Form 8-K - Current report
27 Noviembre 2023 - 3:00PM
Edgar (US Regulatory)
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2023-11-27
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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):
November 27, 2023
INMUNE BIO INC. |
(Exact name of registrant as specified in charter) |
Nevada |
|
001-38793 |
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47-5205835 |
(State or other jurisdiction |
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(Commission File Number) |
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(IRS Employer |
of incorporation) |
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Identification 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)
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 |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.001 per shares |
|
INMB |
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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
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.
Item 8.01. Other Events.
On November 27, 2023,
INmune Bio Inc. (the “Company”), issued a press release announcing that the Company has received European Medicines Agency’s
Authorized Decision from the Agence Nationale de Securite du Medicament et des Produits de Sante in France and the Agencia Espanola de
Medicamentos y Productos Sanitarios in Spain to initiate a Phase II trial in Early Alzheimer’s Disease (AD) with XPro™.
A copy of the press release
is attached herewith as Exhibit 99.1.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
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.
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INMUNE BIO INC. |
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Date: November 27, 2023 |
By: |
/s/ David Moss |
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David Moss |
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Chief Financial Officer |
2
Exhibit 99.1
INmune Bio Receives EMA’s Authorization
in France and Spain for Phase II Clinical Trial of XPro™ for Early Alzheimer’s Disease
Boca Raton, Florida, Nov. 27, 2023 (GLOBE
NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to advancing treatments
that leverage the patient’s innate immune system to combat disease, announced today it has received European Medicines Agency’s
(EMA) Authorized Decision from the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) in France and the Agencia
Espanola de Medicamentos y Productos Sanitarios (AEMPS) in Spain to initiate a Phase II trial in Early Alzheimer’s Disease (AD)
with XPro™.
This authorization follows the acceptance
of the Company’s Clinical Trial Application (CTA) under EU Clinical Trials Regulation and prior EMA’s Authorized Decision in
Poland on Nov 15, 2023. The Spanish and French arms are part of the Company’s international clinical development strategy
for XPro™ in patients with early AD. The trial is currently enrolling patients in Australia, Canada, and the United Kingdom.
“The French and Spanish clinical sites
will significantly broaden the trial in Europe. We are grateful for the collaboration from the ANSM and the AEMPS and look forward
to continuing our progress toward completing enrollment of the Phase II trial. We believe clinical sites in these two countries
will be significant contributors to the Phase II program and will be part of the global Phase III clinical trial,” said RJ Tesi
M.D., CEO of INmune Bio.
The Phase II clinical trial is a global, multi-center,
randomized clinical study in patients diagnosed with early Alzheimer’s disease who have biomarkers of elevated inflammation. In a prior
Phase I open-label trial, INmune Bio met all primary and secondary endpoints. Patients with AD who received XPro™ demonstrated notable
decreases in neuroinflammation, enhanced axonal integrity, and improved synaptic function. Employing advanced MRI imaging techniques enabling
a “virtual biopsy” of the brain, treatment with XPro™ demonstrated improvements in the structural integrity of both
gray and white matter in the brain.
About XPro™
XPro™ (XPro1595, pegipanermin) is a
next-generation selective inhibitor of tumor necrosis factor (TNF) that is currently in clinical trials and acts differently than currently
available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™
could potentially have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation, decreasing
neurodegeneration while improving synaptic function and promoting remyelination. For more information about the importance of targeting
neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s
website.
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@inmunebio.com
Investor Contact:
Jason Nelson
Core IR
(516) 842-9614 x-823
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