Greetings, and welcome to INmune Bio's 2026 third quarter earnings call. As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. in this meeting, there will be no question-and-answer session. Should you have any inquiries, please email them to Mr. Dan Carlson. It is my pleasure to introduce Mr. Dan Carlson, Head of Investor Relations of INmune Bio. Dan?
Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for INmune Bio's third quarter 2026 financial results. Presenting on today's call are David Moss, CEO and co-founder of INmune Bio, Dr. Mark Lowdell, Chief Scientific Officer and co-founder of INmune Bio, and Cory Ellspermann, INmune Bio CFO. Before we begin, I remind everyone that except for statements of historical fact, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those expressed or implied by such forward-looking statements.
Please see the forward-looking statements disclaimer in the company's earnings press release, as well as risk factors in the company's SEC filings, including our most recent quarterly filings with the SEC. There is no assurance of any specific outcome. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change. Except as required by law, INmune Bio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. Now, my pleasure to turn the call over to INmune Bio CEO, David Moss.
Thank you, Dan, and good afternoon, everyone. Thank you for joining us for INmune Bio's third quarter 2026 earnings call. This is an exciting time for INmune Bio. We're getting close to important milestones of entering a new phase in the company's development as we move Ebstrocel towards regulatory approval and prepare to make it available to patients. During the quarter, we made important progress in manufacturing, regulatory preparation, and international patient expansion. Each of these steps brings us closer to our goal of transforming INmune Bio from a clinical-stage company into a commercial-stage company. The immediate focus is on execution as we're getting very close. This involves assembling the complete regulatory package, establishing a practical route to patient access, and carefully allocating capital to these milestones. I want to be clear about our confidence in these activities.
We believe the clinical data presents a compelling case for Ebstrocel as a potentially first-in-class systemic treatment in RDEB. Importantly, Ebstrocel addresses the top concerns from RDEB patients: itch, pain, inflammation, and wounds. Combined with the progress we've made in manufacturing and our discussions with regulators, we believe we're in a strong position as we move towards approval. Of course, the final decisions rest with the regulatory agencies, but our confidence in the program remains very high. Today, I will review our strategy and capital priorities, including how we intend to advance XPro after we've had regulatory clarity on Ebstrocel. Mark will then discuss Ebstrocel's approval process and commercial readiness. Cory will review our financial results, and I will return to summarize the milestones ahead before we take your questions. Before I discuss our regulatory timelines, I want to introduce Alex Hersham, whose child lives with RDEB.
Alex has kindly agreed to join us today to share his perspective as a father and what this disease means for his family. Alex recently visited our manufacturing center in Stevenage and met with the team working on Ebstrocel. For all of us at INmune Bio, hearing directly from families gives our work a deep personal meaning. Behind every clinical endpoint and regulatory milestone is a child, a parent, and a family hoping for a better day's life. Every member of our team, whether in the laboratory, in manufacturing, and across the company, has a role in advancing that goal and shares this mission wholeheartedly. That responsibility gives us urgency and purpose. Our job is to bring the same care and determination to develop potential treatments that families bring to caring for their children every day. Alex, thank you for being here and sharing your family's experience.
I'll turn it over to you.
My son, Abe, is three and a half and has severe recessive dystrophic EB. People tend to think of EB as a skin disease, but day-to-day, it's much more than that. It's his skin, his eyes, and his esophagus. It's itch, pain, constant inflammation, and the exhaustion that comes with all of it. Living with EB means huge stress and a real risk of trauma for him and for us. The daily rhythm is hard, baths are tough, dressing changes are long, and he understandably hates them. Every day starts and ends with care that no two-year-old should have to sit through. VYJUVEK has been a meaningful improvement for Abe. He's been on it for almost three years. It's made a real difference to his wounds, and we're glad to have it. But it's one piece of a much bigger picture.
His eyes are still a very large challenge, although there are a few therapies coming down the track. We need wounds that close longer, and we need better answers for his itch, the inflammation, and his energy. The itch is truly cruel. It is the main cause of his large wounds, including wounds that VYJUVEK had already closed. He scratches, the skin opens, and we start again. Some families have found certain biologics helpful, but nothing works for everyone, and nothing helps consistently. The damage does not stop at the wounds. More wounds means more inflammation, which drives more itch. It takes his sleep, his energy, and so much of his quality of life and ours. A treatment that could genuinely calm the itch and the inflammation behind it would change our lives. That is why continued investment in new approaches matters so much to families like ours.
