INmune Bio (INMB) 2026年第3季法說會：Ebstrocel 目標於2027年2月在英國提出申請

重點摘要

• 2026 年第三季歸屬於普通股股東的淨虧損從 2025 年第三季的 650 萬美元收窄至約 470 萬美元。
• 研發費用從 490 萬美元降至 320 萬美元，一般及行政費用則從 250 萬美元降至 180 萬美元。
• 截至 2026 年 9 月 30 日，現金及約當現金總額約為 1,630 萬美元。隨後在 10 月的融資中募集了 450 萬美元的總收益。
• 管理階層認為，依據公司現有的營運計畫，目前的現金足以支應營運至 2027 年第三季。
• INmune Bio 計劃於 2027 年 2 月初提交 Ebstrocel 的英國上市許可申請。管理階層將 2027 年年中獲得核准視為規劃假設，具體取決於英國 MHRA 的審查進度。
• 公司將 Ebstrocel 列為優先項目，並打算延後對新 XPro 開發計畫的大筆自有資金投資，直至 Ebstrocel 獲得核准為止。

重要財務數據

INmune Bio 於 10 月透過發售普通股與認股權證募集了 450 萬美元的總收益。該交易包括 300 萬股普通股，以及最多可額外認購 300 萬股的認股權證。截至 2026 年 11 月 5 日，已發行普通股約為 3,100 萬股。

該公司還於 7 月透過澳洲的研發退稅補助計畫獲得約 420 萬美元，並於 6 月自英國獲得約 40 萬美元。

業務與營運表現

Ebstrocel 仍是 INmune Bio 的主要研發與資本配置重心。這款針對隱性失養型水疱症 (RDEB) 的細胞藥物，是基於該公司混合、異體、源自臍帶的間質幹細胞平台 CORDStrom 開發而成。

INmune Bio 於 2026 年 10 月 20 日向英國 MHRA 提交了上市許可申請前的最終資料套件。該公司目前打算一次性提交完整的臨床、非臨床、製造與品質資料套件，而非採用滾動式審查。管理階層表示，相較於先前預期，這項調整後的策略可望將潛在的英國核准時間提前 6 至 12 週。

該公司估計，在獲得核准後，英國約有 100 名病患符合使用 Ebstrocel 的資格。預計約有 40 名兒童將在公司出資的確認性第三期試驗中接受治療，該試驗預計於 2027 年第一季展開並持續至 2028 年年中。與英國政府的健保給付協商預計於 2027 年初啟動。

生產製備正邁向商業化規模。管理階層表示，該製程已從三個獨立的主細胞庫生產出具可重複性的批次。最初的商業化規模批次將透過確認性試驗進行驗證。INmune Bio 還透過英國安東尼諾蘭臍帶血庫 (Anthony Nolan UK Cord Blood Bank) 取得臍帶組織，其捐贈者篩檢安排旨在支援美國的生產法規要求。

與 Uniphar 簽署的協議為選定的歐洲、中東和北非市場提供了特定病患用藥管道 (named-patient access) 的合作框架。管理階層表示，此管道可在全面於當地商業化推出之前帶來營收，但必須先確立各國具體安排、醫師處方需求、合法供應協議以及資金或健保給付機制。

針對 XPro，INmune Bio 正利用最佳化技術、人工智慧及傳統分析方法來評估罕見疾病適應症、病患族群和生物標記。該公司尚未選定適應症，也未建立臨床或監管框架。預計由公司出資的大筆研發支出將持續遞延至 Ebstrocel 獲得核准之後。

管理階層指引

管理階層計劃於 2027 年 2 月初提交 Ebstrocel 完整的英國上市許可申請。該公司預期在提交後的 3 至 6 個月內收到 MHRA 的回覆，具體時程取決於申請案有效性驗證、主管機關審查以及補充資料要求。2027 年年中可能獲得核准僅為管理階層的規劃假設，並非保證的決定日期。

