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Thursday, Aug. 6, 2026 at 4:30 p.m. ET
Chief Executive Officer - David J. Moss
Chief Scientific Officer - Mark William Lowdell
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Operator: Welcome to INmune Bio's Second Quarter 26 Earnings Call. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question-and-answer session. You may press star 1 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 2000. 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 approve them. It is now my pleasure to turn the call over to INmune Bio's chief executive officer, David J. Moss.
David J. 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 William Lowdell, our chief scientific officer and the inventor of CORDStrom to discuss Ebstracel 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 Ebstracel, 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 the Ebstracel MAA 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 nonclinical, and clinical evidence packages. The agency also recognized the MISSION EV 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 2027 along with the BLA in The US seeking conditional approval. Manufacturing readiness has advanced in parallel. We successfully processed the first commercial ready umbilical cord 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 into The US national phase and established a working scientific advisory board of international recognized MSC and RDEB experts. The SAB will help strengthen Ebstracel'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 intent to treat population. The teeth 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 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, strengthen the clinical and regulatory foundation of the phase 2 b 3 program. The peer reviewed report showed directionally consistent benefit across clinical and biomarker endpoints in the prespecified inflammation rich subgroup with no amyloid related imaging abnormalities of abnormalities were 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 Immune shareholders while we focus all of our attention and resources on getting Ebstracel to the RDEB patients in great need. With that, I will turn the call over to Dr. Mark William Lowdell to discuss CORDStrom program in greater detail. Mark?
Mark William Lowdell: Thank you, David. I want to focus on 3 key areas in the road to bringing Ebstracel to the market that have been materially derisked since our last call. First, the regulatory package, the manufacturing and supply chain, and the broader platform from which Ebstracel is the first product to market. So first, the MHRA's official minutes from our May 20 twelfth pre MAA scientific advice meeting confirmed their alignment across every question that we submitted covering CMC, nonclinical, 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 Ebstracel pediatric investigation plan in less than 3 months. The pediatric strategy incorporates the planned open label phase 3 confirmatory study and the agency's feedback recognized the MISSION EB 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 Evstrocel 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 the manufacturing innovation center in Stevenage. For Ebstracel, and for subsequent cell drugs from the CORDStrom platform.
The first commercial compliant cord tissue have been processed successfully, and the MSC isolation stage 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 and Cory 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 2 persistent challenges that we have 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 have also strengthened the platform from which the Ebstracel 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 2020.
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. 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 objectives is to submit The UK MAA by the end of Q3 or early Q4 this year, followed by the planned European and US while preparing the platform for future indications.
I will now turn the call over to Cory for a review of our financial results. Cory Ellspermann?
Cory Randall Ellspermann: Thank you, Mark. I will provide a brief overview of our financial results for the second quarter. Net loss attributable to common stockholders for the quarter ended 06/30/2026, was approximately $1.3 million compared to approximately $24.5 million for the quarter ended 06/30/2025. The prior period included a $16.5 million in impairment charge related to acquired in process research and development intangible assets. Research and development expenses totaled the benefit of approximately $800 thousand for the quarter ended 06/30/2026. Compared to approximately $5.8 million of expense for the quarter ended 06/30/2025. 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 06/30/2026, and 06/30/2025. As of 06/30/2026, the company had cash and cash equivalents of approximately $18.4 million And subsequent to 06/30/2026, we received approximately $4.2 million in Australian research and development tax rebate providing nondilutive capital to support our development programs. Based on our current operating plan, we believe our existing cash are sufficient to fund operations into the second quarter of 27. As of 08/06/2026, the company had approximately 27.8 million shares of common stock outstanding.
David J. Moss: I will now turn the call back to David. Thank you, Cory. Before we open the call to for questions, I would like to leave you with a clear view of the value driving milestones ahead. INmune Bio now has 2 differentiated late stage platforms. Ebstracel is approaching global regulatory submissions with a commercial manufacturing and supply foundation in place. XPro is supported by FDA Fast Track designation, and the 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 4 principal milestones.
