Inmune Bio plans Ebstrocel UK application for Feb. 2027
INmune Bio targets a complete UK application in February 2027 and a U.S. BLA in Q2 2027, with the latter subject to FDA feedback.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Inmune Bio, Inc. (INMB) submitted the final pre-Marketing Authorisation Application (pre-MAA) package for investigational Ebstrocel to the UK MHRA on October 21, 2026. After MHRA feedback, it plans a complete UK MAA in February 2027, replacing a rolling submission previously planned for late 2026. The company says the revised approach could advance potential UK approval by approximately six weeks; potential approval in mid-2027 remains subject to MHRA review, and it anticipates a response within 3 to 6 months after submission, subject to validation, review and requests for information.
It also entered a Master Services Agreement with Uniphar Durbin Ireland Limited for international access, distribution and commercialization. Initial plans focus on named-patient access in selected European countries and the Middle East and North Africa, subject to applicable law and country-specific statements of work; expansion requires mutual agreement. For the U.S., INmune Bio has engaged advisors to prepare and submit an FDA Type B meeting request and plans a BLA in Q2 2027, subject to FDA feedback. Ebstrocel remains investigational and has not been approved by FDA, MHRA, EMA or another regulatory authority.
The October 2026 investor presentation also describes an adaptive Phase 2b/3 XPro1595 design, naming CDR-SB as the sole Phase 3 primary endpoint. It says its summary of FDA alignment reflects the company’s interpretation of FDA feedback.
Filing Explained
The investor deck calls Ebstrocel a “proven” beneficial treatment, but its MISSION EB endpoint table reports that the primary three-month skin-score change failed; safety and several secondary measures met.
8-K Event Classification
Key Figures
Key Terms
pre-Marketing Authorisation Application (pre-MAA) regulatory
named-patient access regulatory
chemistry, manufacturing and controls (CMC) regulatory
Biologics License Application (BLA) regulatory
Type B meeting request regulatory
CDR-SB medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When could INMB receive UK approval for Ebstrocel?
What does INMB’s Uniphar agreement cover?
What is INMB’s U.S. regulatory plan for Ebstrocel?
What does INMB’s presentation say about the XPro1595 Phase 2b/3 design?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
INmune Bio Inc. (the “Company”) has prepared a slide deck that the Company intends to use in presentations from time to time (the “Presentation”). The Presentation is furnished as Exhibit 99.3 to this Current Report on Form 8-K.
The information in this Item 7.01 and Exhibit 99.3 of this Current Report on Form 8-K is furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Exhibit 99.3 of this Current Report on Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in any such filing.
Item 8.01. Other Events.
On October 21, 2026, the Company issued two press releases related to Ebstrocel™, the Company’s allogeneic stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), announcing that the Company (i) has entered into a Master Services Agreement with Uniphar Durbin Ireland Limited (“Uniphar”) establishing a scalable framework to support international access, distribution and commercialization of Ebstrocel™, and (ii) has submitted its pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ (CORDStrom™).
Copies of the press releasees are attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release dated October 21, 2026 | |
| 99.2 | Press Release dated October 21, 2026 | |
| 99.3 | Investor Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INMUNE BIO INC. | ||
| Date: October 21, 2026 | By: | /s/ David Moss |
| Name: | David Moss | |
| Title: | Chief Executive Officer | |
2
Exhibit 99.1
INmune Bio Establishes Global Commercialization Framework for Ebstrocel™ Through Strategic Agreement with Uniphar
Initial focus on named-patient access in selected European and MENA markets, providing a capital-efficient foundation for broader commercialization
BOCA RATON, Fla., Oct. 21, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has entered into a Master Services Agreement with Uniphar Durbin Ireland Limited (“Uniphar”) establishing a scalable framework to support international access, distribution and commercialization of Ebstrocel™, the Company’s allogeneic stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB). INmune Bio initially intends to use the framework to pursue named-patient access in selected European countries and in the Middle East and North Africa (MENA), subject to applicable law and country-specific statements of work. The relationship may subsequently expand across Europe and other territories by mutual agreement.
The Company expects named-patient access to be an important component of its international commercialization strategy for Ebstrocel™. Where permitted by local law and implemented through statements of work, this pathway may allow physicians to request Ebstrocel™ for individual eligible patients before local marketing approval or broad commercial availability.
The Uniphar framework is designed to provide the Company with scalable international commercial infrastructure, beginning with named-patient supply, and potentially expanding to broader commercial distribution as regulatory approvals, pricing and reimbursement are secured in individual countries. Depending on the services agreed in individual statements of work, Uniphar may support regulatory feasibility assessments, market access, product storage and distribution, healthcare-provider and treatment-site onboarding, order-to-cash services, medical information, pharmacovigilance support and end-to-end shipment tracking. By leveraging Uniphar’s established infrastructure rather than building country-by-country capabilities internally, the Company believes this model provides a capital-efficient path to establish Ebstrocel™’s international commercial footprint and scale as additional markets become available.
