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CORDStrom Phase III RDEB data to be detailed by INmune Bio (NASDAQ: INMB)

Filing Impact
(Moderate)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

INmune Bio Inc. filed an update noting it will host a webinar on February 26, 2026 at 1:00 p.m. ET to present new clinical data on CORDStrom for treating recessive dystrophic epidermolysis bullosa (RDEB). Clinical investigators from the MissionEB Phase III trial will share real-world experience and highlight systemic disease-modifying results.

The press release also describes CORDStrom as a patent-pending, off-the-shelf cell therapy made from pooled human umbilical cord-derived mesenchymal stromal cells, designed for scalable, consistent manufacturing. INmune Bio is a clinical-stage biotechnology company with three platforms: CORDStrom, XPro for inflammatory conditions, and INKmune for cancer.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): February 19, 2026

 

INMUNE BIO INC.
(Exact name of registrant as specified in charter)

 

Nevada   001-38793   47-5205835
(State or other jurisdiction   (Commission File Number)   (IRS Employer
of incorporation)       Identification No.)

 

225 NE Mizner Blvd., Suite 640, Boca Raton, Florida 33432

(Address of Principal Executive Offices) (Zip Code)

 

(561) 710-0512 

(Registrant’s Telephone Number, Including Area Code)

 

Not Applicable

(Former Name or Former Address, If Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.001 per shares   INMB   The NASDAQ Stock Market LLC

 

 

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 mart 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 8.01. Other Events.

 

On February 19, 2026, INmune Bio Inc. (the “Company”) issued a press release announcing that the Company will host a webinar on CORDStrom for the treatment of recessive dystrophic epidermolysis bullosa on February 26, 2026, at 1:00 p.m. ET. A copy of the press release is attached herewith as Exhibit 99.1 and is incorporated herein by reference.

  

Item 9.01 Financial statements and Exhibits

 

(d) Exhibits.

 

99.1   Press Release, dated February 19, 2026
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: February 19, 2026 By: /s/ David Moss
    David Moss
    Chief Executive Officer

 

 

2

 

Exhibit 99.1

 

 

INmune Bio Announces Upcoming Webinar to Present New Clinical Data on CORDStrom™ for RDEB

 

Clinical investigators from the trial to share real-world experience treating RDEB patients with CORDStrom and present new data from the MissionEB clinical study

 

Boca Raton, FL, Feb. 19, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune” or the “Company”), a late-stage biotechnology company focused on inflammation and immunology, will host a webinar on CORDStrom for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) on February 26, 2026 at 1:00 p.m. ET. 

 

The session will focus on the latest results from the MissionEB Phase III clinical trial, specifically highlighting the systemic disease-modifying capabilities of CORDStrom™ in patients with RDEB

 

Webinar Focus: Beyond Topical Care

 

Unlike current standard-of-care options that are limited to topical wound treatments, CORDStrom™ is being developed as a systemic, disease-modifying therapy.  The upcoming webinar will spotlight new data demonstrating CORDStrom’s impact on key clinical benchmarks in RDEB:

 

EBDASI Skin Score Improvements:  Detailed analysis of changes in the EBDASI (EB Disease Activity and Scarring Index) of CORDStrom™ versus placebo.
   
Nutritional & Weight Gain Data:  Evidence of weight gain in pediatric patients, addressing the critical, “failure to thrive,” often seen in RDEB due to systemic inflammation and gastrointestinal complications.
   
Clinically Relevant Symptom Reductions: Clinical observations related to the reduction in pain and itch, which are primary drivers of patient morbidity.
   
Enhanced Quality of Life: New data and feedback from the principal investigators regarding significant improvements in daily functional measures for patients.

 

Featured Clinical & Scientific Experts

 

The webinar will feature firsthand clinical observations from the investigators who initiated and ran the MissionEB study in the United Kingdom to include insights into the systemic nature of the disease and the scientific rationale behind the use of CORDStrom:

 

Dr. Anna Martinez, MBBS, MRCP, FRCPCH - Principal investigator of the Mission EB Clinical trial.  Dr. Martinez is the United Kingdom’s leading specialist in pediatric RDEB and is internationally recognized for her expertise in rare and complex skin disorders.
   
Prof. Mark Lowdell, PhD, FRCPath FRSB - Chief Scientific Officer and Co-Founder of INmune Bio.  Prof. Lowdell is also Professor of Cell and Tissue Therapy at University College London, where he has led a translational immunotherapy group since 1994.

 

Registration Details

 

To register, click here or copy and paste the link below:

 

https://events.teams.microsoft.com/event/1b0d5c6b-354c-42a0-aa2f-5e4caf91d689@62709ef1-3de5-474b-be74-625402fa32a9

 

About CORDStrom™

 

CORDStrom™ 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 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. Pooling allows tuning of different CORDStrom products with different effector functionsdependent upon selected 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 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, 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

 

 

 

FAQ

What did INmune Bio (INMB) announce about CORDStrom in this 8-K filing?

INmune Bio announced a webinar to present new clinical data on CORDStrom for recessive dystrophic epidermolysis bullosa. The event will share results from the MissionEB Phase III trial and discuss CORDStrom’s potential as a systemic, disease-modifying therapy beyond standard topical wound treatments.

When is INmune Bio’s (INMB) CORDStrom webinar scheduled and what will it cover?

The CORDStrom webinar is scheduled for February 26, 2026 at 1:00 p.m. ET. It will feature clinical investigators from the MissionEB Phase III trial, highlight systemic disease-modifying data in RDEB, and explain the scientific rationale for using CORDStrom as a cell-based therapy.

What is CORDStrom according to INmune Bio’s (INMB) disclosure?

CORDStrom is a patent-pending cell medicine made from pooled human umbilical cord-derived mesenchymal stromal cells for injection or infusion. It is designed as an off-the-shelf, scalable, cGMP-manufactured product platform aimed at treating complex inflammatory and autoimmune diseases, including recessive dystrophic epidermolysis bullosa.

What stage is INmune Bio (INMB) and its CORDStrom program in?

INmune Bio describes itself as a clinical-stage biotechnology company. CORDStrom has completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa, and the upcoming webinar will discuss MissionEB Phase III data. The company notes its product candidates have not yet been approved by major regulatory agencies.

What other product platforms does INmune Bio (INMB) highlight besides CORDStrom?

INmune Bio highlights three product platforms: CORDStrom for pooled umbilical cord-derived cell therapies, XPro, a Dominant-Negative TNF platform targeting inflammation and innate immune dysfunction, and INKmune, a cell-based medicine intended to prime natural killer cells to attack minimal residual cancer disease.

What risks and uncertainties does INmune Bio (INMB) mention around its clinical programs?

INmune Bio states that clinical trials are in early stages and outcomes are uncertain. It notes risks around producing sufficient drug for trials, obtaining substantial additional funding, and successfully executing research, regulatory approvals, and commercialization plans, which could cause actual results to differ from current expectations.

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