Form 8-K - Current report

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): July 10, 2023

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 Boulevard, Suite 640, Boca Raton, FL 33432

(Address of Principal Executive Offices) (Zip Code)

(858) 964-3720

(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))

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. ☐

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 share		INMB		The NASDAQ Stock Market LLC

Item 8.01. Other Events.

On July 10, 2023, INmune Bio Inc. (the “Company”) issued a press release announcing important findings from data presented at the 16^th European Meeting on Glial Cells in Health and Disease. The conference started July 8, 2023 and ends on July 12, 2023, in Berlin, Germany.

On July 11, 2023, the Company issued a press release announcing new findings from data to be presented at the annual Alzheimer’s Association International Conference (the “AAIC”) in Amsterdam, Netherlands. AAIC is the largest medical meeting focused on Alzheimer’s disease.

On July 12, 2023, the Company issued a press release announcing that the Company has been invited to discuss drug development strategies in aging and rejuvenation at the 5th World Aging and Rejuvenation Conference in Frankfurt, Germany on July 17, 2023.

A copy of these press releases are attached herewith as Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3 respectively.

Item 9.01 Financial statements and Exhibits

(d) Exhibits.

99.1		Press Release dated July 10, 2023
99.2		Press Release dated July 11, 2023
99.3		Press Release dated July 12, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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.

Date: July 12, 2023	INMUNE BIO INC.

	By:	/s/ David Moss
		David Moss
		Chief Financial Officer

Exhibit 99.1

INmune Bio Inc. Announces Data Presented at the 16th European Meeting on Glial Cells in Health and Disease Shows that XPro™ Promotes Remyelination by Affecting Astroglial and Microglial Biology

Neutralizing soluble TNF with XPro™ promotes remyelination in cuprizone model after increasing astrocyte and microglia activation responses

Boca Raton, Florida, July 10, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announces important findings from data presented at The 16^th European Meeting on Glial Cells in Health and Disease. The conference runs July 8-12 in Berlin, Germany.

Myelin is a specialized lipid produced by oligodendrocytes that forms the myelin sheath of axons. Axons are the projections that allow neurons to communicate with each other and with other tissues such as muscle, skin, retina, nose and the ear for sight, smell and hearing respectively. An intact and healthy myelin sheath is necessary for axons to work properly. Any damage to the myelin sheath compromises axon function preventing nerve cells from communicating and can result in nerve cell death. Although the pathology of demyelination is easy to see, the biology of demyelination and remyelination is poorly understood. Drug therapy to prevent demyelination are available, but there are no therapies that promote remyelination. Therapies that promote remyelination will be needed to effectively treat many neurodegenerative diseases.

“Demyelination is an important part of the pathology of many neurodegenerative diseases including multiple sclerosis (MS) and Alzheimer’s disease (AD). In the past, microglia cells were thought to drive demyelination,” said Prof. Lesley Probert Ph.D. from the Hellenic Pasteur Institute in Athens, Greece. “This work shows that astrocytes, the most abundant cell in the brain after neurons, like microglia, are intimately involved in driving the neuroinflammation component in demyelinating diseases, and that blocking soluble TNF with XPro™ promotes remyelination.” Prof. Probert’s team has previously shown that XPro™ promotes remyelination in the cuprizone model – a standard model for studying myelin biology in the brain. Work continues to determine how XPro™ affects microglia and astrocyte responses to promote disease resolution and repair. The data presented today demonstrate new findings. First, astrocytes are rapidly activated in response to demyelination. Second, preventing soluble TNF and TNFR1 function in mice using microglia- or astrocyte-specific TNFR1 knockout mice mirrors the effects of XPro™ in increasing beneficial glial responses that results in better remyelination. The third surprise is that traditional biomarkers of astroglial and microglial activation, GFAP and Iba1 respectively, are increased in these myelin-promoting glial cells.

“Until recently, the of role in demyelination and remyelination has been poorly understood. This work shows that microglia and astroglia must express biomarkers of activation to promote remyelination,” said Dr. CJ Barnum VP of CNS Drug Development at INmune Bio. “This finding is contrary to current dogma that suggests decreased glial activation is required to promote remyelination. This finding supports our belief that immunosuppressive therapies that turn off the glial cells will not help repair and regeneration of the brain in neurologic diseases.” These data will be expanded in a detailed publication in the future.

List of Presentations:

Distinct astrocyte activation profiles associated with demyelination in the cuprizone model of multiple sclerosis.

Therapeutic modulation of solTNF-TNFR1 signaling selectively in microglia promotes remyelination in the cortical grey matter.

