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): November 1, 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 2.02 Results of Operations and Financial Condition.

On November 1, 2023, INmune Bio Inc. (the “Company”), issued a press release announcing the Company’s financial results for the quarter ended September 30, 2023 and providing a business update. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information in this Current Report, including the exhibits hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document filed by the Company with the Securities and Exchange Commission, whether made before or after the date of this report, regardless of any general incorporation language in such filing (or any reference to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial statements and Exhibits

(d) Exhibits.

99.1		Press Release for Financial Results and Business Update
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: November 1, 2023	By:	/s/ David Moss
		David Moss
		Chief Financial Officer

Exhibit 99.1

INmune Bio Inc. Announces Third Quarter 2023 Results and Provides Business Update

Company to Host Conference Call Today, November 1, at 4:30pm ET

BOCA RATON, Fla., Nov. 01, 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, today announces its financial results for the quarter ended September 30, 2023 and provides a business update.

Q3 2023 Corporate Highlights:

DN-TNF Platform Highlights (XPro™):

●

AD02 blinded randomized program in patients with Early Alzheimer’s Disease (AD) received authorization of its Clinical Trial Application (CTA) by the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase II trial in Early Alzheimer’s disease (AD) with XPro™. The U.K. CTA is part of the Company’s international clinical development strategy for XPro™ in patients with early AD. The trial is also enrolling patients in Australia and Canada. Recruitment of the trial is increasing and the company anticipates results of the Phase II program towards the end of 2024. Discussions with the FDA remain ongoing, and we continue to believe the clinical hold will be lifted before the end-of-year 2023.

●

Announced expansion of novel MRI biomarker data to include grey matter. Grey matter, the portion of the brain containing nerve cell bodies, has historically been the focus of Alzheimer’s disease research and drug development. Previous MRI biomarker analysis from patients receiving XPro™ for treatment of AD has demonstrated early changes in white matter that predict presence of neuroinflammation and response to XPro™ therapy. The new data, reported at the annual Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands in July, demonstrates improvement in grey matter microstructure in patients with AD. The data confirm that neuroinflammation affects microstructure of both white and gray matter of the brain. These changes can be quantified in a “virtual brain biopsy”. Treatment with XPro™ resulted in improvements in both white and grey matter microstructural elements that may predict improvements in cognition. The data further validates the biomarker package associated with the on-going Phase II trial in patients with Early AD.

●

The findings presented at CTAD demonstrated effective use of home EEG in patients receiving XPRO for treatment of Alzheimer’s disease. Changes in P300 and other EEG measures were seen after treatment with XPRO. These data add to the biomarker package that can be used to develop XPRO for Alzheimer’s disease and other types of dementia.

●

Data was presented at the 16^th European Meeting on Glial Cells in Health and Disease in Berlin showing XPro™ promotes remyelination in animal studies of MS. These data focused on how XPRO promotes microglial cells to phagocytize myelin debris. Removal of myelin debris is a key step in promoting oligodendrocyte function. Oligodendrocytes produce myelin. These data are consistent with the remyelination that is seen in humans with AD after treatment with XPro. To our knowledge, XPRO is maybe the only drug therapy to demonstrate remyelination in humans. Therapies that promote remyelination may be needed to effectively treat many neurodegenerative diseases including Alzheimer’s disease.

●

Presented preclinical data at 38^th Society of Immunotherapy for Cancer showing INB03 is an innate immune checkpoint inhibitor. INB03 neutralizes sTNF, repolarizing tumor-protecting M2 macrophages to M1 anti-tumor macrophages, downregulates expression of SIRPα, and enhances antibody dependent cellular phagocytosis. SIRPα, signal-regulatory protein expressed on macrophages, is part of the SIRPa–CD47 “don’t eat me” pathway, a phagocytosis checkpoint in macrophages and other innate immune cells.

