INmune Bio Q2 2026 Earnings Call - MHRA Alignment Clears Path for Late 2026 Ebstrocel Filing

Operator: Welcome to INmune Bio’s second quarter 2026 earnings call. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question and answer session, at which time you may press star one to ask a question. As a reminder, this conference call is being recorded. A transcript will be available approximately 24 hours after the call. Before we begin, please note that except for statements of historical fact, statements made by management and responses to questions may constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Please review the forward-looking statements disclaimer in today’s earnings release and the risk factors described in the company’s filings with the SEC, including its most recent quarterly report.

Forward-looking statements speak only as of the date they are made and except as required by law. INmune Bio undertakes no obligation to update them. It is now my pleasure to turn the call over to INmune Bio’s Chief Executive Officer, David Moss.

David Moss, Chief Executive Officer, INmune Bio: Thank you for joining INmune Bio’s second quarter conference call. The second quarter and the weeks that followed were defined by execution across both of our late-stage platforms. I will begin with the investor perspective on the progress we have made. I will then turn the call over to Dr. Mark Lowdell, our Chief Scientific Officer and the inventor of CORDStrom, to discuss Ebstrocel and the CORDStrom platform in greater detail. Cory Ellspermann will review our financial results, and I will return to discuss the milestones ahead before we open the call for questions. For Ebstrocel, we secured formal MHRA alignment, received approval of the pediatric investigation plan, completed a commercial manufacturing milestone, and strengthened our long-term supply chain. Together, these achievements materially reduced regulatory and operational risk ahead of our planned U.K. marketing authorization application.

We now expect to submit Ebstrocel MAA to the MHRA by the end of Q3 or early Q4 2026. The application will seek conditional marketing authorization in RDEB and is supported by written MHRA alignment across the CMC, non-clinical, and clinical evidence packages. The agency also recognized the MissionEB data as demonstrating clinical, meaningful, symptomatic benefits, particularly in pain and pruritus. After submitting the MAA in the U.K., we plan to submit the MAA to the EMA in early 2027, along with a BLA in the U.S. seeking conditional approval. Manufacturing readiness has advanced in parallel. We successfully processed the first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult facility in Stevenage and transferred the MSC isolation stage used to manufacture master cell banks into the intended commercial facility.

Combined with our expanded Anthony Nolan agreement, this gives us a scalable supply foundation designed to support U.K., E.U., and U.S. filings and future commercial supply. We also advanced the CORDStrom platform patent application into the U.S. national phase and established a working Scientific Advisory Board of international recognized MSC and RDEB experts. The SAB will help strengthen Ebstrocel’s late-stage development package and prioritize additional disease-specific applications of the CORDStrom platform. XPro also reached important milestones this quarter. The FDA granted Fast Track designation for early Alzheimer’s disease, and the phase II MINDFuL study showed a statistically significant treatment effect on white matter myelin MRI biomarkers in the full modified intent-to-treat population. The treatment difference was P 0.0028 with a Cohen’s d effect size of 0.46. In the biomarker-enriched population, the effect size increased further to 0.59.

Expanded analysis presented at AAIC showed concordant treatment-related effects across independent white matter and cortical gray matter measures at week 24. These data, together with our successful end-of-phase II alignment with the FDA and publication of the MINDFuL results in npj Dementia, strengthen the clinical and regulatory foundation of the phase IIb/III program. The peer-reviewed report shows directionally consistent benefit across clinical and biomarker endpoints in the pre-specified inflammation-rich subgroup with no amyloid-related imaging abnormalities observed. Recent TBI, traumatic brain injury, and oncology data also support broader platform optionality. Although our clinical priority remains Alzheimer’s disease, we continue to evaluate strategic partnership opportunities that could accelerate the program while preserving meaningful value for INmune shareholders while we focus all of our attention and resources on getting Ebstrocel to the RDEB patients who are in great need.

With that, I will turn the call over to Dr. Mark Lowdell to discuss CORDStrom program in greater detail. Mark?