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 two product platforms that are both in clinical trials. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is in clinical trials to determine if it can treat cancer (INB03™), early Alzheimer’s disease, and treatment resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. 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 that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts 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 a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595™, and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA 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 in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact:

David Moss, CFO
(858) 964-3720
info@inmunenbio.com

Investor Contact:

Jason Nelson
Core IR
(516) 842-9614 x-823

Exhibit 99.2

INmune Bio Inc. Announces Novel MRI Biomarker Data Demonstrating Improvement in Gray Matter in Patients with Alzheimer’s Disease

Analysis of MRI scans in participants from an open label Phase 1b study demonstrates that CDM^®, a novel gray matter biomarker, is improved following three months of treatment with XPro1595^TM

Boca Raton, Florida, July 11, 2023 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reveals new findings from data to be presented at the annual Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands. AAIC is the largest medical meeting focused on Alzheimer’s Disease (AD).

“One of the difficulties in developing drugs for AD is the inability to quantify the disease and measure changes at the tissue or microstructure level. The current approaches to measure brain changes utilize imaging techniques that measure the whole brain,” said RJ Tesi, M.D., INmune Bio’s Chief Executive Officer. “To observe whole brain changes in AD often takes a year or longer. Because whole brain changes are a sum of microstructural changes, we can more quickly assess the potential of a therapy through microstructural measurements such as Cortical Disarray Measurement (CDM^®).”

Emerging imaging techniques that assess microstructural changes are rapidly advancing. INmune Bio is a pioneer in the use of novel microstructural neuroimaging biomarkers to measure pharmacodynamic activity of treatment with XPro^TM in patients with AD. INmune previously reported that treatment using XPro^TM improved microstructural changes in the white matter tracts that are most affected in AD patients in participants from our Phase 1b trial. This new analysis reports similar findings in the gray matter of these same participants. The results demonstrate a dose dependent enhancement in gray matter measures throughout the brain in AD patients treated with XPro^TM. The changes in microstructural cortical gray matter structure were measured using Cortical Disarray Measurement and one metric in particular demonstrated significance PerpPD+. CDM^® is a novel gray matter measure that is more effective than standard whole brain volumetric changes in predicting cognitive decline. Notably, the greatest improvement was observed in the gray matter of brain regions where Alzheimer’s disease originates.

To better understand the utility of PerpPD+ in patients with AD treated with XPro™, associations with other AD biomarkers were assessed. Baseline levels of PerpPD+ were highly correlated with baseline levels of cerebral spinal fluid biomarkers of AD pathology (amyloid and tau), inflammation (YKL-40, GFAP and sTREM2), and cognitive status (MMSE scores). “These data provide additional evidence that XPro^TM may be having a specific impact on the brain regions most impacted by AD at the microstructural level within three months of starting treatment,” said CJ Barnum Ph.D., VP of CNS Drug Development at INmune Bio. “These findings serve as indicators of early target engagement for XPro^TM in AD and add further support for use of noninvasive diffusion MRI in AD trials. This new biomarker tool, when added to our existing suite of biomarkers, should improve the speed, and decrease the risk of CNS drug development.”

INmune Bio Presentations Discussed at AAIC 2023

●

Cortical microstructural MRI for detection of early target engagement in AD drug trials: Post-hoc analysis of exploratory outcomes from a phase 1b safety study for XPro1595^TM in AD

●

Clinical and biomarker correlates of region-specific diffusion MRI metrics in a short-term, Phase1b clinical trial for XPro1595^TM in Alzheimer’s disease

About Cortical Disarray Measurement (CDM^®)

PerpPD⁺ is a novel measure of cortical diffusivity and key metric included in the Cortical Disarray Measurement (CDM®) technology developed by Oxford Brain Diagnostics, Ltd, Oxford (UK). Cortical Disarray Measurement (CDM®) software has been granted Breakthrough Device designation by the FDA and is currently in use to assess changes in GM microstructure as a secondary outcome in our ongoing Phase 2 trial for XPro1595^TM in AD. The PerpPD⁺ metric represents the diffusion components perpendicular to cortical GM minicolumns, is an indicator of microscopic disruption in cortical GM when increased in AD and has been shown to be more sensitive than standard volumetrics to changes in other indicators of synaptic structure, neuroinflammation and neurodegeneration across the AD continuum.

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 two product platforms that are both in clinical trials. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is in clinical trials to determine if it can treat cancer (INB03™), Early Alzheimer’s disease, and treatment resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.

About Oxford Brain Diagnostics, Ltd.

