Form 8-K

8-K — Inmune Bio, Inc.

Accession: 0001213900-26-071082

Filed: 2026-06-23

Period: 2026-06-23

CIK: 0001711754

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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):

June 23, 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 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 8.01. Other Events.

On June 23, 2026, INmune

Bio Inc. issued a press release announcing that it has received official, accepted meeting minutes from its recent face-to-face pre-Marketing

Authorization Application (pre-MAA) Scientific Advice meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA)

for CORDStrom™ (Ebstrocel™) in Recessive Dystrophic Epidermolysis Bullosa (RDEB).

A copy of the press release is attached as Exhibit

99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial statements and Exhibits

(d) Exhibits.

99.1

Press Release dated June 23, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: June 23, 2026

By:

/s/ David Moss

Name:

David Moss

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE DATED JUNE 23, 2026

EX-99.1

Filename: ea029563501ex99-1.htm · Sequence: 2

Exhibit 99.1

INmune Bio Receives MHRA Written Alignment Supporting Planned 2026 UK Conditional Marketing Authorization Application for CORDStrom™

in RDEB

● MHRA minutes from May 12 pre-MAA Scientific Advice meeting

confirm agreement across all questions covering CMC, non-clinical and clinical evidence packages

● MHRA pediatric feedback recognizes MissionEB Phase 2 data

as demonstrating clinically meaningful symptomatic benefit, particularity pain and pruritis, and states the data could support positioning

as chronic or intermittent supportive therapy for RDEB

BOCA RATON, Fla, June 23, 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 received official, accepted meeting minutes from its recent face-to-face pre-Marketing Authorization Application (pre-MAA)

Scientific Advice meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) for CORDStrom™ (Ebstrocel™)

in Recessive Dystrophic Epidermolysis Bullosa (RDEB).

The May 12, 2026, meeting resulted in written alignment across all

questions submitted by the Company and provides a clear regulatory path for INmune Bio’s planned 2026 UK Marketing Authorization

Application (MAA) seeking Conditional Marketing Authorization for Ebstrocel™ in RDEB. Ebstrocel™ is the name of the RDEB-specific

investigational formulation derived from INmune Bio’s proprietary CORDStrom™ off-the-shelf, pooled, human umbilical cord-derived

mesenchymal stromal cell platform.

"Definitive MHRA alignment across CMC, non-clinical and clinical

strategy is an important regulatory de-risking milestone for Ebstrocel™ and for the broader CORDStrom™ platform," said

David Moss, Chief Executive Officer of INmune Bio. "The minutes give us a practical roadmap to completing the MAA package for potential

conditional authorization in the UK.”

In addition, the Company received written comments on its pediatric

investigation plan (PIP). In those comments, MHRA recognized MissionEB Phase 2 data as demonstrating “clinically meaningful symptomatic

benefit, particularly in pain and pruritus. While MissionEB demonstrated improvements in wound quality, inflammation, and granulation

during treatment periods, it did not show durable wound closure or sustained reduction in total wound burden after treatment cessation,

which is a significant limitation of the study. Nevertheless, these data could support the positioning as chronic or intermittent supportive

therapy for RDEB.” INmune Bio is incorporating the Agency’s endpoint recommendations into its confirmatory Phase 3 program

to better capture patient-relevant benefits in this ultra-rare disease.

“MHRA’s comments recognize the patient-relevant symptomatic

benefits observed in MissionEB and provide specific guidance on the evidence package, manufacturing transition and confirmatory trial

design needed to support review,” stated David Moss. “We remain on track for our planned 2026 UK MAA submission, with the

EU and US submissions to follow."

"RDEB studies require a development framework that reflects small

patient populations, caregiver-reported outcomes and clinically meaningful symptom changes," said Dr. Mark Lowdell, Chief Scientific

Officer of INmune Bio. "The MHRA feedback has been very valuable, constructive and highly specific. We are implementing MHRA’s

recommendations, including refinements to the primary and secondary endpoints, which move away from a focus on wound closure, and broadening

the planned pediatric age range to 0 to 18 years, before submitting the clinical trial application. The Agency’s openness to Bayesian

analyses and patient/parent-reported evidence is consistent with the realities of rare-disease development and will inform both our conditional-approval

package and our confirmatory Phase 3 strategy."

Key outcomes from the MHRA written advice:

1. CMC and Commercial Manufacturing Framework Validated

The MHRA affirmed that INmune Bio’s proprietary pooled-donor

approach is acceptable, provided it is supported by the Company’s data-characterization package and donor-contribution controls.

The agency also concurred with INmune Bio’s analytical and comparability plans to transition manufacturing to commercial platforms,

including standard microcarrier clearance controls and stability protocols. Importantly, the Company expects to submit certain real-time

manufacturing and stability updates during the formal MAA assessment period.

2. Capital-Efficient Non-Clinical Safety Package Accepted

Regulators agreed with INmune Bio’s strategy to use a focused,

literature-supported non-clinical safety package, supplemented by in vitro safety and pharmacology data. This approach is designed to

satisfy non-clinical safety requirements while avoiding redundant, capital-intensive animal testing that is unlikely to add decision-relevant

information for this cell-therapy product candidate.

3. Rare-Disease Clinical Evidence Framework Clarified

The MHRA provided constructive guidance on the statistical and clinical

evidence challenges inherent in ultra-rare diseases such as RDEB. Regulators noted that traditional frequentist statistical analyses may

be less informative in small orphan populations and invited INmune Bio to incorporate alternative approaches, including Bayesian statistical

models and qualitative patient and parent interview data describing improvements in systemic symptoms such as chronic pain, intractable

itch and sleep quality, to support the Ebstrocel™ MAA. The Agency also gave clear advice about strengthening our analysis

of the qualitative data from the MISSION EB phase II trial for submission, emphasizing the importance of this data. We have taken on board

their advice regarding data analyses for the phase III trial required for substantive approval, which is expected to open in 2026.

INmune Bio is advancing final commercial manufacturing validation activities

and dossier compilation to support the planned UK submission. The Company also intends to use the MHRA feedback to inform future interactions

with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) with additional filings planned in late 2026

or early 2027, subject to regulatory alignment and completion of required submissions.

About CORDStrom™

CORDStrom™ is a patent-pending cell medicine platform comprising

aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells in suspension for injection or infusion. The CORDStrom™

platform leverages 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 and potent cellular medicines that can be produced affordably and with repeatable

specifications. Ebstrocel™ is the indication-specific formulation derived from the CORDStrom™ platform, optimized with anti-inflammatory,

immunomodulatory and wound-healing effector functions to treat the severe systemic effects of RDEB in pediatric patients.

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:

1. 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.

2. 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, 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

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