Dr. Mark Lowdell, Chief Scientific Officer, INmune Bio: Thank you, David. I want to focus on three key areas in the road to bringing Ebstrocel to the market that have been materially de-risked since our last call. First, the regulatory package to manufacturing and supply chain and the broader CORDStrom platform from which Ebstrocel is the first product to market. First, the MHRA’s official minutes from our May 12th pre-MAA scientific advice meeting confirmed their alignment across every question that we submitted, covering CMC, non-clinical, and clinical matters. This is important because it gives us a defined path for the planned conditional marketing authorization application, rather than requiring us to infer what the agency might expect. Second, the MHRA approved the Ebstrocel pediatric investigation plan in less than three months.

The pediatric strategy incorporates the planned open-label phase III confirmatory study. The agency’s feedback recognized the MissionEB phase II data as demonstrating clinically meaningful improvement in symptoms that matter to patients, mostly pain and pruritus or itch. The feedback also supports evaluating Ebstrocel as a chronic or intermittent supportive therapy in RDEB. Third, we completed a key commercial manufacturing milestone at the Cell and Gene Therapy Catapult and the Manufacturing Innovation Centre in Stevenage for Ebstrocel and for subsequent cell drugs from the CORDStrom platform. The first commercial compliant cord tissues have been processed successfully. The MSC isolation stage for manufacture of the master cell banks was transferred into the facility intended to support registration and subsequently future commercial supply.

Our expanded agreement with the Anthony Nolan Cord Blood Bank secures long-term access to qualified umbilical cord tissue for the platform for use in the U.K., the EU, and the U.S. This matters because the CORDStrom platform was designed to solve two persistent challenges that we’ve seen in MSC therapy over the past years, donor variability and manufacturing inconsistency. Our proprietary donor screening, pooling, and expansion processes are intended to produce an off-the-shelf, scalable, batch-to-batch consistent cell medicine, and that is what we have shown the MHRA. The recent manufacturing work brings the initial master cell bank production stage into the commercial-ready manufacturing supply chain. We’ve also strengthened the platform from which the Ebstrocel lead program is derived. The CORDStrom patent application entered the U.S. national phase following a favorable international written opinion, and if granted, could provide broad protection into at least 2045.

In addition, our newly formed scientific advisory board brings together major leaders in MSC clinical translation, potency assessment, manufacturing, rare pediatric skin disease, and additional therapeutic areas that we can focus on. This is a working advisory board with defined priorities including phase III design, translational biomarker identification, potency and release assays, and selection of these additional indications. Taken together, these achievements give us greater confidence that the scientific, clinical, regulatory, and manufacturing components required for a successful filing are now converging. Our immediate objective is to submit the U.K. MAA by the end of Q3 or early Q4 this year, followed by the planned European and U.S. submissions, while preparing the platform for future indications. I’ll now turn the call over to Cory for a review of our financial results. Cory?

Cory Ellspermann, Chief Financial Officer, INmune Bio: Thank you, Mark. I’ll provide a brief overview of our financial results for the second quarter. Net loss attributable to common stockholders for the quarter ended June 30th, 2026, was approximately $1.3 million, compared to approximately $24.5 million for the quarter ended June 30th, 2025. The prior period included a $16.5 million impairment charge related to acquired in-process research and development intangible assets. Research and development expenses totaled the benefit of approximately $0.8 million for the quarter ended June 30th, 2026, compared to approximately $5.8 million of expense for the quarter ended June 30th, 2025. The research and development benefit during the 2026 period was primarily due to the recognition of additional Australian research and development rebate. General and administrative expenses were approximately $2.3 million for each of the quarters ended June 30th, 2026, and June 30th, 2025.

As of June 30th, 2026, the company had cash and cash equivalents of approximately $18.4 million. Subsequent to June 30th, 2026, we received approximately $4.2 million in Australian research and development tax rebate, providing non-dilutive capital to support our development programs. Based on our current operating plan, we believe our existing cash resources are sufficient to fund operations into the second quarter of 2027. As of August 6th, 2026, the company had approximately 27.8 million shares of common stock outstanding. I will now turn the call back to David.