“This agreement marks an important step in moving Ebstrocel™ from clinical development toward commercialization and bringing Ebstrocel to patients internationally,” said David Moss, Chief Executive Officer of INmune Bio. “Uniphar provides access to established market-access, distribution and order-to-cash capabilities across multiple international markets without requiring INmune Bio to build those capabilities country by country. We believe this provides a capital-efficient way to pursue named-patient opportunities in appropriate markets while building the physician relationships, treatment-center experience and commercial infrastructure needed to support broader international commercialization.”
“We are pleased to partner with INmune Bio as it prepares Ebstrocel for international commercialization,” said Ruth Rostron, Head of Expanded Access at Uniphar. “Uniphar has built an integrated global platform to help innovative medicines navigate the complexities of international access, distribution and commercialization. We believe our infrastructure and experience are well suited to support INmune Bio’s strategy for Ebstrocel, beginning with named-patient access opportunities and expanding as the product progresses through its regulatory and commercial journey.”
About Ebstrocel™
Ebstrocel™ (pobistrocel) is INmune Bio’s investigational, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell therapy being developed through the Company’s CORDStrom™ platform for the treatment of RDEB. The platform is designed to address donor variability and manufacturing inconsistency. Ebstrocel™ is investigational and has not been approved by the FDA, MHRA, EMA or any other regulatory authority.
About Uniphar Plc.
Uniphar is a trusted global partner to pharma, medtech and biotech, delivering solutions that connect medicines and technologies with patients worldwide. With over 57 years of experience and partnerships with 200+ multinational clients, Uniphar combines deep expertise, global infrastructure and market insight to meet the evolving needs of the life sciences sector.
Uniphar Pharma integrates Development, Clinical, Access, Medical, Commercial, Distribution and Global Sourcing to support the full product lifecycle – from early-stage research through to commercialization and beyond. Uniphar’s unified platform spans regulatory strategy, clinical trial support, medical affairs, market access, patient engagement, commercial services, distribution and supply chain.
Operating across 160 countries with a global team of 3,600+, Uniphar bridges manufacturers, healthcare providers, and patients — accelerating access to innovative therapies, improving patient outcomes, and delivering value across the healthcare ecosystem.
From molecule to market and beyond.
For more information, please visit www.uniphar.com
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes.
INmune Bio is actively advancing two late-stage product platforms toward registrational milestones:
| ● | CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to
address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts
in RDEB, the platform is transitioning toward regulatory and commercial readiness, with an MAA planned for the UK MHRA in 2026 and EU
EMA in 2027, alongside a planned U.S. regulatory pathway and development of international access and distribution infrastructure. |
| ● | XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to reduce pathological neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. |
To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.
2
Forward Looking Statements
The Company’s product candidates are investigational, and there can be no assurance that any clinical, regulatory or commercial objective will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, timing of key milestones, future plans or expectations, the scope and implementation of the Uniphar relationship, the execution of statements of work, the availability and timing of named-patient or expanded-access sales, potential revenue, potential expansion across Europe, the Middle East and North Africa (MENA) or into Latin America, the anticipated capital efficiency of the distribution model, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™ (EbstrocelTM, pobistrocel), XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contacts:
David
Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Uniphar Contacts:
Media Contacts:
Uniphar: Heather.Hopkin@teamtala.com and Beth.Oshea@teamtala.com
Enquiries:
Uniphar: NPS_Ebstrocel@uniphar.com
3
Exhibit 99.2
INmune Bio Advances Ebstrocel™ Toward Potential UK Approval in Mid-2027
| ● | Final pre-MAA package submitted to MHRA on October 20, 2026 |
| ● | Full MAA submission targeted for early February 2027, under a revised strategy that could bring potential UK approval forward by approximately six weeks |
| ● | U.S. BLA expected to be submitted in Q2, 2027 |
BOCA RATON, Fla., Oct. 21, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has submitted its final pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ (CORDStrom™), its investigational cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The company has updated its regulatory submission strategy, as faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, with potential UK approval in mid-2027, subject to MHRA review.
Following MHRA feedback on the final pre-MAA package, INmune Bio plans to finalize and submit a complete application in February 2027, replacing the sequential rolling submission previously planned to begin in late 2026. Based on progress in chemistry, manufacturing and controls (CMC) and discussions with regulatory advisors, the Company believes this approach could accelerate potential UK approval by approximately six weeks compared with the previously anticipated timeline.
The Company anticipates an MHRA response within three to six months after submission, subject to application validation, agency review and any requests for additional information. Submission of the complete package is intended to support assessment of the clinical, manufacturing and quality data together.
“This is a remarkable achievement by the whole CMC team and our external regulatory advisors allowing us to accelerate the potential approval for Ebstrocel for children with RDEB,” said Mark Lowdell, Chief Scientific Officer of INmune Bio. “Our progress allows us to bring forward the anticipated timeline to commercial supply, subject to approval, for children and families waiting for treatment.”
In parallel, INmune Bio has engaged U.S. regulatory advisors with rare disease expertise to prepare and submit a Type B meeting request to the U.S. Food and Drug Administration (FDA). Subject to feedback from that meeting, the Company plans to submit a Biologics License Application (BLA) in the second quarter of 2027, seeking traditional or accelerated approval, as appropriate.
