Form 8-K

8-K — Inmune Bio, Inc.

Accession: 0001213900-26-099700

Filed: 2026-09-14

Period: 2026-09-08

CIK: 0001711754

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

Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0305404-8k_inmune.htm (Primary)

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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): September 8, 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 ☐

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

5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of

Certain Officers.

September 8, 2026, the Board of Directors (the “Board”) of INmune Bio, Inc. (the “Company”) approved to increase

the number of directors and to set the number of directors serving on the Board at seven, and, pursuant to the Company’s by-Laws,

appointed R. Duane Clark II and James Sapirstein to serve as directors of the Company until the next annual election and until their

successors are duly elected and qualified. The Board also appointed Mr. Clark and Mr. Sapirstein to serve as members of the Nominating

and Corporate Governance Committee of the Board.

Mr.

Clark, age 63, brings more than 40 years of global pharmaceutical and biotechnology leadership, with particular depth in rare diseases,

immunology and specialty-product commercialization. He currently serves as General Manager, U.S. Rare Diseases at Sanofi, where he leads

a multi-billion-dollar business spanning seven rare-disease brands with full profit-and-loss responsibility. His experience includes

multiple product launches, market-access strategy, M&A integration, and leadership across sales, marketing, medical and commercial

operations. Earlier in his career, he led Sanofi’s U.K. and Ireland multiple sclerosis business and held commercial and business-development

roles at CTI Clinical Trial & Consulting Services, Encysive Pharmaceuticals, Astellas Pharma, Ortho Biotech and Marion Laboratories.

Mr. Clark received a B.A. in Business and Marketing from University of Kentucky.

Mr.

Sapirstein, age 65, brings more than 40 years of biopharmaceutical leadership spanning business development, licensing, commercialization,

capital formation and public-company operating experience. He has led six global commercial product launches and participated in more

than 20 additional launches. Mr. Sapirstein is currently the Chief Executive Officer of Cocrystal Pharma, Inc. (Nasdaq: COCP) and the

Chief Executive Officer and Chairman of 8 Prime Biosciences, a private company. Prior to that, from October 2019 to February 2025,

Mr. Sapirstein as Chief Executive Officer and Chairman of Entero Therapeutics, Inc. (Nasdaq: ENTO) (now known as GridAI Technologies

Corp., Nasdaq:GRDX) and as a consultant from February 2025 to March 2026. His career includes senior roles at Gilead Sciences, Bristol

Myers Squibb, Hoffmann-La Roche, Eli Lilly and Serono Laboratories. Mr. Sapirstein currently also serves as the Executive Chairman of

Onconetix, Inc. (Nasdaq: ONCO) and as a director of ZyVersa Therapeutics, Inc (OTC Pink: ZVSA). He also founded and led Tobira Therapeutics

which was later acquired by Allergan and has extensive experience structuring strategic transactions and guiding biotechnology companies

through growth, restructuring and value-creating exits. Mr. Sapirstein received a B.S. in Pharmacy from Rutgers University and his MBA

from Fairleigh Dickinson University.

The

Board has determined that Mr. Clark and Mr. Sapirstein are both independent directors within the meaning of Nasdaq Listing Rule 5605.

Mr. Clark qualifies to serve on the Board because of his extensive experience and leadership in the global pharmaceutical and biotechnology

industries, with particular depth in rare diseases, immunology and specialty-product commercialization. Mr. Sapirstein qualifies to serve

on the Board because of his extensive experience and leadership in the biopharmaceutical industry, which includes business development,

licensing, commercialization, capital formation and public-company operating experience.

Mr.

Clark and Mr. Sapirstein do not have a family relationship with any of the executive officers or directors of the Company. There are

no arrangements or understandings between Mr. Clark and Mr. Sapirstein and any other persons pursuant to which they were selected as

directors, and there are no transactions in which they have an interest requiring disclosure under Item 404(a) of Regulation S-K.

In consideration for their

service as members of the Board, Mr. Clark and Mr. Sapirstein shall each receive, upon approval by the Compensation Committee of the Company,

an option to purchase 100,000 shares of the Company’s common stock under the Third Amended and Restated INmune Bio Inc. 2021 Stock

Incentive Plan. The initial grant will vest in 36 equal monthly installments beginning one month after the grant date, so that the initial

grant is fully vested on the third anniversary of the grant date, in each case subject to their continued service on the Board on each

applicable vesting date. In addition to the initial grant, Mr. Clark and Mr. Sapirstein shall each receive: (i) an annual cash retainer

of $50,000 for their service as directors, payable quarterly in arrears and pro-rated for any partial quarter of service, and (ii) reimbursement

for reasonable and documented out-of-pocket expenses related to their service as members of the Board. In connection with their appointment,

the Company will enter into its standard form of indemnification agreement with Mr. Clark and Mr. Sapirstein.