David Moss, Chief Executive Officer, INmune Bio: Thank you, Cory. Before we open the call for questions, I’d like to leave you with a clear view of the value-driving milestones ahead. INmune Bio now has two differentiated late-stage platforms. Ebstrocel is approaching global regulatory submissions with a commercial manufacturing and supply foundation in place. XPro is supported by FDA Fast Track designation, end of phase II alignment, and statistically significant phase II imaging data. We believe this combination provides both a near-term regulatory opportunity and meaningful long-term pipeline value. Based on our current plans and subject to regulatory feedback, investors should watch for four principal milestones. First, we expect to submit the Ebstrocel marketing authorization application to the U.K. MHRA this year, seeking conditional marketing authorization in RDEB. Second, following the U.K. submission, we plan to submit Ebstrocel to the European Medicines Agency, expanding the regulatory strategy to patients across the European Union early next year.

Third, we plan to submit Ebstrocel Biologics License Application to the U.S. Food and Drug Administration in the first quarter of 2027. Fourth, we continue advancing the XPro registrational strategy and evaluating strategic partnerships supported by FDA Fast Track designation, end of phase II alignment, and increasingly consistent clinical and imaging evidence from MINDFuL. In parallel, we will continue commercial readiness work for Ebstrocel, including manufacturing, supply chain, market access, and distribution planning. The new CORDStrom Scientific Advisory Board will also begin executing against defined priorities for late-stage development and platform expansion. Taken together, these activities provide a clear path to multiple regulatory and strategic value inflection points. Our priority is disciplined execution, completing high-quality submissions, preserving capital, and building the capabilities required to deliver these therapies to patients.

I want to thank our employees for their relentless dedication, our investigators and clinical collaborators for their partnerships, the patients and families who have placed their trust in us, and our shareholders for their continued confidence and support. Our team is motivated, working tremendously hard, and is always thinking about the patients we serve and are dedicated to improving their lives. We believe the next several quarters can redefine INmune Bio as we move from clinical development toward regulatory review and potential commercialization. We look forward to updating you as we execute against these milestones. With that, I’d like to move to questions and answers. Thank you.

Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on a touch-tone phone. Should you wish to cancel your request, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. Once again, that is star one should you wish to ask a question. Your first question is from James Molloy from Alliance Global Partners. Your line is now open.

James Molloy, Analyst, Alliance Global Partners: Hi. Thank you very much for taking my question. On the Ebstrocel, the open-label phase III U.S. trial, is that the 12-month open-label safety trial we had discussed previously, or is this a different trial?

David Moss, Chief Executive Officer, INmune Bio: Hey, David, I’m not sure if you’re on mute.

James Molloy, Analyst, Alliance Global Partners: Of course we’re on mute.

David Moss, Chief Executive Officer, INmune Bio: Sorry about that. Hi, James. It’s David here. We are submitting Ebstrocel for conditional approval, we have a follow-on trial that’ll be running during the approval process. This is a phase III confirmation trial. It’s the same one we spoke about earlier.

James Molloy, Analyst, Alliance Global Partners: I think, yeah, previously, we talked about a 12-month open-label safety trial not needed for filing. Is that this, or is the 12-month safety trial also going to be running in addition to this?

David Moss, Chief Executive Officer, INmune Bio: No, it’s one trial.

James Molloy, Analyst, Alliance Global Partners: Okay.

David Moss, Chief Executive Officer, INmune Bio: It’s safety and confirmation trial.

James Molloy, Analyst, Alliance Global Partners: Okay.

David Moss, Chief Executive Officer, INmune Bio: Yeah.

James Molloy, Analyst, Alliance Global Partners: All right. You guys had already guided to this, and that’s the one you talked about before. Okay, very good.

David Moss, Chief Executive Officer, INmune Bio: That’s right.

James Molloy, Analyst, Alliance Global Partners: When you look at the U.K. filing or the EU filing, sort of the next two filings, what do you guys see as sort of the biggest thing they’ll be looking for that I think we obviously know the potential benefits of Ebstrocel. What do you think are the biggest hurdles that you think they’ll be looking for against approval, and how you’ve addressed those?

David Moss, Chief Executive Officer, INmune Bio: Yeah. The U.K. is very straightforward, very clear. We’re very far along with the discussions that we’ve had with them. If you look at the top complaints from EB patients, RDEB patients, it’s number 1, and 2 is pain and itch. In fact, the FDA did a patient response outcome forum, I think in 2018. You can find it on youtube.com from the FDA’s website. Again, the top complaints are itch and pain. Clearly, itch is also related to wounds. If you have an existing wound and you itch it, you introduce bacteria, you keep it from healing. These patients have such sensitive skin that even if they don’t have a wound and they itch, they can very easily open up a wound.