“Based on positive feedback from our regulatory consultants in the U.S, we are prioritizing our FDA application ahead of an EMA submission, building on Ebstrocel’s U.S. Orphan Drug and Rare Pediatric Disease designations,” said David Moss, Chief Executive Officer of INmune Bio. “With potential UK and U.S. approvals in 2027, we are approaching a pivotal year. Approval in either or both markets would mark a major milestone for INmune Bio and bring Ebstrocel closer to patients and families living with RDEB.”
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. The Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes.
INmune Bio is actively advancing two late-stage product platforms toward registrational milestones:
| ● | CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission. |
| ● | XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform designed to selectively neutralize soluble TNF (sTNF) and reduce neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. |
To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.
Forward Looking Statements
The Company’s product candidates remain in clinical development stage and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including Ebstrocel™, XPro™ and INKmune™ trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contacts:
David Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Exhibit 99.3
Two Late-Stage Platforms Targeting Inflammation- Driven Disease Corporate Presentation October 2026 NASDAQ: INMB
2 Disclaimer This presentation has been prepared by INmune Bio. Inc. ("INmune Bio" or the "Company") solely for information purposes and does not constitute investment, legal, or medical advice. The Company makes no representation or warranty, express or implied, as to the accuracy, completeness, or timeliness of the information or opinions contained in this presentation, and no reliance should be placed on them. Readers should conduct their own independent evaluation. This presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any pricing, reimbursement, market size (TAM), revenue potential, and cost-of-goods (COGS) figures are illustrative, based on internal models and external sources believed to be reliable, and subject to significant uncertainties, including clinical outcomes, competitive dynamics, payer coverage and utilization management, health technology assessments, negotiated discounts/rebates, country-specific policies, and macroeconomic factors. Actual results may differ materially. This presentation contains data, estimates, and other information derived from third-party publications, databases, and reports. Although the Company believes these sources to be generally reliable, such information is subject to interpretation and cannot be verified with complete certainty due to limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other inherent limitations and uncertainties. The Company has not independently verified any of the data from third party sources referred to in this presentation and, accordingly, the accuracy and completeness of such data is not guaranteed. The Company does not assume any responsibility for the accuracy or completeness of this information or for any failure by any such other persons to disclose events which may have occurred or may affect the significance or accuracy of any such information but which are unknown to the Company. References to other products or companies are based on publicly available information as of the date of this presentation and may not be complete or current. Inclusion does not imply endorsement or direct comparability
3 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" Forward-looking statements reflect our current view about future events. When used in this presentation, the words "anticipate," "believe," "estimate," "expect," "future," "intend," "plan," or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this presentation relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward- looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors (including the "Risk Factors" contained in our most recent Annual Report on Form 10-K and any other filings that we have made or may make with the SEC in the future), such as those relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results. Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained herein related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of XPro , and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom , XPro1595 (XPro , pegipanermin), and INKmune® have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
4 Two Late-Stage Platforms Across Inflammation & Immunology Ebstrocel / CORDStrom RDEB regulatory submissions UK pre-MAA package submitted Full UK MAA targeted for February 2027 Potential UK approval in mid-2027 U.S. BLA planned for Q2 2027, subject to FDA feedback. Uniphar agreement supports planned named- patient access in selected European and MENA markets. XPro1595 Selective soluble TNF inhibitor Designed to reduce harmful inflammation while preserving transmembrane TNF signaling that supports immune function and tissue repair. Rare disease expansion Selected TNF-driven diseases could offer smaller, shorter trials and faster development than Alzheimer's. Potential additional PRV opportunity through an eligible pediatric rare disease approval.*