Thank you, Alex, for sharing your family's experience with us. Hearing from you reinforces why this work matters so much to every employee at INmune Bio. We know that families are counting on progress, and our responsibility is to bring urgency, care, and scientific rigor to every step, from manufacturing to regulatory submission, and ultimately, patient access. Your perspective stays with us as we make those decisions. With that purpose in mind, let me turn to the progress we are making with Ebstrocel and the milestones ahead. We remain on track to complete a U.K. marketing authorization application in early February 2027, with potential U.K. approval by the middle of the year. We are also targeting a U.S. BLA application mid-2027, subject to feedback from our planned FDA interaction. We are prioritizing the U.S. application ahead of an EMA submission.
Focusing on the U.K. approval first is important, given this is where we currently have patients waiting for the drug, which Mark will talk about shortly. The trial was completed in the two leading centers that treat RDEB patients, Great Ormond Street Hospital and Birmingham Children's Hospital. Nearly all the patients from the trial are currently waiting to enroll in a confirmation trial, and we have additional patients also seeking treatment. The Uniphar agreement supports that same objective. It gives us a framework to pursue named patient access in selected European and Middle Eastern and North African markets, with the ability to expand the relationship by agreement. Where local rules permit, physicians may be able to request Ebstrocel for eligible patients before local marketing approval or broad commercial availability. We view our partnership with Uniphar as an important commercial validation of the opportunity we are preparing to address.
It brings an experienced international access and distribution organization alongside Ebstrocel as we move towards commercialization. That is a meaningful step in preparation for this program to be a commercial success. Equally important, named patient supplies could provide an earlier source of revenue while awaiting separate approvals and full commercial launches in every country. With Uniphar's sales and distribution network providing the backbone, we believe named patient sales have the potential to become a meaningful source of revenue as access develops. The timing and scale will depend on country-specific implementation, physician requests, lawful supply agreements, and funding or reimbursement. Thus, we are not announcing a revenue forecast or a date for first sales today. Uniphar's existing capability also allow us to pursue these opportunities without building a complete commercial organization country by country. That matters for a company of our size.
We want our spending to support regulatory execution, reliable supply, and access for patients. While Ebstrocel is clearly our top priority, we remain very enthusiastic about XPro's long-term potential. Our confidence is grounded in the important role that TNF plays in inflammatory diseases. Broad TNF inhibitors such as HUMIRA, ENBREL, and Remicade have collectively generated hundreds of billions of dollars in sales in their lifetime. We believe XPro's selective inhibition of soluble TNF offers an opportunity to address diseases where inflammation plays a central role, while potentially offering advantages over traditional TNF inhibitors. Our strategy is to identify a disease driven by the biology XPro targets, with a clearly identifiable patient population and outcomes that can be addressed efficiently in a suitable rare disease that could support a smaller, faster, and more capital-efficient development program than a large Alzheimer's trial.
Qualifying rare pediatric indications may also offer an additional opportunity through the FDA's Priority Review Voucher Program. Our objective is to identify a program that could reach an approval decision and potentially a voucher on a substantially shorter development timeline. A voucher would be awarded only with a qualifying FDA approval and satisfaction of the applicable requirements and program deadlines. We have not yet selected an indication or established a clinical or regulatory timeframe for this work. Our collaboration with Quantum Computing is intended to guide us through that selection process more efficiently. We have years of preclinical research and data from our clinical trials. Our collaboration will use optimization, artificial intelligence, and conventional analytics to examine these datasets alongside public biomedical information and identify diseases, patient population, and biomarkers that warrant further investigation.
It is our intent to accelerate the analytical work at minimal incremental expense to INmune, concentrating resources on the most promising opportunities before committing to clinical development. We will evaluate what analysis actually delivers, including how optimization compares with conventional approaches. This is a practical effort to improve development decisions using information we already have. I want to make our capital priorities explicit. We intend to defer any significant company-funded investment in the new XPro development program until after Ebstrocel approval. We can undertake indication selection, analysis, and partnership discussions now while keeping the organization focused on Ebstrocel. That sequence allows us to preserve XPro's potential while concentrating our resources on Ebstrocel, our closest asset to commercialization. We believe it's the right way to build value across the company for shareholders. With that, I'll turn the call over to Mark for more details on Ebstrocel. Mark?
