INmune Bio (NASDAQ: INMB) deepens Anthony Nolan CORDStrom supply pact
Rhea-AI Filing Summary
INmune Bio Inc. has entered into an amended and restated Material Transfer and License Agreement with its UK subsidiary INmune Bio International and UK charity Anthony Nolan to expand long-term supply of umbilical cord tissue for the CORDStrom™ MSC platform.
Anthony Nolan grants an exclusive, sublicensable license to use, process, test and store donor materials and related products, while INmune Bio and its subsidiary are jointly and severally liable for royalty obligations. Anthony Nolan will receive a 2% royalty on net sales per Product, capped at £5,000,000 annually, plus £400 per umbilical cord tissue for Cell and Gene Therapies Services, with annual CPI-linked fee increases starting January 1, 2027. The agreement runs until terminated under its terms or for ten years from the First Commercial Sale and includes stringent GMP and HTA quality and traceability provisions.
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Insights
Expanded Anthony Nolan pact secures CORDStrom inputs with capped royalties.
The agreement formalizes INmune Bio as a direct party and secures high-quality umbilical cord tissue for the CORDStrom™ mesenchymal stromal cell platform. Anthony Nolan provides donor materials and services under an exclusive, revocable license that becomes irrevocable once donor materials are used.
Economically, Anthony Nolan earns a 2% royalty on net sales per Product, capped at £5,000,000 annually, plus £400 per umbilical cord tissue for Cell and Gene Therapies Services. Fees may rise annually with the UK Consumer Price Index from January 1, 2027, adding an inflation-linked cost element.
The term extends to ten years from the date of First Commercial Sale with multiple termination options and default triggers, so long-term benefits depend on successful commercialization. GMP and HTA requirements, along with traceability and quality management provisions, support regulatory compliance as CORDStrom moves toward potential commercial approval.
8-K Event Classification
Key Figures
Key Terms
Material Definitive Agreement regulatory
Mesenchymal Stromal Cell (MSC) medical
Good Manufacturing Practice (GMP) regulatory
Human Tissue Authority (HTA) regulatory
First Commercial Sale financial
Consumer Price Index (CPI) financial
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01. Entry into a Material Definitive Agreement.
On April 29, 2026, INmune Bio Inc. (the “Company”) entered into an amended and restated Material Transfer and License Agreement (the “Amended and Restated Agreement”) with INmune Bio International (“IMB”), a company incorporated in England and the Company’s wholly-owned subsidiary, and Anthony Nolan (“AN”), a company limited by guarantee incorporated in England, which amended and restated the original agreement signed by IMB and AN on November 29, 2017, as amended and restated on March 21, 2023 (the “Original Agreement”). The Company, which was not a party to the Original Agreement, has agreed to be bound by the terms of the Amended and Restated Agreement as a party thereto with effect from April 29, 2026 and has agreed to be jointly and severally liable with IMB for payment obligations arising under the royalty provisions of the Amended and Restated Agreement.
The expanded collaboration with AN pursuant to the Amended and Restated Agreement secures the long-term provision of high-quality umbilical cord tissue to power the Company’s CORDStrom™ platform.
Pursuant to the Amended and Restated Agreement, AN has granted to IMB an exclusive, revocable (but irrevocable once the AN Donor Materials have been Used, as defined in the Amended and Restated Agreement), with the right to sublicense, a license to, among others, use, process, test and store AN Donor Materials (or any AN Donor Derivatives), AN Donor Products and Existing Cellular Materials, all as defined in the Amended and Restated Agreement and in accordance with the terms of the Amended and Restated Agreement.
Under the terms of the Amended and Restated Agreement, AN will be entitled to a royalty of 2% on net sales of each Product, as defined in the Amended and Restated Agreement, up to an annual cap of £5,000,000. In addition, AN will be entitled to fees equal to £400 plus VAT in respect of the Cell and Gene Therapies Services, as defined in the Amended and Restated Agreement, related to each umbilical cord tissue. On January 1st of each calendar year, from and including January 1, 2027, AN shall be entitled to increase the fees by no more than the percentage increase (if any) in the Consumer Price Index (CPI) published by the Office for National Statistics for the 12-month period ending on the most recent date prior to the relevant increase, for which data is available.
The term of the Amended and Restated Agreement will continue until terminated in accordance with its terms or until the date that is ten (10) years from the date of First Commercial Sale, as defined in the Amended and Restated Agreement. Each party may terminate the Amended and Restated Agreement in whole or in part with immediate effect upon Event of Default, as defined in the Amended and Restated Agreement. In addition, IMB or the Company may terminate the Amended and Restated Agreement at any time by providing 30 days’ written notice to AN and AN may terminate the Amended and Restated Agreement at any time by providing 6 months’ written notice.
The Amended and Restated Agreement contains certain covenants, representations and warranties customary for an agreement of this type and includes additional provisions for traceability and quality management, ensuring that all materials are handled in accordance with Good Manufacturing Practice (GMP) and Human Tissue Authority (HTA) standards.
