INmune Bio Inc.

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🎵 🎵 ¦ ¦ ¦ © transcript Emily Beynon

Please stand by. Your meeting is about to begin. Greetings and welcome to the ImmuneBio'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 ImmuneBio, Daniel.

Thank you, Chloe, and good afternoon, everyone. We thank you for joining us on the call for ImmuneBio's 2025 fourth quarter and year-end financial results. Presenting on today's call are David Moss, CEO and co-founder of ImmuneBio, Dr. Mark Lodell, Chief Scientific Officer and co-founder of ImmuneBio, Dr. C.J. Barnum, Head of Neuroscience, and Corey Elsperman, Indian Bios CFO. Before we begin, I remind everyone that except for statements of historical fact, the statements made by management and responses to question 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, ImmuneBio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. Now, my pleasure to turn the call over to ImmuneBio CEO, David Moss.

Thank you, Dan, and good afternoon, everyone. Thank you for joining us for ImmuneBio'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 RDEP 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 InBio. We completed our mindful Alzheimer's trial, advanced Cordstrom towards registration, and continue to position each of our platform programs for the next stage of development. As we move into 26, 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, epithelmolosa, bullosa, or RdEB. These data showed clinical 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 UK and the United States, and we remain on track to file the MAA in the UK by the end of summer of 26. 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 reliability, the repeatable manufacturing reliability with the worked out MOA along with CMC readiness safety and clinical results is what gives us confidence in the court in cordstrom for our deb importantly we want to highlight that cordstrom is not simply a single asset opportunity but as a platform with broader potential beyond our deb 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 R-DEP 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 R-DEP. 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 EXPRO 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 three. This alignment effectively creates a pre-approved blueprint for a partner to execute. TJ will give you the full picture shortly. On IncMUNE, we completed our phase two 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 different 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 2 study, an important translational data, and a third that is also generated encouraging clinical results. We believe 26 will be an important year for MU-Bio to work to advance Cordstrom towards approval, further clarifying the next steps for the Phase 2b 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 Liddell for an update on Chordstrom. Mark?

Thank you, David, and thank you to everyone who's joined the call today. Welcome. So, as David said, Chordstrom 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. ColdStrom remains truly revolutionary in the MSC field. And 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 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 Chordstrom works by secreting an array of chemical messengers called cytokines, which are used by the body to control inflammation. We know that R-DEB is predominantly a disease of inflammation, and it's driven by cells in the skin which are called type 1 macrophages, or M1 cells. These M1 cells secrete inflammatory cytokines, which drive the itch and lead to the scratching, which causes the skin wound so prevalent in our dead patients and which you'll be familiar with. M1 cells in normal skin also induce itch when provoked, but in our dead 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 messages, cytokines, which enhance wound repair. And when we looked at the serum samples from the patients who were treated with Cordstrom on the UK trial and compared those to those treated with placebo, the Cordstrom recipients all had in their blood cytokines that our mechanisms of action predicted. And 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. So this is the first R-DEV 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. And as David said, we're working tirelessly at present to submit the applications for marketing authorizations in the UK, and then the European Union, and finally the US before the end of the year. We're driving forward so that they're all completed by the end of this year, and we hope to be supplying Cordstrom to our 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're progressing with Cordstrom for our Deb and the marketing authorizations, my group of R&D scientists here in the UK are working on other broader indications and we're seeking business partnerships to develop those through clinical trials and bring those to market accordingly. So as a company we're laser focused on preparing the marketing authorization application for the UK and then the EU and the biologics license application or BLA for the US 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 UK for working so diligently to keep to these timelines, to remain on track, and to use all the resources that we have in the US office to support them. So I'm happy to take questions that you have. But meanwhile, I'll hand over to CJ for the latest update on X-Pro. CJ, the floor is yours.

Thank you, Mark. I'll give you an update on X-Pro and where we're headed. Mindful was our phase two 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 EXPRO across clinical, behavioral, patient-reported, and blood and imaging biomarkers. The phase two identified what works, who it works for, and resolved the open questions so that phase three 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 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 2B gives us a decision point at nine months, a clear go or no go before we commit to the full phase three 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 lacanumab and dinanumab at 18 months. We presented this program to the FDA at the end of phase two 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 expo treatment. At the same time, we are preparing the phase three 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?

