INmune Bio (INMB) Q3 2026 Earnings Call Transcript

DATE

Thursday, Nov. 5, 2026

CALL PARTICIPANTS

• head of investor relations - Daniel Frederick Carlson
• CEO and Co-Founder - David J. Moss
• Chief Scientific Officer and cofounder - Dr. Mark Lowdell
• CFO - Cory Ellspermann

TAKEAWAYS

• Net Loss -- $4.7 million for the third quarter, compared with $6.5 million in the prior year period, driven by reductions in research and development and general and administrative spending.
• Research and Development Expenses -- $3.2 million for the quarter, decreasing from $4.9 million in the third quarter of 2025.
• General and Administrative Expenses -- $1.8 million for the quarter, compared with $2.5 million in the prior year period.
• Cash and Cash Equivalents -- $16.3 million as of Sept. 30, 2026, which the company believes is sufficient to fund operations through the third quarter of 2027.
• Non-Dilutive Funding -- $4.2 million received in July via Australia's R&D rebate program and $400,000 received from the U.K. program in June.
• Common Stock and Warrants Offering -- $4.5 million in gross proceeds raised in October through the sale of 3 million common shares and warrants for up to 3 million additional shares.
• Shares Outstanding -- 31 million shares of common stock as of Nov. 5, 2026.
• UK MAA Submission -- targeted for early Feb. 2027, following the submission of a final pre-MAA package to the MHRA on Oct. 20, 2026.
• Potential UK Approval Timeline -- anticipated by mid-2027, a revised strategy that could advance approval by 6 to 12 weeks compared with previous rolling review expectations.
• U.S. BLA Submission -- planned for mid-2027 for accelerated approval in RDEB, following a planned type B meeting with the FDA in early 2027.
• UK Patient Eligibility -- 100 children identified as eligible for Ebstracel upon approval, with approximately 40 of those children currently participating in the phase 3 trial.
• Phase 3 Trial Timeline -- opening in the first quarter of 2027 and running through mid-2028 at two national centers in the United Kingdom.
• Off-Label Market Opportunity -- estimated at 500 to 600 patients with non-recessive dystrophic epidermolysis bullosa in the wider community.
• Named Patient Sales Partnership -- established through an agreement with Uniphar to provide access in selected European, Middle Eastern, and North African markets.
• Patent Duration -- expected to provide protection extending into at least 2020, following the CORDStrom patent application entering the U.S. national phase in July 2026.
• Manufacturing Scale -- transitioning to commercial supply chain scale, validated through reproducible batches from three independent master cell banks.

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RISKS

• Moss stated, "The timing and scale will depend on country specific implementation, physician requests, lawful supply agreements, and funding or reimbursement," regarding the potential for revenue from named patient sales through the Uniphar partnership.

SUMMARY

INmune Bio Inc. (NASDAQ:INMB) is transitioning from a clinical-stage to a commercial-stage biotechnology company as it advances its lead candidate, Ebstracel, toward regulatory approval for the treatment of recessive dystrophic epidermolysis bullosa. Management reported that the company is prioritizing regulatory submissions in the United Kingdom and the United States, utilizing a revised submission strategy to potentially accelerate the approval timeline in the U.K. market. The company is deferring significant new investment in its secondary asset, XPro, to focus resources on Ebstracel's commercialization while utilizing non-dilutive funding and targeted equity raises to maintain its cash runway into the second half of 2027. The established partnership with Uniphar provides a framework for international patient access and early revenue potential through named patient sales while full marketing authorizations are pending.

• The company's CORDStrom platform utilizes pooled allogeneic umbilical cord-derived mesenchymal stromal cells to overcome donor variability and target specific RDEB complications like itch and inflammation.
• Management is utilizing a collaboration with quantum computing to apply artificial intelligence and optimization to clinical data for selecting rare disease indications for the XPro pipeline.
• Chief Scientific Officer Lowdell noted that the company has secured tissue supply through an agreement with the Anthony Nolan UK Cord Blood Bank and donor screening through Eurofins to support global needs.
• The company intends to target rare pediatric indications for XPro that may qualify for the FDA Priority Review Voucher program upon approval.
• A type B meeting request with the FDA is scheduled for early 2027 to define the clinical and regulatory framework for a biologics license application for Ebstracel.

