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): October 30, 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 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 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 7.01. Regulation FD Disclosure.

On October 31, 2023, INmune Bio Inc. (the “Company”), issued a press release announcing that the Company received an International Search Report and Written Opinion communicating possession of novelty, inventive step, and industrial applicability in all claims pending in an international patent application covering, among other things, its proprietary cell line, INB16, and the INKmune™ therapeutic composition. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information furnished in this Item 7.01 and exhibit 99.1 in Item 9.01 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On October 30, 2023, the Company issued a press release announcing that in collaboration with the Company, Roxana Schillaci Ph.D. of Instituto de Biología y Medicina Experimental in Buenos Aries, Argentina will be presenting data on the use of INB03, a dominant-negative inhibitor of soluble TNF in the treatment of high-risk MUC4 expressing HER2+ breast cancer at the 38th annual Society of Immunotherapy in San Diego, California which runs from November 1-4, 2023. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01 Financial statements and Exhibits

(d) Exhibits.

99.1		Press Release dated October 31, 2023
99.2		Press Release dated October 30, 2023
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: October 31, 2023	By:	/s/ David Moss
		David Moss
		Chief Financial Officer

Exhibit 99.1

INmune Bio Inc. Patent Claims Covering INB16 Cell Line and INKmune™ Therapeutic Composition given Favorable Patentability Opinion by International Search Authority

INmune Bio receives International Search Report and Written Opinion communicating possession of novelty, inventive step, and industrial applicability in all claims pending in an international patent application covering, among other things, its proprietary cell line, INB16, and the INKmune™ therapeutic composition.

Boca Raton, Florida, Oct. 31, 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, announced an update regarding the company’s patent covering its proprietary cell line, “INB16”, as well as the therapeutic composition comprising replication-incompetent INB16 cells known as “INKmune™” and methods of treating cancer by administering INKmune™, with a goal of achieving in vivo priming of natural killer (NK) cells to enhance the ability of a patient’s own NK-cells to effect cancer surveillance, recognition, and killing.

In the written opinion for the international patent application titled, “HUMAN T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA CELL LINE & APPLICATIONS FOR TREATING CANCER,” an examiner from the International Search Authority at the United States Patent & Trademark Office, authorized by the World Intellectual Property Organization under the Patent Cooperation Treaty, issued a favorable patentability opinion with respect to novelty, inventive step and industrial applicability of all claims and concluding that the application contains patentable subject matter. The application discloses and claims the novel INB16 cell line on deposit with the American Type Culture Collection, as well as compositions comprising replication incompetent INB16 cells (“INKmune™”) and methods of treating cancer in patients by administering INKmune™.

“Patents covering novel cell lines are somewhat rare in practice and form a very small number of total patents issued,” said Joshua Schoonover, Esq., in-house General Counsel for the Company. “The company is exploring several potential commercial applications of the INB16 cell line, including uses in cancer research, as well as therapeutic uses, such as applications for treating various cancer indications, or for enhancing other NK cell products to gain advantages, such as improved avidity or memory-like functions.”

The Company intends to leverage the favorable written opinion under the patent prosecution highway, a program offered by the USPTO, EPO and other participating patent offices to accelerate examination and ultimately patent issuance for inventions receiving favorable opinions received from certain patent authorities, including WIPO.

INB16 is a tumor cell line which is relatively insensitive to killing by natural killer (NK) cells from healthy donors and from patients. However, it carries molecules on its surface which bind to critical activating ligands on resting NK (rNK) cells and, when an rNK cell binds to INB16 the rNK becomes primed by the activating ligands. One of the key molecules on the INB16 surface is called CD15 and this binds to a ligand on rNK cells called CD2. Virtually all rNK in the blood express CD2. The Company has shown that this CD15-CD2 interaction is critical and has further mapped the intracellular signaling cascade that it activates. During the next 16 hours after INB16 binding, the rNK becomes “primed” to form what is called a “tumor-primed NK cell” – TpNK. These TpNK have the characteristics of memory-like NK cells described by other groups and which are produced in the lab by priming with a cocktail of inflammatory cytokines (IL12/15/18). TpNK are a type of mlNK and can kill tumor cells that are resistant to rNK cell-killing. This means that they can kill a wide range of clinically relevant cancers and leukemias. In addition, the Company’s in vitro data shows that TpNK cells are able to overcome the immunosuppression of hypoxia and regulatory cells in an active Tumor Microenvironment of solid tumors. The Company is extending these findings to show that INKmune-primed NK cells also overcome immunosuppressive cytokines in the TME as a result of the NK differentiation into a memory-like cell.

