인뮨 바이오(INMB) 2026년 3분기 실적 발표: 에브스트로셀, 2027년 2월 영국 허가 신청 목표

핵심 요약

• 2026년 3분기 보통주 주주 귀속 순손실은 2025년 3분기의 650만 달러에서 약 470만 달러로 축소되었다.
• 연구개발(R&D) 비용은 490만 달러에서 320만 달러로 감소한 반면, 일반관리비는 250만 달러에서 180만 달러로 줄었다.
• 2026년 9월 30일 기준 현금 및 현금성 자산은 총 약 1,630만 달러로 집계됐다. 이후 10월 자금 조달을 통해 총 450만 달러의 조달 금액을 확보했다.
• 경영진은 회사의 기존 운영 계획에 따라 현재 보유 현금으로 2027년 3분기까지 사업 운영 자금을 충당할 수 있을 것으로 보고 있다.
• 인뮨 바이오는 2027년 2월 초 엡스트로셀의 영국 품목허가 신청서를 제출할 계획이다. 경영진은 영국 의약품·의료제품규제청(MHRA)의 심사에 따라 2027년 중반 허가 가능성을 계획 수립을 위한 가정으로 보고 있다.
• 회사는 엡스트로셀을 최우선 과제로 삼고 있으며, 자체 자금이 투입되는 신규 XPro 개발 프로그램에 대한 대규모 투자는 엡스트로셀 승인 이후로 연기할 방침이다.

주요 재무 데이터

인뮨 바이오는 10월 보통주 및 워런트 매각을 통해 총 450만 달러의 조달 금액을 확보했다. 해당 거래에는 보통주 300만 주와 최대 300만 주의 추가 주식을 매수할 수 있는 워런트가 포함되었다. 2026년 11월 5일 기준 발행주식총수는 약 3,100만 주다.

회사는 또한 7월에 호주의 R&D 환급 프로그램을 통해 약 420만 달러를, 6월에는 영국으로부터 약 40만 달러를 수령했다.

사업 및 영업 실적

엡스트로셀은 여전히 인뮨 바이오의 최우선 개발 및 자본 배분 대상이다. 이 열성 이영양성 수포성 표피박리증(RDEB) 특화 세포 치료제는 회사의 풀링 방식 동종 탯줄 유래 중간엽 기질세포 플랫폼인 CORDStrom을 기반으로 한다.

인뮨 바이오는 2026년 10월 20일 영국 MHRA에 최종 사전 품목허가 신청 패키지를 제출했다. 회사는 이제 순차 심사(rolling review) 방식을 활용하는 대신 임상, 비임상, 제조 및 품질 전체 패키지를 일괄 제출할 계획이다. 경영진은 이 수정된 전략을 통해 영국의 승인 가능 시점을 기존 예상보다 6~12주 앞당길 수 있을 것이라고 밝혔다.

회사는 승인 후 약 100명의 영국 환자가 엡스트로셀 투여 대상이 될 수 있을 것으로 추산하고 있다. 2027년 1분기에 시작해 2028년 중반까지 진행될 예정인 회사 자금 지원 확증 임상 3상 시험에서는 약 40명의 소아가 치료를 받을 것으로 예상된다. 영국 정부와의 보험 급여 논의는 2027년 초에 시작될 예정이다.

제조 준비 작업은 상업적 생산 규모를 향해 진행되고 있다. 경영진은 해당 공정을 통해 세 개의 독립적인 마스터 세포은행(MCB)에서 재현성 있는 배치를 생산했다고 밝혔다. 초기 상업적 규모 배치는 확증 임상시험을 통해 검증될 예정이다. 아울러 인뮨 바이오는 앤서니 놀란 영국 제대혈 은행을 통해 탯줄 조직 확보 경로를 마련했으며, 미국 제조 요건을 충족하기 위한 기증자 선별 협약도 체결했다.

유니파(Uniphar)와의 계약은 유럽, 중동 및 북아프리카의 일부 시장에서 지정 환자 대상 공급(named-patient access)을 위한 기반을 제공한다. 경영진은 이 경로를 통해 현지의 전면적인 상업 출시 이전에도 매출을 창출할 수 있을 것이라고 밝혔으나, 이를 위해서는 국가별 협약, 의사의 요청, 적법한 공급 계약, 자금 지원 또는 보험 급여가 먼저 확립되어야 한다.

XPro의 경우 인뮨 바이오는 희귀질환 적응증, 환자군 및 바이오마커를 평가하기 위해 최적화, 인공지능(AI) 및 기존 분석 방식을 활용하고 있다. 회사는 아직 적응증을 선정하거나 임상 또는 규제 프레임워크를 수립하지 않았다. 회사 자금이 투입되는 대규모 개발 지출은 엡스트로셀 승인 이후까지 계속 연기될 것으로 예상된다.

경영진 가이던스

경영진은 2027년 2월 초 엡스트로셀의 영국 품목허가 신청서 전체를 제출할 계획이다. 회사는 신청서 적격성 검증, 규제기관 심사 및 추가 정보 요청 등에 따라 제출 후 3~6개월 이내에 MHRA의 답변이 나올 것으로 예상하고 있다. 2027년 중반 승인 가능성은 경영진의 계획 수립을 위한 가정일 뿐이며 확정된 결정일은 아니다.

미국의 경우 규제 자문단이 2027년 초를 목표로 B형 미팅(Type B meeting) 요청을 준비 중이다. FDA의 피드백은 가속 승인을 위해 2027년으로 계획된 생물학적제제 품목허가 신청(BLA) 시점을 결정하는 데 반영될 예정이다. 경영진은 해당 규제기관 피드백에 따라 2027년 중반을 목표 시점으로 제시한 바 있다. 미국 내 신청은 유럽의약품청(EMA) 제출보다 우선적으로 추진되고 있다.

현재 운영 계획을 바탕으로 경영진은 가용 현금으로 2027년 3분기까지 사업 운영을 지속할 수 있을 것으로 보고 있다.

위험 요인 및 주목할 점

• 최종 승인 결정과 심사 일정은 여전히 MHRA 및 FDA의 결정에 달려 있다.
• MHRA 심사는 신청서 적격성 검증 및 추가 정보 요청에 따라 영향을 받을 수 있다.
• 지정 환자 대상 판매는 국가별 규정, 의사의 수요, 공급 계약, 보험 급여 또는 자금 지원에 좌우된다. 회사는 예상 매출이나 첫 판매 시점을 제시하지 않았다.
• 엡스트로셀의 상업적 규모 제조 공정은 여전히 확증 임상 3상 시험을 위해 생산된 배치를 통한 검증이 필요하다.
• CORDStrom의 미국 특허 출원은 심사 중이며 아직 등록되지 않았다. 특허가 등록될 경우 경영진은 해당 특허군이 최소 2045년까지 보호를 제공할 것으로 기대하고 있다.
• XPro 프로그램은 아직 적응증이 선정되지 않았으며 명확한 임상 및 규제 경로도 수립되지 않았다.

실적 발표 콘퍼런스콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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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