Inmune Bio, Inc. Q4 FY2025 Earnings Call

Greetings, and welcome to 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 my pleasure to introduce Mr. Daniel Carlson, Head of Investor Relations of INmune Bio. Daniel?

Thank you, Cloey, 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. CJ Barnum, Head of Neuroscience; and Cory Ellspermann, INmune Bio's CFO. Before we begin, I remind everyone that except for statements of historical facts, 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 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 and 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 is now my pleasure to turn the call over to INmune Bio's CEO, David Moss.

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. Cory 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, the worked out mechanism of action 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 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 absolute urgency to bring this therapy to patients who need it most. Further, in 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 preapproved blueprint for a partner to execute. CJ will give you the full picture shortly. On INKmune, 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 families 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 clarify the next steps for the Phase IIb 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?

Thank you, David, and thank you to everyone who's joined the call today. Welcome. So as David said, CORDStrom showed great promise in the randomized placebo-controlled trial in RDEB, but it potentially extends way beyond RDEB to other forms of Epidermolysis Bullosa and indeed to other conditions and indications. CORDStrom remains truly revolutionary in the mesenchymal stromal cell field. Last year, we reported that since it's created from mesenchymal stromal cell banks pooled from four or more donors, it has unrivaled stability and reproducibility compared to 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 seedstocks, and we can choose those that have the appropriate potency characteristics 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 mechanism of action of CORDStrom in RDEB. That's pretty unique for a mesenchymal stromal cell product. While the diversity of the product means that working out quite how it delivers its effect is actually very challenging, 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 called Type 1 macrophages, or M1 cells. These M1 cells secrete inflammatory cytokines, which drive itch and lead to scratching, which causes the skin wounds so prevalent in RDEB patients. M1 cells in normal skin also induce itch when provoked, but in RDEB patients, the absence of the protein that binds the skin layers together means that the itch-scratch cycle causes those very severe lesions that are so well known. One of the cytokines secreted by CORDStrom drives the M1 cells in the skin to mature into M2 noninflammatory 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 cytokines that 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 cytokine changes that our mechanism of action predicted. Those patients that had the highest concentrations 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. So this is the first RDEB treatment to have such diverse whole-body clinical benefits, over and above those which we see from skin treatments that are already licensed. The patients, their caregivers and their doctors all want to continue to have access to CORDStrom, and as David said, we're working tirelessly at present to submit the applications for marketing authorizations in the U.K., then the European Union, and finally the U.S. before the end of 2026. We are driving forward; the goal is to complete those filings 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. So while we are progressing with CORDStrom for RDEB and the marketing authorizations, my group of R&D scientists here in the U.K. are working on 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., 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 and to use all the resources that we have in the U.S. office to support. I'm happy to take questions later, but meanwhile I'll hand over to CJ for the latest update on XPro. CJ, the floor is yours.

Thank you, Mark. I'll give you an update on XPro and where we're headed. MINDFuL was our Phase II trial in Alzheimer's disease. We designed it around a simple question: 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 inform 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 six 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 IIb 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 Sum of Boxes, the same primary endpoint used to approve lecanemab and donanemab at 18 months. We presented this program to the FDA at our 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 data set 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.

Thanks, CJ. Before I hand the call to Cory to go through our financial results, I want to emphasize that 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?

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. General and administrative expenses were 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. And 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 the first quarter of 2027. And now, I'll hand the call back to David.

Thanks, Cory. Now I'd like to present upcoming milestones for the company, and then we can start with the Q&A. For the 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 we believe 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 and are actively preparing for next steps. We're advancing partnership and funding discussions to support late-stage development of XPro. Stepping back, we entered 2026 with a focused set of objectives and multiple meaningful opportunities to create value. While the MINDFuL trial did not achieve its top-line primary endpoint due to challenges in powering the patient population properly, the totality of the XPro data set 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, Cloey, please tell people how they can ask questions and poll for questions.

We will now proceed to the question-and-answer session. (Operator Instructions) And we'll take a question from Elmer Piros with Lucid Capital Markets.

David, what I'd like to ask, and maybe Mark can help us out here. If there are any anticipated differences between an MAA and an FDA submission. Have you had interactions with the FDA, and what might be their requirements different from the European or from the U.K. agency?

Yes, that's a very good question. The last time we spoke to the FDA specifically was a little over 13 months ago, and one of the things that's been at the top of my mind is the work we've done so far in RDEB: the products have been made from umbilical cord donors from the U.K., and 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, and 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, and those samples would have to be tested in U.S.-accredited labs. What we're doing at the moment is creating new master seedstock from donors that we can ethically test in the U.S. So that's the biggest difference: we have to create a new master seedstock, which is ongoing at the moment. But as I said earlier, we've worked out the mechanism of action, we now have potency assays, and we've been able to demonstrate that we've made four different master seedstocks experimentally from U.K. donors and they've all been consistent. So the material we make for the FDA filing, which you're going through at the moment, will be those that we take through for commercialization globally. The rest of the questions they came back with were identical to those from the MHRA, and we will present essentially the same data set.

Elmer, if you don't mind, let me just add to that. A few weeks ago, we submitted a pre-MAA package to the MHRA, which effectively functions like a Type B meeting and smooths the process of the full MAA application, speeding the process up. Once we get the feedback from the MHRA—and they have already set a face-to-face meeting with us—we'll put together answers to whatever questions they have and then submit that as a Type B meeting request to the FDA in preparation for the BLA. Those are the steps that will take place.

Yes. And just maybe one more detail around this. Would you have to have the samples tested in U.S. labs before you submit, or can you have that done during the submission or during the evaluation and submit it when you have the results?

What they will ask for is 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, so we will have products that have been made from U.S.-tested donors before we submit the BLA.

Yes. And maybe one question about the XPro program. David, have you had interest or any interactions with potential partners following the feedback you received?

No, good question, Elmer. We have ongoing discussions with some groups. You have to realize we've just received the end-of-Phase II minutes a few weeks ago, so everything is being factored in now. One of the things we intend to do is find a group to help us on the business development perspective because there's interest not just from large pharma but from midsized companies that we think the program is very appropriate for. If you think about it, it's a relatively small investment to see the Phase IIb portion through for a very large potential market. If the Phase IIb portion reads out as we expect with the right patient population—based on what we've learned from the MINDFuL trial—then it's a very clear path to the registration program, as CJ spoke about, linking the earlier cognitive effects to the later functional measures on the CDR scale. So we think this package will be attractive from midsized biotech companies up to large pharma. We expect strong interest.

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.

Thank you, Cloey. 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 positioned INKmune for its next stage of development in prostate cancer. As we move through 2026, our priorities are very clear: advance CORDStrom towards marketing 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.

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.