Oxford Brain Diagnostics Ltd is rethinking how brain health is assessed and managed. Founded in neuropathological and neuroimaging expertise, the company’s patented Cortical Disarray Measurement (CDM®) technology uses MRI brain scan data to support early and differential diagnosis, track progression, and predict the decline of neurodegenerative diseases. Oxford Brain Diagnostics is committed to assessing brain health based on changes in the cellular structure, supporting drug development, and helping clinicians around the world in their fight to defeat Alzheimer’s and other neurodegenerative diseases. For more information, visit https://www.oxfordbraindiagnostics.com

Forward Looking Statements

INmune Bio Contact:

David Moss, CFO
(858) 964-3720
info@inmunenbio.com

Investor Contact:

Jason Nelson
Core IR
(516) 842-9614 x-823

Exhibit 99.3

INmune Bio Inc. to Deliver Keynote Talk at 5th World Aging and Rejuvenation Conference.

RJ Tesi MD, CEO of INmune Bio, to Present Opening Keynote on Drug Development Strategies to Improve Health Span by Treating the Chronic Diseases of Aging

Boca Raton, Florida, July 12, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease has been invited to discuss drug development strategies in aging and rejuvenation at the 5^th World Aging and Rejuvenation Conference in Frankfurt, Germany on July 17, 2023.

Modern medicine has extended the average life span to more than 75 years old in the US.. An unintended consequence of this extended life span is a decline in overall health in the latter years of life. Health span, which refers to the period of life characterized by good health, is currently at odds with life span due to the prevalence of chronic diseases of aging. Chronic diseases of aging affect virtually every organ system, including the heart, brain, eyes, ears, bones, and skeletal muscles. Unfortunately, they contribute to a diminished health span, resulting in shortened life spans, increased elder care costs, and reduced quality of life. Many of these chronic diseases of aging are the result of chronic inflammation, leading the National Institute of Health to term it “inflammaging.” Inflammaging is characterized by a persistent, low-grade inflammation that develops with advancing age, independent of apparent infections, and potentially exacerbates other age-related conditions.

Cognitive aging is one of the most prevalent chronic diseases associated with advancing age. Almost all adults have a gradual decline in cognitive function that becomes meaningful in the mid 50s then accelerates after age 65. . It is important to differentiate cognitive aging from Alzheimer’s disease (AD). AD appears around the eighth decade of life, exhibits more pronounced cognitive dysfunction and is characterized by amyloid plaques. “Cognitive aging is a well-defined disease that has not been the subject of extensive clinical study or intervention,” said CJ Barnum, VP CNS Development at INmune Bio. “We believe cognitive aging is driven by neuroinflammation. INmune Bio has developed biomarkers specifically designed to measure neuroinflammation in Early AD patients, that are well-suited for studying cognitive aging.” The study of inflammaging is still in its early stages, as its cause is a culmination of genetic (ApoE4 gene), epigenetic (diabetes, cardiovascular, autoimmunity), behavioral (obesity, smoking, sedentary living, diet), environmental (pesticides, pollution) and biologic (cellular senescence) factors. Unfortunately, no treatments currently exist for inflammaging.”

“The field of aging research and drug development has many challenges,” said RJ Tesi, MD, CEO of INmune Bio said. “Conducting anti-aging clinical trials based on direct measures of reduced aging is very difficult, if not impossible due to the extensive length of the trials. Biomarkers and surrogate endpoints of aging must be used in order to effectively develop therapies to enhance health span.” The topic of the plenary talk is a strategy to employ innovative neuroimaging biomarkers and sensitive measures of cognitive function that were perfected in our AD program to study cognitive aging. The literature supports the hypothesis that chronic neuroinflammation is a driving factor in cognitive aging. “Because of our experience in treating AD patients with neuroinflammation, we know how to measure and treat neuroinflammation with XPro,” said Dr. Tesi. “We believe the insights gained from treating neuroinflammation in AD should be applicable to the treatment of cognitive aging.”

The talk, entitled: “Using Enrichment Criteria for Clinical Trials in Aging: Using Biomarkers of Peripheral Inflammation to Predict Cognitive Dysfunction” will be presented at 9AM CES on the 17^th of July.

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 two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease, and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. 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 that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts 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 a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA 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 in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact:

David Moss, CFO
(858) 964-3720
info@inmunenbio.com

Investor Contact:

Jason Nelson
Core IR
(516) 842-9614 Ext: 823

Cover	Jul. 10, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 10, 2023
Entity File Number	001-38793
Entity Registrant Name	INMUNE BIO INC.
Entity Central Index Key	0001711754
Entity Tax Identification Number	47-5205835
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	225 NE Mizner Boulevard
Entity Address, Address Line Two	Suite 640
Entity Address, City or Town	Boca Raton
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33432
City Area Code	858
Local Phone Number	964-3720
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	INMB
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false