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): August 13, 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))

 

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. ☐

 

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

 

 

 

 

 

 


Item 8.01. Other Events.


On August 13, 2020, INmune Bio Inc. (the “Company”) issued a press release announcing that the European Patent Office (EPO) has granted EP Pat. No. 2,892,547, titled “A DOMINANT NEGATIVE TNF-ALPHA INHIBITOR FOR USE IN TREATING NEUROLOGICAL DISORDERS OF THE CNS,” which covers XPro1595 and its peripheral administration for treating Alzheimer’s Disease and other diseases of the CNS. The patent, which is set to expire in 2033, is owned by Xencor, Inc. and is licensed exclusively to the Company. 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 August 13, 2020

 

1

 

  

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: August 14, 2020 INMUNE BIO INC.
   
  By: /s/ David Moss
    David Moss
    Chief Financial Officer

 

2

 

  

 

 

Exhibit 99.1

 

 

European Patent Granted Covering INmune Bio’s XPro1595

 

LA JOLLA, Calif., Aug. 13, 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, announced today that the European Patent Office (EPO) has granted EP Pat. No. 2,892,547, titled “A DOMINANT NEGATIVE TNF-ALPHA INHIBITOR FOR USE IN TREATING NEUROLOGICAL DISORDERS OF THE CNS,” which covers XPro1595 and its peripheral administration for treating Alzheimer’s Disease and other diseases of the CNS. The patent, which is set to expire in 2033, is owned by Xencor, Inc. and is licensed exclusively to INmune Bio.

 

“This patent memorializes the discovery that XPro1595 crosses the blood brain barrier in therapeutically-significant quantities, which provides for a less invasive peripheral administration of the drug, as opposed to central administration to the CNS,” said Joshua Schoonover, Assoc. General Counsel of INmune Bio. “As a result of this patented discovery, XPro1595 is distinguished as a next generation anti-TNF therapeutic having properties that are advantageous for treating neuroinflammation.”

 

INmune Bio CEO, RJ Tesi, added: “People from many countries in Europe suffer from a high prevalence of Alzheimer’s disease and other neurologic diseases associated with neuroinflammation. Data from our Phase I trial in AD suggests Xpro1595 may attenuate neuroinflammation in parts of the brain that are clinically relevant. This European patent gives us the freedom to further develop XPro1595 for the treatment of neurologic diseases in this important market.”

 

This patent comes shortly after INmune Bio’s announcement of data showing Xpro1595 decreases neuroinflammation in patients with Alzheimer’s disease.  The data shows XPro1595 reduced neuroinflammation by an average of 40.6% in the arcuate fasciculus, a brain fiber pathway important for language and short-term memory.  A Key Opinion Leader Webinar on XPro1595 Phase 1b interim data of neuroinflammation in patient with Alzheimer’s Disease can be seen by clicking here.

 

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 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 (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.

 

Information about 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™, Quellor™, XPro1595, LIVNate™, and INKmune™ are still in 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. 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
DMoss@INmuneBio.com

 

Investor Contact:
James Carbonara (646) 755-7412
James@haydenir.com