The foregoing summary of the Amended and Restated Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Amended and Restated Agreement, which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On May 5, 2026, the Company issued a press release announcing that it has entered into the Amended and Restated Agreement. A copy of the press release is furnished as Exhibit 99.1 hereto. The information contained in this Item 7.01 and Exhibit 99.1 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 10.1 | Amended and Restated Material Transfer and License Agreement between Anthony Nolan, INmune Bio International and INmune Bio Inc., dated April 29, 2026 | |
| 99.1 | Press Release, dated May 5, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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: May 5, 2026 | By: | /s/ David Moss |
| Name: | David Moss | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
INmune Bio and Anthony Nolan Announce Strategic Expansion of CORDStrom™ MSC Platform Collaboration to Target RDEB, Oncology, and Inflammatory Diseases
LONDON, UK and BOCA RATON, FL, May 05, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune Bio”), a clinical-stage biotechnology company, and Anthony Nolan, a pioneering UK-based charity that set up the world’s first stem cell register and is now driving forward cell therapy advancements, today announced the signing of an amended and restated Material Transfer and License Agreement. This expanded collaboration secures the long-term provision of high-quality umbilical cord tissue to power INmune Bio’s CORDStrom™ platform, the industry’s most advanced Mesenchymal Stromal Cell (MSC) technology designed to deliver consistent, scalable, and “off-the-shelf” cellular therapies which are suitable for supply in UK, EU and US, as well as other global regions.
The restated agreement, effective April 29, 2026, solidifies the partnership between Anthony Nolan’s Cell Therapy and Laboratory Services, which draws on 50 years of pioneering innovation, research and expertise, and INmune Bio’s international and domestic entities to support the development of human medicinal products subject to global regulatory oversight, including the FDA, EMA, and MHRA.
Solving the MSC Consistency Challenge
While MSCs have long shown therapeutic promise, the industry has struggled with donor variability and manufacturing inconsistency. CORDStrom™ addresses these hurdles by utilizing umbilical cord-derived MSCs which are tested, screened and pooled to create standardized “MSC Banks”. By leveraging Anthony Nolan’s Cell Therapy & Laboratory Services’ world-class procurement and screening infrastructure, INmune Bio ensures that every CORDStrom™ product meets rigorous “Materials Acceptance Criteria,” including precise neonatal weight and maternal age specifications, to ensure the highest reproducibility whilst ensuring regulatory compliance.
A Robust Pipeline: From RDEB to Oncology
The collaboration is initially focused on several high-impact “Initial Indications” and next-generation therapeutic candidates:
| ● | Recessive Dystrophic Epidermolysis Bullosa (RDEB): Development of CORDStrom™ as a transformative treatment for this devastating skin-fragility disorder. |
| ● | CORDStrom-col7a: A next-generation systemic treatment for EB designed to address the underlying genetic deficiencies of the disease. |
| ● | CORDStrom-TRAIL (Oncology): Targeted expansion into solid tumors, utilizing the platform’s immunomodulatory capabilities to combat cancer. |
| ● | Inflammatory & Degenerative Diseases: The platform will also be deployed to address the massive unmet needs in Osteoarthritis and Systemic Lupus Erythematosus (SLE). |
Management Commentary
“We view CORDStrom as a tremendous platform that finally solves the fundamental challenge of understanding MSCs as a drug,” said David Moss, CEO of INmune Bio. “By partnering with Anthony Nolan’s Cell Therapy & Laboratory Services, we are combining the most advanced MSC cell platform with the most reliable source of cellular starting material. This collaboration allows us to move beyond the limitations of traditional cell therapy and provide consistent, high-potency treatments for patients suffering from RDEB, cancer, and chronic inflammatory conditions. We remain hugely grateful to the volunteer donors who provide the UC for our program and who consent to UK and US testing to make CORDStrom universally available”.
“Anthony Nolan is committed to supporting the development of innovative cell and gene therapies to help more patients survive and thrive,” said Nicola Alderson, COO of Anthony Nolan. “This partnership with our Cell Therapy and Laboratory Services allows our donor materials to reach their full potential within a cutting-edge manufacturing platform, facilitating the development of medicinal products that meet the highest ethical and regulatory standards for patients worldwide”.
Agreement Terms
The agreement includes rigorous provisions for traceability and quality management, ensuring that all materials are handled in accordance with Good Manufacturing Practice (GMP) and Human Tissue Authority (HTA) standards as INmune Bio prepares for commercial approval of CORDStrom.
About Anthony Nolan
Anthony Nolan is a UK stem cell transplant charity with 50 years of expertise in uniting science and people to push the boundaries of what can be achieved for blood cancer and blood disorder patients.
Its world-leading stem cell register matches potential donors to patients in need of transplants. It carries out cell and gene therapy research to increase transplant success and supports patients through their transplant journeys.
Anthony Nolan helps four people in need of a transplant a day, giving more people a second chance at life. But the charity won’t stop until all patients have access to the treatment they need, so many more survive.
Stem cells hold enormous potential and have the power to help people with blood cancers and blood disorders. This potential inspires everything Anthony Nolan does. Driven by patients, backed by stem cell donors, and powered by science, the charity won’t stop until the lifesaving potential of the cells inside us all has been uncovered.
Join Anthony Nolan’s register or support its research. Together, with your help, Anthony Nolan can unlock the answers inside us anthonynolan.org
About Anthony Nolan’s Cell Therapy and Laboratory Services
Anthony Nolan’s Cell Therapy and Laboratory Services partners with cell and gene therapy developers to provide ethically sourced starting materials and services for research, clinical and commercial use to help more patients survive and thrive.
Powered by Anthony Nolan’s large donor register and 50 years’ experience in the fields of haematopoietic cell therapies, the Cell Therapy & Laboratory Services supports the development of pioneering new treatments. Its operations are focused on the highest standards of donor care and aim to get treatments to patients faster.
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About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: (1) CORDStrom™, a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa; (2) XPro™, a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform designed to selectively neutralize soluble TNF, a key driver of inflammation and innate immune dysfunction; and (3) INKmune®, a cell-based medicine designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with cancer. To learn more, please visit www.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages 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, 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
Anthony Nolan Contact:
press@anthonynolan.org
020 7424 1300.
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