INMB INmune Bio Inc

 

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): January 28, 2025

 

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 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		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per shares		INMB		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 mark 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 January 28, 2025, INmune Bio Inc. (the “Company”), issued a press release announcing that the first patient was treated in the Company’s phase I/II trial in men with metastatic castration-resistant prostate cancer at the West Los Angeles Veterans Administration Hospital.

 

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.

 

99.1		Press Release dated January 28, 2025
104		Cover 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: January 28, 2025	By:	/s/ David Moss
	Name:	David Moss
	Title:	Chief Financial Officer

 

 

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Exhibit 99.1

 

INmune Bio Inc. Expands INKmune Trial in Prostate Cancer to Veterans

 

First patient treated in Phase II portion of clinical trial in metastatic prostate cancer at the West Los Angeles Veterans Administration Hospital

 

Boca Raton, Florida, Jan. 28, 2025 (GLOBE NEWSWIRE) --  INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, has an ongoing Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce the participation of a patient at the West Los Angeles VA Medical Center in the trial. The participant received the investigational intervention, as an out-patient per the protocol, under the care of Matthew Rettig, MD., Chief, Hematology-Oncology, VA Greater Los Angeles Healthcare System, Professor of Medicine and Urology, Medical Director Prostate Cancer Program, David Geffen School of Medicine and the Jonsson Comprehensive Cancer Center at the UCLA.

 

The VA Health Care System provides medical care to the Veterans of the US military. Every year, approximately 15,000 Veterans are diagnosed and treated at the VA for prostate cancer and over 200,000 Veterans are prostate cancer survivors. Under Rettig’s leadership, 900 patients with prostate cancer have participated in over two dozen clinical trials at the West LA VA Medical Center. The Care PC trial is the first using a NK targeted biologic therapy. The Veteran received the “medium” dose of INKmune initiating the Phase II portion of the trial.

 

“The INmune Bio study represents a new immune therapy approach to treating advanced prostate cancer. The study involves the use of cellular therapy treatment that activates NK cells, which are immune cells known to target tumor cells and are in relative abundance in prostate cancer,” said Rettig, Principal Investigator, about the the CarePC program. “Unlike most immunotherapies, this study involves treatment that is given as an outpatient and appears to have minimal side effects, which helps the management of prostate cancer among Veterans and the US population at large.”

 

In 2022, Congress signed into law the Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022, also known as the Cleland-Dole Act. In response to the Cleland-Dole Act, which requires VA to make strides in prostate cancer care, the VA has published a prostate cancer clinical pathway, which expressly considers incorporation of clinical trials, and patient educational materials, and is in the process of creating a national prostate cancer registry. “The Veterans Health Administration is an ideal place to perform clinical trials,” said RJ Tesi MD, CEO of INmune Bio, “it is a large integrated health care system that provides high-quality medical care to a diverse population of patients.” 

 

 

About CaRe PC

 

CaRe PC is an open label Phase I/II trial that will test up to three dose levels of INKmune™ in men with mCRPC. INKmune™ is given in the out-patient setting via an intravenous infusion three times in the first two weeks of treatment (days 1, 8 and 15). No pre-medication or additional cytokines are needed for INKmune therapy. The patient is followed for six months with careful study of immunologic and anti-cancer responses to INKmune™ treatment. Immune responses include changes in numbers of tumor killing memory-like NK cells in the patient’s blood and how long these specialized NK cells remain in the circulation. Anti-tumor responses will be monitored by following the level of prostatic surface antigen (PSA) in the blood. Additionally, we will leverage Artificial Intelligence (AI) to quantify the number and size of metastatic lesions using piflufolastat F 18 - a PSMA (prostate-specific membrane antigen) imaging agent developed by Lantheus marketed as Plarify® and by measuring circulating tumor DNA (ctDNA) in the blood. Up to 30 patients will receive one of three levels of dose of INKmune™.

 

The study uses a novel modified Bayesian design that allows for a 3x3 dose escalation design. Once the Phase I portion is complete, the doses that are safe will be tested simultaneously in the Phase II portion of the trial. Up to 10 patients can be enrolled at each dose level. There are two primary goals of the trial. The first is to demonstrate the safety of INKmune™ in the patient population, men with mCRPC. The second is to determine which dose of INKmune™ should be used in a blinded, randomized registration trial. Determining the best dose of INKmune™ to use in future clinical trials will depend on a combination of immunologic and anti-tumor responses seen in the men treated with INKmune™ therapy.

 

About INKmune™

 

INKmune is an NK cell targeted therapy that is not an NK cell. INKmune is a product designed to improve the function of the patient’s own NK cells. INKmune™ is a patented, pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination. INKmune™ is stable at -80^oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. These INKmune-primed NK cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune therapy does not require any type of conditioning, pre-medication, or cytokine support.

 

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 the 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

Chief Financial Officer
(858) 964-3720

 

info@inmunebio.com

 

Daniel Carlson

 

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

 

 

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Cover	Jan. 28, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 28, 2025
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 Blvd.
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 shares
Trading Symbol	INMB
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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