Form 8-K

8-K — Inmune Bio, Inc.

Accession: 0001213900-26-056599

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0001711754

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

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0290846-8k_inmune.htm (Primary)

EX-99.1 — PRESS RELEASE DATED MAY 14, 2026 (ea029084601ex99-1.htm)

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8-K — CURRENT REPORT

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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):

May 14, 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 May 14, 2026, INmune

Bio Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to

XPro™ (pegipanermin), the company's first-in-class selective soluble TNF inhibitor, for the treatment of early Alzheimer's

disease (AD).

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 May 14, 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: May 14, 2026

By:

/s/ David Moss

Name:

David Moss

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE DATED MAY 14, 2026

EX-99.1

Filename: ea029084601ex99-1.htm · Sequence: 2

Exhibit 99.1

INmune

Bio Receives FDA Fast Track Designation for XPro1595 in Early Alzheimer’s Disease

BOCA

RATON, FL, May 14, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a late-stage biotechnology company focused on inflammation

and immunology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to XPro™ (pegipanermin),

the company’s first-in-class selective soluble TNF inhibitor, for the treatment of early Alzheimer’s disease (AD). The designation specifically

covers XPro™ for treatment of early Alzheimer’s disease encompassing both mild cognitive impairment (MCI) due to AD and mild Alzheimer’s

disease dementia, which represents a large and growing population.

“Receiving

Fast Track designation from the FDA is a transformative milestone for XPro’s development program,” said David Moss, CEO of

INmune Bio. “This recognition underscores the urgent need for innovative treatments that address the underlying neuroinflammation

associated with early Alzheimer’s. We believe XPro™ has the potential to significantly alter the trajectory of this devastating

disease, and we look forward to working more closely with the FDA to bring this therapy to patients as efficiently as possible.”

Fast

Track designation is intended to facilitate development and expedite review of drugs that treat serious conditions and have potential

to address an unmet medical need. Inflammation in the brain is now recognized as an independent, early driver of cognitive decline in

Alzheimer’s disease, and no approved therapy targets these inflammatory pathways. Soluble tumor necrosis factor (sTNF) is believed to

be a key mediator of neuroinflammation associated with disease progression in Alzheimer’s disease. XPro™ selectively neutralizes

sTNF while preserving the immune functions that protect and repair the brain. The designation provides opportunities for more frequent

interactions with FDA and, if relevant criteria are met, eligibility for Rolling Review and other expedited review mechanisms.

“As

clinicians, we see every day the consequences of having limited disease-modifying options for patients with early Alzheimer’s disease,

especially those whose biology suggests inflammation is actively driving their decline,” said Sharon Cohen, M.D., FRCPC, Behavioral Neurologist

and Medical Director of the Toronto Memory Program, and a MINDFuL trial investigator. “The Fast Track designation for XPro™

is encouraging because it acknowledges both the urgency of the unmet need and a mechanistically distinct approach to treating neuroinflammation

in this population. I look forward to continuing this work in the AD04 program.”

“XPro™

is designed to treat the inflammatory biology that drives disease progression in a substantial subset of Alzheimer’s patients,”

said CJ Barnum, Ph.D., Vice President of Neuroscience at INmune Bio. “Phase 2 MINDFuL data, our End-of-Phase 2 alignment with FDA,

and now Fast Track designation reflects a consistent regulatory and scientific case: the right mechanism, in the right patients, with

a clean safety profile. We are positioned to execute the Phase 2b/3 as a precision-medicine registrational program. The enrichment strategy

is intended to identify patients at elevated risk of near-term clinical progression, enabling a more efficient registrational study design

in early Alzheimer’s disease.”

The

escalating prevalence of neurodegenerative disease presents a significant public health challenge, with the Alzheimer’s Association

2026 Facts and Figures report estimating that 7.4 million Americans age 65 or older are now living with Alzheimer’s dementia. This

figure is compounded by an additional 15 million individuals experiencing mild cognitive impairment (MCI), a critical precursor stage

that often precedes the onset of dementia. Notably, approximately 2.9 million of those diagnosed with Alzheimer’s are in the mild stage

of the disease. Together, these populations represent a vital “early symptomatic” window critical for clinical development,

as it represents the window where neuroinflammation and protein pathology can potentially be mitigated before severe functional loss

occurs.

For

more information and the full data set, visit the 2026 Alzheimer’s Disease Facts and Figures report.

About

the Phase 2b/3 Registrational Program

The

Phase 2b/3 seamless adaptive trial is designed to support registration of XPro™ in patients with early Alzheimer’s disease

with biomarkers of inflammation. The program enrolls patients with biologically confirmed early Alzheimer’s disease who also carry biomarkers

of inflammation. The Phase 2b portion is expected to utilize EMACC and plasma pTau217 as decision-gating endpoints for adaptive advancement

into the Phase 3 portion of the study. The Phase 3 portion is expected to evaluate clinical outcomes including CDR-SB over an extended

treatment period.

About

XPro1595 (XPro™)

XPro™

is a next-generation inflammatory cytokine modulator that neutralizes soluble TNF (sTNF) without affecting transmembrane TNF (tmTNF)

or its receptors. This selective targeting is designed to reduce neuroinflammation—a key driver of neurodegeneration in Alzheimer’s

disease—while maintaining the protective immune functions of the body.

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

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