5 Key Patents & Exclusivity Position CORDStromTM XPro1595TM International PCT Stage USPTO (ISA) Favorable Written Opinion on Patentability (all claims) -CoM -Formulation -MoT Nominal Patent Coverage thru 2045 Eligible for PTE up to +5years on approval International PCT Stage USPTO (ISA) Favorable Written Opinion on Patentability (all claims) -CoM -Formulation -MoT Nominal Patent Coverage thru 2045 Eligible for PTE up to +5years on approval US 11,365,229 B2 Expires 2033 -MoT (Neurologic Diseases) Eligible for Ref. Biol. Product Exclusivity (~12 years) Eligible for Ref. Biol. Product Exclusivity (~12 years) ODD Exclusivity (RDEB) ~7years *additional patent properties pending *additional patent properties issued/pending
6 for EB CORDStrom ( Ebstrocel ) Beyond Topical Care: Disease - Modifying Systemic Therapy
7 CORDStrom – a Mesenchymal Stromal Cell (MSC) Platform What is CORDStrom ? Mechanisms Of Action • Pooled, allogeneic donor, umbilical cord - derived Mesenchymal Stromal/Stem Cell (MSC) product (minimum four donors) • Suppression of inflammation: RDEB /EB, OA, trauma, etc • Highly reproducible, off - the- shelf • Immunomodulation: Autoimmune diseases etc • Global IP Filed • Enhanced wound healing: RDEB /EB, post surgery, SLE, etc • Large Volume Manufacturing • Suppression of fibrosis: OA, cardiac repair, RDEB /EB, etc • Cost Effective • Easily genetically modified to deliver payloads
8 Why Historical MSC Development Failed: The Problem of Heterogeneity – AND THE SOLUTION Cell Population Doubling reduces potency over time. The assumption that "all MSCs are the same" led to few approvals. Past failures were not due to a lack of therapeutic potential, but a lack of product consistency. Senescence: Clinically Naive Assumptions. High heterogeneity from donor - to- donor and source - to- source (Bone marrow vs.Adipose). Donor Variation: Lots of subsets (with unknown potency or MOA. Inconsistent Identity: The Consequence The Heterogeneity issue Umbilical Cord derived MSC Pooled donors – homogeneity Product defined on potency. CORDStrom The Answer
Recessive Dystrophic EB
Multisystemic disease RDEB-SG
11 0-18 months 18 months-10 years 10-20 years Over 20 years Squamous cell carcinoma (SCC) The Progressive Nature of Recessive Dystrophic EB (RDEB) 18 Months to 10 Years: The Critical Therapeutic Window
12 1. Pain relief 2. Itch relief 3. Mental health children/YP 4. Impact of inflammation 5. GI issues e.g., dysphagia Prioritisation survey 865 members EB global community 2024-Top 5 issues What Treatments do People Living with DEB Want Right Now? Source: FDA Patient-Focused Drug Development Meeting https://www.youtube.com/live/Ids1WAe5Czo
13 Pruritus is a Clinically Meaningful Endpoint in RDEB Evidence from Danial et al. (2015) and the PEBLES Prospective Registry (2023) Danial et al. (2015) • 146 EB patients • Itch ranked the most bothersome complication • Healing wounds produced greatest itch • Major impact on sleep and quality of life • Defined key itch triggers PEBLES Registry (2023) • 50 RDEB patients • 243 longitudinal assessments over 7 years • Itch present in 93% of assessments • Severe RDEB had highest itch burden • Supports itch as endpoint in future trials Key Clinical Findings ✓Itch is nearly universal in RDEB (93% prevalence) and in wider EB (~85% prevalence) ✓ Patients describe itch as deep, painful and difficult to control ✓Severity increases with disease severity ✓Patients rank itch among the most burdensome symptoms ✓Itch drives the itch–scratch–wound–inflammation cycle ✓Healing wounds produce the greatest itch ✓ Current therapies provide inadequate relief ✓Night-time itch causes significant sleep disruption ✓Heat, sweating, stress and dry skin worsen symptoms ✓ Global disease severity scores do not adequately capture itch ✓Both studies support itch as a clinically meaningful endpoint in RDEB and in wider EB
14 The Itch-Scratch-Wound-Inflammation Cycle in RDEB A self-perpetuating cycle that drives diseases disease burden
15 Why Reducing Pruritus May Reduce Wounds and Long-Term SCC Risk in RDEB Inflammation & Healing Wounds Pruritus (Itch) Scratching New & Recurrent Wounds Chronic Non-healing Wounds Persistent Inflammation ↑ SCC Risk Evidence • Scratching tears fragile skin, enlarges wounds and creates new blisters. • Healing wounds are the itchiest wounds. • Larger wounds are associated with greater itch burden. • MSC and calcipotriol studies showed wound improvement together with itch reduction. • Current evidence strongly supports: ↓ itch → ↓ scratching → ↓ wound burden. • Ebstrocel reduced systemic inflammatory cytokines which drive itch leading to clinically meaningful reduction Implications • Chronic non-healing wounds are the principal substrate for SCC in RDEB. • Persistent inflammation drives repeated tissue injury and malignant transformation. • No study has yet proven that reducing itch lowers SCC incidence. • However, the biological rationale is strong: interrupting the itch–scratch cycle may reduce chronic wounds and, over time, could reduce SCC risk. "Treatment with Ebstrocel infusions in RDEB patients is likely to be disease-modifying, improving itch, skin healing, quality of life and reducing the risk of squamous cell carcinoma later in life" – Professor Anna Martinez, UK clinical lead for paediatric RDEB.
