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Peer Reviewed Study Highlights Therapeutic Potential Around Application of Stromal Cell Therapies Such as INmune Bio's CORDStrom(TM) Platform

MWN-AI** Summary

INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage company focusing on inflammation and immunology, has made headlines with the publication of a study highlighting the therapeutic potential of mesenchymal stromal cell (MSC) therapies, particularly its CORDStrom™ platform. The study, titled "Fate and Function of Exogenously Administered MSCs: Current Insights and Future Directions," was featured in the peer-reviewed journal *Cytotherapy* and initiated through the collaboration of experts in the MSC field, including INmune's own Dr. Nikita M. Patel.

This paper reviews the latest understanding and impending research areas concerning MSCs, addressing crucial topics like systemic and local delivery methods, which are fundamental for optimizing therapies. As noted by Dr. Mark Lowdell, Chief Scientific Officer of INmune, while CORDStrom™ is being primarily developed for recessive dystrophic epidermolysis bullosa (RDEB), the insights gathered from such publications will bolster the platform's overall development aimed at addressing a range of inflammatory and autoimmune conditions.

The CORDStrom™ platform represents a breakthrough in cell medicine, utilizing pooled human umbilical cord-derived MSCs (hucMSCs). These therapies are manufactured to ensure consistency and cost-effectiveness, capable of serving multiple clinical indications through a versatile approach that allows for customization based on specific healing requirements.

INmune Bio's commitment to pioneering MSC therapies continues with plans to submit formal applications for regulatory approval in 2026, underscoring a potentially significant impact on treating complex health issues. As clinical trials progress, the company remains focused on expanding its capabilities in immunological therapies, paving the way for innovative solutions in modern medicine.

MWN-AI** Analysis

As a financial analyst observing the recent developments surrounding INmune Bio, Inc. (NASDAQ: INMB), the publication of a peer-reviewed study highlighting the applications of mesenchymal stromal cell (MSC) therapies, particularly their CORDStrom™ platform, merits attention. This article underscores INmune's potential to revolutionize treatment strategies for various diseases, affording investors a strategic viewpoint on their future prospects.

The CORDStrom™ platform, designed for systemic and localized delivery of umbilical cord-derived MSCs, showcases the company's innovative approach to addressing inflammatory conditions, degenerative diseases, and autoimmune disorders. The study, co-authored by a key figure within INmune, signals a commitment to advancing understanding and therapeutic options in the MSC arena. Analysts should consider the possibility that this foundational research may bolster investor confidence, particularly as INmune aims to file a Biologics License Application (BLA) and a Marketing Authorization Application (MAA) for CORDStrom™ in 2026.

Investors should also stay attuned to regulatory updates since the approval of novel therapies is often accompanied by substantial market movements. The broader implications of MSC therapies could lead to diversification of INmune’s product pipeline, enhancing long-term growth prospects beyond just RDEB. Furthermore, the stringent cGMP manufacturing protocols highlighted ensure consistency and scalability, addressing concerns over regulatory compliance and product reliability.

While forward-looking statements from INmune acknowledge inherent risks, the potential for blockbuster treatments positions the company favorably within the competitive biotech sector. A prudent approach for investors is to monitor trial outcomes, funding opportunities, and partnerships that may arise as the CORDStrom™ platform develops. With exciting advancements on the horizon, INmune Bio, Inc. presents a compelling case for consideration within a growth-oriented portfolio.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

Boca Raton, FL, Dec. 05, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune” or the “Company”), a clinical-stage inflammation and immunology company, announces a recently published overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies, such as INmune’s CORDStrom™ platform. The article, titled, “Fate and Function of Exogenously Administered MSCs: Current Insights and Future Directions,” was published in the peer-reviewed journal Cytotherapy . One of the lead authors of the paper was INmune Bio’s lead scientist for CORDStrom™ R&D, Dr Nikita M. Patel, M.Sci.,Ph.D.

The article, was the result of an invitation-only working party of basic, clinical and translational scientists working on MSCs and available on Cytotherapy’s website , reviews the current knowledge-base and critical gaps in order to formulate experimental questions designed to enhance development of MSC therapies such as the CORDStrom™ platform. These topics included systemic delivery of MSCs, local and/or depot-delivery (which is the method for the Company’s CORDStrom™ platform), and in vivo persistence.

“While CORDStrom™ is initially being developed for use in RDEB, in which we expect to file a BLA and MAA in 2026, publications such as this one provide important scientific background for future development of the CORDStrom™ platform. Stromal cell therapies are an important clinical advancement that may have significant impact in multiple indications including inflammation, immunomodulation, and wound healing,” said Dr. Mark Lowdell, INmune Bio CSO. “Nikita’s role within INmuneBio supports continued advancement in the knowledge base on MSCs. We believe her contributions as one of the senior authors to this article, and the insightful questions asked by the panel, will have an important impact on the development of the use of MSCs in general in addition to the ongoing development of our CORDStrom™ platform.”

About CORDStrom™

CORDStrom™ (pobistrocel) is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom™ platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory, degenerative and autoimmune diseases. CORDStrom™ products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification, independent of donor characteristics. While the first generation CORDStrom™ product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

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 dysfunction to fight disease. The Company’s pipeline include:

  • CORDStrom™ , an allogeneic mesenchymal stromal cell platform that recently completed a randomized, double-blinded study in recessive dystrophic epidermolysis bullosa.
  • DN-TNF Platform (XPro™/XPro1595), for neuroinflammatory and neurodegenerative conditions.
  • INKMune™ , designed to prime natural killer cells (NK) to eliminate minimal residual disease in cancer.

For more information, 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, the timing of key milestones, future plans or expectations for the development of all  drugs in our portfolio 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 of this release.

INmune Bio Contacts:

David Moss
Chief Financial Officer
(561) 710-0512
info@inmunebio.com

Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com


FAQ**

What specific milestones does INmune Bio Inc. (NASDAQ: INMB) anticipate achieving in 2026 regarding the filing of the BLA and MAA for the CORDStrom™ platform?

INmune Bio Inc. anticipates filing the Biologics License Application (BLA) and Marketing Authorization Application (MAA) for its CORDStrom™ platform in 2026, marking a significant advancement in their therapeutic development timeline.

How does the recent publication regarding MSC therapies impact the strategic direction of INmune Bio Inc. (INMB) for future research and development initiatives?

The recent publication on MSC therapies may prompt INmune Bio Inc. to pivot its strategic direction towards enhancing its R&D initiatives in regenerative medicine, potentially exploring novel applications and collaborations to leverage MSC technology for therapeutic advancements.

Can you elaborate on the potential implications of CORDStrom™ technology on treating complex inflammatory and autoimmune diseases, highlighting INmune Bio Inc. (NASDAQ: INMB)?

CORDStrom™ technology by INmune Bio Inc. (NASDAQ: INMB) may revolutionize the treatment of complex inflammatory and autoimmune diseases by enhancing the body's innate immune response, potentially leading to more effective and targeted therapies with fewer side effects.

What are the expected timelines for clinical trials of other products in INmune Bio Inc.’s (INMB) pipeline, such as the DN-TNF Platform and INKMune™, in relation to their partnership with the FDA?

The expected timelines for clinical trials of INmune Bio Inc.’s DN-TNF Platform and INKMune™ will depend on ongoing discussions with the FDA, but typically, early-stage trials may take 1-3 years, while later-stage trials can extend this timeline further.

**MWN-AI FAQ is based on asking OpenAI questions about INmune Bio Inc. (NASDAQ: INMB).

INmune Bio Inc.

NASDAQ: INMB

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