Prepared remarks
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. 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 update them. It is now my pleasure to turn the call over to INmune Bio's chief executive officer, 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 EB data as demonstrating clinically 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 internationally 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 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, strengthen the clinical and regulatory foundation of the phase 2/3 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 observed. Recent TBI 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 Ebstracel to RDEB patients in great need. With that, I will turn the call over to Dr. Mark William 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 Ebstracel to market that have been materially de-risked since our last call: first, the regulatory package; second, manufacturing and supply chain; and third, the broader platform from which Ebstracel is the first product to market. First, the MHRA's official minutes from our May 20th 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 three 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. The feedback also supports evaluating Ebstracel as a chronic or intermittent supportive therapy in RDEB. Third, we completed a key commercial manufacturing milestone at the Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Stevenage for Ebstracel and for subsequent cell drugs from the CORDStrom platform. The first commercial-compliant cord tissue has 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 Anthony Nolan and Cory Blood Bank secures long-term access to qualified umbilical cord tissue for the platform for use in the UK, EU, and US. This matters because the CORDStrom platform was designed to solve two persistent challenges 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 2030. 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 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 UK MAA by the end of Q3 or early Q4 this year, followed by the planned European and US submissions while preparing the platform for future indications. I will now turn the call over to Cory for a review of our financial results.
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 impairment charge related to acquired in-process research and development intangible assets. Research and development expense totaled a 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 an 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. Subsequent to 06/30/2026, we received approximately $4.2 million in Australian research and development tax rebates, providing non-dilutive 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 2027. As of 08/06/2026, the company had approximately 27.8 million shares of common stock outstanding.
Thank you, Cory. Before we open the call for questions, I would like to leave you with a clear view of the value-driving milestones ahead. INmune Bio now has two 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, 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 Ebstracel 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 the Ebstracel Biologics License Application to the US 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 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 work 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. I look forward to updating you as we execute against these milestones. With that, I would like to move to questions and answers.
Questions and answers
Thank you. We will now begin the question-and-answer session. 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. Your first question is from James Francis Molloy from Alliance Global Partners. Your line is now open.
Hi, thank you very much for taking my question. On 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?
Hi, James. It's David here. Because we are submitting Ebstracel for conditional approval, we have a follow-on trial that will be running during the approval process. This is a phase 3 confirmation trial; it is 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 is one trial, and it is a safety and confirmation trial.
Okay. Alright. Because that is what you guys had already guided to, and that is the one you talked about before. Okay. Very good.
That is right.
And when you look at the UK filing or the EU filing, what do you see as the biggest things they will be looking for? I think we obviously know the potential benefits of Ebstracel. What do you think are the biggest hurdles that they will be looking for against approval, and how have you addressed those?
The UK is very straightforward and very clear; we are very far along with the discussions we have had with them. If you look at the top complaints from RDEB patients, number one and two are pain and itch. In fact, the FDA ran a patient-focused drug development meeting in 2018 that you can find on their website, and again, the top complaints are itching and pain. Itch is related to wounds—if you have an existing wound and you itch it, you introduce bacteria and 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. Itch, clinicians will tell you, is a factor with wound healing and opening up new wounds. The regulators in all three jurisdictions realize that; there are published papers around it and trials in itch. We are moving forward with itch and pain as primary endpoints, so we feel very confident about them. It's clear with the investigators and the patients. In our trial, we also saw the EBDASI score, which was not the primary endpoint, pick up wound improvements later in the trial around the six-month mark. If you think about it, over a period when you are not itching, it takes time to see results in terms of wounds, and that is what we saw in the trial.
Okay. And then just going back to the trial—what does the open-label confirmatory trial look like and how many people? I think 12 months is the guidance, correct? What is the thinking on how long to enroll? Is it 12 months from start to finish when you start to have the data? And what is the size of the trial?
We expect it to be somewhere around 40 to 45 patients. We already have about 33 lined up and ready to go. Almost all of those are patients who were on the original trial and want to stay on CORDStrom. We expect to enroll about one to two patients a week. We would like to enroll faster but the principal investigators cannot handle that kind of volume. The trial will run a total of 18 months. It consists of three in-clinic sessions, six infusions in total: two infusions in an in-clinic session repeated three times over the study. We expect to have the data around the middle of 2028.
