8-K - INMB - Equibles

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): October 24, 2024

INMUNE BIO INC.
(Exact<br> name of registrant as specified in charter)
Nevada	001-38793	47-5205835
---	---	---
(State<br> or other jurisdiction	(Commission<br> File Number)	(IRS<br> Employer
of<br> incorporation)		Identification<br> No.)

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

(Address of Principal Executive Offices) (Zip Code)

(858)

964 3720

(Registrant’s Telephone Number, Including Area Code)

NotApplicable

(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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
---	---
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
---	---
☐	Pre-commencement<br> 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<br> 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. ☐

Item8.01. Other Events.

On October 24, 2024, INmune Bio Inc. (the “Company”), issued a press release announcing the publication of a seminal paper in the journal Cell Reports that demonstrates XPro1595 promotes remyelination in an animal model of demyelinating disease.

A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item9.01 Financial statements and Exhibits

(d) Exhibits.

99.1	Press Release dated October 24, 2024
104	Cover<br> 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:<br> October 25, 2024	By:	/s/ David Moss
	Name:	David<br> Moss
	Title:	Chief<br> Financial Officer

Exhibit 99.1

INmuneBio Inc. Announces Publication in Cell Reports Demonstrating XPro™ Promotes Remyelination

Datafrom Animal Model Study Demonstrate XPro™ converts microglia from a demyelinating cell to a remyelinating cell

Multi-yearstudy published has implications for many CNS diseases including Alzheimer’s

BocaRaton, Florida, Oct. 24, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), aclinical-stageinflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announces the publication of a seminal paper in the journal Cell Reports that demonstrates XPro1595 promotes remyelination in an animal model of demyelinating disease. The study, Microglia Regulate Cortical Remyelinationvia ΤNFR1-Dependent Phenotypic Polarization, was performed under the direction of Leslie Probert PhD, Head of Immunology at the Hellenic Pasteur Institute in Athens Greece, and is the culmination of several years of work supported by EU research grants.

Myelin is necessary for fast and efficient communication between neurons. Loss of myelin compromises neuron function and communication and is a key step in the neurodegenerative process of many CNS diseases, including Alzheimer’s Disease.

“Activated microglia play a central role in both demyelination and remyelination,” said Dr. Probert, senior author of the publication. “Our data identify solTNF as a critical cytokine checkpoint that converts microglia from a reparative, remyelinating cell to a damaging, demyelinating cell. These data suggest that blocking soluble TNF is a promising strategy for treating demyelinating diseases.”

“Demyelination is a core mechanism of neurodegeneration that has been overlooked in Alzheimer's disease, despite the evidence that it’s a critical element of the disease's pathology,” said RJ Tesi MD, CEO of INmune Bio. “These new data further support the potential for XPro1595 in neurodegenerative diseases by restoring glia function to improve key components of neurodegeneration at multiple levels, including restoration of synaptic function, remyelination, and ceasing cell loss.”

INmune anticipates reporting top-line cognitive results of an ongoing blinded randomized Phase II in Early AD patients in the first half of 2025.

AboutDemyelination in Alzheimer's Disease

Research shows that demyelination occurs in various brain regions critical for cognition in AD patients. This damage is often associated with the presence of amyloid-beta (Aβ) plaques, suggesting that myelin loss may precede or accompany the classic pathological changes seen in AD. Changes in myelin structure can be detected even before the onset of typical AD symptoms. Advanced imaging techniques have revealed alterations in myelin density and integrity in individuals at risk for AD, indicating that demyelination might serve as an early biomarker for the disease. The mechanisms underlying myelin damage in AD involve oligodendrocyte dysfunction, which can lead to the breakdown of myelin sheaths. This breakdown not only affects neuronal health but may also contribute to the accumulation of Aβ, creating a feedback loop that exacerbates both myelin loss and neurodegeneration. Studies utilizing techniques like myelin water fraction imaging have shown significant reductions in myelin integrity among individuals with mild cognitive impairment and dementia, reinforcing the notion that demyelination is prevalent in AD.

AboutINmune Bio Inc.

INmuneBio, Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that targetthe innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-NegativeTumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driverof innate immune dysfunction and a mechanistic driver of many diseases. XPRO, the first of several DN-TNF products, is in clinical trialsto determine if it can treat patients with Mild Alzheimer’s disease. Additional therapeutic indications including d treatment-resistantdepression and oncology will be pursued when resources allow. The Natural Killer Cell Priming Platform includes INKmune™, a therapydeveloped to prime a patient’s NK cells to treat patients with cancer. INKmune uses a precision medicine approach for the treatmentof a wide variety of hematologic and solid tumor malignancies. The INKmune trial is enrolling patients into a US Phase I/II trial inmen with metastatic castrate resistant prostate cancer. To learn more, please visit www.inmunebio.com.

ForwardLooking Statements

Clinicaltrials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this pressrelease that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private SecuritiesLitigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constituteforward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statementscontained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timingof certain events and circumstances may differ materially from those described by the forward-looking statements as a result of theserisks and uncertainties. INB03™, XPro1595, and INKmune™ are still in clinical trials or preparing to start clinical trialsand have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance thatthey will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actualfuture results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to theCompany’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Companyto continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’sbusiness, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factorsare identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including theCompany’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reportson Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstancethat may arise after the date of this release.

INmuneBio Contact:

DavidMoss, CFO (858) 964-3720info@inmunebio.com

DanielCarlsonHead of Investor Relations(415) 509-4590dcarlson@inmunebio.com

Investor Contact:

MikeMoyerManaging Director – LifeSci Advisorsmmoyer@lifesciadvisors.com