INmune Bio (INMB) 2026年第三季度财报电话会：Ebstrocel英国申报目标定于2027年2月

核心要点

• 2026年第三季度归属于普通股股东的净亏损由2025年第三季度的650万美元收窄至约470万美元。
• 研发费用从490万美元降至320万美元，一般及行政开支从250万美元降至180万美元。
• 截至2026年9月30日，现金及现金等价物总计约1630万美元。此后，公司在10月通过融资募集了450万美元的总收益。
• 管理层认为，在公司现行运营计划下，现有现金将可支持运营至2027年第三季度。
• INmune Bio计划于2027年2月初提交Ebstrocel在英国的上市许可申请。管理层将2027年年中获得潜在批准视为规划假设，具体取决于英国药品和保健品监管局（MHRA）的审查情况。
• 公司正重点推进Ebstrocel，并打算推迟对新XPro研发项目的大额自筹资金投入，直至Ebstrocel获得批准。

关键财务数据

INmune Bio在10月通过发售普通股和认股权证募集了450万美元的总收益。该交易包括300万股普通股以及最多可认购300万股额外股份的认股权证。截至2026年11月5日，已发行普通股约为3100万股。

公司还在7月通过澳大利亚的研发退税计划获得约420万美元，并在6月从英国获得约40万美元。

业务与经营表现

Ebstrocel仍是INmune Bio的首要研发和资本配置重点。这款针对隐性营养不良型大疱性表皮松解症（RDEB）的细胞药物基于该公司的混合、同种异体、脐带来源间充质基质细胞平台CORDStrom。

INmune Bio于2026年10月20日向英国药品和保健品监管局（MHRA）提交了最终的上市许可预申请资料包。该公司现打算一次性提交完整的临床、非临床、生产制造和质量资料包，而非采用滚动审评。管理层表示，与先前预期相比，这一修订后的策略可能使英国的潜在获批时间提前6至12周。

该公司估计，获批后约有100名英国患者可能符合Ebstrocel的用药条件。预计约有40名儿童将在公司出资的确证性3期临床试验中接受治疗，该试验计划于2027年第一季度启动并持续至2028年年中。与英国政府的医保报销谈判预计将于2027年年初启动。

生产准备工作正朝着商业化规模推进。管理层表示，该工艺已从三个独立的主细胞库中生产出具有重现性的批次。首批商业化规模批次将通过确证性试验进行验证。此外，INmune Bio还通过英国安东尼诺兰脐带血库（Anthony Nolan UK Cord Blood Bank）获得了脐带组织供应，其供体筛查安排旨在支持美国的生产监管要求。

与Uniphar达成的协议为在欧洲、中东和北非的部分市场开展指定患者用药项目（named-patient access）提供了框架。管理层表示，在当地全面商业化上市之前，该渠道有望产生收入，但必须先落实各国具体安排、医生申请、合法供应协议以及资金或医保报销支持。

对于XPro，INmune Bio正利用优化算法、人工智能和传统分析方法来评估罕见病适应症、患者群体和生物标志物。公司目前尚未选定适应症，也未确立临床或监管框架。预计大额自筹研发支出在Ebstrocel获批前仍将保持推迟状态。

管理层指引

管理层计划于2027年2月初提交Ebstrocel在英国的完整上市许可申请。公司预计在提交申请后3至6个月内收到MHRA的回复，具体取决于申请审查验证、机构审评以及补充信息的要求。2027年年中获得潜在批准是管理层的规划假设，而非确定的决定日期。

在美国，监管顾问正在准备2027年年初的B类会议申请。FDA的反馈将为计划于2027年提交的加速批准生物制品许可申请（BLA）的时间安排提供依据。管理层此前将2027年年中定为目标，但仍取决于该监管反馈。美国申请的推进优先级高于向EMA的申请提交。

基于当前的运营计划，管理层认为可用现金将支持运营至2027年第三季度。

风险与关注要点

• 最终审批决定和审评时间仍取决于MHRA和FDA。
• MHRA的审评可能会受到申请审查验证及补充资料要求的影响。
• 指定患者用药销售取决于各国具体法规、医生需求、供应协议以及医保报销或资金支持。公司尚未提供收入预测或首次销售日期。
• Ebstrocel的商业化生产工艺仍需通过为确证性3期临床试验生产的批次进行验证。
• CORDStrom的美国专利申请目前仍在审查中，尚未获得授权。管理层预计，若获授权，该专利族将提供至少到2045年的保护期。
• XPro项目尚未选定适应症，也未明确临床和监管路径。

财报电话会议完整纪要

完整财报电话会议逐字稿

管理层陈述

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.

This live transcript is auto-generated without human intervention or review.