Thanks, CJ. Before I hand the call to Corey 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 Corey to go through our financial results. Corey?

Thank you, David. Net loss attributable to common stockholders for the year ended December 31st, 2025 is 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 a 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 31st, 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 two 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 30th, 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. And now I'll hand the call back to David.

Thanks, Corey. Now I'd like to present upcoming milestones for the company, and then we can start with the Q&A. For our course and 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 UK 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. My mind investors that it's our belief that a successful 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. We continue to make strong progress. We've now received the minutes from our end of phase two meeting with the FDA, as CJ had mentioned. and we obtained positive initial feedback on the accelerated approval pathways we're actually preparing for next steps. We're advancing partnership and funding discussions to support late stage development of EXPRO. Stepping back, we entered 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 EXPRO dataset continue 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.

Absolutely. If you'd like to ask a question, press star 1 on your keypad. To leave the queue at any time, press star 2. Once again, that is star 1 to ask a question.

We'll pause for just a moment to allow everyone a chance to join the queue. Once more, that is star and one for your questions. We'll pause another moment.

And we'll take a question from Elmer Piros with Lucid Capital Markets. Your line is open.

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?

Yeah, I'll take that. That's a very good question. Yeah. So 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 RDEB, the product's been made from umbilical cord donors from the UK. And there is a sensitivity about using UK donor materials in the US. And so we asked the FDA specifically whether we would be allowed to use UK donor cords for the US submission. And they came back and said, absolutely, yes, but we would have to screen the UK donors for the standard globally agreed infectious disease markers, but they'd have to be tested in US labs, in clear accredited labs. And so what we're doing at the moment is creating new master seed stock and from donors that we can ethically test in the US. So that's the biggest difference. We have to create a new master seed stock, which is ongoing at the moment. But because, as I said earlier on, we've worked out the methods of action, we now have potency assays. We've been able to demonstrate that We've made four different master seed stocks experimentally from UK donors, and they've all been consistent. So 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. So 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. So, yeah, we will present exactly the same data set.

Thank you. Elmer, if you don't mind, let me just add to that. So the plan is a few weeks ago we submitted essentially a pre-MAA package to the MHRA, which really effectively is like a Type B meeting, and it kind of smooths the process of the full MAA application, speeds the process up. that we intend to file mid-summer. 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 B meeting to the FDA in preparation, really like a pre-BLA, in preparation for the BLA with the FDA. And so that would be the next steps that will take place. I think that might have been a little bit of what you were asking if I'm correct. Yeah, yeah, yeah, yeah.

And 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?

So what they will ask is for a confirmation that we will only supply drug into the U.S. from U.S. tested donors. But 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, thank you. And maybe one question about the course, the expo program. David, have you had any interest, any interactions with potential former partners at ADPD? And what sort of feedback do you get?

No, good question, Wilmer. We have ongoing discussions with some groups. And one of the things that now, you know, you have to realize we just got the end of phase two minutes a few weeks ago, three, four weeks ago now. And so everything's being packaged up. And 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, it's a relatively small investment to see the phase 2B portion for obviously a very large market, potentially one of the largest markets. And if the phase 2B 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 EMAC to the cognitive aspects of CDR, and then getting the functional scale of CDR, which comes after cognitive changes over time. So the link is very logical. The correlation between EMAC and CDR is very logical. And so we think that this package had explained appropriately to the midsize, 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.

Okay. Thank you. Thank you very much, both.

I appreciate it, Elmer. Thank you.

And 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, Chloe. 2025 was a year of significant progress for Immune Bio. We completed and analyzed the mindful Alzheimer's trial, advanced courtrooms towards registration in RDEB, and positioning for its next stage of development in prostate cancer. As we move toward through 2026, our priorities are very clear. Advanced courtrooms towards marketing approval in the UK, EU, and the US. 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 Immune 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.