Item

8.01 Other Events

September 14, 2026, the Company issued a press release (the “Release”) announcing Mr. Clark’s and Mr. Sapirstein’s

appointment to the Board. A copy of the Release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. Exhibits 99.1

shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange

Act”) or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated into any filing of

the Company under the Securities Act of 1933, as amended, or the Exchange Act.

Item

9.01 Financial statements and Exhibits

(d)

Exhibits.

99.1

Press Release dated September 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: September

14, 2026

By:

/s/

David Moss

Name:

David Moss

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE DATED SEPTEMBER 14, 2026

EX-99.1

Filename: ea030540401ex99-1.htm · Sequence: 2

Exhibit

99.1

INmune

Bio Appoints Sanofi Rare-Disease Executive and Biopharma Business Development Leader to Board

Appointments

strengthen rare-disease commercialization planning and strategic partnering capabilities as

Ebstrocel™ advances toward potential

commercialization

BOCA

RATON, Fla., Sept. 14, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology

company focused on inflammation and immunology, today announced the appointments of R. Duane Clark II and James Sapirstein, R.Ph., MBA,

to its Board of Directors. The appointments add commercial and strategic operating expertise as INmune Bio prepares Ebstrocel™

for potential rare-disease commercialization and pursues business-development and partnering opportunities across its pipeline.

Mr.

Clark brings more than 40 years of global pharmaceutical and biotechnology leadership, with particular depth in rare diseases, immunology

and specialty-product commercialization. He currently serves as General Manager, U.S. Rare Diseases at Sanofi, where he leads a multi-billion-dollar

business spanning seven rare-disease brands with full profit-and-loss responsibility. His experience includes multiple product launches,

market-access strategy, M&A integration, and leadership across sales, marketing, medical and commercial operations. Earlier in his

career, he led Sanofi’s U.K. and Ireland multiple sclerosis business and held commercial and business-development roles at CTI

Clinical Trial & Consulting Services, Encysive Pharmaceuticals, Astellas Pharma, Ortho Biotech and Marion Laboratories.

Mr.

Sapirstein brings more than 40 years of biopharmaceutical leadership spanning business development, licensing, commercialization, capital

formation and public-company leadership experience. He has led six global commercial product launches and participated in more than 20

additional launches. His career includes senior roles at Gilead Sciences, Bristol Myers Squibb, Hoffmann-La Roche, Eli Lilly and Serono

Laboratories. He also founded and led Tobira Therapeutics, which was later acquired by Allergan in a transaction with total potential

consideration of up to approximately $1.7 billion, including contingent milestone payments. Mr. Sapirstein also brings extensive experience

structuring strategic transactions and guiding biotechnology companies through growth, restructuring, and value-creating exits.

“These

appointments bring capabilities directly aligned with INmune Bio’s next stage of growth,” said David Moss, Chief Executive

Officer of INmune Bio. “Duane’s rare-disease leadership leading a major rare-disease business will strengthen our planning

for market access and potential commercialization of Ebstrocel. James’s business development, licensing, and financing experience

will support our evaluation of strategic opportunities for our broader pipeline. Together, they add practical experience to help us translate

development progress into potential patient and shareholder value.”

The

new directors strengthen the Board in:

● Rare-disease

commercialization: Guide market access and pricing, patient identification, commercial

infrastructure and launch execution for Ebstrocel™ in recessive dystrophic epidermolysis

bullosa (RDEB) and potential additional rare-disease indications.

● Business

development and strategic transactions: Strengthen the evaluation and negotiation of

licensing, distribution, co-development and other strategic relationships intended to accelerate

development and broaden commercial reach.

● Commercial

scale and execution: Help align clinical, regulatory, manufacturing and commercial functions

as INmune Bio advances from late-stage development toward potential product launches.

“Ebstrocel

has the potential to address important unmet needs in rare disease, and INmune Bio is approaching the stage at which disciplined launch

and market-access planning can become a meaningful competitive advantage,” said Mr. Clark. “I look forward to helping the

Company build a patient-focused commercialization strategy and the capabilities required to execute it.”

“INmune

Bio has multiple opportunities to create value through focused internal development and well-structured strategic partnerships,”

said Mr. Sapirstein. “I look forward to contributing my business-development, transaction and commercialization experience as the

Company evaluates the best path to advance its differentiated platforms.”

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. 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 in 2026

and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission.

● XPro1595™:

A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform designed to selectively neutralize

soluble TNF (sTNF) and reduce 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.

learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.

Forward

Looking Statements

The

Company’s product candidates remain in clinical development stage 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 Ebstrocel™, XPro™ and INKmune™

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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