Thank you, David, and thank you to everyone that's dialed in to listen to us today. This is another quarter in which we've made substantial progress in bringing Ebstrocel towards marketing approval, as David's alluded to, and I remain highly confident in the strength of the applications we're putting together. Our work is focused on completing a submission that brings the clinical, the non-clinical, manufacturing, and quality evidence together in a coherent package. As a reminder, Ebstrocel is the RDEB-specific cellular medicine developed from our CORDStrom platform. CORDStrom is our pooled allogeneic umbilical cord-derived mesenchymal stromal cell therapy, which is a platform which was developed as a drug from the start. By selecting different donor cord-derived MSC cell banks, we can pool cell banks with different potencies, different functions, to define individual MSC drugs to target different diseases.
Ebstrocel is the first product from that platform, and the individual master cell banks pooled in its manufacturing process are each selected as potent to address the major complications of RDEB. You just heard from Alex about the importance of controlling itch, and we've identified cells that manufacture cytokines or cellular messengers that suppress itch. As you know now, RDEB has consequences beyond individual skin wounds, and our development approach is directed towards the systemic treatment for the endpoints like itch that matter to these patients. Our confidence currently reflects the totality of the evidence and the regulatory preparation we've undertaken to date. The MHRA in the U.K. has provided written alignment across the clinical, non-clinical, and manufacturing elements of our planned application, and they've approved our Pediatric Investigation Plan. All of these are critical to getting a commercial license.
Those are substantive milestones that help define the work required for submission. They don't constitute marketing approval, but they give us a clear foundation on which to complete the application. A few weeks ago, on October 20, we submitted our final pre-MAA package to the MHRA. This is the preparatory package for agency feedback ahead of the full application, and it allows us to address outstanding submission questions and finalize the dossier before the formal assessment by the MHRA begins. Following that feedback, we plan to submit the complete marketing authorization application in early February next year.
Progress in chemistry, manufacturing, and controls has supported this revised strategy, because we now intend to submit the multiple elements constituting the full data package all together, so that the evidence can be assessed as a complete application, rather than the slower process we were previously working towards of an early submission, but with a piecemeal rolling review. Work with our regulatory advisors has encouraged us to submit one more pre-MAA package, which we did on October 20, as I said, prior to the full MAA submission. This revised strategy could advance potential U.K. approval of Ebstrocel by between six to 12 weeks compared with our previous expectations from the rolling review process. As we stated in our October release, we anticipate an MHRA response within three to six months following submission, subject to application validation, agency review, and any requests for additional information.
That's the basis of our expectations of a potential approval in mid-2027. It's a planning assumption rather than a guaranteed agency decision date, obviously. After discussion with U.K. clinical experts, our most recent assessment of the clinical need in the U.K. has identified around 100 patients who will be eligible for Ebstrocel upon approval, and we're fully focused on meeting this need. Approximately 40 of these 100 children will be treated in our phase III trial, which goes on until mid-2028, but thereafter will require ongoing treatment. Reimbursement discussions will begin with the U.K. government early in 2027. Once Ebstrocel is approved for the treatment of RDEB in the U.K., we anticipate a demand for off-label use to treat adult patients with RDEB and the wider community of between 500 and 600 patients with non-recessive but dystrophic EB, the DEB patients.
Manufacturing component is especially important for a cell therapy, as I'm sure many of you know, and we've demonstrated that the product supplied to patients can be manufactured consistently and released against appropriate quality standards. The pooling approach that we invented, and which is behind our platform, has been proven to overcome donor variability, and our manufacturing strategy has been validated as providing reproducible batches from three independent master cell banks, all selected for their ability to treat RDEB. We've started the transition to the manufacturing scale for the commercial supply chain, which will be validated in the initial batches made for our confirmatory phase III trial, which will open in Q1 next year.
This trial is funded by us, and we run at the same two U.K. national centers for pediatric RDEB, Great Ormond Street Children's Hospital in London and Birmingham Children's Hospital, the sites that ran the previous trial. We've also established access to high-quality umbilical cord tissue through our relationship with the Anthony Nolan UK Cord Blood Bank, and these tissues can be used to manufacture products for the United States following an agreement with the United States donor screening company, Eurofins. Together, the tissue supply, manufacturing process, and quality controls are now in place to support the transition from clinical development to reliable patient supply for a global need. These are the practical foundations for our confidence. We understand the work that's remaining, we have a defined submission objective, and we believe the program is well-positioned for a positive regulatory outcome.