Itch, if you talk to the investigators, they’ll clearly tell you that itch is a factor with wound healing and persistent wounds and opening up new wounds. The regulators in all three jurisdictions realize that. There’s published papers around that. There have been trials also in itch. We’re moving forward with itch, pain as the primary endpoints. We feel very confident about it. It’s clear with the investigators. It’s clear with the patients. In our trial, we also did, in the ADAS-Cog score, which was not the primary, pick up the wound scores later in the trial, around the six-month mark. Because if you think about it, over a period of time when you’re not itching, it takes a while to see those results in terms of wounds, and that’s what we saw in the trial.

James Molloy, Analyst, Alliance Global Partners: Okay. Just going back to the trial, then I’ll get back in the queue. What does the open-label confirmatory trial look like? How many people? How long? I think 12 months, I think is the guidance, correct? What’s the thinking on how long to enroll? Is it 12 months from start to finish?

David Moss, Chief Executive Officer, INmune Bio: Right.

James Molloy, Analyst, Alliance Global Partners: When you start, when you have the data, what’s the size of the trial?

David Moss, Chief Executive Officer, INmune Bio: Yeah. We expect it to be somewhere around 40 to 45 patients. We already have about 33 lined up, ready to go. Almost all of those, actually, are the patients that were on the original trial that want to stay on CORDStrom. We expect to enroll about one to two patients a week. We’d like to enroll faster, but the PIs just can’t handle that kind of volume. It’ll run a total of 18 months. It’s three sessions of infusion that are six in total. Every 10 days or so, they get two infusions, three times a year for a total of six infusions. We’ll have the data right around the middle of 2028.

James Molloy, Analyst, Alliance Global Partners: Okay, great. Final question, I’ll hop in the queue. What does a potential approval in the UK, what does a launch look like for you guys in the UK?

David Moss, Chief Executive Officer, INmune Bio: Yeah.

James Molloy, Analyst, Alliance Global Partners: Gear up for that and that sort of thing.

David Moss, Chief Executive Officer, INmune Bio: That’s a great question, James. We ran this at the 2 leading centers that treat the most of the children that have RDEB in the UK. They’re the 2 leading children’s hospitals for EB and RDEB. It’s where a good majority of the patients go. The beautiful thing about it is that the clinical investigators are already very familiar with administering the drug. They’re familiar with the results of the drug, and they have the patient population already. My expectation, James, is that within 2 years of approval in the UK, given the 40-ish odd patients that we’ll have on the trial, plus the additional patients that we’ll add, I expect that we should very comfortably within 2 years be right around 100 patients or so, in the UK.

James Molloy, Analyst, Alliance Global Partners: Thank you very much for taking my questions.

David Moss, Chief Executive Officer, INmune Bio: You’re welcome, James.

Operator: Thank you. I think we also have questions coming from Dan.

Dan, Analyst/Moderator: Right. Yeah, David, I’ve gotten a number of questions emailed into me, and I’m going to try and compile them for you. You pretty much covered the first question about the size of the opportunity, but a lot of people are asking if you can just clarify that the company’s INmune’s focus for the foreseeable future is on the CORDStrom program. As a sort of follow-on to the market size, can you talk about the pricing of the drug and what the reimbursement process looks like in the U.K.?

David Moss, Chief Executive Officer, INmune Bio: Yes, happy to do that. First of all, let’s talk population. When you look at the greater EB population, it’s generally about 10%-15% of those suffer from the more severe form of RDEB. In the U.S., it’s somewhere around 2-3,000 patients. In Europe, it’s very similar to those numbers. In the U.K., it’s somewhere around 800 or so patients in total. Now, about 60% of those numbers represent children and the rest represent adults, is the breakdown. In terms of pricing, it’s quite interesting because one of our competitor’s products, Krystal’s, which is VYJUVEK, got approved in the U.K. They’re now going through the price negotiations. It’ll be interesting for us to watch that.

