Form 8-K Inmune Bio, Inc. For: Oct 05

  

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 5, 2020

 

INMUNE BIO INC.

(Exact name of registrant as specified in charter)

 

Nevada		001-38793		47-5205835
(State or other jurisdiction		(Commission		(IRS Employer
of incorporation)		File Number)		Identification No.)

 

1200 Prospect Street, Suite 525, La Jolla, CA 92037

(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 share		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 8.01. Other Events.

 

On October 5, 2020, INmune Bio Inc. (the “Company”) issued a press release announcing that t CJ Barnum PhD, Head of Neurosciences will present data from the ongoing biomarker directed Phase Ib study of neuroinflammation in patients with Alzheimer’s disease.  A copy of the press release is attached as exhibit 99.1.

 

Item 9.01 Financial statements and Exhibits

 

(d) Exhibits.

 

Exhibit Number		Description
99.1		Press Release dated October 5, 2020

 

 

SIGNATURE

 

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.

 

Date: October 6,  2020	INMUNE BIO INC.
	By:	/s/ David Moss
		David Moss
		Chief Financial Officer

 

 

2

 

 

 

 

 

 

Exhibit 99.1

  

INmune Bio, Inc. Presents Preliminary Phase I Data at 21st International Conference on Alzheimer’s Drug Discovery

 

LA JOLLA, Calif., Oct. 05, 2020 (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 announced  that CJ Barnum PhD, Head of Neurosciences will present data from the ongoing biomarker directed Phase Ib study of neuroinflammation in patients with Alzheimer’s disease.  The talk entitled, Phase 1b Study in AD Patients with Neuroinflammation?, will be given today at 11:20AM ET as part of this year’s virtual 21^st International Conference on Alzheimer’s Drug Discovery meeting.  The trial continues to enroll patients and additional data on the Phase Ib study will be presented in the near future.

 

“Neuroinflammation plays an important role in the pathophysiology of Alzheimer’s disease,” said CJ Barnum PhD, Head of Neurosciences at INmune Bio.  “The preliminary data, albeit in a small number of patients, demonstrate that XPro1595, when given via subcutaneous injection, decreases neuroinflammation in the arcuate fasciculus, a white matter tract critical for the proper use of language.”  White Matter Free Water (WMFW) is a novel biomarker of inflammation measured using non-invasive neuroimaging by functional MRI.  Increases in WMFW biomarkers occur in Alzheimer’s patients as the disease progresses.  Preliminary data in the first 6 patients showed that treatment with XPro1595 decreased WMFW on average by 40% in the arcuate fasciculus (range 20-50%). 

 

XPro1595 is a selective inhibitor of soluble Tumor Necrosis Factor (sTNF), a key inflammatory cytokine implicated in causing neuroinflammation in patients with neurologic disease including treatment resistant depression, Alzheimer’s disease and potentially other neurodegenerative diseases.  This Phase Ib multi-center, open label study will enroll patients with biomarkers of inflammation that have Alzheimer’s disease.  Patients are treated for 12 weeks.  Multiple measures of neuroinflammation are studied including biomarkers of inflammation in blood, CSF, and breath as well as neuroimaging biomarkers studied by MRI and behavioral end-points commonly seen in AD patients such as depression, aggression, apathy, anhedonia and sleep disorders. Measures of cognitive decline are measured as part of the trial, but due to the small size, short duration and variable disease status at time of enrollment, changes in cognitive function are not primary endpoints.

 

“The use of novel biomarkers is a hallmark of INmune Bio’s clinical development programs,” said RJ Tesi MD, CEO of INmune Bio. “The use of biomarkers may allow smarter, smaller and faster clinical trials in patients with neurodegenerative diseases.”

 

About XPro1595

 

XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro1595 could have substantial beneficial effects in patients with Alzheimer’s 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 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. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s and treatment resistant depression (XPro595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the 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 malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.

 

 

Forward Looking Statements

 

The Company’s 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 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, LIVNate, Quellor™ and INKmune are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. Our two platforms are beginning clinical trials and there cannot be any assurance of the success of these trials. 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
[email protected]

 

Investor Contact:
Chuck Padala
LifeSci Advisors
(646) 627-8390
[email protected]  

 

Media Contact:
Meredith Sosulski, Ph.D.
LifeSci Communications
(929) 469-3851
[email protected]  

 

 

 

 

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