and we hope to be supplying CORDStrom to RDEB patients in 2027. As I said earlier, the fact that CORDStrom is manufactured from a pool of four or more donor cell banks means that we can select the best donor cells for specific clinical indications. While we’re progressing with CORDStrom for RDEB and the marketing authorizations, my group of R&D scientists here in the U.K. are working on other broader indications, and we’re seeking business partnerships to develop those through clinical trials and bring those to market accordingly.

As a company, we’re laser-focused on preparing the marketing authorization application for the U.K. and then the EU and the Biologics License Application or BLA for the U.S. by the end of 2026. These are highly aggressive timelines, but so far we’ve met all of the deadlines that have been set, and I’m incredibly proud of our team in the U.K. for working so diligently to keep to these timelines, to remain on track, and to use all the resources that we have in the U.S. office to support them. I’m happy to take questions that you have, but meanwhile, I’ll hand over to CJ for the latest update on XPro. CJ, the floor is yours.

David Moss, CEO and Co-founder, INmune Bio: Thank you, Mark. I’ll give you an update on XPro and where we’re headed. MINDFuL was our phase II trial on Alzheimer’s disease. We designed it around a simple question.

David Moss, CEO and Co-founder, INmune Bio: If we pick patients who have both Alzheimer’s pathology and signs of inflammation in their body and we treat the inflammation, do they do better? What we saw was very encouraging. The results consistently favored XPro across clinical, behavioral, patient-reported, and blood and imaging biomarkers. The phase II identified what works, who it works for, and resolved the open questions so that phase III can be successful. These results directly informed how we designed the phase III program. We identified the patient population, those with both Alzheimer’s pathology and biomarkers of inflammation. Decades of Alzheimer’s research show that cognitive changes come first and functional changes follow with time. That’s why the phase III trial runs 18 months, long enough for the cognitive effects we saw at 6 months to show up on the functional measures the FDA requires for approval.

The program is built as an adaptive trial with two stages. Phase II-B gives us a decision point at nine months, a clear go or no-go before we commit to the full phase III investment. If the data hold, the trial continues seamlessly into the registrational stage with the CDR-SB, the same primary endpoint used to approve lecanemab and donanemab at 18 months. We presented this program to the FDA at the end-of-phase II meeting earlier this year. The agency reviewed our data, our enrichment strategy, and our trial design and aligned with our approach. We are now moving forward on several fronts. On the development side, we continue to analyze the MINDFuL dataset to fully understand the impact of XPro treatment.

At the same time, we are preparing the phase III program for initiation, which includes finalizing the protocol based on the FDA’s feedback and pursuing the partnerships and funding needed to execute it. There’s a lot of work ahead, but the foundation is solid. I’ll hand it back to David. I look forward to your questions. David.

David Moss, CEO and Co-founder, INmune Bio: Thanks, CJ. Before I hand the call to Cory to go through our financial results, I want to emphasize from a capital perspective, we remain committed to capital efficiency. Our strategy is built on hitting clear data-driven milestones that allow us to maximize shareholder value while minimizing unnecessary burn. We’re focused on maintaining the lean, execution-oriented culture that has brought us to this stage. With that, let me pass the call to Cory to go through our financial results. Cory.

Cory Ellspermann, Interim Chief Financial Officer, INmune Bio: Thank you, David. Net loss attributable to common stockholders for the year ended December 31, 2025 was approximately $45.9 million, compared to approximately $42.1 million for 2024. Research and development expenses totaled approximately $20.7 million for the year ended December 31, 2025, compared with approximately $33.2 million for 2024, with the decrease due to incurring lower expenses in connection with the Alzheimer’s trial in 2025. G&A expenses was approximately $10.3 million for the year ended December 31, 2025, compared with approximately $9.5 million for 2024. We also recorded a full impairment of our intangible asset of $16.5 million in 2025 following the release of the phase II results of the Alzheimer’s trial, in which the trial did not meet the clinical endpoint.

During 2025, the company sold 3 million shares of common stock for net proceeds of approximately $17.4 million in a registered direct offering. In addition, the company sold approximately 1.3 million shares of common stock for net proceeds of approximately $10.1 million under at-the-market offerings. At December 31, 2025, the company had cash and cash equivalents of approximately $24.8 million. As of March 30, 2026, the company had approximately 26.6 million shares of common stock outstanding. Based on the current operating plan, we believe our cash is sufficient to fund our operations through Q1 2027. Now I’ll hand the call back to David.