在美國方面，監管顧問正在準備 2027 年初提出 Type B 會議申請。FDA 的回饋意見將作為規劃於 2027 年提交生物製劑許可申請 (BLA) 以尋求加速核准的時間依據。管理階層先前將 2027 年年中定為目標，但仍取決於主管機關的回饋。在申請時程上，美國的送件將優先於歐洲藥品管理局 (EMA) 的送件。

根據目前的營運計畫，管理階層認為現有現金將可支應營運至 2027 年第三季。

風險與關注焦點

• 最終核准決定與審查時程仍取決於 MHRA 與 FDA。
• MHRA 的審查可能會受到申請案有效性驗證及補充資料要求的影響。
• 特定病患用藥銷售取決於各國法規、醫師需求、供應協議以及健保給付或資金補助。該公司尚未提供營收預測或首次銷售日期。
• Ebstrocel 的商業化規模製造製程仍需透過為確認性第三期試驗生產的批次進行驗證。
• CORDStrom 的美國專利申請仍在審查中，尚未獲准。管理階層預期，若順利獲准，該專利家族將提供至少至 2045 年的保護期。
• XPro 計畫尚未選定適應症，也未確立明確的臨床與監管路徑。

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管理層陳述

Operator

Transcripts will follow within 24 hours of this conference call. In this meeting, there will be no question and answer sessions. If you have any inquiries, please email them to Mr. Dan Carson. It is my pleasure to introduce Mr. Dan Carson, Head of Investor Relations of INmune Bio.

Daniel Carlson

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.

David Moss

Thank you, Dan, 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'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. This 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.

Unknown Speaker

My son, [ A.B. ], is 3.5 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. Their 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 3-year-old should have to sit through.

Vyjuvek has been a meaningful improvement for Eddie. He's been on it for almost 3 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's 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 doesn't 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's why continued investment in new approaches matters so much to families like us.

David Moss

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 resubmission, 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 UK marketing authorization application in early February 2027 with potential UK approval by the middle of the year. We're also targeting a U.S. BLA application, mid-'27, subject to feedback from our planned FDA interaction. We're prioritizing the U.S. 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 two leading centers that treat RDEB patients, Great Ormond Street Hospital and Birmingham Children's Hospital. Currently 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 East and North Africa 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. Our partnership with Uniphar is 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. And that is a meaningful step in preparation for this program to be a commercial success.

Equally important, named patient supply 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're not announcing a revenue forecast or a date for first sales today. Uniphar's existing capabilities 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, 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. The 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 Inc. 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. That's alongside public biomedical information and identify diseases, patient populations, 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 Lowdell

Thank you, David, and thank you to everyone that's dialed in to listen to us today. So 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. 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. 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, 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. MHRA in the UK has provided written alignment across the clinical, non-clinical, and manufacturing elements of our planned application, and they've approved our paediatric investigation plan. All of these are critical to getting a commercial licence. 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 20th, we submitted our final pre-MAA package to the MHRA, the preparatory package for agency feedback ahead of the full application. 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, early submission but with a piecemeal rolling review. Work with our regulatory advisers has encouraged us to submit one more pre-MAA package, which we did on October 20th, as I said, prior to the full MAA submission. This revised strategy could advance potential UK approval of Ebstrocel 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 3–6 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 UK clinical experts, our most recent assessment of the clinical need in the UK 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 3 trial, which goes on until mid-2028, but thereafter will require ongoing treatment. Reimbursement discussions will begin with the UK government early in 2027. Once Ebstrocel 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.

The manufacturing component is especially important for a cell therapy, as I'm sure many of you know. We've 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'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 3 trial, which will open in Q1 next year. This trial is funded by us and will run at the same two UK national centres for paediatric RDEB, Great Ormond Street Hospital for Children 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 reimbursements are 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 there.

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 favourable 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?

Cory Ellspermann

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. 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 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.

David Moss

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 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'll work with Uniphar to develop country-specific access arrangements. We believe 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 will continue the indication selection work with the goal of identifying and completing identifying compelling rare disease opportunities 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 UK 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. 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 Ebstrocel can become an important treatment for families living with RDEB and a 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.

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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