While INB16 can generate TpNK cells in vitro, it cannot be used to treat NK cells in the blood of patients without being treated to prevent it from further proliferation. To overcome this, the Company uses novel methods to make the INB16 unable to replicate and created a “replication-incompetent cell,” which forms a basis of the biologic called “INKmune™.” The Company has safely treated five patients with hematological cancers and shown that INKmune™ treatment converts patient’s normal resting NK cells into potent memory-like NK cells much like those that can be produced in vitro. More patients are awaiting trial enrolment. Administration of INKmune may be the only way to create mlNK in vivo because the cytokine cocktail used by others would be too toxic to use as a direct treatment.

The Company opened an IND for a US trial of INKmune™ in metastatic castration-resistant prostate cancer. The first site will be initiated in the second week of November, meaning that efforts are ahead of schedule for the planned first patient treatment in this quarter. At least one other site is expected to be opened before the end of the year. A clinical batch of INKmune™ has been manufactured for the first US cohort and is ready to be shipped to a distribution center. Patients at each dose level will receive all three doses of INKmune™ as an out-patient treatment during the six-month trial. Two markers of INKmune™ efficacy will be measured – immunologic activation and therapeutic efficacy as a measure tumor response to INKmune™ therapy, using traditional biomarkers of prostate cancer tumor burden (progression-free survival, changes in blood PSA level, and tumor burden measured by bone and CT scan).

Acronyms:

ATCC: American Type Culture Collection
EPO: European Patent Office
mlNK: memory-like NK cells
NK cell: Natural Killer cell
TME: Tumor Microenvirnoment
TpNK: Tumor Primed NK Cell
USPTO: United States Patent & Trademark Office
WIPO: World Intellectual Property Organization

About INKMUNE

INKmune™ is an investigational biologic substrate that can be administered to a patient for in vivo priming of a patient’s own NK cells. Cancerous cells occur regularly during the lifetime of a healthy individual, but the individual’s NK cells generally surveil, recognize, and often kill these cancerous cells before they become a problem. Sometimes, however, cancer cells can downregulate protein signals or otherwise hide from NK cells, effectively evading killing. INKmune™, a therapeutic composition comprising replication incompetent INB16 cells, is modified to prevent proliferation in a patient’s body, but provides certain signals necessary to stimulate or “prime” NK cells so that they can achieve enhanced surveillance, recognition and killing of cancer cells in a patient. INKmune™ is stable at -80oC 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. Tumor-primed NK (TpNK) 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, CFO
(858) 964-3720
info@inmunenbio.com

Investor Contact:
Jason Nelson, Core IR
(516) 842-9614 x-823

Exhibit 99.2

INmune Bio Inc. Presents Preclinical Data at SITC 2023 Showing INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα

SIRP-CD47 is an innate immune checkpoint known as the “don’t eat me” signal. INB03 downregulates expression of SIRPα on macrophages promote increased cancer cell death by antibody dependent cellular phagocytosis (ADCP).

Boca Raton, Florida, Oct. 30, 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, is presenting data on the use of INB03, a dominant-negative inhibitor of soluble TNF in the treatment of high-risk MUC4 expressing HER2+ breast cancer. Roxana Schillaci Ph.D. of Instituto de Biología y Medicina Experimental in Buenos Aries, Argentina, will present her work at the 38^th annual Society of Immunotherapy in San Diego, California which runs from November 1-4.