INKmune™ Platform:

●

Remain on track to launch Phase I/II open label trial using INKmune™ in metastatic castration-resistant prostate cancer (mCRPC) after clearance of the IND by the Food & Drug Administration (FDA) in May. The trial is expected to enroll the first of 30 patients before end-of-year 2023. Patients will receive three infusions of INKmune™ as out-patient treatment during the six-month trial. Three doses of INKmune™ are being tested in a modified Bayesian Phase I/II trial that uses biomarkers to determine immunologic and tumor response to INKmune.

●

LAUREL, the INKmune™ trial in high risk MDS and AML has shipped INKmune™ to the third clinical site in Athens, Greece. The site is screening patients and expects to treat their first patient imminently, which will close the first dose cohort. Changing management of high risk MDS patients in the UK has resulted in screen failures. The cause of these screen failures has been identified and addressed to help increase recruiting of patient into

●

LAUREL. The Company received regulatory approval on October 20^th for the revised enrollment criteria to increase the pool of potential patients to drive recruitment.

●

Pre-clinical work has confirmed in vitro activity of INKmune™-primed NK cells in nasopharyngeal cancer and renal cell cancers and non-dilutive funding is being sought to progress to trial in Q3-4 2024.

●

Received a 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 (USPTO), authorized by the World Intellectual Property Organization (WIPO) under the Patent Cooperation Treaty (PCT), 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 (ATCC), as well as compositions comprising replication incompetent INB16 cells (“INKmune™”) and methods of treating cancer in patients by administering INKmune™.

Upcoming Events and Milestones:

●

On track to have FDA lift clinical hold on the use of XPRO to treat patients with CNS disease in the US by end-of-year 2023.

●

Top-line results for the Phase II XPro™ trial for treatment of patients with early Alzheimer’s disease with biomarkers of neuroinflammation are expected end-of-year 2024.

●

Initiate a Phase II trial of XPro™ in patients with Treatment-Resistant Depression upon resolution of the ongoing FDA manufacturing review.

●

Webinar on using XPro™ to promote remyelination in neurodegenerative disease.

●

Additional open-label Phase I trial data of INKmune™ in high-risk MDS/AML in 2023.

●

Initiation of open-label Phase I/II trial in prostate cancer in Q4 2023 with patient data expected during 2024.

Financial Results for the Quarter Ended September 30, 2023:

●

Net loss attributable to common stockholders for the quarter ended September 30, 2023, was approximately $8.6 million, compared to approximately $7.7 million during the quarter ended September 30, 2022.

●

Research and development expenses totaled approximately $6.0 million for the quarter ended September 30, 2023, compared to approximately $5.2 million during the quarter ended September 30, 2022.

●

General and administrative expense were approximately $2.6 million for the quarter ended September 30, 2023, compared to approximately $2.4 million during the quarter ended September 30, 2022.

●

Other expense was approximately $0.0 million for the quarter ended September 30, 2023, compared to approximately $0.3 million during the quarter ended September 30, 2022.

●

As of September 30, 2023, the Company had cash and cash equivalents of approximately $41.8 million.

●

As of November 1, 2023, the Company had approximately 18.0 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Third Quarter Conference Call when reaching an operator.

Date: November 1, 2023
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13741726

A live audio webcast of the call can be accessed using this link or clicking here:
https://viavid.webcasts.com/starthere.jsp?ei=1637274&tp_key=e7f5108b08

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through November 8 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13741726.

About XPro™

XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial 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 have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. 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 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 persist for more than 100 days and function in the hypoxic TME because due to upregulated nutrient and mitochondrial survival proteins. INKmune™ is a patient friendly that does not require pre-medication, conditioning or additional cytokine therapy 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 trial in high-MDS/AML in the UK and Europe. The company plans an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US this year.

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™), Mild Alzheimer’s disease, Mild Cognitive Impairment 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.