INDUSTRY GLOSSARY

• RDEB: Recessive Dystrophic Epidermolysis Bullosa, a severe genetic skin condition characterized by chronic wounds, itch, and inflammation.
• MAA: Marketing Authorization Application, the regulatory package submitted to European or U.K. authorities for drug approval.
• BLA: Biologics License Application, the submission required for the FDA to approve a biologic drug in the United States.
• MSC: Mesenchymal Stromal Cells, multipotent cells that can be derived from various tissues, including umbilical cord blood.
• CORDStrom: The company's proprietary platform for developing pooled allogeneic cell therapies.
• Ebstracel: An investigational cell therapy specifically developed for the systemic treatment of RDEB.
• PRV: Priority Review Voucher, an FDA incentive that grants the holder an accelerated six-month review for a future drug application.
• TNF: Tumor Necrosis Factor, a signaling protein involved in systemic inflammation.
• MHRA: Medicines and Healthcare products Regulatory Agency, the regulatory body for medicines in the United Kingdom.

Full Conference Call Transcript

Operator: Greetings, and welcome to INmune Bio's 26 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. Daniel Carlson. It is my pleasure to introduce Mr. Daniel Carlson, head of investor relations of immune bio. Daniel?

Daniel Frederick Carlson: Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for INmune Bio's third quarter 26 Financial Results. Presenting on today's call are David J. Moss, CEO and Co-Founder of Immune Bio, Dr. Mark Lowdell, Chief Scientific Officer and cofounder of InMune Bio and Cory Ellspermann, INmune Bio's 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 2 thousand.

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, Immune Bio disclaims any obligation to update these forward looking statements to reflect future information, events or circumstances.

Now, it is my pleasure to turn the call over to INmune Bio's CEO, David J. Moss.

David J. Moss: Thank you, Daniel, and good afternoon, everyone. Thank you for joining us for INmune Bio's third quarter 26 earnings call. This is an exciting time for INmune Bio. We are getting close to important milestones of entering a new phase in the company's development, as we move Ebstracel 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 are 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 Ebstracel as a potentially first in class systemic treatment in RDEB. Importantly, Ebstracel addresses the top concerns from RDEB patients. Itch, pain, inflammation, and wounds. Combined with the progress we have made in manufacturing and our discussions with regulators, we believe we are in a strong position as we move towards approval. Course, the final decision is 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 have had regulatory clarity on Ebstracel. Mark will then discuss Ebstracel's approval process and commercial readiness. Cory will review our financial results, and I will return to summarize the 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 Ebstracel.

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 will turn it over to you.

Life on AD is 3.5 and has severe recessive dystrophic EB. People tend to think of EB as a skin disease. But day to day, it is much more than that. it is his skin, his eyes, and his esophagus. it is 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 they understandably hate them. Every day starts and ends with care that no 3-year-old should have to sit through.

VYJUVEK has been a meaningful improvement for AB. he is been on it for almost 3 years, it is made a real difference to his wounds, and we are glad to have it. But it is 1 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 had already closed. His scratches, the skin opens, and we start again.

Some families have found certain biologics helpful, but nothing works for everyone and nothing helps consistently. And the damage does not stop at the wounds. More wounds means more information, 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 Ebstracel and the milestones ahead. We remain on track to complete a UK marketing authorization application in early February 2027 with potential UK approval by the middle of the year. We are also targeting a U. S. Application mid-27 subject to feedback on our planned FDA interaction. We are prioritizing The US application ahead of an EMA submission.

Focusing on The UK 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 2 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 the 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 Ebstracel 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 Ebstracel 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 launch 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 Ebstracel 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 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 framework for this work. Our collaboration with quantum computing intends. 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 Immune, 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 Ebstracel approval.

We can undertake indication selection, analysis, and partnership discussions now, while keeping the organization focused on Ebstracel. That sequence allows us to preserve XPro's potential while concentrating our resources on Ebstracel, the closest asset to commercialization. We believe it is the right way to build value across the company for shareholders. With that, I will turn the call over to Mark for more details on Ebstracel. Mark?