With the recent kind of MFN and what we know about rare diseases, the pricing in the U.K. should be relatively close to what we expect in the U.S. We expect it somewhere around GBP 400,000 to GBP 500,000 per year per child. We will start our pricing negotiations right after we file the MAA, will be the timeline for that. If you look at what Krystal has done is they obviously got approval and now they’re in the process of the reimbursement negotiations. You also can get reimbursement before you have the pricing negotiations because the hospitals in the U.K. have the ability to pay and fund the medication while you’re going through that process. There is a budgeting process within the hospitals there to do that. Does that answer the question, Dan?

Dan, Analyst/Moderator: Yeah, that did and brought in some of my next question as well, which he took care of nicely. Thank you. The next question I have here. Basically, in light of recent positive developments, I’m stunned at the current share price. This is from an investor, "I, for one, believe a proper repricing should be in the cards. Would you care to comment?

David Moss, Chief Executive Officer, INmune Bio: Well, I’ve always kind of beat on the drum that we are undervalued, right? I really feel that way. At the end of the day, I think what we have to do is we have to prove ourselves by getting the MAA and getting the product approved. I’ll remind everybody that if we get it approved in the U.S. through accelerated approval, it already has orphan drug designation and rare pediatric disease designation. The orphan drug means it’s an accelerated review process of about 6 months. The rare pediatric disease designation means it comes with what’s called a priority review voucher. Those priority review vouchers can be sold on the secondary market. The last few went for between $150 million to around $200 million.

We like to say they’re between $100 million and $200 million, which we intend to use to help fund the expansion of the CORDStrom platform and the XPro platform. In terms of value, just the PRV alone obviously is quite a bit larger than our current market cap. What we do is we’re just keeping our heads down. We’re being very cautious with resources. As you can see, we actually didn’t burn much this quarter, and we don’t need a huge amount of cash to get to product approval. We’re going to be very judicious about our spending, and we’re going to be very judicious about how we raise money.

I’ll remind shareholders that I’m also one of the larger shareholders of this business, as is Mark, being founders of this company. We’re highly sensitive to dilution, which I think makes us a little bit different than many other biotech companies. We’re going to be prudent. We don’t need a huge amount of cash to get to where we need to go, and we’re going to be doing things like we did this last quarter by being just very special with R&D rebates, negotiating our spending, and being very careful about the amounts of money we raise and how we raise it.

Dan, Analyst/Moderator: Got you. Last question for you. You did touch on this, can you just go over the burn rate as well and sort of capital market strategy?

David Moss, Chief Executive Officer, INmune Bio: I’ll talk about capital market strategy, then Cory, I’ll let you just make a little comment about burn rate. Our capital market strategy is we’re really turning our shareholder base over from the previous XPro shareholders into a rare disease shareholders. It’s a completely new shareholder base. We’ve been spending a lot of time going non-deal roadshows, talking to investors. We’ve been able to get a lot of our XPro shareholders back into the business. They understand the value of what we’re doing with CORDStrom, and we’re starting to get some new ones now, especially as we get closer to proving ourselves with the MAA application and eventually approval in the U.K. That being said, we’re being very careful about spending. Cory, you want to talk about our last quarter burn rate and kind of the future burn rate?

Cory Ellspermann, Chief Financial Officer, INmune Bio: In general, I’d say that our burn rate is maybe $1 million to $1.5 million per month. It’s a little bit unusual what we had in the last 6 months because we took a lot of R&D rebates in, which was great, but we’re not expecting R&D rebates in that amount on a go-forward basis, at least over the next 12 months or so. I’d say $1 million or $1.5 million, and we’ve got cash into Q2 of next year.

David Moss, Chief Executive Officer, INmune Bio: Yep. Exactly. Not a huge burn rate. The ability to raise that money, our goal is really just to raise money through the end of next year and do it very small, very judiciously. It’s not huge amount. Little bit here, a little bit there. We’ve got the ATM available to do that if we need to. We expect to have approval in the U.K. sometime, I think I’m going to say early Q2 next year, but let’s just say Q2 the following year, and then we’ll start to be able to generate revenue.

Dan, Analyst/Moderator: Great. That’s it for investor questions.

David Moss, Chief Executive Officer, INmune Bio: Jenny, I’ll pass it back to you, operator.

Operator: Thank you. That concludes our conference call for today. Thank you everyone for joining. You may all disconnect your lines.