First, we expect to submit the extracellular marketing authorization application to the UK MHRA this year seeking conditional marketing authorization in RDEB. Second, following The UK submission, we plan to submit Ebstracel to the European Medicines Agency expanding the regulatory strategy to patients across the European Union, early next year Third, we plan to submit Ebstracel 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 imaging evidence from MINDFUL.
In parallel, we will continue commercial readiness work for Ebstracel including manufacturing, supply chain, market access, and distribution planning. The new CORDStrom Scientific Advisory Board will also begin against defined priorities for late stage development and platform expansion. Taken together, these activities provide a clear path to multiple regulatory and cert 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 the and our 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. Look forward to updating you as we execute as we execute against these milestones. With that, I would like to move to questions and answers.
Operator: Thank you. Thank you, ladies and gentlemen. We will now begin the and-answer session. Should you wish to cancel your request, please press the star followed by the 2. If you are using a speakerphone, please lift the handset before pressing any case. Your first question is from James Francis Molloy from Alliance Global Partners. Your line is now open.
James Molloy: Hi, thank you very much for taking my question. On the Ebstracel, the open label phase 3 US trial, is that the 12-month open label safety trial you have discussed previously? Is this a different trial?
David J. Moss: Hey, David. I am not sure if you are on mute. Sorry about that. Hi, James. it is David here. Because we are submitting self for conditional approval, we have a follow on trial that will be running during the, approval process. So this is a phase 3 confirmation trial. it is the same 1 we spoke about earlier.
James Molloy: I think if Previously, we talked about a 12-month open-label safety trial. Not needed for filing. Is that this, or is the 12-month safe trial also going to be running in addition to this?
David J. Moss: No. it is 1 trial. And it is a safety and confirmation trial.
James Molloy: Okay. Alright. Because that is what you guys had already guided to this, and that is the 1 you talked about before. Okay. Very good.
James Molloy: And when you look at the UK filing, or the EU filing, sort of the next 2 filings, what you guys see as the biggest sort of the biggest thing they will be looking for that I think we obviously know the potential benefits. Of Ebstracel. What do you think are the biggest hurdles that you think they will be looking for against approval? And how you have addressed those.
David J. Moss: Yeah. So the UK is very straightforward, very clear. We are very far along with the discussions that we have had with them. If you look at the top complaints from ED patients, RDEB patients, it is number 1, and 2 is pain and itch. And in fact, the FDA did a 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 itching 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 do not have a wound and they itch, they can very easily open up a wound. And so itch, if you talk to the investigators, they will clearly tell you that itch is a is a factor with wound healing and opening up new wounds. The regulators in, all 3 jurisdictions, realize that. there is published papers around that. So, you know, there have been trials also in itch. So we are moving forward with itch and pain as a primary endpoint, so we feel very confident about it. it is clear with the investigators. it is clear with the patients.
And, you know, in our trial, we also did see 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 are not itching, takes a while to see those results in terms of wounds, and that is what we saw in the trial.
James Molloy: Okay. And then what does the just going back to the trial, then I will get back in the queue. What does the open label confirmatory trial look like? And how many people how long I think 1, 12-months, I think, is a is the guidance. Correct? And what is the thinking on how long to enroll? Is it 12-months from start to finish when you start when you have the data? And what is the size of the trial?
David J. Moss: Yeah. 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 almost all of those are actually are the patients that were on the original trial that wanna stay on CORDStrom. We expect to enroll about 1 to 2 patients a week. We would like to enroll faster, but the PIs just cannot handle that kind of volume. And it will run a total of 18 months it is 3-- it is 3 sessions, 3 in-sessions of infusion that are, 6 in total.
So every 10 days or so, they get 2 infusions 3 times a year for a total of 6 infusions. And we will have the data right around the middle of 28.
James Molloy: Okay. Great. And then final question. I will hop in the queue. What does a potential approval in The UK what does a launch look like for you guys in The UK? How do you gear for that and that sort of thing.
David J. Moss: No. it is a great question, James. So we ran this at the 2 leading centers that treat most of the children that have RDEB in the UK. They are the 2 leading children's hospitals for EB. and RDEB. it is where a good majority of the patients go. So, the beautiful thing about it is that the clinical investigators are already very familiar with, administering the drug. They are familiar with the results of the drug. And they have the patient population already.