16 Mission EB Phase III: Randomized, Placebo-Controlled Crossover Trial 2012 - Cure EB Charity funded EBSTEM an open label study 10 children with RDEB from Great Ormond Street treated with 3 infusions of bone derived stem cells with promising results lasting up to 6 months 2019 – NIHR / NHS England / CureEB funded a Double blind, placebo controlled, crossover trial at GOSH and BCH for children with RDEB Both UK National centres, 33 enrolled, 31 evaluable – all crossed over from drug to placebo or placebo to drug all remained double blind through treatment and follow-up
17 Mission EB Clinical Trial Summary Month-3 Data • RDEB-Severe patients across all ages (9/30) • No improvement in their skin scores • 25% reduction in ITCH Month-6 Data • Itch reduction maintained 6 months post cell infusions across all of the itch-man scale cohort • The largest itch reduction was seen in the RDEB-S group at month 6 post cell infusion of 27.5% • IscorEB scores improved in all RDEB patients • There is large improvement in all iscorEB scores in RDEB-S cohort not seen at month 3 • overall score 9.3% • patient score 9.6% • clinician score 6.4% • skin score 2.8%
18 Conclusion From Month-6 Data • There is large improvement in all iscorEB scores in RDEB-S cohort not seen at month-3 • The observed skin improvement and wound closure is likely to be disease modifying, improving pain and quality of life and reduce the long-term risk of squamous cell carcinoma
19 Qualitative Results • 13 participants (reporting on 9 cases) • 8 parents • 5 children • Completed blinded interview at two time points • 3 months post UC-MSCs • 3 months post placebo • 12/13 reported benefits on Ebstrocel • 3/13 reported benefits on placebo • 2 post Ebstrocel • 1 treatment naive • 10/13 correctly identified order of treatment
20 Comprehensive Organ System Improvements; Itch Man Scale Severity level 2 - Pre Severity level 3 - Pre Severity level 2 - Post Severity level 3 - Post Severity level 2 - Pre Severity level 3 - Pre Severity level 2 - Post Severity level 3 - Post 0 10 20 30 40 Itch Man Categorical mITT Patients affected % CORDStrom Placebo "I just wait for the sun to come up so I can start the cycle of bandaging the damage I did in my sleep." "The itch is a monster... an itch that feels like it's inside my bones." "The itch is just a different form of pain." "I don't sleep because of the itch. I just wait for the sun to come up." Itches more; sometimes interferes with activity Level 2: Itches a lot; Level 3: difficult to be still, concentrate CS switches 2/3 of pts with grade 3 to grade 2 1/4 of pts on placebo who were grade 2 progress to grade 3 -67% +74% Month 3 - Itch Man Scale improved 17% Month 6 - Itch Man Scale improved 27.5%
21 Comprehensive Organ System Improvements; ISCOREB Improvement Scores Period 1 at 3 and 6 months Ebstrocel is potentially the first systemic therapy with itch and pain relief benefits as key differentiation factors in quality of life. Skin Mouth Eye Joint -5 0 5 10 15 20 Pain indicies Site CS 3m Placebo 3m CS 6m Placebo 6m Improvement Score Eating Bowel -5 0 5 10 15 20 Gastrointestinal symptoms Site Improvement Score General Sleep Hands Leisure School -20 -10 0 10 20 30 Wellbeing Site Improvement Score
22 Overall Summary • Ebstrocel has proven to be beneficial treatment with no safety signals in children with RDEB from the age of 6 months • Intermediate and younger patients under the age of 10 years saw earlier effects with improvement of their skin, pain and itch • Although the most severe and older patients did not show changes in their skin at 3 months, by 6 months their itch and skin scores had improved greatly • "Treatment with Ebstrocel infusions in RDEB patients is likely to be disease- modifying improving itch, skin healing, quality of life and reduce the risk of squamous cell carcinoma later in life" – Professor Anna Martinez, UK clinical lead for paediatric RDEB
23 Uniphar: International Access and Commercialization Agreement signed with Uniphar Durbin Ireland Limited A scalable framework for international access, distribution and future commercialization of Ebstrocel. Initial access markets Selected European countries and the Middle East and North Africa (MENA). Physician-requested supply for individual eligible patients before local marketing approval, where permitted. Capital-efficient commercial model Use Uniphar's established infrastructure for market access, storage, distribution and order-to- cash services. Potential expansion as approvals, pricing and reimbursement are secured. Implementation depends on applicable law and country-specific statements of work. Additional territories and services require mutual agreement. Ebstrocel remains investigational.
24 Ebstrocel – Complex Mechanisms of Action Validated Complex Mechanism of Systemic Resolution: M1 to M2 Shift
25 Ebstrocel Mechanisms of Action - Details M1 to M2 differentiation in vitro M0 M1 control M1 Ebstrocel s/n M2 control 0 500000 1000000 0 20000 40000 60000 80000 MedFI (AU) CD14 CD73 CD163 CD86 CD80 HLA-DR Monocyte differentiation in vitro M1 Ebstrocel M2 PGE2 ENHANCED WOUND HEALING IL-13 TGF-b / VEGF / IGF-1 / HGF / CCL13/17/18/22 Activates M2 & induces M2 migration to wounds IDO Th2 Th17 TNF-a IL-6 Control + Supernatant Control + Supernatant 0 500 1000 1500 2000 50000 100000 150000 200000 𝛼 TNF concentration (pg/mL) M1 polarised M2 polarised P = 0.1531 Control + Supernatant Control + Supernatant 0 10 20 30 40 50 IL-10 concentration (pg/mL) M1 polarised M2 polarised P = 0.0011 P < 0.0001