Mark William Lowdell: Thank you, David, and thank you to everyone that is dialed in to listen to us today. So this is another quarter in which we have made substantial progress. In bringing Ebstracel towards marketing approval, as David's alluded to. And I remain highly confident in the strength of the applications we are putting together. Our work is focused on completing a submission that brings the clinical, the nonclinical, manufacturing and quality evidence together in a coherent package. As a reminder, Ebstracel is the RDEB specific cellular medicine developed from our CORDStrom platform. And 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. Ebstracel 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. We just heard from Alex about the importance of controlling itch, and we have 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 have undertaken to date. MHRA in The UK has provided written alignment across the clinical, nonclinical, and manufacturing elements of our planned application and they have 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 do not 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 finalise 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 altogether, 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 advisers has encouraged us to submit 1 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 UK approval of Ebstracel by between 6 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 3 to 6 months following submission. Subject to application validation. Agency review, and any request for additional information. that is the basis of our expectations of potential approval in mid 27. it is a planning assumption rather than a guaranteed agency decision date, obviously.

After discussion with UK clinical experts, our most recent assessment of the clinical need in The UK has identified around 100 patients who will be eligible for Ebstracel upon approval. And we are fully focused on meeting this need. Approximately 40 of these 100 children will be treated in our phase 3 trial, which goes on until mid 28, but thereafter will require ongoing treatment. Reimbursement discussions will begin with the UK government early in 2027.

Once Ebstracel is approved for the treatment of RDEB in The UK, 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 cell therapy as I am sure many of you know and we have demonstrated that the products supplied to patients can be manufactured consistently and released against appropriate quality standards.

The pooling approach that we invented, which is behind our platform, has been proven to overcome donor variability and our manufacturing strategy has been validated as providing reproducible batches from 3 independent master cell banks all selected for their ability to treat RDEB. We 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 3 trial, which will open in Q1 next year. This trial is funded by us, and we run at the same 2 UK 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 have also established access to high quality umbilical cord tissue through our work 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 is 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 have commissioned a company with a team of regulatory expertise in rare disease indications. They are already preparing a type b meeting request for early 27 and the FDA feedback from that will inform the timing of a 2027 BLA submission for accelerated approval of Ebstracel for RDEB in The US. We are prioritizing that application ahead of the EMA as David said just now. The UNIFAR relationship, which David described, complements our regulatory work by addressing how Ebstracel 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 immune, it is 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 there. Our responsibility is to ensure that the regulatory progress, manufacturing and patient access develop together. Believe we are building the foundations to do that very successfully and I am confident in Ebstracel's potential and in our team's ability to deliver a strong application for regulatory review. Finally, our CORDStrom patent application entered The US 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 2020. Examination remains ongoing, This is a patent application rather than an issued patent. I will now hand over to Cory for an update on the current financials. Cory?

Cory Randall Ellspermann: Thank you, Mark. At this time, I will 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.

And 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. And based on our current operating plan, we believe our cash is sufficient to fund our operations through Q3 of 27. As of November 5, 2026, the company had approximately 31 million shares of common stock outstanding. Now I will hand the call back to David.

David J. Moss: Thank you, Cory, and thank you, Mark. Ebstracel is approaching the milestones that can change the financial and strategic position of INmune Bio. Our confidence in approval is strong. And we are 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 UK application in early February, and the anticipated review process supporting potential UK approval, in mid-27. In The United States, our next regulatory interaction will inform the planned BLA submission. Which you will hear about. Alongside those activities, we will 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 will update investors on material developments rather than assume that the framework agreements alone represent product sales. XPro, will continue the indication selection work, with the goal of identifying and completing and identifying a compelling rare disease opportunity we apply AI optimization and conventional analytics to our clinical and preclinical data and publicly available data sets. We intend to keep significant new company funded development spending behind Ebstracel 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 $400 thousand 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 in concurrent private placement with expected gross proceeds of approximately $4.5 million before fees and expenses from a single healthcare investor, The transaction included 3 million common shares and warrants for up to 3 million additional shares. We have a defined plan an experienced team, and growing commercial infrastructure around our lead program.

We believe Ebstracel 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 milestone. Have a good evening, everybody.

Operator: 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.

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