The poster entitled “INB03: a new immune checkpoint inhibitor that reprograms polarization and promotes ADCP in human macrophages,” shows that INB03 is an innate immune checkpoint inhibitor working through the SIRPα-CD47 pathway to promote ADCP. SIRPα is a surface protein expressed by macrophages that binds to CD47 expressed by tumor cells. SIRPα-CD47 is known as the “don’t eat me” signal that prevents phagocytosis of tumor cells and promotes resistance to immunotherapy. INB03 downregulates SIRPα expression to eliminate the “don’t eat me signal” and promote ADCP. Inhibition of the SIRPα-CD47 pathway has focused predominately on targeting CD47 with anti-CD47 therapeutics. Targeting SIRPα may provide differentiated pharmacokinetic, safety, and efficacy profiles.

“Macrophages play an important role in the control of tumors, but cancer cells have developed very efficient ways to evade attack by the patient’s immune system,” said Roxana Schillaci, Ph.D. of CONECIT and senior author of this work. “TNF promotes expression of SIRPα on macrophages that bind to CD47 on tumor cells to prevent ADCP. Neutralization of sTNF with INB03 downregulates the expression of SIRPα to promote ADCP that should help control tumor growth and prevent resistance to immunotherapy.”

The research presented in the poster examines animal models and human macrophages. INB03 neutralizes sTNF, repolarizing tumor protecting M2 macrophages to M1 anti-tumor macrophages, enhances ADCP with trastuzumab, and reduces SIRPα expression. In mice with trastuzumab resistant breast cancer, INB03 treatment polarizes splenic and tumor-infiltrating macrophages to M1 type macrophages that phagocytize tumor cells and decreased immune checkpoint expression (PD-L1, TIM3, LAG3) in tumor-infiltrating CD8+ T cells.

RJ Tesi MD, CEO of INmune Bio, stated that, “a new therapeutic strategy for treating cancer is to improve the function of tumor-infiltrating macrophages. DN-TNF has been shown to improve macrophage phagocytosis in models of AD, MS, DMD, and cancer.” Microglia are tissue-based macrophages of the brain, while tumor macrophages are the phagocytic cells of the tumor microenvironment (TME). In disease, soluble TNF depresses macrophage phagocytic function, resulting in neurodegeneration, synaptic dysfunction, and demyelination in the brain or tumor growth and resistance to cancer immunotherapy. DN-TNF neutralizes sTNF and returns phagocytic function to normal. In neurodegenerative diseases, DN-TNF promotes microglial phagocytic function to promote remodeling and repair by decreasing neurodegeneration, improving synaptic plasticity, and promoting remyelination. In cancer, DN-TNF repolarizes immunosuppressive macrophages into tumor-killing macrophages and promotes ADCP. In both cases, normalizing phagocytic function should allow for therapeutic benefits.

Acronyms:

DN-TNF: Dominant-Negative Tumor Necrosis Factor
sTNF: Soluble Tumor Necrosis Factor
ADCP: Antibody Dependent Cellular Phagocytosis
SIRPα: Signal-Regulatory Protein Alpha
TME: Tumor Microenviornment
AD: Alzheimer’s Disease
MS: Multiple Scleroisis
DMD: Duchenne Muscular Dystrophy
CNS: Central Nervous System

About INB03

INB03 is a DN-TNF inhibitor that neutralizes soluble TNF (sTNF) without affecting transmembrane TNF (tmTNF) or TNF receptors. Compared to currently available non-selective TNF inhibitors, INB03 preserves the immune response to cancer by decreasing immunosuppressive cells in the TME including TAM and MDSC while promoting recruitment of anti-tumor immune cells including cytolytic CD8+ lymphocytes, NK cells and anti-tumor macrophages. INB03 has completed an open label dose-escalation Phase I trial in patients with advanced cancer. In that trial, INB03 was found to be safe and well tolerated - no dose limiting toxicity was found. INB03 decreased blood biomarkers of inflammation in patients with advanced cancer. INMB is planning a Phase II trial that uses IN03 as part of combination therapy.

About INmune Bio Inc.

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

Cover	Oct. 30, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 30, 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 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	true
Elected Not To Use the Extended Transition Period	false