26 Ebstrocel Mechanisms of Action Proof of MoA in vivo Placebo CPD <20 CPD >20 -20 -10 0 10 20 TNF-a In vivo Delta preRx Placebo CPD <20 CPD >20 -200 -100 0 100 200 HGF Delta preRx Placebo CPD <20 CPD >20 -20 -10 0 10 20 IL-13 in vivo Delta preRx 3D NUC-05 3D NUC-07 3D NUC-08 3D UCT-IN-11 3D WPS-1 3D WPS-2 3D WPS-3 3D WPS-4 3D PDP-1 3D PDP-2 3D PDP-3 3D PDP-4 0 10 20 30 40 Intracellular IDO Percentage expression (%) <20 CPD >20 CPD Itch Mouth Eye Joint -20 0 20 40 IscorEB Pain 3 months Site CPD <20 3m CPD >20 3m Improvement Score Eating Bowel 0 10 20 30 40 50 ISCOREB Gastrointestinal symptoms 3 months Site Improvement Score General Sleep Movement Hands Leisure School -20 0 20 40 60 ISCOREB Wellbeing 3 months Site Improvement Score M1 Ebstrocel M2 PGE2 ENHANCED WOUND HEALING IL-13 TGF-b / VEGF / IGF-1 / HGF / CCL13/17/18/22 Activates M2 & induces M2 migration to wounds Itch & Pain REDUCTION IL-8 Enhances PMN activation INFECTION IDO Th2 Th17 TNF-a IL-6 TGF-b / VEGF / HGF <20 CPD >20 CPD <20 CPD >20 CPD <20 CPD >20 CPD <20 CPD >20 CPD <20 CPD >20 CPD 0 5000 10000 15000 20000 25000 0 50 100 150 200 Effect of CPD on cytokine synthesis pg/ml pg/ml FGF1 FGF2 HGF VEGF IL-8
27 Why Historical MSC Development Failed: The Solutions to Heterogeneity Cell Population Doubling changes potency over time. Senescence: High heterogeneity from donor - to- donor and source - to- source (Bone marrow vs. Adipose vs UC). Donor Variation: Lots of subsets (with unknown potency or MOA. Inconsistent Identity: The Solution The Heterogeneity issue Remove age – UC derived MSC Reduce donor - to- donor differences – POOL donors Overcome senescence – UC derived MSC Reduce cost – close and semi - automate manufacture UNDERSTAND MECHANISMS OF ACTION
28 The CORDStrom Solution: Engineered Homogeneity Through Identity Selection and Pooling Pooling minimizes donor variation, creates a highly reproducible product, and enables massive scalability. Advantage Characterized by standard markers (CD73/90/105) PLUS potency - specific markers (CD10, CD29, CD44,MSCA - 1, and others). Identity Umbilical Cord Tissues (Superior expansion potential and lower heterogeneity vs. adult tissue). Source High Potency High Reproducibility Master Cell Stock Proprietary Pooling Process Minimum 4 " selected" UC Donors
29 Commercial-scale manufacture complete and future-proofed 1. Phase-dependent, scalable 2. Closed Bioprocessing PSS 25/donor WCS 1000 /PSS DP 34,000 /WCS ~100 patients in UK 4 doses/year 45 years from same 4xdonor stock Current scale = 3L Closed from MCB to Final Drug Product 0.5L to 80L 0.2L to 2000L Automated formulation & bag filling x21 per manifold High-capacity (75) controlled rate freezers Supply Reliability Stable long-term storage In development = 15L Available = 80L
Ebstrocel : Updated Regulatory Milestones 30 Completed Pre-MAA package submitted to MHRA February 2027 Full UK MAA targeted after MHRA feedback Mid-2027 Potential UK approval following agency review Q2 2027 U.S. BLA planned, subject to Type B meeting feedback European Union EMA filing prioritized after the FDA application Company targets, not agency commitments. MHRA response expected 3–6 months after submission, subject to validation, review and requests for additional information. Approval is not assured.
31 Conditional / Accelerated Approvals – safety and PRELIMINARY Efficacy data MHRA / EMA / FDA MISSION EB Phase II trial - endpoints Primary Safety - MET Change in EBDASI total score at 3 months – FAILED Secondary Improvement in Total iscorEB – MET (Intermediate Group) Improvement in Pain (FACES score) - MET Improvement in Itch – MET (Itch Man) Reduction in analgesia - MET Improvement in QoL (CHU-9D score) – FAILED @ 3 months MET @6 months Ebstrocel Placebo Reduced 13.30% 0% Remained the same 80% 100% Increased 6.70% 0% Treatment Group Analgesics Qualitative Results • 13 participants (reporting on 9 cases) • 8 parents • 5 children • Completed blinded interview at two time points • 3 months post UC-MSCs • 3 months post placebo • 12/13 reported benefits on Ebstrocel • 3/13 reported benefits on placebo • 2 post Ebstrocel • 1 treatment naive • 10/13 correctly identified order of treatment
32 Ebstrocel : Regulatory Priorities UK: complete application replaces rolling submission Faster CMC progress supports a full MAA in early February 2027. The revised plan could advance potential UK approval by approximately six weeks. U.S.: FDA application ahead of EMA Rare disease regulatory advisors engaged for a Type B meeting request. Q2 2027 BLA target, seeking traditional or accelerated approval as appropriate to FDA feedback. "With potential UK and U.S. approvals in 2027, we are approaching a pivotal year. Approval in either or both markets would mark a major milestone for INmune Bio and bring Ebstrocel closer to patients and families living with RDEB." David Moss, Chief Executive Officer Ebstrocel holds U.S. Orphan Drug and Rare Pediatric Disease designations. Approval pathways and timing remain subject to agency feedback and review.