In the United States, we've commissioned a company with a team of regulatory advisors with expertise in rare disease indications. They're already preparing a Type B meeting request for early 2027, and the FDA feedback from that will inform the timing of a 2027 BLA submission for accelerated approval of Ebstrocel for RDEB in the U.S. We're prioritizing that application ahead of the EMA, as David said just now. The Uniphar relationship, which David described, complements our regulatory work by addressing how Ebstrocel can reach patients internationally. The framework can support named patient supply in eligible markets and potentially broader distribution as local approvals, pricing, and reimbursement established over time. For patients, the opportunity is earlier access where local law allows it. For INmune, it's a way to develop treatment center relationships and supply experience while creating the potential for early revenue.
Individual country arrangements and the required statements of work must be put in place before those opportunities become operational, though. Our responsibility is to ensure that the regulatory progress, manufacturing, and patient access develop together. We believe we're building the foundations to do that very successfully, and I'm confident in Ebstrocel's potential and in our team's ability to deliver a strong application for regulatory review. Finally, our CORDStrom patent application entered the U.S. national phase in July this year, following a favorable international written opinion. If granted, the patent family is expected to provide protection extending into at least 2045. The examination remains ongoing. This is a patent application rather than an issued patent. I'll now hand over to Cory for an update on the current financials. Cory?
Thank you, Mark. At this time, I'll provide a brief overview of our financial results. Net loss attributable to common stockholders for the quarter ended September 30, 2026, was approximately $4.7 million compared with approximately $6.5 million for the quarter ended September 30, 2025. Research and development expenses totaled approximately $3.2 million for the quarter ended September 30, 2026, compared with approximately $4.9 million for the quarter ended September 30, 2025. General and administrative expenses were approximately $1.8 million for the quarter ended September 30, 2026, compared with approximately $2.5 million for the quarter ended September 30, 2025. At September 30, 2026, the company had cash and cash equivalents of approximately $16.3 million. Also, during October, the company raised $4.5 million in gross proceeds from the sale of common stock and warrants to an investor.
Based on our current operating plan, we believe our cash is sufficient to fund our operations through Q3 of 2027. As of November 5, 2026, the company had approximately 31 million shares of common stock outstanding. Now, I'll hand the call back to David.
Thank you, Cory, and thank you, Mark. Ebstrocel is approaching the milestones that can change the financial and strategic position of INmune Bio. Our confidence in approval is strong, and we're preparing the company to turn that opportunity into patient access, distribution, and ultimately a sustainable commercial business. The milestones to watch are the MHRA's feedback on our final pre-MAA package, completion and submission of the U.K. application in early February, and the anticipated review process supporting potential U.K. approval in mid-2027. In the United States, our next regulatory interaction will inform the planned BLA submission, which you will hear about. Alongside those activities, we'll work with Uniphar to develop country-specific access arrangements. We believe lawful named patient sales can generate an earlier route to revenue than waiting for full commercial launches in every market.
As implementation progresses, we'll update investors on material developments rather than assume that the framework agreements alone represent product sales. For XPro, we'll continue the indication selection work with the goal of identifying compelling rare disease opportunity where we apply AI optimization and conventional analytics to our clinical and preclinical data and publicly available datasets. We intend to keep significant new company-funded development spending behind Ebstrocel approval. Our priority is to reach that milestone while preserving the potential of the broader pipeline. We continue to view disciplined capital allocation as essential. During July, we received approximately $4.2 million through Australia's R&D rebate program, following approximately $0.4 million received from the U.K. in June. These receipts provide non-dilutive support for our development activities.
On October 28, we announced a registered direct offering and concurrent private placement with expected gross proceeds of approximately $4.5 million before fees and expenses from a single healthcare investor. The transaction included three million common shares and warrants for up to three million additional shares. We have a defined plan, an experienced team, and growing commercial infrastructure around our lead program. We believe Ebstrocel can become an important treatment for families living with RDEB and the foundation for INmune Bio's next stage of growth. I want to thank our employees, investigators, clinical collaborators, patients and families, and our shareholders for their continued support. We look forward to reporting our progress. Thank you for joining us today. On behalf of the entire INmune Bio team, we look forward to updating you as we reach our next milestones. Have a good evening, everybody.
Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Have a great day.