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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):
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 16th 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.
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 |
2
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 16th 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 XPro1595TM
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 XProTM in patients with AD. INmune previously reported that treatment using XProTM 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 XProTM. 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 XProTM 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 XProTM 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 XPro1595TM in
AD |
| ● | Clinical and biomarker correlates of region-specific diffusion MRI metrics
in a short-term, Phase1b clinical trial for XPro1595TM 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 XPro1595TM 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
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
99.3
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 5th 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 17th 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
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