Phase 3 Open Label Trial – 18 Months 33 10 MISSION EB-DELIVER
Market Landscape: Comparison of Therapeutic Approaches Vyjuvek = Product of Krystal Biotech, Inc.; Filsuvez = Product of Chiesi Farmaceutici S.p.A.; Zevaskyn = Product of Abeona Therapeutics Inc. 34 The TAM is an estimate based on internal assumptions and third-party sources, is a forward-looking statement and does not guarantee any future performance. Actual TAM may differ materially. See "Disclaimer" and "Forward-Looking Statements"
35 Parent Quotes When she has been getting ill she has just been recovering in the same time as her brother, normally illness affects her much more because it causes inflammation. We have just been able to cope with everything so much better and have lots of energy and I suppose life has felt normal I think it's just been lovely to see him having energy and having an appetite , I suppose actually that's the one thing we've noticed as well, she has put on weight
36 Children's Quotes It was less painful, when I itch it's painful so obviously that's not comfortable, but I had less pain, my skin was less itchy, my hands were less hot and when they are hot I itch. That was not happening that much. Normally it would hurt when I have a bath but lately it hasn't been hurting
37 CORDStrom RDEB Summary Quote from a parent: "If it makes only one per cent difference, then I'm happy to come whenever they call us for the trial because that one per cent isn't a lot I know, maybe it's nothing for somebody, but it's a lot for him, one per cent less pain for him is one per cent more real life- that's a lot" MISSION EB Team 2024
38 Approaching Alzheimer's as an Immunologic Disease
39 XPro1595 (XPro): Neutralize TNF while Preserving Immune Function see Steed et al., Science, 301, 2003 XPro1595 is identical to the human soluble TNF monomer with the exception of mutations in the receptor binding domain and another for pegylation. Dominant-Negative in genetics: "A mutation producing a rogue protein that interferes with the function of the native protein."
40 Normal Soluble TNF activity solTNF monomers form active heterotrimers that bind to TNF receptor. Each monomer in the trimer contacts one TNFR subunit
41 XPro1595 MOA
42 XPro1595 is Neuroprotective Normal Etanercept Anti-inflammatory AND immunosuppressive Cuprizone (Model of Multiple Sclerosis) Exacerbated demyelination XPro1595 Anti-inflammatory NOT immunosuppressive Remyelination Adapted from: Karamita et al., 2017
XPro1595 Peer-Reviewed Publications: Breadth of Scientific Validation More Than A Decade of Research Excellence XPro1595's therapeutic potential has been rigorously validated across more than 90 peer-reviewed publications spanning 24 therapeutic areas, 2 dozen independent laboratories, and 3 continents. This extensive body of evidence demonstrates consistent neuroprotective, anti-inflammatory, and disease-modifying effects across diverse pathologies. (See appendix)
44 Cytokines are not informative biomarkers of chronic inflammation (Immune Dysfunction) Adapted from PMID: 27994591 and 18673219
45 Strong Evidence for anti-TNF to Treat Alzheimer's Disease 1. Torres-Acosta N, et al. J Alzheimer's Dis. 2020;78:619–626 2. Fillit H, et al. Neurosci Letters. 1991;129:318-320 3. Tarkowski E, et al. J Clin Immunol. 1999, 19(4):223-230 4. Dickson DW. J Neuropathol Exp. Neurol 1997;56:321-339 5. Paganeli R, et al. Experimental Gerontology. 2002;37:257-263 6. Parker et al. The Journals of Gerontology (2019) 74(3):283 7. Lahiri et al. J Alzheimer's Dis. 2003;5(2): 81-90 8. Blasko et al. FASEB Journal. 1999, 13(1):63-68 9. Gorlovoy et al. FASEB Journal. 2009, 23(8):2502-2513 10. Montgomery et al. Am Journal Pathology. 2013, 182(6):2285-2297 11. Janelsins et al. Am Journal Pathology. 2008, 173(6):1768-1782 12. Lee et al. Molecular Med Rep. 2014, 10(4):1869-1874 13. He et al. J Cell Biol. 2007, 178(5):829-841 Evidence linking TNF to AD TNF inhibitors reduce risk of AD Anti-TNF therapies1 reduce the risk of AD in humans by up to: TNF causes AD pathology in animals TNF increases amyloid7,8 and Tau9-12 TNF causes cell loss and cognitive impairment13 TNF increases with Age TNF levels increase beginning the 3rd or 4th decade of life and correlate with age6 60% TNF increased in AD Patients Plasma and CSF TNF levels increased in AD patients2,3 TNF co-localizes with amyloid plaques4 TNF levels correlate with disease progression5
46 Biomarker Enrichment Rationale Matching drug biology to patient · Predictive enrichment using downstream indicators of TNF-driven biology Enrichment is predictive — identifying patients with TNF-driven disease biology most likely to benefit from XPro1595. hypothesis-driven precision medicine. ADi = Alzheimer's Disease with Inflammation. Cutoffs: hsCRP >1.5 mg/L, ESR >10 mm/hr, HbA1c >6%, APOE ≥1 ε4 allele. Enrichment requires ≥2 of 4. References available upon request
47 Phase 2: Why Did We Miss P-Value in Cognition (EMACC)? No Placebo Decline in mITT Original Key Inclusion Criteria: Enriched Protocol • Age (60 - 85 years) • Diagnosis of mild AD (NIA-AA stage-4)1 • Amyloid-beta positive (Aβ+) • MMSE ≥ 22 • ≥ 2 blood biomarkers of inflammation Expanded Inclusion Criteria: Revised Protocol • Age (50 - 85 years) • Diagnosis of MCI or mild AD (NIA- AA stages 3-4)1 • Amyloid-beta positive (Aβ+) • MMSE ≥ 22 • ≥ 1 blood biomarker of inflammation mITT Population expanded recruitment criteria n=200 Enriched Population Aβ+ and ≥ 2 biomarkers of inflammation n=100 To assess a possible treatment effect of XPro1595 compared to placebo, a decrease in cognition within the placebo-treated group over the study period is necessary. No such decline is observed in the placebo group within the mITT population, but a decline is present in the placebo group among the Enriched population.