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™), Mild Alzheimer’s disease, Mild Cognitive Impairment 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

INmune Bio Contact:
David Moss, CFO (858) 964-3720
info@inmunebio.com

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

The following tables summarize our results of operations for the periods indicated:

INMUNE BIO INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)

	September 30, 2023			December 31, 2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	41,813		$	52,153
Research and development tax credit receivable		2,087			8,099
Other tax receivable		176			362
Prepaid expenses and other current assets		1,535			4,027
Prepaid expenses – related party		-			34
TOTAL CURRENT ASSETS		45,611			64,675

Operating lease – right of use asset		444			507
Other assets		129			99
Acquired in-process research and development intangible assets		16,514			16,514

TOTAL ASSETS	$	62,698		$	81,795

LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities	$	3,675		$	5,206
Accounts payable and accrued liabilities – related parties		79			9
Deferred liabilities		496			616
Current portion of long-term debt		10,000			5,000
Operating lease, current liabilities		106			87
TOTAL CURRENT LIABILITIES		14,356			10,918

Long-term debt, net		2,376			9,697
Long-term operating lease liabilities		430			526
Accrued liability – long-term		804			550
TOTAL LIABILITIES		17,966			21,691

COMMITMENTS AND CONTINGENCIES

Redeemable common stock, $0.001 par value; 75,697 and 0 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively		799			-

STOCKHOLDERS’ EQUITY
Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding		-			-
Common stock, $0.001 par value, 200,000,000 shares authorized, 17,945,995 shares issued and outstanding		18			18
Additional paid-in capital		157,264			151,799
Accumulated other comprehensive loss		(735	)		(699	)
Accumulated deficit		(112,614	)		(91,014	)
TOTAL STOCKHOLDERS’ EQUITY		43,933			60,104

TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY	$	62,698		$	81,795

INMUNE BIO INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2023			2022			2023			2022
REVENUE	$	43		$	98		$	127		$	277

OPERATING EXPENSES
General and administrative		2,586			2,382			7,223			6,929
Research and development		5,985			5,159			14,266			13,657
Total operating expenses		8,571			7,541			21,489			20,586

LOSS FROM OPERATIONS		(8,528	)		(7,443	)		(21,362	)		(20,309	)

OTHER EXPENSE, NET		(35	)		(282	)		(238	)		(1,157	)

NET LOSS	$	(8,563	)	$	(7,725	)	$	(21,600	)	$	(21,466	)

Net loss per common share – basic and diluted	$	(0.48	)	$	(0.43	)	$	(1.20	)	$	(1.20	)

Weighted average common shares outstanding – basic and diluted		18,008,295			17,945,995			17,966,990			17,921,036

COMPREHENSIVE LOSS
Net loss	$	(8,563	)	$	(7,725	)	$	(21,600	)	$	(21,466	)
Other comprehensive loss – foreign currency translation		(23	)		(441	)		(36	)		(1,143	)
Total comprehensive loss	$	(8,586	)	$	(8,166	)	$	(21,636	)	$	(22,609	)

INMUNE BIO INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)

	For the Nine Months Ended September 30,
	2023			2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(21,600	)	$	(21,466	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		5,489			5,361
Accretion of debt discount		179			171
Impairment of operating lease – right of use asset		-			89
Changes in operating assets and liabilities:
Research and development tax credit receivable		6,012			496
Other tax receivable		186			477
Prepaid expenses		2,492			(2,321	)
Prepaid expenses – related party		34			(109	)
Other assets		(30	)		-
Accounts payable and accrued liabilities		(1,531	)		(268	)
Accounts payable and accrued liabilities – related parties		70			(72	)
Deferred liabilities		(120	)		304
Accrued liability – long-term		254			264
Operating lease liabilities		(14	)		83
Net cash used in operating activities		(8,579	)		(16,991	)

CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from sale of common stock		775			699
Repayments of debt		(2,500	)		-
Net proceeds from the exercise of warrants		-			30
Net cash (used in) provided by financing activities		(1,725	)		729

Impact on cash from foreign currency translation		(36	)		(1,143	)

NET DECREASE IN CASH AND CASH EQUIVALENTS		(10,340	)		(17,405	)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD		52,153			74,810
CASH AND CASH EQUIVALENTS AT END OF PERIOD	$	41,813		$	57,405

SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:
Cash paid for income taxes	$	-		$	-
Cash paid for interest expense	$	1,394		$	962

Cover	Nov. 01, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 01, 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