David Moss, CEO and Co-founder, INmune Bio: Thanks, Cory. Now I’d like to present upcoming milestones for the company, and then we can start with the Q&A. For our CORDStrom program, we have several significant milestones ahead, which will really set our track for 2027. As Mark mentioned, we’re on track to file the MAA in the U.K. by mid-summer 2026. A few months after the MAA filing, we expect to submit the MAA to the EMA and then the BLA to the FDA towards the end of the year. We should have feedback from all three geographies in 2027, if not approvals by then. I remind investors that it’s our belief that a successful BLA application would likely result in the company obtaining a priority review voucher from the FDA, given that the program already has orphan drug designation and rare pediatric disease designation.

For XPro, we continue to make strong progress. We’ve now received the minutes from our end-of-phase II meeting with the FDA, as CJ had mentioned, and we obtained positive initial feedback on the accelerated approval pathways we’re actively preparing for next steps. We’re advancing partnership and funding discussions to support late-stage development of XPro. Stepping back, we enter 2026 with a focused set of objectives and multiple meaningful opportunities to create value. While MINDFuL trial did not achieve its top-line primary endpoint due to powering the patient population properly, the totality of XPro dataset continues to support our conviction in the program’s potential in Alzheimer’s disease and other neuroinflammatory disorders. At the same time, we believe CORDStrom is advancing towards a potentially transformative regulatory and commercial inflection point, with the broader platform still not fully reflected in the market.

We appreciate the continued support of our shareholders and the commitment of our team as we work towards these goals. At this point, Chloe, I’d like you to tell people how they can ask questions and poll for questions.

Chloe, Conference Moderator: We’ll take a question from Elemer Piros with Lucid Capital Markets. Your line is open.

Elemer Piros, Analyst, Lucid Capital Markets: Yes. Good afternoon. David, what I’d like to ask, and maybe Mark can help us out here, if there is any anticipated differences between an MAA and an FDA submission. Have you had interactions with the FDA, what might be their requirements different from the European or from the UK agency?

Dr. Mark Lowdell, Chief Scientific Officer and Co-founder, INmune Bio: Yeah, I’ll take that.

Elemer Piros, Analyst, Lucid Capital Markets: Yeah.

Dr. Mark Lowdell, Chief Scientific Officer and Co-founder, INmune Bio: Um, that’s a very-

David Moss, CEO and Co-founder, INmune Bio: Yeah, go ahead, Mark.

Dr. Mark Lowdell, Chief Scientific Officer and Co-founder, INmune Bio: That’s a very good question. Yeah. The last time we spoke to the FDA specifically was a little bit about 13 months ago, and what they came back with were some. One of the things that has been at the top of my mindset is all of the work we’ve done so far in our RDEB, the product’s been made from umbilical cord donors from the U.K. There is a sensitivity about using U.K. donor materials in the U.S. We asked the FDA specifically whether we would be allowed to use U.K. donor cords for the U.S. submission.

They came back and said, "Absolutely, yes, but we would have to screen the U.K. donors for the standard globally agreed infectious disease markers, but they’d have to be tested in U.S. labs, in CLIA-accredited labs." What we’re doing at the moment is creating new master seed stock from donors that we can ethically test in the U.S. That’s the biggest difference. We have to create a new master seed stock, which is ongoing at the moment. Because, as I said earlier on, we’ve worked out the mechanism of action, we now have potency assays. We’ve been able to demonstrate that we’ve made four different master seed stocks experimentally from U.K. donors, and they’ve all been consistent.

The next ones that we make for the FDA filing, which are going through at the moment, will be those that we take through for commercialization globally. That was the principal question that we had, and it was the principal answer they came back with. The rest of the questions they came back with were identical to those from the MHRA. We will present exactly the same data set.

Elemer Piros, Analyst, Lucid Capital Markets: Thank you. Thank you very much, Mark.

David Moss, CEO and Co-founder, INmune Bio: Elemer, let me-

Elemer Piros, Analyst, Lucid Capital Markets: Yeah.