My James, is that within 2 years of approval in The UK, Given the 40 ish odd patients that will have on the trial plus the additional patients that we will add I expect that we should very comfortably within 2 years be right around 100 patients or so in The UK.
James Molloy: Very much for taking my questions.
David J. Moss: You are welcome, James.
Operator: Thank you. I think we also have questions coming from Daniel.
Daniel Frederick Carlson: Right. Yeah, David. So I have gotten a number of questions emailed into me, and I am gonna try and compile them for you. You pretty much covered the first question about the size of the opportunity, but there is a lot of people are asking if you can just clarify that the company's INmune 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?
David J. Moss: Yes. Happy to do that. So first of all, let's talk population. So when you look at the greater EV population, it is generally about 10% to 15% of those suffer from the more severe form of RDEB. In The US, it is somewhere around 2,000 to 3 thousand patients in Europe. it is very similar to those numbers. And in The UK, it is 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 is it is quite interesting because 1 of our competitors' products, Krystal's, which is by VYJUVEK, got approved in The UK.
They are now going through the price negotiations. It will 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 somewhere around $400 thousand to $500 thousand per year per child. We will start our pricing negotiations right after we file the MAA. That will be the timeline for that. And if you look at what Krystal has done is they obviously got approval, and now they are 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 are going through that process. There is a budgeting process within the hospitals there to do that. Did that answer the question, Daniel?
Daniel Frederick Carlson: Yeah. That did and brought in some of my next question as well, which is which he took care of nicely. Thank you.
Analyst: So the next question I have here so it basically, in light of recent positive developments, I am stunned at the current share price. and this is from an investor. I, for 1, believe a proper repricing should be in the cards. Would you care to comment?
David J. Moss: Well, you know, I have always kind of beat on the drum that we are undervalued. Right? I mean, it is it is 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 MA and getting the product approved. I will 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 an accelerated review process of about 6 months.
The rare pediatric disease designation means it comes with what is called a priority review voucher Those priority review vouchers can be sold in the secondary market. The last few went for between $150 to around $200 million. So we like to see that between $102 million and $110 million, Which we intend to use to help fund the expansion of the CORDStrom platform and the XPro platform. 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 are just keeping our heads down We are being very cautious with resources. As you can see, we actually did not burn much this quarter.
And we do not need a huge amount of cash to get to product approval. And so we are gonna be very judicious about our spending, and we are gonna be very judicious about how we raise money. I will remind shareholders that I am also 1 of the larger shareholders of this business being as is Mark. Being founders of this company, and so we are highly sensitive to dilution, which I think makes a little bit different than many other biotech companies. So we are going to be prudent. We do not need a huge amount of cash to get to where we need to go.
And we are gonna 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.
Daniel Frederick Carlson: Gotcha. 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?
David J. Moss: Yes. So I will talk about capital strategy, and then, Cory, I will let you just make a little comment about burn rate.
Daniel Frederick Carlson: So, you know, our capital market strategy is we are really turning our shareholder base over from the previous XPro shareholders. Into a rare disease shareholder base. it is a completely new shareholder base. And we have been spending a lot of time going non deal roadshows, talking to investors. We have been able to get a lot of our XPro shareholders back into the business. They understand the value of what we are doing with CORDStrom. We are 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 are being very careful about spending.
Cory, you wanna talk about, our last quarter burn rate and kind of the future burn rate?
Cory Randall Ellspermann: Well, in general, I would say that we were our burn rate is maybe $1 million to $1.5 million per month. it is 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 are not expecting R&D rebates in that amount on a go forward basis, at least over the next 12 months or so. So I would say $1 million or $1.5 million, and we have got cash into Q2 of next year.
David J. Moss: Yep. Exactly. So not a huge burn rate. And, you know, the ability to raise that money you know, our goal is really just to raise money through the end of next year and do it very small, very judiciously. We just we it is not huge amount. Little bit here, little bit there. And we have 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 am gonna say early Q2 next year, but let's just say Q2 the following year. and then we will start to be able to generate revenue.
Daniel Frederick Carlson: Great. that is it for investor questions. Jenny, I will 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.
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INmune Bio (INMB) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool