INmune Bio Inc (INMB) 2026 Q2 法說會逐字稿

Welcome to INmune Bio's second-quarter 2026 earnings call. (Operator Instructions)

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. There are a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied. We encourage you to 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.

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 UK marketing authorization application.

We now expect to submit Ebstrocel MAA to the MHRA by the end of Q3 or early Q4 '26. 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 UK, we plan to submit the MAA to the EMA in early '27 along with a BLA in the US 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 UK, EU, and US filings, and future commercial supply.

We also advanced the CORDStrom platform patent application into the US national phase and established a working Scientific Advisory Board of internationally 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 2 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 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 2 alignment with the FDA and publication of the MINDFuL results in npj Dementia, strengthened the clinical and regulatory foundation of the Phase 2b/3 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 the CORDStrom program in greater detail. Mark?

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, the manufacturing and supply chain, and the broader CORDStrom platform from which Ebstrocel is the first product to market.

wSo 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 3 confirmatory study, and the agency's feedback recognized the MissionEB Phase 2 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 Center and the Manufacturing Innovation Center in Stevenage for Ebstrocel and for subsequent cell drugs from the CORDStrom platform. The first commercial-compliant cord tissues have been processed successfully and 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 UK, the EU and the US. 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 US 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 3 design, translational biomarker identification, potency and release assays, and selection of these additional indications.

But 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 UK MAA by the end of Q3 or early Q4 this year, followed by the planned European and US submissions, while preparing platform for future indications.

I'll now turn the call over to Cory for a review of our financial results. Cory.

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 30, 2026, was approximately $1.3 million compared to approximately $24.5 million for the quarter ended June 30, 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 a benefit of approximately $0.8 million for the quarter ended June 30, 2026, compared to approximately $5.8 million of expense for the quarter ended June 30, 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 30, 2026 and June 30, 2025. As of June 30, 2026, the company had cash and cash equivalents of approximately $18.4 million. Subsequent to June 30, 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 6, 2026, the company had approximately 27.8 million shares of common stock outstanding.

I will now turn the call back to David.

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 2 alignment, and statistically significant Phase 2 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 UK MHRA this year seeking conditional marketing authorization in RDEB. Second, following the UK 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 US Food and Drug Administration in the first quarter of '27. Fourth, we continue advancing the XPro registrational strategy and evaluating strategic partnerships supported by FDA Fast Track designation, end of Phase 2 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.

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, 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 Instructions) James Molloy, Alliance Global Partners.

On the Ebstrocel, the open-label Phase 3 US trial, is that the 12-month open-label safety trial we discussed previously or is this a different trial?

Hey, David, I'm not sure if you're on mute.

Sorry about that. Hi, James. It's David here. Because we are submitting Ebstrocel for conditional approval, we have a follow-on trial that'll be running during the approval process. So this is a Phase 3 confirmation trial. It's the same one we spoke about earlier.

I think 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?

No. It's one trial. And it's safety and confirmation trial.

Okay. You guys had already got to this and that's the one you talked about before. Okay, very good.

That's right.

Okay. When you look at the UK filing or the EU filing, the next 2 filings, what do you guys see as the biggest, sort of the biggest thing they'll be looking for that, you know, 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?

Yes, so the UK 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 one and number two is pain and itch. Patient response outcome forum.

I think in 2018, you can find it on YouTube, in the, from the FDA's website. And again, the top complaints are itch and pain. And clearly itch is, also related to wounds. You know, 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.

And so 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 3 jurisdictions, realize that. There's published papers around that. So, you know, there have been trials also in itch. So we're moving forward with itch pain as a primary endpoint.

So we feel very confident about it. It's clear with the investigators, it's clear with the patients. And in our trial, we also did in the EBDASI score, which was not the primary, pick up the wound scores later in the trial, around the 6-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.

Okay. And then what does the -- just going back to the trial, then I'll get back in the queue. What does the open-label confirmatory trial look like and how many people? How long -- I think 12 months I think is that is the guidance correct and what's the thinking on how long to enroll? Is it 12 months from start to finish?

Right.

When you start, when you have the data and what's the size of the trial?

Yes, so we expect it to be somewhere around 40 to 45 patients. We already have about 33 lined up, ready to go. Most of those are the patients that were on the original, 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. We'd like to enroll faster, but the PIs just can't handle that kind of volume.

And it'll run a total of 18 months. It's three sessions of infusion that are six in total. So every 10 days or so, they get 2 infusions, 3 times a year for a total of 6 infusions. And we'll have the data right around the middle of '28.

Okay, great. And then a 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? Gear up for that sort of thing.

That's a great question, James. So we ran this at the two leading centers that treat the most of the children that have RDEB in the UK They're the two 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 two 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 two years be right around 100 patients or so, in the UK.

I think we also have questions coming from Dan.

Right. Yes, David, so 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 I'm -- there's a lot of people are asking if you can just clarify that the company's focus for the foreseeable future is on the CORDStrom program, and then as 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 UK?

Yes, happy to do that. So first of all, let's talk population. When you look at the greater EB population, it's generally about 10% to 15% of those suffer from the more severe form of RDEB. In the US, it's somewhere around 2,000 to 3,000 patients. In Europe, it's very similar to those numbers.

And in the UK, 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 UK They're now going through the price negotiations. It'll be interesting for us to watch that. But with the recent kind of MFN and what we know about rare diseases, the pricing in the UK should be relatively close to what we expect in the US

We expect it's somewhere around GBP400,000 to GBP500,000 per year per child. We will start our pricing negotiations right after we file the MAA will be the timeline for that.

And if you look at what Krystal has done is they obviously got approval and now they're in the process of the reimbursement negotiations. Now, you also can get reimbursement before you have the pricing negotiations because the hospitals in the UK 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. Did that answer the question, Dan?

Yes, that did and brought into my next question as well, which you took care of nicely. Thank you. So the next question I have here, so basically, in light of recent positive developments, I'm stunned at the current share price. And this is from an investor. I, for one, believe a proper repricing should be in the cards.

Would you care to comment?

Well, you know, I've always kind of beat on the drum that we are, undervalued, right? I mean, it's, it's, I really feel that way, but 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 US 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 in the secondary market. The last few went for between $100 million and $150 million to around $200 million. So we like to say that between $100 million and $200 million, which we intend to use to help fund the expansion of the CORDStrom platform and the XPro platform. If you, in terms of value, I mean, just the PRV alone, obviously, is quite a bit larger than our current market cap. Really 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. And so 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 being, as is Mark, being founders of this company. And so we're highly sensitive to dilution, which I think makes us a little bit different than many other biotech companies.

So we're going to be prudent. We don't need a huge amount of cash dilution 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.

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

Yes, so I'll talk about capital market strategy and then Cory, I'll let you just make a little comment about burn rate. So, you know, our capital market strategy is, is we're, 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 and we've been spending a lot of time doing 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 UK

That being said, we're being very careful about spending.

Cory, do you want to talk about our last quarter burn rate and the future burn rate?

Well, 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 is 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. So, I'd say $1 million or $1.5 million, and we've got cash into Q2 of next year.

Yes, exactly. So not a huge burn rate. And 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 a huge amount, little bit here, little bit there. And we've got the ATM available to do that if we need to.

And, you know, we expect to have approval in the UK 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.

Great. That's it for investor questions.

Jenny, I'll pass it back to you, operator.

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