48 Phase 2: Consistent Signal in AD Inflammation Enriched Population 6-month RCT · N = 206 (mITT: XPro n=139, placebo n=67) · ADi enrichment: ≥2 of 4 biomarkers AND amyloid positive (n=100) Overall Population (mITT) 72 yrs median age · 51% female · 45% MCI 68.5% APOE4 carriers — highest ARIA risk population 75% amyloid positive — confirmed AD pathology 62.5% ADi population (≥2 inflammatory biomarkers) ADi = Alzheimer's Disease with Inflammation. Requires ≥2 of 4 biomarkers: hsCRP >1.5 mg/L, ESR >10 mm/hr, HbA1C >6%, or ≥1 APOE ε4 allele, in addition to confirmed amyloid positivity Key Findings: ADi Enriched Population Endpoint Effect Size Signal EMACC (primary) Cognitive composite d = 0.27 Clinically meaningful Cortical Disarray (PerpPD+) Gray matter (imaging) d = 0.32 Clinically meaningful NPI Total Score Neuropsychiatric symptoms d = 0.23 Clinically meaningful GFAP (plasma) Astrocyte reactivity d = 0.19 Directionally supportive pTau-217 (plasma) Tau accumulation d = 0.18 Directionally supportive Goal Attainment Scale Patient-reported outcome d = 0.18 Directionally supportive ISRL Delayed recall / memory d = 0.16 Directionally supportive Dose-compliant analyses show increased effect sizes for NPI, pTau-217, and GFAP, Chi-separation — effects attributable to greater XPro1595 exposure * Statistically significant (p=0.0098). Positive Cohen's d favors XPro1595. d ≥ 0.2 = small, d ≥ 0.5 =med- large; but clinically meaningful signal threshold; d < 0.2 = directionally supportive. ADi population (amyloid positive AND ≥2 of 4 inflammatory biomarkers, n ≈ 100). *Chi-separation myelin (imaging) d = 0.59 Clinically meaningful
49 Differentiated Safety Profile No ARIA · Immune Function Preserved · SAEs Lower on Drug 0 ARIA Events Despite a high-risk population: 68.5% APOE4+ · 34% with microbleeds 27% on antithrombotic Placebo infection rates 2× higher XPro1595 preserves systemic immune function — selectively inhibiting inflammatory TNF (sTNF) while preserving protective TNF (tmTNF) Serious & Severe AEs Lower on Drug Both serious and severe events were less frequent on XPro1595 than placebo. Severe events 3× more frequent on placebo. Zero fatal events across 206 patients. ISR & Blinding Considerations ISR rates higher on drug (79%) — majority were mild and transient, characterized by an independent safety board as "more nuisance than safety." Blinding strategy addressed in Phase 3 design. Safety profile supports Phase 3 advancement — predictable, manageable, with no unexpected signals
50 Phase 2b/3 Adaptive Trial Design — FDA Aligned FDA End-of-Phase 2 Meeting Completed Q1 2026; Fast Track Granted Q2 2026 FDA Alignment Enrichment ADi biomarker strategy endorsed Design Adaptive 2b/3 with decision gate accepted Endpoint CDR-SB as sole Phase 3 primary Exploratory Non-enriched cohort recommended Summary represents sponsor interpretation of FDA feedback.
51 CDR-SB Confidence: Why 18 Months Will Work EMACC detects subtle cognitive changes- CDR-SB measures the consequences. The Confidence Bridge: In external AD cohorts, correlation between cognitive composites and CDR-SB strengthens over time: r = 0.41 (early) → r = 0.65 (18 months). Cognition precedes function — the same temporal pattern seen in lecanemab and donanemab. Phase 2b: 3 more months + 3× sample → more time for placebo decline Anti-amyloid precedent: CDR-SB separation emerged at 18 months We have the early signal. Now we need the time.
52 Why CDR-SB Requires More Time: Evidence from External AD Cohorts Enough Cognitive Change Must Occur to Measure Functional Change CDR-SB captures cognitive and functional consequences later – lagging indicator and registrational endpoint Conceptual framework. Curves are illustrative — not derived from trial data. EMACC captures subtle cognitive change early — the leading indicator.
53 Thank You! INmune Bio Inc. 225 NE Mizner Blvd. Ste. 640 Boca Raton, FL 33432 +1 561 710 0512 info@inmunebio.com Investor Relations: Daniel Carlson +1 415 509 4590 dcarlson@inmunebio.com