David Moss, CEO and Co-founder, INmune Bio: Elemer, if you don’t mind, let me just add to that.

Elemer Piros, Analyst, Lucid Capital Markets: Sure.

David Moss, CEO and Co-founder, INmune Bio: The plan is, a few weeks ago, we submitted essentially a pre-MAA package to the MHRA, which really effectively is like a Type D meeting, and it kinda smooths the process of the MA, the full MAA application, speeds the process up, that we would tend to file midsummer. Once we get the feedback from the MHRA, and as Mark will tell you, they’ve already set a face-to-face meeting with us. Once we get that, we’ll put that together with the answers to whatever questions they have or whatever feedback they give us, and then we’ll submit that as a Type D meeting to the FDA, in preparation, really like a pre-BLA, in preparation the BLA with the FDA.

Elemer Piros, Analyst, Lucid Capital Markets: Yeah.

David Moss, CEO and Co-founder, INmune Bio: That’ll be the next steps that’ll take place. I think that might have been a little bit of what you were asking if I’m correct.

Elemer Piros, Analyst, Lucid Capital Markets: Yeah.

David Moss, CEO and Co-founder, INmune Bio: Yeah.

Elemer Piros, Analyst, Lucid Capital Markets: Just maybe one more detail around this. So would you have to have the samples tested in U.S. labs before you submit, or you can have that during the submission or during the evaluation and submit it when you have the results?

Dr. Mark Lowdell, Chief Scientific Officer and Co-founder, INmune Bio: What they will ask is for a confirmation that we will only supply drug into the U.S. from U.S.-tested donors. In point of fact, we’re making the master cell batch now. We will have products that have been made from U.S.-tested donors before we submit the BLA.

Elemer Piros, Analyst, Lucid Capital Markets: Yes. Thank you. Maybe one question about the XPro program. David, have you had any interest, any interactions with potential pharma partners at ABPD?

David Moss, CEO and Co-founder, INmune Bio: So the-

Elemer Piros, Analyst, Lucid Capital Markets: What sort of feedback you get?

David Moss, CEO and Co-founder, INmune Bio: No, good question, Elmer. We have ongoing discussions with some groups, and one of the things that now, you know, we—you have to realize we just got the end of phase II meeting a few weeks ago, three, four weeks ago now. Everything’s being packaged up.

One of the things we intend on doing is finding a group to help us on the BD perspective, because there’s just a lot of, not just large pharma, but mid-sized companies that we think the program is very appropriate for because, if you think about it’s a relatively small investment to see the phase II B portion for obviously a very large market, potentially one of the largest markets, and if the phase II B portion reads out as we expect with the right patient population from what we’ve learned from the MINDFuL trial, then it’s a very clear path to the registration program, as CJ had talked about, linking the cognitive aspects of EMACC to the cognitive aspects of CDR and then getting the functional scale of CDR, which comes after cognitive changes over time. The link is very logical.

The correlation between EMACC and CDR is very logical. We think that this package, if explained appropriately to the mid-size, you know, EBITDA, biotech companies that have an interest in neurology all the way up to the large pharma, I think it’s going to be a very attractive program.

Elemer Piros, Analyst, Lucid Capital Markets: Okay. Thank you. Thank you very much, both.

David Moss, CEO and Co-founder, INmune Bio: I appreciate it, Elemer. Thank you.

Chloe, Conference Moderator: It does appear that there are no further questions at this time. I would like to hand it back to David Moss for any additional or closing remarks.

David Moss, CEO and Co-founder, INmune Bio: Thank you, Chloe. 2025 was a year of significant progress for INmune Bio. We completed and analyzed the MINDFuL Alzheimer’s trial, advanced CORDStrom towards registration in RDEB, and positioning INKmune for its next stage of development in prostate cancer. As we move towards 2026, our priorities are very clear. Advance CORDStrom towards market approval in the U.K., EU, and the U.S. Secure regulatory clarity on the path forward for XPro, and build the partnerships and financial support necessary to bring these programs to patients. On behalf of the entire INmune Bio team, thank you for your continued support and confidence in our mission. We look forward to updating you on our progress in the months ahead. Have a great evening, everybody.

Chloe, Conference Moderator: Thank you. This brings us to the end of today’s meeting. We appreciate your time and participation. You may now disconnect.