Okay. Great. And then final question, I will hop back in the queue. What does a potential approval in the UK look like for you guys? How do you gear up for that and what does launch look like?
That's a great question, James. We ran the program at the two leading centers in the UK that treat most of the children with RDEB; they are the two leading children's hospitals for EB and RDEB. A good majority of the patients go to those centers. The investigators are already very familiar with administering the drug, familiar with the results, and they have the patient population. Given that, within two years of approval in the UK, considering the roughly 40 patients who will have been on the trial plus additional patients we add, I expect we could comfortably be treating around 100 patients or so in the UK.
Very much appreciate you taking my questions.
You're welcome, James.
Thank you. We also have questions coming from Daniel.
Right. Yeah, David. I have 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 focus for the foreseeable future is on the CORDStrom program. And as a 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?
Happy to do that. First, on population: when you look at the greater EB population, generally about 10% to 15% suffer from the more severe form, RDEB. In the US it is somewhere around 2,000 to 3,000 patients; in Europe, it is very similar. In the UK, it's somewhere around 800 patients in total. About 60% of those numbers represent children and the rest represent adults. In terms of pricing, it's interesting because one of our competitor's products, Vyjuvek, got approved in the UK and is now going through price negotiations. It will be interesting for us to watch that. With recent policy changes 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 pricing somewhere around $400,000 to $500,000 per year per child. We will start our pricing negotiations right after we file the MAA. You can also receive reimbursement before pricing negotiations are complete because hospitals in the UK have the ability to pay and fund medication while you go through that process through internal budgeting. I hope that answers your question, Daniel.
Yes. That did and brought in some of my next questions as well, which is great. Thank you.
So, in light of recent positive developments, I'm stunned at the current share price. I, for one, believe a proper re-pricing should be in the cards. Would you care to comment?
I've always believed we are undervalued. At the end of the day, we have to prove ourselves by getting the MAA and getting the product approved. I'll remind everyone that if we get approval in the US through accelerated approval, we already have Orphan Drug designation and Rare Pediatric Disease designation. Orphan Drug designation can provide accelerated review processes and Rare Pediatric Disease designation comes with a Priority Review Voucher. Those priority review vouchers can be sold in the secondary market; recent ones have traded between roughly $150 million and $200 million. We like to see that range; such a voucher could be material relative to our current market capitalization. We intend to use proceeds to help fund expansion of the CORDStrom and XPro platforms. In terms of capital discipline, we have been cautious—this quarter we conserved cash, benefitted from R&D rebates, and are being careful about how and when we raise money. I'm one of the larger shareholders of this business, as is Mark, and we are sensitive to dilution. We will be prudent. We do not need a huge amount of cash to get to product approval. We will continue to be judicious about spending and raising capital.
Gotcha. Last question for you then: you did touch on this, but can you go over the burn rate as well and the capital markets strategy?
I'll talk about capital strategy, and then Cory can comment on burn rate. Our capital markets strategy is focused on turning our shareholder base toward rare disease investors and building a long-term base that understands the value of CORDStrom. We've been doing non-deal roadshows and talking to investors; we've seen many of our XPro shareholders return to the business and are starting to attract new investors as we approach the MAA filing and potential approval. That said, we are careful about spending. Cory?
In general, our burn rate is roughly $1 million to $1.5 million per month. It was somewhat unusual over the last six months because we recognized a larger R&D rebate, which reduced reported spend for the quarter, but we do not expect that level of rebates every quarter over the next 12 months. So plan for about $1 million to $1.5 million per month, and we have cash into the second quarter of next year under our current plan.
Exactly. So it is not a huge burn rate. Our goal is to raise only what we need through the end of next year and do so in small, judicious transactions. We have an ATM available if needed. We expect potential approval in the UK around Q2 next year and then to start generating revenue thereafter.
Great. That is it for investor questions. Jenny, I will pass it back to you.
Thank you. That concludes our conference call for today. Thank you everyone for joining. You may all disconnect your lines.