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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 26, 2024
INMUNE BIO INC. |
(Exact name of registrant as specified in charter) |
Nevada |
|
001-38793 |
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47-5205835 |
(State or other jurisdiction |
|
(Commission File Number) |
|
(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 |
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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 September 26, 2024,
INmune Bio Inc. (the “Company”), issued a press release announcing that the Company is continuing to advance its natural killer
cell therapy, INKmune, in a Phase I/II trial for men with metastatic castration-resistant prostate cancer. In that same press release,
the Company also announced initial results from the first patient cohort in the trial.
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.
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: September 26, 2024 |
By: |
/s/ David Moss |
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David Moss |
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Chief Financial Officer |
2
Exhibit 99.1
INKmune™ Demonstrates Excellent Safety and Increased NK-Cell
Activity in First Dosing Cohort
BOCA RATON, Fla., Sept. 26, 2024 (GLOBE NEWSWIRE) -- INmune
Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology and inflammation company, continues to advance its Natural
Killer (NK) cell therapy, INKmune™, in a Phase I/II trial (the “CaRe PC” trial) for men with metastatic Castration-Resistant
Prostate Cancer (mCRPC). The Company is pleased to announce initial results from the first patient cohort in the trial.
Mark Lowdell, CSO and inventor of INKmune™, said, “The
enrollment of the first cohort ran entirely in-line with our predicted timelines and confirmed the excellent safety profile with all patients
receiving treatment as out-patient without the need for pre-medication of any kind. Furthermore, even at this lowest dose of INKmune™,
there is clear evidence of persistent immunologic effects of INKmune™ treatment in these men with mCRPC.
Blinded analysis of the monitoring blood samples from the first three
patients showed changes in the phenotype and function of the patient’s NK cells. Although this is the lowest dose cohort, 2 of 3
patients showed an increase in circulating activated NK cells and all three showed increased NK cell function sustained for more than
40 days after the final INKmune™ infusion. One patient showed a transient 21% decrease in PSA associated with the increase in NK
cell activity and function.
The CaRe PC trial has recently completed dosing the last patients in
the second of its three dose-escalation cohorts. The third cohort is expected to begin in approximately 30 days. The dose of INKmune™
in the second and third cohort is 3 and 5 times the dose of INKmune™ in the first cohort. All eight clinical sites are now open
and additional results from the trial will be released from the higher dose cohorts as they become available.
About INKmune™
INKmune™ is a pharmaceutical-grade, replication-incompetent human
tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s
resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune™ treatment converts the patient’s own NK cells
into mlNK cells. In patients, INKmune™ primed tumor killing NK cells have persisted for more than 100 days. These cells function
in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins. INKmune™ is a patient friendly
drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune™
is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune™ is tumor
agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal
and nasopharyngeal cancer. INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate
cancer in the United States.
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:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
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