INmune Bio Completes Commercial Manufacturing Milestone Supporting Planned Global Registration Filings for CORDStrom™ Platform
Rhea-AI Summary
INmune Bio (NASDAQ: INMB) reported completion of a key commercial manufacturing milestone for its CORDStrom™ platform, successfully processing its first commercial-ready umbilical cord tissue at the CGT Catapult Manufacturing Innovation Centre in Stevenage, UK, under a commercial agreement with Anthony Nolan Cord Blood Bank.
This transfer of the mesenchymal stromal cell isolation stage enables creation of US-tested master cell banks for Ebstrocel™, the RDEB-specific investigational product, using a process designed to meet MHRA, EMA and FDA standards. According to INmune Bio, commercial manufacturing, pediatric strategy approval, regulatory alignment and ongoing MAA preparation place Ebstrocel™ in the final development stage before planned UK commercialization, aligned with the MHRA draft rare disease therapies framework emphasizing flexible evidence and patient-centered outcomes.
Positive
- First commercial-ready umbilical cord tissue processed at CGT Catapult facility
- Manufacturing process now designed to meet MHRA, EMA and FDA standards
- US-tested master cell banks for Ebstrocel™ to support planned Phase 3 trial
- Regulatory and manufacturing alignment positions Ebstrocel™ for planned UK MAA and commercialization
Negative
- None.
Market reaction: INMB +4.74% on commercial manufacturing milestone
On the day this news was published, INMB gained 4.74%, reflecting a moderate positive market reaction. Argus tracked a peak move of +4.8% during that session. Argus tracked a trough of -3.5% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $55.16M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 15 | preclinical study | Positive | +2.5% | XPro1595 preclinical data addressed Alzheimer’s pathology, memory loss, and pain. |
| Jul 09 | Phase 2 imaging | Positive | +4.1% | Phase 2 imaging data showed statistically significant white matter myelin changes. |
| Jul 01 | U.S. patent phase | Positive | +3.1% | CORDStrom patent application entered the U.S. national phase. |
| Jun 25 | MHRA PIP approval | Positive | +10.4% | MHRA approved the Pediatric Investigation Plan for Ebstrocel. |
| Jun 23 | MHRA written alignment | Positive | -0.7% | MHRA written alignment supported the planned UK conditional authorization application. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Four of the five recent news events were followed by positive 24-hour reactions, while the June 23 MHRA alignment event diverged with a negative reaction.
Key Terms
mesenchymal stromal cell medical
master cell banks technical
conditional marketing authorization regulatory
biologics license application regulatory
allogeneic medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Commercial-Ready Manufacturing Now Supports Planned Phase 3 Confirmation Trial, and US, EU and UK Regulatory Submissions for Future Commercial Supply.
Company Expresses Support for MHRA Draft Rare Disease Therapies Regulatory Framework
BOCA RATON, Fla, July 20, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced a significant manufacturing milestone for its CORDStrom™ platform. The Company has successfully processed its first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult (CGT Catapult) Manufacturing Innovation Centre in Stevenage, UK, under its commercial agreement with Anthony Nolan Cord Blood Bank.
This achievement marks the successful transfer of the mesenchymal stromal cell (MSC) isolation stage for the manufacture of master cell banks (MCBs) into INmune Bio’s commercial manufacturing facility. The process is now commercial-ready to MHRA, EMA and FDA standards, including maternal blood samples infectious disease testing in US-CLIA-accredited laboratories. The successful technology transfer positions the Company to generate its first US tested master cell banks for Ebstrocel™, the RDEB-specific investigational product derived from the CORDStrom™ platform, in support of its planned Phase 3 confirmation clinical trial and future commercial supply.
“Completing this manufacturing transfer is one of the most important operational milestones for the CORDStrom platform. We now have the manufacturing infrastructure required to generate master cell banks that support our planned Phase 3 program and future commercial production using a process designed to satisfy both UK and U.S. regulatory expectations. I am hugely proud of the team for getting to this milestone so quickly,” said Professor Mark W. Lowdell, PhD, FRCPath, FRSB, Chief Scientific Officer of INmune Bio.
“This important milestone reflects the strength of collaboration between Anthony Nolan, the Cell and Gene Therapy Catapult, and INmune Bio, and marks another critical step towards commercial delivery of Ebstrocel™,” said Dr. Ben Weil, MBA, EngD, Head of UK Operations at INmune Bio. “Everyone involved in the CORDStrom™ platform understands the urgency and criticality of developing potentially life-changing medicines to children living with RDEB and other rare diseases. Building a reliable, scalable, and commercial ready manufacturing platform is only possible through the commitment and expertise of all our suppliers and service partners.”
With commercial manufacturing established, pediatric strategy approved, regulatory alignment completed and the MAA preparation underway, INmune Bio believes Ebstrocel™ has entered the final stage of development before planned commercialization in the United Kingdom.
Alignment with MHRA Draft Rare Disease Therapies Regulatory Framework
INmune Bio’s approach to developing Ebstrocel™ for recessive dystrophic epidermolysis bullosa (RDEB), an ultra-rare disease, is directly aligned with the principles recently outlined in the UK Medicines and Healthcare products Regulatory Agency (MHRA) draft rare disease therapies regulatory framework. The Company believes the principles proposed within the draft framework validate the regulatory strategy it has already established with the MHRA for Ebstrocel™. Specifically, the framework emphasizes flexible evidence generation, advanced statistical methodologies, patient-centered outcomes and lifecycle evidence development, principles reflected in the Company's recent written MHRA guidance supporting its planned Conditional Marketing Authorization application.
"Commercial manufacturing is often one of the largest execution risks facing cell therapy companies. Today's milestone demonstrates that we have successfully transitioned from clinical manufacturing toward a scalable commercial process that supports our planned regulatory filings and long-term commercialization strategy. Combined with our recent regulatory alignment from the MHRA and the evolving UK rare disease framework, we believe CORDStrom is exceptionally well positioned for the next stage of development," said David Moss, CEO and co-founder of INmune Bio.
Stakeholders are encouraged to review and respond to the consultation, available at: https://www.gov.uk/government/consultations/draft-rare-disease-therapies-regulatory-framework. Note that this is currently a discussion document and does not yet constitute final guidelines.
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 to regulatory filing phases, with an MAA planned for the UK MHRA and EU EMA in 2026, alongside a planned U.S. Biologics License Application (BLA) submission.
- XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate 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
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, including 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
